Agricultural Marketing Service
Animal and Plant Health Inspection Service
Forest Service
Rural Utilities Service
Engineers Corps
Committee for Purchase From People Who Are Blind or Severely Disabled
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Army Department
Engineers Corps
Energy Efficiency and Renewable Energy Office
Management and Budget Office
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Health Resources and Services Administration
National Institutes of Health
Federal Emergency Management Agency
Indian Affairs Bureau
Land Management Bureau
Reclamation Bureau
Employment Standards Administration
Copyright Office, Library of Congress
Management and Budget Office
Committee for the Implementation of Textile Agreements
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Surface Transportation Board
Comptroller of the Currency
Internal Revenue Service
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.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Office of Government Ethics (OGE).
Final rule; technical amendments.
The Office of Government Ethics is updating its executive branch regulation on financial disclosure to reflect the retroactive statutory increase of the reporting thresholds for gifts and travel reimbursements. In addition, OGE is similarly raising the widely attended gatherings nonsponsor gifts exception dollar ceiling under the executive branchwide standards of ethical conduct regulation.
The amendments to 5 CFR 2634.304 are retroactively effective to January 1, 2005, and the amendments to 5 CFR 2635.204 are effective March 11, 2005.
William E. Gressman, Senior Associate General Counsel, Office of Government Ethics; Telephone: 202-482-9300; TDD: 202-482-9293; FAX: 202-482-9237.
The Office of Government Ethics is amending pertinent sections of its executive branchwide ethics regulations on financial disclosure and standards of ethical conduct (the Standards), as codified at 5 CFR parts 2634 and 2635, in order to update them.
First, OGE is retroactively increasing, to January 1, 2005, the reporting thresholds for gifts, reimbursements and travel expenses in the OGE executive branchwide regulation at 5 CFR 2634.304 (and as illustrated in the four examples following paragraph (d) of that section) for both the public and confidential financial disclosure systems under section 102(a)(2)(A) & (B) of the Ethics in Government Act as amended, 5 U.S.C. app. 102(a)(2)(A) & (B), as extended to the executive branch confidential reporting system by 5 CFR 2634.907(a)(3). The new reporting thresholds for gifts and travel reimbursements being retroactively incorporated in OGE's financial disclosure regulation are “more than $305” for the aggregation threshold for reporting and “$122 or less” for the
These increases are brought about by a recent General Services Administration (GSA) rulemaking raising “minimal value” under the Foreign Gifts and Decorations Act, 5 U.S.C. 7342, to “$305 or less” (from the prior level of $285 or less) for the three-year period 2005-2007, as the Ethics Act and OGE regulatory gifts/travel reimbursements reporting thresholds are tied to any such increase in foreign gifts minimal value over $250. See GSA's rulemaking as published at 70 FR 2317-2318 (part V) (January 12, 2005), revising retroactively to January 1, 2005 the foreign gifts minimal value definition as codified at 41 CFR 102-42.10.
The Office of Government Ethics will continue to adjust the gifts and travel reimbursements reporting thresholds in the future as needed in light of GSA's redefinition of “minimal value” every three years for foreign gifts purposes. See OGE's previous retroactive adjustments of those reporting thresholds, as published at 65 FR 69655-69657 (November 20, 2000) and 67 FR 61761-61762 (October 2, 2002), that were based on GSA's prior redefinitions for the periods 1999-2001 and 2002-2004, respectively.
In addition, OGE is increasing from $285 to $305 the exception ceiling for nonsponsor gifts of free attendance at widely attended gatherings under the standards of ethical conduct regulation, as codified at 5 CFR 2635.204(g)(2) (and as illustrated in the examples following paragraph (g)). This separate regulatory change is effective upon publication in the
Pursuant to 5 U.S.C. 553(b) and (d), as Acting Director of the Office of Government Ethics, I find good cause exists for waiving the general notice of proposed rulemaking, opportunity for public comment and 30-day delay in effectiveness as to these technical updating amendments. The notice, comment and delayed effective date provisions are being waived in part because these technical amendments concern matters of agency organization, practice and procedure. Further, it is in the public interest that correct and up-to-date information be contained in the affected sections of OGE's regulations as soon as possible. The increase in the reporting thresholds for gifts and reimbursements is based on a statutory formula and also lessens the reporting burden somewhat, and thus the effective date of that regulatory revision is being made retroactively effective to January 1, 2005, when the change became effective under the Ethics Act.
As Acting Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this rulemaking will not have a significant economic impact on a substantial number of small entities because it primarily affects Federal employees.
The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this amendatory rulemaking does not contain information collection requirements that require the approval of the Office of Management and Budget.
For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), the final rule will not significantly or uniquely affect small governments and will not result in increased expenditures by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.
The Office of Government Ethics has determined that this amendatory rulemaking is a nonmajor rule under the Congressional Review Act (5 U.S.C. chapter 8) and will submit a report thereon to the U.S. Senate, House of Representatives and General Accounting Office in accordance with that law at the same time this rulemaking document is sent to the Office of the Federal Register for publication in the
In promulgating these technical amendments, OGE has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. These amendments have not been reviewed by the Office of Management and Budget under that Executive order, since they are not deemed “significant” thereunder.
As Acting Director of the Office of Government Ethics, I have reviewed this final amendatory regulation in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.
Certificates of divestiture, Conflict of interests, Financial disclosure, Government employees, Penalties, Privacy, Reporting and recordkeeping requirements, Trusts and trustees.
Conflict of interests, Executive branch standards of ethical conduct, Government employees.
5 U.S.C. App. (Ethics in Government Act of 1978); 26 U.S.C. 1043; Pub. L. 101-410, 104 Stat. 890, 28 U.S.C. 2461 note (Federal Civil Penalties Inflation Adjustment Act of 1990), as amended by Sec. 31001, Pub. L. 104-134, 110 Stat. 1321 (Debt Collection Improvement Act of 1996); E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.
5 U.S.C. 7301, 7351, 7353; 5 U.S.C. App. (Ethics in Government Act of 1978); E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.
Animal and Plant Health Inspection Service, USDA.
Final rule; partial delay of applicability.
The amendments in this final rule delay until further notice the applicability of certain provisions of the rule entitled “Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities,” published in the
Effective March 7, 2005.
Dr. Karen James-Preston, Director, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
On January 4, 2005, we published a final rule in the
Pursuant to an announcement by the Secretary of Agriculture on February 9, 2005, this document delays the applicability of the provisions in that rule as they apply to the importation from Canada of the following commodities when derived from bovines 30 months of age or older when slaughtered: (1) Meat, meat food products, and meat byproducts other than liver;
If the courts allow the January 4, 2005, rule to go into effect while this delay of applicability is in effect, the commodities listed above that are derived from bovines less than 30 months of age when slaughtered must be accompanied to the United States by certification that (1) the age requirement has been met and (2) the commodity was processed in an establishment inspected by the Canadian Food Inspection Agency (CFIA) that operates in compliance with an approved CFIA program to prevent commingling of ruminant products eligible for export to the United States with ruminant products ineligible for export to the United States. Such certification must be made by a full-time salaried veterinary officer of Canada, or by a veterinarian designated and accredited by the Canadian Government, provided the certification is endorsed by a full-time salaried veterinary officer of Canada who represents that the veterinarian issuing the certification was authorized to do so.
To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, the Department's implementation of this action without opportunity for public comment is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and 553(d)(3). Seeking public comment is impracticable, unnecessary, and contrary to the public interest. The delay of applicability is necessary to give Department officials the opportunity for further review and consideration of the specified provisions. Given the scheduled effective date of those provisions, seeking prior public comment on this delay would have been impractical, as well as contrary to the public interest, in the orderly promulgation and implementation of regulations.
Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping requirements, Straw, Transportation.
7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
(a) * * *
The applicability of paragraph (a) to meat, meat byproducts other than liver, and meat food products when such commodities are derived from bovines that were 30 months of age or older when slaughtered is delayed indefinitely.
(b) * * *
The applicability of paragraph (b) to whole or half carcasses derived from bovines that were 30 months of age or older when slaughtered is delayed indefinitely.
(f) * * *
The applicability of paragraph (f) to gelatin derived from the bones of bovines that were 30 months of age or older when slaughtered is delayed indefinitely.
7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
(f) * * *
The applicability of paragraph (f) to tallow derived from bovines that were 30 months of age or older when slaughtered is delayed indefinitely.
(g) * * *
The applicability of paragraph (g) to offal derived from bovines that were 30 months of age or older when slaughtered is delayed indefinitely.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain Boeing Model 747-100B SUD, -300, -400, and -400D series airplanes. This AD requires a one-time inspection for discrepancies of the fuselage frame to tension tie joints at body stations (BS) 1120 through 1220 and to determine if steel splice plates are installed on the fuselage frames, and related investigative and corrective actions. This AD is prompted by reports indicating that severed tension ties were found at the fuselage frame joints at BS 1120 and 1140. We are issuing this AD to prevent fatigue cracking of the fuselage frame to tension tie joints, which could result in severing of the tension ties and consequent rapid decompression of the airplane fuselage.
This AD becomes effective April 15, 2005.
The incorporation by reference of a certain publication listed in the AD is approved by the Director of the Federal Register as of April 15, 2005.
For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.
Docket: The AD docket contains the proposed AD, comments, and any final disposition. You can examine the AD docket on the Internet at
Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 917-6437; fax (425) 917-6590.
The FAA proposed to amend 14 CFR part 39 with an AD for certain Boeing Model 747-100B SUD, -300, -400, and -400D series airplanes. That action, published in the
We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD. The commenter supports the proposed AD.
Boeing has received a Delegation Option Authorization (DOA). We have revised this final rule to delegate the authority to approve an alternative method of compliance for any repair required by this AD to the Authorized Representative for the Boeing DOA Organization rather than the Designated Engineering Representative (DER).
We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD as proposed, with the change described previously.
There are about 537 airplanes of the affected design in the worldwide fleet. This AD will affect about 67 airplanes of U.S. registry. The inspection will take about 2 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $8,710, or $130 per airplane.
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) None.
(c) This AD applies to Model 747-100B SUD, -300, -400, and -400D series airplanes; certificated in any category; as identified in Boeing Special Attention Service Bulletin 747-53-2483, Revision 1, dated August 28, 2003.
(d) This AD was prompted by reports indicating that severed tension ties were found at the fuselage frame joints at body stations (BS) 1120 and 1140. We are issuing this AD to prevent fatigue cracking of the fuselage frame to tension tie joints, which could result in severing of the tension ties
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Before the accumulation of 4,000 total flight cycles, or within 1,000 flight cycles after the effective date of this AD, whichever is later: Perform a detailed inspection for discrepancies of the fuselage frame to tension tie joints at BS 1120 through BS 1220, and to determine if steel splice plates are installed on the fuselage frames. Do the inspection in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-53-2483, Revision 1, dated August 28, 2003. Do any applicable investigative and corrective actions before further flight in accordance with the service bulletin, except as provided by paragraph (h) of this AD.
For the purposes of this AD, a detailed inspection is: “An intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.”
(g) For the purposes of calculating the compliance threshold for the actions required by paragraph (f) of this AD, all pressurized flight cycles, including the number of flight cycles in which cabin differential pressure is at 2.0 pounds per square inch (psi) or less, must be counted when determining the number of flight cycles that have occurred on the airplane. Where the service bulletin and this AD differ, the AD prevails.
(h) For any repairs outside the limits of Boeing Special Attention Service Bulletin 747-53-2483, Revision 1, dated August 28, 2003, or if any aluminum splice plate is installed on the fuselage frames: Before further flight, repair or replace, as applicable, in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or in accordance with data meeting the certification basis of the airplane approved by an Authorized Representative for the Boeing Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair or replacement method to be approved, as required by this paragraph, the approval must specifically refer to this AD.
(i) Inspections and corrective actions accomplished before the effective date of this AD in accordance with Boeing Special Attention Service Bulletin 747-53-2483, dated October 24, 2002, are considered acceptable for compliance with the corresponding actions specified in this AD.
(j) Although the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-53-2483, Revision 1, dated August 28, 2003; describe procedures for submitting certain information to the manufacturer, this AD does not require that action.
(k)(1) The Manager, Seattle ACO, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(l) You must use Boeing Special Attention Service Bulletin 747-53-2483, Revision 1, dated August 28, 2003, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain Boeing transport category airplanes. This AD requires repetitive detailed inspections to detect cracking of the aft and forward surfaces of the bulkhead web at nacelle station 180, and repair if necessary. This AD is prompted by reports of cracking of the web bulkhead at nacelle station 180. We are issuing this AD to detect and correct fatigue cracking of the web bulkhead, and consequent loss of the load path of the bulkhead at nacelle station 180, which when combined with the loss of the midspar load path, could result in the in-flight separation of the engine and strut. Such separation may result in secondary damage to the airplane and consequent reduced controllability of the airplane.
This AD becomes effective April 15, 2005.
The incorporation by reference of certain publications listed in the AD is approved by the Director of the Federal Register as of April 15, 2005.
For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.
Tamara Anderson, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 917-6421; fax (425) 917-6590.
The FAA proposed to amend 14 CFR Part 39 with an AD for certain Boeing Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, and -300 series airplanes; and Model 747SP and 747SR series airplanes; equipped with Pratt and Whitney Model JT9D-3 or -7 (except -70) series engines. That action, published in the
We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public.
Boeing has received a Delegation Option Authorization (DOA). We have revised this final rule to delegate the authority to approve an alternative method of compliance for any repair required by this AD to the Authorized Representative for the Boeing DOA Organization rather than the Designated Engineering Representative.
We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.
This AD will affect about 223 airplanes worldwide and 73 airplanes of U.S. registry. The required actions will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $4,745, or $65 per airplane, per inspection cycle.
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) None.
(c) This AD applies to Boeing Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, and -300 series airplanes; and Model 747SP and 747SR series airplanes; equipped with Pratt and Whitney Model JT9D-3, or -7 (except for -70) series engines; as identified in Boeing Alert Service Bulletin 747-54A2220, dated July 31, 2003; certificated in any category.
(d) This AD was prompted by reports of cracking of the web bulkhead at nacelle station 180. We are issuing this AD to detect and correct fatigue cracking of the web bulkhead, and consequent loss of the load path of the bulkhead at nacelle station 180, which when combined with the loss of the midspar load path, could result in the in-flight separation of the engine and strut. Such separation may result in secondary damage to the airplane and consequent reduced controllability of the airplane.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Within 9 months after the effective date of this AD, do a detailed inspection to detect cracking of the aft and forward surfaces of the bulkhead web at nacelle station 180, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-54A2220, dated July 31, 2003.
(1) If no cracking is detected, repeat the detailed inspection at the applicable intervals specified in the “Repeat Inspection Interval” column of Tables 1 and 2 in Figure 1 of the service bulletin.
(2) If any cracking is detected, before further flight, repair the cracking in accordance with the service bulletin, except as provided by paragraph (f)(3) of this AD. Thereafter, repeat the detailed inspection at the applicable intervals specified in the “Repeat Inspection Interval” column of Tables 1 and 2 in Figure 1 of the service bulletin.
(3) If any cracking exceeds the repair limits specified in the applicable structural repair manual (referenced in the service bulletin), before further flight, repair the cracking in accordance with a method approved by the Manager, Seattle Aircraft Certification Office
(g)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an AR for the Boeing DOA Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(h) You must use Boeing Alert Service Bulletin 747-54A2220, dated July 31, 2003, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600); and Model A310 series airplanes; equipped with certain Honeywell inertial reference units (IRUs). This AD requires revising the Limitations section of the airplane flight manual to prohibit the use of CAT 2 and CAT 3 automatic landing and rollout procedures at certain airports. This AD is prompted by a report that some magnetic deviation tables in the IRU database are obsolete and contain significant differences with the real magnetic deviations. We are issuing this AD to prevent an airplane from deviating from the runway centerline, and possibly departing the runway.
This AD becomes effective April 15, 2005.
The incorporation by reference of certain publications listed in the AD is approved by the Director of the Federal Register as of April 15, 2005.
For service information identified in this AD, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
Tim Backman, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2797; fax (425) 227-1149.
The FAA proposed to amend 14 CFR part 39 with an AD for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600); and Model A310 series airplanes; equipped with certain Honeywell inertial reference units (IRUs). That action, published in the
We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD. The commenter supports the proposed AD.
We have revised Table 2 of this AD to more clearly identify the applicable airplane flight manuals (AFM) to be revised.
In Table 2 of the proposed AD we referenced an incorrect date for the temporary revisions. We have revised Table 2 of this final rule to correct that information.
We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD as proposed, with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.
This AD will affect about 136 airplanes of U.S. registry. The AFM revision will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures,
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) None.
(c) This AD applies to Airbus airplanes, certificated in any category; as identified in Table 1 of this AD:
(d) This AD was prompted by a report that some magnetic deviation tables in the IRU database are obsolete and contain significant differences with the real magnetic deviations. We are issuing this AD to prevent an airplane from deviating from the runway centerline, and possibly departing the runway.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Within 10 days after the effective date of this AD, revise the Limitations section of the Airbus A300-600 AFM; or the Airbus A310 AFM; as applicable; by inserting a copy of the applicable Airbus temporary revision (TR) listed in Table 2 of this AD into the applicable AFM.
When Airbus includes these TRs in the general revisions of the AFM, the general revisions may be inserted in the AFM, provided the relevant information in the general revisions is identical to that in Airbus TRs 6.01.03/08 and 6.01.03/36.
(g) After replacing the Honeywell IRUs with new or modified Honeywell IRUs in accordance with the requirements of AD 2003-20-01, amendment 39-13319 (68 FR 55814), the AFM revision required by paragraph (f) of this AD may be removed.
(h) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(i) French airworthiness directive F-2004-093(B), issued June 23, 2004, also addresses the subject of this AD.
(j) You must use the applicable temporary revision to the applicable Airbus airplane flight manual specified in Table 3 of this AD to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of those documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
You may view the AD docket at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., room PL-401, Nassif Building, Washington, DC.
Federal Aviation Administration, DOT.
Final rule; correction.
This document corrects a typographical error that appeared in airworthiness directive (AD) 2005-03-12 that was published in the
Effective March 21, 2005.
Tim Backman, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2797; fax (425) 227-1149.
Airworthiness Directive (AD) 2005-03-12, amendment 39-13968, applicable to certain Airbus Model A330, A340-200, and A340-300 series airplanes, was published in the
As published, that final rule incorrectly specified the AD number in a single location in the AD as “2005-NM-03-12” instead of “2005-03-12.”
Since no other part of the regulatory information has been changed, the final rule is not being republished in the
The effective date of this AD remains March 21, 2005.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; correction.
The FAA is correcting a typographical error in an existing airworthiness directive (AD) that was published in the
Effective March 18, 2005.
The AD docket contains the proposed AD, comments, and any final disposition. You can examine the AD docket on the Internet at
Suzanne Masterson, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
On January 31, 2005, the FAA issued AD 2005-03-11, amendment 39-13967 (70 FR 7174, February 11, 2005), for certain Boeing Model 767 series airplanes. The AD requires repetitive detailed and eddy current inspections of the aft pressure bulkhead for damage and cracking, and repair if necessary. The AD also requires one-time detailed and high frequency eddy current inspections of any “oil-can” located on the aft pressure bulkhead, and related corrective actions if necessary.
As published, that final rule incorrectly specified the AD number in a single location in the AD as “2005-NM-03-11” instead of “2005-03-11.”
No other part of the regulatory information has been changed; therefore, the final rule is not republished in the
The effective date of this AD remains March 18, 2005.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is superseding an existing airworthiness directive (AD), which applies to certain Boeing Model 727 airplanes. That AD currently requires repetitive detailed inspections to detect cracking, corrosion, and existing stop-drilled repairs of cracking in the upper chord of the rear spar of the wing; and repair if necessary. This new AD requires new repetitive inspections to detect cracks, corrosion, minor surface defects, and existing stop-drilled repairs of cracks in the upper and lower chords of the front and rear spars of the wing; and repair if necessary. This AD is prompted by our determination that further rulemaking action is necessary to require additional actions specified in the referenced service bulletin. We are issuing this AD to prevent structural failure of the wing and fuel leaks in the airplane due to stress corrosion cracking of the wing spar chords.
This AD becomes effective April 15, 2005.
On December 18, 2002 (67 FR 71808, December 3, 2002), the Director of the Federal Register approved the incorporation by reference of Boeing Alert Service Bulletin 727-57A0145, Revision 2, dated October 24, 2002.
For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.
Daniel F. Kutz, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 917-6456; fax (425) 917-6590.
The FAA proposed to amend part 39 of the Federal Aviation Regulations (14 CFR Part 39) with an AD to supersede AD 2002-24-05, amendment 39-12970 (67 FR 71808, December 3, 2002). The existing AD applies to certain Boeing Model 727 airplanes. The proposed AD was published in the
We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD. The commenter supports the proposed AD.
We have revised the subject heading of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models.
Boeing has received a Delegation Option Authorization (DOA). We have revised this final rule to delegate the authority to approve an alternative method of compliance for any repair required by this AD to the Authorized Representative for the Boeing DOA Organization rather than the Designated Engineering Representative (DER).
We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.
There are about 1,426 airplanes of the affected design in the worldwide fleet. This AD will affect about 946 airplanes of U.S. registry.
For Group 1 airplanes identified in the service bulletin, the actions (Part 1 of the Accomplishment Instructions of the service bulletin) that are required by AD 2002-24-05 and retained in this AD take about 8 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the currently required actions is $520 per airplane.
The following table provides the estimated costs for U.S. operators to comply with the new actions required by this AD. The average labor rate is $65 per work hour.
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) This AD supersedes AD 2002-24-05, amendment 39-12970.
(c) This AD applies to Boeing Model 727, 727C, 727-100, -100C, -200, and -200F series airplanes, line numbers 1 through 1832 inclusive; certificated in any category.
(d) This AD was prompted by our determination that further rulemaking action is necessary to require additional actions specified in the referenced service bulletin. We are issuing this AD to prevent structural failure of the wing and fuel leaks in the airplane due to stress corrosion cracking of the wing spar chords.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) The term “the service bulletin,” as used in this AD, means Boeing Alert Service Bulletin 727-57A0145, Revision 2, dated October 24, 2002.
(g) For airplanes specified as “Group 1” airplanes in the service bulletin: Within 20 years after the date of manufacture or within 90 days after December 18, 2002 (the effective date of AD 2002-24-05, amendment 39-12970), whichever occurs later, perform an external detailed inspection for cracking, corrosion, and existing stop-drilled repairs of cracking in the upper chord on the rear spar from Wing Butt Line (WBL) 70.5 through WBL 249.3, per the service bulletin, paragraph 3.B, “Work Instructions,” Part 1. Thereafter, repeat the inspection at intervals not to exceed 2 years.
For the purposes of this AD, a detailed inspection is “an intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirrors, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.”
(h) Accomplish the applicable inspection(s) specified in paragraphs (h)(1) through (h)(7) of this AD at the later of the applicable times specified in the “Threshold” and “Grace Period” columns in Table 1 of this AD, and repeat the inspection(s) at the time specified in the “Repetitive Interval” column of Table 1 of this AD. Accomplishment of the inspection required by paragraph (h)(1) of this AD terminates the repetitive inspection requirements of paragraph (g) of this AD.
(i) If any crack, corrosion, or minor surface defect is detected during any inspection required by this AD, before further flight, do the applicable corrective actions in accordance with Part 7 of the Accomplishment Instructions of the service bulletin, except as provided by paragraph (j) of this AD.
(j) If any crack or corrosion is detected during any inspection required by this AD that exceeds the limits specified in the service bulletin, and the bulletin specifies to contact Boeing for appropriate action: Before further flight, repair in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA; or in accordance with data meeting the certification basis of the airplane approved by an Authorized Representative for the Boeing Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make such findings. For a repair method to be approved, the approval must specifically reference this AD.
(k) If any existing stop-drilled repair of previous cracking is detected during any inspection required by this AD, before further flight, permanently repair crack in accordance with paragraph 3.B., Work Instructions, Part 7, paragraph 2., “Crack Repair” of the Accomplishment Instructions of the service bulletin.
(l) Before further flight following any inspection or repair required by this AD, apply a wet layer of BMS 3-23 organic corrosion inhibiting compound or Boeing equivalent, in accordance with the Accomplishment Instructions of the service bulletin.
(m)(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(2) Alternative methods of compliance, approved previously in accordance with AD 2002-24-05, amendment 39-12970, are
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make such findings. For a repair method to be approved, the approval must specifically reference this AD.
(n) You must use Boeing Alert Service Bulletin 727-57A0145, Revision 2, dated October 24, 2002, to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register previously approved the incorporation by reference of this document as of December 18, 2002 (67 FR 71808, December 3, 2002). For copies of the service information, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all BAE Systems (Operations) Limited (Jetstream) Model 4101 airplanes. This AD requires repetitive detailed inspections of the aft fuselage frames for any discrepancies, and any applicable corrective actions. This AD is prompted by reports of corrosion found on the aft fuselage frames due to the ingress of water or liquid. We are issuing this AD to detect and correct corrosion of the aft fuselage frames, which could result in reduced structural integrity of the fuselage.
This AD becomes effective April 15, 2005.
The incorporation by reference of certain publications listed in the AD is approved by the Director of the Federal Register as of April 15, 2005.
For service information identified in this AD, contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171.
Todd Thompson, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-1175; fax (425) 227-1149.
The FAA proposed to amend 14 CFR Part 39 with an AD for all BAE Systems (Operations) Limited (Jetstream) Model 4101 airplanes. That action, published in the
We provided the public the opportunity to participate in the development of this AD. We have considered the single comment that was submitted on the proposed AD.
The commenter requests that we revise the Discussion section of the proposed AD. The commenter suggests that the sentence that describes the area where corrosion may occur should read, “This corrosion occurs on frame areas below floor panel level, between frames 434 and 555, particularly in the vicinity of the toilet, galley, and baggage door due to the ingress of water or liquid.” The commenter's suggestion points out that, though corrosion particularly occurs in the vicinity of the toilet, galley, and baggage door, it may also occur over a wider area.
We acknowledge that the commenter's suggestion is accurate. However, the Discussion section is not restated in the final rule. Thus, we have made no change to the final rule.
We have revised the applicability statement in paragraph (c) of this AD to identify model designations as published in the most recent type certificate data sheet for the affected models.
We have carefully reviewed the available data, including the comment that was submitted, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.
This AD will affect about 57 airplanes of U.S. registry. The required inspections will take about 30 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this AD for U.S. operators is $111,150, or $1,950 per airplane, per inspection cycle.
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) None.
(c) This AD applies to all BAE Systems (Operations) Limited (Formerly British Aerospace Regional Aircraft) Model 4101 airplanes, certificated in any category.
(d) This AD was prompted by reports of corrosion found on the aft fuselage frames due to the ingress of water or liquid. We are issuing this AD to detect and correct corrosion of the aft fuselage frames, which could result in reduced structural integrity of the fuselage.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Within 12 months after the effective date of this AD, do a detailed inspection of the aft fuselage frames for any discrepancies i.e., corrosion, soft spots, and suspected corrosion), and any applicable corrective actions, in accordance with the Accomplishment Instructions of BAE Systems (Operations) Limited Service Bulletin J41-53-051, dated January 25, 2002; or Revision 1, dated May 2, 2003; except as provided by paragraphs (g) and (i) of this AD. Do any applicable corrective action before further flight.
For the purposes of this AD, a detailed inspection is “an intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirrors magnifying lenses, etc. may be necessary. Surface cleaning and elaborate procedures may be required.”
(g) If any corrosion outside the limits defined in the service bulletin is detected: Before further flight, repair the corrosion according to a method approved by either the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the Civil Aviation Authority (or its delegated agent).
(h) Repeat the inspection and do applicable corrective actions required by paragraph (f) of this AD at intervals not to exceed 24 months.
(i) Although the service bulletins referenced in this AD specify to submit inspection reports to the manufacturer, this AD does not include that requirement.
(j) The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(k) British airworthiness directive 003-01-2002 also addresses the subject of this AD.
(l) You must use BAE Systems (Operations) Limited Service Bulletin J41-53-051, dated January 25, 2002; or BAE Systems (Operations) Limited Service Bulletin J41-53-051, Revision 1, dated May 2, 2003; to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approves the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all BAE Systems (Operations) Limited Model BAe 146 series airplanes. This AD requires repetitive detailed inspections for cracking of the elevator “G” weight support structure, and repairs if necessary. This AD also provides for an optional terminating action. This AD is prompted by reported cracking of the elevator “G” weight support structure. We are issuing this AD to prevent failure of the elevator “G” weight support structure with possible consequent jamming of the right-hand elevator servo tab and reduced controllability of the airplane.
This AD becomes effective April 15, 2005.
The incorporation by reference of certain publications listed in the AD is
For service information identified in this AD, contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171.
Todd Thompson, Aerospace Engineer; International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-1175; fax (425) 227-1149.
The FAA proposed to amend 14 CFR Part 39 with an AD for all BAE Systems (Operations) Limited Model BAe 146 series airplanes. That action, published in the
We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public.
We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.
This AD will affect about 19 airplanes of U.S. registry. The required actions will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this AD for U.S. operators is $1,235, or $65 per airplane, per inspection cycle.
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 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 reasons discussed above, I certify that this AD:
(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) 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. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This AD becomes effective April 15, 2005.
(b) None.
(c) This AD applies to all BAE Systems (Operations) Limited Model BAe 146 series airplanes, certificated in any category.
(d) This AD was prompted by reported cracking of the elevator “G” weight support structure. We are issuing this AD to prevent failure of the elevator “G” weight support structure with possible consequent jamming of the right-hand elevator servo tab and reduced controllability of the airplane.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Before the accumulation of 14,000 total landings, or within 4,000 landings after the effective date of this AD, whichever is later: Perform a one-time general visual inspection of the elevator “G” weight support structure to determine whether BAE Systems (Operations) Limited Modification HCM00654A as described in BAE Systems (Operations) Limited Modification Service Bulletin SB.27-037-00654A, Revision 2, dated May 8, 2003, has been incorporated on the airplane. If it can be conclusively determined that HCM00654A has been incorporated, no further action is required by this AD.
For the purposes of this AD, a general visual inspection is “a visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to enhance visual access to all exposed surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.”
(g) For airplanes on which BAE Systems (Operations) Limited Modification HCM00654A has not been done and
(1) If no crack is found and the structure has not been repaired previously, repeat the inspection at intervals not to exceed 4,000 landings.
(2) If no crack is found but the structure has been repaired previously, repeat the inspection at applicable intervals specified in Appendix 1 of the service bulletin.
For the purposes of this AD, a detailed inspection is “an intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.”
(h) If, before or after any inspection required by this AD, the airplane experiences any incident of nose wheel shimmy; overweight, hard, or high drag/side load landing; flight in severe turbulence; or pitch oscillation: Before further flight, repeat the inspection required by paragraph (g) of this AD. If no crack is found, repeat the inspection required by paragraph (g)(1) or (g)(2) of this AD, as applicable.
(i) If any crack is found during any inspection required by paragraph (g) or (h) of this AD, before further flight, replace the elevator “G” weight support structure in accordance with paragraph (j) of this AD, or repair the structure in accordance with a method approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, or the Civil Aviation Authority (CAA) (or its delegated representative).
(j) Replacement of the existing elevator “G” weight support structure with a new, improved elevator “G” weight support structure in accordance with BAE Systems (Operations) Limited Modification Service Bulletin SB.27-037-00654A, Revision 2, dated May 8, 2003, terminates the repetitive inspections required by paragraph (g) of this AD.
(k) Although the service bulletins referenced in this AD specify to submit certain information to the manufacturer, this AD does not include that requirement.
(l) In accordance with 14 CFR 39.19, the Manager, International Branch, ANM-116, is authorized to approve alternative methods of compliance for this AD.
(m) British airworthiness directive 006-04-2003 also addresses the subject of this AD.
(n) You must use BAE Systems (Operations) Limited Inspection Service Bulletin ISB.27-037, Revision 3, dated April 17, 2003; to perform the inspections and corrective actions that are required by this AD, unless the AD specifies otherwise. If the replacement of the elevator “G” weight support structure is accomplished, you must use BAE Systems (Operations) Limited Modification Service Bulletin SB.27-037-00654A, Revision 2, dated May 8, 2003; to accomplish this replacement. The Director of the Federal Register approves the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For copies of the service information, contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171. For information on the availability of this material at the National Archives and Records Administration (NARA), call (202) 741-6030, or go to
Federal Aviation Administration (FAA), DOT.
Direct final rule; delay of effective dates.
This action revises the direct final rule; request for comments that was published in the
The effective date for the direct final rule published at 69 FR 74953, December 15, 2004, is delayed until 0901 UTC, May 12, 2005.
Joseph R. Yadouga, Air Traffic Division, Airspace Branch, Federal Aviation Administration, Southwest Region, Fort Worth, TX 76193-0520; telephone: (817) 222-5597.
Accordingly, pursuant to the authority delegated to me, the effective date for the Mena Intermountain Municipal Airport, Mena, AR (M39) Class E airspace, as published in the
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Beluga, AK to provide adequate controlled airspace to contain aircraft executing Special Instrument Approach Procedures. This Rule results in new Class E airspace upward from
Effective 0901 UTC, May 12, 2005.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Thursday, December 30, 2004, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to create new Class E airspace upward from 700 ft. above the surface at Beluga, AK (69 FR 78371). The action was proposed in order to establish Class E airspace sufficient in size to contain aircraft while executing Special Instrument Approach Procedures at the Beluga Airport. New Class E controlled airspace extending upward from 700 ft. above the surface within a 5-mile radius of the Beluga Airport is established by this action. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No public comments have been received, thus, the rule is adopted as proposed.
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9M,
This revision to 14 CFR part 71 establishes Class E airspace at Beluga Airport, Alaska. This additional Class E airspace was created to accommodate aircraft executing Special Instrument Flight Procedures and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at Beluga Airport, Alaska.
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. It, therefore—(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 a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, part A, subpart 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing Instrument Approach Procedures for the Beluga Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.
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 700 feet above the surface within a 5-mile radius of the Beluga Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Angoon, AK to provide adequate controlled airspace to contain aircraft executing Special Instrument Approach Procedures. This Rule results in new Class E airspace upward from 700 feet (ft.) above the surface at Angoon Seaplane Base, AK.
0901 UTC, May 12, 2005.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Tuesday, December 21, 2004, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to create new Class E airspace upward from 700 ft. above the surface at Angoon, AK (69 FR 76421). The action was proposed in order to establish Class E airspace sufficient in
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9M,
This revision to 14 CFR part 71 establishes Class E airspace at Angoon Seaplane Base, Alaska. This additional Class E airspace was created to accommodate aircraft executing Instrument Flight Procedures and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at Angoon Seaplane Base, Alaska.
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. It, therefore—(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 a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing Instrument Approach Procedures for the Angoon Seaplane Base and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.
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 700 feet above the surface within a 7.5-mile radius of the Angoon Seaplane Base.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action revises Class E airspace at Point Lay, AK to provide adequate controlled airspace to contain aircraft executing three new Standard Instrument Approach Procedures (SIAPs). This Rule results in new Class E airspace upward from 1,200 feet (ft.) above the surface at Point Lay, AK.
Effective 0901 UTC, May 12, 2005.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Friday, January 7, 2005, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to add to the Class E airspace upward from 1,200 ft. above the surface at Point Lay, AK (70 FR 1396). The action was proposed in order to add Class E airspace sufficient in size to contain aircraft while executing three new SIAPs for the Point Lay Airport. The new approaches are (1) Area Navigation—Global Positioning System (RNAV GPS) Runway 5, original; (2) RNAV (GPS) RWY 23, original; and (3) Non-directional Beacon (NDB) RWY 5, original. Additional Class E controlled airspace extending upward from 1,200 feet above the surface within a 46-mile radius of the Point Lay Airport area is established by this action. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9M,
This revision to 14 CFR part 71 revises Class E airspace at Point Lay, Alaska. Additional Class E airspace is being created to accommodate aircraft executing three new SIAPs and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at Point Lay Airport, Point Lay, Alaska.
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. It, therefore—(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 a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing Instrument Approach Procedures for the Point Lay Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.
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 700 feet above the surface within an 8-mile radius of the Point Lay Airport and that airspace extending upward from 1,200 feet above the surface within a 46-mile radius of the Point Lay, Airport, excluding that airspace outside 12 nautical miles from the State of Alaska shoreline.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action revises Class E airspace at Ketchikan, AK to provide adequate controlled airspace to contain aircraft executing Special Instrument Approach Procedures. This Rule results in additional Class E airspace upward from 700 feet (ft.) above the surface at Ketchikan, AK.
Effective 0901 UTC, May 12, 2005.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Thursday, December 30, 2004, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to add to the Class E airspace upward from 700 ft. above the surface at Ketchikan, AK (69 FR 78370). The action was proposed in order to add Class E airspace sufficient in size to contain aircraft while executing Special Instrument Approach Procedures for the Ketchikan Airport. The reference to Clam Cove Non-directional Beacon (NDB) in the Proposed Rule is deleted in the Final Rule, since the airspace description is no longer based on Clam Cove. Additional Class E controlled airspace is established by this action. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No public comments have been received, thus, the rule is adopted as proposed.
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9M,
This revision to 14 CFR part 71 revises Class E airspace at Ketchikan, Alaska. Additional Class E airspace is being created to accommodate aircraft executing Special Instrument Approach Procedures and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at Ketchikan Airport, Ketchikan, Alaska.
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. It, therefore—(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 a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it creates Class E airspace sufficient in size to contain aircraft executing Instrument Approach Procedures for the Ketchikan Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.
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 700 feet above the surface within 2.0 miles each side of the Ketchikan Localizer east course extending from the Ketchikan Localizer to 9.0 miles southeast of the Ketchikan International Airport and within 1.8 miles each side of the 353° radial of the Annette Island VORTAC extending from 11 miles north of the VORTAC to the Ketchikan Localizer east course and within 1.9 miles either side of the Ketchikan Localizer west course extending from the localizer to 6.7 miles west of the airport and that airspace bounded by 55°24′49″ N 131°53′23″ W 55°27′30″ N 132°03′10″ W 55°31′20″ N 132°00′30″ W 55°27′27″ N 131°48′35″ W.
Federal Aviation Administration (FAA), DOT.
Final rule.
This amendment establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective March 11, 2005. The compliance date for each SIAP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of March 11, 2005.
Availability of matters incorporated by reference in the amendment is as follows:
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected airport is located;
3. The Flight Inspection Area Office which originated the SIAP; or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected airport is located.
Donald P. Pate, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone: (405) 954-4164.
This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.
The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.
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. It, therefore—(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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, and Navigation (air).
Accordingly, pursuant to the authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Import Administration, International Trade Administration, Commerce.
Interim final rule.
The Department of Commerce publishes this interim final rule to implement a Steel Import Monitoring and Analysis (SIMA) System, originally outlined in the President's March 5, 2002, Proclamation on Steel Safeguards.
This interim final rule is effective March 11, 2005. Modifications to SIMA, as stated in Annexes II and III will be implemented on June 9, 2005. Comments on the SIMA system must be submitted on or before 5 p.m. e.s.t., May 10, 2005.
Comments on the SIMA system may be submitted through any of the following:
• Mail: Kelly Parkhill, Director for Industry Support and Analysis, Import Administration, Room 3713, Department of Commerce, 14th and Constitution Ave., NW., Washington, DC 20230.
• E-mail:
• Federal e-Rulemaking portal:
For information on the SIMA system, please contact Kelly Parkhill (202) 482-3791; Julie Al-Saadawi (202) 482-1930.
On December 31, 2002, the Department of Commerce published its final rule on the implementation of the current steel import monitoring system (67 FR 79845). This system was initiated in connection with the implementation of safeguard measures with respect to certain steel products pursuant to section 203 of the Trade Act of 1974 (67 FR 10593). The effective date of the system was February 1, 2003. On December 4, 2003, the President issued a proclamation that terminated the steel safeguard measures, but also directed the Secretary of Commerce to continue the monitoring system until the earlier of March 21, 2005, or such time as the Secretary of Commerce establishes a replacement program. On December 9, 2003, the Department of Commerce published a notice stating that the system would continue in effect as described in the Proclamation until March 21, 2005 (68 FR 68594).
The purpose of the SIMA system is to provide steel producers, steel consumers, importers, and the general public with accurate and timely information on anticipated imports of certain steel products. Currently, the SIMA system requires licenses for imports of certain steel products that were formerly covered under the President's safeguard action. Details of the current system can be found in the final rule (19 CFR 360) published on December 31, 2002 (67 FR 79845).
On August 25, 2004, the Department published an advanced notice of proposed rulemaking soliciting comments from the public on whether to continue the current system beyond its expiration date of March 21, 2005 (69 FR 52211) and, if extended, whether the system should be modified in any way. The Department received 73 submissions from a wide range of interested parties, including steel producers, steel consumers, steel suppliers, and importers, as well as from Congressional and foreign interests. Please refer to the SIMA system's Web site to read comments on the ANPRM and for further information about the SIMA system:
The purpose of the SIMA system is to collect timely detailed statistics on anticipated steel imports and to provide stakeholders with information about import trends in this sector. The SIMA system aggregates detailed import statistics it collects from internet-generated licenses and makes the data available for public analysis on a weekly basis. The data gathering procedure through the online licensing system would remain the same. The monitor would continue to display aggregate statistical tables and graphs of U.S. steel imports combining data from the Census Bureau with data collected from the licensing system. Slightly more detailed information would be displayed in tabular form only.
The Department is implementing the SIMA system, beyond its current expiration date, for a period of four years (
Licensing will continue without interruption on those products covered under the current system (
The Department does not intend to release aggregate data at the port level because of concerns about the potential release of proprietary information. In addition, the Department intends to make no changes to the timing requirement for obtaining an import license and would continue with the current policy that requires a license at the time of Customs' entry summary, although applicants could apply for a license up to two months prior to the expected date of importation.
The Department intends to issue a final rule, responding to comments received on this interim final rule, before September 30, 2005.
All comments responding to this notice will be a matter of public record and available for public inspection and copying at Import Administration's Central Records Unit, Room B-099, between the hours of 8:30 a.m. and 5 p.m. on business days.
The SIMA system must be implemented immediately to prevent a lapse in the import monitoring program. A lapse would subject importers to a severe disruption, creating confusion and uncertainty. Importers would be burdened with the uncertainty of not knowing whether they need to obtain an import license for their product. Importers would also have to change their import process until the SIMA system is implemented, at which time they would again have to change their import process to comply with the licensing requirements. Because this period of lapse would be brief, it would be difficult to determine the licensing requirements at any given time. In addition, this lapse would create unusual and confusing import transactions that would be difficult to resolve. For example, an importer could be faced with the situation where his transaction was initiated during the period when no import license was required, but completed during a time after the implementation of the SIMA system. To avoid such confusion and uncertainty, the SIMA system must be implemented immediately.
In addition, this data provides the industry with real-time information on anticipated steel imports, allowing importers to monitor steel import trends. If this rule is not implemented immediately, the data collected under this system would be less useful to the industry because the information collected during and shortly after the period of lapse would not be complete or accurate. In order to ensure the uninterrupted availability of timely and accurate import data, it is necessary to implement the SIMA system immediately. Finally, upon the effective date of this rule, importers would continue to provide information only on those products covered under the current system. Additional information requirements would not be implemented until 90 days after this rule is effective.
For the reasons above, the Department also finds good cause to waive the 30-day delay in effectiveness. 5 U.S.C. 553(d)(3). The SIMA system must be implemented immediately to prevent a lapse in the import monitoring program. As explained above, if the SIMA system is not implemented immediately, importers would be subject to a severe disruption, which would create confusion and uncertainty. In addition, if this rule is not implemented immediately, the data collected under this system would be less useful to the industry. Finally, the system that is implemented on the effective date of this rule is the same as the system that is currently in place.
Comments regarding the information collection must be submitted on or before 5 p.m., E.S.T., May 10, 2005. All comments on the information collection will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Diana Hynek, Departmental Paperwork, Clearance Officer, Department of Commerce (
This rule has been determined to be significant for purposes of Executive Order 12866.
This rule does not contain policies with federalism implications as that term is defined in EO 13132.
Administrative practice and procedure, Business and industry, Imports, Reporting and recordkeeping requirements, Steel.
13 U.S.C. 301(a) and 302.
(a)
(2) A single license may cover multiple products as long as certain information on the license (
(b)
(c)
(d)
(e)
(a)
(2) This user identification number will be required in order to log on to the steel import license issuance system. A single user identification number will be issued to an importer, customs broker or importer's agent. Operating units within the company (
(b)
(a) In general. Steel import licenses will be issued to registered importers, customs brokers or their agents through an automatic steel import licensing system. The licenses will be issued automatically after the completion of the form.
(b) Customs entry number. Filers are not required to report a Customs entry number to obtain an import license but are encouraged to do so if the Customs entry number is known at the time of filing for the license.
(c) Information required to obtain an import license. (1) The following information is required to be reported in order to obtain an import license (if using the automatic licensing system, some of this information will be provided automatically from information submitted as part of the registration process):
(i) Filer company name and address;
(ii) Filer contact name, phone number, fax number and email address;
(iii) Entry type (
(iv) Importer name;
(v) Exporter name;
(vi) Manufacturer name (filer may state “unknown”);
(vii) Country of origin;
(viii) Country of exportation;
(ix) Expected date of export;
(x) Expected date of import;
(xi) Expected port of entry;
(xii) Current HTS number (from Chapters 72 or 73);
(xiii) Quantity (in kilograms) and
(xiv) Customs value (U.S. $).
(2) Certain fields will be automatically filled out by the automatic license system based on information submitted by the filer (
(3) Upon completion of the form, the importer, customs broker or the importer's agent will certify as to the accuracy and completeness of the information and submit the form electronically. After refreshing the page, the system will automatically issue a steel import license number. The refreshed form containing the submitted information and the newly issued license number will appear on the screen (the “license form”). Filers can print the license form themselves only at that time. For security purposes, users will not be able to retrieve licenses themselves from the license system at a later date for reprinting. If needed, copies of completed license forms can be requested from Commerce during normal business hours.
(d)
(e)
(f)
(a) Throughout the duration of the licensing requirement, Commerce will maintain an import monitoring system on the SIMA system Web site that will report certain aggregate information on imports of steel mill products obtained from the steel licenses. Aggregate data will be reported on a monthly basis by country of origin and steel mill product category and will include import quantity (metric tons), import Customs value (U.S. $), and average unit value ($/metric ton). The Web site will also contain certain aggregate data at the 6-digit Harmonized Tariff Schedule level and will also present a range of historical data for comparison purposes. Provision of this aggregate data on the Web site may be revisited should concerns arise over the possible release of proprietary data.
(b) Reported monthly import data will be refreshed each week with new data
The licensing program will be in effect through March 21, 2009, but may be extended upon review and notification in the
No fees will be charged for obtaining a user identification number, issuing a steel import license or accessing the steel import surge monitoring system.
The automatic licensing system will generally be accessible 24 hours a day, 7 days a week but may be unavailable at selected times for server maintenance. If the system is unavailable for an extended period of time, parties will be able to obtain licenses from Commerce directly via fax during regular business hours. Should the system be inaccessible for an extended period of time, Commerce would advise Customs to consider this as part of mitigation on any liquidated damage claims that may be issued.
Should Commerce determine that a filer consistently files inaccurate licensing information or otherwise abuses the licensing system, Commerce may revoke its electronic licensing privileges without prior notice. The filer will then only be able to obtain a license directly from Commerce. Because of the additional time need to review such forms, Commerce may require up to 10 working days to process such forms. Delays in filing caused by the removal of a filer's electronic filing privilege will not be considered a mitigating factor by the U.S. Customs Service.
The Following annexes will not appear in the Code of Federal Regulations.
Internal Revenue Service (IRS), Treasury.
Temporary regulations.
This document contains temporary regulations relating to additions to the list of items of return information disclosed to the Bureau of the Census (Bureau). The regulation adds two items of return information for use in producing demographic statistics programs, including the Bureau's Small Area Income and Poverty Estimates (SAIPE). The temporary regulations also remove four items that the Bureau has indicated are no longer necessary. The text of these temporary regulations serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section of this issue of the
James O'Leary, (202) 622-4580 (not a toll-free number).
Under section 6103(j)(1), upon written request from the Secretary of Commerce, the Secretary of the Treasury is to furnish to the Bureau return information that is prescribed by Treasury regulations for the purpose of, but only to the extent necessary in, structuring censuses and national economic accounts and conducting related statistical activities authorized by law. Section 301.6103(j)(1)-1 of the regulations further defines such purposes by reference to 13 U.S.C. chapter 5 and provides an itemized description of the return information authorized to be disclosed for such purposes.
This document adopts temporary regulations that authorize the IRS to disclose the additional items of return information that have been requested by the Secretary of Commerce to the extent necessary in developing and preparing demographic statistics, including statutorily mandated Small Area Income and Poverty Estimates (SAIPE). The temporary regulations also remove certain items of return information that are enumerated in the existing regulations but that the Secretary of Commerce has indicated are no longer needed.
Temporary regulations in the Rules and Regulations section of this issue of the
By letter dated May 11, 2004, the Department of Commerce requested that additional items of return information be disclosed to the Bureau for purposes related to conducting the SAIPE program and used to estimate the number of school-aged children in poverty for each of the over 14,000 districts in the United States. Specifically, the Department of Commerce requested Earned Income and the number of Earned Income Tax Credit-eligible qualifying children. The request indicates that under the Improving America's Schools Act of 1994 (Public Law 103-382, 108 Stat. 3518 (October 20, 1994)), these estimates were mandated biennially, and under the No Child Left Behind Act of 2002 (Public Law 107-110, 115 Stat. 1425 (January 8, 2002)), they are required annually.
The regulations also remove four items of return information that the Bureau indicated it no longer requires. These items are: end-of-year code; months actively operated; total number of documents and the total amount reported on the Form 1096 (Annual Summary and Transmittal of U.S. Information Returns) transmitting Forms 1099-MISC (Miscellaneous Income); and Form 941 (Employer's Quarterly Federal Tax Return) indicator and business address on Schedule C (Profit or Loss From Business) of Form 1040. Accordingly, the temporary regulations have removed these items from the enumeration of return information to be disclosed to the Bureau.
It has been determined that these temporary regulations are not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the cross-reference notice of proposed rulemaking published elsewhere in this issue of the
The principal author of these temporary regulations is James C. O'Leary, Office of the Associate Chief
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
26 U.S.C. 7805 * * *
Section 301.6103(j)(1)-1T also issued under 26 U.S.C. 6103(j)(1); * * *
(b)(1) [Reserved]. For further guidance, see § 301.6103(j)(1)-1T(b)(1).
(b)(3) [Reserved]. For further guidance, see § 301.6103(j)(1)-1T(b)(3).
(a) [Reserved]. For further guidance, see § 301.6103(j)(1)-1(a).
(b) Disclosure of return information reflected on returns to officers and employees of the Bureau of the Census.
(1) Officers or employees of the Internal Revenue Service will disclose the following return information reflected on returns of individual taxpayers to officers and employees of the Bureau of the Census for purposes of, but only to the extent necessary in, conducting and preparing, as authorized by chapter 5 of title 13, United States Code, intercensal estimates of population and income for all geographic areas included in the population estimates program and demographic statistics programs, censuses, and related program evaluation:
(i) Taxpayer identity information (as defined in section 6103(b)(6) of the Internal Revenue Code), validity code with respect to the taxpayer identifying number (as described in section 6109), and taxpayer identity information of spouse and dependents, if reported.
(ii) Location codes (including area/district office and campus/service center codes).
(iii) Marital status.
(iv) Number and classification of reported exemptions.
(v) Wage and salary income.
(vi) Dividend income.
(vii) Interest income.
(viii) Gross rent and royalty income.
(ix) Total of—
(A) Wages, salaries, tips, etc.;
(B) Interest income;
(C) Dividend income;
(D) Alimony received;
(E) Business income;
(F) Pensions and annuities;
(G) Income from rents, royalties, partnerships, estates, trusts, etc.;
(H) Farm income;
(I) Unemployment compensation; and
(J) Total Social Security benefits.
(x) Adjusted gross income.
(xi) Type of tax return filed.
(xii) Entity code.
(xiii) Code indicators for Form 1040, Form 1040 (Schedules A, C, D, E, F, and SE), and Form 8814.
(xiv) Posting cycle date relative to filing.
(xv) Social Security benefits.
(xvi) Earned Income (as defined in section 32(c)(2)).
(xvii) Number of Earned Income Tax Credit-eligible qualifying children.
(b)(2) [Reserved]. For further guidance, see § 301.6103(j)(1)-1(b)(2).
(b)(3) Officers or employees of the Internal Revenue Service will disclose the following business related return information reflected on returns of taxpayers to officers and employees of the Bureau of the Census for purposes of, but only to the extent necessary in, conducting and preparing, as authorized by chapter 5 of title 13, United States Code, demographic and economic statistics programs, censuses, and surveys. (The “returns of taxpayers” include, but are not limited to: Form 941; Form 990 series; Form 1040 series and Schedules C and SE; Form 1065 and all attending schedules and Form 8825; Form 1120 series and all attending schedules and Form 8825; Form 851; Form 1096; and other business returns, schedules and forms that the Internal Revenue Service may issue.):
(i) Taxpayer identity information (as defined in section 6103(b)(6)) including parent corporation, shareholder, partner, and employer identity information.
(ii) Gross income, profits, or receipts.
(iii) Returns and allowances.
(iv) Cost of labor, salaries, and wages.
(v) Total expenses or deductions.
(vi) Total assets.
(vii) Beginning- and end-of-year inventory.
(viii) Royalty income.
(ix) Interest income, including portfolio interest.
(x) Rental income, including gross rents.
(xi) Tax-exempt interest income.
(xii) Net gain from sales of business property.
(xiii) Other income.
(xiv) Total income.
(xv) Percentage of stock owned by each shareholder.
(xvi) Percentage of capital ownership of each partner.
(xvii) Principal industrial activity code, including the business description.
(xviii) Consolidated return indicator.
(xix) Wages, tips, and other compensation.
(xx) Social Security wages.
(xxi) Deferred wages.
(xxii) Social Security tip income.
(xxiii) Total Social Security taxable earnings.
(xxiv) Gross distributions from employer-sponsored and individual retirement plans from Form 1099-R.
(b)(4) through (b)(6) [Reserved]. For further guidance, see § 301.6103(j)(1)-1 (b)(4) through (b)(6).
(c) through (d) [Reserved]. For further guidance, see § 301.6103(j)(1)-1(c) and (d).
(e)
Department of Justice.
Final rule.
The Department of Justice is finalizing without change the interim final rule with request for comments published at 68 FR 66534, on November 26, 2003. The interim final rule implemented changes to the government-wide nonprocurement debarment and suspension common rule (NCR) and the associated rule on drug-free workplace requirements. The NCR sets forth the common policies and procedures that Federal Executive branch agencies must use in taking suspension or debarment actions. It also establishes procedures for participants and Federal agencies in entering covered transactions.
This final rule is effective April 11, 2005.
Linda Fallowfield, Attorney Advisor, Office of the General Counsel, Office of Justice Programs, Department of Justice, 810 7th Street, NW., Washington, DC 20531. Telephone: (202) 305-2534. (This is not a toll-free number.) E-mail:
On November 26, 2003, at 68 FR 65534, a number of Federal agencies jointly published a final government-wide nonprocurement debarment and suspension common rule (NCR). At that time, because the Department of Justice (the Department) had not previously proposed changes to the NCR along with the other participating agencies, the Department adopted the NCR on an interim final basis. This interim final rule also separated the Department's drug-free workplace requirements from the uniform requirements on debarment and suspension. The Department did not receive any comments and is now finalizing without change the common rule it adopted on November 26, 2003.
The NCR promotes consistency within the Federal Government and provides uniform requirements for debarment and suspension by Executive branch agencies to protect assistance, loans, benefits, and other nonprocurement activities from waste, fraud, abuse, and poor performance, similar to the system used for Federal procurement activities under Subpart 9.4 of the Federal Acquisition Regulations (FAR). Drug-free workplace requirements were moved from 28 CFR part 67 to 28 CFR part 83. This places the requirements nearer other requirements used predominantly by award officials.
This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation. The Department has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget.
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by approving it, certifies that this regulation will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule addresses Federal agency procedures for suspension and debarment, and it clarifies current requirements under the Nonprocurement Common Rule for Debarment and Suspension by reorganizing information and presenting that information in a plain language, question-and-answer format.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 804. This rule will not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Administrative practice and procedure, Government contracts, Grant programs, Loan programs, Reporting and recordkeeping requirements, Technical assistance, Drug abuse.
Administrative practice and procedure, Drug abuse, Grant programs, Reporting and recordkeeping requirements.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Closure.
NMFS has determined that the available Angling category Atlantic bluefin tuna (BFT) quota for the 2004 fishing year (June 1, 2004 May 31, 2005) is projected to be reached by March 11, 2005. Therefore, the Angling category BFT fishery will close, coastwide, effective March 11, 2005. This action is
Effective 11:30 p.m., local time, March 11, 2005, through May 31, 2005.
HMS Management Division at 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971
NMFS is required, under 50 CFR 635.28 (a)(1), to file with the Office of the
The 2004 final initial BFT quota specifications issued pursuant to 635.27, set an Angling category quota of 76.5 mt to be harvested from the regulatory area during the 2004 fishing year (70 FR 10896, March 7, 2005). On December 10, 2004, NMFS transferred a total of 223.1 mt from the General category to the Angling category establishing an adjusted Angling category BFT quota of 299.6 mt for the 2004 fishing year (69 FR 71732). Based on the available Angling category quota and preliminary information regarding recreational BFT landings for the 2004 fishing year, NMFS projects that the available Angling category quota will be reached by March 11, 2005. Therefore, fishing for, retaining, possessing, or landing BFT by persons aboard vessels permitted in the Atlantic Highly Migratory Species (HMS) Angling, and HMS Charter/Headboat categories, must cease at 11:30 p.m. local time March 11, 2005, in all areas. The intent of this closure is to prevent overharvest of the available quota established for the Angling category. Atlantic HMS Angling and HMS Charter/Headboat category permit holders may tag and release BFT of all sizes while the Angling quota category is closed, subject to the requirements of the tag-and-release program at § 635.26.
The Assistant Administrator for Fisheries, NOAA (AA), finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action. Based on the available Angling category quota for the 2004 fishing year and the most recent information regarding recreational BFT landings, this closure is necessary to prevent overharvest of the adjusted Angling category quota.
This fishery is currently underway and delaying this action would be contrary to the public interest as it will result in additional recreational BFT landings, potentially contributing to an overharvest of the adjusted Angling category quota. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the delay in effectiveness of this action.
NMFS provides notification of closures by publishing the closure notice in the
This action is being taken under 50 CFR 635.23(a)(4) and is exempt from review under Executive Order 12866.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; correction.
This document corrects a February 24, 2005, final rule that implements 2005 and 2006 harvest specifications, reserves, and apportionments thereof, Pacific halibut prohibited species catch (PSC) limits, and associated management measures for the groundfish fishery of the Gulf of Alaska (GOA). Specifically, this document corrects errors in Tables 12 and 13 to the final specifications.
Effective at 1200 hrs, Alaska local time (A.l.t.), February 24, 2005, through 2400 hrs, A.l.t., December 31, 2006.
Copies of the Final Environmental Assessment and Final Regulatory Flexibility Analysis prepared for this action are available from Alaska Region, NMFS, P.O. Box 21668, Juneau, AK 99802, Attn: Lori Durall, or from the Alaska Region website at
Copies of the final 2004 Stock Assessment and Fishery Evaluation report for the groundfish resources of the GOA, dated November 2004, are available from the North Pacific Fishery Management Council, West 4th Avenue, Suite 306, Anchorage, AK 99510-2252, (907-271-2809) or from its website at
Mary Furuness, 907-586-7228, or e-mail at
NMFS published 2005 and 2006 harvest specifications, reserves, and apportionments thereof, Pacific halibut PSC limits, and associated management measures for the groundfish fishery of the GOA on February 24, 2005 (70 FR 8958). That rule lists sideboard limitations for non-exempt American Fisheries Act catcher vessels in the GOA. This document corrects the final rule by reflecting accurately all of the
As published, final rule FR Doc. 05-3581, February 24, 2005 (70 FR 8958) contains errors and needs to be corrected. This action corrects Table 12 (70 FR 8972) and Table 13 (70 FR 8973) to change the dates for the pollock seasons. For the A Season, the dates are January 20 - March 10, and for the C Season, the dates are August 25 - October 1. The corrected Table 13 changes the species names for the second allocation for shortraker rockfish to rougheye rockfish and for the big and longnose skates allocation to longnose skates. Both tables are corrected and reprinted below for the convenience of all interested readers.
All other information previously published remains the same.
16 U.S.C. 1801
Office of the Comptroller of the Currency, Treasury (OCC); Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice of proposed rulemaking.
The OCC, Board, and FDIC (collectively, “federal banking agencies” or “the Agencies”) are issuing this notice of proposed rulemaking that would revise certain provisions of our rules implementing the Community Reinvestment Act (CRA). We plan to take this action in response to public comments received by the federal banking agencies and the Office of Thrift Supervision (OTS) on a February 2004 inter-agency CRA proposal and by the FDIC on its August 2004 CRA proposal. The current proposal would address regulatory burden imposed on some smaller banks by revising the eligibility requirements for CRA evaluation under the lending, investment, and service tests. Specifically, the proposal would provide a simplified lending test and a flexible new community development test for small banks with an asset size between $250 million and $1 billion. Holding company affiliation would not be a factor in determining which CRA evaluation standards applied to a bank. In addition, the proposal would revise the term “community development” to include certain community development activities, including affordable housing, in underserved rural areas and designated disaster areas.
Comments must be received by May 10, 2005.
Comments should be directed to:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
All public comments are available from the Board's Web site at
•
•
•
•
•
The comments reflected a consensus that certain fundamental elements of the regulations are sound, but demonstrated a disagreement over the need and reasons for change. Community organizations advocated that the regulations needed to be changed to reflect developments in the industry and marketplace; financial institutions were concerned principally with reducing burden consistent with maintaining or improving the regulations' effectiveness. In reviewing these comments, the federal banking and thrift agencies were particularly mindful of the need to balance the desire to make changes that might “fine tune” the regulations, with the need to avoid unnecessary and costly disruption to reasonable CRA policies and procedures that the industry has put into place under the current rules.
The commenters were deeply split on the proposal. A majority of over 250 community bank commenters, and all of the trade associations commenting on behalf of community banks, urged the federal banking and thrift federal banking agencies to extend the proposed burden relief to all institutions with assets under $2 billion, or at least to all institutions with assets under $1 billion; a few favored the proposed $500 million threshold. Virtually every one of over 250 community group commenters strongly opposed changing the definition of “small institution” or exempting any more institutions from the three-part test (lending, services, and investments). These commenters urged that the threshold not be changed so that community development activities continue to be evaluated, as they are today, in banks with $250 million or more in assets.
The federal banking and thrift agencies also proposed to revise and clarify the regulations to provide that evidence of certain abusive and illegal credit practices will adversely affect an agency's evaluation of a bank's CRA performance, including evidence of a pattern or practice of extending home mortgage or consumer loans based predominantly on the foreclosure or liquidation value of the collateral by the institution, where the borrower cannot be expected to be able to make the payments required under the terms of the loan. The proposal clarified that a bank's evaluation will be adversely affected by such abusive or illegal credit practices regardless of whether the practices involve loans in the bank's assessment area(s) or in any other location or geography. It also provided that a bank's CRA evaluation can be adversely affected by evidence of such practices by any affiliate, if any loans of that affiliate have been considered in the institution's CRA evaluation.
While commenters differed in their reaction to many aspects of the proposal, many commenters, including community organizations and financial institutions, opposed—as either inadequate or inappropriate—the provision that evidence of collateral-based mortgage lending would adversely affect a bank's CRA evaluation.
On November 24, 2004, the OTS issued another proposed rulemaking to revise the definition of “community development” to permit consideration of such activities in underserved non-metropolitan areas, and to solicit comment on the appropriate consideration of such community development activities in any areas affected by natural disasters or major community disruptions. The OTS
The FDIC's proposal generated approximately 11,500 comment letters. These comments were sent by a wide spectrum of commenters, including over 4,000 from community bankers, over 1,500 from various community organizations, and over 5,000 from individuals. As with the February 2004 interagency proposal, the commenters were deeply divided on the issues presented in the August proposal. Nearly all of the comments received from bankers and banking organizations supported a change in the small bank dollar threshold, primarily as a way to reduce administrative burden. Bankers were mixed on the community development performance criterion. Some supported a community development criterion as an effective compromise, while others opposed the criterion altogether on one of two grounds: (1) Community development lending and investments are already part of the loan-to-deposit performance criterion assessing the level of lending activity
Community groups almost universally opposed any increase in the small bank threshold. These commenters asserted that the burden argument made by banks did not justify a change. This group also uniformly opposed the community development performance criterion on the ground that permitting banks to choose one or more lending, investment, and service activities would lead to cut backs in investments and services currently required under the large bank test. The community group commenters generally supported a separate community development test.
Commenters were mixed on the addition of “rural” to the definition of “community development.” Some supported the proposal because it would permit CRA credit for such rural-based activities as funding local water projects, school construction, or rehabilitation of a Main Street retail district in rural areas lacking sufficient financial resources. Many commenters were concerned that the mere inclusion of the phrase “individuals who reside in rural areas” would permit banks to get CRA credit for loans, investments, or services to middle-class or wealthy individuals.
The CRA requires the federal banking and thrift agencies to assess the record of each insured depository institution in meeting the credit needs of its entire community, including low- and moderate-income neighborhoods, consistent with safe and sound operation of the institution and to take that record into account when the agency evaluates an application by the institution for a deposit facility.
The federal banking agencies continue to believe that it is both worthwhile and possible to improve the CRA rules in ways that reduce unnecessary burden while at the same time maintaining and improving the effective implementation of the CRA. Moreover, we believe that it is important to take steps at this time to develop and propose rules to achieve these goals, and to work toward achieving standards that ultimately can apply on a uniform basis to all banks subject to the CRA. Therefore, the federal banking agencies request comment on proposed regulatory revisions that balance the objective of providing meaningful regulatory relief for additional community banks with the objectives of preserving and encouraging meaningful CRA activities by those same banks.
As noted above, commenters were divided on the merits of that portion of the February 2004 and August 2004 proposals that would have increased the limit on the size of banks that would be eligible for treatment as a “small bank.” The comments in favor of the proposal focused on the potential regulatory relief for insured institutions, while those opposed expressed concern that the proposal would result in decreased community development activities in areas that are particularly in need of credit and investment, notably rural areas.
In light of these comments, the federal banking agencies request comment on this revised proposal. The new proposal addresses both the comments from community banks and comments from community organizations. It responds to community banks concerned about the reduction of undue regulatory burden by extending eligibility for streamlined lending evaluations and the exemption from data reporting to banks under $1 billion without regard to holding company assets. It addresses the concerns of community organizations that urged the federal banking and thrift agencies to continue to evaluate community development participation, by providing that the community development records of banks between $250 million and $1 billion would be separately evaluated and rated, but provides a more streamlined basis than the current rule for doing so. It responds to suggestions from both community banks and community organizations that the definition of “community development” is too confined by proposing a more flexible approach to the types of community development activities that would be considered, and by expanding the definition of community development activities in underserved rural areas and designated disaster areas. In short, the new proposal tries to strike a balance between burden reduction for community banks and effective evaluation of community development by those banks.
The key differences between this proposal and the February 2004 interagency proposal are three-fold. First, as with the FDIC's August 2004
Second, the new proposal would add a flexible new community development test that would be separately rated in CRA examinations for banks with at least $250 million and less than $1 billion in assets (these banks will be referred to as “intermediate small banks”). Ratings for intermediate small banks would be based on a rating on this community development test and on a separate rating for the streamlined small bank lending test. An intermediate small bank would not be eligible for an overall rating of “satisfactory” unless it received ratings of “satisfactory” on both the lending and community development tests.
Third, the definition of “community development” would be expanded to encompass: (1) Affordable housing for individuals in underserved rural areas and designated disaster areas (in addition to low- or moderate-income individuals) and (2) community development activities that revitalize or stabilize underserved rural areas and designated disaster areas (in addition to low- or moderate-income areas).
The current definition of “community development” also does not explicitly provide that it encompasses activities in areas affected by disasters. For example, there has been unnecessary uncertainty about the CRA treatment of bank revitalization activities in areas affected by natural disasters such as hurricanes or in, for example, the commercial and residential areas surrounding the site of the World Trade Center. Affordable housing for individuals in underserved rural areas and in designated disaster areas, and activities that promote the revitalization and stabilization of such areas, such as for infrastructure improvements, community services, and small business development, are fully consistent with the goals and objectives of the CRA because these projects can benefit the entire community, including, but not limited to, low- or moderate-income individuals or neighborhoods.
Under the proposal, intermediate small banks would no longer have to report originations and purchases of small business, small farm, and community development loans. This change would account for most of the cost savings and paperwork burden reduction for intermediate small banks.
The proposal also would annually adjust the asset size for small and intermediate small banks based on changes to the Consumer Price Index. Using an index to adjust dollar figures for the effects of inflation is commonplace, and is used in other federal lending regulations, such as the Home Mortgage Disclosure Act. 12 U.S.C. 2801
As stated above, comments were mixed on the FDIC's inquiry as to whether the community development test should be separated from the current small bank test. Many industry commenters preferred to have a community development criterion, which would permit a bank to engage in one or more community development activities, and opposed a separate community development test. On the other hand, many community organizations and others expressed concern that the criterion was overly flexible and would result in a narrow focus that would ignore a broad range of community needs, including investments.
The OCC, FDIC, and Board believe that the proposal for a separate community development rating presents an appropriate focus on community development activities for intermediate small banks and makes transparent the weight that community development performance receives in the overall rating. Under the proposed community development test for these “intermediate” small banks, community development loans, qualified investments, and community development services would be evaluated together, resulting in a single rating for community development performance. While the lending test for small banks permits consideration of community development lending and qualified investments “as appropriate,” such activities by an intermediate small bank generally would be considered under the community development test. An intermediate small bank's rating for community development would play a significant role in the bank's overall rating, as would its rating on the separate test of the bank's lending. To ensure that community development performance and retail lending are appropriately weighted under the proposal, and given the flexibility that would be available to satisfy the community development test through a variety of activities, an intermediate small bank would have to achieve a rating of at least satisfactory on both tests to be assigned an overall rating of satisfactory.
The number and amount of community development loans, the number and amount of qualified investments, and the provision of community development services, by an intermediate small bank, and the bank's responsiveness through such activities to community development lending, investment, and services needs, would be evaluated in the context of the bank's capacities, business strategy, the needs of the relevant community, and the number and types of opportunities for community development activities. The federal banking agencies intend that the proposed community development test would be applied flexibly to permit a bank to apply its resources strategically to the types of community development activities (loans, investments, and services) that are most responsive to helping to meet community needs, even when those activities are not necessarily innovative, complex, or new.
As noted in the February 2004 proposal, some community banks face intense competition for a limited supply of qualified investments that are safe and sound and yield an acceptable return. Competition for scarce investments also may result in “churning,” or the repeated purchase and sale, of the same pool of investments. To “fill the silo” of investments for purposes of the CRA investment test, these banks may have made or purchased investments that may not be meaningful or responsive to the needs of their community, whereas additional lending or provision of services by the bank could have been more responsive to local community development needs. The OCC, FDIC, and Board recognize that these constraints may affect the investment performance of particular banks, and believe that a more flexible community
As part of the proposed community development test for intermediate small banks, the OCC, FDIC, and Board also anticipate that examiners would use their discretion, using performance context, to assign appropriate weight in a bank's current period rating to prior-period outstanding investments that reflect a substantial financial commitment or outlay by the bank designed to have a multi-year impact, in addition to investments made during the current examination cycle.
In providing this flexibility for intermediate small banks, it is not the intention of the federal banking agencies to permit a bank to simply ignore one or more categories of community development. Nor would the proposal prescribe any required threshold proportion of community development loans, qualified investments, and community development services for these banks. Instead, the OCC, FDIC, and Board would expect that a bank will appropriately assess the needs in its community, engage in different types of community development activities based on those needs and the bank's capacities, and that it will take reasonable steps to apply its community development resources strategically to meet those needs.
Under the proposal, retail banking services provided by intermediate small banks would no longer be evaluated in a separate service test. Instead, services for low- and moderate-income people would be taken into account in the community development test. Under that test, the federal banking agencies would consider bank services intended primarily to benefit low- and moderate-income people, such as low-cost bank accounts and banking services such as low-cost remittance services.
Giving banks more flexibility on how to apply their community development resources to respond to community needs through a more strategic use of loans, investments, and services is intended to reduce burden and make the evaluation of community banks' community development records more effective.
The regulations' present definition of “community development” has been criticized by community banks and community organizations alike for failing to recognize the unique community development needs of certain rural areas. The definition covers four categories of activities, three of which (affordable housing, community services, and economic development) are defined in terms of the activity's targeting of low- or moderate-income people or small businesses or farms, and one of which (revitalization and stabilization activities) is defined in terms of its targeting of low- or moderate-income census tracts. The OCC, FDIC, and Board propose to amend two of the categories—affordable housing and revitalization and stabilization activities—by adding references to individuals in “underserved rural areas” and in “designated disaster areas.”
In response to the FDIC's August 2004 proposal to revise the definition of “community development” to include the provision of affordable housing to individuals in rural areas (in addition to low- or moderate-income individuals under the current rule), several commenters noted that the provision of affordable housing was critical in certain rural areas. Some community organizations serving rural areas commented that the CRA process should promote affordable housing in rural areas across the country.
As described in the “Request for Comments” discussion below, the OCC, FDIC, and Board seek comment on a variety of approaches to identify the community development needs of rural areas. The approach reflected in the proposed amendments is based on the premise that the provision of
With respect to the current definition covering revitalization and stabilization activities, this category does not address revitalization and stabilization activities in most rural counties, since most rural counties do not have any low- or moderate-income census tracts.
Under the revised community development definition, a “designated disaster area” is an area that has received an official designation as a disaster area.
The OCC, FDIC, and Board again propose to revise the regulations to address the impact on a bank's CRA rating of evidence of discrimination or other illegal credit practices. The regulations would provide that evidence of discrimination, or evidence of credit practices that violate an applicable law, rule, or regulation, will adversely affect an agency's evaluation of a bank's CRA performance. The regulations also would be revised to include an illustrative list of such practices, including evidence of discrimination against applicants on a prohibited basis in violation of, for example, the Equal Credit Opportunity (15 U.S.C. 1691
Under the proposal, a bank's evaluation will be adversely affected by such practices regardless of whether the practices involve loans in the bank's assessment area(s) or in any other location or geography. In addition, a bank's CRA evaluation also can be adversely affected by evidence of such practices by any affiliate, if any loans of that affiliate have been considered in the bank's CRA evaluation.
In response to comments on the February 2004 proposal, the federal banking agencies do not propose to include in the CRA regulations a provision that evidence of collateral-based lending also can adversely affect an agency's evaluation of a bank's CRA performance.
The OCC, FDIC, and Board welcome comments on any aspect of this proposal, particularly, those issues noted below.
• The federal banking agencies invite comment on whether other approaches would be more appropriate to addressing the CRA burdens and obligations of banks with less than $1 billion in assets. Is there another appropriate asset threshold to use when defining intermediate small banks, and, if so, why?
• We seek comment on the proposal to adjust the asset size for small and intermediate small banks on an ongoing basis, based on changes to the Consumer Price Index.
• Under the proposal, banks with assets between $250 million and $1 billion will no longer be required to report data on small business, small farm, and community development lending. The federal banking agencies seek comment specifically addressing whether and how the public has used the loan information that has been reported to date by such intermediate small banks (for example, by reference to specific studies on bank lending patterns that used the data), and whether other sources of data about this lending can be used for such purposes going forward.
• Does the proposal provide more flexibility in how an intermediate small bank may apply its community development resources through a more strategic use of loans, investments and services? Does the proposal to permit examiners to use performance context to give consideration in a current-period rating, to prior-period outstanding investments that reflect a substantial financial commitment by the bank, also provide more flexibility for intermediate small banks?
• Does the proposal to evaluate all community development activities of intermediate small banks under one test have the potential to make the evaluations of those banks' community development performance more effective than under the current regulation?
• Should the community development test for intermediate small banks be separately rated as proposed? If so, should an intermediate small bank be required to achieve a rating of at least “satisfactory” under both the small bank lending and community development tests to achieve an overall “satisfactory” CRA rating? Should the bank's community development test performance be weighted equally with its lending test performance in assigning an overall CRA rating? Would other ratings floors or weights be appropriate to provide greater flexibility in certain circumstances? If so, under what circumstances?
• The federal banking agencies seek comment on whether the existing definition of “community development” provides sufficient recognition for community services to individuals residing in underserved rural areas and designated disaster areas and, if not, how to encourage the provision of such services to persons in underserved rural areas and designated disaster areas that have the greatest need.
• We also seek comment on the merits of the proposed treatment of the definition of “community development” in underserved rural and designated disaster areas and invite suggestions for alternatives.
• We seek comment on the proper way to define “rural.” Should we adopt a definition and, if so, which one? For example, should all areas outside a metropolitan area be considered “rural”? Alternatively, should the federal banking agencies define rural consistent with the definition employed by the Census Bureau? The Census Bureau defines any territory or population not meeting its criteria for “urban” to be “rural.” Are there other definitions the federal banking agencies should consider?
• We also seek comment on the proper way to define “underserved” when used in connection with rural areas. Should we adopt a definition and, if so, which one? For example, should the term refer solely to those rural areas showing signs of economic distress or lack of investment? If so, what indicia should the federal banking agencies use to identify such rural areas? Should we use criteria from other federal programs, such as the Community Development
• Should “underserved rural area” be defined in the regulation to also encompass those rural areas that have been targeted by a governmental agency for redevelopment, without regard to median income characteristics of the area?
• Should “underserved rural area” be limited to low- and moderate-income areas, without regard to whether those areas show signs of economic distress, lack of investment, or are targeted for redevelopment by a governmental agency? If so, should the OCC, FDIC, and Board adopt a different method than currently exists in the regulation for determining when a rural area is low- or moderate-income? For example, under the current regulations, the area must be a low- or moderate-income census tract, which the regulations define as a tract with median family income that does not exceed 80% of the statewide non-metropolitan median family income. Would raising the low- and moderate-income threshold in non-metropolitan communities from 80% of non-metropolitan median family income to some higher figure, such as 85%, 90%, or 100%, more appropriately identify underserved rural areas? Alternatively, would identifying another measure of median income instead of the non-metropolitan median income, such as the statewide median income, more appropriately define low- and moderate-income for purposes of defining underserved rural areas by reference to low- and moderate-income characteristics?
• As proposed, the definition of “community development” would encompass affordable housing for people who do not meet the regulatory definition of “low- or moderate-income” if, and only if, they reside in underserved rural areas. The federal banking agencies seek comment on whether the current regulatory definition of “low- or moderate-income individual” is unduly restrictive for purposes of identifying individuals in rural areas who need affordable housing. If so, in what ways?
Section 722 of the Gramm-Leach-Bliley Act, Pub. L. 106-102, sec. 722, 113 Stat. 1338, 1471 (Nov. 12, 1999), requires the federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. We invite your comments on how to make the proposal easier to understand. For example:
• Have we organized the material to suit your needs? If not, how could this material be better organized?
• Are the requirements in the proposal clearly stated? If not, how could the regulation be more clearly stated?
• Does the proposal contain language or jargon that is not clear? If so, which language requires clarification?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the regulation easier to understand? If so, what changes to the format would make the regulation easier to understand?
• What else could we do to make the regulation easier to understand?
In addition, we invite your comments on the impact of this proposal on community banks. The federal banking agencies recognize that community banks operate with more limited resources than larger institutions and may present a different risk profile. Thus, the federal banking agencies specifically request comments on the impact of the proposal on community banks' current resources and available personnel with the requisite expertise, and whether the goals of the proposal could be achieved, for community banks, through an alternative approach.
The Small Business Administration (SBA) has defined “small entities” for banking purposes as a bank or savings institution with less than $150 million in assets.
The proposal to eliminate the $1 billion holding company threshold as a factor in determining whether banks will be subject to the streamlined CRA examination or the more in-depth CRA examination applicable to larger institutions will impact a limited number of small banks, which are affiliated with holding companies with assets over $1 billion. The FDIC estimates that only 110 of approximately 5,300 FDIC-regulated banks had assets of under $150 million and were affiliated with a holding company with over $1 billion in assets. The OCC estimates that only 36 of approximately 2,000 OCC-regulated banks met these criteria. Because so few small banks will be affected by the proposed revisions to Parts 25 and 345, a regulatory flexibility analysis is not required. Nevertheless, the OCC and FDIC are willing, in response to any comments received regarding the proposal's economic impact on small banks with assets of under $150 million, to reevaluate the RFA certifications and, if appropriate, publish regulatory flexibility analyses in conjunction with the issuance of any final rule.
As described in the
The Supplementary Information describes the proposal's objectives. The legal basis for the proposed rule is section 806 of the CRA.
The proposed rule would apply to all state-chartered banks that are members of the Federal Reserve System; there are approximately 932 such banks. The RFA requires the Board to consider the effect of the proposal on small entities, which are defined for RFA purposes as all banks with assets of less than $150 million. There are 473 state member banks with less than $150 million of assets. All but about 12 state member banks with assets of less than $150 million are already subject to a streamlined CRA process that is unaffected by this proposal. The rule would eliminate data reporting requirements for these 12 state member banks by eliminating holding-company affiliation as a disqualification for treatment as a “small bank” under the CRA regulations.
The Board does not believe that the proposed rule imposes any new reporting or recordkeeping requirements, as defined in section 603 of the RFA. As noted, the rule would eliminate holding-company affiliation as a disqualification for treatment as a “small bank” under the CRA regulations. Accordingly, the rule would eliminate data reporting requirements for about 12 state member banks with assets of less than $150 million. As noted above, all other state member banks with assets under $150 million are already exempt from this reporting requirement.
The Board believes that the proposed revisions to the definition of “community development” would not place additional compliance costs or burdens on small institutions. Instead, this proposal would add greater flexibility to the definition in response to requests made by many small banks. The Board believes the same of the provisions regarding the effect of evidence of illegal credit practices on CRA evaluations. State banks of all sizes are already subject to laws against such practices, and the proposal would not affect that.
The Board seeks information and comment on whether application of the proposed rule would impose any costs, compliance requirements, or changes in operating procedures in addition to or which may differ from those arising from the application of the statute.
The Board does not believe there are any federal statutes or regulations that would duplicate, overlap, or conflict with the proposed rule. The Board seeks comment regarding any statues or regulations, including state or local statutes or regulations, that would duplicate, overlap, or conflict with the proposed rule.
The proposed rule maintains the approach of the existing CRA regulations in exempting small entities from reporting requirements and providing for streamlined lending evaluations for small entities. A complete exemption of small entities from all of the CRA's requirements would be impermissible under the CRA statute. The Board welcomes comments on any significant alternatives that would minimize the impact of the proposed rule on small entities.
The OCC has determined that this proposed rule is not a significant regulatory action under Executive Order 12866.
Section 202 of the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4 (2 U.S.C. 1532) (Unfunded Mandates Act), requires that an agency prepare a budgetary impact statement before promulgating any rule likely to result in a Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. The OCC has determined that the proposal will not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, the proposal is not subject to section 202 of the Unfunded Mandates Act.
In accordance with the requirements of the Paperwork Reduction Act of 1995, the Agencies may not conduct or sponsor, and the respondent is not required to respond to, an information collection (IC) unless it displays a currently valid Office of Management and Budget (OMB) control number (OCC, 1557-0160; Board, 7100-0197; and FDIC, 3064-0092).
The FDIC has obtained OMB-approval for the paperwork burden associated with its CRA regulation at 12 CFR Part 345 under OMB IC 3064-0092. The change in burden to IC 3064-0092 associated with this proposal to raise the threshold for small banks from those with under $250 million in assets to those with under $1 billion in assets was submitted to and approved by OMB in connection with a similar proposal published by the FDIC in August 2004 (69 FR 51611, Aug. 20, 2004). This interagency proposal would not, if adopted as final, result in any added change in burden to IC 3064-0092. Therefore, the FDIC is not required to make a submission to OMB under the Paperwork Reduction Act at this time. Nevertheless, the FDIC joins the OCC and the Board in seeking additional comment on the paperwork burden associated with the current proposal.
The Agencies give notice that, at the end of the comment period, the proposed collections of information, along with an analysis of the comments, and recommendations received, will be submitted to OMB for review and approval.
Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the Agencies' functions, including whether the information has practical utility;
(b) The accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations
Comments should be addressed to:
All public comments are available from the Board's Web site at
Comments should also be sent to Mark D. Menchik, Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, Washington, DC 20503. Comments may also be sent by e-mail to
Estimated Time per Response: Small business and small farm loan register, 219 hours; Consumer loan data, 326 hours; Other loan data, 25 hours; Assessment area delineation, 2 hours; Small business and small farm loan data, 8 hours; Community development loan data, 13 hours; HMDA out-of-MSA loan data, 253 hours; Data on lending by a consortium or third party, 17 hours; Affiliated lending data, 38 hours; Request for designation as a wholesale or limited purpose bank, 4 hours; and Public file, 10 hours.
The OCC has determined that this proposal does not have any Federalism implications, as required by Executive Order 13132.
Community development, Credit, Investments, National banks, Reporting and recordkeeping requirements.
Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.
Banks, Banking, Community development, Credit, Investments, Reporting and recordkeeping requirements.
For the reasons discussed in the joint preamble, part 25 of chapter I of title 12 of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for part 25 continues to read as follows:
12 U.S.C. 21, 22, 26, 27, 30, 36, 93a, 161, 215, 215a, 481, 1814, 1816, 1828(c), 1835a, 2901 through 2907, and 3101 through 3111.
2. In § 25.12, revise paragraphs (g)(1), (g)(4), and (u) to read as follows:
(g)
(1) Affordable housing (including multifamily rental housing) for low- or moderate-income individuals, individuals in underserved rural areas, or individuals located in designated disaster areas;
(4) Activities that revitalize or stabilize low- or moderate-income geographies, underserved rural areas, or designated disaster areas.
(u)
(2)
3. Revise § 25.26 to read as follows:
(a)
(2)
(b)
(1) The bank's loan-to-deposit ratio, adjusted for seasonal variation, and, as appropriate, other lending-related activities, such as loan originations for sale to the secondary markets, community development loans, or qualified investments;
(2) The percentage of loans and, as appropriate, other lending-related activities located in the bank's assessment area(s);
(3) The bank's record of lending to and, as appropriate, engaging in other lending-related activities for borrowers of different income levels and businesses and farms of different sizes;
(4) The geographic distribution of the bank's loans; and
(5) The bank's record of taking action, if warranted, in response to written complaints about its performance in helping to meet credit needs in its assessment area(s).
(c)
(1) The number and amount of community development loans;
(2) The number and amount of qualified investments;
(3) The extent to which the bank provides community development services; and
(4) The bank's responsiveness through such activities to community development lending, investment, and services needs.
3a. Revise § 25.28, paragraph (c) to read as follows:
(c)
(1) The OCC's evaluation of a bank's CRA performance is adversely affected by evidence of discriminatory or other illegal credit practices in any geography by the bank or in any assessment area by any affiliate whose loans have been considered as part of the bank's lending performance. In connection with any type of lending activity described in § 25.22(a), evidence of discriminatory or other credit practices that violate an applicable law, rule, or regulation includes, but is not limited to:
(i) Discrimination against applicants on a prohibited basis in violation, for example, of the Equal Credit Opportunity Act or the Fair Housing Act;
(ii) Violations of the Home Ownership and Equity Protection Act;
(iii) Violations of section 5 of the Federal Trade Commission Act;
(iv) Violations of section 8 of the Real Estate Settlement Procedures Act; and
(v) Violations of the Truth in Lending Act provisions regarding a consumer's right of rescission.
(2) In determining the effect of evidence of practices described in paragraph (c)(1) of this section on the bank's assigned rating, the OCC considers the nature, extent, and strength of the evidence of the practices; the policies and procedures that the bank (or affiliate, as applicable) has in place to prevent the practices; any corrective action that the bank (or affiliate, as applicable) has taken or has committed to take, including voluntary corrective action resulting from self-assessment; and any other relevant information.
4. In Appendix A to part 25, revise paragraph (d) to read as follows:
(d)
(A) A reasonable loan-to-deposit ratio (considering seasonal variations) given the bank's size, financial condition, the credit needs of its assessment area(s), and taking into account, as appropriate, other lending-related activities such as loan originations for sale to the secondary markets and community development loans and qualified investments;
(B) A majority of its loans and, as appropriate, other lending-related activities, are in its assessment area;
(C) A distribution of loans to and, as appropriate, other lending-related activities for individuals of different income levels (including low- and moderate-income individuals) and businesses and farms of different sizes that is reasonable given the demographics of the bank's assessment area(s);
(D) A record of taking appropriate action, when warranted, in response to written complaints, if any, about the bank's performance in helping to meet the credit needs of its assessment area(s); and
(E) A reasonable geographic distribution of loans given the bank's assessment area(s).
(ii)
(iii)
(2)
(ii)
(iii)
(3)
(ii)
(B) A small bank that is not an intermediate small bank that meets each of the standards for a “satisfactory” rating under the lending test and exceeds some or all of those standards may warrant consideration for an overall rating of “outstanding.” In assessing whether a bank's performance is “outstanding,” the OCC considers the extent to which the bank exceeds each of the performance standards for a “satisfactory” rating and its performance in making qualified investments and its performance in providing branches and other services and delivery systems that enhance credit availability in its assessment area(s).
(iii)
For the reasons set forth in the joint preamble, the Board of Governors of the Federal Reserve System proposes to amend part 228 of chapter II of title 12 of the Code of Federal Regulations as follows:
1. The authority citation for part 228 continues to read as follows:
12 U.S.C. 321, 325, 1828(c), 1842, 1843, 1844, and 2901
2. In § 228.12, revise paragraphs (g)(1), (g)(4), and (u) to read as follows:
(g)
(1) Affordable housing (including multifamily rental housing) for low-or moderate-income individuals, individuals in underserved rural areas, or individuals located in designated disaster areas;
(4) Activities that revitalize or stabilize low- or moderate-income geographies, underserved rural areas, or designated disaster areas.
(u)
(2)
3. Revise § 228.26 to read as follows:
(a)
(2)
(b)
(1) The bank's loan-to-deposit ratio, adjusted for seasonal variation, and, as appropriate, other lending-related activities, such as loan originations for sale to the secondary markets, community development loans, or qualified investments;
(2) The percentage of loans and, as appropriate, other lending-related activities located in the bank's assessment area(s);
(3) The bank's record of lending to and, as appropriate, engaging in other lending-related activities for borrowers of different income levels and businesses and farms of different sizes;
(4) The geographic distribution of the bank's loans; and
(5) The bank's record of taking action, if warranted, in response to written complaints about its performance in helping to meet credit needs in its assessment area(s).
(c)
(1) The number and amount of community development loans;
(2) The number and amount of qualified investments;
(3) The extent to which the bank provides community development services; and
(4) The bank's responsiveness through such activities to community development lending, investment, and services needs.
3a. Revise § 228.28(c) to read as follows:
(c)
(i) Discrimination against applicants on a prohibited basis in violation, for example, of the Equal Credit Opportunity Act or the Fair Housing Act;
(ii) Violations of the Home Ownership and Equity Protection Act;
(iii) Violations of section 5 of the Federal Trade Commission Act;
(iv) Violations of section 8 of the Real Estate Settlement Procedures Act; and
(v) Violations of the Truth in Lending Act provisions regarding a consumer's right of rescission.
(2) In determining the effect of evidence of practices described in paragraph (c)(1) of this section on the bank's assigned rating, the Board considers the nature, extent, and strength of the evidence of the practices; the policies and procedures that the bank (or affiliate, as applicable) has in place to prevent the practices; any corrective action that the bank (or affiliate, as applicable) has taken or has committed to take, including voluntary corrective action resulting from self-assessment; and any other relevant information.
4. In Appendix A to part 228, revise paragraph (d) to read as follows:
(d)
(A) A reasonable loan-to-deposit ratio (considering seasonal variations) given the bank's size, financial condition, the credit needs of its assessment area(s), and taking into account, as appropriate, other lending-related activities such as loan originations for sale to the secondary markets and community development loans and qualified investments;
(B) A majority of its loans and, as appropriate, other lending-related activities, are in its assessment area;
(C) A distribution of loans to and, as appropriate, other lending-related activities for individuals of different income levels (including low- and moderate-income individuals) and businesses and farms of different sizes that is reasonable given the demographics of the bank's assessment area(s);
(D) A record of taking appropriate action, when warranted, in response to written complaints, if any, about the bank's performance in helping to meet the credit needs of its assessment area(s); and
(E) A reasonable geographic distribution of loans given the bank's assessment area(s).
(ii)
(iii)
(2)
(ii)
(iii)
(3)
(ii)
(B) A small bank that is not an intermediate small bank that meets each of the standards for a “satisfactory” rating under the lending test and exceeds some or all of those standards may warrant consideration for an overall rating of “outstanding.” In assessing whether a bank's performance is “outstanding,” the Board considers the extent to which the bank exceeds each of the performance standards for a “satisfactory” rating and its performance in making qualified investments and its performance in providing branches and other services and delivery systems that enhance credit availability in its assessment area(s).
(iii)
For the reasons set forth in the joint preamble, the Board of Directors of the Federal Deposit Insurance Corporation proposes to amend part 345 of chapter III of title 12 of the Code of Federal Regulations to read as follows:
1. The authority citation for part 345 continues to read as follows:
12 U.S.C. 1814-1817, 1819-1820, 1828, 1831u and 2901-2907, 3103-3104, and 3108(a).
2. In § 345.12, revise paragraphs (g)(1), (g)(4), and (u) to read as follows:
(g)
(1) Affordable housing (including multifamily rental housing) for low- or moderate-income individuals, individuals in underserved rural areas, or individuals located in designated disaster areas;
(4) Activities that revitalize or stabilize low- or moderate-income geographies, underserved rural areas, or designated disaster areas.
(u)
(2)
3. Revise § 345.26 to read as follows:
(a)
(2)
(b)
(1) The bank's loan-to-deposit ratio, adjusted for seasonal variation, and, as appropriate, other lending-related activities, such as loan originations for sale to the secondary markets, community development loans, or qualified investments;
(2) The percentage of loans and, as appropriate, other lending-related activities located in the bank's assessment area(s);
(3) The bank's record of lending to and, as appropriate, engaging in other lending-related activities for borrowers of different income levels and businesses and farms of different sizes;
(4) The geographic distribution of the bank's loans; and
(5) The bank's record of taking action, if warranted, in response to written complaints about its performance in helping to meet credit needs in its assessment area(s).
(c)
(1) The number and amount of community development loans;
(2) The number and amount of qualified investments;
(3) The extent to which the bank provides community development services; and
(4) The bank's responsiveness through such activities to community development lending, investment, and services needs.
3a. Revise § 345.28(c) to read as follows:
(c)
(i) Discrimination against applicants on a prohibited basis in violation, for example, of the Equal Credit Opportunity Act or the Fair Housing Act;
(ii) Violations of the Home Ownership and Equity Protection Act;
(iii) Violations of section 5 of the Federal Trade Commission Act;
(iv) Violations of section 8 of the Real Estate Settlement Procedures Act; and
(v) Violations of the Truth in Lending Act provisions regarding a consumer's right of rescission.
(2) In determining the effect of evidence of practices described in paragraph (c)(1) of this section on the bank's assigned rating, the FDIC considers the nature, extent, and strength of the evidence of the practices; the policies and procedures that the bank (or affiliate, as applicable) has in place to prevent the practices; any corrective action that the bank (or affiliate, as applicable) has taken or has committed to take, including voluntary corrective action resulting from self-assessment; and any other relevant information.
4. In Appendix A to part 345, revise paragraph (d) to read as follows:
(d)
(i)
(A) A reasonable loan-to-deposit ratio (considering seasonal variations) given the bank's size, financial condition, the credit needs of its assessment area(s), and taking into account, as appropriate, other lending-related activities such as loan originations for sale to the secondary markets and community development loans and qualified investments;
(B) A majority of its loans and, as appropriate, other lending-related activities, are in its assessment area;
(C) A distribution of loans to and, as appropriate, other lending-related activities for individuals of different income levels (including low- and moderate-income individuals) and businesses and farms of different sizes that is reasonable given the demographics of the bank's assessment area(s);
(D) A record of taking appropriate action, when warranted, in response to written complaints, if any, about the bank's performance in helping to meet the credit needs of its assessment area(s); and
(E) A reasonable geographic distribution of loans given the bank's assessment area(s).
(ii)
(iii)
(2)
(ii)
(iii)
(3)
(ii)
(B) A small bank that is not an intermediate small bank that meets each of the standards for a “satisfactory” rating under the lending test and exceeds some or all of those standards may warrant consideration for an overall rating of “outstanding.” In assessing whether a bank's performance is “outstanding,” the FDIC considers the extent to which the bank exceeds each of the performance standards for a “satisfactory” rating and its performance in making qualified investments and its performance in providing branches and other services and delivery systems that enhance credit availability in its assessment area(s).
(iii)
By order of the Board of Directors.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking.
This notice proposes to establish Class D airspace at Front Range Airport, Denver, Co. An Airport Traffic Control Tower (ATCT) is being constructed at Front Range Airport, Denver, CO which will meet criteria for Class D airspace, Class D airspace is required when the ATCT is open, and to contain and protect Standard Instrument Approach Procedures (SIAPs) and other Instrument Flight Rules (IFR) operations at the airport. This action would establish Class D airspace extending upward from the surface to 8,000 feet Mean Sea Level (MSL) within a 5.1 nautical mile radius of the airport.
Comments must be received on or before April 11, 2005.
Send comments on this proposal to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2005-20248/Airspace Docket No. 05-AWP-1, at the beginning of your comments. You may also submit comments on the Internet at
An informal docket may also be examined during normal business hours at the office of the Regional Air Traffic Division, Federal Aviation Administration, Room 2010, 15000 Aviation Boulevard, Lawndale California, 90261.
Larry Tonish, Airspace Specialist, Airspace Branch, Air Traffic Division, Federal Aviation Administration, 15000 Aviation Boulevard, Lawndale, California; telephone (310) 725-6613.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2005-20248/Airspace Docket No. 05-AWP-1.” The postcard will be date/time stamped and returned to the commenter. All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
The FAA is considering an amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) to establish Class D airspace at Front Range Airport, Denver, CO. An ATCT is being constructed at Front Range Airport, and Class D airspace is required during the hours the ATCT is open. Class D controlled airspace is necessary for the safety of aircraft executing SIAPs and other IFR operations at Front Range 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 Directors.
Class D airspace designations for airspace areas extending upward from the surface of the earth are published in Paragraph 5000 of FAA Order 7400.9M, dated August 30, 2004, and effective September 16, 2004, 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 proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (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.
Airspace, Incorporation by reference, navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for Part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., 389.
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, is amended as follows:
That airspace extending upward from the surface to 8,000 feet MSL within a 5.1 nautical mile radius of the Front Range Airport, Denver, CO, excluding the Denver International Airport Class B. This Class D airspace area is effective during the specific days and times established in advance by a Notice to Airmen. The effective days and times will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking.
This action proposes to revise the Class E airspace at Nome, AK. New Standard instrument approach procedures (SIAP's) are being published for Nome, AK. Additional Class E airspace is needed to contain aircraft executing instrument approaches at Nome Airport. Adoption of this proposal would result in additional Class E surface area and Class E airspace upward from 700 feet (ft.) and 1,200 ft. above the surface at Nome, AK.
Comments must be received on or before April 25, 2005.
Send comments on the proposal to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2005-20449/Airspace Docket No. 05-AAL-06, at the beginning of your comments. You may also submit comments on the Internet at
An informal docket may also be examined during normal business hours at the office of the Manager, Safety, Alaska Flight Services Operations, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2005-20449/Airspace Docket No. 05-AAL-06.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration, Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591 or by calling (202) 267-8783. Communications must identify both docket numbers for this notice. Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is considering an amendment to the Code of Federal Regulations (14 CFR part 71), by adding Class E airspace at Nome, AK. The intended effect of this proposal is to revise the Class E surface area and Class E airspace upward from 700 ft. and 1,200 ft above the surface to contain Instrument Flight Rules (IFR) operations at Nome, AK.
The FAA Instrument Flight Procedures Production and Maintenance Branch has developed four new SIAPs for the Nome Airport. The new approaches are (1) Area Navigation (Global Positioning System) (RNAV GPS) Runway (RWY) 3, original; (2) RNAV (GPS) RWY 10, original; (3) RNAV (GPS) RWY 28, original; and (4) Non-directional Beacon (NDB)-A, original. Revised Class E surface area and Class E controlled airspace extending upward from 700 ft. and 1,200 ft. above the surface of the Nome Airport would be created by this action. The proposed airspace is sufficient to contain aircraft executing the new instrument procedures for the Nome Airport.
The area would be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as surface areas are published in paragraph 6002, and the Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 in FAA Order 7400.9M,
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it proposes to revise Class E airspace sufficient to contain aircraft executing instrument approaches at Nome Airport and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for 14 CFR part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9M,
Within a 4.1-mile radius of the Nome Airport and within 3.4 miles each side of the Nome Airport 106° bearing extending from the 4.1-mile radius to 13.2 miles east of the airport, and within 3.4 miles each side of the Nome Airport 288° bearing extending from the 4.1-mile radius to 6 miles west of the airport, and within 3.5 miles each side of the Nome Airport 229° bearing extending from the 4.1-mile radius to 6 miles west of the airport. This Class E airspace area is effective during the specific dates and time established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface within an 25-mile radius of the Nome Airport excluding that airspace beyond 12-miles of the shoreline; and that airspace extending upward from 1,200 feet above the surface within an 77.4-mile radius of the Nome VORTAC, excluding that airspace beyond 12-miles of the shoreline.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations that provide guidance regarding the treatment of payments made on account of sickness or accident disability under a workers' compensation law for purposes of the Federal Insurance Contributions Act (FICA).
Written and electronic comments must be received by June 9, 2005.
Send submissions to: CC: PA:LPD: PR (REG-160315-03), room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-160315-03), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayer may submit comments electronically, via the IRS Internet site at
Concerning the proposed regulations, David Ford of the Office of Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities), (202) 622-6040; concerning submissions of comments, the hearing and/or to be placed on the building access list to attend the hearing, LaNita M. VanDyke, (202) 622-7180 (not toll-free numbers).
This document contains proposed amendments to 26 CFR part 31 under section 3121 of the Internal Revenue Code (the Code.) Section 3121(a)(2)(A) of the Code excepts from “wages” for FICA tax purposes payments to an employee or any of his dependents on account of sickness or accident disability only if the payments are received under a “workmen's compensation law”, hereinafter referred to as a workers” compensation law. The amendment to the regulations provides that for purposes of section 3121(a)(2)(A) a workers' compensation law includes a statute in the nature of a workers' compensation act.
Section 3121(a) defines wages for FICA purposes as all remuneration for employment unless specifically excepted. Section 3121(a)(2)(A) excepts from wages the amount of any payment (including any amount paid by an employer for insurance or annuities, or into a fund, to provide for any such payment) made to or on behalf of, an employee or any of his dependents under a plan or system established by an employer which makes provision for his employees generally (or for his employees generally and their dependents) or for a class or classes of his employees (or for a class or classes of his employees and their dependents), on account of sickness or accident disability, but only if the employee receives the payments under a workers' compensation law. Section 3121(a)(4) provides that wages does not include any payment on account of sickness or accident disability made by an employer to or on behalf of an employee after the expiration of 6 calendar months following the last calendar month in which the employee worked for the employer. Thus, unless made under a workers' compensation law, payments received on account of sickness or accident disability are wages subject to FICA during the first 6 months the employee is out of work.
Prior to its amendment by section 3(b)(1) of Public Law 97-123, (95 Stat. 1659 1982-6 I.R.B. 7)) (the 1981 Act), section 3121(a)(2)(B), the predecessor to section 3121(a)(2)(A), excluded from wages any payments made under a plan or system established by an employer on account of sickness or accident disability. There was no requirement that payments be made under a workers' compensation law. Thus, the 1981 Act narrowed the sick pay exclusion by limiting the exclusion from FICA to payments made under a worker's compensation law. Section 3(e) of the 1981 Act did not amend the Code, but specifies for purposes of section 3121(a) of the Code that a payment under a workers' compensation law does not include a payment made pursuant to a State temporary disability insurance law.
On July 6, 1982, the IRS issued Temporary regulations (TD 7823, 47 FR 29225, July 6, 1982). Section 32.1(a)(1) of the Temporary Employment Tax Regulations follows the amendments made by the 1981 Act providing that payments on account of sickness or accident disability are excluded from wages for FICA purposes only if paid under a workers' compensation law. Section 32.1(a)(1). Further, Section 32.1(c) provides that a payment under a workers' compensation law does not include a payment made pursuant to a State temporary disability insurance law. Thus, such payments are wages for FICA purposes. The temporary regulations do not address the FICA tax treatment of payments made under a statute in the nature of a workers' compensation act.
For income tax purposes, section 104(a)(1) provides that gross income does not include amounts received under workers' compensation acts as compensation for personal injuries or sickness. Section 1.104-1(b) of the Income Tax Regulations states that section 104(a)(1) of the Code excludes from gross income amounts received by an employee under a workers' compensation act or under a statute in the nature of a workers' compensation act that provides compensation to the employee for personal injury or sickness incurred in the course of employment.
The IRS takes the position that gross income for income tax purposes is a separate concept from wages for purposes of FICA. Furthermore, exclusions from wages for FICA purposes are to be construed narrowly. Thus, amounts that are excluded from gross income, in the absence of a specific statutory or regulatory exclusion from wages, constitute wages for FICA.
Pursuant to the income tax regulations, payments made under a statute in the nature of a workers' compensation act are excluded from gross income under section 104. However, there is no regulation at present addressing whether such payments are excluded from wages for FICA purposes.
Through 1989, the IRS issued several private letter rulings concluding that payments made under a statute in the nature of a workers' compensation act were excluded from gross income and exempt from FICA. In 1990, based on the Service's position that the exclusion from gross income did not necessarily
Questions have arisen concerning the FICA tax treatment of payments made under a statute in the nature of a workers' compensation act to employees of States and local governments who are not eligible to receive payments under a workers' compensation law. Accordingly, the IRS and Treasury are seeking to provide rules to clarify the treatment of such payments during the first six months the employee is out of work.
Under the proposed regulations, payments made under a statute in the nature of a workers' compensation act will be treated as having been made under a workers' compensation law and, therefore, will be excluded from wages for FICA purposes. Thus, the regulations adopt the same position that was published in Rev. Proc. 82-20, the most contemporaneous guidance to the legislation that created the current statutory scheme. The proposed regulations thus align the interpretation of what constitutes payments received under a workers' compensation law for purposes of section 3121(a)(2)(A) with the interpretation of amounts received under a workers' compensation law for purposes of section 104(a)(1).
These proposed regulations are intended to address only the treatment of payments under a statute in the nature of a workers' compensation act for FICA purposes. The existing temporary regulations under section 31.1 which address the FICA treatment of payments under a workers' compensation law also provide guidance to third parties making payments on account of sickness or accident disability. Treasury and the IRS are not proposing any changes to the regulations with respect to the FICA treatment of third-party sick pay. To the extent it is necessary to modify the temporary regulations to harmonize them with these proposed regulations, the third-party sick pay provisions will be preserved. To the extent necessary, future guidance will also address the treatment of payments on account of sickness or accident disability for Federal Unemployment Tax Act and Railroad Retirement Tax Act purposes.
It is proposed that these regulations apply to payments made on or after the date the proposed regulation is published as Final in the
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. In addition, because no collection of information is imposed on small entities, the provisions of the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply, and, therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Code, this notice of proposed rulemaking will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on the impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department request comments on all aspects of the proposed regulations and how they can be made easier to understand. All comments will be available for public inspection and copying. A public hearing may be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the
The principal author of these regulations is David Ford of the Office of Division Counsel/Associate Chief Counsel (Tax Exempt/Government Entities). However, other personnel from the IRS and Treasury Department participated in their development.
Employment taxes and collection of income at the source.
Accordingly, 26 CFR part 31 is proposed to be amended as follows:
26 U.S.C. 7805 * * *.
1. Revising the section heading.
2. Removing paragraph (a)(1).
3. Redesignating paragraphs (a)(2) through (a)(4) as (a)(1) through (a)(3), respectively.
4. Revising newly designated paragraph (a)(1).
5. Redesignating paragraph (d) as paragraph (f).
6. Adding new paragraphs (d) and (e).
The revisions and additions are as follows:
(a) * * *
(1) Sickness or accident disability of an employee or any of his dependents, only if payment is received under a workers' compensation law;
(d)
(2) For purposes of paragraph (a)(1) of this section, a payment made under a workers' compensation law does not include a payment made pursuant to a State temporary disability insurance law.
(3) If an employee receives a payment on account of sickness or accident disability that is not made under a workers' compensation law or a statute in the nature of a workers' compensation act, the payment is not excluded from wages as defined by section 3121(a)(2)(A) even if the payment must be repaid if the employee receives a workers' compensation award or an award under a statute in the nature of a workers' compensation act with respect to the same period of absence from work.
(4) If an employee receives a payment on account of non-occupational injury sickness or accident disability such payment is not excluded from wages, as defined by section 3121(a)(2)(A).
(e)
A local government employee is injured while performing work-related
The facts are the same as in Example 1 except that the local ordinance requires the employer to continue to pay the employee's full salary while the employee is unable to work due to an injury whether or not the injury is work-related. Thus, the local ordinance does not limit benefits to instances of work-related disability. A benefit paid under an ordinance that does not limit benefits to instances of work-related injuries is not a statute in the nature of a workers' compensation act. Therefore, the salary the injured employee receives from the employer while out of work is wages subject to FICA even though the employee's injury is work-related.
The facts are the same as in Example 1 except that the local ordinance includes a rebuttable presumption that certain injuries, including any heart attack incurred by a firefighter or other law enforcement personnel is work-related. The presumption in the ordinance does not eliminate the requirement that the injury be work-related in order to entitle the injured worker to full salary. Therefore, the ordinance is a statute in the nature of a workers' compensation act, and the salary the injured employee receives pursuant to the ordinance is excluded from wages under section 3121(a)(2)(A).
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking by cross-reference to temporary regulations.
In the Rules and Regulations section of this issue of
Written and electronic comments and requests for a public hearing must be received by June 9, 2005.
Send submissions to: CC:PA:LPD:PR (REG-147195-04), room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-148864-03), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC or sent electronically, via the IRS Internet site at:
Concerning submission of comments, Treena Garrett, (202) 622-7180 (not a toll-free number); concerning the temporary regulations, James O'Leary, (202) 622-4580 (not a toll-free number).
Under section 6103(j)(1), upon written request from the Secretary of Commerce, the Secretary of the Treasury is to furnish to the Bureau of the Census (Bureau) return information that is prescribed by Treasury regulations for the purpose of, but only to the extent necessary in, structuring censuses and national economic accounts and conducting related statistical activities authorized by law. Section 301.6103(j)(1)-1 of the regulations provides an itemized description of the return information authorized to be disclosed for this purpose. Periodically, the disclosure regulations are amended to reflect the changing needs of the Bureau for data for its statutorily authorized statistical activities.
This document contains proposed regulations authorizing IRS personnel to disclose additional items of return information that have been requested by the Secretary of Commerce, and to remove certain items of return information that are enumerated in the existing regulations but that the Secretary of Commerce has indicated are no longer needed.
Temporary regulations in the Rules and Regulations section of this issue of the
The text of the temporary regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations explains the proposed regulations.
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, these proposed regulations will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any electronic and written comments (a signed original and eight (8) copies) that are submitted timely to the IRS. The IRS and Treasury Department specifically request comments on the clarity of the proposed regulations and how they can be made easier to understand. All comments will be available for public inspection and copying. A public hearing may be scheduled if requested in writing by a person that timely submits comments. If a public hearing is scheduled, notice of the date, time, and place for the hearing will be published in the
The principal author of these regulations is James C. O'Leary, Office of the Associate Chief Counsel (Procedure & Administration), Disclosure and Privacy Law Division.
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 301 is proposed to be amended as follows:
26 U.S.C. 7805 * * *.
Section 301.6103(j)(1)-1 also issued under 26 U.S.C. 6103(j)(1); * * *.
Office of the Chief Acquisition Officer, General Services Administration (GSA).
Advance notice of proposed rulemaking and notice of public meeting.
The General Services Administration (GSA) is requesting comments from both Government and industry on whether the General Services Administration Acquisition Regulation (GSAR) should be revised to include a waiver of consequential damages for contracts awarded for commercial item under the FAR. GSA is also requesting comments on whether “post award” audit provisions should be included in its Multiple Award Schedules (MAS) contracts and Governmentwide acquisition contracts (GWACs).
Submit comments identified by GSAR ANPR 2005-N01 by any of the following methods:
• Federal eRulemaking Portal:
• Agency Web Site:
• E-mail:
• Fax: 202-501-4067.
• Mail: General Services Administration, Regulatory Secretariat (VIR), 1800 F Street, NW, Room 4035, ATTN: Laurieann Duarte, Washington, DC 20405.
To facilitate discussions at the public meeting, interested parties are encouraged to provide, no later than March 25, 2005 written comments on issues they would like addressed at the meeting. There will be no record kept of this meeting, any comments to be made a part of the administrative record must be in writing and must be submitted to GSA at the address below within two weeks following the public meeting.
The meeting will be held at the General Services Administration, National Capital Region, 301 7th and D Street, SW, Washington, DC 20407, Auditorium. Participants are encouraged to check the Web site prior to the public meeting to ensure the location has not changed. Interested parties may register and submit electronic comments at
Mr. Ernest Woodson, Procurement Analyst, Contract Policy Division, 202-501-3775.
Currently, FAR Part 12, Acquisition of Commercial Items, prescribes polices and procedures unique to the acquisition of commercial items under FAR Part 12. FAR Part 12 implements the Government's preference for the acquisition of commercial items as contained in Title VIII of the Federal Acquisition Streamlining Act of 1994 by establishing policies more closely resembling those of the commercial marketplace. The clause, FAR 52.212-4, Contract Terms and Conditions—Commercial Items, that includes terms and conditions applicable to each acquisition procured under FAR Part 12 is, to the maximum extent practicable, consistent with customary commercial practices. The clause includes a provision, FAR 52.212-4(p), Limitation of liability, that provides; “Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.” Also, FAR 12.302(b) allows the contracting officer to tailor the clause at FAR 52.212-4 to adapt to market conditions for each commercial acquisition. In addition to the limitation of liability clause and the provision at FAR 12.302, Federal contracts typically include a broad range of standard contract clauses such as warranties and liquidated damages that provide exclusive remedies for nonperformance that limit the Government to the specific remedies set forth in the clause.
Likewise, the Contract Disputes Act of 1978 provides for the resolution of any failure on the part of the Government and the contractor to reach agreement on any request for equitable adjustment, claim, appeal, or action arising under or relating to a Government contract to be a dispute to be resolved in accordance with FAR 52.233-1, Disputes.
Notwithstanding specific adjustments and other remedies provided in Government contracts for contractor deficiencies or nonperformance, concerns have been raised that—
• FAR clause 52.212-4(p) and the “tailoring” provision at FAR 12.302, do not reach the level of commercial standards and that unlimited consequential or other incidental or special damages are not necessary and are, in fact, counterproductive to efficient procurement, raising costs and establishing barriers to commercial companies considering whether to do business with the Federal Government;
• Although FAR 12.302 permits contracting officers to tailor the limitation of liability clause at FAR 52.212-4(p), some companies assert that contracting officers are unwilling to do so, leaving contractors with a take-it or leave-it option and contracts that deviate from the commercial marketplace, making contractors in general less willing to sign on to such contracts;
• The commercial practice, unlike FAR 52.212-4(p), that waives liability for consequential damages resulting from any defect or deficiencies in accepted items, provides for a complete wavier of consequential damages;
• Contractors would make risk decisions and negotiate Government contracts without having to add an uncertainty premium as to liability protection, if FAR Part 12 were appropriately amended to reflect commercial practices; and
• Contractors also request that we make the waiver of consequential damages for commercial products and services available under other provisions of the FAR.
Similarly, the General Accounting Office and periodically GSA's IG raise concerns regarding GSA's right to access and examine contractor records after contract award. GSA's primary vehicle for conducting post-award audits is GSAR 552.215-70, Examination of Records by GSA, that gives the Administrator of GSA, or any duly authorized representative, typically the GSA Inspector General's Office of Audits, access to and the right to examine contractor records relating to over billings, billing errors, compliance with the Industrial Funding Fee (IFF) clause of the contract, and compliance with the Price Reduction Clause under MAS contracts.
In addition to the GSA Examination of Records clause, GSA may use a number of other authorities to conduct a post-award review of a contractor's records. These other authorities include FAR 52.212-5 which authorizes the Comptroller General of the United States to access and examine a contractor's directly pertinent records involving transactions related to the contract; GSAR 515.209-70(b) that permits a contracting officer to modify the GSA Examination of Records Clause to define the specific area of audit (e.g., the use or disposition of Government-furnished property, compliance with price reduction clause, etc.), and the right of the GSA Inspector General to issue subpoenas for contractor records under the Inspector General Act of 1978.
Contractors' major concerns with GSA's post-award audit authority include complaints that they are too broad and not consistent with commercial contract practices.
In consideration of the above concerns, we have questions as to how the taxpayer may benefit from any revisions to the GSAR to address contractor concerns regarding limitation of liability or post-award audits. We are also interested in learning what, if any, impact the Services Acquisition Reform Act of 2002 and 2003 has on the issue of revising the GSAR to address limitations of liability.
In this advance notice of proposed rulemaking and notice of public meeting, GSA is seeking input from both Government and industry on whether the GSAR should be revised to waive consequential damages in the purchase of commercial items under FAR Parts 12, 13, 14, and 15 and whether GSA should modify its policy and practices with regard to the addition of post award audit clauses into contracts it awards.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes specifications for the spiny dogfish fishery for the 2005 fishing year, which is May 1, 2005, through April 30, 2006. The implementing regulations for the Spiny Dogfish Fishery Management Plan (FMP) require NMFS to publish specifications for the upcoming fishing year and to provide an opportunity for public comment. The intent of this rulemaking is to specify the commercial quota and other management measures, such as possession limits, to rebuild the spiny dogfish resource.
Public comments must be received (see
Comments on the proposed specifications should be sent:
• Mail: Paper, disk, or CD-ROM comments should be sent to Patricia A. Kurkul, Regional Administrator, Northeast Region, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930-2298. Mark on the outside of the envelope, “Comments—2005 Spiny Dogfish Specifications.”
• FAX: Fax comments to (978) 281-9135.
• E-mail: E-mail comments to
• Comments may also be submitted electronically through the Federal e-Rulemaking portal:
Copies of supporting documents used by the Joint Spiny Dogfish Committee and the Spiny Dogfish Monitoring Committee; the Environmental Assessment, Regulatory Impact Review, Initial Regulatory Flexibility Analysis (EA/RIR/IRFA); and the Essential Fish Habitat Assessment (EFHA) are available from Daniel Furlong, Executive Director, Mid-Atlantic Fishery Management Council, Federal Building, Room 2115, 300 South Street, Dover, DE 19904. The EA, RIR, IRFA, and EFHA are accessible via the Internet at
Eric Jay Dolin, Fishery Policy Analyst, (978)281-9259, fax (978)281z6 9135.
Spiny dogfish were declared overfished by NMFS on April 3, 1998, and added to that year's list of overfished stocks in the
The regulations implementing the FMP at 50 CFR part 648, subpart L, outline the process for specifying annually the commercial quota and other management measures (e.g., minimum or maximum fish sizes, seasons, mesh size restrictions, possession limits, and other gear restrictions) for the spiny dogfish fishery to achieve the annual target F specified in the FMP. The target F for the 2005 fishing year is not to exceed 0.08.
The Spiny Dogfish Monitoring Committee (Monitoring Committee), comprised of representatives from states; MAFMC staff; New England Fishery Management Council (NEFMC) staff; NMFS staff; and two non-voting, ex-officio industry representatives (one each from the MAFMC and NEFMC regions) is required to review annually the best available information and to recommend a commercial quota and other management measures necessary to achieve the target F for the upcoming fishing year. The Council's Joint Spiny Dogfish Committee (Joint Committee) then considers the Monitoring Committee's recommendations and any public comment in making its recommendation to the two Councils. Afterwards, the MAFMC and the NEFMC make their recommendations to NMFS. NMFS reviews those recommendations to assure they are consistent with the FMP, and may modify them if necessary. NMFS then publishes proposed measures for public comment.
The Monitoring Committee met on September 24, 2004, and developed recommendations for the 2005 fishery based on stock conditions estimated from the latest stock status updates. According to the latest (2004) spring survey values, the 3-year moving average of total stock biomass decreased from 916 million lb (415 million kg) in 2001-2003 to 857 million lb (389 million kg) in 2002-2004. Mature female biomass decreased from 144 million lb (65.3 million kg) in 2001-2003 to 132 million lb (59.9 million kg) in 2002-2004. Pup abundance, however, increased from 338 thousand lb (153,314 kg) in 2001-2003 to 1.440 million lb (653,173 kg) in 2002-2004.
Although the FMP stipulates a target fishing mortality rate of F=0.08 for the upcoming fishing year, the 37
Because the updated stock status information reviewed by the Monitoring Committee indicated that mature female biomass had not increased in 2004 compared to 2003 estimates, the Monitoring Committee could find no biological justification for deviating from the advice of the 37th SARC. The Monitoring Committee, therefore, recommended maintaining the status quo management measures for the upcoming fishing year to encourage the rebuilding of the mature female biomass. These measures are: an annual incidental catch quota of 4 million lb (1.81 million kg) divided into two semi-annual quota periods (quota period 1 (May 1, 2005 October 31, 2005) = 2.316 million lb (1.05 million kg), and quota period 2 (November 1, 2005 April 30, 2006) = 1.684 million lb (763,849 kg)), and possession limits of 600 lb (272 kg) for quota period 1 and 300 lb (136 kg) for quota period 2 (vessels are prohibited from landing more than the specified amount in any one calendar day).
The Joint Committee met on October 4, 2004, and recommended that, for the 2005 fishing year (May 1, 2005 April 30, 2006), the Councils adopt a quota of 4 million lb (1.81 million kg), and that possession limits be set at 1,500 lb (680 kg) of male spiny dogfish (i.e., a prohibition on the possession of female spiny dogfish) for the entire year. In the view of the Joint Committee, the increased possession limits would accommodate the high volume demand required by the processing sector of the spiny dogfish fishery, while the prohibition on possession of female spiny dogfish would help protect that component of the stock. At its October 4, 2004, meeting, the MAFMC reviewed the Monitoring Committee and Joint Committee recommendations, and adopted the Joint Committee's recommended specifications for the 2005 fishing year. The NEFMC, on the other hand, at its November 18, 2004, meeting, endorsed the Monitoring Committee's recommendations; namely, maintaining the status quo.
On November 9, 2004, the ASFMC Spiny Dogfish and Coastal Shark Management Board approved specifications for the 2005 fishing year, which are the same as the Federal status quo.
NMFS reviewed both Councils' recommendations and concluded that maintaining the status quo, which is the same as the Monitoring Committee's recommendation, would better assure that the target F is not exceeded. NMFS proposes a commercial spiny dogfish quota of 4 million lb (1.81 million kg) for the 2005 fishing year to be divided into two semi-annual periods as follows: 2,316,000 lb (1.05 million kg) for quota period 1 (May 1, 2005 - Oct. 31, 2005); and 1,684,000 lb (763,849 kg) for quota period 2 (Nov. 1, 2005 - April 30, 2006). In addition, NMFS proposes to maintain possession limits of 600 lb (272 kg) for quota period 1, and 300 lb (136 kg) for quota period 2, to discourage a directed fishery. The directed fishery has traditionally targeted large, mature female spiny dogfish, the stock component that is most in need of protection and rebuilding. Maintaining the limits of 600 lb (272 kg) and 300 lb (136 kg) for quota periods 1 and 2, respectively, would allow for the retention of spiny dogfish caught incidentally while fishing for other species, but discourage directed fishing and, therefore, provide protection for mature female spiny dogfish.
Maintaining the status quo would also be consistent with the measures being implemented under the ASMFC's Interstate Fishery Management Plan in state waters. This would have the benefit of establishing consistent management measures in Federal and state jurisdictions.
This action is authorized by 50 CFR part 648 and has been determined to be
The Council prepared an IRFA, as required by section 603 of the Regulatory Flexibility Act, which describes the economic impacts this proposed rule, if adopted, would have on small entities. A copy of the IRFA can be obtained from the Council or NMFS (see
A description of the reasons why this action is being considered, and the objectives of and legal basis for this action, is contained in the preamble to this proposed rule and is not repeated here.
All of the potentially affected businesses are considered small entities under the standards described in NMFS guidelines because they have gross receipts that do not exceed $3.5 million annually. Information from the 2003 fishing year was used to evaluate impacts of this action, as that is the most recent year for which data are complete. According to unpublished NMFS permit file data, 3,025 vessels possessed Federal spiny dogfish permits in 2003, while 94 of these vessels contributed to overall landings.
This action does not contain any new collection-of-information, reporting, recordkeeping, or other compliance requirements. It does not duplicate, overlap, or conflict with any other Federal rules.
The IRFA considered three alternatives. The action recommended in this proposed rule includes a commercial quota of 4 million lb (1.81 million kg), and possession limits of 600 lb (272 kg) during quota period 1 and 300 lb (136 kg) during quota period 2. Alternative 2 evaluates the MAFMC proposal, which would set a 4-million-lb (1.81 million kg) quota, with possession limits of 1,500 lb (680 kg) of male-only spiny dogfish in both quota periods. Alternative 3 evaluates the impact of having no management measures (no action).
Because, under Alternative 1, the specifications would remain unchanged, revenues from dogfish harvest under this alternative should be equivalent to the status quo, except for changes in market value. Note, however, that the 2003 quota (4.00 million lb (1.81 million kg)) is 27.0 percent more than what was actually landed (3.14 million lb (1.42 million kg)). Therefore, unlike previous years, in which the quota was exceeded, the federally permitted fleet should not experience a decrease in dogfish fishing opportunity, were this alternative to be implemented.
In addition to the quota of 4.0 million lb (1.81 million kg), Alternative 1 includes continuation of status quo possession limits of 600 lb (272 kg) in quota period 1 and 300 (176 kg) during quota period 2 in 2004. Continuation of these possession limits in 2005 is, therefore, not expected to result in significant revenue loss. These very low possession limits were recommended for the explicit purpose of eliminating the directed harvest of spiny dogfish. While the short-term economic impacts of the status quo possession limits are negative relative to higher possession limits (Alternative 2) or an unregulated fishery (Alternative 3), Alternative 1 rebuilds the stock fastest and thus economic and social benefits of a recovered stock will be realized more quickly.
No gross revenue impacts are anticipated as a function of the Alternative 2 quota relative to the status quo/Alternative 1, since the recommended quotas are identical. Additionally, the potential for increases in revenue from the larger possession limit allowance is precluded by the implementation of status quo possession limits by the ASMFC. This leaves the male-only possession restriction as the only potential source of revenue impacts under Alternative 2. The likelihood of a directed male-only spiny dogfish fishery developing in the Exclusive Economic Zone is low, since the fact that females attain a larger maximum size makes them more generally marketable. As such, it likely that retention of spiny dogfish in the Exclusive Economic Zone will decrease under Alternative 2. This would represent a slight loss, given that an estimated 1.8 percent of the total 2003 spiny dogfish landings came from the Exclusive Economic Zone. As such, it is unlikely that this alternative will produce significant revenue impacts.
Given that no quota is specified in Alternative 3, landings are expected to return to the levels approximately equal to those observed in the unregulated period of the fishery (about 25 million lb (11.3 million kg)). This would constitute a 525-percent increase in landings compared to the status quo (4.0 million lb (1.81 million kg)) and a 696-percent increase in landings compared to actual 2003 landings (3.14 million lb (1.42 million kg). Although the short-term social and economic benefits of an unregulated fishery would be much greater than those associated with Alternatives 1 and 2, fishing mortality is expected to rise above the threshold level that allows the stock to replace itself such that stock rebuilding could not occur. In the long term, unregulated harvest would lead to depletion of the spiny dogfish population, which would eventually eliminate the spiny dogfish fishery altogether.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collectin of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Agricultural Marketing Service, USDA.
Notice; withdrawal.
The Agricultural Marketing Service (AMS) is withdrawing the notice soliciting comments on its proposal to amend the voluntary United States Standards for Grades of Cucumbers. After reviewing and considering the comments received, the Agency has decided not to proceed with this action.
March 11, 2005.
David Priester, Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Room 1661 South Building, STOP 0240, Washington, DC 20250-0240, Fax (202) 720-8871 or call (202) 720-2185; e-mail
At a 2003 meeting with the Fruit and Vegetable Industry Advisory Committee, AMS was asked to review all the fresh fruit and vegetable grade standards for usefulness in serving the industry. AMS had identified the United States Standards for Grades of Cucumbers for a possible revision. The United States Standards for Grades of Cucumbers were last amended March 1, 1958.
On June 25, 2004, a notice requesting comments on the possible revision of the standards by incorporating industry terms as well as other changes was published in the
Three comments were received during the official period for comment. One comment from a consumer did not support revising the standard. One comment from an industry member supported the inclusion of industry terms. The commenter stated, “I feel we should have two categories for Super Selects: #1 criteria being a 66-76 count and a #2 criteria being a 56-65 count.” However, another industry member commented, “That the terms Super Select, Select, Small, Large and Plain are commonly used by the industry to convey the desired size, quality and condition of cucumbers but that the criteria for these terms are not consistently defined. This commenter noted that the meaning is often interpreted differently by various trading partners.” This industry member further stated, “* * * that wholesale receivers and the greater produce industry would be better served if current trading practices were supported by a system of U.S. grade standards that establish reasonable parameters for size, consistency of size within packs and provide more meaningful definitions for quality and condition.” However, the commenter did not include those definitions.
While some members of the industry agree that a consistency of size and specific count ranges would promote orderly marketing, different segments within the industry are divided over the meanings of industry terms. In view of the lack of any substantial consensus as to whether the proposed inclusion of industry terms would meet the needs of the entire industry, the notice is being withdrawn. The withdrawal of this notice will provide industry representatives with an opportunity for further discussions in the areas of mutual concern.
After reviewing and considering the comments received, the Agency has decided not to proceed with the action. Therefore, the notice published June 25, 2004 (69 FR 35572), is withdrawn.
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice; request for public comment.
The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is soliciting comments on it's proposal to revise the United States Standards for Grades of Kale. This action is being taken at the request of the Fruit and Vegetable Industry Advisory Committee, which asked AMS to review the grade standards for possible revision. AMS is proposing to revise the standards to allow percentages to be determined by count rather than weight. AMS is also proposing to revise the application of tolerances for packages which contain less than 15 specimens. Additionally, based on a request from an industry group, the North American Perishable Agriculture Receivers (NAPAR), AMS is proposing to allow the standards to be used for kale leaves and bunches of leaves in addition to kale plants. The proposed revision would bring the standards for kale in line with current marketing practices, thereby improving the usefulness in serving the industry.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 1661, South Building, Stop 0240, Washington, DC 20250-0240; Fax (202)
Comments should make reference to the dates and page number of this issue of the
David L. Priester, at the above address or call (202) 720-2185; E-mail
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal Marketing Orders or U.S. Import Requirements no longer appear in the Code of Federal Regulations, but are maintained by USDA/AMS/Fruit and Vegetable Programs.
AMS is proposing to revise the voluntary U.S. Standards for Grades of Kale using procedures that appear in Part 36 Title 7 of the Code of Federal Regulations (7 CFR Part 36). These standards were last revised in 1934.
Prior to undertaking research and other work associated with revision of the grade standards, AMS published a notice in the
In response to our request for comments, AMS received one comment from an industry group, NAPAR. The comment was in favor of the proposed revision.
The proposed revision will allow percentages to be determined by count rather than weight. AMS is also proposing to revise the application of tolerances for packages which contain less than 15 specimens. This change will allow double the tolerances specified, and that at least one defective specimen may be permitted in any sample, as long as the average for the entire lot is within the tolerance specified for the grade.
AMS also received a request from NAPAR to allow the standards to be used for kale leaves and bunched kale leaves in addition to kale plants. Currently the standards only apply to kale plants. This proposal will bring the standards for kale in line with current marketing practices, thereby, improving the usefulness of the standards in serving the industry.
The official grade of a lot of kale covered by these standards is determined by the procedures set forth in the Regulations Governing Inspection, Certification, and Standards of Fresh Fruits, Vegetables and Other Products (Sec. 51.1 to 51.61).
This notice provides for a 60-day comment period for interested parties to comment on changes to the standard.
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice; request for public comment.
The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is soliciting comments on the proposed voluntary U.S. Standards for Grades of Mangos. Members of the Fruit and Vegetable Industry Advisory Committee, the Fresh Produce Association of the Americas and other members of the mango industry have requested this action to be taken. The proposed standards would provide industry with a common language and uniform basis for trading, thus promoting orderly and efficient marketing of mangos.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Room 1661, South Building, Stop 0240, Washington, DC 20250-0240, fax (202) 720-8871, e-mail
The draft of the United States Standards for Grades of Mangos is available by accessing AMS's home page on the Internet at:
David L. Priester, at the above address or call (202) 720-2185, e-mail
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal Marketing Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by the USDA/AMS/Fruit and Vegetable Programs.
AMS is proposing to establish voluntary U.S. Standards for Grades of Mangos using the procedures that appear in part 36 title 7 of the Code of Federal Regulations (7 CFR part 36).
On December 16, 2003, AMS published a notice in the
Based on those comments, AMS has developed proposed grade standards for mangos. These standards contain sections pertaining to grades, sizes,
According to AMS' Market News Branch Summaries referenced in the Fresh Fruit and Vegetable Shipments Report, from 1993 through 2003 mango importation continued to steadily increase in the U.S. Recently, the mango industry stressed the need for U.S. standards which would provide a uniform basis for trading mangos that are imported, exported, or marketed domestically.
The adoption of these proposed standards would provide the rapidly growing mango industry with U.S. grade standards similar to those extensively in use by the fresh produce industry to assist in orderly marketing of other commodities.
The official grade of a lot of mangos covered by these standards will be determined by the procedures set forth in the Regulations Governing Inspection, Certification, and Standards of Fresh Fruits, Vegetables and Other Products (Sec. 51.1 to 51.61).
This notice provides for a 60 day comment period for interested parties to comment on the proposed U.S. Standards for Grades of Mangos.
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice; request for public comment.
The Agricultural Marketing Service (AMS), is soliciting comments on its proposal to revise the United States Standards for Grades of Persian (Tahiti) Limes. Specifically, AMS is proposing to revise the color and juice requirements. The proposed revision would simplify the two requirements in the standards which are complex and difficult to apply. These changes would bring the lime standards in line with other citrus standards, thereby, improving the usefulness in serving the industry.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 1661 South Building, Stop 0240, Washington, DC 20250-0240, fax (202) 720-8871, E-mail
David L. Priester, at the above address or call (202) 720-2185, E-mail
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables that are not requirements of Federal Marketing Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by USDA, AMS, Fruit and Vegetable Programs.
AMS is proposing to revise the voluntary U.S. Standards for Grades of Persian (Tahiti) Limes using the procedures that appear in Part 36 Title 7 of the Code of Federal Regulations (7 CFR Part 36). These standards were last revised in 1958.
Prior to undertaking research and other work associated with revision of the grade standards, AMS decided to seek public comments on the petition. A notice requesting comments on the possible revision of the U.S. Standards for Grades of Persian (Tahiti) Limes was published in the June 25, 2004,
In response to the request for comments, AMS received two comments. One comment from a private individual which did not support the revision. One comment from a national association of produce receivers favored the revision.
Based on the comments received and information gathered, AMS is proposing to revise the standards for limes following the standard format for U.S. Grade Standards. The proposed revisions would remove the requirements related to color which specify the percentage of the lime surface that shall have good green color. The standard also specify's that limes which fail to meet a grade due to blanching shall be designated as “Mixed Color” and limes that fail to meet a grade because of turning yellow due to ripening shall be designated as “Turning.” Also, the proposed revision would remove the juice content requirement. This will result in limes with lesser color and juice content to be scored as defects using the existing “Damage” and “Serious Damage” definitions for “Blanching,” “Yellow Color” and “Dryness or Mushy Condition.” Therefore, when individual limes fail to meet the above requirements, they will be scored as defects against a given U.S. grade, and if the number of defects exceeds the total grade tolerance, the limes would fail to meet the U.S. grade. This proposal will bring the standards for limes in line with the other U.S. standards for citrus. AMS believes that
This notice provides for a 60-day comment period for interested parties to comment on the proposed revision of the U.S. Standards for Grades of Persian (Tahiti) Limes.
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice.
The Agricultural Marketing Service (AMS), prior to undertaking research and other work associated with revising official grade standards, is soliciting comments on the possible revisions to the United States Standards for Grades of Snap Beans. At a 2003 meeting with the Fruit and Vegetable Industry Advisory Committee, AMS was asked to review all the fresh fruit and vegetable grade standards for usefulness in serving the industry. As a result, AMS has identified that the standard may need to be modified to allow percentages to be determined by count and not weight. Additionally, AMS is seeking comments regarding any other revisions that may be necessary to better serve the industry.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 1661 South Building, Stop 0240, Washington, DC 20250-0240; Fax (202) 720-8871, E-mail
David L. Priester, at the above address or call (202) 720-2185; E-mail
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal Marketing Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by USDA/AMS/Fruit and Vegetable Programs.
AMS is proposing to revise the voluntary United States Standards for Grades of Snap Beans using procedures that appear in Part 36 Title 7 of the Code of Federal Regulations (7 CFR Part 36). These standards were last revised in 1990.
At a 2003 meeting with the Fruit and Vegetable Industry Advisory Committee, AMS was asked to review all the fresh fruit and vegetable grade standards for usefulness in serving the industry. AMS has identified the United States Standards for Grades of Snap Beans for a possible revision. As a result, AMS has identified that the standard may need to be modified to allow percentages to be determined by count and not weight. However, prior to undertaking detailed work to develop proposed revisions to the standards, AMS is soliciting comments on the possible revision to the standards and the probable impact on distributors, processors, and growers. Additionally, AMS is seeking comments regarding any other revisions that may be necessary to better serve the industry.
This notice provides for a 60-day comment period for interested parties to comment on changes to the standards. Should AMS conclude that there is a need for the revisions of the standards, the proposed revisions will be published in the
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice; request for public comment.
The Agricultural Marketing Service (AMS), of the Department of Agriculture, is soliciting comments on a proposal to revise the United States Standards for Grades of Strawberries. AMS has received a petition from the California Strawberry Commission (CSC), requesting that the current standards be modified to allow percentages be determined on the basis of count and not volume. Additionally, AMS is seeking comments regarding any other revisions that may be necessary to better serve the industry.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 1661 South Building, Stop 0240, Washington, DC 20250-0240; Fax (202) 720-8871, E-mail
David L. Priester, at the above address
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal Marketing Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by USDA/AMS/Fruit and Vegetable Programs.
AMS is proposing to revise the voluntary United States Standards for Grades of Strawberries using procedures that appear in Part 36 Title 7 of the Code of Federal Regulations (7 CFR Part 36). These standards were last revised in 1965.
AMS received a petition from the CSC requesting a revision to the United States Standards for Grades of Strawberries. The standards are established under the authority of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627). The petitioner represents more than 700 strawberry growers, shippers, and processors.
The petitioner is requesting that USDA revise the standards to allow that percentages be determined on the basis of count and not volume. Currently the standards state that the percentages of defects will be determined on the basis of volume. The volume is determined by counting the berries in a sample, and then dividing the total number of berries into 100 percent. The resulting number will be the percentage by volume of the average size berry in the sample. For example, in a sample that has 25 berries the average size berry will be equal to 4 percent with smaller berries representing less and larger berries representing more of the percentage by volume in the sample. Industry believes determining percentages by count will simplify tolerance determination.
Prior to undertaking detailed work to develop a proposed revision to the standard, AMS is soliciting comments on the petition submitted to revise the United States Standards for Grades of Strawberries.
This notice provides for a 60-day comment period for interested parties to comment on changes to the standards. Should AMS conclude that revisions are needed, the Agency will develop a proposed revised standard that will be published in the
7 U.S.C. 1621-1627.
Agricultural Marketing Service, USDA.
Notice, request for public comment.
The Agricultural Marketing Service (AMS), of the Department of Agriculture (USDA) is soliciting comments on it's proposal to revise the United States Standards for Grades of Sweet Peppers. This action is being taken at the request of the Fruit and Vegetable Industry Advisory Committee, which asked AMS to review the grade standards for possible revision. AMS is proposing to revise the standards to report decay affecting the stems under the serious damage tolerance in all grades instead of the more restrictive tolerance of two percent for decay. Additionally, AMS is proposing to amend the similar varietal requirement to allow mixed colors and/or types when designated as speciality packs and remove the unclassified category. AMS is proposing to remove the requirement to re-designate lots of sweet peppers as “Mixed Color” in the grade statement when peppers fail to meet the color requirement. AMS is also proposing to include the Mixed Color designation as an option for any lot of sweet peppers intentionally packed with peppers of different color. The proposed revisions would bring the standards for sweet peppers in line with current marketing practices, thereby improving the usefulness of the standards in serving the industry.
Comments must be received by May 10, 2005.
Interested persons are invited to submit written comments to the Standardization Section, Fresh Products Branch, Fruit and Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 1661 South Building, Stop 0240, Washington, DC 20250-0240; fax (202) 720-8871, e-mail
David L. Priester, at the above address or call (202) 720-2185; e-mail
Section 203(c) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621-1627), as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices * * *.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Fruits and Vegetables not connected with Federal Marketing Orders or U.S. Import Requirements, no longer appear in the Code of Federal Regulations, but are maintained by USDA/AMS/Fruit and Vegetable Programs.
AMS is proposing to revise the voluntary U.S. Standards for Grades of Sweet Peppers using procedures that appear in Part 36 Title 7 of the Code of Federal Regulations (7 CFR Part 36). These standards were last revised in 1989.
Prior to undertaking research and other work associated with revision of the grade standards, AMS published a notice in the
In response to our request for comments, AMS received three
One comment from an industry association which represents growers, packers and shippers is in favor of the proposal to amend the United States Standards for Grades of Sweet Peppers by separating the scoring and reporting of decay affecting the walls and calyxes from decay affecting the stems only. The proposed tolerances would allow decay affecting the stems only to be scored under the serious damage tolerance in all grades, and decay affecting the walls and/or calyxes shall continue to be scored under the more restrictive tolerance of two percent for decay.
AMS also received one comment from an industry group which represents receivers. The comment did not support the proposed revision to the decay tolerance. The commenter stated that all decay has a serious negative impact on the appearance and marketability of the product and requested not to change the decay tolerances. AMS also received one comment from an industry association which represents producers. The commenter proposes that decay affecting the stems and calyxes should not be scored against any grade, and should only be noted on the inspectors's notesheet and not reported on the certificate. AMS has reviewed stem decay affecting various commodities and believes the proposed changes would bring sweet peppers in line with other grade standards with regards to stem decay. Decay affecting the stem only does not affect the edible portion of the pepper, and does not affect the marketability to the same degree as decay affecting the walls and/or calyx. AMS believes a revision to the decay tolerance is warranted to better serve the industry.
Further, AMS requested comments on the use of color terms “chocolate” and “suntan” which are trade terms used by the industry to describe the color of some peppers. AMS received one comment regarding trade terms for color. The comment does not support including the industry terms into the grade standards. The commenter believes the use of such terms will result in a dispute over nearly every shipment. In view of the above, AMS does not recommend inclusion of such trade terms into the existing grade standard.
AMS received one comment requesting the grade standards designate how hybrid varieties which turn several colors should be scored. Currently the standard allows characteristic color other than green to be specified in connection with the grade. Additionally, when peppers fail to meet the color requirements of the grade for green lots or specified color, they are designated as Mixed Color. Current marketing practices for specialty packs which include mixed colors and/or types of sweet peppers would not meet the similar varietal characteristic requirements for all grades in the standards. Accordingly, AMS is proposing to amend the similar varietal requirement to allow mixed colors and/or types of sweet peppers when designated as a mixed or speciality pack.
AMS requested comments on industry terms for size based on 1
AMS proposes to eliminate the unclassified category. This section is not a grade and only serves to show that no grade has been applied to the lot. Since this designation is rarely used and may create some confusion in the marketplace, it should be discontinued.
The official grade of a lot of sweet peppers covered by these standards are determined by the procedures set forth in the Regulations Governing Inspection, Certification, and Standards of Fresh Fruits, Vegetables and Other Products (Sec. 51.1 to 51.61).
This notice provides for a 60-day comment period for interested parties to comment on changes to the standards.
7 U.S.C. 1621-1627.
Forest Service, USDA.
Notice of meeting.
The New Mexico Collaborative Forest Restoration Program Technical Advisory Panel will meet in Albuquerque, New Mexico. The purpose of the meeting is to provide recommendations to the Register Forest, USDA Forest Service Southwestern Region, on which forest restoration grant proposals submitted in response to the Collaborative Forest Restoration Program Request For Proposals best meet the objectives of the Community Forest Restoration Act (Title VI, Pub. L. 106-393).
The meeting will be held April 25-29, 2005, beginning at 1 p.m. on Monday, April 25 and ending at approximately 4 p.m. on Friday, April 29.
The meeting will be held at the Nativo Lodge, 6000 Pan American Freeway NE., Albuquerque, NM 87109, (505) 798-4300. Written comments should be sent to Walter Dunn, at the Cooperative and International Forestry Staff, USDA Forest Service, 333 Broadway SE., Albuquerque, NM 87102. Comments may also be sent via e-mail to
All comments, including names and address when provided, are place in the record and are available for public inspection and copying. The public may
Walter Dunn, Designated Federal Official, at (505) 842-3425, Elaine Waterbury, at (505) 842-3881, or Angela Sandoval, at (505) 842-3289. Cooperative and International Forestry Staff, USDA Forest Service, 333 Broadway SE., Albuquerque, NM 87102.
Individuals who use telecommunications devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 betweeen 8 a.m. and 8 p.m., eastern standard time, Monday through Friday.
The meeting is open to the public. Panel discussion is limited to Forest Service staff and Panel members. However, project proponents may respond to questions of clarification from Panel members or Forest Service staff. Persons who wish to bring Collaborative Forest Restoration Program grant proposal review matters to the attention of the Panel may file written statements with the Panel staff before or after the meeting. Public input sessions will be provided and individuals who submitted written statements prior to the public input sessions will have the opportunity to address the Panel at those sessions.
Forest Service, USDA.
Notice of meeting.
The Glenn/Colusa County Resource Advisory Committee (RAC) will meet in Willows, California. Agenda items to be covered include: (1) introductions, (2) approval of minutes, (3) public comment, (4) project proposal/possible action, (5) Web site update, (6) national RAC meeting, (7) general discussion, (8) next agenda.
The meeting will be held on March 28, 2005, from 1:30 p.m. and end at approximately 4:30 p.m.
The meeting will be held at the Mendocino National Forest Supervisor's Office, 825 N. Humboldt Ave., Willows, CA 95988. Individuals wishing to speak or propose agenda items must send their names and proposals to Jim Giachino, DFO, 825 N. Humboldt Ave., Willows, CA 95988.
Bobbin Gaddini, Committee Coordinator, USDA, Mendocino National Forest, Grindstone Ranger District, P.O. Box 164, Elk Creek, CA 95939. (530) 968-1815; e-mail
The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, persons who wish to bring matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by March 25, 2005, will have the opportunity to address the committee at those sessions.
Forest Service, USDA.
Notice of meeting.
Pursuant to the authorities in the Federal Advisory Committees Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393) the Alpine County Resource Advisory Committee (RAC) will meet on Monday, April 25, at 18:00 at the Diamond Valley School for business meetings. The purpose of the meeting is to discuss issues relating to implementing the Secure Rural Schools and Community Self-Determination Act of 2000 (Payment to States) and expenditure of Title II funds. The meetings are open to the public.
Monday, April 25, 2005, at 18:00 hours.
The meeting will be held at the Diamond Valley School, 35 Hawkside Drive, Markleeville, California 96120. Send written comments to Franklin Pemberton, Alpine County RAC coordinator, c/o USDA Forest Service, Humboldt-Toiyabe N.F., Carson Ranger District 1536 So. Carson Street, Carson City, NV 89701.
Alpine Co. RAC Coordinator, Frank Pemberton at (775)-884-8150; or Gary Schiff, Carson District Ranger and Designated Federal Officer, at (775)-884-8100, or electronically to
The Meeting is open to the public. Council discussion is limited to Forest Service staff and Council members. However, persons who wish to bring urban and community forestry matters to the attention of the council may file written statements with the Council staff before and after the meeting.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by May 10, 2005.
You may submit comments by any of the following methods:
• E-mail: RUSComments@usda.gov. Include in the subject line of the message “0572-0051.” The e-mail must identify, in the text of the message, the name of the individual (and name of the entity if applicable) who is submitting the comment.
• Mail: Addressed to Richard Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, United States Department of Agriculture, 1400 Independence Avenue, SW., STOP 1522, Washington, DC 20250-1522.
• Hand Delivery/Courier: Addressed to Richard Annan, Director, Program Development and Regulatory Analysis,
Richard Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, 1400 Independence Ave., SW., STOP 1522, Room 5168 South Building, Washington, DC 20250-1522. Telephone: (202) 720-0784. FAX: (202) 720-4120.
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for revision and extension.
Comments are invited on: (a) 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; (b) 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; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to 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. Comments may be sent via the methods that appear in the
Copies of this information collection can be obtained from Michele Brooks, Program Development and Regulatory Analysis, at (202) 690-1078. FAX: (202) 720-4120
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to Procurement List.
The Committee is proposing to add to the Procurement List products and services 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.
Sheryl D. Kennerly, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail
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 the notice for each product or service will be required to procure the products and services 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 and services to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products and services 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 services 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 and services are proposed for addition to Procurement List for production by the nonprofit agencies listed:
Committee for Purchase from People Who Are Blind or Severely Disabled.
Additions to and deletions from 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, and deletes from the Procurement List products previously furnished by such agencies.
April 10, 2005.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259.
Sheryl D. Kennerly, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail
On January 7 2005, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (70 FR 1413) of proposed additions to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the services and impact of the additions 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:
On September 3, 2004, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (69 FR 53884) of proposed deletions to the Procurement List. After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer 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 may result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may 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 deleted from the Procurement List.
Office of the Secretary, Department of Commerce
Extension of deadline for submitting nominations.
On March 1, 2005, the Department of Commerce (the “Department”) published a notice in the
Nominations must be received by the Department at the address listed below no later than 4 p.m. (EST) on March 25, 2005.
Nominations of potential members may be submitted by (i) postal mail, (ii) facsimile, or (iii) e-mail. Please submit nominations by postal mail to David A. Sampson, Assistant Secretary for Economic Development, Economic Development Administration, Department of Commerce, Room 7800, 1401 Constitution Avenue, NW., Washington, DC 20230. Nominations may be submitted via facsimile to (202) 273-4723; all facsimiles should be addressed to the attention of Assistant
The Office of Chief Counsel, Economic Development Administration, Department of Commerce, Room 7005, 1401 Constitution Avenue, NW., Washington DC 20230, telephone (202) 482-4687.
On February 3, 2005, the Secretary of Commerce (the “Secretary”) and the Secretary of Housing and Urban Development jointly announced the President's Strengthening America's Communities Initiative (the “Initiative”). The Initiative proposes to transfer and consolidate 18 Federal economic and community development programs from the Departments of Agriculture, Commerce, Health and Human Services, Housing and Urban Development and Treasury within the Department, ultimately comprising a $3.71 billion unified grant program.
On February 9, 2005, the President's Domestic Policy Council requested the Secretary form the Committee. The objectives and duties of the Committee will be to provide advice and recommendations to the Secretary, and to develop a comprehensive written report of policy parameters to assist in implementing the Initiative, including advising on its legislation, regulations and other guidance. The Committee's report will encompass all aspects of the envisioned Initiative, including policy findings and declarations, organizational structure, eligibility, program delivery, monitoring and performance measures. The Committee is expected to deliver its report to the Secretary by May 31, 2005. Thereafter, the Committee may be asked to advise the Secretary on additional issues relating to the Initiative.
The Committee is intended to have a balanced membership from diverse backgrounds and geographical regions, including the private sector, state, local and tribal government officials, community-based organizations, academia and the research community. Nominees should possess an extensive knowledge of, and background in, the fields of rural or urban economic or community development. Nominees should also possess recognized development policy expertise and excellent leadership, communication and organizational skills. The evaluation criteria for selecting members and the specific instructions for submitting nominations contained in the March 1, 2005 notice shall continue to apply. Additional information on the Initiative is available on the Department's Web site at
Section 301 of title 5 United States Code and 15 CFR part 4, subpart B authorize and govern collection of this information. The primary use of this information is to allow officials of the Department and its operating units to review applications and to conduct vetting of applicants to make decisions concerning the nomination or re-nomination of candidates for membership on the Committee. Records may be disclosed under the following routine use circumstances: (1) To any Federal, state, or local agency maintaining civil, criminal, or other relevant enforcement information, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring, or retention of an individual; the issuance of a security clearance; the letting of a contract; or the issuance of a license, grant, or benefit. (2) To any Federal, state, local, or foreign agency charged with the responsibility of investigating or prosecuting any violation or potential violation of law or contract, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute or contract, rule, regulation, or order, to protect the interests of the Department. (3) To any Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring, or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or any other benefit of the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decisions on the matter. (4) To a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record. (5) To the Department of Justice in connection with determining whether disclosure is of the record is required under the Freedom of Information Act.
Collection of this information, including your Social Security number is voluntary but failure to furnish it will result in your application not being considered. Collection of your Social Security number is authorized under Executive Order No. 9397. The Department will use this number to distinguish you from other members of the public who may have the same or similar name.
Import Administration, International Trade Administration, Department of Commerce.
On October 20, 2004, the Department of Commerce published a preliminary determination in the antidumping duty investigation of live swine from Canada. We gave interested parties an opportunity to comment on the preliminary determination. Based upon the results of verification and our analysis of the comments received, we have made certain changes. We continue to find that live swine from Canada were sold in the United States below normal value during the period of investigation. The final weighted-average dumping margins are listed below in the section entitled “Continuation of Suspension of Liquidation.”
Cole Kyle or Andrew Smith, 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) 482-1503 or (202) 482-1276, respectively.
On October 20, 2004, the Department of Commerce (“the Department”) published in the
Since the
On October 25, 2004, Excel requested that the Department reconsider its preliminary decision to rescind its selection of Excel as a mandatory respondent in this investigation.
On November 3, 2004, the Department decided to verify Excel's questionnaire responses.
On November 29, 2004, Premium Pork Canada, Inc. (“Premium Pork”) withdrew from this investigation.
In November and December 2004, and January 2005, we conducted verifications of the sales and cost of production (“COP”) questionnaire responses submitted by Ontario Pork Producers' Marketing Board (“Ontario Pork”), Hytek, Inc. (“Hytek”), and Excel Swine Services, Inc. (“Excel”) at each company's headquarters and at certain farm locations. We issued verification reports in January 2005.
We received case and rebuttal briefs from the Illinois Pork Producers Association, the Indiana Pork Advocacy Coalition, the Iowa Pork Producers Association, the Minnesota Pork Producers Association, the Missouri Pork Association, the Nebraska Pork Producers Association, Inc., the North Carolina Pork Council, Inc., the Ohio Pork Producers Council, and 119 individual producers of live swine
The merchandise covered by this investigation is all live swine (“swine” or “subject merchandise”) from Canada except breeding stock swine. Live swine are defined as four-legged, monogastric (single-chambered stomach), litter-bearing (litters typically range from 8 to 12 animals), of the species
Specifically excluded from this scope are breeding stock, including U.S. Department of Agriculture (“USDA”) certified purebred breeding stock and all other breeding stock. The designation of the product as “breeding stock” indicates the acceptability of the product for use as breeding live swine. This designation is presumed to indicate that these products are being used for breeding stock only. However, should the petitioners or other interested parties provide a reasonable basis to believe or suspect that there exists a pattern of importation of such products for other than this application, end-use certification for the importation of such products may be required.
Although the
In the
On August 4, 2004, the petitioners submitted a response to the GOC's scope exclusion request and proposed modified scope language. The petitioners stated they did not oppose the GOC's request to exclude hybrid breeding stock, but were concerned about the potential for circumvention of any CVD or antidumping duty (“AD”) order on live swine from Canada through non-breeding swine entering the domestic market as breeding stock. Thus, the petitioners proposed modified scope language that would require end-use certification if the petitioners or other interested parties provide a reasonable basis to believe or suspect that there exists a pattern of importation of such products for other than this application. Moreover, on July 30, 2004, the petitioners submitted a request to the International Trade Commission (“ITC”) to modify the
On August 9, 2004, both the GOC and the respondent companies submitted comments to respond to the petitioners' proposed revised scope. Both the GOC and the respondent companies stated that they generally agreed with the petitioners' modified scope language, with the two following exceptions: (1) They contended that the petitioners' language setting forth the mechanics of any end use certification procedure was premature and unnecessary, and (2) they argued that the petitioners' language stating that “all products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope” was unnecessary because the physical description of the merchandise in scope remains determinative.
On August 12, 2004, the petitioners submitted a response to the August 9,
As further discussed in the August 16, 2004 memorandum entitled “
The period of investigation (“POI”) is January 1, 2003, through December 31, 2003. This period corresponds to the four most recent fiscal quarters prior to the filing of the petition on March 5, 2004.
Section 776(a)(2) of the Act provides that the Department shall apply “facts otherwise available” if,
Section 782(e) of the Act further provides that the Department shall not decline to consider information that is submitted by an interested party and that is necessary to the determination but does not meet all the applicable requirements established by the Department if (1) the information is submitted by the deadline established for its submission; (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 in providing the information and meeting the requirements established by the Department with respect to the information; and (5) the information can be used without undue difficulties.
Premium Pork responded to the Department's questionnaires and otherwise participated in this investigation until November 29, 2004, two weeks before Premium Pork's scheduled verification. On November 29, 2004, Premium Pork withdrew from this investigation because of its impending dissolution.
In applying facts otherwise available, section 776(b) of the Act provides that the Department may use an inference adverse to the interests of a party that has failed to cooperate by not acting to the best of its ability to comply with the Department's requests for information.
In this case, Premium Pork ultimately failed to cooperate to the best of its ability because it failed to participate in verification. Therefore, the Department finds that in selecting from among the facts otherwise available, an adverse inference is warranted.
As adverse facts available, we have assigned Premium Pork a margin of 18.87 percent, the highest price-to-price margin alleged in the petition, in accordance with section 776(b)(1). Section 776(b) of the Act notes that an adverse facts available rate may include reliance on information derived from: (1) The petition; (2) a final determination in the investigation; (3) any previous review; or (4) any other information placed on the record. Thus, the statute does not limit the specific sources from which the Department may obtain information for use as facts available. The
Section 776(c) of the Act mandates that the Department, to the extent practicable, shall corroborate secondary information (such as petition data) using independent sources reasonably at its disposal. In accordance with the law, the Department, to the extent practicable, will examine the reliability and relevance of the information used.
To corroborate the margin assigned to Premium Pork, we compared the normal values and U.S. prices submitted by the petitioners, as amended by the Department in the April 7, 2004,
With respect to the relevance aspect of corroboration, however, the Department will consider information reasonably at its disposal as to whether there are circumstances that would render a margin inappropriate. Where circumstances indicate that the selected margin is not appropriate as adverse facts available, the Department will disregard the margin and determine an appropriate margin (
Accordingly, we have assigned Premium Pork the rate of 18.87 percent as total adverse facts available. This is consistent with section 776(b) of the Act which states that adverse inferences may include reliance on information derived from the petition.
We calculated constructed export price, export price, and normal value based on the same methodologies used in the
We used the sales databases submitted by Ontario Pork after verification, which include the minor corrections presented at verification. We revised Ontario Pork's advertising expenses.
We used the U.S. database submitted by Excel after verification in our margin calculations, which includes the minor corrections presented at verification. In addition, we disregarded sales of substandard merchandise.
We used the databases submitted by Hytek after verification, which include the minor corrections presented at verification. For Hytek's U.S. sales, we accounted for an additional billing adjustment and direct selling expense which were presented as minor corrections at verification. In our product comparisons, we prevented matches between U.S. sales of isoweans and home market sales of spent boars.
We calculated the cost of production (“COP”) and constructed value (“CV”) for Ontario Pork, Hytek, and Excel based on the same methodologies used in the
Pursuant to section 773(b)(1) of the Act, where less than 20 percent of a respondent's sales of a given product during the POI were at prices less than the COP, we do not disregard any below-cost sales of that product because we determine that in such instances the below-cost sales were not made in “substantial quantities.” Where 20 percent or more of a respondent's sales of a given product are at prices less than the COP, we determine that the below-cost sales represent “substantial quantities” within an extended period of time, in accordance with section 773(b)(1)(A) of the Act. In such cases, we also determine whether such sales were made at prices which would not permit recovery of all costs within a reasonable period of time, in accordance with section 773(b)(1)(B) of the Act.
With respect to Ontario Pork and Hytek, for certain products, more than 20 percent of the comparison market sales were at prices less than the COP and, thus, the below-cost sales were made within an extended period of time in substantial quantities. In addition, these sales were made at prices that did not provide for the recovery of costs within a reasonable period of time. We therefore excluded these sales and used the remaining sales, if any, as the basis for determining NV, in accordance with section 773(b)(1) of the Act.
As provided in section 782(i)(1) of the Act, we verified the information submitted by the respondents during November and December, 2004, and January, 2005. We used standard verification procedures, including examination of relevant accounting and production records, as well as original source documents provided by the respondents.
All issues raised in the petitioners' and the respondents' case and rebuttal briefs are addressed in the March 4, 2005,
In accordance with section 735(c)(1)(B)(ii) of the Act, we are directing the U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all imports of subject merchandise from Canada, except merchandise produced and exported by Hytek, that are entered, or withdrawn from warehouse, for consumption on or after October 20, 2004, the date of publication of the
In accordance with section 735(d) of the Act, we have notified the International Trade Commission (“ITC”) of our determination. As our final determination is affirmative, the ITC will, within 45 days, determine whether these imports are materially injuring, or threatening material injury to, the U.S. industry. If the ITC determines that material injury, or threat of material injury, does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order.
This notice also serves as a reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, U.S. Department of Commerce.
Effective Date: March 11, 2005.
Maisha Cryor or Steven Ryan, at (202)
On August 24, 2004, the Department of Commerce (the Department) initiated an administrative review of the antidumping duty order on silicon metal from Brazil.
Pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), the Department shall make a preliminary determination in an administrative review of an antidumping duty order within 245 days after the last day of the anniversary month of the date of publication of the order. The Act further provides, however, that the Department may extend that 245-day period to 365 days if it determines it is not practicable to complete the review within the foregoing time period. The preliminary results of this antidumping duty administrative review of silicon metal from Brazil are currently scheduled to be completed on April 2, 2005. However, the Department finds that it is not practicable to complete the preliminary results in this administrative review of silicon metal from Brazil within this time limit because additional time is needed to fully address issues relating to affiliation, treatment of value added taxes, reconciliation of costs to financial statements and the calculation of the total cost of manufacturing, as well as to conduct mandatory verifications of the questionnaire responses and supplemental questionnaire responses.
Therefore, in accordance with section 751(a)(3)(A) of the Act, the Department is extending the time limit for completion of the preliminary results of this review until August 1, 2005, which is the next business day after 365 days from the last day of the anniversary month of the date of publication of the order. The deadline for the final results of this administrative review continues to be 120 days after the publication of the preliminary results.
This notice is issued and published in accordance with section 751(a)(3)(A) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce has made a final determination that countervailable subsidies are not being provided to producers or exporters of live swine from Canada.
March 11, 2005.
Melani Miller Harig, Stephen Cho, Daniel J. Alexy, and Marc Rivitz, AD/CVD Operations, Office 1, Import Administration, U.S. Department of Commerce, Room 3099, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone (202) 482-0116, (202) 482-3798, (202) 482-1540, and (202) 482-1382, respectively.
The petitioners in this investigation are the Illinois Pork Producers Association, the Indiana Pork Advocacy Coalition, the Iowa Pork Producers Association, the Minnesota Pork Producers Association, the Missouri Pork Association, the Nebraska Pork Producers Association, Inc., the North Carolina Pork Council, Inc., the Ohio Pork Producers Council, and 119 individual producers of live swine
The following events have occurred since the publication of the preliminary determination in the
On September 9, 2004, the petitioners submitted comments on the upcoming verifications.
On September 14, 2004, the petitioners submitted arguments relating to certain requests made by the Government of Canada (“GOC”) for business proprietary treatment in its questionnaire responses. The GOC filed a response to this submission on September 22, 2004.
On September 17 and 27, 2004, Sureleen-Albion Agra Inc. (“Sureleen”)/Bujet Sow Group (“BSG”) and Hytek Ltd. (“Hytek”), respectively, submitted new factual information and corrections to their previous responses. The GOC also submitted revised information from its questionnaire responses on October 5, 2004.
From September 27, 2004 through October 8, 2004, and October 18, 2004 through October 21, 2004, we conducted verification of the questionnaire responses submitted by the GOC; the Governments of Ontario, Manitoba, Saskatchewan, and Alberta; Sureleen/BSG; Hytek; Premium Pork Canada Inc.; Hart Feeds Limited; Elite Swine Inc./Maple Leaf Foods Inc.; Park View Colony Farms Ltd.; and Willow Creek
We received case briefs from the petitioners and the Government of Saskatchewan on January 7, 2005. The respondents (collectively) and the petitioners submitted rebuttal briefs on January 14, 2005. We held a hearing in this investigation on January 19, 2005. Public transcripts from this hearing are available in the Department of Commerce's (“Department”) Central Records Unit in Room B-099 of the main Department building (“CRU”).
The period for which we are measuring subsidies, or the period of investigation, is calendar year 2003.
The merchandise covered by this investigation is all live swine (“swine” or “subject merchandise”) from Canada except breeding stock swine. Live swine are defined as four-legged, monogastric (single-chambered stomach), litter-bearing (litters typically range from 8 to 12 animals), of the species
Specifically excluded from this scope are breeding stock, including U.S. Department of Agriculture (“USDA”) certified purebred breeding stock and all other breeding stock. The designation of the product as “breeding stock” indicates the acceptability of the product for use as breeding live swine. This designation is presumed to indicate that these products are being used for breeding stock only. However, should the petitioners or other interested parties provide a reasonable basis to believe or suspect that there exists a pattern of importation of such products for other than this application, end-use certification for the importation of such products may be required.
Although the
In the
On August 4, 2004, the petitioners submitted a response to the GOC's scope exclusion request and proposed modified scope language. The petitioners stated they did not oppose the GOC's request to exclude hybrid breeding stock, but were concerned about the potential for circumvention of any AD or countervailing duty (“CVD”) order on live swine from Canada through non-breeding swine entering the domestic market as breeding stock. Thus, the petitioners proposed modified scope language that would require end-use certification if the petitioners or other interested parties provide a reasonable basis to believe or suspect that there exists a pattern of importation of such products for other than this application. Moreover, on July 30, 2004, the petitioners submitted a request to the International Trade Commission (“ITC”) to modify the
On August 9, 2004, both the GOC and the respondent companies submitted comments to respond to the petitioners' proposed revised scope. Both the GOC and the respondent companies stated that they generally agreed with the petitioners' modified scope language, with the two following exceptions: 1) they contended that the petitioners' language setting forth the mechanics of any end use certification procedure was premature and unnecessary, and 2) they argued that the petitioners' language stating that “all products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope” was unnecessary because the physical description of the merchandise in scope remains determinative.
On August 12, 2004, the petitioners submitted a response to the August 9, 2004 comments from the GOC and the respondents. The petitioners reiterated their support for their proposed modification to the scope language. They argued that 1) their proposed language had been used before by the Department in other proceedings; 2) since U.S. importers bear the burden of paying the duties, the importers should be required to certify to the end use of the product; and 3) with the petitioners' concerns about circumvention, the “physical description” language provided an important clarification that all live swine except for the excluded products are included in the scope.
As further discussed in the August 16, 2004 memorandum entitled “
Because Canada is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Tariff Act of 1930, as amended by the Uruguay Round Agreements Act effective January 1, 1995 (“the Act”), the ITC is required to determine whether imports of the subject merchandise from Canada materially injure, or threaten material injury to, a U.S. industry. On May 10, 2004, the ITC transmitted to the Department its preliminary determination that there is a reasonable indication that an industry in the United States is being materially injured by reason of imports from Canada of the subject merchandise.
All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the March 4, 2005 “Issues and Decision Memorandum” from Barbara E. Tillman, Acting Deputy Assistant Secretary for Import Administration, to Joseph A. Spetrini, Acting Assistant Secretary for Import Administration (“
In the
In accordance with section 705(d) of the Act, we will notify the ITC of our determination.
This notice serves as the only reminder to parties subject to Administrative Protective Order (“APO”) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply is a violation of the APO.
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
International Trade Administration (ITA), Department of Commerce.
Notice and request for applications.
ITA is soliciting U.S. export promotion projects to be conducted by eligible entities for periods of up to three years. Project award periods normally begin between October 1, 2005 and January 1, 2006, but may begin as late as April 1, 2006. MDCP awards help to underwrite the start-up costs of new export ventures that export multipliers are often reluctant to undertake without Federal Government support. MDCP aims to develop, maintain and expand foreign markets for non-agricultural goods and services produced in the United States.
Proposals must be received by ITA no later than 5 p.m. EST, April 25, 2005. A public meeting to discuss the competition will be held on March 18, 2005, at 2 p.m. in Room 6059 at the address indicated below.
Proposals must be submitted to ITA, U.S. Department of Commerce, HCHB 3215; Washington, DC 20230, or via e-mail to
Interested parties who are unable to access information via Internet or who have questions may contact Mr. Brad Hess by mail (see
15 U.S.C. 4723.
(1) Export Success Potential (20%). This is the potential of the project to generate export success stories and/or export initiatives in both the short-term and medium-term.
(2) Performance Measures (20%). Applicants must provide quantifiable estimates of how the project will increase or enhance the U.S. industry's export presence in the foreign market(s).
(3) Partnership and Priorities (20%). This criterion indicates the degree to which the project initiates or enhances partnership with ITA and the degree to which the proposal furthers or is compatible with ITA's priorities.
(4) Creativity and Capacity (20%). Applicants demonstrate creativity, innovation, and realism in the project work plan as well as their institutional capacity to carry out the work plan.
(5) Budget and Sustainability (20%). This criterion indicates the reasonableness and effectiveness of the itemized budget for project activities, the amount of the cash match that is readily available, and the probability that the project can be continued on a self-sustained basis after the completion of the award.
The five criteria together constitute the application score. At 20 points per criterion, the total possible score is 100.
The ITA priorities referred to under Evaluation Criteria (3) and Selection Factor (2) are listed below. ITA is interested in receiving proposals to promote U.S. exports that include, but are not limited to, projects that: (1) Improve the competitiveness of U.S. manufacturing and service industries by addressing impediments to innovation and cost reduction; (2) Increase competitiveness of U.S. industries by addressing non-tariff barriers, especially those related to standards; (3) Capitalize on trade opportunities resulting from trade agreements; (4) Increase overall export awareness and awareness of ITA programs and services among U.S. companies, by making SMEs export-ready or by facilitating deal-making; (5) Ensure compliance with trade agreements; (6) Increase the competitiveness of U.S. industries by developing commercial infrastructure in emerging economies; (7) Develop non-traditional approaches to creating demand for the products/services developed from new U.S. technologies; and (8) Support the Administration's broader foreign policy objectives through trade-related initiatives.
The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements contained in the
This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 424 and 424A, 424B, SF-LLL, and CD-346 has been approved by OMB under the respective control numbers 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.
This notice has been determined to be not significant for purposes of Executive Order 12866.
It has been determined that this notice does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
Prior notice and an opportunity for public comments are not required by the Administrative Procedure Act or any other law for this notice concerning grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
International Trade Administration, Department of Commerce.
Notice to business development mission to Afghanistan, April 24-27, 2005.
The International Trade Administration of the U.S. Department of Commerce is organizing a business development mission to Afghanistan on April 24-27, 2005. The mission will assist U.S. businesses exploring trade and investment opportunities in Afghanistan. A senior U.S. Department of Commerce official will lead a delegation of approximately 10 to 15 U.S.-based senior executives of small, medium, and large U.S. firms. Companies may represent, but are not limited to, the following priority sectors: construction, telecommunications, agribusiness, energy, and financial services. The mission will include briefings from U.S. Embassy staff and Afghan Government officials, prearranged one-on-one meetings, and a networking reception. The mission will reaffirm the U.S. Government's support towards bilateral relations and seek to expand opportunities for U.S. companies in Afghanistan.
Office of Global Trade Programs, Room 2012, Department of Commerce, Washington, DC 20230; Tel: (202) 482-4457; Fax: (202) 482-0178.
The International Trade Administration of the U.S. Department of Commerce is organizing a business development mission to Afghanistan on April 24-27, 2005. The mission will assist U.S. businesses exploring trade and investment opportunities in Afghanistan. A senior U.S. Department of Commerce official will lead a delegation of approximately 10 to 15 U.S.-based senior executives of small, medium, and large U.S. firms. Companies may represent, but are not limited to, the following priority sectors: construction, telecommunications, agribusiness, energy, and financial services. The mission will include briefings from U.S. Embassy staff and
Since the Taliban's fall from power in late 2001, Afghanistan is undergoing a transformation thanks to the United States and the international community. The Afghan Government seeks to revive the economy in order to improve the lives of Afghans, create jobs, attract foreign investment, and earn desperately needed hard currency. The agricultural, energy, housing, light industries and trading sectors present significant needs for development.
Although economic statistics on Afghanistan may not be reliable, the International Monetary Fund reports the gross domestic product (GDP) is estimated at $4.4 billion, and GDP per capita is about $250 per year. The estimated GDP growth rate for 2003-2004 was 16%, following a growth rate of 20% for 2002-2003. Economic recovery from more than twenty war-ravaged years is most visible in agriculture, construction and services sectors, driven by the international reconstruction effort.
The Afghan Government is taking many steps to build the mechanisms necessary for a viable commercial environment. The Afghan Government passed new investment and commercial banking laws to facilitate commercial and banking transactions. The Afghan Government created a “one-stop shop” for investors to receive necessary documents and other information for establishing a business venture in Afghanistan. With assistance from the U.S. Agency for International Development, the Ministry of Finance has embarked on an aggressive strategy to simplify and improve customs and border procedures to further facilitate trade between Afghanistan and the world. The Afghan Government is also working with the international community to reform the judicial system.
The basic business infrastructure, including telecommunications, commercial regulations and office support, is slowly improving. Given the tenuous security situation throughout the country, there is a shortage of insurance options for transporters and investors. The first of three industrial parks is scheduled to open in the Spring 2005.
U.S. Department of Commerce Assistant Secretary William H. Lash, III visited Kabul in August 2004. He was encouraged to see the progress in reconstruction, the potential for U.S. companies, and the entrepreneurial spirit of the Afghans. It is for this reason the mission is being planned.
The mission aims to further U.S. commercial policy objectives and to advance specific U.S. business interests. The mission will
• Assess the commercial climate as well as export and investment opportunities in Afghanistan;
• Advance mission participants' specific business interests by introducing them to key Afghan government officials and potential business partners;
• Encourage continued progress in economic development in Afghanistan; and Enhance the dialogue between government and industry on issues affecting the development of bilateral commercial relations.
The business development mission will expose participants to high-level contacts and provide access to the Afghan market. U.S. Embassy officials will provide a detailed briefing on the economic, commercial and political climate as well as current investment and reconstruction opportunities. Meetings will be arranged with appropriate government ministries, including the Afghan Investment Support Agency, the Ministries of Commerce, and Foreign Affairs, as well as sectoral ministries.
In addition to private sector representatives, U.S. Government economic agencies may also participate.
The precise schedule will depend on the availability of local government and business officials and the specific goals of the mission participants. The tentative trip itinerary will be as follows:
Arrive in Kabul; Overview; Briefing by U.S. Embassy.
Briefings by: Afghanistan Investment Support Agency/Ministry of Commerce; U.S. Agency for International Development and possible prime contractors; Ministry of Finance; Ministry of Foreign Affairs; One-on-one meetings with sectoral ministries.
Meetings with Afghan businesses, Afghan-American Chamber of Commerce, and Afghanistan International Chamber of Commerce; One-on-one meetings with sectoral ministries.
Briefings by: World Bank representatives; Asian Development Bank representatives. Depart Kabul.
The recruitment and selection of private sector participants for this mission will be conducted according to the “Statement of Policy Governing Department of Commerce-Overseas Trade Missions” established in March 1997. Approximately 10 to 15 companies will be selected for the mission according to the criteria set out below.
• Consistency of company's goals with the scope and desired outcome of the mission;
• Relevance of a company's business and product line to the identified growth sectors;
• Rank of the designated company representative;
• Past, present, or prospective relevant international business activity;
• Diversity of company size, type, location, demographics, and traditional under-representation in business; and
• Timely receipt of the company's signed and completed application, participation agreement, and participation fee.
Recruitment will begin immediately and will be conducted in an open and public manner, including publication in the
An applicant's partisan, political activities (including political contribution) are entirely irrelevant to the selection process. The fee to
National Institute of Standards and Technology, Commerce.
Notice.
The National Institute of Standards and Technology (NIST) announces that the NIST Center for Neutron Research (NCNR) Financial Assistance Program is soliciting applications for financial assistance for FY 2005. The
All applications, paper and electronic, must be received at the address listed below no later than 5 p.m. Eastern Standard Time on April 1, 2005. Late applications will not be reviewed nor considered.
Paper applications must be submitted to: Kim Stavish, National Institute of Standards and Technology, NIST Center for Neutron Research, STOP 8560, Gaithersburg, Maryland 20899-8560, phone (301) 975-2672. Electronic applications and associated proposal information should be uploaded to
For complete information about this program and instructions for applying by paper or electronically, read the Federal Funding Opportunity (FFO) Notice at
NIST will give preference to full-scope proposals. However applicants may choose to submit proposals covering full or partial amounts of the funding available. Partial funding proposals may be limited to specific program objectives. NIST will determine whether to fund one award for the full amount; to divide available funds into multiple awards of any size, and negotiate scopes of work and budgets as appropriate; or not to select any proposal for funding, upon completing the selection process described below.
15 U.S.C. 272 (b)(4,7) and (c)(8,10,16,17,19).
Responsive proposals will be reviewed by an independent, objective panel composed of at least four individuals who are knowledgeable
The NCNR Director, serving as the Selection Official, will make the award selection. In making the award selection, the NCNR Director will take into consideration the panels' technical evaluation. The NCNR Director, as the selecting official, may choose a proposal out of rank order based upon one or more of the following factors: (1) Availability of funds, (2) redundancy, (3) balance/distribution of funds by research areas described above in the Program description of this Notice, (4) program objectives described above in the Program Description section of this Notice, (5) logistical concerns, and (6) preference for full-scope proposals. If an award is made to an applicant that deviates from the scores of the reviewers, the NCNR Director shall justify the selection in writing based on selection factors described above. The NCNR Director may select all, none, or some of the applications for funding.
The final approval of selected applications and award of financial assistance will be made by the NIST Grants Officer based on compliance with application requirements as published in this notice, compliance with applicable legal and regulatory requirements, compliance with Federal policies that best further the objectives of the Department of Commerce, and whether the recommended applicants appear to be responsible. Applicants may be asked to modify objectives, work plans, or budgets and provide supplemental information required by the agency prior to award. The award decision of the Grants Officer is final. Applicants should allow up to 90 days processing time.
Unsuccessful applicants will be notified in writing. The Program will retain one copy of each unsuccessful application for three years for record keeping purposes. The remaining copies will be destroyed.
1. Qualifications and experience of the Principle Investigator in neutron scattering research, as demonstrated by extensive publications and invited lectures in condensed matter physics, chemistry, material science, macromolecular science or related fields (10%).
2. Qualifications and experience of the proposed university staff in neutron scattering research or in related scientific or engineering areas that are key to the activities contained in the proposal, as demonstrated by resumes of staff proposed for this program (25%).
3. Quality of the proposed research and development plan and its potential impact on neutron scattering science, particularly in the areas of macromolecular science, condensed matter physics, and chemistry (20%).
4. Quality of the plan in terms of providing research assistance to U.S. neutron researchers using the NCNR facilities, including related training, education, and outreach (30%).
5. Quality of the plan to integrate university staff effectively into the activities of the NCNR facility, including establishing robust communications between the university and the NCNR (10%).
6. Cost effectiveness of the plan (5%).
If an applicant proposes collaboration with NIST, the statement of work should include a statement of this intention, a description of the collaboration, and prominently identify the NIST employee(s) involved, if known. Any collaboration by a NIST employee must be approved by appropriate NIST management and is at the sole discretion of NIST. Prior to beginning the merit review process, NIST will verify the approval of the proposed collaboration. Any unapproved collaboration will be stricken from the proposal prior to the merit review.
Any use of NIST-owned intellectual property by a proposer is at the sole discretion of NIST and will be negotiated on a case-by-case basis if a project is deemed meritorious. The applicant should indicate within the statement of work whether it already has a license to use such intellectual property or whether it intends to seek one.
If any inventions made in whole or in part by a NIST employee arise in the course of an award made pursuant to this notice, the United States government may retain its ownership rights in any such invention. Licensing or other disposition of NIST's rights in such inventions will be determined solely by NIST, and include the possibility of NIST putting the intellectual property into the public domain.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.
On December 3, 2000, the U.S. Department of Health and Human Services (DHHS) introduced a new Federal-wide Assurance of Protection of Human Subjects (FWA). The FWA covers all of an institution's Federally supported human subjects research, and eliminates the need for other types of Assurance documents. The Office for Human Research Protections (OHRP) has suspended processing of multiple project assurance (MPA) renewals. All existing MPAs will remain in force until further notice. For information about FWAs, please see the OHRP Web site at
In accordance with the DHHS change, NIST will continue to accept the submission of human subjects protocols that have been approved by Institutional Review Boards (IRBs) possessing a current, valid MPA from DHHS. NIST also will accept the submission of human subjects protocols that have been approved by IRBs possessing a current, valid FWA from DHHS. NIST will not issue a single project assurance (SPA) for any IRB reviewing any human subjects protocol proposed to NIST.
On August 9, 2001, the President announced his decision to allow Federal funds to be used for research on existing human embryonic stem cell lines as long as prior to his announcement (1) the derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated and (2) the embryo from which the stem cell line was derived no longer had the possibility of development as a human being. NIST will follow guidance issued by the National Institutes of Health at
National Institute of Standards and Technology, Department of Commerce.
Notice of partially closed meeting.
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app. 2, notice is hereby given that the Advanced Technology Program Advisory Committee, National Institute of Standards and Technology (NIST), will meet Tuesday, March 22, 2005, from 9 a.m. to 3 p.m. The Advanced Technology Program Advisory Committee is composed of nine members appointed by the Director of NIST; who are eminent in such fields as business, research, new product development, engineering, education, and management consulting. The purpose of this meeting is to review and make recommendations regarding general policy for the Advanced Technology Program (ATP), its organization, its budget, and its programs within the framework of applicable national policies as set forth by the President and the Congress. The agenda will include presentations on Insights from the Task Force on Innovation; Science and Technology in Austria: Small County, Great Expectations; Survey of ATP Applicants 2002; and Insights from “Innovate America: National Innovation Initiative Report. A discussion scheduled to begin at 1 p.m. and to end at 3 p.m. on March 22, 2005, on ATP budget issues will be closed. Agenda may change to accommodate Committee business. All visitors to the National Institute of Standards and Technology site will have to pre-register to be admitted. Please submit your name, time of arrival, e-mail address and phone number to Donna Paul no later than Friday, March 18 and she will provide you with instructions for admittance. Ms. Paul's e-mail address is
The meeting will convene Tuesday, March 22, at 9 a.m. and will adjourn at 3 p.m. on Tuesday, March 22, 2005.
The meeting will be held at the National Institute of Standards and Technology, Administration Building, Employees' Lounge, Gaithersburg,
Donna Paul, National Institute of Standards and Technology, Gaithersburg, Maryland 20899-4700, telephone number (301) 975-2162.
The Assistant Secretary for Administration, with the concurrence of the General Counsel, formally determined on December 27, 2004, that portions of the meeting of the Advanced Technology Program Advisory Committee which involve discussion of proposed funding of the Advanced Technology Program may be closed in accordance with 5 U.S.C. 552b(c)(9)(B), because that portion will divulge matters the premature disclosure of which would be likely to significantly frustrate implementation of proposed agency actions.
National Institute of Standards and Technology, Department of Commerce.
Meeting/workshop notice.
The National Institute of Standards and Technology (NIST) will host, in conjunction with the American National Standards Institute, a public workshop from 9 a.m. to noon on April 15, 2005, at the Department of Commerce, Herbert C. Hoover Building, 14th Street and Constitution Ave., NW., Washington, DC. The purpose of the workshop is to raise awareness of the effort currently underway to complete the United States Standards Strategy; to engage stakeholders in a dialogue of its principles, strategic initiatives and tactics; and to invite public comment. The results of the workshop discussions will be included in a compilation of public comments and considered in a final draft of the U.S. Standards Strategy. There is no charge for the workshop, but pre-registration is required. To register electronically, please send an e-mail message containing the attendee's name, title, organization, telephone, telefax and e-mail address to
The workshop will begin on April 15, 2005, at 9 a.m. and conclude at noon.
The workshop will be held at the Department of Commerce, Herbert C. Hoover Building, 14th Street and Constitution Avenue, NW., Washington, DC. Please note admittance instructions under
Mary Saunders, Chief, Standards Services Division, 100 Bureau Drive/MS 2100, Gaithersburg, MD 20899-2100, phone: (301) 975-4000 or e-mail
The United States Standards Strategy is a revision of the National Standards Strategy for the United States (NSS) (first edition—August 2000). The NSS was developed by a committee of private and public sector stakeholders in the U.S. standards system, under the sponsorship of the American National Standards Institute (ANSI). It was intended to serve as a strategic framework to help guide standards-related activities impacting trade, market-access, emerging national priorities, and more. Strategic and tactical initiatives contained within this framework were developed so that they could then be used by diverse interests to meet their respective national and individual organizational objectives. In mid-2004, ANSI convened a committee to review and revise the NSS. More than 100 representatives of industry; small, medium and large enterprise; standards developers and consortium; consumer groups; and federal and state government have participated in the review process. An initial draft of the second edition of the Strategy was issued for public review and comment in March 2005 (to access the draft text, refer to the Web site
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of final determination and discussion of underlying biological analysis.
NMFS has evaluated the joint resource management plan (RMP) for harvest of Puget Sound chinook salmon provided by the Puget Sound Treaty Tribes and the Washington Department of Fish and Wildlife (WDFW) pursuant to the protective regulations promulgated for Puget Sound chinook salmon under the Endangered Species Act (ESA). The RMP specifies the management of commercial, recreational and tribal salmon fisheries and steelhead net fisheries that potentially affect listed Puget Sound chinook salmon from May 1, 2004, through April 30, 2010.
The co-managers propose that the resource management plan be in effect for six years, from May 1, 2004, through April 30, 2010. However, a biological opinion issued by NMFS on June 10, 2004, titled “Effects of Programs Administered by the Bureau of Indian Affairs supporting tribal salmon fisheries management in Puget Sound and Puget Sound salmon fishing activities authorized by the U.S. Fish and Wildlife Services during the 2004 fishing season”, is effective through April 30, 2005. Therefore, NMFS' evaluation and determination under the ESA 4(d) rule will only address May 1, 2005 to April 30, 2010, of the proposed duration of the RMP. This document serves to notify the public that NMFS, by delegated authority from the Secretary of Commerce (Secretary), has determined pursuant to the Tribal Rule and the government-to-government processes therein that implementing and enforcing the RMP from May 1, 2005, to April 30, 2010, will not appreciably reduce the likelihood of survival and recovery of the Puget Sound chinook salmon Evolutionarily Significant Unit (ESU).
The final determination on the take limit was made on February 28, 2005.
Sustainable Fisheries Division, National Marine Fisheries
Susan Bishop at: 206/526-4587, or e-mail:
This notice is relevant to the Puget Sound chinook salmon (
The full texts of NMFS' determination and the final Evaluation are available on the Internet at the NMFS, Sustainable Fisheries Division web site at:
In March, 2004, the Puget Sound Treaty Tribes and the WDFW (co-managers) provided a jointly developed RMP that encompasses Strait of Juan de Fuca and Puget Sound salmon fisheries affecting the Puget Sound chinook salmon ESU. The RMP is effective from May 1, 2004, through April 30, 2010. Harvest objectives specified in the RMP account for fisheries-related mortality of Puget Sound chinook throughout its migratory range, from Oregon and Washington to Alaska. The RMP also includes implementation, monitoring and evaluation procedures designed to ensure fisheries are consistent with these objectives. On April 15, 2004, at 69 FR 19975, NMFS published a notice of availability for public review and comment in the
As required by section 223.203 (b)(6) of the ESA 4 (d) rule, NMFS must determine pursuant to 50 CFR 223.209 and pursuant to the government to government processes therein whether the RMP for Puget Sound chinook would appreciably reduce the likelihood of survival and recovery of the Puget Sound chinook and other affected threatened ESUs. NMFS must take comments on how the RMP addresses the criteria in section 223.203 (b)(4) in making that determination.
The RMP's approach to establishing management objectives is risk averse and progressive, including (1) management objectives, based on natural production and natural spawning, have been established for the majority of naturally producing populations which historically had self-sustaining chinook populations and for which data is available. These management units represent the entire range of life history types (races) and geographic distribution that comprise the Puget Sound chinook salmon ESU; (2) the RMP derives exploitation rates based on conservative, quantifiable standards directly related to recovery, which take into account scientific uncertainty; (3) in isolating the effect of harvest on survival and recovery, the approach is valuable in ensuring that harvest actions do not impede recovery, regardless of the contribution of the hatcheries, habitat, hydropower.. At the same time, the approach is linked to the other hatcheries, habitat, hydropower by taking into account current environmental and habitat conditions; (4) the proposed objectives are generally consistent with NMFS' rebuilding exploitation rates (RER), population standards previously used to assess the likelihood of survival and recovery of the Puget Sound chinook salmon ESU. These standards included an assessment of the long-term effects of exploitation rates at these levels; (5) the RMP includes specific and integrated monitoring programs to maintain and improve population assessment methodologies as well as to evaluate the effectiveness of harvest management actions and objectives. The RMP also includes provisions for an annual report. This report will assess compliance with, parameter validation of, and effectiveness of the RMP objectives.
A more detailed discussion of NMFS' evaluation is on the Sustainable Fisheries Division web site (see Electronic Access, under the heading,
NMFS published a notice in the
Comments received from the public in response to the NMFS announcement of the PEPD for review are summarized as follows:
On Tuesday, May11, 2004, NMFS received e-mail comments from Mr. Robert Hayman of the Skagit River System Cooperative. The comments were submitted in the form of electronic versions of three documents: “NMFSFinalE&DComments504.doc”; “BYExplRateCalcs2004 PopStatFix 404.xls”; and “SkgtSFCkProjectn4E&D404.xls”. Under the implementation of the RMP, the projected range of exploitation rates for the Skagit summer/fall chinook salmon management unit was estimated to be 48 to 56 percent (Table 3 in the PEPD). The PEPD qualified this projection by stating that this range of exploitation rates probably overestimates the actual rates under the RMP. Mr. Hayman agreed with this assessment and requested that his three documents be included as part of the public record on the PEPD “so that they are available if further elaboration is needed about the Evaluation and Determination's assessment of Skagit summer/fall chinook.” No change to the PEPD was necessary.
On Tuesday, May11, 2004, NMFS received comments from Mr. Sam Wright. Mr. Wright commented that the Final Environmental Impact Statement (FEIS) should be completed prior to soliciting public review comments on the PEPD. Mr. Wright's comments were primarily directed at the Draft Environmental Impact Statement (DEIS). The comments addressed the alternatives of the DEIS and proposed an additional alternative, which he referred to as Alternative 1A. He asked that these comments on the DEIS be incorporated by reference. Mr. Wright provided no other direct comments on the PEPD. The discussion on the various alternatives is not directly applicable to the PEPD. Mr. Wright's comments pertaining to the DEIS were addressed in the FEIS process.
On Monday, May 17, 2004, through e-mail, NMFS received comments on the PEPD from the Washington Trout (WT). The commenter recommends that NMFS substantively revise the PEPD before a final determination is developed. The structure of the WT's comments was presented in nine identified sections. These sections were: Introduction; Minimum Fishery Regime; Management Objectives and Indicators; Recovery Exploitation Rates; Upper Management Thresholds; Low Abundance Thresholds; Critical Exploitation Rate Ceiling; Critical Exploitation Rate Ceiling; and Other Issues of Concern. In responding to the WT's comments, NMFS will use a similar structure.
In recognition of tribal management authority and the Federal Government's trust responsibility to the tribes, NMFS is committed to considering their judgment and expertise regarding the conservation of trust resources. Consistent with this commitment and as a matter of policy, NMFS has sought, where there is appropriate tribal management, to work with tribal managers to provide limited tribal fishery opportunities, so long as the risk to the population remains within acceptable limits.
A complete list of all references cited herein is available upon request (see
Under section 4 of the ESA, NMFS, by delegated authority from the Secretary, is required to adopt such regulations as it deems necessary and advisable for the conservation of the species listed as threatened. The ESA salmon and steelhead 4 (d) rule (65 FR 42422, July 10, 2000) specifies categories of activities that are adequately regulated to provide for the conservation of listed salmonids and sets out the criteria for such activities. The rule further provides that the prohibitions of paragraph (a) of the rule do not apply to actions undertaken in compliance with a RMP developed jointly by the State of Washington and the Tribes and determined by NMFS to be in accordance with the salmon and steelhead 4 (d) rule (65 FR 42422, July 10, 2000).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The NMFS publishes this notice to extend the application deadline for the Western Pacific Demonstration Projects initiative. The original solicitation was published in the
Application packages must be received by 5 p.m. Hawaii standard time on April 4, 2005.
The address for submitting proposals electronically is:
Paper submissions should be sent to the following address: Western Pacific Demonstration Projects Coordinator, National Marine Fisheries Service, Pacific Islands Regional Office, 1601 Kapiolani Blvd, Honolulu, HI 96814 ATTN: WPDP Federal Program Officer.
Scott W.S. Bloom, phone: 808-973-2935 ext. 218, fax: 808-973-2941, or e-mail:
This notice extends the solicitation period of the Western Pacific Demonstration Projects initiative announced in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Public meeting.
The New England Fishery Management Council (Council) will hold a three-day Council meeting on March 29-31, 2005, to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
The meeting will be held on Tuesday, March 29, 2005, beginning at 9 a.m. and on Wednesday and Thursday, March 30 and 31, beginning at 8:30 a.m.
The meeting will be held at the Hotel Viking, One Bellevue Avenue, Newport, RI 02840; telephone (401) 847-3300. Requests for special accommodations should be addressed to the New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone (978) 465-0492.
Paul J. Howard, Executive Director, New England Fishery Management Council, (978) 465-0492.
Following introductions, the Council will receive reports from the Council Chairman, Executive Director, the NMFS Regional Administrator, Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council liaisons, NOAA General Counsel, representatives of the U.S. Coast Guard, NMFS Enforcement and the Atlantic States Marine Fisheries Commission. Additional reports to the Council will address the recent Gear Conflict Workshop held by members of the fishing industry and an update on the New England Fleet Visioning Project. During the morning session, the Council will receive two briefings on ecosystem approaches to fisheries management, followed by a question and answer period.
Following a lunch break, there will be an opportunity to review and comment on the draft proposed rule for Framework Adjustment 17 to the Sea Scallop Fishery Management Plan (FMP). During this discussion, there will be a particular focus on the “power down” provision for scallop general category vessel that are required to carry vessel monitoring systems. There will be initial Council action on Framework Adjustment 1 to the Spiny Dogfish FMP, a modification to the plan that would allow multi-year specifications to be set for the fishery. At the end of the day, NOAA Fisheries staff will brief the Council on the alternatives contained in the Draft Environmental Impacts Statement for the Atlantic Large Whale Take Reduction Plan and the potential impact of the proposed measures on Council fishery management plans.
During the Wednesday morning session, the Council Executive Director will provide a report on a draft Council Conservation and Management Policy. Following Council comments and possible approval of the policy, the remainder of the day will be used to address bycatch issues. Specifically, the Council's Bycatch Committee will discuss bycatch reduction measures for the herring, whiting and groundfish fisheries. The Council will make final decisions concerning which measures would be the most appropriate to implement through a possible framework adjustment, or alternatively, through Emergency Action, Flexible Area Action System, or other vehicle. If the Council agrees to implement measures through a framework, final action could be taken at this meeting to approve measures for inclusion in the Northeast Multipspecies and/or Herring FMPs.
The morning session will begin with a summary of the activities currently underway and associated with development of EFH Omnibus Amendment #2. An open period for public comments on subjects not otherwise listed on the agenda also will be provided. A report from the Groundfish Committee will follow. Issues to be addressed include final action on Framework Adjustment 41 to the Northeast Multispecies FMP (access to Closed Area I hook gear sector/haddock special access program for non-sector vessels) a report on the development of the biennial framework adjustment for fishing years 2005-2006 and recommendations for the Eastern U.S. Canada Area for fishing year 2005.
Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see
The Committee for the Implementation of Textile Agreements (CITA).
Denial of the request alleging that certain anti-microbial elastomeric filament yarn, of the specifications below, classified in under subheadings 5402.49.9005 and 5404.10.8005 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the domestic industry in commercial quantities in a timely manner under the CBTPA, AGOA, and ATPDEA.
On January 3, 2005 the Chairman of CITA received a petition from Alston & Bird, LLP, on behalf of Ge-Ray Fabrics, Inc., alleging that certain anti-microbial elastomeric filament yarn, of the specifications
Shikha Bhatnagar, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-3400.
Section 112(b)(5)(B) of the AGOA; Section 213(b)(2)(A)(v)(II) of the Caribbean Basin Economic Recovery Act, as added by Section 211(a) of the CBTPA; Sections 1 and 6 of Executive Order No. 13191 of January 17, 2001; Presidential Proclamations 7350 and 7351 of October 4, 2000; Section 204 (b)(3)(B)(ii) of the ATPDEA, Presidential Proclamation 7616 of October 31, 2002, Executive Order 13277 of November 19, 2002, and the United States Trade Representative's Notice of Redelegation of Authority and Further Assignment of Functions of November 25, 2002.
The AGOA, the CBTPA, and the ATPDEA provide for quota- and duty-free treatment for qualifying textile and apparel products. Such treatment is generally limited to products manufactured from yarns and fabrics formed in the United States or a beneficiary country. The AGOA, the CBTPA, and the ATPDEA also provide for quota- and duty-free treatment for apparel articles that are both cut (or knit-to-shape) and sewn or otherwise assembled in one or more beneficiary countries from fabric or yarn that is not formed in the United States, if it has been determined that such fabric or yarn cannot be supplied by the domestic industry in commercial quantities in a timely manner. In Executive Order No. 13191 (66 FR 7271) and pursuant to Executive Order No. 13277 (67 FR 70305) and the United States Trade Representative's Notice of Redelegation of Authority and Further Assignment of Functions (67 FR 71606), CITA has been delegated the authority to determine whether yarns or fabrics cannot be supplied by the domestic industry in commercial quantities in a timely manner under the AGOA, the CBTPA, or the ATPDEA. On March 6, 2001, CITA published procedures that it will follow in considering requests (66 FR 13502).
On January 3, 2005 the Chairman of CITA received a petition from Alston & Bird, LLP, on behalf of Ge-Ray Fabrics, Inc., alleging that certain anti-microbial elastomeric filament yarn in under subheadings 5402.49.9005 and 5404.10.8005 of the Harmonized Tariff Schedule of the United States (HTSUS), cannot be supplied by the domestic industry in commercial quantities in a timely manner. The petition requested that knit apparel articles from such yarns or from U.S. formed fabrics containing such yarns, be eligible for preferential treatment under the AGOA, the CBTPA, and the ATPDEA.
On January 10, 2005, CITA published a Federal Register notice requesting public comments on the request, particularly with respect to whether these yarns can be supplied by the domestic industry in commercial quantities in a timely manner. See Request for Public Comments on a Commercial Availability Request under the African Growth and Opportunity Act (AGOA), Caribbean Basin Trade Partnership Act (CBTPA), and the Andean Trade Promotion and Drug Eradication Act (ATPDEA), 70 FR 1694 (January 10, 2005). On January 26, 2005, CITA and USTR offered to hold consultations with the House Ways and Means Committee and the Senate Finance Committee, but no consultations were requested. We also requested advice from the U.S. International Trade Commission and the relevant Industry Trade Advisory Committees.
CITA found that anti-microbial elastomeric yarn can be supplied by the domestic industry in commercial quantities and in a timely manner. Specifically, CITA found that there are several domestic manufacturers who currently produce the subject yarns and are capable of producing the subject yarn, or a substitutable yarn with the same characteristics, in commercial quantities and in a timely manner.
On the basis of currently available information and our review of this request, CITA has determined that there is domestic capacity to supply the subject product, or a substitutable product, in commercial quantities in a timely manner. Ge-Ray's request is denied.
Department of Defense.
Notice of advisory committee meeting date change.
On Tuesday, February 1, 2005 (70 FR 5169) the Department of Defense announced open meetings of the Defense Science Board (DSB) Task Force on Manufacturing Technology. These meetings will now be closed to the public. Both meetings will be held at Strategic Analysis Inc., 3601 Wilson Boulevard, Suite 600, Arlington, VA.
Department of the Army, DoD.
Notice of open meeting.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. I), announcement is made of the following committee meeting:
To request advance approval or obtain
This meeting is open to the public. Any interested person may attend, appear before, make a presentation, or file statements with the Committee after receiving advance approval for participation.
Department of the Army, DoD.
Notice to alter a system of records.
The Department of the Army is proposing to alter a system of records notice in its existing inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
This proposed action will be effective without further notice on April 11, 2005 unless comments are received which result in a contrary determination.
Department of the Army, Freedom of Information/Privacy Division, U.S. Army Records Management and Declassification Agency, ATTN: AHRC-PDD-FPZ, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22325-3905.
Ms. Janice Thornton at (703) 428-6497.
The Department of the Army systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on February 1, 2005, to the House Committee on Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, ‘Federal Agency Responsibilities for Maintaining Records About Individuals,’ dated February 8, 1996 (February 20, 1996, 61 FR 6427).
Occupational Health Records (March 27, 2003, 68 FR 14959).
Add to entry “and ergonomic evaluations”.
Add to entry “gender, pay plan and grade,” and “ergonomic evaluations,” and “job requirements, physical demands”.
Add to entry “ergonomic recommendations and corrections”.
Add “individual” to entry.
Occupational Health Records.
U.S. Army Medical Command, 1216 Stanley Road, Suite 25m Fort Sam Houston, TX 78234-5053.
U.S. Army Center for Health Promotion and Preventive Medicine, 5158 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5403.
Active duty army, their family members, U.S. Army Reserve, National Guard on active duty or in drill status, U.S. Military Academy and Reserve Officer Training Corps cadets, when engaged in directed training, foreign national military assigned to Army components, Department of the Army civilian and non-appropriated fund personnel employed by the Army for whom specific occupational health examinations and ergonomic evaluations have been conducted and/or requested.
Name, Social Security Number, date and place of birth, marital status, gender, pay plan and grade, dates of medical surveillance tests and ergonomic evaluations and their results, job requirements, physical demands, documents reflecting the training, experience and certification to work within hazardous environments, including personnel monitoring results and work are monitoring readings. Exposures to chemicals, radiation, physical environment, non-human primates, and similar and related documents; personnel protective equipment and medical programs required to limit exposure to environmental safety and health hazards are also included.
10 U.S.C. 3013, Secretary of the Army; 5 U.S.C. 7902, Safety Programs; 29 U.S.C. 668, Programs of Federal Agencies; 29 CFR 1910, Occupational Safety and Health Standards; Army Regulation 40-5, Preventive Medicine; E.O. 12223, Occupational Safety Health Programs for Federal Employees; and E.O. 9397 (SSN).
To maintain a permanent record of work places, training, exposures, medial surveillance, ergonomic recommendations and corrections, and any medical care provided for eligible individuals.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
Information may be disclosed to appropriate Government agencies whose responsibility falls within the occupational health statutes identified under ‘Authority’ above.
The DoD ‘Blanket Routine Uses’ set forth at the beginning of the Army's compilation of systems of records notices also apply to this system.
This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025.18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.
Paper records, printouts, magnetic tapes and electronic storage media.
By individual's name and/or Social Security Number.
Access to all records is restricted to designated individuals whose official duties dictate an official need to know. Information in automated media is further protected from unauthorized access in locked rooms. All individuals afforded access are given periodic orientations concerning sensitivity of personal information and requirement to prevent unauthorized disclosure.
Records are maintained by employing office until employee is separated at which time records are filed with the individual personnel record for 30 years. GB agent records maintain for 40 years then destroy.
Chief Information Officer, Office of the Surgeon General, U.S. Army Medical Command, 2050 Worth Road, Suite 13, Fort Sam Houston, TX 78234-6013.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to Chief Information Officer, Office of the Surgeon General, U.S. Army Medical Command, 2050 Worth Road, Suite 13, Fort Sam Houston, TX 78234-6013, or to the Patient Administrator at the appropriate medical treatment facility.
For ergonomic evaluations the individual should address written inquiries to the Commander, U.S. Army Center for Health Promotion and Preventive Medicine, 5158 Blackhawk Road, Aberdeen, MD 21010-5403.
Individual must provide full name, Social Security Number, current address, telephone number, details of last location of record or employment, and signature.
Individuals seeking access to information about themselves contained in this system should address written inquiries to Chief Information Officer, Office of the Surgeon General, U.S. Army Medical Command, 2050 Worth Road, Suite 13, Fort Sam Houston, TX 78234-6013, or to the Patient Administrator at the appropriate medical treatment facility.
For ergonomic evaluations the individual should address written inquiries to the Commander, U.S. Army Center for Health Promotion and Preventive Medicine, 5158 Blackhawk Road, Aberdeen, MD 21010-5403.
Individual must provide full name, Social Security Number, current address, telephone number, details of last location of record or employment, and signature.
The Army's rules for accessing records, and for contesting contents and appealing initial determination are contained in Army Regulation 340-21; 32 CFR part 505; or may be obtained from the system manager.
From individuals and Army Medical records and reports.
None.
Department of the Army, U.S. Army Corps of Engineers, DOD.
Notice.
The Walla Walla District of the U.S. Army Corps of Engineers (Corps) is withdrawing its intent to prepare a Supplemental Environmental Impact Statement (SEIS) to the July 2002 Final Dredged Material Management Plan (DMMP) and Environmental Impact Statement (EIS): McNary Reservoir and Lower Snake River Reservoirs (DMMP/EIS). The Notice of Intent was for the SEIS published in the
Mr. Jack Sands, Program Manager, Walla Walla District, Corps of Engineers, CENWW-PM-PPM, 201 North Third Avenue, Walla Walla, WA 99362, phone (509) 527-7287, or Ms. Sandra Simmons, Environmental Coordinator, Walla Walla District, Corps of Engineers, CENWW-PD-EC, 201 North Third Avenue, Walla Walla, WA 99362, phone (509) 527-7265.
The DMMP/EIS defined the programmatic approach the Corps planned to follow for the next 20 years for maintaining the congressionally authorized navigation channel by managing sediment deposition, dredging, and disposing of dredged material removed from those reaches of the Columbia, Snake, and Clearwater Rivers that make up that portion of the Columbia/Snake Rivers Inland Navigation Waterway within the Walla Walla District boundaries. The DMMP/EIS also addressed the need to provide flow conveyance at the confluence of the Snake and Clearwater Rivers at Lewiston, Idaho, as dredging has been used to maintain adequate flow conveyance in this area. The DMMP/EIS considered four alternatives: (1) No Action (No Change), Maintenance Dredging with In-Water Disposal; (2) Maintenance Dredging with In-Water Disposal to Create Fish Habitat and a 3-Foot levee Raise; (3) Maintenance Dredging with Upland Disposal and a 3-Foot Levee Raise; and (4) Maintenance Dredging with Beneficial Use of Dredged Material and a 3-Foot Levee Raise. This supplement was to reorganize and clarify information already included in the DMMP/EIS, expand the discussions and evaluations of measures considered in the DMMP/EIS, incorporate new information and data collected subsequent to the issuance of the DMMP/EIS, and modify alternatives, including the preferred alternative. When completed and approved, this SEIS, along with the DMMP/EIS, was to constitute the Corps' long-term programmatic plan for maintaining the congressionally-authorized navigation channel within the Walla Walla District.
The DMMP/EIS and additional environmental compliance documentation addressing navigation channel maintenance were challenged in court. Preliminary injunctions resulting from these challenges halted planned maintenance activities. The Corps is currently reviewing the previous documentation and will issue a new Notice of Intent, if applicable, announcing future environmental compliance that addresses navigation
Department of Education.
Update notice.
The Secretary provides an update to the list of ATB tests to include the WorkKeys Program test—Forms Reading for Information: A01AA, A02AA, C01AA, D10AA, and Applied Mathematics: A01BB, A02BB, C01BB, and D01BB. The Secretary has approved the WorkKeys Program test and its passing scores under section 484(d) of the Higher Education Act of 1965, as amended (HEA), and the implementing regulations in 34 CFR Part 668, Subpart J. An institution may use the WorkKeys Program test as an approved ATB test to determine if a student who does not have a high school diploma or its recognized equivalent is eligible to receive funds under any title IV, HEA program. The title IV, HEA programs include the Federal Pell Grant, Federal Family Education Loan, William D. Ford Federal Direct Loan, Federal Perkins Loan, Federal Work-Study, Federal Supplemental Educational Opportunity Grant, and the Leveraging Educational Assistance Partnership (LEAP) programs.
David Morgan, U.S. Department of Education, Federal Student Aid, Union Center Plaza, 830 First Street, NE., Washington, DC 20202-5345. Telephone: (202) 377-4033.
If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Individuals with disabilities may obtain a copy of this document in an alternative format (
The Secretary is amending the list of approved ATB tests and passing scores that was published in the
1. ASSET Program: Basic Skills Tests (Reading, Writing, and Numerical)—Forms B2, C2, D2 and E2.
2. Career Programs Assessment (CPAT) Basic Skills Subtests (Language Usage, Reading and Numerical)—Forms B and C.
3. COMPASS Subtests: Prealgebra/Numerical Skills Placement, Reading Placement, and Writing Placement.
4. Combined English Language Skills Assessment (CELSA), Forms 1 and 2.
The CELSA test is approved only for certain students whose native language is not English as provided in 34 CFR 668.153(a)(2).
5. Computerized Placement Tests (CPTs)/Accuplacer (Reading Comprehension, Sentence Skills, and Arithmetic).
6.
7. Wonderlic Basic Skills Test (WBST)—Verbal Forms VS-1 & VS-2, Quantitative Forms QS-1 & QS-2.
8. WorkKeys Program—Reading for Information Forms A01AA, A02AA, C01AA & D10AA; Applied Mathematics Forms A01BB, A02BB, C01BB, & D01BB.
Reading for Information—Forms A01AA (76), A02AA (75), C01AA (77) & D10AA (77);
Applied Mathematics—Forms A01BB (73), A02BB (74), C01BB (73) & D01BB (73).
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO) toll free, at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.
The official version of this document is the document published in the
20 U.S.C. 1091(d).
United States Election Assistance Commission.
Notice of public meeting agenda.
Tuesday, March 22, 2005, 10 a.m.-12 noon.
U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 2005 (Metro Stop: Metro Center).
The Commission will receive reports on the following: Title II Requirements Payments Update; Technical Guidelines Development Committee Update; Election Day Survey Analysis Update; Other Administrative Matters. The Commission will receive presentations on the following: The Role of the United States Election Assistance Commission as a Clearinghouse.
Bryan Whitener, Telephone: (202) 566-3100.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice.
In this notice, the Department of Energy (DOE or Department) is forecasting the representative average unit costs of five residential energy sources for the year 2005 pursuant to the Energy Policy and Conservation Act. The five sources are electricity, natural gas, No. 2 heating oil, propane, and kerosene.
Samuel Johnson, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Forrestal Building, Mail Station EE-2J, 1000 Independence Avenue, SW., Washington, DC 20585-0121, (202) 586-0854,
Francine Pinto, Esq., U.S. Department of Energy, Office of General Counsel, Forrestal Building, Mail Station GC-72, 1000 Independence Avenue, SW., Washington, DC 20585-0103, (202) 586-7432,
Thomas DePriest, Esq., U.S. Department of Energy, Office of General Counsel, Forrestal Building, Mail Station GC-72, 1000 Independence Avenue, SW., Washington, DC 20585-0103, (202) 586-2946,
Section 323 of the Energy Policy and Conservation Act (Act) (42 U.S.C. 6291-6309) requires that DOE prescribe test procedures for the determination of the estimated annual operating costs or other measures of energy consumption for certain consumer products specified in the Act. (42 U.S.C. 6293) These test procedures are found in Title 10 of the Code of Federal Regulations (CFR) part 430, subpart B.
Section 323(b) of the Act requires that the estimated annual operating costs of a covered product be calculated from measurements of energy use in a representative average use cycle or period of use and from representative average unit costs of the energy needed to operate such product during such cycle. (42 U.S.C. 6293(b)) The section further requires that DOE provide information to manufacturers regarding the representative average unit costs of energy. (42 U.S.C. 6293(b)(4)) This cost information should be used by manufacturers to meet their obligations under section 323(c) of the Act. Most notably, these costs are used to comply with Federal Trade Commission (FTC) requirements for labeling. Manufacturers are required to use the revised DOE representative average unit costs when the FTC publishes new ranges of comparability for specific covered products, 16 CFR part 305. Interested parties can also find information covering the FTC labeling requirements at
The Department last published representative average unit costs of residential energy for use in the Energy Conservation Program for Consumer Products Other Than Automobiles on January 27, 2004 (69 FR 3907). Effective April 11, 2005, the cost figures published on January 27, 2004, will be superseded by the cost figures set forth in this notice.
The Department's Energy Information Administration (EIA) has developed the 2004 representative average unit after-tax costs found in this notice. The representative average unit after-tax costs for electricity, natural gas, No. 2 heating oil, and propane are based on simulations used to produce the October 2004, EIA
The 2005 representative average unit costs under section 323(b)(4) of the Act are set forth in Table 1, and will become
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 the
ERP No. D-AFS-B65011-00 Rating LO, White Mountain National Forest, Propose Land and Resource Management Plan, Forest Plan Revision Implementation, Carroll, Coos and Grafton Counties, NH and Oxford County, ME.
ERP No. D-COE-F36166-OH Rating EC2, Mill Creek, Ohio Flood Damage Reduction Project, To Reduce Damages to Communities, Hamilton County, OH.
ERP No. D-FHW-E40803-TN Rating EC2, TN-397 (Mack Hatcher Parkway Extension) Construction from US-31 (TN-6, Columbia Avenue) South of Franklin to US-341 (TN-106, Hillsboro Road) North of Franklin, Williamson County and the City of Franklin, TN.
ERP No. D-FRC-B03011-MA Rating EU3, Weaver's Cove Liquefied Natural Gas (LNG) Project, Construct and Operate Onshore Liquefied Natural Gas Import and Interstate Natural Gas Transmission Facilities, Falls River, Bristol County, MA.
ERP No. D-FRC-B03012-RI Rating EC2, KeySpan Liquefied Natural Gas (LNG) Facility Upgrade Project, Construction and Operation, and Algonquin Gas Transmission Project, Proposal for Site, Construct and Operate a New Natural Gas Pipeline, Coast Guard Permit, U.S. Army COE Section 10 and 404 Permits, Providence County, RI and New England.
ERP No. D-IBR-K39089-CA Rating EC2, Folsom Dam Road Access Restriction Project, Control Access to Folsom Dam, City of Folsom, CA.
ERP No. D-NIH-B81009-MA Rating EC2, National Emerging Infectious Diseases Laboratories, Construction of a National Biocontainment Laboratory, BioSquare Research Park, Boston University Medical Center Campus, Boston, MA.
ERP No. D-NPS-B65012-ME Rating LO, Schoodic General Management Plan Amendment, Implementation, Acadia National Park, ME.
ERP No. D-NPS-K65276-AZ Rating EC2, Chiricahua National Monument
ERP No. D-NRC-B06005-CT Rating EC2, GENERIC—License Renewal of Nuclear Plants for the Millstone Power Station, Units 2 and 3, Supplement 22 to NUREG-1437, Implementation, New London County, CT.
ERP No. DC-IBW-K24017-00 Rating LO, South Bay International Wastewater Treatment Plan (SBIWTP), To Address Treatment Alternatives from Tijuana, Mexico that cross into United States/Mexico Border in San Diego County, CA.
ERP No. F-BLM-K65274-NV, Las Vegas Valley Disposal Boundary Project, Disposal and Use of Public Land under the Management of (BLM), Implementation, Clark County, NV.
ERP No. F-BLM-L65440-OR Upper Deschutes Resource Management Plan, Implementation, Deschutes, Klamath, Jefferson and Cook Counties, OR.
ERP No. F-FHW-C40159-NJ Penns Neck Area Transportation Service Improvements, Phase I Archeological Survey, US 1, Sections 2S and 3J, Funding, West Windsor and Princeton Townships, Mercer County, and Plainsboro Township, Middlesex County, NJ.
ERP No. FA-FTA-C40046-NY Erie Canal Harbor Project (formerly known as the Buffalo Inner Harbor Development Project) Updated Information on the Original Project, City of Buffalo, Erie County, NY.
ERP No. F1-FHW-F40356-WI US 10 Highway Improvements between Marshfield and Appleton, Trestik Road—CTH“K” (Stevens Point Bypass), Funding and COE Section 404 Permit, Portage County, WI.
Export-Import Bank of the U.S.
Notice and request for comments.
The Export-Import Bank, as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before April 11, 2005, to be assured of consideration.
Direct all comments to David Rostker, Office of Management and Budget, Office of Information and Regulatory Affairs, NEOB Room 10202, Washington, DC 20503, (202) 395-3897.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 25, 2005.
Board of Governors of the Federal Reserve System, March 7, 2005.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 4, 2005.
Board of Governors of the Federal Reserve System, March 7, 2005.
Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 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 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.
To obtain copies of the supporting statement and any related forms for the
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 371-5976 or send an e-mail to
Evaluating Tools for Health Promotion and Disease Prevention—New—Office of Genomics and Disease Prevention (OGDP), Centers for Disease Control and Prevention (CDC).
Although family history is a risk factor for most chronic diseases of public health significance, it is underutilized in the practice of preventive medicine and public health for assessing disease risk and influencing early detection and prevention strategies. It has been known for years that people who have close relatives with certain diseases (such as heart disease, diabetes, and cancers), are more likely to develop those diseases themselves. Geneticists have long recognized the value of family history for discovering inherited disorders, usually the result of single gene mutations. Although single gene disorders are typically associated with a large magnitude of risk, they account for a small proportion of individuals with a genetic risk for common, chronic diseases. Most of the genetic susceptibility to these disorders is the result of multiple genes interacting with multiple environmental factors. Family history is more than genetics; it reflects the consequences of inherited genetic susceptibilities, shared environment, shared cultures and common behaviors. All of these factors are important when estimating disease risk. In early 2002, the CDC Office of Genomics and Disease Prevention (OGDP) in collaboration with several CDC programs and NIH institutes began an initiative to develop a family history tool for identifying apparently healthy people who may be at increased risk for a number of common diseases. The major activities of this initiative have included: (1) Reviews of the literature for approximately 25 diseases; (2) assessments of family history tools currently in use or under development; (3) a meeting of experts to provide input into the process; (4) development of criteria for determining which diseases to include in the tool; (5) development of a framework for evaluating a family history tool and the development of a tool.
As a result of this initiative, a personal computer-based familial risk assessment tool was developed to be used as a public health strategy to improve health and prevent disease. The assessment tool is called, “Family Healthware.” This tool will be used to collect information about the disease history of a person's first- and second-degree relatives (mother, father, children, siblings, grandparents, aunts, and uncles), use family history information to assess risk for common diseases of adulthood, and influence early detection and prevention strategies. The current version of the tool focuses on six diseases—heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancers.
The proposed project is a study to evaluate the clinical utility of the “Family Healthware” tool by determining whether family history risk assessment, stratification, and personalized prevention messages have any impact on health behaviors, and use of medical services. In 2003, CDC awarded funding to three research centers to collaborate on a study set in primary care clinics to assess the clinical utility of the family history tool. Eligibility for the study will be determined by a brief screening test completed by patients from the primary care clinic. It is anticipated that only a small number will be ineligible to continue since the majority of patients will be pre-screened for eligibility based on a medical record review prior to the screening test.
The primary care clinics affiliated with the three research centers will be randomized into two groups. Patients participating in the study will all complete the pre-test, post-test and family history tool, however, the order in which they do so is dependent upon the group to which they are randomized. In the intervention group, patients attending the primary care clinics will be asked to complete the family history tool and a pre-test that includes an assessment of risk factors, preventive behaviors, use of medical services, and perception of risk. The patients will be provided with an assessment of their familial risk (average, above average, much above average) for each of the six diseases and information about preventive measures (
The purpose of having patients in the control group complete the family history tool post intervention is so that the analysis can be stratified by familial risk level in both patient groups. The hypothesis to be tested in this study is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services. There is no cost to respondents participating in this
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting:
The Director, Management Analysis and Services Office has been delegated the authority to sign
The Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), NCEH/ATSDR announces the following subcommittee meeting:
Agenda items are tentative and subject to change as priorities changes.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
1.
2.
3.
4.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at
Written comments and recommendations for the proposed information collections must be mailed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Christopher Martin, New Executive Office Building, Room 10235, Washington, DC 20503.
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.
2.
3.
4.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS” Web Site address at
Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the CMS Paperwork Reduction Act Reports Clearance Officer designated at the address below:
CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
In compliance with the requirement for the opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The purpose of the universal newborn hearing screening and intervention evaluation project is to describe the efficacy, or lack thereof, of a national program to assure that all newborn infants are screened for hearing loss before discharge from the newborn nursery, and that those infants who do not pass the initial screening procedures have timely and appropriate follow-up,
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 14-45, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 day of this notice.
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 NIH Advisory Board for Clinical Research.
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 notify the Contact Person listed below in advance of the meeting.
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 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.
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 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 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 of 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 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.
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.
Notice is hereby given of a change in the meeting of the National Institute of General Medical Sciences Special Emphasis Panel, March 14, 2005, 8 a.m. to March 15, 2005, 5 p.m., Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817 which was published in the
The meeting dates and times have not changed. However, the panel name has been changed from Small Scale Centers for the Protein Structure Initiative to Specialized Centers for the Protein Structure Initiative. 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 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 propoerty 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 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 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 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.
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(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Advisory Committee on Research on Women's Health.
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 notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the 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.
Information is also available on the Institute's/Center's home page:
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, March 14, 2005, 10 a.m. to March 14, 2005, 12 p.m., Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD, 20814 which was published in the
The meeting will be held at the Holiday Inn Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting date and time remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, March 16, 2005, 8 a.m. to March 16, 2005, 6 p.m., Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814 which was published in the
The meetings will be held at the Holiday Inn Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting date and time remain the same. 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 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.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, U.S. Department of Homeland Security.
Notice and request for comments.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed new information collection. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)), this notice seeks comments concerning FEMA's Web site usability study to identify visitors' information needs, usage patterns, preferences, ease of use, and overall satisfaction.
This proposed information collection is supported by various regulations, legislation and presidential mandates requiring government agencies to build citizen-centered websites, including Section 4 of the President's Management Agenda, the E-Government Act of 2002, and the Recommended Policies and Guidelines for Federal Public Web sites submitted to the Office of Management and Budget (OMB) by the Interagency Committee on Government Information. All of these authorities stipulate that federal agencies develop and administer their electronic capabilities based on customer needs and formulate IT performance criteria consistent with a more responsive and cost-effective government. Furthermore, the E-Government Act further outlines specific mandates for disaster activities, including that: “The Federal Emergency Management Agency, shall initiate pilot projects'that further the goal of maximizing the utility of information technology in disaster management.” This collection attempts to better understand FEMA's website visitors' information and transactional needs and their overall experience navigating the site. Findings will assist program managers to enhance the website's appearance, content, and ease of use in order to improve its ability to better serve the public.
Interested persons should submit written comments to Muriel B. Anderson, Chief, Records Management Section, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security, 500 C Street, SW., Room 316, Washington, DC 20472.
Contact Cindy Taylor, Assistant Director of Public Affairs at (202) 646-4600 for additional information. You may contact Ms. Anderson for copies of the proposed collection of information at facsimile number (202) 646-3347 or e-mail address:
U.S. Fire Administration (USFA), Federal Emergency Management Agency (FEMA), Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice of open meeting.
In accordance with section 10 (a) (2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, FEMA announces the following committee meeting:
The meeting will be open to the public in the Emmitsburg commuting area with seating available on a first-come, first-served basis. Members of the general public who plan to participate in the meeting should contact the Office of the Superintendent, National Fire Academy, U.S. Fire Administration, 16825 South Seton Avenue, Emmitsburg, MD 21727, (301) 447-1117, on or before April 1, 2005.
Minutes of the meeting will be prepared and will be available for public viewing in the Office of the U.S. Fire Administrator, U.S. Fire Administration, Federal Emergency Management Agency, Emmitsburg, Maryland 21727. Copies of the minutes will be available upon request within 60 days after the meeting.
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.
March 11, 2005.
Kathy Ezzell, Department of Housing and Urban Development, Room 7262, 451 Seventh Street, SW., 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 1-800-927-7588.
In accordance with the December 12, 1988 court order in
Bureau of Indian Affairs, Interior.
Notice.
This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency for compliance with the National Environmental Policy Act, and the City of Richmond (City), California, as lead agency for compliance with the California Environmental Quality Act, intend to gather information necessary for preparing an Environmental Impact Statement (EIS)/Environmental Impact Report (EIR) for a proposed 415± acre trust acquisition and casino/resort project to be located within the City of Richmond, Contra Costa County, California. The purpose of the proposed action is to restore the Guidiville land base of the Guidiville Band of Pomo Indians of the Guidiville Rancheria (Tribe) and help provide for the economic development of the tribe. The proposed action would additionally serve to meet the City's requirements under the Base Realignment and Closure Act to use a closed Navy fuel depot for economic development purposes. This notice also announces a public scoping meeting to identify potential issues and alternatives for inclusion in the EIS/EIR.
Written comments on the scope and implementation of this proposal must arrive by April 15, 2005. The public scoping meeting will be held March 31, 2005, from 7 p.m. to 9 p.m., or until the last public comment is received.
You may mail or hand carry written comments to Clay Gregory, Regional Director, Pacific Regional Office, Bureau of Indian Affairs, 2800 Cottage Way, Sacramento, California 95825. The public scoping meeting will be held at the Richmond Memorial Auditorium, 403 Civic Center Plaza, Richmond, California.
John Rydzik, (916) 978-6042.
The Tribe proposes that 415± acres of land be taken into trust to restore its terminated tribal land base for its people. The 415± acres encompass nine contiguous parcels in the City of Richmond, more commonly known as the former Point Molate Naval Fuel Depot. The project site is located 2 miles northeast of the Richmond-San Rafael Bridge tollbooth, after exiting at Western Avenue off of Highway 580 while heading west.
The Tribe wishes to use the property for multiple tribal purposes, including economic development and the provision of governmental services. The City wishes to use the property for economic development purposes, promoting employment, enhancing City revenues and improving municipal services. More specifically, the Tribe and City contemplate that the site will be used for the development of gaming and related entertainment, retail and lodging facilities, tribal government facilities, police and fire services, public parks, open space, a ferry terminal, public transportation and possible housing. The eventual size and scope of these facilities may be altered based on information obtained through the EIS/EIR process, but the Tribe and City's current proposal is for approximately 150,000 square feet of gaming floor, 300,000 square feet of retail facilities, 25,000 square feet of convention and entertainment facilities, an approximately 400 room hotel and a second phase 700 room hotel, 29 cottages remodeled into hotel suites or offices, a boutique spa/hotel, a fire station, tribal governmental offices, a tribal cultural center, 220+ acres of open space or submerged lands, 40 acres of public parks, a public trail, the ferry terminal and possible limited housing units. The proposed development would also include parking facilities for approximately 3000 vehicles for patrons and employees.
The proposed action encompasses the various federal approvals which would be required to implement the Tribe's efforts to establish a restored tribal land base, including approval of the Tribe's fee-to-trust application, approval of the Tribe's gaming management contract and approval of the Tribe's request for a reservation proclamation pursuant to a court approved stipulation in
Areas of environmental concern identified so far for analysis in the EIS/EIR include land resources, water resources, coastal zone planning consistency, air quality, living resources, cultural resources, Indian burial remains, socioeconomic conditions, traffic and transportation, land use, public utilities and services, noise, lighting, hazardous materials, environmental justice, soils remediation, visual resources/aesthetics, homeland security issues, Bay Trail construction, historical building restoration, and cumulative impacts. The range of issues and alternatives to be addressed in the EIS/EIR may be expanded based on comments received in response to this notice and at the public scoping meeting.
Comments, including names and addresses of respondents, will be available for public review at the BIA address shown in the
This notice is published in accordance with section 1503.1 of the Council of Environmental Quality Regulations (40 CFR Parts 1500 through 1508) implementing the procedural requirements of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4371
Bureau of Indian Affairs, Interior.
Notice of Class III gaming compacts taking effect.
Notice is given that the Tribal-State Compacts between the Kaw Nation, the Kickapoo Tribe, the Peoria Tribe and the State of Oklahoma are considered to have been approved and are in effect.
March 11, 2005.
George T. Skibine, Director, Office of Indian Gaming Management, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, (202) 219-4066.
Under Section 11(d)(7)(D) of the Indian Gaming Regulatory Act of 1988 (IGRA), Public Law 100-497, 25 U.S.C. 2710, the Secretary of the Interior must publish in the
Bureau of Land Management, Interior.
Nevada Department of Wildlife and Eureka County.
Notice of availability.
Pursuant to Section 102(2)(c) of the National Environmental Policy Act of 1969 and the Council on Environmental Quality Regulations found at 40 CFR Parts 1500-1508, notice is hereby given of the availability of the Draft Supplemental Environmental Impact Statement (DSEIS) for comment, prepared by the Battle Mountain Field Office of the Bureau of Land Management (BLM). The statement analyzes the environmental effects of the Proposed Action and the No Action Alternatives.
Written comments must be post-marked or otherwise delivered by 4:30 p.m. (Pacific Time Zone) by no later than 45 days after the date of publication of this Notice in the
Written comments should be addressed to the Bureau of Land Management, attn: Caleb Hiner, Battle Mountain Field Office, 50 Bastian Road, Battle Mountain, Nevada 89820. Comments, including names and addresses of respondents, will be available for public review at the address listed below during regular business hours, Monday-Friday, excluding holidays. Individual respondents may request confidentiality. If you wish to withhold your name or street address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. However, we will not consider anonymous comments. Such requests to withhold your name or street address from public review will be honored to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives of officials of organizations or businesses, will be available for public inspection in their entirety.
A limited number of copies of the DSEIS may be obtained at the Battle Mountain BLM Field Office.
Caleb Hiner, Battle Mountain BLM at (775) 635-4052.
The Proposed Action would develop the East Archimedes deposit which was defined in the original EIS (approved February 3, 1997) as a Reasonably Foreseeable Future Action. The Proposed Action would consist of an extension of the existing pit, expansion of the existing west and east waste rock disposal areas, the expansion of the existing heap leach pad, and construction of dewatering facilities. Under the Proposed Action, an estimated additional 744 acres of disturbance would occur. All disturbances proposed under the expansion falls within the footprint of the project boundary as analyzed in the original EIS.
Bureau of Reclamation, Interior.
Notice.
Notice is hereby given of contractual actions that have been proposed to the Bureau of Reclamation (Reclamation) and were pending through December 31, 2004, and contract actions that have been completed or discontinued since the last publication of this notice on October 4, 2004. From the date of this publication, future quarterly notices during this calendar year will be limited to new, modified, discontinued, or completed contract actions. This annual notice should be used as a point of reference to identify changes in future notices. This notice is one of a variety of means used to inform the public about proposed contractual actions for capital recovery and management of project resources and facilities consistent with section 9(f) of the Reclamation Project Act of 1939. Additional announcements of individual contract actions may be published in the
The identity of the approving officer and other information pertaining to a specific contract proposal may be obtained by calling or writing the appropriate regional office at the address and telephone number given for each region in the
Sandra L. Simons, Manager, Contract Services Office, Bureau of Reclamation, PO Box 25007, Denver, Colorado 80225-0007; telephone 303-445-2902.
Consistent with section 9(f) of the Reclamation Project Act of 1939 and the rules and regulations published in 52 FR 11954, April 13, 1987 (43 CFR 426.22), Reclamation will publish notice of proposed or amendatory contract actions for any contract for the delivery of project water for authorized uses in newspapers of general circulation in the affected area at least 60 days prior to contract execution. Announcements may be in the form of news releases, legal notices, official letters, memorandums, or other forms of written material. Meetings, workshops, and/or hearings may also be used, as appropriate, to provide local publicity. The public participation procedures do not apply to proposed contracts for the sale of surplus or interim irrigation water for a term of 1 year or less. Either of the contracting parties may invite the public to observe contract proceedings. All public participation procedures will be coordinated with those involved in complying with the National Environmental Policy Act. Pursuant to the “Final Revised Public Participation Procedures” for water resource-related contract negotiations, published in 47 FR 7763, February 22, 1982, a tabulation is provided of all proposed contractual actions in each of the five Reclamation regions. When contract negotiations are completed, and prior to execution, each proposed contract form must be approved by the Secretary of the Interior, or pursuant to delegated or redelegated authority, the Commissioner of Reclamation or one of the regional directors. In some instances, congressional review and approval of a report, water rate, or other terms and
Public participation in and receipt of comments on contract proposals will be facilitated by adherence to the following procedures:
1. Only persons authorized to act on behalf of the contracting entities may negotiate the terms and conditions of a specific contract proposal.
2. Advance notice of meetings or hearings will be furnished to those parties that have made a timely written request for such notice to the appropriate regional or project office of Reclamation.
3. Written correspondence regarding proposed contracts may be made available to the general public pursuant to the terms and procedures of the Freedom of Information Act, as amended.
4. Written comments on a proposed contract or contract action must be submitted to the appropriate regional officials at the locations and within the time limits set forth in the advance public notices.
5. All written comments received and testimony presented at any public hearings will be reviewed and summarized by the appropriate regional office for use by the contract approving authority.
6. Copies of specific proposed contracts may be obtained from the appropriate regional director or his designated public contact as they become available for review and comment.
7. In the event modifications are made in the form of a proposed contract, the appropriate regional director shall determine whether republication of the notice and/or extension of the comment period is necessary.
Factors considered in making such a determination shall include, but are not limited to (i) the significance of the modification, and (ii) the degree of public interest which has been expressed over the course of the negotiations. At a minimum, the regional director shall furnish revised contracts to all parties who requested the contract in response to the initial public notice.
1. Irrigation, M&I, and Miscellaneous Water Users; Idaho, Oregon, Washington, Montana, and Wyoming: Temporary or interim water service contracts for irrigation, M&I, or miscellaneous use to provide up to 10,000 acre-feet of water annually for terms up to 5 years; long-term contracts for similar service for up to 1,000 acre-feet of water annually.
2. Rogue River Basin Water Users, Rogue River Basin Project, Oregon: Water service contracts; $8 per acre-foot per annum.
3. Willamette Basin Water Users, Willamette Basin Project, Oregon: Water service contracts; $8 per acre-foot per annum.
4. Pioneer Ditch Company, Boise Project, Idaho; Clark and Edwards Canal and Irrigation Company, Enterprise Canal Company, Ltd., Lenroot Canal Company, Liberty Park Canal Company, Poplar ID, all in the Minidoka Project, Idaho; Juniper Flat District Improvement Company, Wapinitia Project, Oregon: Amendatory repayment and water service contracts; purpose is to conform to the RRA.
5. Palmer Creek Water District Improvement Company, Willamette Basin Project, Oregon: Irrigation water service contract for approximately 13,000 acre-feet.
6. North Unit ID, Deschutes Project, Oregon: Warren Act contract with cost of service charge to allow for use of project facilities to convey nonproject water.
7. Trendwest Resorts, Yakima Project, Washington: Long-term water exchange contract for assignment of Teanaway River and Big Creek water rights to Reclamation for instream flow use in exchange for annual use of up to 3,500 acre-feet of water from Cle Elum Reservoir for a proposed resort development.
8. City of Cle Elum, Yakima Project, Washington: Contract for up to 2,170 acre-feet of water for municipal use.
9. Burley ID, Minidoka Project, Idaho-Wyoming: Supplemental and amendatory contract providing for the transfer of O&M of the headworks of the Main South Side Canal and works incidental thereto.
10. Minidoka ID, Minidoka Project, Idaho-Wyoming: Supplemental and amendatory contract providing for the transfer of O&M of the headworks of the Main North Side Canal and works incidental thereto.
11. Queener Irrigation Improvement District, Willamette Basin Project, Oregon: Renewal of long-term water service contract to provide up to 2,150 acre-feet of stored water from the Willamette Basin Project (a Corps of Engineers' project) for the purpose of irrigation within the district's service area.
12. Vale and Warmsprings IDs, Vale Project, Oregon: Repayment contract for reimbursable cost of SOD modifications to Warm Springs Dam.
13. West Extension ID, Umatilla Project, Oregon: Contract for long-term boundary expansion to include lands outside of federally recognized district boundaries.
14. Greenberry ID, Willamette Basin Project, Oregon: Irrigation water service contract for approximately 7,500 acre-feet of project water.
15. Twenty-three irrigation districts of the Arrowrock Division, Boise Project, Idaho: Repayment agreements with districts with spaceholder contracts for repayment, per legislation, of reimbursable share of costs to rehabilitate Arrowrock Dam Outlet Gates under the O&M program.
16. Eighteen irrigation water user entities, Boise Project, Idaho: Long-term renewal and/or conversion of 19 irrigation water service contracts for supplemental irrigation use of up to 71,018 acre-feet of storage space in Lucky Peak Reservoir, a Corps of Engineers' project on the Boise River, Idaho.
The following action has been completed since the last publication of this notice on October 4, 2004:
1. (16) Westland ID, Umatilla Project, Oregon: Contract for long-term boundary expansion to include lands outside of federally recognized district boundaries. Contract executed on September 14, 2004.
1. Irrigation water districts, individual irrigators, M&I and miscellaneous water users, Mid-Pacific Region projects other than CVP: Temporary (interim) water service contracts for available project water for irrigation, M&I, or fish and wildlife purposes providing up to 10,000 acre-feet of water annually for terms up to 5 years; temporary Warren Act contracts for use of project facilities for terms up to 1 year; temporary
Upon written request, copies of the standard forms of temporary water service contracts for the various types of service are available from the Regional Director at the address shown above.
2. Contractors from the American River Division, Cross Valley Canal, Delta Division, Friant Division, Sacramento River Division, San Felipe Division, Shasta Division, Trinity River Division, and West San Joaquin Division; CVP; California: Renewal of up to 114 long-term water service contracts; water quantities for these contracts total in excess of 3.4M acre-feet. These contract actions will be accomplished through long-term renewal contracts pursuant to Pub. L. 102-575. Prior to completion of negotiation of long-term renewal contracts, existing interim renewal water service contracts may be renewed through successive interim renewal of contracts.
3. Redwood Valley County WD, SRPA, California: Restructuring the repayment schedule pursuant to Pub. L. 100-516.
4. El Dorado County Water Agency, CVP, California: M&I water service contract to supplement existing water supply: 15,000 acre-feet for El Dorado County Water Agency authorized by Pub. L. 101-514.
5. Sutter Extension WD, Delano-Earlimart ID, and the State of California Department of Water Resources; CVP; California: Pursuant to Pub. L. 102-575, cooperative agreements with non-Federal entities for the purpose of providing funding for CVP refuge water wheeling facility improvements to provide water for refuge and private wetlands.
6. CVP Service Area, California: Temporary water purchase agreements for acquisition of 20,000 to 200,000 acre-feet of water for fish and wildlife purposes as authorized by the Central Valley Project Improvement Act for terms of up to 3 years.
7. City of Roseville, CVP, California: Execution of long-term Warren Act contract for conveyance of nonproject water provided from the Placer County Water Agency. This contract will allow CVP facilities to be used to deliver nonproject water to the City of Roseville for use within its service area.
8. Sacramento Municipal Utility District, CVP, California: Amendment of existing water service contract to allow for additional points of diversion and assignment of up to 30,000 acre-feet of project water to the Sacramento County Water Agency. The amended contract will conform to current Reclamation law.
9. El Dorado ID, CVP, California: Execution of long-term Warren Act contracts for conveyance of nonproject water (one contract for ditch rights in the amount of 3,344 acre-feet, and one contract for Project 184 in the amount of 11,000 acre-feet). The contracts will allow CVP facilities to be used to deliver nonproject water to El Dorado ID for use within its service area.
10. Horsefly, Klamath, Langell Valley, and Tulelake IDs; Klamath Project; Oregon: Repayment contracts for SOD work on Clear Lake Dam. These districts will share in repayment of costs, and each district will have a separate contract. Initial contract should be ready by April 2005.
11. Casitas Municipal WD, Ventura Project, California: Repayment contract for SOD work on Casitas Dam.
12. Warren Act Contracts, CVP, California: Execution of long-term Warren Act contracts (up to 25 years) with various entities for conveyance of nonproject water in the Delta-Mendota Canal and the Friant Division facilities.
13. Tuolumne Utilities District (formerly Tuolumne Regional WD), CVP, California: Long-term water service contract for up to 9,000 acre-feet from New Melones Reservoir, and possibly long-term contract for storage of nonproject water in New Melones Reservoir.
14. Banta Carbona ID, CVP, California: Long-term Warren Act contract for conveyance of nonproject water in the Delta-Mendota Canal.
15. Plain View WD, CVP, California: Long-term Warren Act contract for conveyance of nonproject water in the Delta-Mendota Canal.
16. Byron-Bethany ID, CVP, California: Long-term Warren Act contract for conveyance of nonproject water in the Delta-Mendota Canal.
17. Sacramento Area Flood Control Agency, CVP, California: Execution of a long-term operations agreement for flood control operations of Folsom Dam and Reservoir to allow for recovery of costs associated with operating a variable flood control pool of 400,000 to 670,000 acre-feet of water during the flood control season. This agreement is to conform to Federal law.
18. Colusa County WD, CVP, California: Proposed long-term Warren Act contract for conveyance of up to 4,500 acre-feet of ground water through the Tehama-Colusa Canal.
19. Madera-Chowchilla Water and Power Authority, CVP, California: Agreement to transfer the operation, maintenance, and replacement and certain financial and administrative activities related to the Madera Canal and associated works.
20. Carpinteria WD, Cachuma Project, California: Contract to transfer title of distribution system to the district. Title transfer authorized by Pub. L. 108-315, “Carpinteria and Montecito Water Distribution Conveyance Act of 2004.”
21. Montecito WD, Cachuma Project, California: Contract to transfer title of distribution system to the district. Title transfer authorized by Pub. L. 108-315, “Carpinteria and Montecito Water Distribution Conveyance Act of 2004.”
22. City of Vallejo, Solano Project, California: Execution of long-term Warren Act contract for conveyance of nonproject water. This contract will allow Solano Project facilities to be used to deliver nonproject water to the City of Vallejo for use within its service area.
23. Sacramento Suburban WD, CVP, California: Execution of long-term Warren Act contract for conveyance of nonproject water. This contract will allow CVP facilities to be used to deliver nonproject water to the Sacramento Suburban WD for use within its service area.
24. Truckee Meadows Water Authority, Town of Fernley, State of California, City of Reno, City of Sparks, Washoe County, State of Nevada, Truckee-Carson ID, and any other local interest or Native American Tribal interest, who may have negotiated rights under Pub. L. 101-618; Nevada and California: Contract for the storage of non-Federal water in Truckee River reservoirs as authorized by Pub. L. 101-618 and the Preliminary Settlement Agreement. The contracts shall be consistent with the Truckee River Water Quality Settlement Agreement and the terms and conditions of the proposed Truckee River Operating Agreement.
25. Sacramento River Settlement Contracts, CVP, California: Up to 145 contracts and one contract with Colusa Drain Mutual Water Company will be renewed; water quantities for these contracts total 2.2M acre-feet. These contracts will be renewed for a period of 40 years. The contracts will reflect an agreement to settle the dispute over water rights' claims on the Sacramento River and the Colusa Basin Drain.
26. San Joaquin Valley National Cemetery, U.S. Department of Veteran Affairs; Delta Division, CVP; California: Renewal of the long-term water service contract for up to 850 acre-feet with conveyance through the California State Aqueduct pursuant to the CVP-State Water Project wheeling agreement.
27. A Canal Fish Screens, Klamath Project, Oregon: Negotiation of an O&M
28. Ady Canal Headgates, Klamath Project, Oregon: Transfer of operational control to Klamath Drainage District of the headgates located at the railroad. Reclamation does not own the land at the headgates, only operational control pursuant to a railroad agreement.
29. Pajaro Valley Water Management Agency, CVP, California: Proposed assignment of 27,000 acre-feet of Broadview WD's entire CVP supply to Pajaro Valley Water Management Agency for M&I use.
30. Orland Unit Water Users Association, Orland Project, California: Repayment contract for the SOD costs assigned to the irrigation purposes of Stony Gorge Dam.
31. Delta Lands Reclamation District No. 770, CVP, California: Long-term operations contract for conveying nonproject flood flows.
32. Widren WD, CVP, California: Proposed assignment of up to 2,990 acre-feet of Widren WD's CVP water to Westlands WD for irrigation use.
33. Pershing County Water Conservation District, Pershing County, Lander County, and the State of Nevada; Humboldt Project; Nevada: Title transfer to lands and features of Humboldt Project.
34. Plain View WD, CVP, California: Reorganization and proposed full contract assignment of Plain View WD's CVP supply to Byron-Bethany ID.
35. PacifiCorp, Klamath Basin Area Office, Klamath Project, Oregon: Execution of long-term agreement for lease of power privilege and the O&M of Link River Dam. This agreement will provide for operations of Link River Dam, coordinated operations with the non-Federal Keno Dam, and provision of power by PacifiCorp for Klamath Project purposes to ensure project water deliveries to meet Endangered Species Act requirements.
36. Cachuma Operation and Maintenance Board, Cachuma Project, California: Repayment of SOD work on Lauro Dam.
The following action has been completed since the last publication of this notice on October 4, 2004:
1. (37) Centinella WD, CVP, California: Proposed assignment of up to 2,500 acre-feet of Centinella WD's CVP water to Westlands WD for irrigation use. Assignment executed on November 9, 2004.
1. Milton and Jean Phillips, BCP, Arizona: Colorado River water delivery contract for 60 acre-feet of Colorado River water per year as recommended by the Arizona Department of Water Resources.
2. John J. Peach, BCP, Arizona: Colorado River water delivery contract for 456 acre-feet of Colorado River water per year as recommended by the Arizona Department of Water Resources.
3. GOBO Farms, BCP, Arizona: Colorado River water delivery contract for 924 acre-feet of Colorado River water per year as recommended by the Arizona Department of Water Resources.
4. Brooke Water Co., BCP, Arizona: Amend contract for an additional 120 acre-feet per year of Colorado River water for domestic uses, as recommended by the Arizona Department of Water Resources.
5. Miscellaneous PPR No. 11, BCP, Arizona: Assign a portion of the PPR from Holpal to McNulty
6. Beattie Farms SW, BCP, Arizona: Contract for 1,110 acre-feet per year of fourth priority water for agricultural purposes.
7. Maricopa-Stanfield IDD, CAP, Arizona: Amend distribution system repayment contract No. 4-07-30-W0047 to reschedule repayment pursuant to June 28, 1996 agreement.
8. Indian and non-Indian agricultural and M&I water users, CAP, Arizona: New and amendatory contracts for repayment of Federal expenditures for construction of distribution systems.
9. San Tan ID, CAP, Arizona: Amend distribution system repayment contract No. 6-07-30-W0120 to increase the repayment obligation by approximately $168,000.
10. Central Arizona IDD, CAP, Arizona: Amend distribution system repayment contract No. 4-07-30-W0048 to modify repayment terms pursuant to final order issued by U.S. Bankruptcy Court, District of Arizona.
11. Coachella Valley WD and/or The Metropolitan WD of Southern California, BCP, California: Contract to fund the Department of the Interior's expenses to conserve seepage water from the Coachella Branch of the All-American Canal in accordance with Title II of the San Luis Rey Indian Water Rights Settlement Act, dated November 17, 1988.
12. Salt River Pima-Maricopa Indian Community, CAP, Arizona: O&M contract for its CAP water distribution system.
13. Miscellaneous PPR No. 38, BCP, California: Assign Schroeder's portion of the PPR to Murphy Broadcasting.
14. Berneil Water Co., CAP, Arizona: Partial assignment of 200 acre-feet of water per year to the Cave Creek Water Company.
15. Canyon Forest Village II Corporation, BCP, Arizona: Colorado River water delivery contract for up to 400 acre-feet per year of unused Arizona apportionment or surplus apportionment for domestic use.
16. Gila Project Works, Gila Project, Arizona: Title transfer of facilities and certain lands in the Wellton-Mohawk Division from the United States to the Wellton-Mohawk IDD.
17. Gila River Indian Community, CAP, Arizona: Amend CAP water delivery contract and distribution system repayment and operation, maintenance, and replacement, contract pursuant to the Arizona Water Settlements Act, Pub. L. 108-451, enacted December 10, 2004.
18. North Gila Valley IDD, Yuma ID, and Yuma Mesa IDD; Yuma Mesa Division, Gila Project; Arizona: Administrative action to amend each district's Colorado River water delivery contract to effectuate a change from a “pooled” water entitlement for the Division to a quantified entitlement for each district.
19. Indian and/or non-Indian M&I users, CAP, Arizona: New or amendatory water service contracts or subcontracts in accordance with an anticipated final record of decision for reallocation of CAP water, as discussed in the Secretary of the Interior's notice published on page 41456 of the FR on July 30, 1999.
20. Litchfield Park Service Company, CAP, Arizona: Proposed partial assignments of subcontract for 5,590 acre-feet of CAP M&I water to the Central Arizona Water Conservation District, which is exercising its authority as the Central Arizona Groundwater Replenishment District, and to the cities of Avondale, Carefree, and Goodyear.
21. Shepard Water Company, Inc., BCP, Arizona: Contract for the annual delivery of 50 acre-feet of fourth priority water per year for domestic use.
22. Jessen Family Limited Partnership, BCP, Arizona: Contract for delivery of 1,080 acre-feet of Colorado River water for agricultural purposes.
23. City of Somerton, BCP, Arizona: Contract for the annual delivery of up to 750 acre-feet of Colorado River water per year for domestic use as recommended by the Arizona Department of Water Resources.
24. Various Irrigation Districts, CAP, Arizona: Amend distribution system repayment contracts to provide for partial assumption of debt by the
25. Mohave County Water Authority, BCP, Arizona: Amendatory Colorado River water delivery contract to include the delivery of 3,500 acre-feet per year of fourth priority water and to delete the delivery of 3,500 acre-feet per year of fifth or sixth priority water.
26. All-American Canal, BCP, California: Agreement among Reclamation, Imperial ID, Metropolitan WD, and Coachella Valley WD for the federally funded construction of a reservoir(s) and associated facilities that will improve the regulation and management of Colorado River water (Federal legislation pending).
27. Tohono O'odham Nation, CAP, Arizona: Amend CAP water delivery contract pursuant to the Arizona Water Settlements Act, Pub. L. 108-451, enacted December 10, 2004.
28. Sunrise Water Company, CAP, Arizona: Proposed assignment of subcontract for 944 acre-feet of CAP M&I water per year to the Central Arizona Water Conservation District, which is exercising its authority as the Central Arizona Groundwater Replenishment District.
29. West End Water Company, CAP, Arizona: Proposed assignment of subcontract for 157 acre-feet of CAP M&I water per year to the Central Arizona Water Conservation District, which is exercising its authority as the Central Arizona Groundwater Replenishment District.
30. New River Utilities Company, CAP, Arizona: Proposed assignment of subcontract for 1,885 acre-feet of CAP M&I water to the Central Arizona Water Conservation District, which is exercising its authority as the Central Arizona Groundwater Replenishment District.
31. Cibola Valley IDD, BCP, Arizona: Contingent upon completion of sale documents, proposed assignment and transfer of a portion of the district's right to divert up to 24,120 acre-feet of Colorado River per year to the Mohave County Water Authority, the Hopi Tribe, and Reclamation.
32. Metropolitan WD and others, BCP, Arizona and California: Contract to provide for the recovery by Metropolitan WD of interstate underground storage credits previously placed in underground storage in Arizona by the Central Arizona Water Conservation District under agreements executed in 1992 and 1994, and to document the Arizona Water Banking Authority's responsibility in agreeing to Arizona's forbearance in the use of Colorado River water to permit the Secretary of the Interior to release that quantity of water for diversion and use by the Metropolitan WD.
33. Wellton-Mohawk IDD, BCP, Arizona: Amend contract No. 1-07-30-W0021 to revise the authority to deliver domestic use water from 5,000 to 10,000 acre-feet per calendar year, which is within the district's current overall Colorado River water entitlement.
34. Fisher's Landing Water and Sewer Works, LLC, BCP Arizona: Contract for 53 acre-feet annually of Colorado River water to be used to account for domestic water use on residential properties located within the Castle Dome area of Martinez Lake.
35. Yuma County Water Users Association, BCP, Arizona: Supplemental contract for the O&M of the Yuma Project, Valley Division.
36. Forbearance agreements, BCP, Arizona and California: Develop and execute short-term agreements to implement a demonstration forbearance program to evaluate the feasibility of acquiring water, through a voluntary land fallowing program, to replace drainage water currently being bypassed to the Cienega de Santa Clara.
37. Miscellaneous PPR No. 43, BCP, California: Contract with the City of Needles, for 1,500 acre-feet diversion and 950 acre-feet consumptive use.
38. Arizona Water Settlements Act, CAP, Arizona: Implementation of the contracting requirements of Title I—Central Arizona Project Settlement, Title II—Gila River Indian Community Water Rights Settlement, Title III—Southern Arizona Water Rights Settlement, and Title IV—San Carlos Apache Tribe Water Rights Settlement.
39. Southern Nevada Water Authority, Colorado River Commission of Nevada, and the Metropolitan WD of Southern California; BCP; California and Nevada: A storage and interstate release agreement establishing a procedure that the Secretary of the Interior will follow to achieve an interstate contractual distribution of Colorado River water.
The following action has been discontinued since the last publication of this notice on October 4, 2004:
1. (33) Central Arizona Water Conservation District and the Arizona Department of Water Resources, CAP, Arizona: Arizona Water Settlement Agreement to address outstanding CAP water allocation issues, subject to completion of final record of decision for reallocation of CAP water as discussed in the Secretary of the Interior's notice published in the FR on July 30, 1999 (64 FR 41456).
The following actions have been completed since the last publication of this notice on October 4, 2004:
1. (11) Imperial ID/Coachella Valley WD and/or The Metropolitan WD of Southern California, BCP, California: Contract to fund the Department of the Interior's expenses to conserve All-American Canal seepage water in accordance with Title II of the San Luis Rey Indian Water Rights Settlement Act, dated November 17, 1988.
2. (14) Arizona State Land Department, BCP, Arizona: Colorado River water delivery contract for 1,534 acre-feet per year for domestic use.
3. (19) ASARCO Inc., CAP, Arizona: Amendment of subcontract to extend the deadline for giving notice of termination on exchange.
4. (48) Mr. and Mrs. West, BCP, California: Assignment of contract No. 6-07-30-W0342 from Mr. and Mrs. West to Ronald E. and Shannon L. Williamson.
1. Individual irrigators, M&I, and miscellaneous water users; Initial Units, CRSP; Utah, Wyoming, Colorado, and New Mexico: Temporary (interim) water service contracts for surplus project water for irrigation or M&I use to provide up to 10,000 acre-feet of water annually for terms up to 10 years; long-term contracts for similar service for up to 1,000 acre-feet of water annually.
(a) Ron Connell, Aspinall Storage Unit, CRSP: Mr. Connell has requested a 40-year water service contract for 6 acre-feet of water out of Blue Mesa Reservoir. Mr. Connell has submitted an augmentation plan to Water District 4, Case No. 04CW168.
(b) Oxbow Mining, LLC, Aspinall Storage Unit, CRSP: Oxbow Mining, LLC has requested 242 acre-feet of M&I water out of the Blue Mesa reservoir, which requires that an augmentation plan be presented to the Division 4 Water Court.
2. Taos Area, San Juan-Chama Project, New Mexico: The United States is reserving 2,990 acre-feet of project water for potential use in an Indian water rights settlement in the Taos, New Mexico area.
3. Various Contactors, San Juan-Chama Project, New Mexico: The United States proposes to lease water from various contractors to stabilize flows in a critical reach of the Rio Grande in order to meet the needs of irrigators and preserve habitat for the silvery minnow.
4. Uncompahgre Valley Water Users Association, Upper Gunnison River
5. Southern Ute Indian Tribe, Florida Project, Colorado: Supplement to contract No. 14-06-400-3038, dated May 7, 1963, for an additional 181 acre-feet of project water, plus 563 acre-feet of project water pursuant to the 1986 Colorado Ute Indian Water Rights Final Settlement Agreement.
6. Sanpete County Water Conservancy District, Narrows Project, Utah: Application for a SRPA loan and grant to construct a dam, reservoir, and pipeline to annually supply approximately 5,000 acre-feet of water through a transmountain diversion from upper Gooseberry Creek in the Price River drainage (Colorado River Basin) to the San Pitch—Savor River (Great Basin).
7. Individual Irrigators, Carlsbad Project, New Mexico: The United States proposes to enter into long-term forbearance lease agreements with individuals who have privately held water rights to divert nonproject water either directly from the Pecos River or from shallow/artesian wells in the Pecos River Watershed. This action will result in additional water in the Pecos River to make up for the water depletions caused by changes in operations at Summer Dam which were made to improve conditions for a threatened species, the Pecos bluntnose shiner.
8. La Plata Conservancy District, Animas-La Plata Project, Colorado and New Mexico: Cost sharing/repayment contract for up to 1,560 acre-feet per year of M&I water; contract terms to be consistent with the Colorado Ute Settlement Act Amendments of 2000 (Title III of Pub. L. 106-554).
9. LeChee Chapter of the Navajo Nation, Glen Canyon Unit, CRSP, Arizona: Long-term contract for 950 acre-feet of water for municipal purposes.
10. Pine River ID, Pine River Project, Colorado: Contract to allow the district to convert up to approximately 10,000 acre-feet of project irrigation water to municipal, domestic, and industrial uses.
11. City of Page, Glen Canyon Unit, CRSP, Arizona: Long-term contract for 1,000 acre-feet of water for municipal purposes.
12. El Paso County Water Improvement District No. 1 and Isleta del Sur Pueblo, Rio Grande Project, Texas: Contract to convert up to 1,000 acre-feet of the Pueblo's project irrigation water to use for traditional and religious purposes.
13. Carlsbad ID and the NMISC, Carlsbad Project, New Mexico: Contract to convert irrigation water appurtenant to up to 6,000 acres of land within the project for use by the NMISC for delivery to Texas to meet New Mexico's Pecos River Compact obligation.
14. Animas-La Plata Water Conservancy District, Animas-La Plata Project, Colorado and New Mexico: Contract to transfer the operation, maintenance, and replacement responsibilities of most project facilities to the district, pursuant to Section 6 of the Reclamation Act of June 17, 1902, and other Reclamation laws.
15. Project Operations Committee, Animas-La Plata Project, Colorado and New Mexico: Agreement among the United States, the Southern Ute Indian Tribe, the Ute Mountain Ute Tribe, the Navajo Nation, the San Juan Water Commission, the Animas-La Plata Water Conservancy District, the State of Colorado, and the La Plata Conservancy District of New Mexico to coordinate and oversee the necessary operation, maintenance, and replacement activities of the project works.
16. Southern Ute Indian Tribe, Animas-La Plata Project, Colorado and New Mexico: Water delivery contract for 33,519 acre-feet of M&I water; contract terms to be consistent with the Colorado Ute Settlement Act Amendments of 2000 (Title III of Pub. L. 106-554).
17. Ute Mountain Ute Tribe, Animas-La Plata Project, Colorado and New Mexico: Water delivery contract for 33,519 acre-feet of M&I water; contract terms to be consistent with the Colorado Ute Settlement Act Amendments of 2000 (Title III of Pub. L. 106-554).
18. Navajo Nation, Animas-La Plata Project, Colorado and New Mexico: Water delivery contract for 4,680 acre-feet of M&I water; contract terms to be consistent with the Colorado Ute Settlement Act Amendments of 2000 (Title III of Pub. L. 106-554).
19. Various contractors including the Town of Mancos and the Mancos Rural Water Company, Mancos Project, Colorado: Small or short-term contracts to carry nonproject water through project facilities for municipal purposes under authority of Pub. L. 106-549.
20. State of Colorado, Animas-La Plata Project, Colorado and New Mexico: Cost sharing/repayment contract for up to 10,440 acre-feet per year of M&I water; contract terms to be consistent with the Colorado Ute Settlement Act Amendments of 2000 (Title III of Pub. L. 106-554).
21. Coon Creek Reservoir and Ditch Company, Collbran Project: The Coon Creek Reservoir and Ditch Company and the Collbran Conservancy District have requested a nonproject irrigation carriage contract (40-year) to have 3 cfs, not to exceed 1,000 acre-feet annually, of their direct flow irrigation water rights diverted into and delivered through the existing Southside Canal, a feature of Collbran Project delivery structures.
22. Central Utah Water Conservancy District, Bonneville Unit, Central Utah Project, Utah: Negotiate a repayment contract for 60,000 acre-feet per year of M&I water from the Utah Lake System.
23. Carlsbad ID and the NMISC, Carlsbad Project, New Mexico: Contract for storage and delivery of water produced by the NMISC's River Augmentation Program, among Reclamation, Carlsbad ID, and the NMISC. This will allow for storage of NMISC water in project facilities resulting in additional project water supply.
24. Town of Palisade, Palisade ID, Mesa County ID, Reclamation, and the U.S. Fish and Wildlife Service; CRSP: The Colorado River is critical habitat for four endangered fish species. These agencies are entering into an agreement for each to provide the following: Reclamation shall provide cost-share funding for the recovery monitoring and research, and O&M (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392); the districts are willing to allow the U.S. Fish and Wildlife Service and Reclamation to construct the fish passage; and the Town of Palisade proposes to provide related safety features on or near the fish passage.
25. Public Service Company of New Mexico, Reclamation, and the U.S. Fish and Wildlife Service; San Juan River Basin Recovery Implementation Program: The agreement identifies that Reclamation may provide cost-share funding for the recovery monitoring and research, and O&M (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392) of the constructed fish passage.
26. Reclamation, U.S. Fish and Wildlife Service, and the Colorado River Water Conservation District; Recovery Implementation Program for Endangered Fish Species in the Upper Colorado River Basin: Reclamation will provide cost-share funding for enlargement of Elkhead Reservoir (October 30, 2000, 114 Stat. 1602, Pub. L. 106-392) in a separate grant agreement.
27. The Grand Valley Water Users Association and U.S. Fish and Wildlife Service: Construction and O&M of a fish passage and fish screen facilities at the Grand Valley Diversion Dam and Government Highline Canal facilities to
28. Mancos Rural Water Company, Mancos Project, Colorado: Contract to allow the Mancos Rural Water Company to convert an additional 300 acre-feet of project irrigation water to municipal, domestic, and industrial uses.
The following action has been discontinued since the last publication of this notice on October 4, 2004:
1. (1)(g) United Companies, Aspinall Storage Unit, CRSP: United Companies has requested 7 acre-feet of M&I water out of Blue Mesa Reservoir for the Delta No. 1 Gravel Pit.
The following actions have been completed since the last publication of this notice on October 4, 2004:
1. (1)(e) Thomas Chapman, Aspinall Storage Unit, CRSP: Mr. Chapman has requested a 40-year water service contract for 1 acre-foot of water out of Blue Mesa Reservoir to support his pending plan of augmentation, Water Division 4. Contract executed on November 2, 2004.
2. (1)(h) Mountain View Amish-Mennonite Church, Aspinall Storage Unit, CRSP: The Church as requested 1 acre-foot of M&I water out of Blue Mesa Reservoir, Water Division 4, case No. 04CW106. Contract executed on September 29, 2004.
3. (28) U.S. Fish and Wildlife Service, San Juan River Basin Recovery Implementation Program, Aspinall Storage Unit, CRSP: The U.S. Fish and Wildlife Service has requested 14 acre-feet of water out of Blue Mesa Reservoir to be used at the Chipeta Unit ponds at the Hotchkiss National Fish Hatchery. The ponds are to be used to grow out the two San Juan River Basin endangered fish species. Contract executed on September 15, 2004.
1. Individual irrigators, M&I, and miscellaneous water users, Colorado, Kansas, Montana, Nebraska, North Dakota, Oklahoma, South Dakota, Texas, and Wyoming: Temporary (interim) water service contracts for the sale, conveyance, storage, and exchange of surplus project water and nonproject water for irrigation or M&I use to provide up to 10,000 acre-feet of water annually for a term of up to 1 year.
2. Green Mountain Reservoir, Colorado-Big Thompson Project, Colorado: Water service contracts for irrigation and M&I; contracts for sale of water from the marketable yield to water users within the Colorado River Basin of western Colorado.
3. Ruedi Reservoir, Fryingpan-Arkansas Project, Colorado: Second round water sales from the regulatory capacity of Ruedi Reservoir. Water service and repayment contracts for up to 17,000 acre-feet annually for M&I use.
4. Garrison Diversion Unit, P-SMBP, North Dakota: Renegotiation of the master repayment contract with Garrison Diversion Conservancy District to conform with the Dakota Water Resources Act of 2000; negotiation of repayment contracts with irrigators and M&I users.
5. City of Rapid City, Rapid Valley Unit, P-SMBP, South Dakota: Contract renewal for storage capacity in Pactola Reservoir. A temporary (1 year not to exceed 10,000 acre-feet) water service contract has been executed with the City of Rapid City, Rapid Valley Unit, for use of water from Pactola Reservoir. A long-term storage contract is being negotiated for water stored in Pactola Reservoir. Legislation is pending for change in the authorized use of Pactola storage.
6. Mid-Dakota Rural Water System, Inc., South Dakota: Pursuant to the Reclamation Projects Authorization and Adjustment Act of 1992, the Secretary of the Interior is authorized to make grants and loans to Mid-Dakota Rural Water System, Inc., a non-profit corporation, for the planning and construction of a rural water supply system.
7. City of Berthoud, Colorado-Big Thompson Project, Colorado: Long-term contract for conveyance of nonproject M&I water through Colorado-Big Thompson Project facilities.
8. City of Cheyenne, Kendrick Project, Wyoming: Negotiate a long-term contract for storage space for replacement water on a daily basis in Seminoe Reservoir. A temporary contract has been issued pending negotiation of the long-term contract.
9. Highland-Hanover ID, Hanover-Bluff Unit, P-SMBP, Wyoming: Negotiate long-term water service contract; includes provisions for repayment of construction costs.
10. Upper Bluff ID, Hanover-Bluff Unit, P-SMBP, Wyoming: Negotiate long-term water service contract; includes provisions for repayment of construction cost.
11. Fort Clark ID, P-SMBP, North Dakota: Negotiation of water service contract to continue delivery of project water to the district.
12. Western Heart River ID, Heart Butte Unit, P-SMBP, North Dakota: Negotiation of water service contract to continue delivery of project water to the district.
13. Sisk Ranch, Inc., Lower Marias Unit, P-SMBP, Montana: Initiating a long-term contract for up to 552 acre-feet of storage water from Tiber Reservoir to irrigate 276 acres. Temporary contracts have been issued to allow continued delivery of water.
14. I.J. Peterson Ranch, Inc., Lower Marias Unit, P-SMBP, Montana: Initiating a long-term contract for up to 478 acre-feet of storage water from Tiber Reservoir to irrigate 239 acres. Temporary contracts have been issued to allow continued delivery of water.
15. Morkrid Enterprises, Inc., Lower Marias Unit, P-SMBP, Montana: Initiating a long-term contract for up to 3,751 acre-feet of storage water from Tiber Reservoir to irrigate 1,875 acres. Temporary contracts have been issued to allow continued delivery of water.
16. Dickinson-Heart River Mutual Aid Corporation, Dickinson Unit, P-SMBP, North Dakota: Negotiate renewal of water service contract for irrigation of lands below Dickinson Dam in western North Dakota.
17. Savage ID, P-SMBP, Montana: The district is currently seeking title transfer. The contract is subject to renewal pending outcome of the title transfer process. A 5-year interim contract has been executed to ensure a continuous water supply.
18. City of Fort Collins, Colorado—Big Thompson Project, Colorado: Long-term contracts for conveyance and storage of nonproject M&I water through Colorado—Big Thompson Project facilities.
19. Standing Rock Sioux Tribe, P-SMBP, North Dakota: Negotiate a long-term water service contract with the Standing Rock Sioux Tribe in North Dakota for irrigation of up to 2,380 acres of land within the reservation.
20. Glendo Unit, P-SMBP, Wyoming: Contract renewal for long-term water service contracts with Burbank Ditch, New Grattan Ditch Company, Torrington ID, Lucerne Canal and Power Company, and Wright and Murphy Ditch Company.
21. Glendo Unit, P-SMBP, Nebraska: Contract renewal for long-term water service contracts with Bridgeport, Enterprise, and Mitchell IDs, and Central Nebraska Public Power and ID.
22. Helena Valley Unit, P-SMBP, Montana: Negotiating with Helena Valley ID for renewal of Part A of the A/B contract which expired December 31, 2004.
23. Crow Creek Unit, P-SMBP, Montana: Negotiating with Toston ID for renewal of Part A of the A/B contract which expired December 31, 2004.
24. Dickinson Parks and Recreation District, Dickinson Unit, P-SMBP,
25. Clark Canyon Water Supply Company, East Bench Unit, P-SMBP, Montana: Initiating renewal of contract No. 14-06-600-3592 which expires December 31, 2005.
26. East Bench ID, East Bench Unit, P-SMBP, Montana: Initiating renewal of contract No. 14-06-600-3593 which expires December 31, 2005.
27. Tiber Enterprises, Inc., Lower Marias Unit, P-SMBP, Montana: Initiating a long-term contract for up to 1,388 acre-feet of storage water from Tiber Reservoir to irrigate 694 acres. Temporary contracts have been issued to allow continued delivery of water.
28. Helena Valley Unit, P-SMBP, Montana: Initiating negotiations for contract renewal for an annual supply of water for domestic and M&I use to the City of Helena, Montana.
29. Canadian River Municipal Water Authority, Lake Meredith Salinity Control Project, New Mexico and Texas: Negotiation of a contract for the transfer of control (care and O&M) of the project to the Authority in accordance with Pub. L. 102-575, Title VIII, Section 804(c).
30. Fryingpan-Arkansas Project, Colorado: Consideration of excess capacity contracts in the Fryingpan-Arkansas Project.
31. Fryingpan-Arkansas Project, Colorado: Consideration of requests for long-term contracts for the use of excess capacity in the Fryingpan-Arkansas Project from the Southeastern Colorado Water Conservancy District, the City of Aurora, and the Colorado Springs Utilities.
32. Individual irrigators, Heart Butte Unit, P-SMBP, North Dakota: Renew long-term water service contracts for minor amounts of less than 1,000 acre-feet of irrigation water annually from the Heart River below Heart Butte Dam.
33. Municipal Subdistrict of the Northern Colorado Water Conservancy District, Colorado—Big Thompson Project, Colorado: Consideration of a new long-term contract or amendment of contract No. 4-07-70-W0107 with the Municipal Subdistrict and the Northern Colorado Water Conservancy District for the proposed Windy Gap Firming Project.
34. Northern Integrated Supply Project, Colorado-Big Thompson Project, Colorado: Consideration of a new long-term contract with approximately 14 regional water suppliers and the Northern Colorado Water Conservancy District for the Northern Integrated Supply Project.
35. Hill County WD, Milk River Project, Montana: Initiating renewal of municipal water supply contract No. 14-06-600-8954 which expires August 1, 2006. The proposal includes splitting the contract between Hill County WD and North Havre County WD which both receive their full water supply under the current contract.
36. Stutsman County Park Board, Jamestown Unit, P-SMBP, North Dakota: The Board is requesting a contract for minor amounts of water under a long-term contract to serve domestic needs for cabin owners at Jamestown Reservoir, North Dakota.
37. City of Huron, P-SMBP, South Dakota: Renewal of long-term operation, maintenance, and replacement agreement for O&M of the James Diversion Dam, South Dakota, with the City of Huron, South Dakota, or negotiation of water service and O&M with other interested, but as of yet, unidentified entity.
38. Garrison Diversion Unit, P-SMBP, North Dakota: Contracts to provide for project use pumping power or project use pumping power and supplemental irrigation water with various irrigation districts in North Dakota, covering a combined maximum 28,000 acres within the boundaries and limits set by the Dakota Water Resources Act of 2000.
39. Security Water and Sanitation District, Fryingpan-Arkansas Project, Colorado: Consideration of a request for a long-term contract for the use of excess capacity in the Fryingpan-Arkansas Project.
40. City of Fountain, Colorado; Fryingpan-Arkansas Project; Colorado: Consideration of a request for a long-term contract for the use of excess capacity in the Fryingpan-Arkansas Project.
41. Colorado Springs Utilities, Colorado Springs, Colorado; Colorado-Big Thompson Project; Colorado: Consideration of a request for a long-term agreement for water substitution and power interference in the Colorado-Big Thompson Project.
42. Pueblo West Metropolitan District, Pueblo West, Colorado; Fryingpan-Arkansas Project; Colorado: Consideration of a request for a 5-to 10-year contract for the use of excess capacity in the Fryingpan-Arkansas Project.
43. LeClair ID, Boysen Unit, P-SMBP, Wyoming: Contract renewal of long-term water service contract.
44. Riverton Valley ID, Boysen Unit, P-SMBP, Wyoming: Contract renewal of long-term water service contract.
The following actions have been completed since the last publication of this notice on October 4, 2004:
1. (39) Frenchman Valley ID; Frenchman Unit, Frenchman-Cambridge Division, P-SMBP; Culbertson, Nebraska: The District requested a deferment of its 2004 repayment and reserve fund obligations. A request was prepared to amend contract No. 009E6B0123 to defer payments in accordance with the Act of September 21, 1959. An amendatory contract was executed on September 23, 2004.
2. (40) Bostwick ID in Nebraska; Franklin Superior-Courtland and Courtland Units, Bostwick Division, P-SMBP; Red Cloud, Nebraska: The District requested a deferment of its 2004 repayment and water service obligations. A request was prepared to amend contract No. 009E6B0121 to defer payments in accordance with the Act of September 21, 1959. An amendatory contract was executed on September 23, 2004.
3. (41) Frenchman-Cambridge ID; Meeker-Driftwood, Red Willow, and Cambridge Units; Frenchman-Cambridge Division; P-SMBP; Cambridge, Nebraska: The District requested a deferment of its repayment obligation. A request was prepared to amend contract No. 009D6B0122 to defer payments in accordance with the Act of September 21, 1959. An amendatory contract was executed on September 23, 2004.
4. (43) East Bench ID, East Bench Unit, P-SMBP, Montana: The District requested a deferment of its 2004 distribution works repayment obligation. A request is being prepared to amend contract No. 14-06-600-3593 to defer payments in accordance with the Act of September 21, 1959. An amendatory contract was executed on September 23, 2004.
5. (46) Tom Green County Water Control and Improvement District No. 1, San Angelo Project, Texas: Public Law 108-231 dated May 28, 2004, authorized the Secretary of the Interior to extend the repayment period for the District from 40 to 50 years. A contract amendment was executed on November 1, 2004.
U.S. International Trade Commission.
Institution of investigation pursuant to 19 U.S.C. 1337 and provisional acceptance of motion for temporary relief.
Notice is hereby given that a complaint and motion for temporary relief were filed with the U.S. International Trade Commission on January 28, 2005, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Stant Manufacturing, Inc., of Connersville, Indiana. The complaint alleges violations of section 337 in the importation into the United States, the sale for importation, and the sale within the United States after importation of automotive fuel caps and components thereof by reason of infringement of claims 1, 5, and 6 of U.S. Patent No. 5,449,086, claims 32, 38, 39, and 41 of U.S. Patent No. 5,794,806, claims 1, 2, 10, and 13-15 of U.S. Patent No. 5,480,055, and claims 11-13, 19-22, 24-29, 31, 32, and 34-42 of U.S. Patent No. 4,678,097. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and permanent cease and desist orders.
The motion for temporary relief requests that the Commission issue a temporary limited exclusion order and temporary cease and desist orders prohibiting the importation into and the sale within the United States after importation of certain automotive fuel caps and components thereof that infringe claim 1 of U.S. Patent No. 5,449,086, claims 38 and 39 of U.S. Patent No. 5,794,806, and claims 1 and 2 of U.S. Patent No. 5,480,055 during the course of the Commission's investigation.
The complaint and motion for temporary relief, except for any confidential information contained therein, are 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., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Jay H. Reiziss, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone 202-205-2579.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2003). The authority for provisional acceptance of the motion for temporary relief is contained in section 210.58, 19 CFR 210.58.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation, of certain automotive fuel caps or components thereof by reason of infringement of one or more of claims 1, 5, and 6 of U.S. Patent No. 5,449,086, claims 32, 38, 39, and 41 of U.S. Patent No. 5,794,806, claims 1, 2, 10, and 13-15 of U.S. Patent No. 5,480,055, and claims 11-13, 19-22, 24-29, 31, 32, and 34-42 of U.S. Patent No. 4,678,097 and whether an industry in the United States exists as required by subsection (a)(2) of section 337.
(2) Pursuant to section 210.58 of the Commission's Rules of Practice and Procedure, 19 CFR 210.58, the motion for temporary relief under subsection (e) of section 337 of the Tariff Act of 1930, which was filed with the complaint, is provisionally accepted and referred to the presiding administrative law judge for investigation.
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is—Stant Manufacturing, Inc., 1620 Columbia Avenue, Connersville, IN 47331.
(b) The respondents are the following companies and individuals alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) Jay H. Reiziss, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436, who shall be the Commission investigative attorney, party to this investigation; and
(4) For the investigation so instituted, the Honorable Sidney Harris is designated as the presiding administrative law judge.
Responses to the complaint, the motion for temporary relief, and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 and 210.59 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13 and 210.59. Pursuant to 19 CFR 201.16(d), 210.13(a), and 210.59, such responses will be considered by the Commission if received not later than 10 days after the date of service by the Commission of the complaint, the motion for temporary relief, and the notice of investigation. Extensions of time for submitting the responses to the complaint, motion for temporary relief, and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint, in the motion for temporary relief, and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint, the motion for temporary relief, and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint, the motion for temporary relief, and this notice and to enter both an initial determination and
By order of the Commission.
United States International Trade Commission.
March 15, 2005 at 9:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Housing Terms and Conditions (WH-521). A copy of the proposed information collection request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the
Ms. Hazel M. Bell, U.S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone (202) 693-0418, fax (202) 693-1451, e-mail
The Migrant and Seasonal Agricultural Worker Protection Act (MSPA), 29 U.S.C. 1801
The Department of Labor 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,
The Department of Labor seeks the approval of the extension of this information collection to carry out it's statutory responsibility to ensure that farm labor contractor, agricultural employer or agricultural association providing housing to any migrant agricultural worker to post in a conspicuous place, or present to the migrant worker, a statement of any housing occupancy terms and conditions.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
General wage determination decisions of the Secretary of Labor are issued in accordance with applicable law and are based on the information obtained by the Department of Labor from its study of local wage conditions and data made available from other sources. They specify the basic hourly wage rates and fringe benefits which are determined to be prevailing for the described classes of laborers and mechanics employed on construction projects of a similar character and in the localities specified therein.
The determinations in these decisions of prevailing rates and fringe benefits have been made in accordance with 29 CFR Part 1, by authority of the Secretary of Labor pursuant to the provisions of the Davis-Bacon Act of March 3, 1931, as amended (46 Stat. 1494, as amended, 40 U.S.C. 276a) and of other Federal statutes referred to in 29 CFR Part 1, appendix, as well as such additional statutes as may from time to time be enacted containing provisions for the payment of wages determined to be prevailing by the Secretary of Labor in accordance with the Davis-Bacon Act. The prevailing rates and fringe benefits determined in these decisions shall, in accordance with the provisions of the foregoing statutes, constitute the minimum wages payable on Federal and federally assisted construction projects to laborers and mechanics of the specified classes engaged on contract work of the character and in the localities described therein.
Good cause is hereby found for not utilizing notice and public comment procedure thereon prior to the issuance of these determinations as prescribed in 5 U.S.C. 553 and not providing for delay in the effective date as prescribed in that section, because the necessity to issue current construction industry wage determinations frequently and in large volume causes procedures to be impractical and contrary to the public interest.
General wage determination decisions, and modifications and supersedes decisions thereto, contain no expiration dates and are effective from the date of notice in the
Any person, organization, or governmental agency having an interest in the rates determined as prevailing is encouraged to submit wage rate and fringe benefit information for consideration be the Department. Further information and self-explanatory forms for the purpose of submitting this data may be obtained by writing to the U.S. Department of Labor, Employment Standards Administration, Wage and Hour Division, Division of Wage Determinations, 200 Constitution Avenue, NW., Room S-3014, Washington, DC 20210.
The number of decisions listed to the Government Printing Office document entitled “General Wage Determinations Issued Under the Davis-Bacon and related Acts” being modified are listed by Volume and State. Dates of publication in the
General wage determinations issued under the Davis-Bacon and related Acts, including those noted above, may be found in the Government Printing Office (GPO) document entitled “General Wage Determinations Issued Under The Davis-Bacon And Related Acts”. This publication is available at each of the 50 Government Depository Libraries and many of the 1,400 Government Depository Libraries across the country.
General wage determinations issued under the Davis-Bacon and related Acts are available electronically at no cost on the Government Printing Office site at
Hard-copy subscriptions may be purchased from: Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, (202) 512-1800.
When ordering hard-copy subscription(s), be sure to specify the State(s) of interest, since subscriptions may be ordered for any or all of the six separate volumes, arranged by State. Subscriptions include an annual edition (issued in January or February) which includes all current general wage determinations for the States covered by each volume. Throughout the remainder of the year, regular weekly updates will be distributed to subscribers.
Copyright Office, Library of Congress.
Public notice.
The Copyright Office of the Library of Congress is announcing receipt of a notice of intent to audit DMX Music, Inc., for its transmissions of sound recordings to business establishments made under an exemption to the digital performance right. This audit intends to review transmissions to business establishments made by DMX Music, Inc., for the years 2002, 2003, and 2004.
Tanya M. Sandros, Associate General Counsel, or Abioye E. Oyewole, CARP Specialist, Copyright Arbitration Royalty Panel (CARP), P.O. Box 70977, Southwest Station, Washington, DC 20024-0977. Telephone: (202) 707-8380. Telefax: (202) 707-3423.
Section 106(6) of the Copyright Act, title 17 of the United States Code, gives the copyright owner of a sound recording the right to perform the sound recording publicly by means of a digital audio transmission, subject to certain limitations. Among these limitations is an exemption from the digital performance right for services making digital transmissions of sound recordings to a business establishment for use in the ordinary course of its business (henceforth, “Business Establishment Services”), provided that two conditions are met: 1) the business recipient does not retransmit the transmissions outside of its premises or the immediate surrounding vicinity and, 2) the transmissions do not exceed the sound recording performance complement. While Business Establishment Services do not pay royalty fees for the right to transmit the sound recording, they do make ephemeral phonorecords under a statutory license,
Pursuant to § 262.6 of title 37 of the Code of Federal Regulations, as the Designated Agent, SoundExchange may conduct a single audit of a Licensee, such as DMX Music, Inc., for the purpose of verifying their royalty payments. As a preliminary matter, the Designated Agent is required to submit a notice of its intent to audit a Licensee with the Copyright Office and to serve this notice on the service to be audited. 37 CFR 262.6(c).
On February 16, 2005, SoundExchange filed with the Copyright Office a notice of intent to audit DMX Music, Inc.,
In accordance with this regulation, the Office is publishing today's notice to fulfill this requirement with respect to SoundExchange's notice of intent to audit.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.
Thursday, April 7, 2005, 8:30 a.m. to 10:30 a.m. Pacific Time.
Jet Propulsion Laboratory, Von Karman Auditorium, 4800 Oak Grove Drive, Pasadena, CA 91109.
Mr. Mark D. Erminger, Aerospace Safety Advisory Panel Executive Director, Code Q-1, National Aeronautics and Space Administration, Washington, DC 20546, (202) 358-0914.
The Aerospace Safety Advisory Panel will hold its Quarterly Meeting. This discussion is pursuant to carrying out its statutory duties for which the Panel reviews, identifies, evaluates, and advises on those program activities, systems, procedures, and management activities that can contribute to program risk. Priority is given to those programs that involve the safety of human flight. The major subjects covered will be: Jet Propulsion Laboratory Programs and NASA Management. The Aerospace Safety Advisory Panel is composed of nine members and one ex-officio member.
The meeting will be open to the public up to the seating capacity of the room (50).
Seating will be on a first-come basis. Please contact Ms. Susan Burch on (202) 358-0914 at least 24 hours in advance to reserve a seat. Visitors will be requested to sign a visitor's register. Photographs will only be permitted during the first 10 minutes of the meeting. During the first 30 minutes of the meeting, members of the public may make a 5-minute verbal presentation to the Panel on the subject of safety in NASA. To do so, please contact Ms. Susan Burch on (202) 358-0914 at least 24 hours in advance. Any member of the public is permitted to file a written statement with the Panel at the time of the meeting. Verbal presentations and written comments should be limited to the subject of safety in NASA.
U.S. Nuclear Regulatory Commission (NRC).
Notice of pending NRC action to submit an information collection request to OMB and solicitation of public comment.
The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by May 10, 2005, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room located at One White Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville, MD. OMB clearance requests are available at the NRC worldwide Web site (
Comments and questions about the information collection requirements may be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-5 F53, Washington, DC 20555-0001, by telephone at (301) 415-7233, or by Internet electronic mail at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Issuance of Order imposing requirements for the protection of certain safeguards information.
Cynthia Barr, Project Manager, Licensing and Inspection Directorate, Spent Fuel Project Office, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, MD 20852. Telephone: (301) 415-4015; fax number: (301) 415-8555; e-mail
In accordance with the Atomic Energy Act of 1954 and 10 CFR Part 72, BNFL Fuel Solutions Corporation, (BNFL) holds Certificate of Compliance No. 1007 for the Model No. Ventilated Storage Cask (VSC-24). In a phone call on January 31, 2005, BNFL agreed to meet with the U.S. Nuclear Regulatory Commission (NRC) staff with Safeguards Information security measures in place. The purpose of the meeting(s) is to discuss the NRC's engineering evaluations performed to evaluate the safety and security of an array of VSC-24 storage casks. The meeting(s) will be closed to the public.
Following the September 11, 2001, simultaneous terrorist events at the World Trade Center (WTC) in New York City and at the Pentagon in Virginia, the U.S. Government issued a nationwide alert for the potential of additional terrorist acts within the United States. The NRC initiated a comprehensive review of all NRC-licensed activities to evaluate those activities against threats. As part of that review, U.S. Nuclear Regulatory Commission initiated an engineering study to assess the consequences of a terrorist event, similar in magnitude to the WTC and Pentagon, on spent nuclear fuel transportation packages and storage casks. The NRC staff intends to discuss specific information on the engineering evaluations performed for the VSC-24 storage casks with BNFL. However, the Commission has determined that the material to be discussed at the meeting(s) is Safeguards Information, will not be released to the public, and must be protected from unauthorized disclosure. Therefore, the Commission is imposing the requirements, as set forth in 10 CFR 73.21, so that BNFL can receive this information for review and comment at the closed meeting. This Order also imposes requirements for the protection of Safeguards Information in the hands of any person
The Commission has broad statutory authority to protect and prohibit the unauthorized disclosure of Safeguards Information. Section 147 of the Atomic Energy Act of 1954, as amended, grants the Commission explicit authority to “issue such orders, as necessary to prohibit the unauthorized disclosure of safeguards information * * *”. This authority extends to information concerning special nuclear material, source material, and byproduct material, as well as production and utilization facilities. Licensees and all persons who produce, receive, or acquire Safeguards Information must ensure proper handling and protection of Safeguards Information to avoid unauthorized disclosure in accordance with the specific requirements for the protection of Safeguards Information as contained in 10 CFR 73.21. The Commission hereby provides notice that it intends to treat all violations of the requirements contained in 10 CFR 73.21, applicable to the handling and unauthorized disclosure of Safeguards Information, as serious breaches of adequate protection of the public health and safety and the common defense and security of the United States. Access to Safeguards Information is limited to those persons who have established the need-to-know the information, and are considered to be trustworthy and reliable. A need-to-know means a determination by a person having responsibility for protecting Safeguards Information that a proposed recipient's access to Safeguards Information is necessary in the performance of official, contractual, or duties of employment. Licensees and all other persons who obtain Safeguards Information must ensure that they develop, maintain and implement strict policies and procedures for the proper handling of Safeguards Information to prevent unauthorized disclosure, in accordance with the requirements in 10 CFR 73.21. BNFL must ensure that all contractors whose employees may have access to Safeguards Information either adhere to the licensee's policies and procedures on Safeguards Information or develop, maintain and implement their own acceptable policies and procedures. BNFL remains responsible for the conduct of their contractors. The policies and procedures necessary to ensure compliance with applicable requirements contained in 10 CFR 73.21 must address, at a minimum, the following: The general performance requirement that each person who produces, receives, or acquires Safeguards Information shall ensure that Safeguards Information is protected against unauthorized disclosure; protection of Safeguards Information at fixed sites, in use and in storage, and while in transit; correspondence containing Safeguards Information; access to Safeguards Information; preparation, marking, reproduction and destruction of documents; external transmission of documents; use of automatic data processing systems; and removal of the Safeguards Information category.
In order to provide assurance that BNFL is implementing prudent measures to achieve a consistent level of protection, to prohibit the unauthorized disclosure of Safeguards Information, BNFL shall implement the requirements identified in 10 CFR 73.21. The Commission recognizes that BNFL may have already initiated many of the measures set forth in 10 CFR 73.21 to this Order for handling of Safeguards Information in conjunction with a previous NRC Order. In addition, pursuant to 10 CFR 2.202, I find that in light of the common defense and security matters identified above, which warrant the issuance of this Order, the public health, safety and interest require that this Order be effective immediately.
Accordingly, pursuant to Sections 53, 57, 62, 63, 81, 161b, 161i, 161o, 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 72,
The Director, Office of Nuclear Materials Safety and Safeguards, may in writing, relax or rescind any of the above conditions upon demonstration by the licensee.
In accordance with 10 CFR 2.202, BNFL must, and any other person adversely affected by this Order may,
If a hearing is requested by BNFL or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. 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), BNFL 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 III above shall be final twenty (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 III shall be final when the extension expires if a hearing request has not been received.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Issuance of Order imposing requirements for the protection of certain safeguards information.
Cynthia Barr, Project Manager, Licensing and Inspection Directorate, Spent Fuel Project Office, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, MD 20852. Telephone: (301) 415-4015; fax number: (301) 415-8555; e-mail
In accordance with the Atomic Energy Act of 1954 and 10 CFR Part 71, NAC International, Inc., (NAC) holds Certificate of Compliance Nos. 9010 for the Model No. NLI 1/2 and 9270 for the Model No. NAC-UMS transportation packages. In a phone call on January 27, 2005, NAC agreed to meet with the U.S. Nuclear Regulatory Commission (NRC) staff with Safeguards Information security measures in place. The purpose of the meeting(s) is to discuss the NRC's engineering evaluations performed to evaluate the safety and security of a single NLI 1/2 and an array of NAC-UMS transportation packages. The meeting(s) will be closed to the public.
Following the September 11, 2001, simultaneous terrorist events at the World Trade Center (WTC) in New York City and at the Pentagon in Virginia, the U.S. Government issued a nationwide alert for the potential of additional terrorist acts within the United States. The NRC initiated a comprehensive review of all NRC-licensed activities to evaluate those activities against threats. As part of that review, U.S. Nuclear Regulatory Commission initiated an engineering study to assess the consequences of a terrorist event, similar in magnitude to the WTC and Pentagon, on spent nuclear fuel transportation packages. The NRC staff intends to discuss specific information on the engineering evaluations performed for the NLI 1/2 and NAC-UMS transportation packages with NAC. However, the Commission has determined that the material to be discussed at the meeting(s) is Safeguards Information, will not be released to the public, and must be protected from unauthorized disclosure. Therefore, the Commission is imposing the requirements, as set forth in 10 CFR 73.21, so that NAC can receive this information for review and comment at the closed meeting. This Order also imposes requirements for the protection of Safeguards Information in the hands of any person,
The Commission has broad statutory authority to protect and prohibit the unauthorized disclosure of Safeguards Information. Section 147 of the Atomic Energy Act of 1954, as amended, grants the Commission explicit authority to “issue such orders, as necessary to prohibit the unauthorized disclosure of safeguards information * * *”. This authority extends to information concerning special nuclear material, source material, and byproduct material, as well as production and utilization facilities. Licensees and all persons who produce, receive, or acquire Safeguards Information must ensure proper handling and protection of Safeguards Information to avoid unauthorized disclosure in accordance with the specific requirements for the protection of Safeguards Information as contained in 10 CFR 73.21. The Commission hereby provides notice that it intends to
In order to provide assurance that NAC is implementing prudent measures to achieve a consistent level of protection, to prohibit the unauthorized disclosure of Safeguards Information, NAC shall implement the requirements identified in 10 CFR 73.21. The Commission recognizes that NAC may have already initiated many of the measures set forth in 10 CFR 73.21 to this Order for handling of Safeguards Information in conjunction with a previous NRC Order. In addition, pursuant to 10 CFR 2.202, I find that in light of the common defense and security matters identified above, which warrant the issuance of this Order, the public health, safety and interest require that this Order be effective immediately.
Accordingly, pursuant to Sections 53, 57, 62, 63, 81, 161b, 161i, 161o, 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 71,
The Director, Office of Nuclear Materials Safety and Safeguards, may in writing, relax or rescind any of the above conditions upon demonstration by the licensee.
In accordance with 10 CFR 2.202, NAC must, and any other person adversely affected by this Order may, submit an answer to this Order, and may request a hearing on this Order, within twenty (20) days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time in which to request a hearing must be made in writing to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and include a statement of good cause for the extension. Any request for a hearing shall be submitted to the Secretary, Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, ATTN: Rulemakings and Adjudications Staff, Washington, DC 20555. Copies also shall be sent to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, to the Assistant General Counsel for Materials Litigation and Enforcement at the same address, and to NAC if the hearing request is by a person other than NAC. Because of possible disruptions in delivery of mail to United States Government offices, it is requested that requests for hearing be transmitted to the Secretary of the Commission either by means of facsimile transmission to 301-415-1101 or by e-mail to
If a hearing is requested by NAC or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. 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), NAC 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 III above shall be final twenty (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 III shall be final when the extension expires if a hearing request has not been received.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Issuance of order imposing requirements for the protection of certain safeguards information.
Cynthia Barr, Project Manager, Licensing and Inspection Directorate, Spent Fuel Project Office, Office of
In accordance with the Atomic Energy Act of 1954 and 10 CFR part 72, Transnuclear, Inc., (Transnuclear) holds Certificate of Compliance No. 1004 for the Model No. NUHOMS®-32PT storage cask and Certificate of Compliance No. 1027 for the Model No. TN-68 storage cask. In a phone call on January 27, 2005, Transnuclear agreed to meet with the U.S. Nuclear Regulatory Commission (NRC) staff with Safeguards Information security measures in place. The purpose of the meeting(s) is to discuss the NRC's engineering evaluations performed to evaluate the safety and security of an array of NUHOMS®-32PT and an array of TN-68 storage casks. The meeting(s) will be closed to the public.
Following the September 11, 2001, simultaneous terrorist events at the World Trade Center (WTC) in New York City and at the Pentagon in Virginia, the U.S. Government issued a nationwide alert for the potential of additional terrorist acts within the United States. The NRC initiated a comprehensive review of all NRC-licensed activities to evaluate those activities against threats. As part of that review, U.S. Nuclear Regulatory Commission initiated an engineering study to assess the consequences of a terrorist event, similar in magnitude to the WTC and Pentagon, on spent nuclear fuel transportation packages and storage casks. The NRC staff intends to discuss specific information on the engineering evaluations performed for the NUHOMS®-32PT and the TN-68 storage casks with Transnuclear. However, the Commission has determined that the material to be discussed at the meeting(s) is Safeguards Information, will not be released to the public, and must be protected from unauthorized disclosure. Therefore, the Commission is imposing the requirements, as set forth in 10 CFR 73.21, so that Transnuclear can receive this information for review and comment at the closed meeting. This Order also imposes requirements for the protection of Safeguards Information in the hands of any person,
The Commission has broad statutory authority to protect and prohibit the unauthorized disclosure of Safeguards Information. Section 147 of the Atomic Energy Act of 1954, as amended, grants the Commission explicit authority to “issue such orders, as necessary to prohibit the unauthorized disclosure of safeguards information * * *”. This authority extends to information concerning special nuclear material, source material, and byproduct material, as well as production and utilization facilities. Licensees and all persons who produce, receive, or acquire Safeguards Information must ensure proper handling and protection of Safeguards Information to avoid unauthorized disclosure in accordance with the specific requirements for the protection of Safeguards Information as contained in 10 CFR 73.21. The Commission hereby provides notice that it intends to treat all violations of the requirements contained in 10 CFR 73.21, applicable to the handling and unauthorized disclosure of Safeguards Information, as serious breaches of adequate protection of the public health and safety and the common defense and security of the United States. Access to Safeguards Information is limited to those persons who have established the need-to-know the information, and are considered to be trustworthy and reliable. A need-to-know means a determination by a person having responsibility for protecting Safeguards Information that a proposed recipient's access to Safeguards Information is necessary in the performance of official, contractual, or duties of employment. Licensees and all other persons who obtain Safeguards Information must ensure that they develop, maintain and implement strict policies and procedures for the proper handling of Safeguards Information to prevent unauthorized disclosure, in accordance with the requirements in 10 CFR 73.21. Transnuclear must ensure that all contractors whose employees may have access to Safeguards Information either adhere to the licensee's policies and procedures on Safeguards Information or develop, maintain and implement their own acceptable policies and procedures. Transnuclear remains responsible for the conduct of their contractors. The policies and procedures necessary to ensure compliance with applicable requirements contained in 10 CFR 73.21 must address, at a minimum, the following: The general performance requirement that each person who produces, receives, or acquires Safeguards Information shall ensure that Safeguards Information is protected against unauthorized disclosure; protection of Safeguards Information at fixed sites, in use and in storage, and while in transit; correspondence containing Safeguards Information; access to Safeguards Information; preparation, marking, reproduction and destruction of documents; external transmission of documents; use of automatic data processing systems; and removal of the Safeguards Information category.
In order to provide assurance that Transnuclear is implementing prudent measures to achieve a consistent level of protection, to prohibit the unauthorized disclosure of Safeguards Information, Transnuclear shall implement the requirements identified in 10 CFR 73.21. The Commission recognizes that Transnuclear may have already initiated many of the measures set forth in 10 CFR 73.21 to this Order for handling of Safeguards Information in conjunction with a previous NRC Order. In addition, pursuant to 10 CFR 2.202, I find that in light of the common defense and security matters identified above, which warrant the issuance of this Order, the public health, safety and interest require that this Order be effective immediately.
Accordingly, pursuant to Sections 53, 57, 62, 63, 81, 161b, 161i, 161o, 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 72,
The Director, Office of Nuclear Materials Safety and Safeguards, may in writing, relax or rescind any of the above conditions upon demonstration by the licensee.
In accordance with 10 CFR 2.202, Transnuclear must, and any other person adversely affected by this Order
If a hearing is requested by Transnuclear or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. 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), Transnuclear 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 III above shall be final twenty (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 III shall be final when the extension expires if a hearing request has not been received. A request for hearing shall not stay the immediate effectiveness of this Order.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of availability.
John T. Buckley, Mail Stop: T-7E18, Decommissioning Directorate, Division of Waste Management and Environmental Protection, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone: (301) 415-6607, and Internet:
The Nuclear Regulatory Commission's (NRC's) Office of Nuclear Material Safety and Safeguards (NMSS) is announcing the availability of NUREG-1814, “Status of Decommissioning Program—2004 Annual Report.” This NUREG provides a comprehensive overview of the NRC's decommissioning program. Its purpose is to provide a stand-alone reference document which describes the decommissioning process and summarizes the current status of all decommissioning activities including the decommissioning of complex decommissioning sites, commercial reactors, research and test reactors, uranium mill tailings facilities; and fuel cycle facilities. In addition, this report discusses accomplishments in the decommissioning program since publication of the 2003 annual report (SECY-03-0161); and it identifies the key decommissioning program issues which the staff will address in fiscal year (FY) 2005.
NUREG-1814 is available for inspection and copying for a fee at the Commission's Public Document Room, U.S. NRC's Headquarters Building, 11555 Rockville Pike (First Floor), Rockville, Maryland. The Public Document Room is open from 7:45 a.m. to 4:15 p.m., Monday through Friday, except on Federal holidays.
NUREG-1814 is also available for inspection at NRC's Public Electronic Reading Room at:
For the Nuclear Regulatory Commission.
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board will publish periodic summaries of proposed data collections.
Under Section 2 of the Railroad Retirement Act, dependency on an employee for one-half support at the time of an employee's death can be a condition affecting entitlement to a survivor annuity and can affect the amount of both spouse and survivor annuities. One-half support is also a condition which may negate the public service pension offset in Tier I for a spouse or widow(er). The Railroad Retirement Board (RRB) utilizes Form G-134, Statement Regarding Contributions and Support, to secure information needed to adequately determine if the applicant meets the one-half support requirement. One form is completed by each respondent.
Non-burden impacting editorial and formatting changes are being proposed to Form G-134 for clarification purposes.
The estimated annual respondent burden is as follows:
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections.
Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
To request more information or to obtain a copy of the information collection justification, forms, and/or supporting material, please call the RRB Clearance Officer at (312) 751-3363 or send an e-mail request to
The following information collection is pending at the RRB and will be submitted to OMB 60 days from the date of this notice. Therefore, your comments should be received within 60 days of this notice.
The survivor student annuity is usually paid by direct deposit at a financial institution to the student's checking or savings account or a joint bank account with the parent. The requirements for eligibility as a student are prescribed in 20 CFR 216.74, and include students in independent study or home schooling.
The RRB requires evidence of full-time school attendance in order to determine that a child is entitled to student benefits. The RRB utilizes the following forms to conduct its student monitoring program. Form G-315, Student Questionnaire, obtains certification of a student's full-time school attendance. It also obtains information on a student's marital status, Social Security benefits, and employment which are needed to determine entitlement or continued entitlement to benefits under the RRA. Form G-315a, Statement of School Official, is used to obtain verification from a school that a student attends school full-time and provides their expected graduation date. Form G-315a.1, School Officials Notice of Cessation of Full-Time Attendance, is used by a school to notify the RRB that a student has ceased full-time school attendance.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Amex proposes to amend Rule 900—ANTE to provide a revised date for the implementation of the Amex New Trading Environment (“ANTE”) System for the three hundred most actively traded option classes. The text of the proposed rule change is set forth below. Proposed new language is in
(a) Applicability—The Exchange's new trading system (known as the ANTE System or ANTE) will be rolled-out over a period of time (approximately eighteen months) on a specialist post-by-specialist post basis. [It is anticipated that t]
Moreover, the Rules in this Chapter (Trading of Options Contracts) shall be applicable to (i) the trading on and through the facilities of the Exchange of option contracts issued by the Options Clearing Corporation and the terms and conditions thereof; and (ii) the exercise and settlement, the handling of orders, and the conduct of accounts and other matters, relating to option contracts dealt in by any member or member organization. Except to the extent that specific Rules in this Chapter govern, or unless the context otherwise requires, the provisions of the Constitution and of all other Rules and policies of the Board of Governors shall be applicable to the trading on the Exchange of option contracts. Pursuant to the provisions of Article I, Section 3(i) of the Constitution, option contracts (as defined below) are included within the definition of “security” or “securities” as such terms are used in the Constitution and the Rules of the Exchange.
(b) through (d)—No changes.
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.
On May 20, 2004, the Commission approved the Amex's proposal to implement a new options trading platform known as the ANTE. On May 25, 2004, the Amex began rolling out the ANTE System on its trading floor on a specialist's post-by-specialist's post basis. At that time, the Exchange anticipated the three hundred most actively traded option classes would be trading on the ANTE System by January 31, 2005. However, as of January 31, 2005, 260 of the 300 most active options classes, and 1,627 out of 1,920 total option classes are trading on the ANTE System.
The Exchange now anticipates that all of the three hundred most active option classes (that is, the remaining 40 classes) will be on the ANTE System by March 31, 2005. The Amex plans to put a systems enhancement in place in February 2005, which will alleviate the capacity issues that can occur when the most active classes begin trading on ANTE. Once the enhancement is in place, the most active classes will begin to be traded on ANTE. The Exchange believes that maintaining two systems for the trading of options—the legacy system (XTOPS, AODB and Auto-Ex) and ANTE-—is costly. As a result, the Exchange is working diligently to have all option classes on the ANTE System by March 31, 2005 in order to retire its legacy systems before its original estimated date of completion, which was the end of the second quarter.
Furthermore, the Exchange notes that the roll-out schedule presently contained in Rule 900 (a)—ANTE does not reflect the roll-out schedule approved by the Commission on May
The Exchange believes that the proposed rule change, as amended, is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change, as amended, will impose any burden on competition.
No written comments were solicited or received with respect to the proposed rule change, as amended.
The foregoing proposed rule change, as amended, has become effective pursuant to Section 19(b)(3)(A)(i) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change, as amended, 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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-Amex-2005-013. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
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 Amex is proposing to amend Exchange Rule 904 to increase the
In its filing with the Commission, the Amex 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 Amex is proposing several changes to Exchange Rule 904 to increase position and exercise limits. Exchange Rule 904 subjects equity options to one of five different position limits depending on the trading volume and outstanding shares of the underlying security. Rule 905 establishes exercise limits for the corresponding options at the same levels.
The standard position limits were last increased on December 31, 1998.
The Exchange also proposes the adoption of a new equity hedge exemption to the existing exemptions currently provided under Commentary .09 to Exchange Rule 904. Specifically, new Commentary .09(5) to Exchange Rule 904 would allow for a “reverse collar” hedge exemption where a long call position is accompanied by a short put position, where the long call expires with the short put and the strike price of the long call equals or exceeds the short put and where each long call and short put position is hedged with 100 shares of the underlying security (or other adjusted number of shares). Neither side of the long call short put can be in-the-money at the time the position is established. The Exchange believes this is consistent with the existing Commentary .09(4) to Exchange Rule 904, which provides for an exemption for a “collar,” and Commentary .09(2) and (3) to Exchange Rule 904, which provide for a hedge exemption for reverse conversions and conversions, respectively.
Since the inception of standardized options trading, the options exchanges have had rules imposing limits on the aggregate number of options contracts that a member or customer could hold or exercise. These rules are intended to prevent the establishment of options positions that can be used or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In particular, position and exercise limits are designed to minimize the potential for mini-manipulations and for corners or squeezes of the underlying market. In addition such limits serve to reduce the possibility for disruption of the options market itself, especially in illiquid options classes.
The Exchange believes that the existing surveillance procedures and reporting requirements at the Amex, other options exchanges, and at the several clearing firms are capable of
Furthermore, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.
The Exchange believes that restrictive equity position limits prevent large customers, such as mutual funds and pension funds, from using options to gain meaningful exposure to individual stocks. This can result in lost liquidity in both the options market and the stock market. In addition, the Exchange has found that restrictive limits and narrow hedge exemption relief restrict member firms from adequately facilitating customer order flow and offsetting the risks of such facilitations in the listed options market. The fact that position limits are calculated on a gross rather than a delta basis also is an impediment.
Finally, equity position limits have been gradually expanded from 1,000 contracts in 1973 to the current level of 75,000 contracts for options on the largest and most active underlying securities. To date, the Exchange believes that there have been no adverse affects on the market as a result of these past increases in the limits for equity option contracts.
The Exchange believes that the proposed rule change is consistent with Section 6 of the Act
The proposed rule change will impose no burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received by the Exchange on this proposal.
The proposed rule change has been designated by the Amex as a “non-controversial” rule change pursuant to Section 19(b)(3)(A) of the Act
The foregoing rule change: (1) Does not significantly affect the protection of investors or the public interest, (2) does not impose any significant burden on competition, and (3) by its terms does not become operative for 30 days after the date of this filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest. Consequently, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Pursuant to Rule 19b-4(f)(6)(iii), a proposed “non-controversial” rule change does not become operative for 30 days after the date of filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, and the Amex gave the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission.
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 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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File No. SR-Amex-2005-029. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
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 BSE proposes to amend Section 7 (Position Limits), Section 8 (Exemptions from Position Limits), and Section 9 (Exercise Limits) of Chapter III of the Rules of the Boston Options Exchange (“BOX”) to increase the standard position and exercise limits for equity options contracts and options on the Nasdaq-100 Index Tracking Stock (“QQQQ”) for a pilot program of six months. The text of the proposed rule change is available on the BSE's Web site (
In its filing with the Commission, the BSE 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 is proposing several changes to Section 7 (Position Limits), Section 8 (Exemptions from Position Limits), and Section 9 (Exercise Limits) of Chapter III of the BOX Rules. Section 7 of Chapter III of the BOX Rules subjects equity options to one of five different position limits depending on the trading volume and outstanding shares of the underlying security. Section 8 of Chapter III of the BOX Rules establishes certain qualified hedging transactions and positions that are exempt from established options position limits as prescribed under Section 7 of Chapter III of the BOX Rules. Section 9 of Chapter III of the BOX Rules establishes exercise limits for the corresponding options at the same levels as the corresponding security's position limits. On February 23, 2005, the Commission granted accelerated approval of a rule change proposed by the Chicago Board Options Exchange, Inc. (“CBOE”) relating to position and exercise limits.
The BOX's standard position limits have been in effect since the BOX commenced trading in February 2004. These standard position limits are the same as the standard position limits at the other options exchanges at that time, which were last increased on December 31, 1998.
The Exchange also proposes the adoption of a new equity hedge exemption to the existing exemptions currently provided under Section 8 of Chapter III of the BOX Rules. Specifically, new subparagraph (a)(v) of Section 8 of Chapter III of the BOX Rules would allow for a “reverse collar” hedge exemption to apply when a long call position is accompanied by a short put position, and the long call expires with the short put. In addition, the strike price of the long call must equal or exceed the short put, and each long call and short put position must be hedged with 100 shares of the underlying security (or other adjusted number of shares). Neither side of the long call short put can be in-the-money at the time the position is established. The Exchange believes this is consistent with existing subparagraph (a)(iv) of Section 8 of Chapter III of the BOX Rules, which provides for an exemption for a “collar,” and subparagraphs (a)(ii) and (a)(iii) of Section 8 of Chapter III of the BOX Rules, which provide for a hedge exemption for reverse conversions and conversions, respectively.
Since the inception of standardized options trading, the options exchanges have had rules imposing limits on the aggregate number of options contracts that a member or customer could hold or exercise. These rules are intended to prevent the establishment of options positions that can be used or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In particular, position and exercise limits are designed to minimize the potential for mini-manipulations and for corners or squeezes of the underlying market. In addition such limits serve to reduce the possibility for disruption of the options market itself, especially in illiquid options classes.
The Exchange believes that the existing surveillance procedures and reporting requirements at the BOX, other options exchanges, and at the several clearing firms are capable of properly identifying unusual and/or illegal trading activity. In addition, when the Commission reviewed BOX's regulatory program before allowing BOX to begin trading, the Commission did not uncover any material inconsistencies or shortcomings in the manner in which BOXR's market surveillance of BOX would be conducted. These procedures utilize daily monitoring of market movements via automated surveillance techniques to identify unusual activity in both options and in underlying stocks.
Furthermore, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.
The Exchange believes that restrictive equity position limits prevent large customers, such as mutual funds and pension funds, from using options to gain meaningful exposure to individual stocks. This can result in lost liquidity in both the options market and the stock market. In addition, the Exchange has found that restrictive limits and narrow hedge exemption relief restrict member firms from adequately facilitating customer order flow and offsetting the risks of such facilitations in the listed options market. The fact that position limits are calculated on a gross rather than a delta basis also is an impediment.
Finally, equity position limits have been gradually expanded from 1,000
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on the proposed rule change.
The proposed rule change has been designated by the BSE as a “non-controversial” rule change pursuant to Section 19(b)(3)(A) of the Act
The foregoing rule change: (1) Does not significantly affect the protection of investors or the public interest, (2) does not impose any significant burden on competition, and (3) by its terms does not become operative for 30 days after the date of this filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest. Consequently, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Pursuant to Rule 19b-4(f)(6)(iii), a proposed “non-controversial” rule change does not become operative for 30 days after the date of filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, and the BSE gave the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission.
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 Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, 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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File No. SR-BSE-2005-10. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On March 9, 2004, National Association of Securities Dealers, Inc. (“NASD”), through its wholly owned subsidiary, NASD Dispute Resolution, Inc. (“Dispute Resolution”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change amends NASD Rule 10315 to permit arbitrations to occur in a foreign hearing location in order to accommodate parties who desire to conduct their arbitrations abroad. Under the proposal, the foreign hearing location process will be strictly voluntary. According to NASD, once Dispute Resolution has determined that an arbitration can be handled using a foreign hearing location, Dispute Resolution will inform claimants about the availability and the additional costs of the appropriate foreign hearing location, as well as seek the agreement of the respondents if a claimant wishes to use a foreign hearing location. Under the proposal, parties will pay an additional surcharge for use of the foreign hearing location. Also, under the proposal, all foreign arbitrators selected by NASD to conduct arbitrations in foreign hearing locations must: (1) Meet NASD background qualifications for arbitrators; (2) receive training on NASD arbitration rules and procedures; and (3) satisfy at least the same training and testing requirements as those arbitrators who serve in U.S. locations of NASD. In addition, the proposed rule change amends IM-10104 to allow the Director to authorize a higher or additional honorarium for the use of a foreign hearing location to cover the additional daily cost for the foreign arbitrators' service in that location. Under the proposal, this surcharge will initially be apportioned equally among the parties, unless they agree otherwise, but the foreign arbitrators will retain the authority to apportion the surcharge as provided for in NASD Rules 10205 and 10332.
According to NASD, the NASD Dispute Resolution Business Development staff, with the cooperation of the administrative staff of the groups providing the foreign arbitrators, will administer all cases designated for hearing in a foreign location. Also, according to NASD, the first foreign hearing location for NASD arbitrations will be in London. NASD represented that Dispute Resolution has formed a relationship with the Chartered Institute of Arbitrators (“CIArb”), which is based in London and maintains a worldwide roster of neutrals. NASD believes that a partnership between CIArb and NASD will provide its international constituents with access to a local roster of experienced neutrals, as well as the convenience and cost efficiency of conducting hearing sessions within a reasonable distance from their place of business or residence.
The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities association.
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”)
PCX proposes to amend PCX Rule 6.75 relating to split price transactions. The text of the proposed rule change is set forth below.
Rule 6.75(h) Priority on Split Price Transaction
(1) Purchase
(2) [Sale priority. If an OTP Holder or OTP Firm sells one or more option contracts of a particular series at a particular price or prices, he shall, at the next higher price at which another OTP Holder or OTP Firm offers, have priority in selling up to the equivalent number of option contracts of the same series that he sold at the lower price or prices, provided that his offer is made promptly and that the sale so effected represents the opposite side of a transaction with the same order or bid as the earlier sale or sales.]
(3) No Change.
(4)
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.
PCX Rule 6.75(h) establishes priority for split-price transactions. Generally, an OTP Holder or OTP Firm buying (selling) at a particular price shall have priority over other OTP Holders or OTP Firms purchasing (selling) up to an equivalent number of contracts of the same order at the next lower (higher) price. Awarding split price priority serves as an inducement to OTP Holders and OTP Firms to bid (offer) more aggressively for an order that may require a split-price execution by giving them priority at the next lower (higher) price point. For example, assume the market is $1.00-$1.20, 300 up when a floor broker (“FB”) receives instructions from a customer that it would like to buy 500 options at a price or prices no higher than $1.20. The FB could attempt to execute the order in open outcry at a price better than the displayed market of $1.20. Assume a market maker (“MM”) in the crowd is willing to sell 250 contracts at $1.15 provided he can also sell the remaining 250 contracts at $1.20. Under current PCX rules, that MM could offer $1.15 for 250 contracts and then, by virtue of the split price priority rule, he/she would have priority for the balance of the order (up to 250 contracts) over other crowd members. If executed, the resulting net price of $1.175 is better than the current displayed market of $1.20, which results in a better fill for the customer.
One limitation on the ability of crowd participants to use the split price priority rule is the rule's requirement that orders in the limit order book (“Book”) have priority over the OTP Holder or OTP Firm attempting to fill the balance of the order at the split price. Using the example above, if the $1.20 price represented orders in the Book, those orders would have priority over the MM at $1.20. This means that a MM who is willing to trade at $1.15 and $1.20 may be completely unwilling to trade at the better price of $1.15 if he/she cannot trade the balance of the order at $1.20 because of the requirement to yield to existing customer interest in the Book. This jeopardizes the FB's ability to execute the first part of the order at a price of $1.15, thereby potentially making it difficult to achieve price improvement for the customer at the PCX. Instead, the order may trade at another exchange that has no impediments,
Under newly proposed paragraph (2) of Rule 6.75, an OTP Holder or OTP Firm with an order for at least 100 contracts who buys (sells) at least 50 contracts at a particular price would have price priority over all others in
The Exchange believes that it is reasonable to make a limited exception to the customer priority rule to allow split price trading. In this regard, the proposed exception would be similar in operation to the limited priority exception that exists for Combination, Spread, Ratio and Straddle orders (contained in Rule 6.75, Commentary .04). This priority exception generally provides that a crowd member affecting a qualifying order may trade ahead of the Book on one side of the order provided the other side of the order betters the Book. This exception was intended to facilitate the trading of Combination, Spread, Ratio and Straddle orders, which by virtue of their multi-legged composition could be more difficult to trade without a limited exception to the priority rule for one of the legs. The purpose behind the proposed split-price priority exception is the same—to facilitate the execution of large orders, which by virtue of their size and the need to execute them at multiple prices may be difficult to execute without a limited exception to the priority rules. The proposed exception would operate in the same manner as the Combination, Spread, Ratio and Straddle order exception by allowing an OTP Holder or OTP Firm affecting a trade that betters the market to have priority on the balance of that trade at the next pricing increment even if there are orders in the Book at the same price.
To address potential concerns regarding Section 11(a) of the Act,
For the above reasons, the Exchange believes that the proposed rule change would enhance competition. The Exchange believes that the proposed rule change is consistent with Section 6(b)
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.
Written comments on the proposed rule change 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 the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act,
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the thirty-day operative delay is consistent with the protection of investors and the public interest
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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. All submissions should refer to File Number SR-PCX-2005-25. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
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 Phlx proposes to amend Exchange Rule 1001 to increase the standard position and exercise limits for equity options contracts and options on the Nasdaq-100 Index Tracking Stock (“QQQQ”) on a six month pilot basis beginning on the effective date of the proposed rule change. The text of the proposed rule change is available on the Phlx's Web site (
In its filing with the Commission, the Phlx 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 Phlx 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 amend Exchange Rule 1001, Position Limits, to establish increased position and exercise limits for equity options and options overlying QQQQ, on a six-month pilot basis. Position limits impose a ceiling on the number of option contracts in each class on the same side of the market relating to the same underlying security that can be held or written by an investor or group of investors acting in concert. Exchange Rule 1002 (not proposed to be amended herein) establishes corresponding exercise limits.
Exchange Rule 1001 subjects equity options to one of five different position limits depending on the trading volume and outstanding shares of the underlying security. Exchange Rule 1002 establishes exercise limits for the corresponding options at the same levels as the corresponding security's position limits.
In 1998, the Commission approved an Exchange proposal (and similar proposals of other options exchanges) to increase standard option position and exercise limits to their current levels.
The proposal would also adopt a new equity hedge exemption to the existing exemptions currently provided under Commentary .07 to Exchange Rule 1001. Specifically, new Commentary .07(5) to Rule 1001 would allow for a “reverse collar” hedge exemption, where a long call position is accompanied by a short put position where the long call expires with the short put and the strike price of the long call equals or exceeds the short put, and where each long call and short put position is hedged with 100 shares of the underlying security (or other adjusted number of shares). Neither side of the long call/short put can be in-the-money at the time the position is established. The Exchange believes this is consistent with existing Commentary .07(4) to Exchange Rule 1001, which provides for an exemption for a “collar,” and Commentary .07(2) and (3), which allow for a hedge exemption for “reverse conversions” and “conversions,” respectively.
Since the inception of standardized options trading, the options exchanges have had rules imposing limits on the aggregate number of options contracts that a member or customer could hold or exercise. These rules are intended to prevent the establishment of options positions that can be used or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In particular, position and exercise limits are designed to minimize the potential for mini-manipulations and for corners or squeezes of the underlying market. In addition such limits serve to reduce the possibility for disruption of the options market itself, especially in illiquid options classes.
As the anniversary of listed options trading approaches its thirty-fifth year, the Exchange believes that the existing surveillance procedures and reporting requirements at the Phlx, other options exchanges, and at the several clearing firms are capable of properly identifying unusual and/or illegal trading activity. In addition, routine oversight inspections of the Exchange's regulatory programs by the Commission have not uncovered any material inconsistencies or shortcomings in the manner in which the Exchange's market surveillance is conducted. These procedures utilize daily monitoring of market movements via automated surveillance techniques to identify unusual activity in both options and in underlying stocks. Furthermore, the significant increases in unhedged options capital charges resulting from the September 1997 adoption of risk-based haircuts in combination with the Exchange margin requirements applicable to these products under Exchange rules, serve as a more effective protection than do position limits.
Furthermore, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.
The Exchange believes that restrictive equity position limits prevent large customers, such as mutual funds and pension funds, from using options to gain meaningful exposure to individual stocks. This can result in lost liquidity in both the options market and the equity market. In addition, the Exchange has found that restrictive limits and narrow hedge exemption relief restrict member firms from adequately facilitating customer order flow and offsetting the risks of such facilitations in the listed options market. The fact that position limits are calculated on a
Finally, equity position limits have been gradually expanded from 1,000 contracts in 1973 to the current level of 75,000 contracts for the largest and most active stocks. To date, the Exchange believes that there have been no adverse affects on the market as a result of these past increases in the limits for equity option contracts.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any inappropriate burden on competition.
No written comments were either solicited or received.
The proposed rule change has been designated by the Phlx as a “non-controversial” rule change pursuant to Section 19(b)(3)(A) of the Act
The foregoing rule change: (1) Does not significantly affect the protection of investors or the public interest, (2) does not impose any significant burden on competition, and (3) by its terms does not become operative for 30 days after the date of this filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest. Consequently, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Pursuant to Rule 19b-4(f)(6)(iii), a proposed “non-controversial” rule change does not become operative for 30 days after the date of filing, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, and the Exchange gave the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission.
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 Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, 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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File No. SR-Phlx-2005-17. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Indiana (FEMA-1573-DR), dated January 21, 2005.
Submit completed loan applications to: U.S. Small Business Administration, Disaster Area Office 1, 360 Rainbow Blvd. South 3rd Floor, Niagara Falls, NY 14303.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Indiana, dated January 21, 2005, is hereby amended to establish the incident period for this disaster as beginning January 1, 2005, and continuing through February 11, 2005.
All other information in the original declaration remains unchanged.
Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Louisiana, dated 03/03/2005.
Submit completed loan applications to: U.S. Small Business Administration, Disaster Area Office 1, 360 Rainbow Blvd. South 3rd Floor, Niagara Falls, NY 14303.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration on 03/03/2005, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The number assigned to this disaster for physical damage is 10066 C and for economic injury is 10067 0.
The State which received an EIDL Declaration # is Louisiana.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of West Virginia (FEMA-1574-DR), dated February 1, 2005.
Submit completed loan applications to: U.S. Small Business Administration, Disaster Area Office 1, 360 Rainbow Blvd. South 3rd Floor, Niagara Falls, NY 14303.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of West Virginia, dated February 1, 2005, is hereby amended to establish the incident period for this disaster as beginning January 4, 2005, and continuing through January 25, 2005.
All other information in the original declaration remains unchanged.
In accordance with the provisions of the Convention on Cultural Property Implementation Act (19 U.S.C. 2601
The Committee's responsibilities are carried out in accordance with provisions of the Convention on Cultural Property Implementation Act (19 U.S.C. 2601
The Committee also invites written comments that specifically address the determinations under Section 303(a)(1) of the Convention on Cultural Property Implementation Act, 19 U.S.C. 2602, pursuant to which the Committee must make findings. This citation for the determinations can be found at the Web site noted above. Written comments must be received no later than March 17, 2005, and may be faxed to (202) 260-4893, if 5 pages or less. Written comments greater than five pages must be sent in multiple copies (20 copies) via express mail to: Cultural Heritage Center, Department of State Annex 44, 301 4th St., SW., Rm. 334, Washington, DC 20547. Express mail is recommended for timely delivery.
Pursuant to section 301 of the Omnibus Diplomatic Security and Antiterrorism Act of 1986, as amended (22 U.S.C. 4831
I have appointed David C. Fields, a retired U.S. ambassador, as Chair of the Board. He will be assisted by Melvin Harrison, John Geoff O'Connell, Carolee Heileman, Robert Benedetti and by the Executive Secretary to the Board, Mark Jackson. They bring to their deliberations distinguished backgrounds in government service and in the private sector.
The Board will submit its conclusions and recommendations to me within 60 days of its first meeting, unless the Chair determines a need for additional time. Appropriate action will be taken and reports submitted to Congress on any recommendations made by the Board.
Anyone with information relevant to the Board's examination of this incident should contact the Board promptly at (202) 647-5204 or send a fax to the Board at (202) 647-3282.
This notice shall be published in the
The following Agreements were filed with the Department of Transportation under the provisions of 49 U.S.C. Sections 412 and 414. Answers may be filed within 21 days after the filing of the application.
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (See 14 CFR 301.201
Federal Aviation Administration, DOT.
Extension of public comment period.
This notice advises the public that the comment period for the O'Hare Modernization Draft Environmental Impact Statement (DEIS) Chicago O'Hare International Airport, Chicago, Illinois, is extended.
The comment period of the DEIS, ending on March 23, 2005, is extended to April 6, 2005.
By notice dated January 21, 2005, the Federal Aviation Administration (FAA) announced the availability of the DEIS for the Chicago O'Hare International Airport. In that notice, the FAA described the schedule for public hearings regarding the DEIS and advised that the public comment period would close Wednesday, March 23, 2005. The public hearings were held as scheduled on February 22, 23, and 24, 2005.
As set forth in the January 21, 2005, notice, all comments are to be submitted to Michael W. MacMullen of the FAA, at the address shown below.
Michael W. MacMullen, Airports Environmental Program Manager, Federal Aviation Administration, Chicago Airports District Office, 2300 East Devon Avenue, Des Plaines, IL 60018. Telephone: 847-294-8339, Fax: 847-7046; e-mail address:
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemption; request for comments.
This notice publishes the FMCSA decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 30 individuals. The FMCSA has statutory authority to exempt individuals from vision standards if the exemptions granted will not compromise safety. The agency has concluded that granting these exemptions will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
This decision is effective March 23, 2005. Comments from interested persons should be submitted by April 11, 2005.
You may submit comments identified by DOT DMS Docket Numbers FMCSA-99-6156, FMCSA-2000-7165, FMCSA-2000-7363, FMCSA-2000-7918, and FMCSA-2000-8398 by any of the following methods:
•
•
•
•
•
Maggi Gunnels, Office of Bus and Truck Standards and Operations, (202) 366-4001, FMCSA, Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001. Office hours are from 8 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays.
Under 49 U.S.C. 31315 and 31136(e), the FMCSA may renew an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two year period if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381. This notice addresses 30 individuals who have requested renewal of their exemptions in a timely manner. The FMCSA has evaluated these 30 applications for renewal on their merits and decided to extend each exemption for a renewable two year period. They are:
These exemptions are extended subject to the following conditions: (1) That each individual have a physical exam every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the standard in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retain a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by the FMCSA. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31315 and 31136(e).
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. In accordance with 49 U.S.C. 31315 and 31136(e), each of the 30 applicants has satisfied the entry conditions for obtaining an exemption from the vision requirements (64 FR 54948; 65 FR 159; 67 FR 57266; 65 FR 33406; 65 FR 57234; 68 FR 13360; 65 FR 45817; 65 FR 77066; 65 FR 66286; 66 FR 13825; 68 FR 10300; 65 FR 78256; 66 FR 16311). Each of these 30 applicants has requested timely renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the standard specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption standards. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, the FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
The FMCSA will review comments received at any time concerning a particular driver's safety record and determine if the continuation of the exemption is consistent with the requirements at 49 U.S.C. 31315 and 31136(e). However, the FMCSA requests that interested parties with specific data concerning the safety records of these drivers submit comments by April 11, 2005.
In the past the FMCSA has received comments from Advocates for Highway and Auto Safety (Advocates) expressing continued opposition to the FMCSA's procedures for renewing exemptions from the vision requirement in 49 CFR 391.41(b)(10). Specifically, Advocates objects to the agency's extension of the exemptions without any opportunity for public comment prior to the decision to renew, and reliance on a summary statement of evidence to make its decision to extend the exemption of each driver.
The issues raised by Advocates were addressed at length in 69 FR 51346 (August 18, 2004). The FMCSA
Watco Companies, Inc. (Watco), has filed a verified notice of exemption to continue in control of Appalachian & Ohio Railroad, Inc. (AO), upon AO's becoming a Class III rail carrier.
The transaction is scheduled to be consummated on or shortly after March 25, 2005.
This transaction is related to a concurrently filed verified notice of exemption in STB Finance Docket No. 34653,
Watco, a Kansas corporation, is a noncarrier that currently controls 10 Class III rail carriers: South Kansas and Oklahoma Railroad Company (SKO), Palouse River & Coulee City Railroad, Inc. (PRCC), Timber Rock Railroad, Inc. (TIBR), Stillwater Central Railroad (SLWC), Eastern Idaho Railroad, Inc. (EIRR), Kansas & Oklahoma Railroad, Inc. (K&O), Pennsylvania Southwestern Railroad, Inc. (PSWR), Great Northwest Railroad, Inc. (GNR), Kaw River Railroad, Inc. (KRR), and Mission Mountain Railroad, Inc. (MMT).
Applicant states that: (1) The rail lines operated by SKO, PRCC, TIBR, SLWC, EIRR, K&O, PSWR, GNR, KRR, and MMT do not connect with the rail lines being leased by AO; (2) the continuance in control is not part of a series of anticipated transactions that would connect the rail lines being acquired by AO with any railroad in the Watco corporate family; and (3) neither AO nor any of the carriers controlled by Watco are Class I rail carriers. Therefore, the transaction is exempt from the prior approval requirements of 49 U.S.C. 11323.
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under sections 11324 and 11325 that involve only Class III rail carriers. Accordingly, the Board may not impose labor protective conditions here, because all of the carriers involved are Class III carriers.
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. 34654, must be filed with the Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Karl Morell, Of Counsel, Ball Janik LLP, 1455 F Street, NW., Suite 225, Washington, DC 20005.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Appalachian & Ohio Railroad, Inc. (AO), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to lease, from CSX Transportation, Inc. (CSXT), and operate approximately 158.22 miles of rail line extending between: (1) milepost BUC 0.0, at Berkeley Run Jct., WV, and milepost BUC 119.0, at Cowen, WV; (2) milepost BUN 0.0, at Berryburg Jct., WV, and milepost BUN 4.0, at the Sentinel Mine near Berryburg Jct.; (3) milepost BUO 0.0, at Century Jct., WV, and milepost BUO 5.05, at the Century Mine, near Century Jct.; (4) milepost BUJ 0.0, at Buckhannon, WV, and milepost BUJ 1.65, near Buckhannon; (5) milepost BUF 0.0, at Burnsville, WV, and milepost BUF 6.2, at Gilmer, WV; (6) milepost BUR 0.0, at Cowen, and milepost BUR 1.0, near Cowen; (7) milepost BUH 0.0, at Hampton Jct., WV, and milepost BUH 17.0, at Alexander, WV; and (8) milepost BTF 0.0, at Island Creek Jct., WV, and milepost BTF 4.32, near Island Creek Jct.
AO certifies that its projected revenues as a result of this transaction will not exceed those that would qualify it as a Class III rail carrier. However, because its projected annual revenues will exceed $5 million, AO also certifies that it has complied with the posting and service requirements of 49 CFR 1150.32(e). In accordance with that section, the transaction cannot be consummated before March 22, 2005, the effective date of the exemption. The transaction is scheduled to be consummated on or shortly after March 25, 2005.
This transaction is related to STB Finance Docket No. 34654,
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. 34653, must be filed with
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of the Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before April 11, 2005 to be assured of consideration.
The Department of the Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before April 11, 2005 to be assured of consideration.
The Department of the Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. Copies of the submission(s)
Written comments should be received on or before April 11, 2005 to be assured of consideration.
Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice and request for comment.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the OCC, the Board, and the FDIC (the “agencies”) may not conduct or sponsor, and the 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 Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, has approved the agencies' publication for public comment of proposed revisions to the Consolidated Reports of Condition and Income (Call Report), which are currently approved collections of information. At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the FFIEC and the agencies should modify the proposed revisions prior to giving final approval. The agencies will then submit the revisions to OMB for review and approval.
Comments must be submitted on or before May 10, 2005.
Interested parties are invited to submit written comments to any or all of the agencies. All comments, which should refer to the OMB control number(s), will be shared among the agencies.
•
•
•
•
•
•
•
•
All public comments are available from the Board's Web site at
•
•
•
•
A copy of the comments may also be submitted to the OMB desk officer for the agencies: Mark Menchik, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503, or electronic mail to
For further information about the revisions discussed in this notice, please contact any of the agency clearance officers whose names appear below. In addition, copies of Call Report forms can be obtained at the FFIEC's Web site (
The agencies are proposing to revise the Call Report, which is currently an approved collection of information for each of the agencies.
The effect of the proposed revisions to the reporting requirements will vary from institution to institution depending on the extent to which an institution acquires loans with evidence of deterioration of credit quality since origination, including acquisitions of such loans in business combinations accounted for using the purchase method. The agencies expect that the proposed revisions will generally apply only to the limited number of institutions that are involved in purchase business combinations or that engage in purchases of loans with credit quality problems as a business activity. Furthermore, the proposed revisions entail the reporting of information included in disclosures required under applicable generally accepted accounting principles. Therefore, the agencies estimate that the implementation of these reporting revisions will result in a nominal increase in the current reporting burden imposed on all banks by the Call Report. The following burden estimates include the proposed revisions.
The estimated time per response for the Call Report is an average, which varies by agency because of differences in the composition of the institutions under each agency's supervision (
These information collections are mandatory: 12 U.S.C. 161 (for national banks), 12 U.S.C. 324 (for state member banks), and 12 U.S.C. 1817 (for insured state nonmember commercial and savings banks). Except for selected items, these information collections are not given confidential treatment.
Institutions file Call Reports with the agencies each quarter for the agencies' use in monitoring the condition, performance, and risk profile of individual institutions and the industry as a whole. In addition, Call Reports provide the most current statistical data available for evaluating institutions' corporate applications such as mergers, for identifying areas of focus for both on-site and off-site examinations, and for monetary and other public policy purposes. Call Reports are also used to calculate all institutions' deposit insurance and Financing Corporation assessments and national banks' semiannual assessment fees.
This joint notice and request for comment addresses proposed revisions
The proposed revisions to the Call Report have been approved for publication by the FFIEC. The agencies intend to implement the proposed Call Report changes as of the June 30, 2005, report date. Nonetheless, as is customary for Call Report changes, if the information required to be reported in accordance with the proposed reporting revisions is not readily available, institutions are advised that they may report reasonable estimates of this information for the report date as of which the proposed changes first take effect.
In December 2003, the AICPA issued SOP 03-3. In general, this Statement of Position applies to “purchased impaired loans,”
Under SOP 03-3, a purchased impaired loan is initially recorded at its purchase price (in a purchase business combination, the present value of amounts to be received). The Statement of Position limits the yield that may be accreted on the loan (the accretable yield) to the excess of the bank's estimate of the undiscounted principal, interest, and other cash flows expected at acquisition to be collected on the loan over the bank's initial investment in the loan. The excess of contractually required cash flows over the cash flows expected to be collected on the loan, which is referred to as the nonaccretable difference, must not be recognized as an adjustment of yield, loss accrual, or valuation allowance. Neither the accretable yield nor the nonaccretable difference may be shown on the balance sheet. After acquisition, increases in the cash flows expected to be collected generally should be recognized prospectively as an adjustment of the loan's yield over its remaining life. Decreases in cash flows expected to be collected should be recognized as an impairment through an addition to the loan loss allowance.
The Statement of Position prohibits a bank from “carrying over” or creating valuation allowances (loan loss allowances) in the initial accounting for purchased impaired loans. This prohibition applies to the purchase of an individual impaired loan, a pool or group of impaired loans, and impaired loans acquired in a purchase business combination. As a consequence, SOP 03-3 provides that valuation allowances should reflect only those losses incurred after acquisition, that is, the present value of all cash flows expected at acquisition that ultimately are not to be received. Thus, because of the accounting model set forth in SOP 03-3, banks will need to segregate their purchased impaired loans, if any, from the remainder of their loan portfolio for purposes of determining their overall allowance for loan and lease losses.
According to the Basis for Conclusions of SOP 03-3, the AICPA's Accounting Standards Executive Committee “believes that the accounting for acquired loans within the scope of this SOP is sufficiently different from the accounting for originated loans, particularly with respect to provisions for impairment, such that the amount of loans accounted for in accordance with this SOP should be disclosed separately in the notes to financial statements.” The agencies agree with this assessment and have considered the disclosures required by SOP 03-3. Therefore, to assist the agencies in understanding the relationship between the allowance for loan and lease losses and the carrying amount of the loan portfolios of those banks whose portfolios include purchased impaired loans, the agencies are proposing to add three items to the Call Report. All three of these items represent information included in the disclosures required by SOP 03-3. The agencies would add two Memorandum items to Schedule RC-C, part I, Loans and Leases: (1) The outstanding balance
The agencies also plan to revise the instructions to Schedule RC-N, Past Due and Nonaccrual Loans, Leases, and Other Assets, to explain how purchased impaired loans should be reported in this schedule. SOP 03-3 does not prohibit placing loans on nonaccrual status and any nonaccrual purchased impaired loans should be reported accordingly in Schedule RC-N. For those purchased impaired loans that are not on nonaccrual status, banks should determine their delinquency status in accordance with the contractual repayment terms of the loans without regard to the purchase price of (initial investment in) these loans or the amount and timing of the cash flows expected at acquisition.
Public comment is requested on all aspects of this joint notice. In addition, comments are invited on:
(a) Whether the proposed revisions to the Call Report collections of information are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;
(b) The accuracy of the agencies' estimates of the burden of the information collections as they are proposed to be revised, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.
Comments submitted in response to this joint notice will be shared among the agencies and will be summarized or included in the agencies' requests for OMB approval. All comments will become a matter of public record. Written comments should address the accuracy of the burden estimates and ways to minimize burden as well as other relevant aspects of the information collection request.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1028, Application for Recognition of Exemption Under Section 521 of the Internal Revenue Code.
Written comments should be received on or before May 10, 2005 to be assured of consideration.
Direct all written comments to Glenn P. Kirkland, Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala at the Internal Revenue Service, room 6516, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3634, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice.
An open meeting of the Area 1 Taxpayer Advocacy Panel will be conducted (via teleconference). The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, April 6, 2005.
Marisa Knispel at 1-888-912-1227 (toll-free), or 718-488-3557 (non toll-free).
An open meeting of the Area 1 Taxpayer Advocacy Panel will be held Wednesday, April 6, 2005 from 3 p.m. ET to 4 p.m. ET via a telephone conference call. Individual comments will be limited to 5 minutes. If you would like to have the TAP consider a written statement, please call 1-888-912-1227 or 718-488-3557, or write Marisa Knispel, TAP Office, 10 MetroTech Center, 625 Fulton Street, Brooklyn, NY 11201. Due to limited conference lines, notification of intent to participate in the telephone conference call meeting must be made with Marisa Knispel. Ms. Knispel can be reached at 1-888-912-1227 or 718-488-3557, or post comments to the Web site:
The agenda will include various IRS issues.
Internal Revenue Service (IRS), Treasury.
Notice.
An open meeting of the Small Business/Self Employed—Taxpayer Burden Reduction Committee of the Taxpayer Advocacy Panel will be conducted (via teleconference). The TAP will be discussing issues pertaining to increasing compliance and lessening the burden for Small Business/Self Employed individuals.
The meeting will be held Thursday, April 7, 2005.
Marisa Knispel at 1-888-912-1227 or 718-488-3557.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Small Business/Self Employed—Taxpayer Burden Reduction Committee of the Taxpayer Advocacy Panel will be held Thursday, April 7, 2005 from 3 p.m. ET to 4:30 p.m. ET via a telephone conference call. If you would like to have the TAP consider a written statement, please call 1-888-912-1227 or 718-488-3557, or write to Marisa Knispel, TAP Office, 10 Metro Tech Center, 625 Fulton Street, Brooklyn, NY 11201. Due to limited conference lines, notification of intent to participate in the telephone conference call meeting must be made with Marisa Knispel. Ms. Knispel can be reached at 1-888-912-1227 or 718-488-3557, or post comments to the Web site:
The agenda will include the following: Various IRS issues.
Environmental Protection Agency (EPA).
Proposed rule.
EPA proposes to update and revise its data requirements for the registration of conventional pesticide products. These data requirements and those already codified in part 158 of title 40 of the Code of Federal Regulations (CFR), are intended to provide EPA with data and other information necessary for the registration of a conventional pesticide chemical. Since the data requirements in part 158 were first codified in 1984, information needed to support the registration of a pesticide chemical has evolved as the general scientific understanding of the potential hazards posed by pesticides has grown. Over the years, updated data requirements were developed by EPA using a process that involved public participation and extensive involvement by the scientific community, including peer review by the FIFRA Scientific Advisory Panel (SAP). Most of the data requirements contained in this proposal have been applied on a case-by-case basis to support individual applications, or imposed via Data Call-In (DCI) on all registrants of similar products. Although the data requirements imposed have progressed as scientific understanding and concerns have evolved, the codified data requirements have not been updated to keep pace. This proposal involves changes to the codified data requirements that pertain to product chemistry, toxicology, residue chemistry, applicator exposure, post-application exposure, nontarget terrestrial and aquatic organisms, nontarget plant protection, and environmental fate. Coupled with updating data requirements, EPA proposes to add a few new studies, reformat the requirements, and revise its general procedures and policies associated with data submission. By codifying existing data requirements which are currently applied on a case-by-case basis, the pesticide industry, along with other partners in the regulated community, attain a better understanding and are better prepared for the pesticide registration process. This proposed rule does not apply to the data requirements for the registration of antimicrobial pesticide products; inert ingredients for pesticide products; spray drift, product performance (efficacy); or biochemical, and microbial pesticides.
Comments must be received on or before June 9, 2005.
Submit your comments, identified by Docket ID No. OPP-2004-0387, by one of the following methods:
•
•
•
•
•
Vera Au, Field and External Affairs Division (FEAD), Office of Pesticide Programs, Mailcode: 7506C, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (703) 308-9069: fax number: 703-305-5884; e-mail address:
You may be affected by this action if you are a producer or registrant of a pesticide product, including agricultural, residential, and industrial pesticides, but not including antimicrobial, biochemical or microbial pesticides, or inert ingredients in pesticide products. This proposal also may 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
Chemical Producers (NAICS 32532),
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, please consult the appropriate Branch Chief in the Registration Division of the Office of Pesticide Programs at 703-305-5447.
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions - The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
This preamble is organized according to the outline in this unit.
EPA is authorized to regulate pesticides under two federal statutes. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) regulates the sale, distribution, and use of pesticide products through a licensing (registration) scheme. The Federal Food, Drug and Cosmetic Act (FFDCA), among other things, regulates the safety of pesticide residues in food and feed. Both FIFRA and FFDCA were amended in 1996 by the Food Quality Protection Act (FQPA) to strengthen the protections offered, with particular emphasis on protection of children.
This action is issued under the authority of secs. 3, 4, 5, 10, 12, and 25 of FIFRA (7 U.S.C. 136-136y) and sec. 408 of FFDCA (21 U.S.C. 346a). The data required for a registration, reregistration, experimental use permit, or tolerance are listed in 40 CFR part 158.
Under FIFRA, every pesticide product must be registered (or specifically exempted from registration under FIFRA sec. 25(b)) with EPA before it may be sold or distributed in the United States. To obtain a registration, an applicant or registrant must demonstrate to the Agency's satisfaction that, among other things, the pesticide product, when used in accordance with widespread and commonly recognized practice, will not cause “unreasonable adverse effects” to humans or the environment. This safety determination, as defined in the statute, requires the Agency to consider the risk of the use of the pesticide and weigh this against its benefit. EPA must determine that the safety standard contained in FIFRA is met before granting a federal pesticide registration.
1.
2.
3.
FFDCA mandates EPA to determine that the level of pesticide chemical residues in food and feed will be safe for human consumption. An applicant must petition the Agency for a tolerance (maximum residue level) for a pesticide that is to be used in or around food or feed commodities, or could otherwise come in contact with food or feed. The safety standard set under FFDCA sec. 408(b) and (c) defines safe as “a reasonable certainty that no harm ” will result from exposures to pesticide chemical residues. In making this determination, EPA is directed to consider aggregate risks from multiple sources of pesticide exposure, including anticipated food, drinking water, and other non-occupational exposures for which there is reliable information. Under FFDCA sec. 408(b)(2)(C), EPA must make a separate finding of safety for infants and children. In addition, EPA must take into account a variety of other factors, enumerated in sec. 408(b)(2)(D), including the cumulative risks associated with pesticides having a common mechanism of toxicity. The combination of aggregate and cumulative exposure increases the nature and scope of EPA's risk assessment, and potentially the types and amounts of data needed to determine that the FFDCA safety standard is met.
1.
• Permanent tolerances that support registration under FIFRA;
• Tolerances for imported products which are established to allow importation of pesticide-treated commodities, but for which no U.S. registration is sought;
• Time-limited tolerances which are established for FIFRA sec. 18 emergency exemptions; and
• Temporary tolerances established for experimental use permits under FIFRA sec. 5.
2.
Unless EPA is able to establish or maintain a needed tolerance or exemption under FFDCA, a pesticide cannot be registered under FIFRA for a food/feed use. FQPA created a specific linkage (FIFRA sec. 2(bb)) between the “unreasonable adverse effects” finding under FIFRA and the determination of pesticide residue safety of “reasonable certainty of no harm” under FFDCA. In essence, a pesticide that is inconsistent with, or does not meet, the FFDCA sec. 408 safety standard poses an unreasonable adverse effect that precludes new or continued registration. Thus, both FIFRA and FFDCA standards must be met for pesticides intended to be registered in the United States for food or feed uses.
Given this linkage between registration and tolerances, it makes sense for EPA to define data requirements for both purposes: the data required to support a determination of “reasonable certainty of no harm” under FFDCA are an integral part of the data needed for an “unreasonable adverse effects” determination under FIFRA. Consequently, when promulgated, these proposed data requirements would encompass the basic data requirements for both registration and tolerance-setting determinations. EPA will retain its authority to require additional data on a case-by-case basis.
Under the FFDCA and the FIFRA, anyone seeking to register a pesticide product is required to provide information to EPA that demonstrates their products can be used without posing unreasonable risk to human health and the environment, and for food uses, that there is a reasonable certainty that no harm will result from exposures to the residues of their pesticide product. As appropriate for the particular pesticide product, EPA uses the information provided to evaluate the pesticide for a wide range of adverse human health effects, from eye and skin irritation to cancer and birth defects, and to assess how the pesticide affects animal and plant species, non-target insect species, and what happens to the pesticide in soil, water, and air.
First promulgated in 1984, the data requirements in 40 CFR part 158 outline the kinds of data and related information typically needed to register a pesticide. The data requirements are organized by major pesticide type (
In essence, the data requirements identify the questions that the registrant will need to answer regarding the safety of a pesticide product before the Agency can register it. The data requirements address both components of a risk assessment,
1.
The current provisions in part 158 were originally promulgated in October, 1984. Prior to this, data requirements for the registration of pesticides were contained in a variety of guidance documents, not in regulatory form. Part 158 was intended to be a concise presentation of what data were required and under what circumstances. Once codified, part 158 specified standard hazard and exposure studies required for registration and tolerance setting and also identified conditions under which more specialized studies might be required. Guidelines,
2.
The purpose for harmonizing these guidelines into a single set of OPPTS guidelines is to minimize variations among the testing procedures that must be performed to meet the Agency's data requirements under FIFRA and TSCA. The guidelines themselves do not impose mandatory requirements. Instead, they present recognized standards for conducting acceptable tests, guidance on evaluating and reporting data, definition of terms, and suggested study protocols. As such, pesticide registrants may use a non-guideline protocol to generate the data required by part 158. Typically the registrant will use the available guideline, in which case the study protocol would simply cite the relevant guideline. If the registrant deviates from these guidelines, or is asked to provide data where there isn't yet a final guideline available, the registrant will discuss the variation with EPA and will explain and justify the methods chosen in the study protocol. Non-guideline protocols are accepted, provided that the study protocol meets the purpose of the test standards specified in the guidelines, and provides data of suitable quality and completeness as typified by the protocols cited in the guidelines. More information about the unified library and these guidelines is available at
1.
2.
At the time the 1993 report was released, EPA had already begun work on many of the recommendations to improve the quality of its risk assessments. New testing guidelines and protocols were developed. Since then, many of the testing requirements recommended by the NRC have been incorporated into the Agency's standard evaluation requirements and practices. In addition, in line with the Council's recommendations and the FIFRA Scientific Advisory Panel's (SAP) advice, EPA recently expanded its neurotoxicity and developmental neurotoxicity study requirements. These updated requirements are contained in this proposal.
3.
Throughout the 1990s, EPA has been continually working on improving data requirements. Under FFDCA, as amended by FQPA, EPA must reassess all existing pesticide tolerances and exemptions against the expanded and more rigorous safety standard. Beginning in 1994, and increasingly since the enactment of FQPA, EPA has changed aspects of its data requirements and risk assessment process to improve its ability to assess exposure more accurately and to strengthen its understanding of the potential pesticide risk to children. As mentioned, risk assessments must now consider data relating to aggregate exposure (exposure to pesticides from food, drinking water, and non-occupational routes such as home and garden uses) and cumulative risk (effects from exposures to multiple pesticides that share a common mechanism of toxicity). These measures necessitate collection of additional data on drinking water and non-occupational and residential exposure.
This proposal applies only to conventional pesticides. In general, a conventional pesticide is considered as a synthetic chemical or a natural substance with a toxic mode of action. It is applicable to both manufacturing-use and end-use products. It does not include data requirements for antimicrobial, biochemical or microbial pesticides; inert ingredients; or changes to existing spray drift or product performance (efficacy) data requirements for conventional chemicals.
EPA has a number of objectives in proposing this regulation to update and revise the data requirements in 40 CFR part 158. First, this proposal will update the requirements in part 158 to reflect changes that have occurred over time and which are generally applied already.
Second, this proposal will provide clarity on the data requirements themselves, with data requirements reformatted to promote efficiency in registration decision processes. Third, information developed in fulfilling these data requirements will improve the scientific basis supporting increasingly complex risk management decisions.
1.
This regulation will reflect the changes in data requirement practices that have evolved through practice since the 1984 data requirement rule was promulgated and address data needed to meet requirements created by statutory amendments to FIFRA and FFDCA. In addition, the rule will eliminate redundant data submission requirements.
EPA's underlying principle in development of this regulation is to strike an appropriate balance between the need for adequate data to make informed risk management decisions while minimizing the data collection burden.
Until this proposal is promulgated, the Agency will continue to use existing authority in 40 CFR part 158, to obtain these data on a case-by-case basis should they be necessary to support a registration.
2.
3.
i.
ii.
iii.
iv.
However, since EPA continues to allow applicants to submit and use their own study protocols to generate data that they subsequently submit to EPA, and there are differences in the mandate and authorities between EPA and OECD countries, the data submitted to EPA under part 158 would be expected to satisfy OECD standards under most circumstances, but perhaps not in all cases.
v.
vi.
This proposal concerns prospective data requirements for future registrations of pesticides. That is, these proposed data requirements would apply to all new registrations of pesticides after the rule is finalized. The Agency does not intend to apply these requirements retrospectively to all existing pesticide registrations. While the intended future applicability of this proposed rule is to new applications, 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 future programmatic changes and priorities on existing pesticides.
This proposal is the first in a series of revisions aimed at comprehensively updating EPA's pesticide data requirements. The data requirements discussed in this proposal pertain to conventional pesticides. Future proposals will address data requirements for antimicrobial pesticides, biochemical and microbial pesticides, inert ingredients in pesticide products, and product performance data requirements.
Part 158 is currently divided into four subparts:
• Subpart A, General Provisions
• Subpart B, How to Use Data Tables
• Subpart C, Product Chemistry Data Requirements
• Subpart D, Data Requirements Tables
EPA proposes to reorganize part 158 to more closely correspond with the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) Harmonized Guidelines, primarily by creating a series of new subparts to replace subpart D. Each subpart will address an individual scientific discipline or data type. In this preamble, EPA will refer to the proposed new subpart and section designations when discussing the data requirements. Table 1 below provides a cross-reference between the current and proposed new subparts. Future new subparts are included for information.
Further, EPA proposes to remove the current Appendix A, which contains a compendium of pesticide use sites and use categories to help determine data requirements. This will be separately issued and maintained as a guidance document.
FIFRA is a licensing statute, under which regulatory decisions on the registrability of an individual product is based upon data specific to the product and its uses. EPA is authorized to require the submission of data that it needs to make the registration decision in the context of any individual application for registration, amended registration or reregistration. EPA may also impose a data requirement after registration in order to maintain the registration, using specific Data Call-In (DCI) authority of FIFRA sec. 3(c)(2)(B).
Since 1984, when part 158 was first promulgated, EPA's data requirements have evolved as the general scientific understanding of the potential hazards posed by pesticides has grown. Most of the data requirements contained in this new proposal have been applied on a case-by-case basis to support individual applications, or imposed via a DCI on all registrants of similar products. Thus EPA's actual data requirements have progressed as scientific understanding and concerns have evolved, but part 158 data requirements have not been updated to keep pace.
The result of this regulatory lag is that EPA regards many data requirements in today's proposal to be “newly codified requirements,” routinely applied in practice on a case-by-case basis but simply not codified in the CFR. However, because they have not been codified, they are considered to be “new requirements” never before imposed on the regulated industry. For the purposes of this proposal, EPA has evaluated the costs and burdens of all proposed requirements, whether “new” or “newly codified ” against the data requirements as originally promulgated in 1984, termed “ existing requirements.” Many of these studies can be categorized as rarely to infrequently required.
In this preamble, EPA is proposing new and revised data requirements that encompass all three categories of requirements:
1. EPA is proposing “new requirements,” never before imposed on any registrant.
2. EPA is proposing “newly codified requirements,” which have been applied on a case-by-case basis, but are not in the CFR.
3. EPA is proposing revisions to “existing requirements.”
Part 158 is a massive and complex set of tables that describe pesticide data requirements. Each data requirement is currently established and its scope and applicability defined according to a number of parameters. Having comprehensively evaluated its data requirement parameters, EPA is proposing changes in all areas of data requirements. Some of these changes are clarifications or housekeeping changes without cost or burden, others have the effect of increasing or decreasing the burden of the data requirement. The types of changes may be broadly categorized as follows:
1.
ii.
iii.
iv.
v.
vi.
vii.
2.
ii.
iii.
iv.
Each data requirement for which a revision is proposed is discussed in detail in subsequent units of this preamble. Readers are referred to the table in Unit XXIII. for a line-by-line listing of every current and proposed data requirement and the types of changes proposed. If no change is proposed, the table contains a notation to that effect.
Subpart A serves as an introduction to the data requirements in part 158. As proposed, current material has been substantially revised to be more concise and easier to understand. EPA has eliminated much of the redundancy in current subpart A and streamlined the remaining material. Unless otherwise superseded by part 174, the regulations of this part apply to plant-incorporated protectants.
1.
2.
EPA proposes to reorganize for clarity the data submission requirements of § 152.32. EPA would eliminate descriptions of EPA assignment of MRID numbers, as this internal action does not bear upon applicant requirements. Applicants would continue to format data submissions in support of regulatory actions according to current Agency procedures. The proposed rule makes clear that administrative non-data elements of a submission (forms, labels, and correspondence) are not subject to formatting requirements.
The Agency also proposes to eliminate specific media and copy requirements from the regulatory text because these requirements are subject to change as the Agency implements new strategies to reduce the paperwork burden on data submitters and to simplify the submission process. The Agency intends to provide updated guidance in a new PR Notice that will supersede PR Notice 86-5. EPA has a web page that provides guidance for both paper and electronic data submission.
After a series of pilots EPA has developed a standard for electronic submission of data using Adobe Acrobat Portable Document Format and related tools for pesticide data submitters to create electronic versions of documents. Extensive guidance has been developed and posted on the EPA web page dedicated to electronic submissions(
Registrants should note that regulations in part 159 concerning FIFRA sec. 6(a)(2) submissions require that such data be formatted according to the requirements of this section.
EPA proposes to clarify its policies on confidentiality claims asserted by submitters and on the release of information by the Agency. Section 158.33 discusses information that may be claimed as confidential and the procedures for asserting such a claim. It also discusses information that may be released by EPA, and circumstances under which such information can be released. Any release of information by EPA would be in accordance with FIFRA sec. 10, FFDCA sec. 408, and EPA regulations under the Freedom of Information Act (5 U.S.C. 552) found in 40 CFR part 2. The revisions to procedures for asserting confidentiality claims would not apply to data submitted to the Agency before the date of promulgation of this rule. Further regulatory provisions regarding confidentiality can be found at 40 CFR part 2.
1.
The likely intent of Congress was to accord information submitted in support of a tolerance or exemption the same confidentiality protections that apply to data submitted under FIFRA, especially considering the extent to which FIFRA and FFDCA were intertwined more closely by FQPA. Treating information submitted under the two statutes identically means that they are subject to the same protections (
2.
FIFRA sec. 10(d)(1) provides that “information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the effects of such pesticide on any organism or the behavior of such pesticide in the environment, including, but not limited to, data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation
Excepted from that mandatory disclosure requirement is certain information pertaining to manufacturing and quality control processes and to inert ingredients, which is given qualified protection under FIFRA secs. 10(d)(1)(A), (B), or (C). This exception has been frequently misinterpreted to mean that all such information is made categorically confidential by sec. 10(d)(1). In fact, as decided by the
EPA believes that, with the exception of information pertaining to a pesticide that has never been registered, all information submitted in accordance with part 158 (including information submitted in connection with an application for a tolerance or exemption) constitutes safety and efficacy information subject to sec. 10(d)(1). All of the information subject to part 158 concerns “the effects of such pesticide on any organism or the behavior of such pesticide in the environment.” This includes not only studies regarding hazard and fate, but also information such as product chemistry, which is collected by the Agency for the very purpose of determining the effects of the pesticide on organisms and its behavior in the environment.
In addition to providing submitters with an opportunity to designate information as subject to one of the exceptions in FIFRA secs. 10(d)(1)(A), (B), or (C) (a feature also contained in the current version of § 158.33), EPA proposes to include a provision that all information that has not been so designated and that pertains to a registered or previously registered pesticide be deemed non-confidential by operation of law, without further notice to the submitter (subject to the requirements of sec. 10(g) regarding disclosure to multinational entities). This provision would not apply to information that was submitted prior to May 4, 1988, the effective date of the current regulation contained in § 158.33, and thus the first time that claims under sec. 10 (d)(1)(A), (B), or (C) were required to be identified.
3.
At the same time, the period prior to registration is of special importance for public participation in the registration process. Under FIFRA sec. 3(c)(4), EPA publishes a
Because of the possibility that some pre-registration information may be legitimately confidential, EPA does not believe that it can categorically determine all such information to be non-confidential. The provisions in this proposal requiring the submitter to specify which information is claimed as confidential will simplify access to information not so claimed, but EPA is soliciting comment on other mechanisms to facilitate public access to pre-registration information.
4.
5.
In Class Determinations 3-85 (50 FR 48833, November 27, 1985) and 1-99 (64 FR 70019, December 15, 1999) EPA elucidated the criteria for determining whether information and documents derived from studies or reports submitted to the agency are subject to the restrictions of FIFRA sec. 10(g). In order to be outside the scope of sec. 10(g), documents must not (1) “contain or consist of any complete unpublished report submitted to EPA ” or (2) “contain or consist of 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.” (50 FR 48834). Although the application of these class determinations is limited to data reviews created by the Agency (3-85) and information regarding unreasonable adverse effects of
6.
EPA proposes to revise the flagging requirements of § 158.34, established in 1985, without changing the substance of the requirement. Currently, applicants for registration and amended registration, and submitters of data under FIFRA sec. 3(c)(2)(B) are required to flag certain toxicology studies that show results potentially indicating an adverse effect. EPA proposes to make minor revisions to update and clarify the criteria to encompass the new types of toxicology studies being proposed today. Specifically, EPA proposes to:
1. Reduce the number of study criteria from 11 to 7 by combining certain studies under one criterion. The new criteria would eliminate distinctions between subchronic and chronic studies in most cases.
2. Combine reproductive, prenatal developmental toxicity and developmental neurotoxicity studies under one criterion to better focus on effects on children and infants.
3. Consolidate the criteria that address the No-Observed-Adverse-Effect Levels (NOAEL) into a single criterion covering all studies from which NOAELs are derived. In so doing, EPA would change references to cholinesterase inhibition to “acute toxicity.” This change acknowledges that NOAELs are now derived for a number of acute toxicity effects, not just cholinesterase inhibition. In a similar vein, EPA would eliminate the specific “less than 10X” and “less than 100X” triggers for NOAEL study flagging in favor of a more general description of “less than the current NOAEL.” Both of these changes could result in more studies being flagged.
4. Update the guidelines references, and terminology,
EPA proposes to reformat its waiver process, currently contained in § 158.45, but to retain its provisions. This proposal retains the flexibility of the current provisions for applicants to request, and EPA to evaluate, the need for data on a case-by-case basis depending on individual chemicals and use patterns. One of the benefits of updating part 158 as proposed today is that the improvements in clarity and transparency of the data requirements will greatly assist both the Agency and applicants in addressing data waivers.
1.
2.
Moreover, the improved transparency of the requirements and conditions in new part 158 means that an applicant will be able to ascertain with reasonable certainty the likelihood that EPA would consider favorably a waiver request. EPA believes that improved clarity will also reduce the number of frivolous, inappropriate, or ill-supported waiver requests. Thus, EPA believes it will be able to respond in a reasonable period of time to a waiver request. If EPA requires a lengthy period to reach a decision on a waiver request which is denied, the Agency will generally consider time extensions to accommodate legitimate and reasonable registrant needs, whether to define acceptable protocols, evaluate alternative tests that might satisfy the Agency's requirements, or allow for consideration of laboratory capacity.
Current § 158.60 outlines a number of non-regulatory policies EPA adopted to limit the economic impact of data requirements on minor use products while ensuring that the Agency had adequate data to assess the potential risks and benefits of these pesticides. Because minor use policies by themselves are somewhat fluid and subject to change periodically, EPA proposes to remove § 158.60. EPA, however, remains committed to the minor use program by imposing the mandates contained in FIFRA that relate to minor uses, such as extending exclusive use of minor use data, granting minor use waivers, and expediting minor use registrations. The Agency believes that tiered testing, outlined elsewhere in this proposal, coupled with its waiver policy in § 158.45 and priority review status, limit the economic burden for all pesticides by ensuring that registrants are required to develop only those studies that are essential for an appropriate safety evaluation.
EPA proposes to revise subpart B to update use patterns and clarify the steps needed to determine the appropriate data requirements from the tables in subparts, D, E, F, J, K, N, O, and U. Pesticide use patterns that are used to determine required testing have been revised for all of the data requirements tables to reflect the expanded use patterns contained in this proposal (see below).
EPA proposes to subdivide the current 9 major use patterns listed in Appendix A of part 158 to 15 to more fully address nonagricultural uses. The revised use patterns would be terrestrial food crop, terrestrial feed crop, and terrestrial nonfood crop; aquatic food crop, aquatic nonfood crop, aquatic nonfood outdoor use and aquatic nonfood industrial use; greenhouse food crop and greenhouse nonfood crop; forestry; residential outdoor; indoor food; indoor nonfood; indoor medical; and indoor residential use. As mentioned above, the Agency proposes to remove the Pesticide Use Index (Appendix A) from the regulations because it is not a requirement. Instead, the Index will become a separate guidance document and placed on EPA's website and made available to the public. A guidance document would be easier to update and would provide the regulated community with the most current information.
Subpart B would contain a step-wise process to assist the applicant in determining the data needed to support its particular product. 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 proposed here as they relate to their specific product prior to and during the registration process.
EPA is continuing its current system of identifying the applicability of data requirements in the data tables. Because of the variety of chemicals and use patterns, and because EPA must retain flexibility to tailor data requirements to its needs, it uses only qualitative descriptors in the tables. These are used for convenience to make the table format feasible, but serve only 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.
The table descriptors NR (not required), R (required), and CR (conditionally required) can be viewed as markers along a spectrum of the likelihood that the data requirement applies. 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. Although only an approximation, if percentages were to be assigned, R could be viewed as representing the range of 50% to 100% and CR the range up to 50%. EPA welcomes comment on ways to characterize the data requirements that would better serve applicant needs.
EPA is continuing its longstanding system of identifying test substances in the tables. The standard descriptors of test substance are the following:
1. The technical grade of active ingredient (TGAI), used when evaluating the inherent toxicity or chemical characteristics of a pesticide.
2. The manufacturing use product (MP), used in certain product chemistry tests, usually for labeling purposes.
3. The pure active ingredient (PAI), used in certain product chemistry tests requiring extremely basic chemical properties or manufacturing process information.
4. The pure active ingredient, radioactive (PAIRA), used primarily in residue chemistry studies when residues at very low levels (ppm) must be quantified in plant or animal tissue.
5. The end-use product (EP), used as the test substance when the Agency wants to refine its hazard or chemical profile based on actual concentrations, or needs to determine the impact of added inert ingredients on the hazard or chemical profile.
6. The typical end-use product (TEP), used as a representative product in tests that might otherwise require duplicative testing of a number of EPs.
Where changes in the test substance are proposed, such changes are described in the discussion of each proposed revision. EPA welcomes comment on its test substances and how the Agency uses them in a testing regimen. Such comments should be made in the context of the specific data requirement for which changes are proposed.
Finally, the Agency is requesting comment on the best way to identify data requirements for EUPS. Some people believe that the brackets indicating what data requirements also apply to EUPs in the current data tables complicate the tables with extraneous symbols and codes. In an effort to make the data tables simpler and easier for an applicant to understand, one suggestion is to separate the EUP data requirements from the main data tables and make them a stand-alone table. Revised EUP data requirements could be housed in 40 CFR part 158 (data requirements) or in part 172 (EUP requirements). As part of this proposal, EUP data requirements for each discipline have been identified either in the regulatory text accompanying the data table or, as brackets, within the body of the table, itself. In general, the Agency proposes to retain the existing data requirements for EUPs with a few minor changes in the areas of environmental fate and ecological effects. The Agency is soliciting opinions on this approach or other approaches that may prove more efficient and useful to the applicant. If an alternative approach is accepted, the Agency may in the final rule, reformat the regulatory text or data tables.
The guidelines for the environmental fate series are currently being updated and where applicable, harmonized with the guidelines established by the OECD. Therefore, the Agency is showing the current guideline numbers in the preamble, regulatory text, and tables. If, before the final rule has been promulgated, these guidelines have been issued, EPA will insert the new guideline numbers in the Final Rule.
The Agency proposes to retain the material currently in § 158.202 Purposes of the registration data requirements in subpart D, Data Requirements Tables. Since a series of new subparts will replace subpart D, this material will be moved to subpart B.
The Agency uses product chemistry information to determine whether impurities of toxicological or environmental concern are present in pesticides and formulated products.
The Agency proposes to list entries in the data requirements table for product identification, composition, analysis, and certification of limits requirements. These requirements are currently contained in § § 158.155 through 158.180, and are proposed to be retained unchanged as new § § 158.320 through 158.355. Inclusion in the table for product chemistry is for the convenience of applicants--the requirements themselves are not affected by including them in the table. The test notes refer applicants to the subsequent section that discuss the requirements in detail.
The Agency's current policy as described in Pesticide Registration Notice 98-1 (January 12, 1998) allows applicants and registrants to submit a summary of the physical and chemical properties of non-integrated pesticide products, EPA Form 8570-36, rather than submit the studies upon which these data are based. The self-certification statement (EPA Form 8570-37) must be signed and dated by the applicant certifying that the submitted information was conducted in full compliance with the regulations (Attachment 2 to PR notice 98-1). The PR notice applies to applications for registration of manufacturing-use and end-use products of all pesticide products produced by a non-integrated formulation system.
1.
2.
ii.
3.
ii.
iii.
iv.
The Agency uses a tiered system of ecological effects testing to assess the potential risks of pesticides to aquatic and terrestrial vertebrates, invertebrates, and plants. These tests include studies arranged in a hierarchy from basic laboratory tests to applied field tests. The results of each tier are evaluated to determine the potential impacts on fish, wildlife and other nontarget organisms, and to indicate whether further laboratory and/or field studies are needed. These data requirements provide the Agency with ecological effects information, which, in turn, allows the Agency to determine if precautionary statements concerning toxicity or potential adverse effects to nontarget organisms are necessary.
Higher tiered studies may be required when basic toxicity data and predicted exposure levels or environmental conditions suggest the potential for adverse effects. Field data are used to examine acute and chronic adverse effects on captive or monitored populations under natural or near-natural environments. Such studies are required only when the potential for adverse effects is high, based on the results of lower tier studies, or to confirm the need for mitigation measures. In some cases, the results of field studies may give rise to the need for further testing.
The Agency is proposing two additional data requirements as well as other minor revisions that would clarify the existing data requirements. In some cases, the proposal is to change the
In addition, as discussed in more detail in this section, the Agency proposes to require an additional test species for the avian oral toxicity study, because current data requirements may not adequately characterize the risks that pesticides pose to songbirds. The Agency also proposes to conditionally require sediment testing to better assess the effects of sediment bound pesticide residues in aquatic environments. The Agency is proposing to require independent laboratory validation of environmental chemistry methods for terrestrial and aquatic field testing.
Finally, the Agency is proposing to eliminate the requirement for avian dietary testing for indoor and greenhouse uses, and to simplify the test notes for these requirements. The Agency invites comments on all aspects of these data requirements.
1.
2.
EPA's Contaminated Sediment Management Strategy (USEPA 1998) (Ref. 3) has been recently developed to provide a more unified approach to testing and risk assessment of aquatic species which inhabit and feed in the benthic environment. Testing would consist of whole sediment (spiked) tests; testing can also consist of chronic whole sediment toxicity tests and/or sampling for residues and biological monitoring of pesticides in the sediment after exposure. EPA has developed test protocols for chronic whole sediment tests of invertebrates. Test guidelines will be developed from these protocols. Protocols for further tests (
i.
ii.
3.
The Agency proposes to revise and simplify the test notes for the avian acute toxicity test. The single current footnote is structurally complex, so EPA has subdivided it into 4 test notes that are easier to understand and apply.
In addition, the Agency proposes to conditionally require testing of the typical end-use product (TEP) of granular and non-granular end-use products because the inherent toxicity of end-use products is better defined by testing the product. End-use products may contain chemicals that enhance efficacy by acting as solvents, stickers, and wetting agents. Although these chemicals are listed as inerts, their individual toxicity or combination with one another or the active ingredient (a.i.), may be more toxic than the technical grade of the active ingredient (TGAI).
i.
This proposal would also add as a conditional requirement data on one avian species for aquatic nonfood residential uses if the acute avian oral LD
ii.
iii.
iv.
v.
Although indoor and greenhouse uses usually require only one species of fish to be tested, in some instances a second fish species may be needed. For example, a chemical may be shown to be stable in the environment (
vi.
vii.
For the freshwater fish early-life stage and invertebrate life-cycle studies, the Agency proposes to change the conditional requirement for terrestrial and aquatic (food crop and nonfood) and forestry uses to required, and change the aquatic nonfood residential use to not required.
Currently, the freshwater invertebrate life cycle and fish early life stage tests are conditionally required for terrestrial, aquatic (food crop and nonfood), and forestry uses. When promulgated in 1984, one basis for the conditional nature of the requirements was that only one of the two tests was required, depending on whether fish or invertebrates were more sensitive in the acute studies. However, when a pesticide enters the aquatic environment, both groups of organisms will be exposed. Moreover, acute sensitivity is not a reliable indicator of chronic sensitivity, whether in the same or a different group of organisms, so that chronic data are needed regardless of the results of acute testing.
The proposed change to “not required” for aquatic nonfood residential use is due to the fact that the current “aquatic nonfood” use pattern is proposed to be split into aquatic
In addition, the Agency proposes to require both of these tests for all turf uses including residential, since exposure varies. This change is warranted because the relative sensitivity of fish and invertebrates can vary widely across chemicals. Currently, only the most sensitive of the two organisms, either fish or aquatic invertebrates, as determined by Tier I acute studies, is tested. However, since both organisms will be exposed when a pesticide enters an aquatic environment and the acute sensitivity of an invertebrate may not accurately predict the chronic sensitivity in fish and vice versa, the Agency believes that both species should be tested for chronic effects. The Agency cannot make the assumption that a chemical is not chronically toxic at much lower concentrations than some ratio of the LC
viii.
ix.
x.
xi.
xii.
Over the last several years, the Agency has been requiring, on a case-by-case basis for certain pesticides, data demonstrating specific geographic location(s) of threatened and endangered species (listed species), which can then be compared with areas of potential pesticide use. These data have been required when EPA determined that the estimated environmental concentration of the pesticide when applied according to the labeling appears to exceed the Agency's numeric concern levels for listed species. The specific species for which location information was needed, has been determined on a case-by-case basis based upon the use pattern of the pesticide and the sites on which it may be used. These special data are currently not required by part 158, and have only been requested on a few occasions; however, the Agency anticipates that they may be requested in the future in connection with other registration and reregistration actions. In response to a Data Call-In notice for data on the location of all listed species, an industry task force is working to develop a database that may partly fulfill Agency needs,
In addition, through discussions about methods to evaluate the potential risks of pesticides to listed species, EPA and the Fish and Wildlife Service and the National Marine Fisheries Service (jointly referred to as the Services) identified several aspects of EPA's current approach for which there is some scientific uncertainty. While the Services agreed that EPA was using the best available scientific and commercial information to assess risks to listed species, the Services and EPA also agreed that where uncertainties existed, further research and investigation might help to develop improved risk assessment approaches. The Agency recognizes that such research also could lead, in the long run, to additional data requirements for registration. Accordingly, the Agency seeks input on research areas that may be necessary to effectively characterize potential risks to listed endangered species from pesticide use. These include research to address the following types of uncertainties:
• Product use information by geographic location below the state and county levels
• Toxicity data and environmental fate measurements/exposure model predictions with end use products
• Toxicity data from surrogate species that quantify dose-response relationships for effects relevant to critical life stages of endangered species
• Measured or estimated values of physiological, biochemical, and morphological characteristics of endangered species and surrogate species to refine chemical-specific interspecies toxicity extrapolations
• Toxicity, exposure, uptake and elimination data to better determine any differences in interspecies sensitivity of non-target and endangered plant species exposed to herbicides
• Toxicity data to characterize potential effects to freshwater mussels
• Toxicity data to characterize potential effects to reptiles and amphibians.
The Agency seeks comment on:
1. The relative value of each of these research areas in better refining assessments of potential risks to listed species.
2. Input on specific research directions in these areas, including methodologies, protocols etc., that would be appropriate and useful in assessing the potential risks to listed species.
3. Other types of research that would be of value in refining potential risks of a pesticide to a listed species.
4. The extent to which potential research areas reflect uncertainties that apply to pesticides generically; to chemical stressors generically, or to types of pesticides or chemicals stressors.
Toxicology studies are required by the Agency to assess the hazard of the pesticide to humans and domestic animals. These hazard data, when combined with exposure data, form the basis for the human risk assessment. Generally, using animals as a surrogate for humans, tests are carried out by the oral, dermal or inhalation route depending on the pesticide's pattern of use and physical form. The duration of the toxicity study approximates the estimated duration of human exposure, while considering species differences in maturational milestones and overall life span. Typical exposures may be “acute” (single dose), “subchronic” (intermediate), or “chronic” (long-term). If a pesticide is used on food and requires a tolerance, the dietary exposure may be over a lifetime, or a significant portion of a lifetime, and thus chronic/cancer and multi-generation reproductive studies would be required. Studies would be required to assess the hazard during a potentially susceptible stage of life,
In addition, EPA's Risk Assessment Guidelines set forth principles and procedures to guide EPA scientists in the conduct of Agency risk assessments, and to inform Agency decision makers and the public about these procedures. The guidelines emphasize that risk assessments will be conducted on a case-by-case basis, giving full consideration to all relevant scientific information. This case-by-case approach means that Agency experts review the scientific information on each agent and use the most scientifically appropriate interpretation to assess risk. The guidelines also stress that this information will be fully presented in Agency risk assessment documents, and that Agency scientists will identify the strengths and weaknesses of each assessment by describing uncertainties, assumptions, and limitations, as well as the scientific basis and rationale for each assessment.
This proposal includes the requirements for pesticides retained from the current 40 CFR 158.340 as well as proposed revisions that have been peer reviewed by the SAP. The basic data set proposed here includes toxicity studies needed to support high exposure pesticides, such as food use pesticides.
1. Acute studies (oral, dermal, and inhalation toxicity tests, eye and skin irritation tests and dermal sensitization)
2. Subchronic (90-day) feeding studies in rodents and nonrodents
3. Chronic feeding studies in rodents and nonrodents
4. Cancer studies in two species of rodents (rat and mouse preferred)
5. Prenatal developmental toxicity studies in rodents and nonrodents (rat and rabbit preferred)
6. Two-generation reproduction study in rodents (rat preferred)
7. General metabolism study in rodents
8. Mutagenicity battery
9. Acute and subchronic neurotoxicity studies in rats
10. Immunotoxicity study in rodents
11. Developmental neurotoxicity study in rodents
1.
Generally, data requirements will proceed from single to multiple exposures, from shorter to longer duration, and from simpler to more complex. Different studies may be conducted simultaneously and various studies may be done in combination as well (an approach encouraged by the Agency to optimize resources and reduce the number of animals used in testing). Knowledge gained from results of earlier studies should be used to design subsequent study protocols in order to attain the greatest confidence in the results of the higher-order studies. For instance, conducting the subchronic (90-day) feeding study prior to the two-generation reproduction study would provide information on target organs that may be affected and that need to be specifically evaluated in the two-generation reproduction study.
2.
i. A fairly volatile pesticide is used in the home where long-term exposure by both inhalation and dermal routes are expected. In this case, the toxicity studies required would be similar to that for a food-use chemical.
ii. In another example, a termite control pesticide is buried in the lawn near the house. There is very little exposure to anyone including the applicator. In this case, only Tier 1 data would be needed. In general, the level of toxicity studies will be determined by the magnitude, frequency and duration of the estimated human exposure.
The second option would allow registrants and applicants of nonfood use pesticides to submit both toxicological studies and human exposure data simultaneously. For this option, toxicological data would be submitted under a tiered system. Agency review of the first-tier toxicological studies and the simultaneously submitted exposure data then would determine the need, for second- or third-tier toxicological studies. This option would permit flexibility in study requirements based on the identification and characterization of adverse treatment-
Under this second option, the required first-tier studies would consist of: Acute studies, a subchronic 90-day dermal study or a subchronic 90-day inhalation study, an acute and subchronic neurotoxicity screening battery in the rat, prenatal developmental toxicity studies in two species, two-generation reproduction study in rodents (rat preferred), immunotoxicity study in rodents, and a full initial battery of mutagenicity studies. The conditionally required second-tier studies would include both subchronic 90-day feeding studies, and sometimes a dermal penetration study. Depending on the results of completed studies, conditionally required third-tier studies would include both Chronic Feeding studies, both carcinogenicity studies, a reproduction study, and a metabolism study. In addition, depending upon the results in the initial neurotoxicity and mutagenicity batteries, further neurotoxicity or mutagenicity testing may be required to address possible identified risk concerns.
EPA's proposed toxicology data requirements encompass studies expected to improve the Agency's understanding of the potential pesticide hazard to humans, including subpopulations such as infants and children. The proposed table in this subpart contains the toxicology data requirements EPA would rely on to identify potential hazards to humans and domestic animals for all conventional pesticides. These include acute, subchronic and chronic toxicity studies, as well as carcinogenicity, prenatal developmental toxicity, reproductive toxicity, mutagenicity, neurotoxicity and other specialized studies.
EPA recognizes that toxicology testing represents a large economic burden on registrants and incorporates the use of test animals. Consequently, the Agency works with industry, the scientific community, and advocates, to ensure that data requirements are imposed only when needed to make a sound scientific safety finding required under the law. Because of this concern, the Agency has adopted guidelines whereby several toxicological endpoints may be derived from one study and has instituted other avenues for combining studies. The Agency also recognizes that, in general, lower exposure uses often correlate with lower risk. Consequently, the Agency has adopted an approach that tends to levy more extensive data requirements on high exposure uses like food uses. It is also reflected in the tiering system for data submissions for nonfood uses and in the layout of the data tables.
1.
Because the immune system is highly complex, studies not specifically conducted to assess immunotoxic endpoints are inadequate to characterize a pesticide's potential immunotoxicity, even if some tissues subject to immunotoxic insult are examined. While data from hematology, lymphoid organ weights, and histopathology of routine chronic or subchronic toxicity studies may offer useful information on potential immunotoxic effects, these endpoints alone are insufficient to predict immunotoxicity (Refs. 7 and 8). Therefore, the Agency is proposing to require functional immunotoxicity testing along with the data from endpoints in other studies to predict the potential risk of pesticides on the immune system more accurately. The Agency invites public comment on all aspects of its proposed data requirement for functional immunotoxicity.
2.
The Agency encourages registrants consider the use of combined study protocols in satisfying this requirement. A prenatal developmental toxicity study segment could be added to a two-generation reproduction study in rodents (guideline 870.3800). This can be accomplished by utilizing a second mating of the parental animals of either generation. The dams would undergo cesarean section at one day prior to expected delivery and a separate evaluation would proceed as specified in guideline 870.3700. By combining protocols in this manner, a single study would satisfy the requirement for both prenatal developmental and reproductive toxicity in the rodent. While it is recognized that the cost of the reproduction study would increase somewhat due to the additional work scope, the total cost of the combined study would be substantially less than that incurred by conducting the two studies separately. Moreover, a combined reproduction/developmental protocol would not require the purchase of additional animals, and would increase the efficient utilization of the animals being studied. The second required prenatal developmental toxicity study would then be performed on the rabbit.
ii.
A new adult neurotoxicity test battery of seven studies would replace the current adult neurotoxicity test requirements. The current adult neurotoxicity test battery consists of three studies: acute delayed neurotoxicity (hen), 90-day neurotoxicity (hen), and 90-day neurotoxicity (mammal). In the current part 158, an adult acute neurotoxicity study in mammals is not listed. However, an adult subchronic neurotoxicity study is required if the acute oral, dermal, or inhalation toxicity studies show neurotoxicity or neuropathy. Currently, the neurotoxicity studies can be triggered either by statistically and/or biologically significant findings.
Under the proposal, some of these tests would be routinely required and others would be conditionally required. Two studies that would be required are an acute and a subchronic 90-day neurotoxicity study (guideline 870.6200) in rats. The acute study would be required to detect possible effects resulting from a single exposure. The subchronic study is intended to detect possible effects resulting from repeated or longer-term exposures. The requirement for a subchronic neurotoxicity study also may be satisfied by incorporating the required neurotoxicity testing into the standard 90-day subchronic feeding study in rats (guideline 870.3100). The acute and subchronic neurotoxicity studies in adult rats, in addition to providing data on the potential for neurotoxicity, also provide a basis for comparison of the potential for age-related differences in impacts on the nervous system with results from the developmental neurotoxicity study, if needed, for the same chemical.
A new, conditionally required, 28-day delayed neurotoxicity study in hens (guideline 870.6100) would be added. The 28-day delayed neurotoxicity test would be required if results of the acute neurotoxicity study (guideline 870.6100) 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. The Summary Report of the 1990 OECD Ad Hoc Meeting (Ref. 9) adds:
In the assessment and evaluation of the toxic characteristics of organophosphorus substances, the determination of the subchronic delayed neurotoxicity may be carried out, usually after initial information on delayed neurotoxicity has been obtained by acute testing or by the demonstration of inhibition and aging of neurotoxic esterase and acetylcholinesterase in hen neural tissue.
The Agency believes that to evaluate the specific type of delayed neurotoxicity associated with some organophosphorus esters and related substances, a subchronic 28-day study in hens, rather than a 90-day study, would provide sufficient data. Thus, the duration of the subchronic hen study has been shortened from 90 days to 28 days. This is based on the finding that test chemicals reach equilibrium from both a pharmacokinetic and pharmacodynamic perpective; that is, the levels that cause effects,
The last three studies that comprise the neurotoxicity test battery are also new data requirements. The scheduled controlled operant behavior, peripheral nerve function, and sensory evoked potential neuropathology studies would be conditionally required if the results of the acute and/or the subchronic neurotoxicity studies show adverse effects on the central nervous system which affect learning, memory or performance, or adverse effects on visual, auditory, or somatosensory senses and/or concerns for peripheral neuropathy. The scheduled controlled operant behavior study (guideline 870.6500) evaluates substances that have been observed to produce neurotoxic signs in other studies (
iii.
1. The pesticide causes treatment-related neurological effects in adult animal studies, such as:
• Clinical signs of neurotoxicity
• Neuropathology
• Functional or behavioral effects
2. The pesticide causes treatment-related neurological effects in
• Nervous system malformations or neuropathy
• Brain weight changes in offspring
• Functional or behavioral changes in the offspring
3. The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies
4. The pesticide evokes 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
In practice, EPA evaluates each pesticide using all available toxicological information that might indicate a need for a developmental neurotoxicity study. The developmental neurotoxicity study (guideline 870.6300) has been requested on a case-by-case basis for certain chemicals for food use and nonfood use registrations since the guideline was finalized in 1991. The Agency is proposing to conditionally require developmental neurotoxicity studies for all neurotoxic pesticides and/or when other criteria are met that indicated a potential for toxicity to the developing nervous system, based upon a weight-of-evidence evaluation of the toxicological database.
The criteria used in this evaluation were developed through extensive scientific peer review, including a 1999 FIFRA SAP expert review (and public comment) on the use of the FQPA 10X factor in pesticide risk assessment (Ref. 11). The Panel concluded that these criteria were reasonable and useful indicators which would increase concern for pre-/postnatal toxicity. EPA proposes the (conditional) addition of the developmental neurotoxicity study to the toxicology testing requirements since the two developmental toxicity studies do not include an in-depth assessment of the development of the nervous system. The SAP acknowledged that the criteria were not adequate for identifying every potential developmental neurotoxicant, supporting the Agency's concern about the criteria's limitations. Accordingly, the SAP agreed with the Agency's approach of calling in the full range of neurotoxicity studies, including developmental neurotoxicity, for existing conventional chemistry food-use pesticides that are known neurotoxicants, and for all new conventional food-use pesticides.
The prenatal developmental toxicity study (guideline 870.3700) and the two-generation reproduction study (guideline 870.3800), evaluate the potential for toxicity to offspring following pre- and/or postnatal exposure to a test substance. The prenatal developmental toxicity study, in which the maternal animals are exposed during pregnancy, is designed to assess fetal growth, viability, and the presence of structural alterations (
Currently, discussions on alternative testing paradigms are underway by the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) under the Agricultural Chemical Safety Assessment Technical Committee. The consensus of this effort to date (ILSI, 2001) (Ref. 12) is that toxicological testing should move away from a rigid guideline-based screening approach and towards a more knowledge-based approach such as is currently used for pharmaceutical testing (
Under this paradigm, both the selection of studies that would be required, as well as the design of the tests themselves, could be influenced by other substantive and reliable information about the pesticide. Such information could include toxicity and dose-response data from other guideline or non-guideline studies, structure-activity relationships, data on the mechanism or mode of action of the chemical, pharmacokinetic data, studies that examine age-related sensitivity or susceptibility to chemical exposure, and information on potential or actual exposure to humans. These data could be used to inform a more targeted testing approach in the design of studies or to support a position that the requirement for specific toxicology tests listed in part 158 should be waived (under the authority described in § 158.45). For example, on a chemical-by-chemical basis, the design of prenatal developmental toxicity and/or two-generation reproductive toxicity studies (both of which examine toxicological effects on immature animals) could be refined, or alternative tests that examine appropriate functional or structural endpoints would be considered. The proposed HESI approach to testing pesticides is anticipated to be published early summer 2005. Once published, the Agency would consider this approach and make appropriate recommendations following internal and external peer review.
In the case of the developmental neurotoxicity study, 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 some chemicals, it might be concluded that adequate testing of the developing nervous system would be best accomplished with a standard developmental neurotoxicity study (guideline 870.6300). Refinements to the guideline study could include, for example, changes to the route and/or duration of exposure (
In the case of organophosphorus and n-methyl carbamate pesticides whose primary mode of neurotoxic action is inhibition of acetyl cholinesterase, a comparative cholinesterase assay could be conducted in lieu of the DNT given that the inhibition of cholinesterase (ChEI) is the most sensitive effect for these classes of chemicals. Regulation on a threshold (or benchmark) dose for
Whenever feasible, the Agency encourages registrants to conduct developmental neurotoxicity studies in combination with a two-generation reproduction study. In addition, if preliminary evidence indicates the need for evaluation of structural or functional toxicity of other organ systems in immature animals, these could also be examined within the context of the reproduction study. For developmental neurotoxicity assessment, this can be accomplished, for example, by utilizing the second generation (F
iv.
The Agency has selected the bacterial assay because it is a primary test for detecting intrinsic mutagenicity of many classes of biologically active chemicals. The genetics of each test strain of
Since there are many different mutagenicity tests available besides those in the initial battery, other types of testing by the registrant or other investigators may have been performed in the course of product research and development. In addition to the initial battery, data from such mutagenicity tests must be submitted to the Agency, along with a reference list of all studies and papers known to the applicant or registrant concerning the mutagenicity of the test chemical. Having this information at the beginning of a mutagenicity assessment will greatly facilitate EPA's effort to provide a more accurate assessment of the mutagenicity of the pesticide in question.
3.
ii.
iii.
Dermal toxicity testing for nonfood uses would be required if the dermal route is the major route of exposure. In this latter case, a 90-day study (guideline 870.3250) is proposed to be required, in lieu of the shorter, subchronic study. This proposed conditional requirement is necessary in order to assess potential hazards associated with dermal exposure. If the major route of exposure for nonfood uses is the dermal route, the 21- to 28-day subchronic dermal toxicity test is insufficient to identify potential hazards.
iv.
The Agency is proposing to formalize this routine practice by including these studies in the part 158 data requirements. The requirement for the 90-day oral study (guideline 870.3100) will be modified to include “two rodent species- rat and mouse preferred”. Both rodent species would be required for food use pesticides and conditionally required for nonfood uses.
v.
This change is predicated on the fact that reproductive toxicity testing endpoints are not assessed in any of the other required studies for the nonfood uses, and that these other studies do not provide adequate triggers which would indicate the potential for reproductive adverse effects.Multi-generation reproductive studies provide critical scientific information needed to characterize potential hazard to the human population during a number of sensitive life stages,
The need for a reproduction study in Tier 1 is bolstered by information developed by the Pest Management Regulatory Agency (PMRA) of Canada. (Ref. 17). In 1997, PMRA provided to the Agency the results of a preliminary study, which retrospectively evaluated reproduction studies as they affected risk assessment needs. The study was presented in the context of antimicrobial pesticides, for which a tiered toxicology testing scheme was being discussed. However, the results apply to similar tiered testing schemes across a broader spectrum of uses, such as what EPA is proposing for nonfood uses.
One aspect of the PMRA study looked to determine whether a reduced Tier 1 set of toxicology studies (consisting of acute toxicity, subchronic toxicity, developmental toxicity, and mutagenicity studies, but not a reproduction study) would adequately identify reproductive endpoints or concerns for risk assessment purposes. PMRA's results are telling with respect to reproductive effects:
• For 67% of the evaluated chemicals (12/18) with reproductive endpoints of concern, the reduced Tier 1 data set would not have predicted reproductive effects identified in a reproduction study
• Reproductive effects were not limited to a particular class of pesticide
• Chemical structure was not useful as a predictive tool (of reproductive effects)
• Mutagenicity studies were not helpful (in predicting reproductive effects)
EPA believes their results support the inclusion of reproduction studies in the Tier 1 nonfood testing regimen.
vi.
The data base to assess pre- and post-natal toxicity varies depending on the nature of the chemical. Some chemicals may need additional data in addition to the core data set for an adequate evaluation of potential hazards. The following studies may be required on a case-by-case basis to support the registration of particular pesticide products and the Agency has begun developing test guidelines for some of these studies. As the Agency's experience with these studies increases and if the studies are imposed more regularly, EPA may propose to include them in future revisions to part 158.
• pharmacokinetics in fetuses and/or young animals
• direct dosing of neonates prior to weaning for exposure through the maternal route
• specialized developmental neurotoxicity of more sensitive sensory and/or cognitive functions
• developmental immunotoxicity
• developmental carcinogenesis
• enhanced evaluation of potential endocrine disruption.
EPA solicits public comment on the Agency's possible request for such data, including the circumstances under which such data should be required.
Plant protection studies are used by the Agency to evaluate the potential for adverse pesticidal effects to nontarget terrestrial and aquatic plant species. Nontarget plants include crop plants growing within the target or treated area (such as crop plants which are growing with weeds or plants which are hosts for insects and disease organisms), and those growing outside the target area (adjacent crop plants, endangered plants, and plants that are important to fish and wildlife for food and cover). Data from the plant protection studies will be used to determine if protective measures, such as precautionary labeling, are needed.
Data on plant protection include short-term acute greenhouse and simulated or full field studies arranged in a hierarchy from basic tests to applied field tests. The results of each tier of tests must be evaluated to determine the potential of the pesticide to cause adverse effects, and to determine whether further testing is required. Tier I and II studies are short-term and relatively inexpensive. They are required broadly to assess a pesticide's potential to harm plants in the early stages of plant growth (the first 14 to 21 days). The short-term acute greenhouse studies provide basic toxicity data which are used in a deterministic risk assessment screen. These data are used to establish acute toxicity levels of the pesticide to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on plants; and to indicate whether further greenhouse and/or field studies are needed.
If additional, more refined, information is needed, Tier III field studies would be triggered. Simulated field and full field studies may be required when basic data and environmental conditions suggest that the risk exceeds the Agency's level of concern for nontarget plants and the information sought is necessary to adequately refine the Agency's assessment of risk. Data from these studies are used to estimate the potential for adverse effects on plant reproduction and survival, taking into account the measured or estimated residues in the environment.
EPA is not proposing major changes to the plant protection data requirements from those currently listed in part 158. The proposed data requirements are being expanded to include use patterns where the potential for off-target exposure via surface run-off and spray drift are likely, or for uses that may result in discharges to the aquatic environment. The seed germination study would be eliminated.
In addition, the Agency is proposing to require independent laboratory validation of the environmental chemistry methods for terrestrial and aquatic field testing. Other changes include changes in test substance, conditions under which a test is required or in some cases, not required, and clarification of test notes. These changes are not expected to increase the burden of the existing data requirements.
1.
2.
3.
ii.
The Agency also proposes that seedling emergence and vegetative vigor studies be conducted using the TEP instead of the currently required TGAI. The TEP that contains the highest percentage of active ingredient, and/or is the most commonly used, would be required. TEP testing eliminates the need for a separate solvent control because the solvent is already contained in the product formulation.
The Agency also proposes that vegetative vigor studies with granular or bait formulations not be required. Since the protocol for this study requires that the pesticide be applied directly to the plant surface, tests using granular or bait formulations would not be practical.
iii.
iv.
While toxicology data depict the potential hazard of a pesticide, residue chemistry, applicator and post-application data serve to estimate the potential exposure to the chemical. Residue chemistry data (subpart O) provide EPA with dietary exposure information, applicator (subpart U) and post-application (subpart K) exposure data provide exposure data from other routes, such as dermal, inhalation, and oral.
The post-application data requirements are being revised because the existing data requirements no longer meet the needs of the Agency to protect human health from unreasonable adverse risks in all post-application settings. Data to determine post-application exposure are essential to assess the risk to people resulting from exposure to pesticides after they have been applied. Results from the post-application residue studies assess the presence of pesticide residues, while exposure monitoring data are used to determine the quantity of the pesticide and any of its potentially harmful degradates or metabolites to which people may be exposed. These data, in conjunction with appropriate toxicology information, are used to determine whether post-application risks are of concern at residential and occupational sites, and to develop, when appropriate, post-application restrictions.
The 1984 data requirements were developed to assess the risks to agricultural workers and others who must enter a treated field. The data were, and still are, required to protect these workers from exposures resulting from pesticide residues remaining on crops. Over the years, occupational safety concerns have led to the development of a number of state and federal programs for agricultural worker protection. More recently, the Agency has become increasingly concerned about post-application risks to persons in occupational settings other than conventional food, feed and fiber crop agriculture. Additional studies and information are needed to assess the risks to workers in nurseries and greenhouses, forests, golf courses, animal facilities, and other settings where a person may be exposed to pesticides. Depending on the setting and the type of application, exposure can result from residues on foliage (including turf grass), soil, or indoor surfaces.
The proposed data requirements also are being expanded to encompass potential risks from other settings where people may be exposed, such as golf courses, recreation areas, schools, and hospitals, regardless of whether they are on the job or are simple bystanders. The Agency has long been aware of the need for exposure data in this area. Under current practice, post-application exposure data are generally required for both occupational and residential settings. Currently, post-application exposure studies are required on a case-by-case basis when specific exposure and toxicity criteria triggers have been met. Moreover, FFDCA now mandates that EPA perform additional scientific analyses which have not been a routine part of the Agency's risk assessment process, such as the assessment of aggregate exposures from multiple pathways including dietary and non-dietary routes. Such exposures to pesticides have been associated with a significant proportion of reported incidents in the record.
Residential use sites, for data requirement purposes, encompass more than what would normally be considered homeowner use. A “resident” is a member of the general public, and “exposure” from a residential use site includes post-application exposure to anyone who, in the course of their daily activities, comes in contact with a pesticide after it has been applied. Post-application residential exposure to pesticides can occur in a variety of indoor and outdoor environments, and a vast number of different human activities can occur at these sites after the pesticides has been applied. Data reflecting new exposure patterns are required to determine whether a product may be used safely in and around homes, golf courses, parks, recreation areas, schools, hospitals, and public buildings. Numerous pesticides contribute to outdoor residential exposure including lawn chemicals, landscaping and garden products, rodent poison, and treated lumber. Indoor exposures can result from ant and roach killers, termite treatments, pet flea and tick products, and treated paint. While use of some products may result in intermittent exposures, use of others can result in people's exposure to the pesticide or its residues on a daily basis. In addition to acute or episodic exposures, chronic exposure to pesticides used in residential settings may be of concern.
EPA's current post-application exposure data base is not comprehensive, especially regarding exposures to pesticides in nonagricultural settings. The new data that would be collected under the approach outlined in this proposal would allow the Agency to conduct improved exposure assessments for residential and occupational sites. In addition, such post-application studies would allow the Agency to assess aggregated and cumulative risks to consumers, with special emphasis on children. The Agency invites public comment on all aspects of its proposed data requirements for post-application exposure.
EPA proposes to revise the toxicity and exposure criteria for post-application exposure studies. The Agency currently requires pesticide post-application exposure data when it determines that risks resulting from post-application exposures may be a concern in occupational or residential settings. The criteria for requiring post-application exposure monitoring data would be expanded to include a wider number of potential exposure scenarios in both occupational and non-occupational settings. The
1.
EPA is proposing that the toxicity criteria be based on all aspects of the toxicity of the active ingredient. Post-application exposure data would be required, as determined by the Agency, if the active ingredient meets any of the following including:
• Evidence of potentially significant adverse effects have been observed in applicable toxicity studies,
• Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.
2.
i.
• Occupational human post-application exposure to pesticide residues on plants or in soil could occur as the result of cultivation, pruning, harvesting, mowing or other work related activity. Such plants include agricultural food, feed, and fiber commodities, forest trees, horticultural plants in commercial greenhouses or nurseries, and turf grass,
• Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such plants include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.
ii.
• Occupational human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at agricultural or commercial sites, such as, but not limited to, agricultural animal facilities and industrial or manufacturing facilities,
• 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, inside homes, daycare centers, hospitals, schools, and other public buildings.
The need for data from potential exposure resulting from situations not covered by these examples should be discussed with the Agency.
At a minimum, residue dissipation, exposure studies, and selected toxicity data are needed to assess post-application risk and determine, when appropriate, entry restrictions. Product use information, including registrant-generated or other surveys on actual use, and descriptions of human activity information are also used to define and refine post-application exposure and risk estimates.
The dissipation of pesticide residues may occur on foliage, soil, or indoor surfaces. To determine dissipation rate, the Agency uses, depending on the use of the pesticide, dislodgeable foliar residue dissipation data, turf grass transferable residue dissipation data, soil residue dissipation data, and/or indoor surface residue dissipation data. To determine the level of post-application human exposure, EPA may use dermal exposure, inhalation exposure, and/or nondietary ingestion studies. In some instances, such as exposure to swimmers, where passive dosimetry methods are not feasible, EPA may require a biological monitoring study. The Agency does not believe that this study will be commonly required. Certain toxicity data also are used in conjunction with the dissipation and exposure data. Typically, this information is obtained through existing toxicity data requirements (see Unit XI of this preamble and subpart F in the proposed regulatory text).
Post-application exposure monitoring data are proposed to be pesticide- or formulation-specific, however, surrogate exposure data may be submitted, if appropriate. In general, the studies required for estimating post-application exposure are dependent upon the pesticide site and use patterns, potentially exposed populations, significant exposure routes, and the time duration over which the exposure occurs. The employment of exposure mitigating measures, such as packaging or use restrictions,
1.
2.
i.
ii.
In addition, the Agency proposes to allow registrants to submit biological monitoring data in addition to, or in lieu of, dermal or inhalation passive dosimetry data provided adequate pharmacokinetic data are available and sufficiently understood to interpret the results.
iii.
iv.
In many cases, product use information coupled with the description of human activity information are used to help the Agency determine the most likely route(s) of exposure, whether through the skin, through the lungs, or through incidental ingestion.
v.
vi.
(1) lawns (soil that contains pesticide residues);
(2) residential plantings (pesticide-treated foliage);
(3) outdoor surfaces (decks);
(4) indoor surfaces (pesticide-treated paint chips);
(5) residential fabrics (clothing, bedding, carpets);
(6) insect and rodent baits.
Nondietary ingestion may also occur through hand-to-mouth or object-to-mouth transfer of pesticide residues during activities performed by children (e.g., crawling) that put them in close proximity with treated surfaces.
Studies would address such concerns as examining behavior patterns,monitoring the amount of soil or residue in the rinsate from hand-washing,and developing science-based models or formulas to estimate the inadvertent exposure. The results from these studies will be used to assess the risks associated with the incidental ingestion of pesticides by children following pesticide applications in residential settings. The Agency is primarily concerned with nondietary exposures immediately following application of the pesticide, therefore dissipation studies alone would not provide the information needed to assess risks from nondietary ingestion exposures. This study would not be required for occupational uses.
3.
i.
ii.
iii.
4.
At this time, EPA generally is not allowing the use of surrogate data for any of the post-application residue data (guidelines 875.2100, 875.2200, 875.2300, and 875.3000). EPA encourages applicants and registrants to generate needed exposure data using the pesticide product for which the registration is sought. Surrogate data are, however, accepted under certain circumstances for post-application exposure monitoring. The Agency recognizes the need to impose exposure data requirements judiciously to avoid unnecessary economic burdens on applicants. Surrogate exposure data estimations must have adequate information to address post- application exposure data requirements and must contain adequate replicates of acceptable quality data to reflect the exposure of concern, such as the type of plant or indoor surface and the post-application activity. When the data meet these criteria, the residue transfer coefficients derived from surrogate studies may be used to assess the occupational and residential post-application exposure to the pesticide. When surrogate data, however, prove inadequate for the Agency to estimate likely exposures, applicants and registrants will be required to submit the data required in subpart K.
Surrogate data may be obtained from several reliable sources. Some surrogate post-application data for workers in agricultural settings is available through the Agricultural Reentry Task Force. The task force has submitted to the Agency post-application exposure data. A database was developed that contains transfer coefficients for various agricultural work tasks and crops. Some surrogate post-application data for pesticide applications in residential settings is available through the Outdoor Residential Exposure Task Force. This task force submitted data to the Agency on post-application exposures following the use of different types of pesticide formulations typically found in outdoor residential settings.
In addition, the Agency may accept surrogate exposure data estimations from other agencies, such as the National Institute of Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), or the OECD to satisfy post-application exposure data requirements, if the data meet the basic quality assurance, quality control, good laboratory practice, and other scientific requirements set by EPA. Moreover, if EPA determines that industrial standards, such as the workplace standards set by OSHA, provide adequate protection for a particular pesticide use pattern exposure, data may not be required for that use pattern. The Agency invites public comment on all aspects of its proposal regarding the use of surrogate exposure data.
Under current part 158, EPA requires a series of individual laboratory studies as well as field studies to assess the behavior and fate of a pesticide in the environment. Controlled environmental fate and transport laboratory studies are used to determine the persistence, mobility, and bioconcentration potential of a pesticide active ingredient and its major degradates. The studies offer information on how, or by what mechanism, the pesticide degrades or dissipates, the rate at which it degradates or dissipates, where it goes, and what transformation products are formed. Data from these studies are used as inputs to exposure models. These models estimate the expected environmental concentrations of the pesticide and its degradates under various environmental and use conditions. The laboratory studies also help to focus field study design by providing information on which transformation products are likely to be produced, and thus need to be tracked, and the environmental media (
A conceptual model (hypothesis) is developed using assumptions derived from the laboratory data. Since the laboratory studies are controlled and evaluate specific fate and transport properties individually (
The field and laboratory data are integrated to characterize the persistence and transport of the pesticide and its degradates in the environment. From these data, quantitative environmental fate and drinking water exposure assessments are developed. Model-estimated environmental concentrations of the pesticide in different media under various pesticide application and site scenarios are calculated. These estimates of exposure are used in conjunction with toxicity data to assess whether a pesticide has the potential to cause adverse effects on human health and the environment, such as, wildlife, fish, and plants, including endangered species.
Persistence studies assess what happens to a pesticide when it interacts with water, soil, air, and sunlight. Mobility studies attempt to predict the potential of the pesticide to volatilize into the atmosphere, move into ground or surface waters, or bind to soil. Bioconcentration studies evaluate the potential to partition to aquatic biota and the degree to which bioconcentration can be reversed should external exposure to the active ingredient or degradates be reduced or eliminated. These studies are designed to help characterize how a pesticide active ingredient dissipates once it is released into the environment and to identify the major degradates that may result from these processes.
Degradation studies include hydrolysis, photodegradation in water, photodegradation in air, and photodegradation on soil. The hydrolysis study determines the potential of the pesticide to degrade from the influence of water alone. Photodegradation studies determine the potential to degrade in water, soil, or air when exposed to sunlight. During these studies, data are also collected concerning the identity, formation and persistence of major degradates.
Metabolism studies include aerobic soil metabolism, anaerobic soil metabolism, anaerobic aquatic metabolism, and aerobic aquatic metabolism. The soil microbial metabolism studies determine the persistence of the pesticide when it interacts with soil microorganisms under aerobic and anaerobic conditions. The aquatic metabolism studies produce similar data, but are generated by pesticide interaction with microorganisms in a water/sediment system. These studies also identify the significant degradates that result from biological degradation.
Mobility studies, which include leaching, adsorption/desorption, and volatility, provide information on the mode of transport and eventual destination of the pesticide in the environment. Scientists can predict the degree of pesticide mobility in soil from data generated from leaching and adsorption/desorption studies.
Bioconcentration studies in aquatic organisms are used to estimate the potential of a pesticide, under controlled laboratory conditions, to partition to the organisms from respiratory and dermal exposures. These studies also provide information on the degree to which bioconcentration of a pesticide or degradate can be reversed should pesticide levels in the surrounding aquatic environment be reduced.
Field studies which identify the environmental dissipation processes, assess the transformation, transport, and fate of a pesticide under actual use conditions with typically applied pesticide product at representative field sites. These studies characterize the relative importance of each route of dissipation of the pesticide and its major degradates. Data generated from field dissipation studies can provide more realistic estimates (albeit limited in time and space) of the persistence and transport of an active ingredient and its degradates when the pesticide product is applied under actual use conditions.
The Agency is proposing to revise the environmental fate data requirements. The Agency is proposing to expand the applicable use pattern for the aerobic soil metabolism, terrestrial field dissipation, and aquatic field dissipation studies. The ground water monitoring study would be added as a separate requirement in the table.
The Agency is also proposing to require independent laboratory validation of the environmental chemistry methods used to generate data associated with the dissipation studies. Two residue studies, confined and field rotational crops, would be moved to the residue chemistry data requirements (subpart O). The long-term soil field dissipation study would be merged with the terrestrial field dissipation study. The accumulation study in irrigated crops would be eliminated. Other changes include conditions under which the tests are required or in some circumstances not required, and clarification of test notes.
1.
2.
ii.
a. high persistence;
b. high mobility;
c. high potential to bioaccumulate;
d. high acute toxicity to aquatic organisms;
e. high potential for aquatic exposure.
iii.
The likelihood of a pesticide to leach to ground water is initially evaluated by considering the persistence and mobility of the chemical indicated in environmental fate laboratory studies and the field dissipation study required under part 158, and through use of a screening-level simulation model. When the potential for environmental risk is indicated, or cannot be evaluated definitively by this screening assessment, monitoring is used to evaluate the potential of a pesticide to contaminate ground water resources. The results of prospective ground water monitoring studies can provide evidence not available from laboratory studies that natural factors cause a pesticide to degrade without contamination of water resources. Alternatively, they can provide evidence to indicate that ground water contamination could result from use according to the pesticide label, and they can help to quantify the levels at which that can occur.
In providing answers about the potential of a pesticide to leach into ground water and the magnitude of contamination under the most environmentally vulnerable and typical use conditions, ground water monitoring data give risk managers the information they need to make appropriate regulatory decisions. Measured concentrations of pesticides in ground water from prospective ground water monitoring studies are used as screening estimates of potential drinking water exposure for human dietary risk assessments. These studies are also often the best tool with which to estimate pesticide concentrations in drinking water drawn from shallow private wells. Monitoring of private drinking water wells is not required under the Safe Drinking Water Act, and data are therefore scarce for most pesticides.
Under certain circumstances, the Agency also requires ground water monitoring in specified use areas in order to investigate the extent of ground water contamination from previous pesticide use. The use-specific and soil-specific data from field scale monitoring studies also are intended to provide verification for estimates from modeling used to predict the impact of long-term pesticide use on water quality in other use areas. The results of prospective ground water monitoring studies have been and will be used to develop and improve models which allow the Agency to better evaluate the leaching potential of pesticides when data are scarce.
If a pesticide is determined to have a strong potential to leach into ground water and in doing so, poses a risk to human health or the environment, the Agency intends to work with industry to develop the appropriate risk reduction and mitigation measures. Thus, in some cases, ground water monitoring would be required to confirm the effectiveness of these mitigation actions or any other regulatory measures and to elicit appropriate regulatory responses that effectively prevent pollution of ground water resources. The Agency believes that this study will be rarely required.
The Agency is also proposing to require independent laboratory validation of the environmental chemistry methods used to generate data associated with this study. As previously discussed, this evaluation will be used by the Agency reviewers to verify the results of the data submitted.
3.
ii.
iii.
iv.
v.
vi.
Note also that the Agency is reasserting that Anaerobic Soil Metabolism studies (guideline 835.4200) are required for terrestrial food crop, feed crop, and terrestrial nonfood uses. Due to a printing error, this data requirement was inadvertently omitted from the data tables in 1991 and subsequent publications of the CFR. This action would restore the data requirement in the table. The scope and nature of the requirement would not change.
vii.
viii.
a. The octanol/water partition coefficients of the pesticide/major degradates are less than 1,000 (indicative of a relatively low potential for accumulation in fish),
b. There are no potential exposures to fish and other nontarget aquatic organisms, or
c. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
ix.
x.
xi.
Residue chemistry data are used by the Agency to estimate people's dietary exposure to pesticide residues from food. The residue chemistry data base is designed to determine the composition of the pesticide residue and how much of that residue is present in the food people eat. Residue chemistry studies include those which define the nature of the residue,
In addition to dietary risk assessments, residue chemistry data are used to establish pesticide tolerances which, in turn, are used for enforcement purposes (see Unit XV.B. below). Therefore, methods for detecting the presence and amount of the residue are needed. Detection methods are used by EPA for study validation purposes, and by FDA, USDA, and the states for food inspection purposes.
EPA is proposing changes to the residue chemistry data requirements to better estimate dietary exposure to pesticide residues in or on food or feed, to more accurately assess and reassess tolerances and tolerance exemptions, and to provide additional tools for the enforcement of pesticide residue tolerances to ensure that food entering the commercial market meets the “reasonable certainty of no harm” standard under FFDCA. The Agency is proposing to codify data needs that have evolved since the 1984 regulations were issued, and clarify and simplify existing data requirements.
1.
2.
The residue chemistry data table has been modified to include general use patterns that include food uses, plus the residential outdoor use pattern. EPA is not proposing significant changes to the residue chemistry data requirements from those currently listed in part 158. Two data requirements would be added as separate requirements in the data table. These data (storage stability and multiresidue methods) have been imposed by the Agency on a case-by-case basis. The Reduction In Residue study is now called “anticipated residues;” a longstanding independent method validation is being proposed; and two residue studies, confined and field rotational crops, which were formerly environmental fate data requirements, would be moved to the residue chemistry data requirements. Other changes include changes in test substance, conditions under which the test is required, and clarification of test notes. These are not expected to substantively increase the nature or burden of the existing data requirement.
1.
2.
ii.
3.
The Agency is also proposing to change the test substance for this study from the pure active ingredient, radio-labeled (PAIRA) “and plant metabolites” to the PAIRA “or plant metabolite.” The test substance “metabolites” will be changed to “metabolite” to prevent dosing with more than one compound in any one study. This is needed because in studies involving simultaneous dosing with both the active ingredient and plant metabolites, it is impossible to determine the amount of metabolite due to active metabolism from that introduced through dosing. Simultaneous dosing with the active ingredient and any metabolites may not produce useful results, because the active ingredient and metabolites may have different metabolic pathways that cannot be differentiated. In most cases dosing with only the parent compound is necessary. However, in cases where plant and animal metabolites are found to differ, a separate study in which livestock are dosed with a unique plant metabolite may also be required.
The livestock metabolism study would be required when a pesticide is applied to livestock premises or is used in livestock drinking water. Such applications may result in both oral and dermal exposure of animals to the pesticide and, depending on the results, may precipitate magnitude of the residue studies to quantify the residues in meat, milk, poultry, and eggs. Finally, the Agency proposes to delete the conditional requirement for the nature of the residue in livestock study for residential outdoor uses since livestock are not found in this use pattern.
ii.
As part of this data requirement, the Agency is also proposing to require an independent laboratory validation of residue analytical methods to ensure the accuracy and reproducibility of data used for tolerance enforcement purposes. As previously discussed, this policy has been in place since 1988.
iii.
iv.
Unlike the livestock metabolism studies, however, livestock feeding studies are generally not required when residues are not demonstrated to be present in the feed. The Agency proposes to clarify that data generally are not required when:
1. Residues are not found on feed items or
2. Livestock metabolism studies indicate minimal transfer of the pesticide residue to tissues, milk or eggs. For those pesticides which leave non-detectable or low residues in feed items and for which the livestock metabolism study shows little transfer of radioactivity to tissues, the Agency may be able to conclude that data on the level of residues in livestock and their byproducts are not necessary.
v.
vi.
The Agency also proposes to add a test note to this study to address the need for residue data on acutely toxic pesticides in single servings of raw agricultural commodities. Most residue data provided to the Agency are based on composited samples. For example, 20 apples collected from different trees may be blended together prior to determining the pesticide residues. This procedure is adequate for estimating dietary risk from pesticides whose toxic effects arise from exposure over a long time period; however, data on composited samples may not be adequate for assessing acute risk from ingestion of single servings of a raw agricultural commodity bearing pesticide residues (
vii.
Individuals who handle pesticides are subject to potential risks stemming from pesticide exposure. Because of this, exposure data tailored specifically to address pesticide handlers are crucial. Pesticide handlers (
The current data requirements in part 158 do not contain studies to determine applicator exposure from pesticide use. The Agency, however, has long been aware of the necessity for applicator data to assess the risks from handling pesticides and has frequently asked for such data. In 1987, the Agency published guidelines for such studies. Since that time, applicator exposure studies have been requested when specific exposure and toxicity criteria triggers were met. Since EPA believes these data are essential for fulfilling its mandate to protect human health from pesticide risk, including aggregated and cumulative risks, it is proposing to make the applicator exposure studies a standard part of its regulatory data requirements.
EPA proposes to codify requirements for application exposure data in part 158 as a new subpart U. The purpose of codifying these data requirements is to assist pesticide registrants and others in determining which studies are required, and aid them in designing and conducting field studies that measure potential dermal and respiratory exposure to pesticides during handling activities. These test requirements cover exposure monitoring studies for people involved in mixing, loading, and applying pesticides; flagging during aerial applications; and other tasks, such as cleaning of equipment and spill cleanup that result in direct contact with pesticides. The requirements cover not only agricultural applicators, but other occupational applicators and residential applicators as well.
The Agency proposes to establish toxicity and exposure criteria for applicator exposure studies. These criteria are based on the toxicity of the active ingredient and the proposed exposure pattern of the product.
1.
Specifically, EPA is proposing that the toxicity criteria be based on the toxicity of the active ingredient. Applicator exposure monitoring data would be required, as determined by the Agency, if the active ingredient meets any of the following criteria:
i. Evidence of potentially significant adverse effects have been observed in applicable toxicity studies. For example, toxicity studies may indicate that the active ingredient is a possible or likely human carcinogen and that carcinogenic risk can be assessed using a linear extrapolation approach with a Q
ii. Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from handling of the pesticide. For example, EPA reviews data in the:
a. Office of Pesticide Programs Incident Data System reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers);
b. Toxic Exposure Surveillance System (a national data collection system of Poison Control Center data);
c. National Pesticide Information Center database (NPIC is a toll-free information service supported by the Office of Pesticide Programs that fields calls about human and animal incidents); and
d. California Department of Pesticide Regulation exposure incident database. California physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. CDPR has collected uniform data on suspected pesticide poisonings since 1982.
2.
Specifically, EPA is proposing the following exposure criteria. Data would be required, as determined by the Agency, if either of the following conditions is met:
i. Dermal exposure is likely to occur when used as directed on the label,
ii. Respiratory exposure is likely to occur when used as directed on the label.
Because these exposure scenarios are covered under the broad categories of occupational and residential, the table in § 158.1520 lists only these two use patterns.
The Agency may also require data when exposure is likely, when the pesticide is used in a commonly recognized and widespread manner. Thus, if the Agency knows that a
1.
2.
i.
ii
iii.
iv.
v.
3.
Surrogate applicator exposure data may adequately satisfy these data requirements under certain circumstances. Surrogate applicator data must be generated using comparable methods and under similar usage conditions as the product under review. Surrogate exposure data estimations must have adequate information to address handler exposure data requirements and must contain adequate replicates of acceptable quality data to reflect the specific use prescribed by the label, including formulation type, application equipment, methods and rates, personal protective equipment, engineering controls and other pertinent use directions or restrictions.
Surrogate data may be obtained from several reliable sources. For many years, the Agency has been expanding its Pesticide Handlers Exposure Database (PHED) which provides surrogate data for a wide variety of handler exposure scenarios. PHED is a generic database containing measured exposure data for persons involved in the handling or application of pesticides in the field and contains data for over 2000 monitored exposure events. Users can select data from each major PHED file (
Some surrogate data for outdoor pesticide applications in residential settings (occupational and residential handlers) also is available through the Outdoor Residential Exposure Task Force. The Task Force has submitted data to the Agency on mixer, loader, and applicator exposures during use of several types of equipment typically found in residential settings. The Agency may accept surrogate exposure data estimations from NIOSH, OSHA,
EPA is proposing today a major restructuring of current part 158 for clarity and comprehensibility, but is not proposing substantive revisions to all portions of current part 158. Several specific sections of part 158 may be revised in the future, including the following:
• Section 158.440 Spray drift data requirements
• Section 158.640 Product performance data requirements
• Section 158.690 Biochemical pesticide data requirements
• Section 158.740 Microbial pesticide data requirements
In addition, the Agency intends later to propose other changes to current part 158, including the creation of separate subparts to address data requirements for the registration of antimicrobial pesticide products and biochemical and microbial pesticide products.
In order to accommodate the restructuring of part 158 without creating confusion for readers of this proposal, EPA proposes to revise the Table of Contents for part 158 to include the future subpart designations for these sections, and to add and reserve the appropriate subparts in the revised part 158. The regulatory text of the sections for which no change is proposed is not reprinted in this proposal, and EPA is not requesting comment on any aspect of those unchanged data requirements.
If EPA does not issue these other proposals before this proposal is issued in final form, EPA will transfer the contents of the current part 158 that are not specifically addressed in this proposal into their new subparts, essentially unchanged. This step will be necessary because at that time subpart D which currently contains the sections will be redesignated to contain only product chemistry data requirements.
At the same time, EPA expects to make needed technical revisions to accommodate the new structure of part 158, without changing the substance of the data requirements. For example, section numbers will be assigned within the new subpart; cross-references will be updated; and footnotes will be restructured as test notes and given Arabic numerals,
In 1988, Congress directed the National Academy of Sciences to study the vulnerability of infants and children to dietary pesticides. The National Research Council was charged with “examining scientific and policy issues faced by government agencies, particularly EPA, in regulating pesticide residues in foods consumed by infants and children.” In so doing, the NRC was asked to:
• Examine the adequacy of current risk assessment policies and methods;
• Assess information on the dietary intakes of infants and children;
• Evaluate data on pesticide residues in the food supply;
• Identify toxicological issues; and
• Develop relevant research priorities.
The Council reviewed current EPA practices and data requirements related to dietary risk assessment as well as testing modifications planned by the Agency. In 1993, the NRC issued a report (Ref. 1) entitled, “Pesticides in the Diets of Infants and Children.” The panel of experts concluded that, at that time, EPA approaches to data requirements and risk assessments emphasized the evaluation of the effects of pesticides in mature animals and, in general, there was a lack of data on pesticide toxicity in developing organisms.
The Council was not specifically charged with evaluating the data requirements as proposed today. Nonetheless, the Council made recommendations with respect to regulatory needs for data development that EPA is today proposing:
• The report stated the need to investigate the effects of pesticide exposure on immunotoxic responses in infants and children. “Analysis of the impact or toxicity of agricultural chemicals on the immune system is essential. Regulatory development of a battery of consensus tests is critical to protect the developing immune system.” (Ref. 1, p. 110).
• The report supported the Agency's proposed requirement for acute and subchronic neurotoxicity testing for pesticides and “encourages the agency to make this a general requirement for all food-use pesticides.” (Ref. 1, p. 156).
• The report strongly encouraged further work in the area of developmental neurotoxicity. “Neurodevelopmental effects must be part of the battery of end points evaluated for toxicants.... Regulatory development of a battery of consensus tests will be .... necessary to ensure public confidence.” (Ref. 1, p. 110).
• The report suggested that the Agency impose a requirement for developmental toxicity for all classes of pesticides registered for food uses. “A modified reproductive/developmental toxicity study in the rat is suggested for registration of all food-use pesticides.... the committee recommends that this study be made a requirement for registration for all food-use pesticides.” (Ref. 1, p. 155)
Other recommendations by the Council included an
In 1994, EPA held a 2-day meeting of the SAP to review the Agency's proposed amendments to the data requirements for pesticide registrations contained in 40 CFR part 158. The SAP was asked to comment on each data requirement and identify, in their opinion, which ones were necessary to fully and thoroughly evaluate the potential hazard of a chemical compound and which ones were not intrinsically useful in providing practical scientific information. The revisions presented to the Panel,
1.
2.
For the few studies the SAP did not endorse, the Panel could not find a significant scientific justification for the routine use of the data. For example, due to increased concerns about the potential effects of pesticides on the visual system, special visual system testing was suggested by the NRC as a data requirement. The Panel, however, concluded that there was insufficient scientific evidence to require special visual system testing. After reviewing its toxicology data base, at that time, for visual effects,
Similarly, the SAP did not recommend additional testing on
In 1998, EPA presented the SAP an issues paper on the use of the FQPA safety factor to address the special sensitivity of infants and children to pesticides. Here the Agency presented the Panel another, and more detailed, discussion of the toxicology data base, especially in regard to developmental neurotoxicity testing criteria and requirements. The developmental neurotoxicity study specifically was put in the context of the appropriateness of a possible additional safety factor. At that time, the SAP did not reach a consensus on whether this study should be routinely or conditionally required. The issue of what is a complete and reliable data set was brought before the SAP again in May 1999. The majority of the Panel supported the Agency's approach to applying data requirements but advised the Agency to revisit the first tier toxicology data base every few years to update data requirements as needed. The Panel also agreed with the Agency in the need to require the neurotoxicity battery of studies, including developmental neurotoxicity testing, for new conventional high exposure,
3.
4.
Working in collaboration with Health Canada, and OECD, EPA drafted guidelines for post-application exposures studies. They were peer-reviewed by EPA's Office of Research and Development, the California Department of Pesticide Regulation, representatives from academia, and the American Crop Protection Association. The Agency presented its post-application exposure guidelines and standard operating procedures to the SAP in 1998 and again in 1999. In 1999, the SAP approved and commended the Agency for making significant strides toward developing scenario-based residential and non-occupational exposure assessments that are sufficiently conservative as to not underestimate exposures. (Ref. 11)
5.
6.
EPA is working closely with other countries toward greater uniformity in testing, reviewing and evaluating pesticides. The benefits of international regulatory cooperation on pesticides are potentially great: improved science through greater information exchange, and reduced regulatory and resource burdens on national governments and regulated parties through harmonized pesticide registration review. Over the last several years, substantial progress has been made toward international cooperation on pesticide regulatory review. Member countries of the OECD, including the United States, have agreed upon harmonized guidance for the formats of industry data submissions (dossiers) and country data review reports (monographs). Countries now frequently exchange pesticide reviews or consult with one another on key technical aspects of a review. EPA has worked jointly with Canada, dividing up detailed evaluation work on a number of pesticides. The Agency has entered into information exchange and comparative review arrangements on a pilot basis with other countries, as well. The objective of these work sharing arrangements has been to pool scientific knowledge and to use resources in the most efficient way possible.
As the international regulatory community works toward greater harmonization on pesticide review, attention has turned to data requirements, how they compare from one country to another and what can or should be done to establish common requirements. To the extent that data requirements for pesticide registration are similar, sharing reviews and comparing evaluations is easier and more meaningful. Establishing similar requirements also can reduce the resources that must be spent to conduct testing. Requirements that differ considerably from one country to another can mean that registrants who are looking to register a pesticide in more than one country must conduct many different studies to satisfy all the various national requirements.
The United States and Canada have worked together to harmonize data requirements across all disciplines. Data requirements and protocols for the two countries have been carefully compared. The data requirements proposed in this document represent U.S. national requirements but they reflect extensive consultation with Canada and are harmonized with Canada's requirements to a high degree. The two countries plan to continue to work together to keep data requirements for all disciplines as similar as possible.
OECD Member countries have had discussions about harmonizing data requirements within the OECD community. The pesticide industry took on the complex task of looking at data requirement differences among Member countries to identify areas that might benefit from harmonization. They presented their preliminary findings to the OECD Working Group on Pesticides meeting in June 2001. They reported, consistent with the positions of scientific reviewers in OECD Member countries, that toxicology data requirements are quite similar across countries. Issues can arise sometimes, however, because study protocols or guidelines used to generate the studies to meet the requirements are not always harmonized. In other words, a particular study requirement might be the same from one country to the next, but the study submitted to meet the requirement can run into problems if done according to a protocol that is acceptable in one country but not another. Overall, however, it appears that reasonable harmonization has been achieved for toxicology studies done according to OECD Guidelines revised since 1997. This does not mean that there is no room for additional harmonization work on toxicology data requirements and study guidelines, but rather that there are other testing areas where there is much less consistency on data requirements and study protocols across countries.
Ecotoxicological and environmental fate studies present a particular challenge for harmonization. Data requirements in these areas can differ considerably from one country to another depending upon how countries' tiered approaches to data requirements are applied. National data requirements have to be tied to national use patterns and environmental and ecological conditions. A reliable environmental hazard assessment, for example, must be based on studies that accurately reflect the climate, soil types and agricultural practices of the country doing the assessment. Because ecological and environmental studies must be representative of national conditions to adequately support national risk assessments, harmonization of data requirements and study protocols for these types of studies can be difficult. Harmonization can require extensive dialogue between scientists to determine which data requirements can act as common requirements. Harmonization can also involve protocol/guideline development or revisions in order for the studies produced to meet common data requirements to be widely accepted.
In the United States, all research with human subjects conducted or supported by the Federal government is governed by a set of regulations referred to as the Common Rule. The Common Rule contains requirements designed to protect human subjects of research and to ensure that they are treated ethically. EPA, along with 16 other federal departments and agencies, promulgated the Common Rule in 1991. See 40 CFR part 26 (EPA's Common Rule). In all of the scientific research with human subjects conducted or supported by EPA, the Agency has been and remains committed to full compliance with the Common Rule
Both the current version of part 158 and the version of part 158 being proposed contain requirements for the conduct of studies that involve testing with human participants. These studies include: metabolism and pharmacokinetic studies, biological monitoring studies, human exposure studies, and insect repellent efficacy studies. It should be noted that neither the current nor proposed version of the part 158 contains a provision that requires testing of human participants in a study designed to identify or quantify a toxic endpoint. If studies required under part 158 were conducted or supported by EPA (or another Federal agency), they would be subject to the Common Rule. Although the Common Rule applies only to research conducted or supported by Federal agencies, EPA recognizes that many public and private research and academic institutions and private companies, both in the United States and in other countries, including non-federal U.S. and non-U.S. governmental organizations, have their own specific policies related to the protection of human participants in research.
EPA has been considering its policies and rules regarding the conduct of studies involving human participants by organizations that are not part of the Federal government and that do not receive support from a Federal agency. (These are referred to as “third party” researchers). On February 8, 2005 (70 FR 6661)(FRL-7695-4), EPA issued a
The Health and Environmental Sciences Institute (HESI)/International Life Sciences Institute initiated a project in 2001 titled “Developing Strategies for Agricultural Safety Evaluation.” The purpose of this project was to bring together scientific experts from government, academia and industry, including the international community to determine whether the current testing paradigm for pesticide chemicals could be made more efficient and accurate. Agency scientists from EPA's Office of Pesticide Programs and Office of Research and Development are involved in this project. The HESI technical work groups have developed a tiered approach that takes into account the toxicological properties and the use pattern of the chemicals, and attempts to minimize the number of animals necessary to produce a thorough health assessment of the chemicals of interest. The HESI reports are anticipated to be submitted for publication in the
Information on the HESI project can be found at the following website:
The Agency is committed to the development and use of alternative approaches to animal testing. The Agency understands many people's concern about the use of animals for research and data development purposes. EPA has received comments concerning the use of new and revised test methods which would reduce the number of test animals in studies, or refine procedures to make them less stressful to animals. Where testing is needed to develop scientifically adequate data, the Agency is committed to reducing or replacing, wherever possible, the number of animals used for testing by incorporating
Taking into consideration principles of sound science and the requirements of FIFRA to protect humans (including sensitive subpopulations) and the environment from unreasonable uncertainty of no harm from pesticide exposure, the Agency is committed to avoiding unnecessary or duplicative animal testing. For example, currently EPA accepts data on the pH of a chemical as a screen to judge whether the chemical may be corrosive to the eye or skin. Making this determination avoids actual testing on animals. Many long-term studies can be combined so that several toxicological end-points can be discerned from fewer studies. The Agency already has bridging and batching policies in place to allow the use of acute toxicity, sensitization, or irritation test data on products to be used to support other products. At EPA's initiative, these policies have been incorporated into the new Globally Harmonized System for Classification and Labeling.
The Agency plays an important role in the Federal Interagency Committee for the Validation of Alternative Methods (ICCVAM) (
1. Encourage the reduction of the number of animals used in testing.
2. Seek opportunities to replace test methods requiring animals with alternative test methods when acceptable alternative methods are available.
3. Refine existing test methods to optimize animal use when there is no substitute for animal testing.
Guideline 870.1100 references the use of appropriate alternative test protocols as a means of reducing the number of animals used to evaluate acute effects of chemical exposure. Yet the Agency and the scientific community also recognize that test guidelines are designed to be updated and supplemented frequently. As new tests and test batteries are validated, the Agency presents them to the SAP. The Agency considers the SAP's determination of the reliability of the test guidelines and their applicability to meeting its regulatory needs under FIFRA. After SAP review, the Agency is planning to incorporate validated
Table 3 contains a line-by-line listing of every data requirement contained in current part 158, as well as new requirements proposed today, organized in the order of the proposed new subparts D through U. Columns 1 and 2 contain Pesticide Assessment Guideline numbers and current titles, respectively. Columns 3 and 4 contain OPPTS Harmonized Guidelines numbers and proposed titles, respectively. Column 5 contains an explanation of the changes proposed for each requirement, or that no change is proposed.
EPA invites you to provide your views on the various options as proposed, other approaches, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final rule. In addition, the Agency welcomes specific comments on the following topics of particular interest to the Agency:
1.
2.
3.
4.
5.
6.
The Agency has 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 listed in the “EDOCKET” index available at
1. National Research Council, “Pesticides in the Diets of Infants and Children,” National Academy Press, Washington, D.C., 1993.
2. Mineau et al., 2001. Pesticide Acute Toxicity Reference Values for Birds,
3. U.S. Environmental Protection Agency. 1998. EPA's Contaminated Sediment Management Strategy. EPA-823-R-98-001. Office of Water, 4305, Washington, D.C.
4. Bennett et al., Overview of Methods for Evaluating Effects of Pesticides on Reproduction in Birds., U.S. EPA, Environmental Research Laboratory, Corvalis, OR., EPA 600/3-91/048.
5. Bennet et al., 1990. Effects on the Duration and Timing of Dietary Methyl Parathion Exposure on Bobwhite Reproduction,
6. Bennett et al., 1991. Effects of Dietary Exposure to Methyl Parathion on Egg-laying and Incubation in Mallards,
7. Luster et al., 1992. Risk Assessment in Immunotoxicology I. Sensitivity and Predictability of Immune tests,
8. Luster et al., 1993. Risk Assessment in Immunotoxicology II. Relationships Between Immune and Host Resistance Tests,
9. USEPA (1990) 1990 OECD Ad Hoc Meeting on Neurotoxicity Testing. Summary Report. September 1990. Eastern Research Group, MA.
10. Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington D.C, February, 2002.
11. FIFRA Scientific Advisory Panel. SAP Report No. 99-03, May 25, 1999 FIFRA Scientific Advisory Panel Meeting, May 25-27, 1999, held at the Sheraton Crystal City Hotel, Arlington, Virginia.
12. ILSI (2001) Developing strategies for agricultural chemical safety evaluation, a report from an April 22-23, 2001 workshop. ILSI Health and Environmental Sciences Institute.
13. USEPA (U.S. Environmental Protection Agency), Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Series 84, Mutagenicity, Addendum 9, Office of Pesticides and Toxic Substances, EPA-540/09-91-122, NTIS Publication No. PB91-158394, Washington, DC, 1991.
14. K. Dearfield, A. Auletta, M. Cimino and M. Moore, Considerations in the U.S. Environmental Protection Agency's testing approach for mutagenicity, Mutation Research 258 (1991) 259-283.
15. USEPA (U.S. Environmental Protection Agency), Guidelines for mutagenicity risk assessment, 51 FR 34006-34012 (1986).
16. Dourson, M.L., Knauf, L.A., and Swartout, J.C. (1972). On Reference Dose (RfD) and its underlying toxicity data base. Toxicology and Industrial Health 8:171-189.
17. Health Canada, Pesticide Management Regulatory Agency (1997) Reproductive Toxicity Testing in Proposed 40 CFR part 158, Subdivision W - Data Requirements for Antimicrobial Pesticides. November 1997 draft. Attachment to memorandum from Don Grant (PMRA) to Norm Cook/Tim McMahon/Sue Makris (USEPA/OPP), December 1, 1997.
18. Spielmann, H., and Gerbracht, U. (2001). The use of dogs as second species in regulatory testing of pesticides. Part II: subacute, subchronic and chronic studies in the dog.
19. U. S. EPA, 2004. “Economic Analysis of the Proposed Rule Changing Data Requirements for Conventional Pesticides,” BEAD/OPP/USEPA, Washington, DC. Document ID No. 2004-0387-00.
In accordance with FIFRA sec. 25(a), this proposal was submitted to the FIFRA SAP, the Secretary of Agriculture, and appropriate Congressional Committees. The SAP has waived its review of this proposal, and no comments were received from any of the Congressional Committees. USDA participated fully in the OMB interagency review process, and where warranted, changes were made to the proposal based upon its comments.
Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) determined that this proposed rule is a “significant regulatory action” under sec. 3(f) of the Executive Order because this action might raise novel legal or policy issues or otherwise have a potentially significant impact on pesticide producers or registrants of pesticide products. As a result of this OMB determination, EPA submitted this proposed rulemaking to OMB for review under Executive Order 12866 and any changes made in response to OMB comments have been documented in the public docket for this rulemaking as required by sec. 6(a)(3)(E) of the Executive Order.
EPA has prepared an economic analysis of the potential costs associated with this proposed action, which is contained in a document entitled “Economic Analysis of the Proposed Rule Changing Data Requirements for Conventional Pesticides” (Ref. 19). A copy of this Economic Analysis is available in the public docket for this action, and is briefly summarized here.
The cost of the proposed rule is calculated as the estimated costs for the
Using the currently codified requirements as the baseline for the impact analysis, the total annual impact to the pesticide industry is estimated to be about $51 million. Of this estimated total annual impact, about $28.9 million per year represents the cost of new data requirements that were imposed over the years but were not specified in the existing part 158, and about $21.6 million represents the cost of modified or expanded existing data requirements (
To calculate the potential costs associated with this proposal, EPA first identified the test necessary to generate the data required, and then gathered information on the price that laboratories might charge a firm to conduct that test for the firm. We assumed that the data required would always need to be generated, but often the data are already available because the firm generated it for their own use. In such cases, the firm would simply need to submit those data to EPA, which involves less burden and cost than generating it. Some firms may have surrogate data that could be used, while others may qualify for a waiver. Both of which also involve less costs than generating the data anew. For each test identified, we averaged the low and high cost estimates provided by the various laboratories. Variations can be related to differences in the assumptions about the test performed (
EPA then used historical data on pesticide registration actions that occurred over a 7 year period (1996-2002) to identify the entities that sought pesticide registration actions in the past. The data required for each registration action depends on several factors, including the type of registration action (
The Agency prepared an industry profile using the same historical data on pesticide registration actions to identify the companies involved in those actions, and based it on public information gathered about those companies. EPA also used this industry profile to analyze the potential impacts of the proposed rule on small businesses, the results of which are summarized in Unit XXVII.C. The incremental costs, and a more detailed discussion of the estimating methodology employed in the analysis are presented in the economic impact analysis prepared for this proposed rule (Ref. 19).
Since the likely overall impact of this proposal on businesses is small, the Agency believes that a deleterious effect on the availability of pesticides to users is unlikely. On balance, the Agency believes that the costs of the rule are justified by the benefits from enhanced protection of human health and the environment.
The data requirements in part 158 potentially apply to new pesticides submitted for registration, to new uses of currently registered pesticides, and to existing chemicals whose databases are subject to Agency review to determine if they continue to meet registration standards. For these existing chemicals, part 158 data requirements are potentially relevant to three review programs.
Reregistration (mandated in 1988) and tolerance reassessment (mandated in 1996) are well underway. Data requirements under those programs have largely been imposed on registrants of existing chemicals, and the data have been submitted. EPA anticipates that by the time this proposed rule is promulgated, few of the data requirements will remain to be imposed for existing chemicals. Only those that are “new” or “newly codified ” (
Should such data be needed for reregistration or tolerance reassessment after promulgation of this rule, EPA anticipates that it will articulate the specific burden and costs associated with each DCI pursuant to the appropriate Information Collection Request (ICR) approvals under the Paperwork Reduction Act (PRA). Since the approval process for the PRA requires that EPA characterize the information collection burdens and costs incurred by registrants to comply with a DCI, a complete estimate of the burden and costs for the DCIs will be provided at that time. EPA believes that the public process associated with the PRA approval for the DCI related ICRs is a reasonable way to account for the data costs without double counting the burden. Accordingly, in this proposal EPA has not evaluated the potential burden of the proposed data requirements on registrants of existing chemicals.
A third program, registration review, mandated in 1996, requires that EPA establish a program for the periodic review of existing chemicals (goal is every 15 years). Any data requirements to be levied under that program will also be imposed under a DCI. At this time, EPA is developing a proposed rule to establish procedures for this program. An Advance Notice of Proposed Rulemaking was published in the
The data requirements in this proposed rule are expected to apply to all chemicals subject to registration review (
Accordingly, EPA intends to describe generally the burden and costs of potential data requirements at the time the registration review rule is proposed, and ultimately, to more accurately and fully characterize the individual DCI burden and costs during the public process associated with PRA approval.
Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
EPA has determined that this proposed rule imposes no significant additional information collection and paperwork burden. The information collection activity contained in this proposed rule,
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 special review are currently approved under OMB Control No. 2070-0057 (EPA ICR No. 0922).
These existing ICRs cover the paperwork activities contained in this proposal because these activities already occur as part of the Agency's existing program activities. These program activities are an integral part of the Agency pesticide program and the corresponding ICRs will continue to be regularly renewed pursuant to the PRA. The approved burden in these ICRs were already increased in 1996 to accommodate the potential increased burden related to the implementation of the new safety standard imposed in 1996 by FQPA.
The total estimated 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.
Comments are requested on the Agency's need for this information, the accuracy of the burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. The Agency is particularly interested in receiving comment on the estimated testing costs and burdens that are presented in the Economic Analysis, as well as suggestions for how the Agency might best be able to provide updated and more detailed estimates in the context of the individual ICRs during the regular renewals of those ICRs every 3 years. Send comments to EPA as part of your overall comments on this proposed action in the manner specified in Unit I.C. In the final rule, the Agency will address any comments received regarding the information collection requirements contained in this proposal.
Pursuant to sec. 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601
As part of the economic analysis prepared for this rulemaking, EPA used historical data to prepare an industry profile of potentially impacted entities prepared for the economic analysis for this rulemaking, EPA determined that this proposed rule is not expected to impact any small not-for-profit organizations or small governmental jurisdictions. As such, the small entity impact analysis prepared as part of the economic analysis evaluated potentially impacted businesses that could be considered small businesses as defined by the Small Business Administration, which uses the maximum number of employees or sales for businesses in each industry sector, as that sector is defined by NAICS. For example, entities defined as Pesticide and Other Agricultural Chemical Manufacturing (325320) are considered to be a small business if they employ 500 or fewer people.
Although, as illustrated by the industry profile, the conventional pesticide industry is primarily composed of large, multi-national corporations, EPA used historical data to evaluate potential impacts on small firms that could be subject to the proposed requirements.
To determine the universe of small entities that could be subject to the proposed requirements, the Agency used workforce data to determine the size for 565 firms for which financial data had been gathered for the economic analysis. Based on that data, EPA determined that 449 qualified as small businesses using the SBA definition. Using the resulting ratio of 79%, the Agency estimated that out of the total 1804 firms in the pesticide industry, approximately 1434 firms might qualify as small and could make up the universe of small entities that could be subject to the proposed requirements.
EPA then used historical data to estimate the number of small entities potentially impacted, and the extent of that potential impact. EPA used workforce data gathered on 120 firms identified as impacted by the proposal using historical data to determine the size of 97 firms. Based on that data, we determined that 49 firms of the 97 firms (51%) qualified as small businesses.
EPA is particularly interested in receiving comment from small businesses as to the benefits, costs and impacts of this proposed rule. Any comments regarding the estimated potential small entity economic impacts that this proposed regulatory action may impose on small entities should be submitted to the Agency in the manner specified in Unit I.
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 XXVII.A., the annual costs associated with this action are estimated to total $51 million. This cost represents the incremental cost to applicant and registrants attributed to the additional or modified data requirements contained in this proposal. In addition, since State, local, and tribal governments are rarely a pesticide applicant or registrant, the proposed rule is not expected to significantly or uniquely affect small governments. Accordingly, this action is not subject to the requirements of secs. 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 (
This proposed 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
Administrative practice and procedure, Agricultural commodities,
Therefore, it is proposed that chapter I of title 40 of the Code of Federal Regulations be amended as follows:
1. In part 152:
a. The authority citation continues to read as follows:
7 U.S.C. 136-136y. Subpart U is also issued under 31 U.S.C. 9701.
b. In § 152.50, by amending paragraph (f)(1) by revising the reference “FIFRA sec. 3(c)(1)(D)” to read “FIFRA sec. 3(c)(1)(F),” and by revising paragraph (f)(2) to read as follows:
(f) * * *
(2) An applicant must furnish any data specified in part 158 of this chapter that are required by the Agency to determine that the product meets the registration standard of FIFRA sec. 3(c)(5) or 3(c)(7), as applicable, and FIFRA sec. 10. An applicant may request a waiver of any data requirement by following the procedures in § 158.45 of this chapter. Each study must comply with:
(i) Section 158.32 of this chapter, with respect to format of 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.
2. In part 158:
a. By revising the authority citation to read as follows:
7 U.S.C. 136-136y; 21 U.S.C. 346a.
b. By revising the table of contents for part 158 to read as follows:
c. By revising subpart A to read as follows:
(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.
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, amended registration, or reregistration
(2) An application for an experimental use permit under FIFRA sec. 5.
(3) An application for an exemption under FIFRA sec. 18.
(4) A petition or other request for establishment or modification of a tolerance, for an exemption for the need for a tolerance, or for other clearance under FFDCA sec. 408.
(5) A submission of data in response to a notice issued by EPA under FIFRA sec. 3(c)(2)(B).
(6) Any other application, petition, or submission sent to EPA intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide.
(7) For the purposes of this part, an applicant includes a registrant.
(a) This subpart describes the data that are required to support the registration of each pesticide product. The information specified in this part must be submitted with each application for new or amended registration or for reregistration, if it has not been submitted previously or if the previously submitted information is not complete and accurate.
(b) The requirements of this part apply to the following applicants:
(1) Any person who submits an application for a new or amended registration in accordance with FIFRA sec. 3.
(2) Any person who submits an application for an experimental use permit in accordance with FIFRA sec. 5.
(3) Any person who petitions the Agency to establish, modify, or revoke a tolerance or exemption from a tolerance in accordance with FFDCA sec. 408.
(4) Any person who submits data or information to support the continuation of a registration in accordance with FIFRA sec. 3 or 4.
(a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgements for pesticide products. EPA maintains its authority to tailor data needs to 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)
(i) Registration, amended registration or reregistration.
(ii) Experimental use permit.
(iii) Data Call-in.
(iv) Establishment, modification or revocation of a tolerance or exemption.
(v) Submission of adverse effects information under FIFRA sec. 6(a)(2).
(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 submitted study, full identification of the other study with which it should be associated in review.
(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.
(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.
(3) Information designated as releasable to state or foreign governments in accordance with paragraph (c)(4) of 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.
(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.
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.
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 the 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 believes the data requirement should be waived. In addition, the applicant must describe any unsuccessful attempts to generate the required data, furnish any other information which the applicant(s) believes would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement.
(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
(a)
(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 of the pesticide.
(a)
(b)
d. By revising subpart B to read as follows:
(a)
(1) Terrestrial food crop use.
(2) Terrestrial feed crop use.
(3) Terrestrial nonfood crop use.
(4) Aquatic food crop use.
(5) Aquatic nonfood residential use.
(6) Aquatic nonfood outdoor use.
(7) Aquatic nonfood industrial use.
(8) Greenhouse food crop use.
(9) Greenhouse nonfood crop use.
(10) Forestry use.
(11) Residential outdoor use.
(12) Residential indoor use.
(13) Indoor food use.
(14) Indoor nonfood use.
(15) Indoor medical use.
(b)
(c) Applicants unsure of the correct use category for their particular product should consult the Agency.
Some data and information specified in this part are required (R) for the evaluation of some or all types of products. However, other data and
(a) Data designated as “required” (R) for products with a given use pattern are required by EPA to evaluate the risks or benefits of a product having that use pattern. Further clarification of the applicability of the data requirement often is located in the test notes accompanying the table.
(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.
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. Brackets indicate which data requirements also apply to experimental use permits (EUPS).
(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 covers 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. For toxicology studies, if the data are intended to support a manufacturing-use product, use the first column. If the data are intended to support an end-use product, use the information listed in the second column.
(ii) The test substances columns specify which substance is to be subjected to testing. Applicants should note that the substance that should 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 last column. See § 158.70(c) for information pertaining to the guidelines and how to obtain copies.
(a)
(b) [Reserved].
(c)
(2) Information on the chemical identity and composition of the pesticide product, the amounts, frequency and time of the pesticide application, and results of test 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.
(d)
(2)
(3)
(4)
(5)
(6)
(e)
(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, oncogenicity, and possibly, other health effects.
(6)
(f)
(g)
(h)
(2)
(3)
(i)
e. By removing and reserving subpart C.
f. By revising subpart D to read as follows:
The following terms are defined for the purposes of this subpart:
(a)
(2) Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
(3) All product chemistry data, as described in this section, are required to be submitted to support a request for an experimental use permit.
(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 is required only if the active ingredient is expected to come in contact with either material during storage.
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. True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
23. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
24. Required for water insoluble test substances (
25. Required for all organic chemicals unless they dissociate in water or are partially or completely soluble in water.
26. Not required for salts.
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 contains 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 in the product.
(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 him), concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.
(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 form 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 provide a preliminary analysis of each technical grade of active ingredient contained in the product to identify all impurities present at 0. 1 percent or greater of the technical grade of the active ingredient. The preliminary analysis should be conducted at the point in the production process after which no further chemical reactions designed to produce or purify the substances are intended.
(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, unless the product label bears a statement prohibiting use after a certain date, in which case 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.
g. By adding subpart E to read as follows:
(a)
(b)
(2) Data are also required for the general use patterns of aquatic food crop, aquatic nonfood residential, aquatic nonfood outdoor, forestry and residential outdoor use.
(3) In general, for all outdoor end-use products including turf, the following studies are required: two avian oral LD
(c) Key: R=Required; CR=Conditionally required; NR=Not required; [ ]=Required or conditionally required for an experimental use permit; TGAI=Technical grade of the active ingredient; TEP=Typical end-use product; PAI=Pure active ingredient; Commas between the test substances (
(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 not required for liquid formulations for greenhouse and indoor uses. Study not required if there is no potential for environmental exposure.
3. Data using the TEP are conditionally required based on the results of the avian acute oral (TGAI) and avian subacute dietary tests, intended use pattern, and environmental fate characteristics that indicate potential exposure.
4. Data are preferred on redwing blackbird (
5. Data are preferred on mallard and bobwhite quail.
6. For aquatic nonfood residential uses, data are required to support liquid and solid formulated products on one species if the avian oral LD
7. 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.
8. Tests are required based on the results of lower tier studies such as acute, subacute or reproduction bird and mammal testing, intended use pattern, and environmental fate characteristics that indicate potential exposure.
9. 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.
10. Data are preferred on rainbow trout and bluegill for terrestrial, aquatic, forestry, and residential outdoor uses. For indoor and greenhouse uses, testing with only one of either fish species is required. Generally, a second species will not be required for indoor and greenhouse use if the selected species LC
11. Freshwater fish LC
i. The end-use pesticide will be introduced directly into an aquatic environment (
ii. The maximum expected environmental concentration (MEEC) or the estimated environmental concentration in the aquatic environment is equal to or greater than one-half the LC
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.
12. Data are preferred on
13. Data are preferred on eastern oyster (
14. Data are generally not required for other, non-turf, outdoor residential uses,
15. Data are preferred on rainbow trout. If fathead minnow (
16. Data are preferred on oppossum shrimp (
17. Data are required on estuarine species if the product is:
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 in water is equal to or greater than 0.01 of the acute EC
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 (
18. Data are preferred on sheepshead minnow (
19. Data are required on estuarine 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.
20. Data are required 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 [See Hazard Evaluation Division Standard Evaluation Procedure Ecological Risk Assessment (EPA-540/09-86-167)] is greater than or equal to 0.1 of the no-observed-effect level in the fish early life-stage or invertebrate life-cycle test;
ii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
21. Required based on the results of fish or aquatic nontarget organism accumulation studies (guidelines 850.1730 and 850.1950).
22. Tests 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.
23. Testing is required if the soil partition coefficient (K
24. Testing is required if:
i. The estimated environmental concentration is equal to or greater than the acute sediment EC
ii. The soil partition coefficient (K
(iii) The half-life of the pesticide in the sediment is greater than 10 days in either the aerobic soil or aquatic metabolism studies. Registrants should consult with the Agency on appropriate test protocols.
25. Data required only when the formulation contains one or more active ingredients having an acute LD
26. 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 arthropods other than bees that indicate potential chronic, reproductive, or behavioral effects.
27. This requirement is reserved pending further evaluation by EPA to determine what and when data should be required, and to develop appropriate test methods.
h. By adding subpart F to read as follows:
(a)
(b)
(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.
(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 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 (
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. Additional measurements such as cholinesterase activity for certain pesticides,
8. Required in rat for nonfood use pesticides if oral exposure could occur, such as through drinking water.
9. A 90-day range-finding study in both rats and mice is required to determine 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.
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.
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,
15. Required if results of acute neurotoxicity study (guideline 870.6100) 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 (guideline 870.6200).
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 be established.
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. Chronic rodent feeding study (food use) - 24 months.
ii. Chronic rodent feeding study (nonfood use) - 12 months.
iii. Chronic nonrodent feeding study - 12 months.
iv. Mouse carcinogenicity study - 18 months.
v. 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 time, duration, or magnitude of exposure.
ii. The use requires a tolerance or an exemption from the requirement of a tolerance be established.
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 (guideline 870.3100) conducted in the same species may be required.
22. Testing in two species is required for all uses.
23. Unless the chemical or physical properties of the test substance, or the pattern of exposure, suggest a more appropriate route of exposure, the oral route, by oral intubation, is preferred.
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 two-generation reproduction study in rodents (870.3800) by utilizing a second mating of the parental animals in either generation. The dams are to undergo a cesarean section at one day prior to expected delivery date and evaluated separately as specified in guideline 870.3700.
26. 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.
27. A DNT would be required using a weight-of-the-evidence approach when:
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/or postnatal exposure (
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 (
28. The use of a combined study that utilizes the two-generation reproduction study in rodents (870.3800) as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is encouraged.
29. 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.
30. 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
ii.) CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
31. Choice of assays. Assays using rodent bone marrow, using either metaphase analysis (aberrations), or micronucleus assay are preferred.
32. 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.
33. 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.
34. Required if toxic effects are identified in the oral or inhalation study. A risk assessment assuming that dermal absorption is equal to oral absorption must be performed to determine if the study is required, and to identify the doses and duration of exposure for which dermal absorption is to be quantified.
35. May be required based on adverse effects seen in the acute or subchronic neurotoxicity screening studies, or other studies, or if the test substance is structurally related to a chemical known to cause effects best assessed by these studies.
For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.820, § 158.1110, and § 158.1420) studies. The options in this paragraph do not apply to pesticides used in or on food. 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
(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 (guidelines 870.1100 - 870.2600)
(ii) A subchronic 90-day dermal study (guideline 870.3250) or a subchronic 90-day inhalation study (guideline 870.3465)
(iii) An acute and subchronic neurotoxicity screening battery in the rat (guidelines 870.6100 and 870.6200); a developmental neurotoxicity study in the rat (guideline 870.6300)
(iv) Prenatal developmental toxicity studies in both the rat and rabbit (guideline 870.3700).
(v) Reproduction and fertility studies in rats (guideline 870.3800)
(vi) Battery of mutagenicity studies (guideline 870.5100 - 870.5395)
(vii) Immunotoxicity study (guideline 870.7800)
(2) The conditionally required second-tier studies include:
(i) Subchronic 90-day feeding studies in both the rodent and nonrodent (guidelines 870.3100 and 870.3150)
(ii) Dermal penetration study (guideline 870.7600)
(3) The conditionally required third-tier studies include:
(i) Chronic feeding studies in both the rodent and nonrodent (guideline 870.4100)
(ii) Carcinogenicity (guidelines 870.4200)
(iii) Metabolism study (guideline 870.7485)
(iv) Additional mutagenicity testing (no guideline number)
i. By adding subpart G entitled “Product Performance”.
j. By redesignating § 158.640 as § 158.610 and adding redesignated § 158.610 to subpart G.
k. By adding and reserving subparts H and I.
l. By adding subpart J to read as follows:
(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. Required for all outdoor pesticide uses except for known phytotoxicants (such as herbicides, desiccants, defoliants).
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, defoliants, and plant growth regulators.
5. Required if a terrestrial species exhibits a 25 percent or greater detrimental effect in Tier I.
6. Required if an aquatic species exhibits a 50 percent or greater detrimental effect in Tier I.
7. Not required for aquatic residential uses.
8. Environmental chemistry methods used to generate data must include results of a successful confirmatory method trial by an independent laboratory.
9. Tests are required based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
m. By adding subpart K to read as follows:
(a) Certain measures taken to reduce or mitigate exposure may affect the need for data. Where label, formulation, or packaging and use restrictions,
(b) If EPA determines that industrial standards, such as the workplace standards set by 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.
(c) 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 § 158.820(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 plants 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, inside 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 (
n. By adding subpart L entitled “Biochemical Pesticides.”
o. By redesignating § 158.690 as § 158.910 and adding § 158.910 to subpart L.
p. By adding subpart M entitled “Microbial Pesticides.”
q. By redesignating § 158.740 as § 158.1010 and adding redesignated § 158.1010 to subpart M.
r. By adding subpart N to read as follows:
(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, Henry's Law Constant. 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. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. The environmental chemistry methods must include a statement of no data confidentiality claims,
7. 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.
8. Agency approval of a protocol is necessary prior to initiation of the study.
9. Requirement based on use patterns and other environmental factors that indicate potential exposure.
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.
11. Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic organisms.
12. 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.
s. Subpart O is added to read as follows:
The following terms are defined for the purposes of this subpart:
(a)
(2) All residue chemistry data requirements, as described in this section, are required for an experimental use permit.
(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. Food uses in general require a more extensive database to characterize the extent of the exposure, whereas nonfood uses which are of shorter duration, may require fewer studies. Uses 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, indoor nonfood use, and indoor residential use.
(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 use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
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 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 it is reasonably foreseeable that a food or feed crop could be subsequently planted on the site of the pesticide application.
8. A residue analytical method suitable for enforcement purposes is required whenever a numeric tolerance (including temporary and time-limited tolerance) is proposed, and may be required for a tolerance exemption.
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 (guideline 860.1000).
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
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. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
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. These studies, however, may be waived by the Agency in cases where the residue levels are low or the animal metabolism studies indicate negligible transfer of the pesticide and/or metabolite(s) to tissues, milk, and eggs.
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. Required if pesticide or metabolite residues of toxicological concern are found in crops at the appropriate plant back intervals from a confined rotational crop study (guideline 860.1850).
t. By adding subpart P consisting of § 158.1300 which is reserved.
u. By adding subpart R entitled “Spray Drift.”
v. By redesignating § 158.440 as § 158.1410 and adding redesignated § 158.1410 to subpart R.
w. Subpart U is added to read as follows:
(a) If EPA determines that industrial standards, such as the workplace standards set by 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 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 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 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. 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 (
3. Data are required for outdoor occupational site if the product is applied outdoors.
4. Data are required for residential use sites if the product is applied outdoors.
5. Data are required for occupational sites if the product is applied indoors.
6. Data are required for residential use sites if the product is applied indoors.
7. Data reporting and calculations are required when handler exposure data are submitted.
x. By adding subpart V consisting of § 158.1600 which is reserved.
y. By adding subpart W consisting of § 158.1700 which is reserved.
z. By removing Appendix A.
U.S. Election Assistance Commission (EAC).
Notice.
Pursuant to sections 254(a)(11)(A) and 255(b) of the Help America Vote Act (HAVA), Public Law 107-252, the U.S. Election Assistance Commission (EAC) hereby causes to be published in the
This notice is effective upon publication in the
Bryan Whitener, Telephone 202-566-3100 or 1-866-747-1471 (toll-free).
Any comments regarding the plans published herewith should be made in writing to the chief election official of the individual States at the address listed below.
On March 24, 2004, the U.S. Election Assistance Commission published in the
The submissions from Oklahoma, South Dakota and Texas address material changes in the administration of their original State plans and, in accordance with HAVA section 254(a)(12), provide information on how the State succeeded in carrying out the previous State plan. Among other matters, South Dakota and Texas are submitting changes that address the HAVA requirements payment allocated to the State in Fiscal Year 2004, a prerequisite for the States to receive these funds. Oklahoma had previously addressed the use of such funds and appears to be making no material changes to that use. (Oklahoma has received its 2003 and 2004 requirements payments. Texas has received its 2003 requirements payment. South Dakota's certification for its 2003 requirements payment is pending.)
Upon the expiration of 30 days from March 11, 2005, these States will be eligible to implement any material changes addressed in the plans that are published herein, in accordance with HAVA section 254(a)(11)(C). At that time, in accordance with HAVA section 253(d), South Dakota and Texas also may file a statement of certification to obtain the fiscal year 2004 requirements payments. These statements of certification must confirm that the State is in compliance with all of the requirements referred to in HAVA section 253(b) and must be provided to the Election Assistance Commission in order for the State to receive a requirements payment under HAVA Title II, Subtitle D.
EAC notes that plans published herein include only those that have already met the notice and comment requirements of HAVA section 256, as required by HAVA section 254(a)(11)(B). EAC wishes to acknowledge the effort that went into revising the State plans and encourages further public comment, in writing, to the chief election official of the individual States at the address listed below.
The Honorable Michael Clingman, Secretary, State Election Board, P.O. Box 53158, Oklahoma City, Oklahoma 73152, Phone: 405/521-2391, Fax: 405/521-6457, E-mail:
The Honorable Chris Nelson, Secretary of State, State Capitol Bldg., Ste 204, 500 E Capitol, Pierre, South Dakota 57501-5070, Phone: 605/773-3537, Fax: 605/773-6580, E-mail:
The Honorable Roger Williams, Secretary of State, P.O. Box 12887, Austin, Texas 78711-2887, Phone: 512/463-5770, Fax: 512/475-2761, E-mail:
Thank you for your interest in improving the voting process in America.
Office of Management and Budget, Executive Office of the President.
Notice of solicitation of comments on the Economic Classification Policy Committee's recommendations for the 2007 revision of the North American Industry Classification System.
Under Title 44 U.S.C. 3504(e), the Office of Management and Budget (OMB) seeks public comment on the advisability of adopting the proposed North American Industry Classification System (NAICS) updates for 2007. NAICS is a system for classifying establishments (individual business locations) by type of economic activity. Mexico's Instituto Nacional de Estadística, Geografía e Informática (INEGI), Statistics Canada, and the United States Office of Management and Budget, through its Economic Classification Policy Committee (ECPC), collaborated on NAICS to make the industry statistics produced by the three countries comparable. OMB's Economic Classification Policy Committee recommends an update of the industry classification system to clarify existing industry definitions and content, recognize new and emerging industries, and correct errors and omissions.
This notice: (1) Summarizes the background for the proposed revisions to NAICS 2002 in Part I, (2) contains a summary of public comments in Part II, (3) details multiple requests and major changes in the proposed structure agreed to by the three countries in Part III, and (4) provides a comprehensive listing of proposed changes for national industries and their links to NAICS 2002 industries in Part IV.
OMB published a notification of intention to revise portions of NAICS in a December 27, 2002,
After considering all proposals from the public, consulting with U.S. data users and industry groups, and undertaking extensive discussions with Statistics Canada and Mexico's INEGI, the ECPC in collaboration with INEGI and Statistics Canada developed recommendations for revisions to NAICS that would apply to all three North American countries. These revisions focus on improving the description of current industries, identifying new and emerging industries, and recommending changes to industry content based on research and implementation experience. There are no changes specifically recommended to increase international comparability.
The ECPC recommends that NAICS United States 2007 incorporate changes as shown in Parts III and IV of this notice.
Following an extensive process of development and discussions by the ECPC, with maximum possible public input, OMB seeks comment on the advisability of revising NAICS to incorporate the changes published in this notice. The modified NAICS would be employed in relevant data collections by all U.S. statistical agencies beginning with the reference year 2007. Statistics Canada and INEGI are recommending acceptance of the proposed revisions of the NAICS system for industry classification in the statistical programs of their national systems and are seeking comments in their respective countries. Representatives of the three countries will hold further discussions to consider public comments that they receive.
To ensure consideration of comments on the adoption and implementation of the NAICS revisions detailed in this notice, comments must be in writing. Please submit comments as soon as possible, but no later than June 9, 2005. Please be aware of delays in mail processing at Federal facilities due to heightened security. Respondents are encouraged to send both a hard copy and a second copy via fax or e-mail. This proposed revision to NAICS would become effective in the U.S. for publication of establishment data that refer to periods beginning on or after January 1, 2007.
Please send correspondence about the adoption and implementation of proposed NAICS revisions as shown in this
Please address inquiries about the content of industries or requests for electronic copies of the tables to: John Murphy, Chair, Economic Classification Policy Committee, Bureau of the Census, Room 2641-3, Washington, DC 20233, telephone number: (301) 763-5172, fax number: (301) 457-1343, e-mail:
Paul Bugg, 10201 New Executive Office Building., Washington, DC 20503, e-mail address:
NAICS is a system for classifying establishments (individual business locations) by type of economic activity. Its purposes are: (1) To facilitate the collection, tabulation, presentation, and analysis of data relating to establishments, and (2) to promote uniformity and comparability in the presentation and analysis of statistical data describing the North American economy. NAICS is used by Federal statistical agencies that collect or publish data by industry. It is also widely used by State agencies, trade associations, private businesses, and other organizations.
Mexico's Instituto Nacional de Estadística, Geografía e Informática, Statistics Canada, and the United States Office of Management and Budget, through its Economic Classification Policy Committee, collaborated on NAICS to make the industry statistics produced by the three countries comparable. NAICS is the first industry classification system developed in accordance with a single principle of aggregation, the principle that producing units that use similar production processes should be grouped together in the classification.
NAICS also reflects in a much more explicit way the enormous changes in technology and in the growth and
For the three countries, NAICS provides a consistent framework for the collection, tabulation, presentation, and analysis of industry statistics used by government policy analysts, by academics and researchers, by the business community, and by the public. However, because of different national economic and institutional structures as well as limited resources and time for constructing NAICS, its structure was not made entirely comparable at the individual industry level across all three countries. For some sectors and subsectors, the statistical agencies of the three countries agreed to harmonize NAICS based on sectoral boundaries rather than on a detailed industry structure. NAICS comparability is limited to the sector level for wholesale trade, retail trade, and public administration.
The four principles of NAICS are:
(1) NAICS is erected on a production-oriented conceptual framework. This means that producing units that use the same or similar production processes are grouped together in NAICS.
(2) NAICS gives special attention to developing production-oriented classifications for (a) new and emerging industries, (b) service industries in general, and (c) industries engaged in the production of advanced technologies.
(3) Time series continuity is maintained to the extent possible.
(4) The system strives for compatibility with the two-digit level of the International Standard Industrial Classification of All Economic Activities (ISIC Rev. 3) of the United Nations.
The ECPC is committed to maintaining the principles of NAICS during revisions. The December 27, 2002, solicitation for public comment on questions related to a potential revision of NAICS in 2007 was directly tied to the application of the four NAICS principles.
NAICS uses a hierarchical structure to classify establishments from the broadest level to the most detailed level using the following format:
In response to the December 27, 2002,
The ECPC received nine comments that addressed the issue of priorities for a potential revision of NAICS in 2007 based on the four principles. The ECPC recognized that the application of one principle, such as international comparability, could be at the expense of another principle, such as time series comparability. The ECPC sought public comment on the relative priority of each principle or a ranking of priorities for the principles. The response to the
The ECPC recommends and has applied the following general guidance when considering changes to NAICS in 2007:
(1) Because of the cost of change and disruption of statistical data that has already resulted from the ongoing implementation of NAICS, the ECPC will limit the scope of the changes for 2007 and recommend only essential changes to the system;
(2) The ECPC will recommend new and emerging industries identified through public comment that are supported by the guiding principles of NAICS;
(3) The ECPC will approach improvements in international comparability using a better concordance approach rather than making structural changes to NAICS to improve comparability; and
(4) The ECPC will make changes to account for errors and omissions as well as recommending narrative improvements to clarify the content of existing industries.
The ECPC also relied on the policy direction of the Office of Management and Budget and the positions of the ECPC member agencies (Bureau of Economic Analysis, Bureau of Labor Statistics, and Bureau of the Census) when evaluating specific proposals for changes to NAICS in 2007. The ECPC reviewed each individual proposal within the existing framework of the principles of NAICS. Additional considerations that resulted in recommendations for or against change included issues of relevance, size, and time series continuity.
The ECPC received 60 comments that requested specific changes to NAICS industries for 2007. Twenty-two of those comments requested industries for biotechnology, three requested changes to the definition of optometrists, and three requested a new industry for design/build in the construction sector of NAICS. The balance of the comments addressed single issues, such as requests for new industries or clarifications for activities including wedding videography, rope and cordage manufacturing, simulation, e-learning, denturists, rental and leasing of recreational vehicles, physical therapy, travel goods wholesaling, and similar requests.
The ECPC received a number of comments that suggested changes to NAICS that were not accepted. Each of these suggestions was carefully considered. Some suggestions were modified by the ECPC to better meet the objectives of NAICS. Other suggestions proposed products (rather than industries); these will be considered in the North American Product Classification System (NAPCS), a new product classification system currently under development. Still other
When a proposal was not accepted, it was usually because: (a) The resulting industry would have been too small in the U.S.; (b) the specialization ratio of the resulting industry, a measure of the degree to which establishments in the industry are similar to one another and different from establishments in other industries, was too low; or (c) the proposal did not meet the production-oriented criterion for forming an industry in NAICS.
The ECPC received 22 separate responses requesting the creation of new industries for medical biotechnology products, food and agricultural biotechnology products, and industrial biotechnology products. The proposals were assigned docket numbers: 07-0013, 07-0014, 07-0015, 07-0016, 07-0018, 07-0019, 07-0020, 07-0022, 07-0023, 07-0024, 07-0025, 07-0026, 07-0027, 07-0028, 07-0029, 07-0030, 07-0031, 07-0036, 07-0037, 07-0041, 07-0044, and 07-0049. The proposals did not contain information regarding the size of the potential industries, importance of the industries in Canada or Mexico, or any information regarding the separate production function justification for creating the new industries. In order to evaluate the proposals, the ECPC consulted with an industry trade association to clarify the requests for new industries.
The ECPC clarified the requests as proposals to create industries for establishments that use biotechnology inputs, use biotechnology processes, or produce biotechnology outputs. The practical impact of these proposals would be to group a number of establishments that are currently classified in the Agriculture, Forestry, Fishing, and Hunting; Manufacturing; and Professional, Scientific and Technical Services sectors of NAICS.
The ECPC used the principles of NAICS to evaluate these requests. The ECPC recommends against creating the three industries requested based on the mixture of production processes that would be involved. These activities are currently classified throughout the NAICS system. For example, growing genetically-modified crops is in farming, production of biotech enzymes is in the chemicals subsector of NAICS, and manufacturing foods from biotech inputs is classified in food manufacturing. The ECPC considered the production processes and similarities to other production processes already separately identified in NAICS. Growing a genetically-modified crop may require a different production function from growing a more traditional version of the crop because of decreased need for pesticides or other inputs. Nevertheless, the production process is still closer to other agriculture production processes than it is to manufacturing production processes or professional service production processes. A similar rationale applies to food manufacturing production processes, pharmaceutical manufacturing production processes, and industrial manufacturing production processes.
The ECPC recognized the importance of biotechnology as an emerging technology that should be accounted for in NAICS. While recommending against the proposals received in response to the
The ECPC also reviewed the results of a biotechnology use survey conducted by the Department of Commerce and reviewed preliminary survey results regarding biotechnology research and development from the 2002 Economic Census. Both sources indicate that the proposed industry will be supportable in collection and publication. The ECPC recommends that public commenters on this issue work with statistical data collection programs in order to ensure that adequate biotechnology product detail is included in future data collection efforts.
Three public comments requested changes to the definition of optometrist used in the NAICS United States 2002 manual. These proposals were assigned docket numbers 07-0001, 07-0004, and 07-0035. The ECPC reviewed the proposals and information from the American Optometric Association and is recommending changes to the definition that would more accurately describe the industry but would not change the content of the industry in NAICS 2007.
Three public comments requested a new industry for design/build firms. These proposals were assigned docket numbers 07-0052, 07-0053, and 07-0054. Similar proposals were received in both 1997 and 2002. The ECPC remains opposed to using project delivery methods to define industries in the construction sector. The concept of using project delivery methods was exhaustively reviewed with Canada and Mexico during the 2002 revision of the construction sector. During the 2007 revision process, the ECPC met on several occasions with those who requested this new industry and discussed the criteria for industries in NAICS, providing background on the use of products in Census Bureau programs and the development of the North American Product Classification System currently underway. The ECPC recommends that interested parties work with statistical data collection programs in order to ensure that more exhaustive survey items for the design/build delivery method are included in future data collection efforts.
The ECPC also reviewed the structure of the telecommunications industries in NAICS 2002 in light of continuing change in the industry. The ECPC is recommending changes in the subsectors for Telecommunications (517); Internet Service Providers, Web Search Portals, and Data Processing Services (518); and Other Information Services (519).
Infrastructure operators increasingly provide a bundle of voice, data, and video services. Traditional telephone companies are providing broadband Internet access and video services, along with telephone service. Traditional television cable companies are also providing broadband Internet access services and telephone services. While there is considerable interest in tracking changes in these industries over time, it
The proposal for telecommunications creates three groupings based on the infrastructure operated to provide a variety of audio, video, data, and telephony services. The three primary infrastructure types are wired, wireless, and satellite. In addition, there is a fourth industry group that includes some support activities and resellers who directly buy and resell time on networks (
The wired telecommunications carriers would include units that build and operate their own wired networks, as well as those that lease access to lines and then provide services to customers using those facilities. This categorization is to acknowledge that the infrastructure used to provide services can be leased or purchased. The services provided would include telephony, data, and video services, as well as any future services provided using the infrastructure. The grouping would exclude units who are pure resellers—units that buy a block of minutes and resell them without providing any additional service; these units would be included in the “all other telecommunications” grouping. Wired telecommunications carriers would also include those that use a fixed wireless “connection” for the last mile. By exception, satellite television providers will be included in this industry.
The wireless telecommunications carriers would include the units that have spectrum licenses and provide telephony, Internet access, or video services using that spectrum. Wireless telecommunications carriers would not include pure resellers. Mobile virtual network operators (MVNO) providing mobile telephony or other services will be defined as resellers and excluded from this industry. MVNO's do not have infrastructure or spectrum licenses; rather they resell the services of wireless telecommunication carriers.
The satellite telecommunications industry will remain defined as units primarily engaged in providing point-to-point telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.
The fourth grouping of other telecommunications services would include the current content of NAICS 51791, Other Telecommunications, and the pure resellers in separate national industries. Resellers will be classified in NAICS 517911, Telecommunications Resellers, and other telecommunications services will be classified in NAICS 517919, All Other Telecommunications. This industry will include pure VoIP providers (providing VoIP to customers who already have a broadband connection), as well as dial-up Internet service providers (providing access to the Internet through a customer-initiated connection to the telecom system).
Web search portals would be combined with Internet publishing and broadcasting. These types of units were identified separately in NAICS 2002, because they are different from either publishers or broadcasters. The definition of Internet publishing and broadcasting is limited to exclusively publishing and broadcasting on the Internet and the ECPC continues to support the classification of Internet publishers and broadcasters separate from the traditional publishing and broadcasting industries. These establishments will be placed in 519, Other Information Services, as a five-digit NAICS class.
This proposal to restructure the telecommunications industries in NAICS reduces or eliminates industry distinctions based on the product being offered in the telecommunications section of NAICS. The anticipated growth of VoIP, the continued expansion of broadband Internet access, the development of bundles of services provided over available infrastructures, and a desire for a robust structure that will remain relevant, all affected the development of this proposal. It is difficult to predict what the telecommunications industries will look like in the future. This production function approach, based on the infrastructure used rather than the current regulatory constraints or product distinctions, should withstand industry changes better than the current product-oriented structure.
The downside to this proposal is that separate data for cable distribution and telephone service providers will not be available at the industry level. The ECPC understands that this will result in a loss of data. The application of new technologies, such as Internet telephony, is expected to further blur existing lines. The industry classification will not be updated again until 2012. The ECPC has concluded that the existing industry structure will not be viable in the years ahead and therefore recommends that these changes be made now. The ECPC particularly encourages comments supporting or opposing this recommendation. Although separate national industries are expected to cause problems based on regulatory actions in the future, industries for wired telecommunications carriers and for cable and other program distribution could be reinstated at the six-digit level. This would not affect continuity at the five-digit level if separate collection becomes impossible.
A tabular summary of changes to the Information Sector is included in Part IV.
The balance of the comments represented single requests for specific changes. While these requests and the associated ECPC recommendations are not listed in this notice unless a structure or industry content change was recommended, a summary of the decision for each docket received is available on the World Wide Web at
The ECPC is recommending several NAICS industry title changes to more clearly describe the existing content of industries. These title changes do not change the content of industries but rather refine how they are described. Part IV below presents the ECPC recommendations for revisions to NAICS United States for 2007.
NAICS Sector 21, Mining, will be changed to “Mining, Quarrying, and Oil and Gas Extraction.”
NAICS 23821, Electrical Contractors, will be changed to “Electrical Contractors and Other Wiring Installation Contractors.”
NAICS 238210, Electrical Contractors, will be changed to “Electrical Contractors and Other Wiring Installation Contractors.”
NAICS 316999, All Other Leather Good Manufacturing, will be changed to “All Other Leather Good and Allied Product Manufacturing.”
NAICS 322221, Coated and Laminated Packaging Paper and Plastics Film Manufacturing, will be changed to “Coated and Laminated Packaging Paper Manufacturing.”
NAICS 322223, Plastics, Foil, and Coated Paper Bag Manufacturing, will be changed to “Coated Paper Bag and Pouch Manufacturing.”
NAICS 326111, Plastics Bag Manufacturing, will be changed to “Plastics Bag and Pouch Manufacturing.”
NAICS 441221, Motorcycle Dealers, will be changed to “Motorcycle, ATV, and Personal Watercraft Dealers.”
NAICS 492110, Couriers, will be changed to “Couriers and Express Delivery Services.”
NAICS 541612, Human Resources and Executive Search Consulting Services, will be changed to “Human Resources Consulting Services.”
NAICS Industry Group 5418, Advertising and Related Services, will be changed to “Advertising, Public Relations, and Related Services.”
NAICS 56131, Employment Placement Agencies, will be changed to “Employment Placement Agencies and Executive Search Services.”
NAICS 722212, Cafeterias, will be changed to “Cafeterias, Grill Buffets, and Buffets.”
The standard approach to preserving time series continuity after classification revisions is to create linkages where the series break. This is accomplished by producing the data series using both the old and new classifications for a given period of transition. With the dual classifications of data, analysts can assess the full impact of the revision. Data producers then may measure the reallocation of the data at aggregate industry levels and develop a concordance between the old and new series for that given point in time. The concordance creates a crosswalk between the old and new classification systems. Statistical agencies in the U.S. are planning links between the 2002 NAICS and 2007 NAICS (with U.S. national detail).
Table 1 presents the proposed NAICS 2007 industries defined by their NAICS United States 2002 content. Table 2 lists, in NAICS United States 2002 order, the disposition of all industries recommended for change and their resulting relationship to NAICS United States 2007 proposed industries.