Aging Administration
Animal and Plant Health Inspection Service
Forest Service
Rural Telephone Bank
Engineers Corps
Committee for Purchase From People Who Are Blind or Severely Disabled
Inspector General Office, Health and Human Services Department
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National Oceanic and Atmospheric Administration
Army Department
Defense Logistics Agency
Engineers Corps
Presidential Documents
Aging Administration
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Inspector General Office, Health and Human Services Department
Blackstone River Valley National Heritage Corridor Commission
Indian Affairs Bureau
Land Management Bureau
Reclamation Bureau
Employment and Training Administration
Employment Standards Administration
Pension and Welfare Benefits Administration
Centers for Disease Control and Prevention
Food and Drug Administration
Federal Aviation Administration
Surface Transportation Board
Alcohol, Tobacco and Firearms Bureau
Thrift Supervision Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration, DOT.
Final rule; request for comments; correction
This document makes a correction to Airworthiness Directive (AD) 2002-23-08, applicable to Rolls-Royce plc. (RR) models RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-B-75 turbofan engines. AD 2002-23-08 was published in the
December 16, 2002.
Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803-5299; telephone (781) 238-7178; fax (781) 238-7199.
A final rule; request for comments airworthiness directive FR Doc. 02-29001, applicable to models RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-B-75 turbofan engines, was published in the
On page 71094, in the second column, second paragraph, in the
Federal Aviation Administration, DOT.
Final rule.
This amendment adopts a new airworthiness directive (AD), applicable to certain McDonnell Douglas Model DC-9-10, -20, -30, -40, and -50 series airplanes, and C-9 (military) airplanes, that requires a one-time visual inspection of circuit breakers to determine the manufacturer of the circuit breakers, and corrective action, if necessary. The actions specified by this AD are intended to prevent internal overheating and arcing of circuit breakers and airplane wiring due to long-term use and breakdown of internal components of the circuit breakers, which could result in smoke and fire in the flight compartment and main cabin. This action is intended to address the identified unsafe condition.
Effective January 17, 2003.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of January 17, 2003.
The service information referenced in this AD may be obtained from Boeing Commercial Aircraft Group, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024). This information may be examined at the Federal Aviation Administration (FAA), Transport Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
Elvin Wheeler, Aerospace Engineer, Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone (562) 627-5344; fax (562) 627-5210.
A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas Model DC-9-10, -20, -30, -40, and -50 series airplanes; and C-9 (military) airplanes was published in the
Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the single comment received.
The commenter expresses concern that, although the applicability in the proposed AD only specifies Model DC-9 and MD-80 series airplanes, the referenced circuit breakers (manufactured by Wood Electric Corporation or Wood Electric Division of Potter Brumfield Corporation), may be fitted to other FAA type-certificated products or aircraft. The commenter asks for confirmation that this is or is not the case.
We agree that the subject circuit breakers can be installed on other FAA type-certificated products. We previously issued other rulemaking actions that address the commenter's concern. AD 2001-08-16, amendment 39-12193, was issued on April 17, 2001
We have changed the service bulletin citation throughout this final rule to exclude the Evaluation Form. (The form is intended to be completed by operators and submitted to the manufacturer to provide input on the quality of the service bulletin; however, this AD does not include such a requirement.)
After careful review of the available data, including the comment noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the change previously described. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.
There are approximately 830 Model DC-9 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 540 airplanes of U.S. registry will be affected by this AD, that it will take approximately 80 work hours per airplane to accomplish the inspection of the circuit breakers (over 700 installed on each airplane), and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $2,592,000, or $4,800 per airplane.
The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.
The regulations adopted herein 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.
For the reasons discussed above, I certify that this action (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. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
This AD applies to each airplane identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (c) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.
To prevent internal overheating and arcing of circuit breakers and airplane wiring due to long-term use and breakdown of internal components of the circuit breakers, which could result in smoke and fire in the flight compartment and main cabin, accomplish the following:
(a) Within 18 months after the effective date of this AD: Perform a one-time general visual inspection of circuit breakers to determine the manufacturer of the circuit breaker, in accordance with McDonnell Douglas Alert Service Bulletin DC9-24A171, Revision 01, dated September 21, 1999, excluding Evaluation Form.
For the purposes of this AD, a general visual inspection is defined as “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 under normally available lighting conditions such as daylight, hangar lighting, flashlight, or drop-light, 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.”
(1) If no Wood Electric Corporation or Wood Electric Division of Potter Brumfield Corporation circuit breaker is found, no further action is required by this AD.
(2) If any Wood Electric Corporation or Wood Electric Division of Potter Brumfield Corporation circuit breaker is found, prior to further flight, replace the circuit breaker with a new circuit breaker in accordance with the service bulletin.
(b) As of the effective date of this AD, no person shall install, on any airplane,
(c) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, Los Angeles Aircraft Certification Office (ACO), FAA. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, Los Angeles ACO.
Information concerning the existence of approved alternative methods of compliance with this AD, if any, may be obtained from the Los Angeles ACO.
(d) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.
(e) The actions shall be done in accordance with McDonnell Douglas Alert Service Bulletin DC9-24A171, Revision 01, dated September 21, 1999, excluding Evaluation Form. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from Boeing Commercial Aircraft Group, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024). Copies may be inspected at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California; or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment becomes effective on January 17, 2003.
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 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 December 13, 2002. 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 December 13, 2002.
Availability of matter 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 affected airport is located; or
3. The Flight Inspection Area Office which originated the SIAP.
4. The Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.
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 on each SIAP is contained in the appropriate FAA Form 8260 and the National Flight Data Center (FDC)/Permanent (P) Notices to Airmen (NOTAM) which are incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation's Regulations (FAR). 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 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the content of the following FDC/P NOTAMs for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs, the respective FDC/T NOTAMs have been canceled.
The FDC/P NOTAMs for the SIAPs contained in this amendment are based on the criteria contained in the U.S.
Further, the SIAPs contained in this amendment are based on the criteria contained in the TERPS. 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 these 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. 40103, 40113, 40120, 44701; 49 U.S.C. 106(g); and 14 CFR 11.49(b)(2).
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS/DEM, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows: (Effective upon publication)
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 December 13, 2002. 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 December 13, 2002.
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 Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.
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
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, 40113, 40120, 44701; and 14 CFR 11.49(b)(2).
By amending: §97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; §97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; §97.27 NDB, NDB/DME; §97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV; §97.31 RADAR SIAPs; §97.33 RNAV SIAPs; and §97.35 COPTER SIAPs, identified as follows:
The FAA published the following procedures in Docket No. 30332; Amdt No. 30332; Amdt No. 3025 to Part 97 of the Federal Aviation Regulations (Vol. 67, FR No. 195, Page 62639; dated Tuesday, October 08, 2002) under section 97.29 effective November 28, 2002 which are hereby rescinded:
Refer to FDC NOTAM 2/2295 and (General Notice) GENOT 2/59 for further information.
The FAA published the following procedures in Doctket No. 30341; Amdt No. 3033 to Part 97 of the Federal Aviation Regulations (Vol. 67, FR No. 232, Page 71818; dated Tuesday, December 3, 2002) under section 97.29 effective January 23, 2003 which are hereby rescinded:
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is reclassifying the cutaneous carbon dioxide (PcCO
This rule is effective January 13, 2003.
William A. Noe, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609, ext. 174.
The act (21 U.S.C. 301
Under the 1976 amendments, class II devices were defined as those devices for which there is insufficient information to show that general controls themselves will assure safety and effectiveness, but for which there is sufficient information to establish performance standards to provide such assurance. The SMDA broadened the definition of class II devices to mean those devices for which there is insufficient information to show that general controls themselves will assure safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act).
It is the agency's position that it is not necessary to obtain a new classification recommendation from a panel that had recommended classification into class II prior to the SMDA. If a panel recommended that a device be classified into class II under the 1976 definition of class II, which included only performance standards as a class II control, clearly the Panel's recommendation for class II status would not change if controls, in addition to performance standards, could be added.
Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) The device is reclassified into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act, as amended by FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.
Reclassification of classified preamendments devices is governed by section 513(e) of the act. This section provides that FDA may, by rulemaking, reclassify a device (in a proceeding that parallels the initial classification proceeding) based upon “new information.” The reclassification can be initiated by FDA or by the petition of an interested person. The term “new information,” as used in section 513(e) of the act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g.,
Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see
In accordance with section 513(e) of the act and 21 CFR 860.130(b)(1), based on new information with respect to the device, FDA, on its own initiative, is reclassifying the PcCO
FDAMA added a new section 510(m) to the act. Section 510(m) of the act provides that a class II device may be
In the
FDA also identified the document “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO
Interested persons were invited to comment on the proposed rule by April 15, 2002, and on the draft special control guidance document by May 13, 2002. FDA received no comments on the proposed rule. FDA received two comments on the draft guidance document and they are discussed in the notice of availability for the guidance published elsewhere in this issue of the
Based on a review of the available information, FDA concludes that the guidance document “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO
FDA is adopting the assessment of the risks to public health stated in the proposed rule published on February 12, 2002. Furthermore, FDA is issuing a final rule that revises §§ 868.2480 and 868.2500, thereby reclassifying the generic type of device, PcCO
For the convenience of the reader, FDA is adding new § 868.1(e) to inform the reader where to find guidance documents referenced in 21 CFR part 868.
The agency has determined under 21 CFR 25.34(b) that these classification actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of the cutaneous oxygen monitor from class III will relieve all manufacturers of these devices of the cost of complying with the premarket approval requirements in section 515 of the act. Furthermore, this rule may permit small potential competitors to enter the marketplace by lowering their costs.
Compliance with special controls for the cutaneous oxygen monitor and the cutaneous carbon dioxide monitor will not impose significant new costs on affected manufacturers because most of these devices already comply with the special controls. Based upon its review of the information submitted in premarket notifications for these devices, FDA believes that manufacturers presently marketing these devices are in conformance with the guidance document. The guidance document assures that, in the future, these generic types of devices will be at least as safe and effective as the presently marketed devices. These devices are already subject to premarket notification and labeling requirements. The guidance document advises manufacturers on appropriate means of complying with these requirements
.The agency, therefore, certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In addition, this rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement of analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and
The final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA) is not required.
The information collections addressed in the special control guidance document identified by this rule have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (part 807, subpart E, OMB control number 0910-0120). The labeling provisions addressed in the guidance have been approved by OMB in accordance with the PRA under OMB control number 0910-0485.
Medical devices.
1. The authority citation for 21 CFR part 868 continues to read as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html.
(b)
(a)
(b)
Department of State.
Final rule.
This rule removes the Department's regulations concerning the documentation of immigrants under section 124 of Immigration Act of 1990 (IMMACT 90). This section provided immigrant status for certain aliens who were resident and employed in Hong Kong. Qualifying aliens could be granted immigrant status during fiscal years 1991 and 1993 and could be granted extended immigrant visa validity up to January 1, 2002. Since this category of visas no longer exists, the Department is removing the regulations.
December 13, 2002.
Pam Chavez, Legislation and Regulations Division, Visa Services, Department of State, Washington, DC 20522-0113.
Section 124 of the Immigration Act of 1990 (IMMACT 90) created a special immigrant visa classification for residents of Hong Kong employed by either U.S. owned or operated businesses or by the American Consulate General in Hong Kong. Visas for business employees were to have been issued during fiscal years 1991 and 1993. Section 154 of IMMACT 90 also provided for an extension of validity of these visas through January 1, 2002. Visas for Consulate General employees were to have been issued by January 1, 2001. Since these visas are no longer being issued and since the extended validity period has now expired, the Department is removing the regulations pertaining to this class of immigrants.
The Department is publishing this rule as a final rule, since it is merely removing regulations that governed a class of immigrants which no longer exists.
The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will not 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 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 is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or 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 import markets.
The Department of State does not consider this rule to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. In addition, the Department is exempt from Executive Order 12866 except to the extent that it is promulgating regulations in conjunction with a domestic agency that are significant regulatory actions. The
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.
This rule does not impose any new reporting or record-keeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Aliens, Immigrants, Passports and Visas.
Pension Benefit Guaranty Corporation.
Final rule.
The Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating single-employer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in January 2003. Interest assumptions are also published on the PBGC's Web site (
January 1, 2003.
Harold J. Ashner, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.)
The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.
Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to part 4022).
Accordingly, this amendment (1) adds to Appendix B to part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during January 2003, (2) adds to Appendix B to part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during January 2003, and (3) adds to Appendix C to part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during January 2003.
For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 5.30 percent for the first 20 years following the valuation date and 5.25 percent thereafter. These interest assumptions (in comparison with those in effect for December 2002) reflect a 5-year decrease in the period during which the initial rate applies (from a period of 25 years following the valuation date to a period of 20 years following the valuation date). The initial rate, in effect during the 20-year period, is unchanged from the initial rate in effect for December 2002. The ultimate rate, in effect thereafter, represents an increase (from the ultimate rate in effect for December 2002) of 1.00 percent.
The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 4.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions are unchanged from those in effect for December 2002.
For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).
The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions.
Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during January 2003, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply.
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
Employee benefit plans, Pension insurance, Pensions.
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.
Environmental Protection Agency.
Notice of partial deletion of the West Virginia Ordnance Works Site from the National Priorities List.
The Environmental Protection Agency (EPA) Region III announces the partial deletion of portions of the West Virginia Ordnance Works (WVOW) site from the National Priorities List (NPL). The NPL constitutes appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA), as amended. EPA and the State of West Virginia have determined that all appropriate responses under CERCLA have been implemented at the portions of the site being deleted from the NPL and that no further cleanup by responsible parties is appropriate. Moreover, EPA and the State of West Virginia have determined that response actions conducted at the site to date remain protective of public health, welfare, and the environment.
December 13, 2002.
Comprehensive information on this release is available for viewing at the site information repositories at the following locations:
Mr. Jack Potosnak, PE, Remedial Project Manager, U.S. EPA Region III (3HS13), 1650 Arch Street, Philadelphia, PA 19103-2029, (215) 814-3362.
The portions of the site to be deleted from the NPL are the OU-11 Sellite Plant, the OU-12 North and South Powerhouses and Vicinity, the ENV-6 Wetlands Mitigation area, ESI-3 Tract 21, the ESI-5 Refueling Depot, and the ESI-9 Main and Outgoing Classification Yards.
A Notice of Intent to Delete for this site was published October 22, 2002 (67 FR 64846). The closing date for comments on the Notice of Intent to Delete was November 21, 2002. EPA received no comments.
EPA identifies releases which appear to present a significant risk to public health, welfare, or the environment, and it maintains the NPL as the list of those releases. Releases on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund. Any release deleted from the NPL remains eligible for Fund-financed remedial actions in the unlikely event that conditions at the site warrant such action. Section 300.425(e)(3) of the NCP states that Fund-financed actions may be taken at sites deleted from the NPL. Deletion of a site from the NPL does not affect responsible party liability or impede agency efforts to recover costs associated with response efforts.
Environmental protection, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Reporting and recordkeeping requirements, Superfund.
40 CFR part 300 is amended as follows:
33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
Centers for Medicare & Medicaid Services (CMS), HHS.
Interim final rule.
This interim final rule sets forth the process for establishing a realistic and equitable payment amount for all Medicare Part B services (other than physician services) when the existing payment amounts are inherently unreasonable because they are either grossly excessive or deficient. We also do not intend to apply this rule to services paid under a prospective payment system, such as outpatient hospital or home health. This rule describes the factors we (or our carrier) will consider and the procedures we will follow in establishing realistic and equitable payment amounts. This rule also responds to the public comments we received on the interim final rule with comment period that described the factors we will follow in establishing realistic and equitable payment amounts. In addition, the rule responds to a General Accounting Office report (as required by section 223 of the Balanced Budget Refinement Act of 1999), and it implements sections 1842(b)(8) and (b)(9) of the Social Security Act as revised by section 4316 of the Balanced Budget Act of 1997.
In commenting, please refer to file code CMS-1908-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission or e-mail. Mail written comments (one original and three copies) to the following address only:
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1908-IFC, P.O. Box 8017, Baltimore, MD 21244-8017.
Please allow sufficient time for mailed comments to be timely received in the event of delivery delays.
If you prefer, you may deliver (by hand or courier) your written comments (one original and three copies) to one of the following addresses:
(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for commenters wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and could be considered late.
For information on viewing public comments, see the beginning of the
William Long, (410) 786-5655.
Title XVIII of the Social Security Act (the Act) contains various methodologies for making payment under Part B of the Medicare program. These payment methodologies vary among the different categories of items and services covered under Part B.
Section 4316 of the Balanced Budget Act of 1997 (BBA), Pub. L. 105-33, enacted on August 5, 1997, however, permits the Secretary to deviate from the payment methodologies prescribed in title XVIII of the Act if their application results in a payment amount that, because it is determined to be grossly excessive or deficient, is not inherently reasonable. Section 4316 of the BBA also requires the Secretary to describe the factors to be considered in determining an amount that is realistic and equitable.
The inherent reasonableness concept is not new to the statute. The Secretary has always taken the position that the authority to regulate unreasonable payment amounts is inherent in his authority to determine reasonable charges according to section 1842 of the Act. Moreover, effective September 10, 1986, section 9304(a) of the Consolidated Omnibus Budget Reconciliation Act (COBRA) (Pub. L. 99-272) of 1985 added section 1842(b)(8) and (b)(9) of the Act. These provisions expressly authorize the Secretary to deviate from the payment methodologies prescribed in the Act if their application results in a payment amount for a particular service or group of services, that is determined to be grossly excessive or deficient and is therefore, not inherently reasonable. The statute requires the Secretary to describe in regulations the factors to be considered in determining an amount that is realistic and equitable.
Regulations implementing this provision are contained in 42 CFR 405.502(g) and (h) and were published on August 11, 1986 in the
As implemented by the current regulations, section 1842(b)(8) of the Act applies not only to our authority to establish national reasonable charge limits, but also to our carriers' authority to establish carrier-level reasonable charge limits on grossly excessive or deficient charges.
Section 4316 of the BBA amends section 1842(b)(8) of the Act and includes the following key differences:
• It excludes physician services from application of inherent reasonableness.
• It extends the authority to establish special payment limits to Medicare carriers regardless of the methodology used for determining payment and simplifies the inherent reasonableness process for adjustments to payment amounts that are 15 percent or less.
On January 7, 1998 we published in the
In the January 7, 1998 interim final rule, we revised § 405.502(g) and (h) by excluding references to physician services. We also deleted specific references to the reasonable charge payment methodology. We deleted these references because the inherent reasonableness provisions apply to all Part B services, except physician services, irrespective of the payment methodology. However, we do not intend to apply this rule to services paid under a prospective payment system, such as outpatient hospital or home health services. We also reflected the change in the statute that permitted us to simplify the process for making adjustments to payment amounts for a category of items or services when the increase or decrease in the payment amount is no more than 15 percent per year. (For purposes of § 405.502(g) and (h), a “category of items or services” may consist of a single item or service or any number of items or services.)
Although the BBA gives the Secretary discretion to reduce the number of factors that are used to make inherent reasonableness determinations, we retained all but one of the factors that appear in § 405.502(g)(1), because they remain as appropriate examples of factors that may result in deficient or excessive payment amounts. We removed the factor related to the use of new technology for which an extensive charge history does not exist because there was already in place an alternative process for establishing payment amounts for new items or services for which an extensive charge history does not exist. (We reinserted this example in the final regulation; however, due to comments we received requesting that this example not be deleted.)
When we implemented section 9304(a) of COBRA of 1985, we interpreted the statute as codifying both our authority and a carrier's authority to establish realistic and equitable payment amounts. We interpreted the provisions of section 4316 of the BBA in the same way. Thus, the final regulations describe the circumstances and factors our carriers and we would use in setting realistic and equitable payment amounts if the existing payment amounts are grossly excessive or deficient.
Section 4316 of the BBA amends section 1842(b)(8), adding provisions that apply if a reduction or increase would vary the payment amount by 15 percent or less “during any year.” (Other provisions apply to larger increases and decreases.) Under this authority, we (or a carrier) may determine that more than a 15-percent adjustment is warranted, but we may choose to apply only a 15-percent adjustment in any given year and use the “15 percent” methodology. For example, we (or a carrier) may determine that a 25-percent reduction is warranted. However, the adjustment could be accomplished over 2 years—15 percent applied the first year, and 10 percent applied the following year.
Other than these BBA changes and some minor modifications, the revised 1998 interim final regulations were the same as the final regulations that were published in the
While amended section 1842(b)(8)(C) of the Act does not specifically require that we include all the factors for making inherent reasonableness determinations for a category of items or services currently contained in § 405.502(g), it permits the Secretary to consider any additional factors determined to be appropriate. The additional pre-BBA factors we may consider, in accordance with current § 405.502(g)(1), include the following:
• The market place is not competitive.
• The payment amounts in a particular locality grossly exceed amounts paid in other localities for the category of items or services.
• The payment amounts grossly exceed acquisition or production costs for the category of items or services.
• There have been increases in payment amounts that cannot be explained by inflation or technology.
Section 223 of the Balanced Budget Refinement Act (BBRA) of 1999, Pub. L. 106-113, enacted on November 29, 1999, prohibits the use of the inherent reasonableness authority until the following events have occurred:
This report entitled “Medicare Payments-Use of Revised ‘Inherent Reasonableness’ Generally Appropriate (GAO/HEHS-OO-79)” was released by the General Accounting Office (GAO) in July 2000. A discussion of this report and our response to its recommendations is contained in section IV of this regulation.
This regulation constitutes a notice of final rulemaking relating to inherent reasonableness authority. In addition to responding to the GAO Report, this regulation also responds to the comments received regarding the interim final regulation that was published January 7, 1998. Section V of this regulation includes our responses to these comments. However, we are issuing this regulation as an interim final rule so that the public will have an additional opportunity to comment. We are particularly interested in receiving comments on two provisions that contain further specificity than found in the 1998 interim final rule. These two provisions are the definitions of “grossly excessive” and “grossly deficient” in § 405.502(g)(1)(ii) and the criteria for using valid and reliable data in § 405.502(g)(4). Comments on the 1998 interim final rule are addressed in section V of this interim final rule.
The criteria set forth in the interim final rule were never intended to include every set of circumstances where inherent reasonableness would be considered appropriate. We have reviewed the criteria that were included in the interim final rule. These same criteria were also included in the 1986 final regulation and are, therefore, not new but have been in effect for over 10 years. These criteria were originally established by the Congress. We believe the criteria remain as appropriate today as they were when the Congress established them, and we would need compelling reasons for determining that any of the criteria are inappropriate. A more detailed discussion of the criteria is contained in section V of this preamble. Once again, we would point out that these criteria are furnished as examples of situations of possible grossly excessive or deficient payment amounts and we believe they are realistic and continue to be relevant. In addition, the criteria were never intended to include every set of circumstances for which inherent reasonableness would be considered appropriate.
The regulation has been revised to include a new section that provides a methodology taken from the GAO report to ensure the use of valid and reliable data (§ 405.502(g)(4)). The criteria include doing the following:
• Develop written guidelines for data collection and analysis;
• Ensure consistency in any survey to collect and analyze pricing data.
• Develop a consistent set of survey questions to use when requesting retail prices.
• Ensure that sampled prices fully represent the range of prices nationally.
• Consider the geographic distribution of Medicare beneficiaries.
• Consider relative prices in the various localities to ensure that an appropriate mix of areas with high, medium, and low consumer prices was included.
• Consider criteria to define populous State, less populous State, urban area, and rural area.
• Consider a consistent approach in selecting retail outlets within selected cities.
• Consider whether the distribution of sampled prices from localities surveyed is fully representative of the distribution of the U.S. population.
• Consider the products generally used by beneficiaries and collect prices of these products.
• When using wholesale costs, consider the cost of the services necessary to furnish a product to beneficiaries.
In July 2000, the GAO released a report entitled “Medicare Payments—Use of Revised ‘Inherent Reasonableness’ Generally Appropriate (GAO/HEHS-00-79).” This interim final regulation responds to the GAO report and, in section V, responds to the comments received regarding the January 7, 1998 interim final regulation. In its report, the GAO found that CMS's use of the revised inherent reasonableness process was generally appropriate. Also, the GAO made four specific recommendations that are discussed below.
In addition, the statute provides two different processes once a determination is made that a payment amount is grossly excessive or deficient. That is, the statute specifies a process for adjustments of 15 percent or more in a given year and a simplified process for adjustments of less than 15 percent in a given year. However, the statute does not define what constitutes a grossly excessive or deficient payment amount. Nevertheless, the statute places significant importance on a 15 percent criterion. For this reason, we believe that differences between current and proposed payment amounts of less than 15 percent should not be considered grossly excessive or grossly deficient and therefore do not provide a sufficient basis for using Inherent Reasonableness authority. This definition does not preclude adjustments of less than 15 percent in a given year once it is determined that an overall adjustment of 15 percent or more is justified.
The following are the GAO's main criticisms of this retail price survey as stated in the report and our responses:
• The carriers' sampling plan was developed without fully considering the geographic distribution of Medicare beneficiaries.
Based on this criticism from the GAO, in the future we will ensure that greater consideration is given to survey design including the geographic distribution of Medicare beneficiaries for the purpose of conducting retail price surveys.
• The carriers did not consider relative prices in the localities from which they sampled, which would have helped ensure that an appropriate mix of areas with high, medium, and low consumer prices was included.
The carriers surveyed both large and small States, urban and rural areas, and independent and chain stores for this purpose. In the future, we will take steps to ensure that consideration is given to including areas with high, medium, and low consumer prices.
• The carriers did not establish criteria to define populous State, less populous State, urban area, rural area, and, consequently, each carrier used different criteria in selecting locations.
• We will adopt more standard definitions of what constitutes populous States, less populous States, urban areas, and rural areas and will ensure that the carriers use these definitions.
• The carriers were not consistent in how they chose retail outlets within selected cities.
While the carriers surveyed both independent and chain stores, we will instruct the carriers to be more consistent in the methodology they use to make these selections.
• The carriers did not use consistent methods to collect and analyze the pricing data and did not develop written guidelines for data collection and analysis.
The carriers did use written spreadsheets to contain the basic information that they were looking for when they contacted each retail store. The method that was used was a simple example of price shopping, namely, pricing data were collected by contacting retail stores to find out how much they charge for a certain list of items. The carriers followed general guidelines that were provided by CMS. We will issue more detailed guidelines to the carriers to ensure that a more standardized method is used when obtaining pricing information in the future.
Also, based on these GAO criticisms of the carriers price survey, the carriers will not finalize their September 1998 proposed adjustments since the methodology used by the carriers' for making the proposed adjustments does not reflect the revised regulatory criteria recommended by GAO for making inherent reasonableness determinations. Likewise, the CMS inherent reasonableness proposals that were published in August 1999 will not be finalized since the methodology used for making the proposed adjustments also do not reflect the revised criteria recommended by GAO and adapted in this final regulation.
The January 7, 1998 interim final rule invited comments. The specific comments and our responses to these comments follow:
Whether attempting to adjust payments centrally through a
• The effects on the Medicare program, including costs, savings, assignment rates, beneficiary liability, and quality of care.
• What entities would be affected such as classes of providers or suppliers and beneficiaries.
• How significantly would these entities be affected.
• How would the adjustment affect beneficiary access to items or services.
The intent of these requirements is to assure that carriers collect sufficient information on market prices and potential effects on suppliers and beneficiaries before taking action.
When base year data are not available and more current prices are used, the carriers decrease the more current prices by a “deflation” factor in order to approximate the base year price for gap-filling purposes. The deflation factors are based on the percentage change in the consumer price index for all urban consumers (CPI-U) from the mid-point of the fee schedule base period to the mid-point of the year that the price is in effect. The gap-filling process is only used when the base year data required by the statute for use in calculating the fee schedules do not exist. We believe that this methodology does result in adequate payment amounts by taking into account comparable prices, retail prices, and inflationary factors. However, we can adjust gap-filled fee schedule amounts that we determine are grossly excessive or grossly deficient using the inherent reasonableness process.
As authorized by section 1842(a) of the Act, carriers, under our direction, have historically been used to make determinations regarding payment amounts, coverage determinations, in the absence of a national coverage determination, and utilization safeguards. Also, section 1842(b) of the Act specifies that inherent reasonableness adjustments of more than 15 percent a year must be published in the
CMS acted within its authority in delegating the revised inherent reasonableness process to the carriers. The BBA was important in removing the barriers that prevented the carriers from conducting inherent reasonableness reviews. * * * Moreover, delegation is proper because pricing Medicare goods and services is already a responsibility of the carriers and the statute does not specifically preclude delegation of this authority to the carriers.
Also, we note that the GAO report addressed this issue and concluded that a notice of proposed rulemaking was not necessary. Specifically, the GAO report states that “going through the notice of proposed rulemaking to issue inherent reasonableness regulations would have serious financial implications for Medicare and its beneficiaries.” In addition, the GAO states that “CMS's reliance on the good cause exception to bypass formal notice and comment rulemaking procedures seems reasonable.”
In response to comments on the January 7, 1998 interim final rule, we made the following changes in this interim final rule:
• Clarified § 405.502(g)(1)(ii) by stating that a payment amount will not be considered grossly excessive or grossly deficient if the overall payment adjustment is less than 15 percent.
• Amended § 405.502(g)(1)(iii) by clarifying the difference between a national determination and a carrier determination.
• Added § 405.502(g)(2)(vii)(H) to include an example of new technology that exists and is not reflected in the existing payment allowance.
• Amended § 405.502(g)(3)(ii) by adding “proposed payment amounts and the” to the first sentence to provide suppliers the opportunity to comment on the carrier's proposed payment allowances as well as the factors the carrier considered; and adding a requirement that a carrier notify us in writing of any final limits it plans to establish.
• Added § 405.502(g)(4) to include the criteria for using valid and reliable data.
• Added § 405.502(g)(5) to provide that when payment adjustments of more than 15 percent are spread out over multiple years, subsequent adjustments will be reviewed for their appropriateness.
However, because we are interested in receiving comments on this rule, particularly the two provisions that contain further specificity than found in the 1998 interim final rule, we are publishing this rule as an interim final rule and are soliciting comments. These two provisions are the definitions of “grossly excessive” and “grossly deficient” in § 405.502(g)(1)(ii) and the criteria for using valid and reliable data in § 405.502(g)(4). We already received comments on the other provisions when we published the interim final rule in January 1998. These comments are addressed in section V of this interim final rule.
This document does not impose information collection and recordkeeping requirements. Consequently, it does not need to be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review) and the Regulatory Flexibility Act (RFA) (September 16, 1980 Public Law 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more annually). This regulation has no immediate economic effect on current Medicare payments. However, it establishes a process that could be used in the future to establish reasonable and equitable payment amounts. Because this rule does not include any actual inherent reasonableness determinations, it has no immediate impact on Medicare's payment amounts. However, we do believe that the future use of inherent reasonableness has the potential to have significant impact; therefore it is a major rule. This belief is based on a June 2002 OIG report indicating that Medicare may be overpaying between $130 million and $958 million per year for 16 items of medical equipment. In addition, the GAO recently indicated that Medicare may be overpaying for medical equipment by more than 20 percent. However, these reports were not done to the specifications we are establishing in this rule and, therefore, they may not be an accurate estimate of the specific dollar impact that could result from the future application of inherent reasonableness under these requirements. Since we recognize the potential for future payment adjustments, either upward or
We lack such data because until we publish this rule, and we are able to conduct an inherent reasonableness study using the criteria described in this rule, we are unable to determine whether Medicare is overpaying or underpaying for items or services and to what degree. We do not know if, or when, or for which services, we would make payment adjustments, or the percentage adjustment we would make, or even the particular industry that would be affected. Also, we do not know if these adjustments would increase or decrease Medicare payment amounts. As a result, we cannot anticipate the specific dollar effect or impact on suppliers and beneficiaries.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $26 million or less in any 1 year (see 65 FR 69432 for details). For purposes of the RFA, all suppliers of Medicare Part B services are considered to be small entities. Individuals and States are not included in the definition of a small entity. Since this rule does not include any actual inherent reasonableness determinations, it will not have an impact on small businesses. However, it establishes a process that could be used in the future to establish reasonable and equitable payment amounts.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This regulation does not mandate expenditures by State, local, or tribal governments, or by the private sector. Therefore, the requirements of section 202 do not apply.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable.
We do not expect suppliers of Part B services to be immediately affected by this rule since the rule will have no immediate impact on Medicare's payment amounts. However, we do believe that use of inherent reasonableness has the potential to significantly impact small businesses in the future. This belief is based on a June 2002 OIG report indicating that Medicare may be overpaying between $130 million and $958 million per year for 16 items of medical equipment. In addition, the GAO recently indicated that Medicare may be overpaying for medical equipment by more than 20 percent. However, we are still unable to predict the specific dollar impact on the future application of inherent reasonableness. Since we recognize the potential for future payment adjustments, either upward or downward, when CMS makes adjustments we will publish in the
After publication of this regulation, if CMS initiates an inherent reasonableness determination that results in payment adjustments in excess of $100 million in any one year, CMS will publish in the
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(g)
(ii) CMS or a carrier may determine that the standard rules for calculating payment amounts set forth in this subpart for a category of items or services identified in section 1861(s) of the Act (other than physician services paid under section 1848 of the Act and those items and services for which payment is made under a prospective payment system, such as outpatient hospital or home health) will result in grossly deficient or excessive amounts. A payment amount will not be considered grossly excessive or deficient if it is determined that an overall payment adjustment of less than 15 percent is necessary to produce a realistic and equitable payment amount. For CMS initiated adjustments, CMS will publish in the
(iii) If CMS or the carrier determines that the standard rules for calculating payment amounts for a category of items or services will result in grossly deficient or excessive amounts, CMS, or the carrier, may establish special payment limits that are realistic and equitable for a category of items or services. If CMS makes a determination, it is considered a national determination. A carrier determination is one made by a carrier/intermediary or groups of carriers/intermediaries even if the determination applies to all State fees.
(iv) The limit on the payment amount is either an upper limit to correct a grossly excessive payment amount or a lower limit to correct a grossly deficient payment amount.
(v) The limit is either a specific dollar amount or is based on a special method to be used in determining the payment amount.
(vi) Except as provided in paragraph (h) of this section, a payment limit for a given year may not vary by more than 15 percent from the payment amount established for the preceding year.
(vii)
(A) The marketplace is not competitive. This includes circumstances in which the marketplace for a category of items or services is not truly competitive because a limited number of suppliers furnish the item or service.
(B) Medicare and Medicaid are the sole or primary sources of payment for a category of items or services.
(C) The payment amounts for a category of items or services do not reflect changing technology, increased facility with that technology, or changes in acquisition, production, or supplier costs.
(D) The payment amounts for a category of items or services in a particular locality are grossly higher or lower than payment amounts in other comparable localities for the category of items or services, taking into account the relative costs of furnishing the category of items or services in the different localities.
(E) Payment amounts for a category of items or services are grossly higher or lower than acquisition or production costs for the category of items or services.
(F) There have been increases in payment amounts for a category of items or services that cannot be explained by inflation or technology.
(G) The payment amounts for a category of items or services are grossly higher or lower than the payments made for the same category of items or services by other purchasers in the same locality.
(H) A new technology exists which is not reflected in the existing payment allowances.
(2)
(i)
(ii)
(iii)
(iv)
(v)
(3)
(ii)(A)
(
(
(
(
(B) The carrier must evaluate the comments it receives. The carrier must notify CMS in writing of any final limits it plans to establish. CMS will acknowledge in writing to the carrier that it received the carrier's notification. After the carrier has received CMS's acknowledgement, the carrier must inform the affected suppliers and State Medicaid agencies of any final limits it
(4)
(i) Develop written guidelines for data collection and analysis;
(ii) Ensure consistency in any survey to collect and analyze pricing data.
(iii) Develop a consistent set of survey questions to use when requesting retail prices.
(iv) Ensure that sampled prices fully represent the range of prices nationally.
(v) Consider the geographic distribution of Medicare beneficiaries.
(vi) Consider relative prices in the various localities to ensure that an appropriate mix of areas with high, medium, and low consumer prices was included.
(vii) Consider criteria to define populous State, less populous State, urban area, and rural area.
(viii) Consider a consistent approach in selecting retail outlets within selected cities.
(ix) Consider whether the distribution of sampled prices from localities surveyed is fully representative of the distribution of the U.S. population.
(x) Consider the products generally used by beneficiaries and collect prices of these products.
(xi) When using wholesale costs, consider the cost of the services necessary to furnish a product to beneficiaries.
(5) If CMS or a carrier makes a payment adjustment of more than 15 percent spread over multiple years, CMS or the carrier will review market prices in the years subsequent to the year that the initial reduction is effective in order to ensure that further reductions continue to be appropriate.
(h)
(1)
(2)
(3)
(i)
(A) Explains the factors and data that CMS considered in determining that the payment amount for a category of items or services is grossly excessive or deficient;
(B) Specifies the proposed payment amount or methodology to be established for a category of items or services;
(C) Explains the factors and data that CMS considered in determining the payment amount or methodology, including the economic justification for a uniform fee or payment limit if it is proposed;
(D) Explains the potential impacts of a limit on a category of items or services as described in paragraph (h)(1) of this section; and
(E) Allows no less than 60 days for public comment on the proposed payment limit for the category of items or services.
(ii)
(A) Explains the factors and data that CMS considered, including the economic justification for any uniform fee or payment limit established; and
(B) Responds to the public comments.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare—Supplementary Medical Insurance)
Federal Communications Commission.
Final rule.
In view of the Federal Communications Commission's commitment to ultimately require equipment operating in the 764-776 MHz and 794-806 MHz band (“700 MHz public safety band”) General Use and State License channels to meet a spectrum efficiency requirement of one voice channel per 6.25 kHz, the Commission in this item adopted a phased-in implementation of (
Effective January 13, 2003.
Roberto Mussenden, Esq., 202/418-0680,
This is a summary of the Federal Communications Commission's Report and Order, FCC 02-216, adopted on July 16, 2002, and released on August 2, 2002. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Qualex International, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at:
1. In this
2. In keeping with the Commission's safe harbor guidelines to facilitate use of the 764-776 MHz and 794-806 MHz band, we are mindful that the migration path we adopt today must not hinder the development and deployment of public safety equipment nor delay the planning and construction of pubic safety systems in this band. Specifically, we adopt the following measures to ensure efficient, effective and maximized use of the narrowband General Use and State License channels of the 700 MHz public safety band:
• Allow the marketing, manufacture and importation of 12.5 kHz equipment until December 31, 2006.
• Accept applications for filing to use 12.5 kHz equipment that are filed on or before December 31, 2006.
• Accept applications for filing for new systems to use 6.25 kHz equipment that are filed after December 31, 2006.
• Permit legacy licensees to continue using 12.5 kHz based systems until December 31, 2016.
• Permit legacy licensees to purchase dual mode equipment (operates in 12.5 or 6.25 kHz mode) for system expansion or maintenance and operate it in the 12.5 kHz mode until December 31, 2016.
• Ban the marketing, manufacture and importation of equipment that is exclusively 12.5 kHz effective after December 31, 2006.
• Cease type certifying equipment that is exclusively 12.5 kHz after December 31, 2006.
• Require use of 6.25 kHz equipment exclusively effective after December 31, 2016.
3. Appendix B contains a Final Regulatory Flexibility Analysis (FRFA) with respect to the
4. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), An Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the
5. The need is to resolve outstanding migration issues regarding a migration path for the General Use and State License channels located within the 700 MHz public safety band. Resolution entails requiring a 6.25 kHz requirement for the General Use and State License channels. Our objective is to promote the efficient, effective, and maximum use of 700 MHz public safety band and not hinder development and deployment of public safety equipment. Specifically, the rules adopted herein will: Require licensees in the narrowband General Use and State License channels, whose applications are filed after December 31, 2006, to operate only in voice mode using a voice efficiency standard of at least one voice path per 6.25 kHz of spectrum bandwidth; allow licensees in the narrowband General Use and State License channels, whose applications are filed on or before December 31, 2006 (“legacy licensees”), to operate in voice mode using a voice efficiency standard of at least one voice path per 12.5 kHz of spectrum bandwidth until December 31, 2016; allow legacy licensees to buy dual mode equipment (
6. No comments were submitted in response to the IRFA. Comments were submitted in response to the
7. The RFA directs agencies to provide a description of and, where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operations; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).
8. A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 1992, there were approximately 275,801 small organizations. “Small governmental jurisdiction” generally means “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.” As of 1992, there were approximately 85,006 such jurisdictions in the United States. This number includes 38,978 counties, cities, and towns; of these, 37,566, or ninety-six percent, have populations of fewer than 50,000. The Census Bureau estimates that this ratio is approximately accurate for all governmental entities. Thus, of the 85,006 governmental entities, we estimate that 81,600 (ninety-one percent) are small entities.
9.
10.
11.
12. There were 1,509 TV stations operating in the nation in 1992. That number has remained fairly constant as indicated by the approximately 1,551 operating TV broadcasting stations in the nation as of February 28, 1997. For 1992 the number of TV stations that produced less than $10.0 million in revenue was 1,155 establishments, or approximately 77 percent of the 1,509 establishments. There are currently 95 full service analog TV stations, either operating or with approved construction permits on channels 60-69. In the DTV Proceeding, we adopted a DTV Table that provides only 15 allotments for DTV stations on channels 60-69 in the continental United States. There are seven DTV allotments in channels 60-69 outside the continental United States. Thus, the rules will affect approximately 117 TV stations; approximately 90 of those stations may be considered small businesses. These estimates may overstate the number of small entities since the revenue figures on which they are based do not include or aggregate revenues from non-TV affiliated companies. We recognize that the rules may also impact minority-owned and women-owned stations, some of which may be small entities. In 2000, minorities owned and controlled 23 (1.9 percent) of 1,288 full power commercial TV stations in the United States. According to the U.S. Bureau of the Census, in 1987 women owned and controlled 27 (1.9 percent) of 1,342 commercial and non-commercial TV stations in the United States.
13. There are currently 4,977 TV translator stations and 1,952 LPTV stations. Approximately 1,309 low power TV and TV translator stations are on channels 60-69 which could be affected by policies in this proceeding. The Commission does not collect financial information of any broadcast facility and the Department of Commerce does not collect financial information on these broadcast facilities. We will assume for present purposes, however, that most of these broadcast facilities, including LPTV stations, could be classified as small businesses. As indicated earlier, approximately 77 percent of TV stations are designated under this analysis as potentially small businesses. Given this, LPTV and TV translator stations would not likely have revenues that exceed the SBA maximum to be designated as small businesses.
14. The
15. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
16. The rules adopted in the
17. We note that tighter technical specifications generally allow more intense spectrum use, but may result in higher equipment costs. Conversely, although wider tolerances may allow manufacturers to use less costly component parts in transmitting equipment, they also may result in less efficient spectrum use. Because the Commission is statutorily required to consider the safety of life and property in its consideration of spectrum management issues, we believe that the technical regulations we adopt herein provide a reasonably balanced approach in meeting the Commission's mandate.
18. As for radio equipment for use on the 700 MHz public safety band, we believe that the rules we adopt today will foster competition in the market for radio equipment for use in the 700 MHz public safety band, and thereby increase the opportunity for small entities to enter this market. As for smaller public safety entities, the rules we adopt today are designed to allow them (and all public safety entities) a full 10-year life cycle for equipment they may purchase between now and December 31, 2006. We do not believe there are feasible alternatives to these rules, in that they are the narrowly tailored to allow both early access to the 700 MHz public safety band, and give early entrants into that spectrum a full life span for the equipment they use. Although we considered whether to permit smaller entities, specifically those operating in rural areas, to operate indefinitely using a 12.5 kHz voice efficiency standard, we rejected this approach because we wanted to ensure certainty and consistency of operations by all licensees as described in the
19.
20. Authority for the issuance of this Fifth Report and Order is contained in Sections 4(i), 4(j), 7(a), 302, 303(b), 303(f), 303(g), 303(r), 307(e), 332(a), and 332(c) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 157(a), 302, 303(b), 303(f), 303(g), 303(r), 307(e), 332(a), 332(c).
21. Part 90 of the Commission's Rules, 47 CFR Part 90 is amended as specified in rule changes.
22. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center,
Communications equipment, Radio, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 90 as follows:
Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7).
This subpart sets forth the general technical requirements for use of frequencies and equipment in the radio services governed by this part. Such requirements include standards for acceptability of equipment, frequency tolerance, modulation, emissions, power, and bandwidths. Special additional technical standards applicable to certain frequency bands and certain specialized uses are set forth in subparts J, K, N, and R.
(m) Applications for part 90 certification received after December 31, 2006 will not be granted to transmitters designed to operate in the voice mode on channels designated in §§ 90.531(b)(5) or 90.531(b)(6) that do not provide at least one voice path per 6.25 kHz of spectrum bandwidth.
(n) Transmitters designed to operate in the voice mode on channels designated in §§ 90.531(b)(5) or 90.531(b)(6) that do not provide at least one voice path per 6.25 kHz of spectrum bandwidth shall not be manufactured in, or imported into the United States after December 31, 2006. Marketing of these transmitters shall not be permitted after December 31, 2006.
(b) * * *
(5)
(6)
(d) * * *
(1)
(a) Public safety transmitters operating in the 764-776 MHz and 794-806 MHz bands must conform to the limitations on interference to Canadian television stations contained in
(b) Transmitters designed to operate in the narrowband segment using digital modulation must be capable of maintaining a minimum data (non-voice) rate of 4.8 kbps per 6.25 kHz of bandwidth.
(c) Transmitters designed to operate in the wideband segment using digital modulation must be capable of maintaining a minimum data (non-voice) rate of 384 kbps per 150 kHz of bandwidth.
(d) The following provisions apply to licensees operating in the channels designated in §§ 90.531(b)(5) or 90.531(b)(6).
(1) With the exception of licensees designated in paragraph (d) (2) of this section, after December 31, 2006, licensees may only operate in voice mode in these channels at a voice efficiency of at least one voice path per 6.25 kHz of spectrum bandwidth.
(2) Licensees authorized to operate systems in the voice mode on these channels from applications filed on or before December 31, 2006, may continue operating in the voice mode on these channels (including modification applications of such licensees granted after December 31, 2006, for expansion or maintenance of such systems) at a voice efficiency of at least one voice path per 12.5 kHz of spectrum bandwidth until December 31, 2016.
(3) The licensees designated in paragraph (d)(2) of this section must, no later than January 31, 2017, file a declaration through the Universal Licensing System that they are operating these channels at a voice efficiency of at least one voice path per 6.25 kHz of spectrum bandwidth.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Directed fishery reopening.
NMFS announces that commercial quota is available to allow the directed fishery for Loligo squid to remain open. Vessels issued a Federal moratorium permit to harvest Loligo squid in excess of the incidental catch allowance may continue landing Loligo squid after 0001 hours, December 12, 2002. The intent of this action is to allow for the full utilization of the commercial quota allocated to the Loligo squid directed fishery.
Effective 0001 hours, December 12, 2002, through December 31, 2002.
Paul H. Jones, Fishery Policy Analyst, 978-281-9273, fax 978-281-9135, e-mail paul.h.jones@noaa.gov.
Section 648.22 of part 50 CFR requires NMFS to close the directed
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration, DOT.
Notice of proposed rulemaking (NPRM).
The Federal Aviation Administration (FAA) proposes to supersede an existing airworthiness directive (AD), 98-18-12, applicable to certain Textron Lycoming reciprocating engines with certain Crane/Lear Romec “AN” rotary fuel pumps installed. That AD currently requires initial and follow-up torque check inspections of pump relief valve attaching screws. This proposal would require the same initial and follow-up torque check inspections of relief valve attaching screws, and add as a terminating action, replacement of the affected fuel pump at or before the overhaul interval, with a fuel pump having a new design valve housing. This proposal is prompted by the introduction of a new design pump relief valve housing and associated parts that provide enhanced resistance to fuel leakage, and the need for clarification of the requirements of the current AD. The actions specified by the proposed AD are intended to prevent rotary fuel pump leaks, which could result in an engine failure, engine fire, and damage to or loss of aircraft.
Comments must be received by February 11, 2003.
Submit comments in triplicate to the Federal Aviation Administration (FAA), New England Region, Office of the Regional Counsel, Attention: Rules Docket No. 97-ANE-50-AD, 12 New England Executive Park, Burlington, MA 01803-5299. Comments may be inspected at this location, by appointment, between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. Comments may also be sent via the Internet using the following address:
The service information referenced in the proposed rule may be obtained from Lycoming, 652 Oliver St., Williamsport, PA 17701; telephone; (717) 327-7080, fax; (717) 327-7100. This information may be examined, by appointment, at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA.
Norm Perenson, Aerospace Engineer, New York Aircraft Certification Office, FAA, Engine and Propeller Directorate, 10 Fifth Street, 3rd floor, Valley Stream, NY 11581-1200; telephone (516) 256-7537; fax (516) 568-2716.
Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.
Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 97-ANE-50-AD.” The postcard will be date stamped and returned to the commenter.
Any person may obtain a copy of this NPRM by submitting a request to the FAA, New England Region, Office of the Regional Counsel, Attention: Rules Docket No. 97-ANE-50-AD, 12 New England Executive Park, Burlington, MA 01803-5299.
On September 1, 1998, the FAA issued AD 98-18-12, Amendment 39-10728 (63 FR 48571, September 11, 1998), applicable to certain Textron Lycoming reciprocating engines with Crane/Lear Romec “AN” rotary fuel pump series RG9080, RG9570, and RG17980 installed. That AD requires initial and follow-up torque check inspections of pump relief valve attaching hardware screws, to prevent fuel leakage. That condition, if not corrected, could result in an engine failure, engine fire, and damage to or loss of aircraft.
Since AD 98-18-12 was issued, the manufacturer of the fuel pump has introduced a new design pump relief valve housing and associated parts, that provides enhanced resistance to fuel leakage on Crane/Lear Romec “AN” rotary fuel pumps, series RG9080, RG9570, and RG17980. The proposed AD would also address two concerns with the current AD:
• Initial and follow-up torque checks of affected pumps used as replacement pumps; and
• Compliance time for follow-up torque checks.
Additionally, the current AD does not specify an exact time by when follow-up torque checks must be performed. The current AD requires, and the proposal would require, that operators perform those follow-up torque checks after waiting a minimum time, either 50 hours TIS or 6 months, in order to allow the gasket to seat. Follow-up torque checks performed too soon after the
The FAA has reviewed and approved the technical contents of Lycoming Service Bulletin (SB) No. 529B, dated June 10, 2002, that describes procedures for initial and follow-up torque check inspections of affected pump relief valve attaching screws.
Since an unsafe condition has been identified that is likely to exist or develop on other Textron Lycoming reciprocating engines with Crane/Lear Romec “AN” rotary fuel pump series RG9080, RG9570, and RG17980 installed, the proposed AD would supersede AD 98-18-12, maintaining the same requirement for initial and follow-up torque check inspections of relief valve attaching screws, and add as a terminating action, replacement of the fuel pump with one having a newly designed valve housing. The actions must be done in accordance with the service bulletin described previously.
There are about 16,000 engines with Crane/Lear Romec “AN” rotary fuel pumps of the affected design in the worldwide fleet. The FAA estimates that 9,600 pumps installed on aircraft of U.S. registry would be affected by this proposed AD. The FAA also estimates that it would take approximately 3 work hours per pump to perform the proposed actions, and that the average labor rate is $60 per work hour. Required parts would cost approximately $300 per pump. Based on these figures, the total cost of the proposed AD on U.S. operators is estimated to be $4,608,000.
This proposed rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this proposed rule.
For the reasons discussed above, I certify that this proposed regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. Section 39.13 is amended by removing Amendment 39-10728 (63 FR 48571, September 11, 1998), and by adding a new airworthiness directive, to read as follows:
This airworthiness directive (AD) is applicable to Textron Lycoming IO-320, LIO-320, IO-360, HIO-360, TIO-360, LTIO-360, GO-435, GO-480, IGO-480-A1B6, IO-540, IGO-540, AEIO-540, HIO-540, TIO-540, LTIO-540, TIGO-541, IO-720, and TIO-720 reciprocating engines, with Crane/Lear Romec RG9080, RG9570, and RG17980 series “AN” rotary fuel pumps listed in Table 1 installed. Table 1 follows:
These engines are installed on, but not limited to fuel injected, reciprocating engine-powered aircraft manufactured by Cessna, The New Piper, Inc., Mooney, Raytheon (Beech), Bellanca, Champion, Partenavia, Rockwell, Schweizer, Enstrom, Aerospatiale (SOCATA), Maule, Aero Commander, Helio, Hiller, and Pacific Aerospace Corp.
This AD applies to each engine identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area
Required as indicated, unless already done.
To prevent rotary fuel pump leaks, which could result in an engine failure, engine fire, and damage to or loss of the aircraft, accomplish the following:
(a) If the Lear/Romec part number (P/N) on rotary fuel pumps, series RG9080, RG9570, or RG17980 has an “/M” suffix, the pump has been modified, and no further action is required.
(b) If the P/N does not have an “/M” suffix, perform initial and follow-up torque check inspections of pump relief valve attaching screws in accordance with the Accomplishment Instructions of Lycoming Service Bulletin (SB) No. 529B, dated June 10, 2002, as follows:
(1) Within 10 hours time-in-service (TIS), or 30 days after the effective date of this AD, whichever occurs first, perform the initial torque check inspection. If the torque does not meet the specifications in Lycoming SB No. 529B, dated June 10, 2002, tighten screws to the required torque in accordance with that SB.
(2) Perform follow-up torque check inspections at 50 hour intervals TIS, or 6 months since the previous torque check inspection, whichever occurs first. If the torque does not meet the specification in Lycoming SB No. 529B, dated June 10, 2002, during this follow-up inspection, tighten screws to the required torque in accordance with that SB.
(3) Continue the follow-up torque check inspections required by paragraph (a)(2) of this AD until:
(i) The accumulation of 100 hours TIS since the inspection with the torque remaining within the SB specification; or
(ii) The torque meets the SB specification during the initial inspection and a subsequent inspection taking place after accumulating an additional 50 hours TIS also meets the SB specification.
(4) After the accumulation of 100 hours TIS since the inspection with the torque remaining within the SB specification; visually inspect the pump at 50-hour intervals until the pump is replaced with a modified pump (with the “/M” after the part number).
(c) Replacement of a rotary fuel pump series RG9080, RG9570, or RG17980, with an unmodified pump (without the “/M” after the part number) requires repeating the initial and follow-up inspections in accordance with paragraph (b) of this AD.
(d) Replacement of a rotary fuel pump series RG9080, RG9570, or RG17980, with a modified pump (with the “/M” after the part number) constitutes terminating action for the inspection requirements specified in paragraphs (b)(1) through (b)(4) of this AD.
(e) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, New York Aircraft Certification Office (ACO). Operators must submit their request through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, New York ACO.
Information concerning the existence of approved alternative methods of compliance with this airworthiness directive, if any, may be obtained from the New York ACO.
(f) Special flight permits may be issued in accordance with §§ 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the aircraft to a location where the inspection requirements of this AD can be done.
Federal Aviation Administration, DOT.
Notice of proposed rulemaking (NPRM).
This document proposes the adoption of a new airworthiness directive (AD) that is applicable to certain Aerospatiale Model ATR42-500 series airplanes, and Model ATR72-102, -202, -212, and -212A series airplanes. This proposal would require replacement of insulation blankets constructed of metallized polyethyleneteraphthalate (MPET) located from sections 11 through 16 of the fuselage with new insulation blankets constructed of Terul 18
Comments must be received by January 13, 2003.
Submit comments in triplicate to the Federal Aviation Administration (FAA), Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2002-NM-73-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056. Comments may be inspected at this location between 9 a.m. and 3 p.m., Monday through Friday, except Federal holidays. Comments may be submitted via fax to (425) 227-1232. Comments may also be sent via the Internet using the following address:
The service information referenced in the proposed rule may be obtained from Aerospatiale, 316 Route de Bayonne, 31060 Toulouse, Cedex 03, France. This information may be examined at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington.
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2125; fax (425) 227-1149.
Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained
Submit comments using the following format:
• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.
• For each issue, state what specific change to the proposed AD is being requested.
• Include justification (
Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-73-AD.” The postcard will be date stamped and returned to the commenter.
Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2002-NM-73-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.
The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on certain Aerospatiale Model ATR42-500 series airplanes, and Model ATR72-102, -202, -212, and -212A series airplanes. The DGAC advises that it has received reports of fires initiated by an electrical short circuit behind a sidewall, in which the flammability characteristics of thermal/acoustical insulation material constructed of metallized polyethyleneteraphthalate (MPET) may have been a contributing factor. Although reported incidents have not occured on ATR airplane models, the DGAC has issued French airworthiness directives 2001-635-061(B) and 2001-636-088(B), both dated December 26, 2001, in order to assure the continued airworthiness of Aerospatiale Model ATR42-500 series airplanes, and Model ATR72-102, -202, -212, and -212A series airplanes in France.
Insulation blankets constructed of MPET that are installed in the fuselage, if not removed, could propagate a small fire that is the result of an otherwise harmless electrical arc and could lead to a much larger fire.
The manufacturer has issued Avions de Transport Regional Service Bulletin ATR42-25-0134 (for Model ATR42-500 series airplanes); and ATR72-25-1074 (for Model ATR72-102, -202, -212, -212A series airplanes); both dated January 24, 2002. These service bulletins describe procedures for replacing the existing insulation blankets constructed of MPET located from sections 11 through 16 of the fuselage with new, improved insulation blankets constructed of Terul 18
These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.
Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the applicable service bulletin described previously.
The proposed AD would differ from the parallel French airworthiness directives in that it would require accomplishment of the replacement within 5 years after the effective date of this AD. The parallel French airworthiness directives require accomplishment of the replacement during the next “eight-year calendar check and before May 31, 2009.” In developing an appropriate compliance time for this proposed AD, the FAA considered not only the DGAC's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, the compliance time mandated in previously issued ADs concerning insulation blankets constructed of MPET installed on other transport category airplanes, and the average utilization of the affected fleet.
The FAA's intent is that the replacement be conducted during a regularly scheduled maintenance visit for the majority of the affected fleet, when the airplanes would be located at a base where special equipment and trained personnel would be readily available, if necessary. In order to meet the deadline, the FAA expects early planning and anticipates that operators will have to take advantage of every heavy maintenance opportunity. In light of these factors, the FAA finds a 5-year compliance time for completing the required actions to be warranted, in that it represents an appropriate interval of time allowable for affected airplanes to continue to operate without compromising safety. The difference in compliance time has been coordinated with and acknowledged by the DGAC.
The FAA estimates that 2 Aerospatiale Model ATR42-500 series airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 500 work hours per airplane to accomplish the proposed replacement, and that the average labor rate is $60 per work hour. Required parts would cost approximately $50,000 per airplane. Based on these figures, the cost impact of the proposed AD on U.S. operators of Model ATR42-500 series airplanes is estimated to be $160,000 or $80,000 per airplane.
The FAA estimates that 19 Aerospatiale Model ATR72-102, -202, -212, and -212A series airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 500 work hours per airplane to accomplish the proposed replacement, and that the average labor rate is $60 per work hour. Required parts would cost approximately $60,000 per airplane. Based on these figures, the cost impact of the proposed AD on U.S. operators of Model ATR72-102, -202, -212, and -212A series airplanes is
The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.
The regulations proposed herein would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.
For the reasons discussed above, I certify that this proposed regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. Section 39.13 is amended by adding the following new airworthiness directive:
This AD applies to each airplane identified in the preceding applicability provision, regardless of whether it has been otherwise modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (c) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.
To ensure that insulation blankets constructed of metallized polyethyleneteraphthalate (MPET) are removed from the fuselage, to prevent propagation of a fire that is the result of an otherwise harmless electrical arc and could lead to a much larger fire, accomplish the following:
(a) Within 5 years after the effective date of this AD, replace insulation blankets located from sections 11 through 16 inclusive of the fuselage with new, improved insulation blankets constructed of Terul 18
Although paragraph (a) of this AD allows up to 5 years for the required replacement, the FAA encourages operators to review their airplanes to assess their individual needs for materials and plan accordingly. The FAA anticipates that operators will accomplish the requirements of this AD at the earliest practicable maintenance opportunity to lessen the burden toward the end of the compliance time.
(b) As of the effective date of this AD, no person shall install an insulation blanket constructed of MPET on any airplane.
(c) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, International Branch, ANM-116.
Information concerning the existence of approved alternative methods of compliance with this AD, if any, may be obtained from the International Branch, ANM-116.
(d) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.
The subject of this AD is addressed in French airworthiness directives 2001-635-061(B) and 2 001-636-088(B), both dated December 26, 2001.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to reclassify the arrhythmia detector and alarm from class III (premarket approval) to class II (special controls) based on new information regarding the device. FDA is also proposing to revise the identification of the arrhythmia detector and alarm to separate the automated external defibrillator (AED) from the identification of the arrhythmia detector and alarm. FDA intends to propose the reclassification of the AED at a later time. FDA is taking this action in response to petitions submitted under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe
Submit written or electronic comments by March 13, 2003.
Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: http://www.fda.gov/dockets/ecomments.
Carole C. Carey, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609.
The act, as amended by the 1976 amendments (Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public Law 105-115), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendment devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
A preamendments device that has been classified into class III may be marketed, by means of premarket notification (510(k)) procedures, without submission of a premarket approval application until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.
The SMDA added section 515(i) to the act. This section requires FDA to issue an order to manufacturers of preamendment class III devices and substantially equivalent postamendments devices for which no final regulation requiring the submission of premarket approval applications (PMAs) has been issued. This order requires such manufacturers to submit to the agency a summary of, and a citation to, any information known or otherwise available to them respecting such devices, including adverse safety and effectiveness information that has not been submitted under section 519 of the act (21 U.S.C. 360i). Section 519 of the act requires manufacturers, importers, distributors, and device user facilities to submit adverse event reports of certain device-related events and reports of certain corrective actions taken. Section 515(i) of the act also directs FDA to either revise the classification of the device into class I or class II or require the device to remain in class III and establish a schedule for the promulgation of a rule requiring the submission of PMAs for those devices remaining in class III.
In the
In the
Reclassification of classified preamendments devices is governed by section 513(e) of the act. This section provides that FDA may, by rulemaking, reclassify a device based upon “new information.” The reclassification can be initiated by FDA or by the petition of an interested person.
The term “new information,” as used in section 513(e) of the act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g.,
Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of changes in “medical science.”
(See
The arrhythmia detector and alarm subject to this proposal was classified in part 870 (21 CFR part 870) by a final rule published in the
FDA is addressing three petitions to reclassify arrhythmia detectors and alarms from the Health Industry Manufacturers Association (HIMA) (now known as Advamed); Quinton Instrument Co.; and Zymed Medical Instrumentation (Refs. 1 through 3) and safety and effectiveness information (“515(i) submissions”) submitted by Datascope Corp.; Hogan and Harton L.L.P.; Life Sensing Instrument Co.; Inc.; Medical Data Electronics; Mennen Medical Ltd.; Mortara Instrument; and, Olsson, Frank and Weeda, P.C. (Refs. 4 through 10).
FDA is not addressing at this time the petitions submitted by HIMA (Advamed) to reclassify automated external defibrillators (AEDs) from class III to class II. This device is primarily designed for a different intended use than the arrhythmia detector and alarm. An AED has a shock advisory algorithm, automatically detects a shockable cardiac rhythm, and automatically delivers an electric shock (fully automated device) or delivers a shock when activated by the operator (semi-automated device). Defibrillators are preamendment class II devices under § 870.5300. Arrhythmia detectors and alarms are preamendment class III devices under § 870.1025. AEDs are devices found substantially equivalent to the class III arrhythmia detector and alarm (§ 870.1025) in response to a 510(k) because they are a combination of the class II defibrillator and the class III arrhythmia detector and alarm. FDA, therefore, found them equivalent to the higher class of the combined devices. In a future issue of the
FDA is proposing to add a new identification of the AEDs to read as follows:
An automated external defibrillator is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. The device analyzes the patient's electrocardiogram, interprets the cardiac rhythm and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
The name of the classification regulation, arrhythmia detector and alarm and the identification of these devices will remain unchanged.
FDA is proposing that the arrhythmia detector and alarm be reclassified from class III to class II. FDA believes that the guidance document identified in section VIII of this document as the special control would provide reasonable assurance of the safety and effectiveness of the device. Therefore, in accordance with sections 513(e) and 515(i) of the act and 21 CFR 860.130, based on new information with respect to the device, FDA is proposing to reclassify the arrhythmia detector and alarm preamendment class III device into class II.
The agency does not intend to exempt this proposed class II device from premarket notification (510(k)) submissions as permitted by section 510(m) of the act.
FDA believes that it needs to review the information to address the risks identified in the guidance document in order to assure that a new device is at least as safe and effective as legally marketed devices.
After considering the information discussed by the panel during the original classification proceedings, as well as published literature, medical device reports (MDR), and section 515(i) of the act submissions of safety and effectiveness information, FDA has evaluated the risks associated with the arrhythmia detector and alarm. FDA now believes that the following are the risks to health associated with the use of the arrhythmia detector and alarm:
Inaccurate electrocardiogram (ECG) waveform measurement and analysis can lead to misdiagnosis and could result in failure-to-alarm in the case of life threatening arrhythmias or cause false alarms to be activated. Conditions exist under which an algorithm may misclassify portions of the ECG waveform. Inadequate design and poor signal processing techniques in the presence of artifact or noise can also result in miscounting of heart rate and misclassification of arrhythmias. Noise degrades signal quality and is affected by patient motion, electromagnetic interference, and improper electrode placement. It may distort the signal to the point the data are invalid or cannot be analyzed.
Although the algorithm in most commercially available devices today has improved accuracy in both beat detection and beat classification with enhanced noise reduction techniques, it is extremely difficult to design a system that accurately analyzes 100 percent of all arrhythmias. Algorithm accuracy is a potential safety and effectiveness issue; however, it is not frequently reported as an adverse event. Approximately 6 percent of the MDR and complaint data are attributed to algorithm accuracy (Ref. 1). The ability of ST-segment measurement algorithm performance to predict clinical conditions has not been completely validated. Literature indicates that this capability is helpful for patients who have the potential of experiencing ischemic episodes and some clinicians believe changes in the ST segment can be indicative of myocardial ischemia (Refs. 11 through 15).
The performance of an automated, computerized, arrhythmia monitor system is dependent on the accuracy of the arrhythmia detection and identification algorithm. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk.
Many patients on ECG monitoring systems also have pacemakers. This condition poses a particular problem as the detection of pacemaker pulse artifact during “loss of capture” (heart does not respond to the pacing pulse stimulus), may inappropriately be interpreted as a normal beat. Failure of a heart rate alarm to occur during loss of capture compromises the patient's condition and may result in death. In the early 1990s, Emergency Care Research Institute (ECRI) investigated the difficulties in monitoring pacemaker patients (Ref. 16). Their initial testing of the patient monitors demonstrated the devices' limited ability to reliably reject simulated pacemaker signals. A
The level of training and quality of user training greatly affect the safe and effective operation of arrhythmia monitoring systems. An unattended monitor, or use by untrained or improperly trained clinical staff, can adversely affect system performance. In a system where excessive false alarms occur (from causes described in previous paragraphs), this may result in user failure to respond promptly to critical alarms. Furthermore, caregivers could develop a negative attitude from the false alarms, eroding user confidence in the device and resulting in deactivation of the alarm or failure to reset the alarm. HIMA (Advamed) indicated that approximately 15 percent (9 of 59) of the MDRs from 1984 to 1995 were attributed to alarm functionality (i.e., alarms turned off by the staff) (Ref. 1). Other device performance concerns are difficulty in using the device and the device taking too much time to use (i.e., setting up the patient and ensuring that the algorithm has learned the appropriate rhythms) (Ref. 18).
Loss of alarm at central station or bedside may occur due to software crash, hardware failure preventing communication, and/or the inability of central station to receive data/alarms from the bedside monitor.
Excessive patient leakage current may result in electrically induced cardiac arrhythmias.
After considering the data and information contained in the petitions, 515(i) submissions of safety and effectiveness information, published literature, and over 20 years of device experience in the clinical environment, FDA believes that the arrhythmia detector and alarm can be reclassified into class II. Special controls, in addition to general controls, can address the risks described above and provide reasonable assurance of the safety and effectiveness of the device. FDA believes there is sufficient information to establish special controls to provide such assurance.
In addition to the potential risks of the arrhythmia detector and alarm described in section V of this document, there is reasonable knowledge of the benefits of the device. Specifically, arrhythmia detector and alarm monitoring systems allow cardiac monitoring of patients who are at significant risk of immediate life-threatening arrhythmias, such as patients suspected of having acute myocardial infarction, patients who have been recently resuscitated from cardiac arrest, and patients with unstable angina (Ref. 19). When monitoring for evidence of cardiac ischemia, the ST-segment monitoring feature in the arrhythmia detector and alarm devices allows timely notification of ST- segment changes. The integrated alarm system alerts caregivers to any life threatening arrhythmias that require their immediate attention and assessment of the patient's condition before treatment intervention. In addition to patient cardiac monitoring in critical areas, it is also frequently used in noncritical settings to improve patient care management and serve as a labor saving device. The computerized documentation or trending of arrhythmia events is far more efficient than piecing together pages of ECG strips.
Based on the available information, FDA believes that the special controls discussed in section VII of thus document are capable of providing reasonable assurance of the safety and effectiveness of the arrhythmia detector and alarm with regard to the identified risks to health of this device.
FDA believes that the special control guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA,” in addition to general controls, can address the risks to health described in section V of this document. Elsewhere in this issue of the
If adopted, following the effective date of a final rule classifying the device, any firm submitting a 510(k) premarket notification for the device would need to address the issues covered in the special control guidance. However, the firm would need to show only that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
The guidance document contains specific recommendations with regard to the information and testing in the premarket notification application. Particular sections of the guidance document address the following topics:
• Safety testing (software validation, electrical safety and environmental handling testing, electromagnetic compatibility),
• Performance testing, and
• Labeling.
Safety testing as described in the guidance document includes software validation, electrical safety and environmental handling testing, and electromagnetic compatibility. The in vitro safety testing can help control the risks of incorrect pacemaker pulse detection and other risks associated with the use of the device, such as loss of alarm at central station or bedside monitor, excessive patient leakage current, injury to patient's skin, and electrical shock to the operator. Proper design can improve the paced patient algorithm performance. For example, the pace pulse detection should be implemented on the unfiltered ECG signal prior to processing of the waveform by the QRS beat detector. Most of the other concerns addressed in this section of the guidance are well known and are generic to microprocessor-controlled, software-driven, electromedical devices. This section of the guidance makes recommendations on the qualification testing to evaluate the device electrical safety requirements, its ability to function after exposure to environmental hazards, electromagnetic compatibility in the intended environment of use, and software validation based on the use of relevant
The section on performance testing of the guidance document can help control the risks of misdiagnosis from inaccurate ECG signal measurement and misclassified waveforms. The availability of annotated arrhythmia databases has allowed detection algorithms to be tested on the same data. It is recommended that manufacturers properly test the accuracy of the automated arrhythmia detection and ST-segment measurement algorithms, and disclose the results of those tests. This section of the guidance document also emphasizes testing to demonstrate conformance to relevant ECG standards, testing alarm accuracy within a few seconds of the onset of critical life threatening arrhythmias, and testing other alarms functions including those related to system tasks. The guidance also recommends comparative testing to a legally marketed predicate device. If the device incorporates significant new features, additional testing may be necessary. These tests may be conducted in the laboratory and/or clinical settings.
As described in the guidance, labeling can help control the delayed responses to life threatening arrhythmias due to user error, improper training, and unattended monitors. In addition to conformance to the labeling regulations at 21 CFR part 801, the user (operator) manual should contain detailed operating instructions designed to reduce risks from user error with the device. Furthermore, the device should be operated only by persons with specific training in the use of the device.
FDA believes that the arrhythmia detector and alarm can be reclassified into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.
The agency has determined under 21 CFR 25.34(b) that this proposed classification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform act of 1995 (Public Law 104-4). Executive order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages, distributive impacts, and equity). The agency believes that this proposed rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the proposed rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of this device from class III to class II will relieve all manufacturers of the device of the cost of complying with the premarket approval requirements in section 515 of the act. Manufacturers of class III arrhythmia detectors and alarms currently are required to submit premarket notifications. The guidance document reflects existing FDA practice in the review of these premarket notifications. FDA expects that manufacturers of cleared arrhythmia detectors and alarms will not have to take any additional action in response to this rule, if FDA finalizes this rule. This rule will help expedite the review process for any new manufacturers of these devices. Because reclassification will reduce regulatory costs with respect to this device, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs. The agency therefore certifies that this proposed rule, if issued, will not have a significant economic impact on a substantial number of small entities. In addition, this proposed rule will not impose costs of $100 million or more on either the private sector or state, local, and tribal governments in the aggregate, and therefore a summary statement of analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.
Interested persons may submit to the Dockets Management Branch (see
The following references have been placed on display in the Dockets Management Branch (see
1. HIMA (Health Industry Manufacturers Association), reclassification petition, Docket No. 94N-0418, vol. 1-7, Washington, DC, August 14, 1996.
2. Quinton Instrument Co., reclassification petition, Docket No. 94N-0418, vol. 1, WA, August 14, 1996.
3. Zymed Medical Instrumentation, reclassification petition, Docket No. 96P-0276/CCP 1, vol. 1, CA, August 7, 1996.
4. Datascope Corp., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, NJ, October 2, 1996.
5. Hogan and Hartson L. L. P. for Cardiac Telecom Corp., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, Washington, DC, August 14, 1996.
6. Life Sensing Instrument Co., Inc., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, TN, July 15, 1996.
7. Medical Data Electronics, Inc., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, CA, August 14, 1996.
8. Mennen Medical Ltd., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, October 25, 1996.
9. Mortara Instrument, Inc., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, WI, August 14, 1996.
10. Olsson, Frank and Weeda, P. C. for QMED, Inc., submission of safety and effectiveness information, Docket No. 94N-0418, vol. 1, Washington, DC, August 15, 1996.
11. Ellis, J. et al., “Comparison of Two Automated ST-Segment Analysis Systems, EKG (Including T Wave Inversion Analysis), and Transesophageal Echocardiography for the Diagnosis of Intraoperative Myocardial Ischemia,” abstract (included in Ref. 1).
12. Gottlieb, S. et al., “Silent Ischemia on Holter Monitoring Predicts Mortality in High-Risk Postinfarction Patients,”
13. Krucoff, M., “Identification of High Risk Patients with Silent Myocardial Ischemia After Percutaneous Transluminal Coronary Angioplasty by Multilead Monitoring,”
14. Muller, J. and Barash, P., “Automated ST-Segment Monitoring,”
15. Nademanee, K. et al., “Characteristics and Clinical Significance of Silent Myocardial Ischemia in Unstable Angina,”
16. ECRI, “Physiologic Patient Monitors,” update,
17. ECRI, “Ambulatory Telemetry Arrhythmia Monitoring Systems (including Guidance Section: Implementation and Effective Use of Telemetry Arrhythmia Monitoring Systems,”
18. Badura, F., “Nurse Acceptance of a Computerized Arrhythmia Monitoring System,”
19. Emergency Cardiac Care Committee of the American College of Cardiology, “Recommended Guidelines for In-Hospital Cardiac Monitoring of Adults for Detection of Arrhythmias,”
Medical devices.
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 870.1 is amended by adding paragraph (e) to read as follows:
(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html.
(2)
(b)
(2)
(3)
Department of State.
Proposed rule with request for comments.
Under current regulations, crewmen working on vessels and aircraft bound for the United States are able to obtain crew list visas without submitting individual application forms or undergoing background checks that would apply to many if they applied for individual visas. In light of the security concerns resulting from the events of September 11, 2001, the Department can no longer justify issuance of a visa without the full application process. This rule proposes to amend the regulations to eliminate the crew list visa.
Written comments must be received on or before February 11, 2003.
Written comments may be submitted to the Chief, Legislation and Regulations Division, Visa Services, Department of State, Washington, DC 20520-0106, by fax to 202-663-3898 or by e-mail to
Pam Chavez, Legislation and Regulations Division, Visa Services, Department of State, Washington, DC 20520-0106, 202-663-1206 or e-mail
The Department's current regulation at 22 CFR 41.42(a) defines crew list visa as follows: “A crew list visa is a nonimmigrant visa issued on a manifest of crewmen of a vessel or aircraft and includes all aliens listed in the manifest unless otherwise stated. It constitutes a valid nonimmigrant visa within the meaning of INA 212(a)(7)(B)(i)(II).”
Authority for the issuance of a crew list visa is derived from sections 101(a)(15)(D) and 221(f) of the Immigration and Nationality Act, 8 U.S.C. 1101(a)(15)(D) and 1201(f), respectively. Section 101(a)(15)(D) exempts aliens serving in good faith as crewmen on board a vessel (other than a fishing vessel having its home port or an operating base in the United States, unless temporarily landing in Guam), or aircraft from being deemed immigrants. Section 221(f) permits an alien to enter the United States on the basis of a crew manifest that has been visaed by a consular officer. However, the latter section does not require a consular officer to visa a crew manifest and in those cases where the consular officer does agree to do so, it authorizes the officer to deny admission to any alien from the crew list visa. Further, the use of the visaed crew list appears to have been intended principally as a temporary or emergency measure to be used only until such time as it becomes practicable to issue individual documents to each member of a vessel's or aircraft's crew.
To obtain a crew list visa, the representative or agent of a foreign vessel or aircraft must submit a master list of all crewmen employed on the
Applicants applying for crew list visas are not required to complete the Forms DS-156, Nonimmigrant Visa Application, or DS-157, Supplemental Nonimmigrant Visa Application or submit a passport, nor are they required to undergo an interview.
While consular officers are required to conduct background checks, including a check of the computerized name check system, for applicants for crew list visas, background checks are not as reliable for crew list applicants since it is not possible to verify with certainty that the names submitted on the crew list are spelled correctly. In addition, since crew list visa applicants ordinarily are not interviewed, consular officers have no opportunity to question them regarding such things as employment history or knowledge of their trade.
The Enhanced Border Security and Visa Entry Reform Act of 2002 (Pub. L. 107-173) requires that all visas issued after October 26, 2004 have a biometric indicator. This means crew list visas would necessarily be eliminated by that date. Additionally, since September 11, the Department has been amending its regulations to ensure that every effort is made to screen out undesirable aliens. The Department is, therefore, amending its regulations to eliminate crew list visas and ensure that each crewmember entering the United States will complete the nonimmigrant visa application forms, submit a valid passport and undergo an interview and background checks.
In terms of the actual cost of a visa, per crewman, in general the cost of an individual visa will be no more than it is, per crewman, on a crew list visa, and in most cases over a period of years will average out to be less. For crew list visas each crewman already pays an individual processing,
Nevertheless, in preliminary discussions with representatives of the shipping industry, most comments about the economic impact of this proposed rule have been associated with the difficulties and costs that will be presented to the industry should issuance of individual visas result in long and expensive delays waiting in port for visas to be issued. These representatives say that tight and sometimes erratic scheduling, and a constant shifting of crew members are features of the industry that need to be taken into consideration in implementing a requirement for individual visas. Therefore, the Department invites all interested parties to comment specifically on the economic and manning impacts of this rule, as proposed, and to suggest measures the Department might consider when implementing the rule that would minimize any negative impacts of this type.
This rule proposes to remove the Department's regulations at 22 CFR 41.42 that establish the crew list visa. By doing so, all crewmembers entering the United States would be required to apply for individual crew visas.
The Department is publishing this rule as a proposed rule with a 60-day provision for post-promulgation public comments.
The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will not 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 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 is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or 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.
The Department of State considers this rule to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Therefore, it has been submitted for review 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 the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
Aliens, Nonimmigrants, Passports, Visas.
In view of the foregoing, 22 CFR Part 41 is amended as follows:
1. The authority citation for Part 41 continues to read:
8 U.S.C. 1104; Pub. L. 105-277, 112 Stat. 2681-795 through 2681-801.
Remove and reserve section 41.42.
Agency for International Development, Office of the Inspector General.
Notice.
This notice is hereby given of the appointment of members of the updated USAID OIG SES Performance Review Board.
November 26, 2002.
Michael G. Carroll, Assistant Inspector General for Management, Office of Inspector General, U.S. Agency for International Development, 1300 Pennsylvania Avenue, NW, Room 8.08-029, Washington, DC 20523-8700; telephone 202-712-0010; fax 202-216-3392; Internet e-mail address:
5 U.S.C. 4314(b)(c) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management at 5 CFR part 430, subpart C and § 430.307 thereof in particular, one or more Senior Executive Service performance review boards. In order to ensure an adequate level of staffing and to avoid a constant series of recusals, these newly designated members of USAID's OIG SES Performance Review Board are being drawn, as in the past, primarily from the SES ranks of other agencies because USAID OIG only has five SES members. The board shall review and evaluate the initial appraisal of each USAID OIG senior executive's performance by his or her supervisor, along with any recommendations to the appointing authority relative to the performance of the senior executive. This notice updates the membership of the USAID OIG's SES Performance Review Board as it was last published.
Approved: November 26, 2002.
The following have been selected as regular members of the SES Performance Review Board of the U.S. Agency for International Development, Office of Inspector General:
James R. Ebbitt, Deputy Inspector General.
Adrienne Rish, Assistant Inspector General for Investigations.
Michael G. Carroll, Assistant Inspector General for Management.
Robert S. Perkins, Legal Counsel.
Bruce Crandlemire, Assistant Inspector General for Audit.
Aletha Brown, Inspector General, Equal Employment Opportunity Commission.
Melissa Heist, Assistant Inspector General for Audit, Environmental Protection Agency.
Edward Blansitt, Deputy Inspector General, Department of Commerce.
Michael Speedling, Assistant Inspector General for Investigations, Environmental Protection Agency.
Kwai Chan, Assistant Inspector General for Program Evaluation, Environmental Protection Agency.
Forest Service USDA.
Notice; intent to prepare environmental impact statement.
The USDA, Forest Service, will prepare an environmental impact statement (EIS) to disclose the environmental effects of a proposed amendment to the Gallatin National Forest Land and Resource Management Plan (Forest Plan) that will establish direction for public recreational use and access using the Forest's road and trail system. For each road and trail the Amendment will specify the types of uses that are appropriate including pleasure driving, high clearance and off-road vehicle use, motorcycle use, biking, horseback riding, snowmobiling, hiking, skiing and snowshoeing. The amendment will also establish travel management goals, objectives and standards for sub-areas within the Gallatin National Forest.
The Gallatin National Forest Land and Resource Management Plan (Forest Plan) provides overall guidance for land management activities that occur on the Forest. Forest plans are developed, revised, and amended in compliance with the National Forest Management Act of 1976 (NFMA); and the regulations for National Forest Land and Resource Management Planning at 36 CFR part 219. This amendment would remove some existing Forest Plan provisions pertaining to travel management and replace them with an overall travel management plan specific to roads and trails. A range of 4 to 6 alternatives are targeted for consideration in the travel planning process.
Alternatives are expected to be ready for public review and comment by February or March, 2003. Requests to receive information and notification of opportunities to provide comments should be received prior to that time.
Requests to be placed on the travel planning mailing list should be sent to Pam Bentley, Gallatin National Forest Supervisors Office, P.O. Box 130, Bozeman, Montana, 59771-0130.
Steve Christiansen, Travel Planning Interdisciplinary Team Leader, Gallatin National Forest Supervisors Office, (406) 587-6750.
The Gallatin National Forest includes approximately 1.9 million acres of public land adjacent to the northern and western boundaries of Yellowstone National Park. It lies within all or portions of Sweet Grass, Park, Carbon, Meagher, Gallatin, and Madison Counties, Montana. Local communities include Bozeman, Big Sky, West Yellowstone, Livingston, Big Timber, Gardiner, and Cooke City, Montana. There are over 1300 miles of road and
The purpose for a Gallatin National Forest Travel Management Plan and Amendment are to: (1) Provide for public access and recreational demand of the road and trail system on the Forest considering both the quantity and quality of opportunity to be provided. (2) Bring road and trail use into compliance with laws, regulations, and other higher level management direction. (3) Correct unacceptable resource damage that may be occurring due to the use of or condition of Forest roads and trails. (4) Provide for public understanding of the types of use and season of use allowed for each road and trail. (5) Identify administrative access routes to facilitate management of a variety of resources on the Gallatin National Forest. (6) Replace outdated, ineffective, and/or unclear Forest Plan standards and other direction applicable to road and trail management.
As a beginning to the travel planning process the Forest Service has prepared a “benchmark” travel management plan alternative. The benchmark is not considered an agency proposal or preferred alternative because it does not have the benefit of public input or preliminary environmental analysis. It has been developed as a conceptual travel management plan to focus interested citizen and user group participation and initial environmental analysis from Forest Service specialists. Based on early public comment and analysis the benchmark will be used to develop a range of 4 to 6 alternatives that represent various interests and respond to environmental issues. The alternatives will represent “proposed options” for a travel management plan and will be made available for review, comment, and modification during the late winter/early spring of 2003. The benchmark can be viewed on the Gallatin National Forest Web site at
Comments on the alternatives from the public and other agencies will be used in preparation of a Draft Environmental Impact Statement (DEIS). More specifically, comments will be used to modify and refine the alternatives and identify potential resource issues (environmental effects) that should be considered in analysis.
The Draft EIS is expected to be filed with the Environmental Protection Agency (EPA) and available for public review on January of 2004. At that time, the EPA will publish a Notice of Availability of the Draft EIS in the
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions.
Because of these court rulings, it is very important that those interested in this proposed action participate during comment periods provided so that substantive comments and objections are made available to the Forest Service at a time when they can meaningfully consider them. To assist the Forest Service in identifying and considering issues, comments should be specific to concerns associated with the management of roads and trails on the Gallatin National Forest. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in structuring comments.
I am the responsible official for this Environmental Impact Statement and the ultimate decision for a Gallatin National Forest Travel Management Plan and Forest Plan Amendment. My address is Forest Supervisor, Gallatin National Forest, P.O. Box 130, Federal Building, Bozeman, MT 59771.
Forest Service, USDA.
Notice of intent to prepare environmental impact statement.
The USDA, Forest Service will prepare an environmental impact statement (EIS) on a proposal to improve the Copper Creek Road, which includes repaving existing pavement, paving existing gravel, upgrading dirt surface to gravel, and widening a single-lane bridge to a two lane-bridge on an existing two-lane road. This project includes 14.2 miles of Copper Creek Road from the junction at State Highway 200 passing through Forest Service, State, and private land.
The Copper Creek Road provides access to Snowbank Lake, Copper Creek Campground, and the Indian Meadow Trailhead for accessing the Scapegoat Wilderness.
Comments concerning the proposal and scope of the analysis must be received in writing by January 17, 2003. The draft EIS is expected to be completed in summer of 2003 with the final EIS slated for fall/winter of 2003.
Send written comments to Martie Schramm, Acting District Ranger, Helena National Forest, Lincoln Ranger District, 7269 Highway 200, Lincoln, MT 59644. Phone: (406) 362-3425. Martie Schramm is also the responsible official for this project.
Charlie McKenna, Forest Engineer, Helena National Forest, 2880 Skyway Drive, Helena, MT 59601. Phone (406) 449-5201.
The Lincoln Ranger District of the Helena National Forest has identified the need for reduced sedimentation produced from erosion of the Copper
Concerns for fish occupying this drainage include sediment running off the aggregate surface of the road and adjacent road cuts as-well-as several locations of the drainage that are cutting towards the roadbed, and fish passage barriers existing at two locations cutting off potential fish habitat.
In addition, Copper Creek Road in its current configuration has several traffic hazards including a one-lane bridge that constricts traffic flow and has approaches with poor visibility, roadbed alignment with several narrow curves where driver vision is limited, and the aggregate-surface segment of the road frequently develops washboards and large potholes creating unsafe conditions for drivers.
The Lincoln Ranger District, Helena National Forest, proposes to make improvements to 14.2 mi of Copper Creek Road, located in the Lincoln Ranger District, in Lewis and Clark County, Montana. The project would include re-paving the existing 2.6 mi of paved road, paving an additional 5.9 mi of the existing aggregate-surface (gravel) road, improving the 5.7 mi of single-lane native-surface road above Copper Creek Campground, replacing a one-lane bridge with a two-lane bridge, replacing culverts to reestablish fish passage and to withstand 100-year flood events, and realigning some segments away from Copper Creek. These realignments may require construction of retaining walls for some road cuts and where space is limited, engineered structures may be installed between the active stream channel and the road fill to minimize further encroachment.
The segment from the junction with State Highway 200 to Copper Creek Campground would meet the minimum standards necessary to support the intended uses and improve user safety, while protecting affected resources. The Lincoln Ranger District proposes to reconstruct the road to an American Association of State Highway and Transportation Officials design standard corresponding to “Rural Recreational and Scenic Roads.” This design standard includes an overall width (including shoulders) of 20 ft (6 m). The proposed design speed would be low (0 to 45 mph).
The project includes mitigation measures to reduce impacts to riparian areas, wildlife habitat and other resources. These measures would include but not limited to:
a. Revegetating all disturbed areas with approved native vegetation.
b. Controlling sediment movement by use of temporary structures such as fabric fences and straw bales during construction.
c. Reducing impacts to streams by minimizing activities within the active stream channel, and temporarily diverting the stream when activities within the active stream channel can not be avoided.
d. Avoiding or minimizing removal of desirable woody debris and disturbance to existing vegetation adjacent to streams to maintain filter strips
e. Timing all construction activities to minimize disturbance to wildlife.
f. Halting construction and stabilizing the activity area prior to winter to minimize sediment yield at peak flows during spring thaw, as required by the Forest Plan.
Copper Creek provides critical spawning habitat for upper Blackfoot River fluvial bull trout, a species listed as threatened under the Endangered Species Act. Bull trout spawning occurs both upstream and downstream of Snowbank Lake. Westslope cutthroat trout (a sensitive species) are also found in Copper Creek.
Alternatives being considered at this time are this proposal and the no action (proceed with current maintenance).
The Forest Service is seeking information and comments from Federal, State and local agencies as well as individuals and organizations that may be interested in, or affected by, the proposed action. Preparation of the Draft Environmental Impact Statement will use information from responses received from this NOI, a public meeting this December in Lincoln, MT, and through a mailing informing the public of this proposal. The Forest Service invites written comments and suggestions related to and within the scope of this proposal.
In order to proceed, this proposal may require the following permits from the State of Montana:
• Application for Short-Term Water Quality Standard for Turbidity Related to Construction Activity (318 Authorization).
• Stream Protection Act 124 Permit.
• Clean Water Act Section 401 Water Quality Certification.
The comment period on the draft environmental impact statement will be a minimum of 45-days from the date the Environmental Protection Agency publishes the notice of availability in the
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions.
To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points (
Comments received, including the names and addresses of those who comment, will be considered part of the public record on this proposal and will be available for public inspection.
The Lincoln Ranger District anticipates beginning construction on the project in late summer 2004, stopping construction during the winter months, and resuming construction the following year. The project is expected to take 12 months to complete, including winter shutdown.
No change to travel restrictions associated with this road or other roads and trails accessed by this road would occur, as part of this action.
The decision framework refers to the scope of the decision that will be issued at the conclusion of this analysis by the responsible official. The decision will be based on information disclosed in the environmental document, contained in the Project Analysis File, and comments submitted during the scoping of the proposed action and the comment period.
The Responsible Official may decide whether or not to:
• Select the Proposed Action,
• Select an alternative to the Proposed Action, or
• Select portions from the developed range of alternatives and combine them in a logical package.
In selecting one of the above options, the terms and conditions of the selection will be fully displayed and understood. Within the parameters of this decision space, it will also be determined if a Helena Land and Resource Management Plan amendment would be necessary. The decision maker will take into consideration relationships of alternatives to the identified significant issues.
Forest Service, USDA.
Revision of notice of intent to prepare an environmental impact statement.
The Forest Service (FS) issued a notice of intent (NOI) published in the
This NOI amends the original NOI of May 3, 2002, by adding two additional projects and opening a new round of public scoping.
Comments concerning issues, alternatives and the scope of the analysis must be received within 30 days from the date of publication of this revision of notice of intent in the
Send written comments to Elaine J. Zieroth, Forest Supervisor, Manti-La Sal National Forest, 599 West Price River Drive, Price, Utah 84501, ATTN: Leland Matheson.
Aaron Howe, Mineral and Lands Staff Officer, Manti-La Sal National Forest, 599 West Price River Drive, Price, Utah 84501.
The previous NOI stated that the FS was going to prepare an EIS to “decide whether to authorize SITLA to construct a new road and reconstruct existing roads”, so that SITLA could have access to their land which is surrounded by the Manti-La Sal National Forest. This revised NOI is outlining expanded activities associated with SITLA (timber harvest to the North and a natural gas well to the South) and Prima Oil Company natural gas well in the same East Mountain area of the National Forest.
The Forest Service will prepare an EIS to disclose effects and provide the basis for deciding whether to authorize SITLA to construct a new road and reconstruct existing Forest Service roads across National Forest System Lands, for access to their inholdings on East Mountain for project activities. A segment of the new access route and a portion of the existing roads to be reconstructed traverse portions of the East Mountain Inventoried Roadless Area. SITLA inholdings addressed in this revision consist of one section: Section 36, Township 16 South (T16S), Range 6 East (R6E), Salt Lake Median (SLM) about 640 acres. Provisions of the Alaska National Interest Lands Conservation Act (ANILCA) of 1980, section 1323(a) (16 U.S.C. 3210) provides that the owners of non-Federal land within the National Forest shall be provided adequate access to their land. Regulations implementing section 1323(a) are set forth in title 36, Code of Federal Regulations, part 251, subpart D—Access to Non-Federal Lands. The Forest Service Policy is further explained in the Forest Service Manual (FSM) 5400 and 2700. Access must comply with other laws and regulations such as the Threatened and Endangered Species Act, Clean Water Act, Historic Preservation Act, and the National Environmental Protection Act.
Prima Oil and Gas Company has proposed to drill a natural gas exploration well on National Forest System Lands southwest of the Inventoried Roadless Area adjacent to an existing Forest Service Road. The proposed well site is located as follows: NE
The purpose and need for this action is three fold, SITLA, Prima Oil & Gas and the Forest Service. SITLA's purpose and need is to have an adequate access route across National Forest System Lands to SITLA inholdings for resource management activities on these lands.
Prima Oil & Gas Company's purpose and need is to explore for and produce any economic reserves of natural gas within their lease agreement. The responsible agencies must provide reasonable opportunities to accomplish this consistent with the rights granted by the Leases consistent with Forest Plan direction.
The Forest Service purpose and need is to evaluate the requests from SITLA and Prima Oil & Gas and then to determine whether to authorize permits for access, consistent with applicable laws, regulations, and Forest Service Policy.
The FS is proposing to authorize SITLA to construct a private road and reconstruct Forest Service Roads 50145 (Flat Canyon Road) and 50244 (Big East Road). The Flat Canyon Road will be reconstructed from Forest Service Road 50040 to the SITLA inholdings at Section 36, T16S, R6E, SLM. Forest Service Road 50244 will be reconstructed from the intersection of
The Forest Service also proposes to allow Prima Oil & Gas Company access to their lease via Forest Service Roads and use of National Forest System Lands to construct an oil and gas drill pad consistent with the conditions of Primas lease and the Manti La Sal Land Management and Resource Plan. The drill pad is proposed to be located at the intersection of Forest Service Roads 50244 and 50145.
The Responsible Official for the Record of Decision is Elaine J. Zieroth, Forest Supervisor, Manti-LaSal National Forest, 599 West Price River Drive, Price, Utah 84501.
This revised notice of intent initiates a new scoping process which guides the development of the EIS. Scoping will be by newspaper legal notice, mailings to interested parties and quarterly schedule of proposed actions. No public meetings are planned.
Preliminary issues have been identified. They include the effects to the undeveloped character of the East Mountain Inventoried Roadless Area, land stability and effects to wildlife.
If you choose to participate, your comments should be in writing and as specific as possible. All comments will be considered. Please note: comments submitted, as well as the names and addresses of those who comment, are considered part of the public record and will be released if requested under the Freedom of Information Act. If you provide a comment, you will remain on our mailing list for this project. If you do not comment but want to remain on the mailing list, please notify us. Those who do not comment or otherwise notify us will be dropped from the mailing list for this project. The estimated dates for filing the draft EIS is April 2003 and the FEIS is August 2003.
A DEIS will be prepared for comment. The comment period on the DEIS will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the
The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of DEIS must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions.
To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the DEIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the DEIS or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.
40 CFR 1501.7 and 1508.22; Forest Service Handbook 1909.15, section 21 and 21.2.
Rural Telephone Bank, USDA.
Privatization discussion meeting.
10 a.m., Friday, December 20, 2002.
Room 4062, South Building, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Washington, DC.
Open.
The business advisor will report on the status of current privatization projects. A teleconference will be arranged for out-of-town Board members' participation.
Roberta D. Purcell, Assistant Governor, Rural Telephone Bank, (202) 720-9554.
Committee for Purchase from People Who Are Blind or Severely Disabled.
Additions to Procurement List.
This action adds to the Procurement List services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
January 12, 2003.
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 Kennerly (703) 603-7740.
On October 11 and October 18, 2002, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (67 FR 63376 and 64351) 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
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 services to the Government.
2. The action will result in authorizing small entities to furnish the services.
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 services proposed for addition to the Procurement List.
Accordingly, the following services are added to the Procurement List:
This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.
Import Administration, International Trade Administration, Department of Commerce.
On August 7, 2002, the Department of Commerce (the Department) published the preliminary results of its administrative review of the antidumping duty order on canned pineapple fruit (CPF) from Thailand. This review covers eight producers/exporters of the subject merchandise. The period of review (POR) is July 1, 2000, through June 30, 2001. Based on our analysis of the comments received, these final results differ from the preliminary results. The final results are listed below in the
December 13, 2002.
David Layton or Charles Riggle, Office 5, Group II, AD/CVD Enforcement, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-0371 and (202) 482-0650, respectively.
Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Tariff Act of 1930 (the Act) by the Uruguay Round Agreements Act (URAA). In addition, unless otherwise indicated, all citations to the Department regulations are references to the provisions codified at 19 CFR Part 351 (2001).
This review covers the following producers/exporters of merchandise subject to the antidumping duty order on canned pineapple fruit from Thailand: Vita Food Factory (1989) Co., Ltd. (Vita), Kuiburi Fruit Canning Co., Ltd. (Kuiburi), Malee Sampran Public Co., Ltd. (Malee), Siam Food Products Public Co., Ltd. (SFP), The Thai Pineapple Public Co., Ltd. (TIPCO), Thai Pineapple Canning Industry Corp., Ltd. (TPC), Dole Food Company, Inc., Dole Packaged Foods Company, and Dole Thailand, Ltd. (collectively, Dole), and Siam Fruit Canning (1988) Co., Ltd. (SIFCO).
On August 7, 2002, the Department published the preliminary results of this review and invited interested parties to comment on those results.
On September 6, 2002, Malee and SFP requested a public hearing, but withdrew their requests on September 19, 2002. As a result, no public hearing was held.
The product covered by this order is CPF, defined as pineapple processed and/or prepared into various product forms, including rings, pieces, chunks, tidbits, and crushed pineapple, that is packed and cooked in metal cans with either pineapple juice or sugar syrup added. CPF is currently classifiable under subheadings 2008.20.0010 and 2008.20.0090 of the Harmonized Tariff Schedule of the United States (HTSUS). HTSUS 2008.20.0010 covers CPF packed in a sugar-based syrup; HTSUS 2008.20.0090 covers CPF packed without added sugar (
On September 17, 2001, in response to the Department's questionnaire, Praft stated that it made no shipments of subject merchandise to the United States during the POR. We received no comments regarding our preliminary decision to rescind the review with respect to Praft and, consistent with the preliminary results, we are rescinding the review with respect to Praft.
All issues raised in the case and rebuttal briefs by parties to this review are addressed in the “Issues and Decision Memorandum for the Final Results of the Administrative Review of the Antidumping Duty Order on Canned Pineapple Fruit from Thailand” from Bernard T. Carreau, Deputy Assistant Secretary for Group II, Import Administration, to Faryar Shirzad, Assistant Secretary for Import Administration, dated December 5, 2002 (Decision Memorandum), which is hereby adopted by this notice.
A list of the issues which parties have raised and to which we have responded, all of which are addressed in the Decision Memorandum, is attached to this notice as an Appendix. Parties can find a complete discussion of all issues raised in this review and the corresponding recommendations in this public memorandum, which is on file in the Central Records Unit (CRU), room B-099 of the main Commerce building.
In addition, a complete version of the Decision Memorandum can be accessed directly on the Internet at http://ia.ita.doc.gov/. The paper copy and electronic version of the Decision Memorandum are identical in content.
Except for the calculations for Dole and Malee, we calculated export price and normal value based on the same methodology used in the preliminary results. Changes to the export price calculation for Dole and the indirect selling expenses for Malee are detailed in their respective analysis memoranda.
Except for Malee, we calculated the cost of production (COP) for the merchandise based on the same methodology used in the preliminary results. Changes to the general and administrative expense ratio for Malee are detailed in the Decision Memorandum.
On July 31, 2001, SFP requested that the Department revoke the antidumping order in part as regards SFP based on the absence of dumping pursuant to 19 CFR 351.222(b)(2). SFP submitted, along with its revocation request, a certification stating that: (1) the company sold subject merchandise at not less than normal value during the POR, and that in the future it would not sell such merchandise at less than normal value (
Based on the final results of this review and the final results of the two preceding reviews (
Furthermore, the Department has found that SFP's aggregate sales to the United States have been made in commercial quantities during the last three segments of this proceeding. See Memorandum to Bernard Carreau, Deputy Assistant Secretary for Group II, Import Administration from David Layton, Import Compliance Specialist, Office 5, Import Administration: “Preliminary Determination to Revoke in Part the Antidumping Duty Order on Canned Pineapple Fruit from Thailand” dated July 31, 2002, on file in the CRU.
Based on the above facts, the Department determines that the continued application of the antidumping duty order is not necessary to offset dumping by SFP. SFP has also agreed in writing to its immediate reinstatement in the order, as long as any producer or exporter is subject to the order, should the Department conclude that SFP, subsequent to the revocation, sold the subject merchandise at less than normal value. Therefore, we will revoke the order with respect to merchandise produced and exported by SFP. In accordance with 19 CFR 351.222(f), we will terminate the suspension of liquidation for any such merchandise entered, or withdrawn from warehouse, for consumption on or after July 1, 2001. The Department will further instruct the Customs Service to refund with interest any cash deposit on entries made after June 30, 2001.
As a result of our review, we determine that the following weighted-average percentage margins exist for the period July 1, 2000, through June 30, 2001:
The Department shall determine, and the Customs Service shall assess, antidumping duties on all appropriate entries. In accordance with 19 CFR 351.212(b)(1), we have calculated importer-specific assessment rates by dividing the dumping margin found on the subject merchandise examined by the entered value of such merchandise. Where the importer-specific assessment rate is above
Furthermore, the following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results of administrative review, as provided by section 751(a) of the Act: (1) for the
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred, and in the subsequent assessment of double antidumping duties.
This notice also is the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order 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 issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Notice of extension of time limit for the final results of antidumping duty administrative review.
The Department of Commerce is extending the time limit for the final results of the administrative review of the antidumping duty order on fresh garlic from the People's Republic of China until no later than January 21, 2003. The period of review is November 1, 2000, through October 31, 2001. This extension is made pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended.
December 13, 2002.
Edythe Artman, AD/CVD Enforcement 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington, D.C. 20230; telephone: (202) 482-3931.
On August 9, 2002, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on fresh garlic from the People's Republic of China. See
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), provides that the Department will issue the final results of an administrative review within 120 days after the date on which the preliminary results were published. It further provides that, if it is not practicable to complete the review within the 120-day period, the Department may extend the period by 60 days.
The Department has determined that it is not practicable to complete the administrative review within the 120-day period because the comments received from the parties with regard to the preliminary results present a number of complex factual and legal questions about the assignment of antidumping duty margins and, in particular, the application of facts available. Therefore, in accordance with section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2) (2002), the Department is extending the time limit for completion of the final results by 43 days. The final results of review will be due no later than January 21, 2003.
Import Administration, International Trade Administration, Department of Commerce.
Notice of Rescission of Antidumping Duty Administrative Review.
December 13, 2002.
On September 25, 2002, the Department of Commerce (the Department) published in the
Vicki Schepker or Keith Nickerson, at (202) 482-1756 or (202) 482-3813, respectively, AD/CVD Enforcement Office V, Group II, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW, Washington, DC 20230.
Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Tariff Act of 1930 (the Act) by the Uruguay Round Agreements Act (URAA). In addition, unless otherwise indicated, all citations to the Department's regulations are to 19 CFR Part 351 (April 2002).
In accordance with 19 CFR 351.213(b), on August 27 and August 30, 2002, respectively DuPont and Ausimont requested an administrative review of the antidumping duty order on granular polytetrafluoroethylene resin from Italy. On September 25, 2002, in accordance with 19 CFR 351.221(c)(1)(i), we initiated an administrative review of this order for the period August 1, 2001, through July 31, 2002 (67 FR 60211). DuPont and Ausimont withdrew their requests for this review on October 18 and 28, 2002, respectively.
The Department's regulations at 19 CFR 351.213(d)(1) provide that the Department will rescind an administrative review if the party that requested the review withdraws its request for review within 90 days of the date of publication of the notice of initiation of the requested review, or withdraws its request at a later date if the Department determines that it is reasonable to extend the time limit for withdrawing the request. Both DuPont and Ausimont withdrew their requests within the 90-day period. Accordingly, we are rescinding this review. The Department will issue appropriate assessment instructions to the U.S. Customs Service within 15 days of publication of this notice. This notice is issued and published in accordance with section 751 of the Act (19 U.S.C. 1675) and 19 CFR 351.213(d)(4).
Import Administration, International Trade Administration, Department of Commerce.
Notice of final results and partial rescission of antidumping duty administrative review of stainless steel sheet and strip in coils from Taiwan.
SUMMARY: On July 9, 2002, the Department of Commerce (“the Department”) published in the Federal Register the preliminary results and partial rescission of its administrative review of the antidumping duty order on stainless steel sheet and strip in coils from Taiwan.
Based on our analysis of the comments received, we have made changes in the margin calculations for Chia Far. Therefore, the final results differ from the
December 13, 2002.
FOR FURTHER INFORMATION CONTACT: Laurel LaCivita (Ta Chen) (YUSCO); Cheryl Werner (Chia Far); Marlene Hewitt (Tung Mung); or Bob Bolling, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th and Constitution Avenue, N.W., Washington, D.C. 20230; telephone: (202) 482-4243, (202) 482-2667, (202) 482-1385 or (202) 482-3434, respectively.
Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Act by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations at 19 CFR part 351 (2001).
On July 9, 20021, the Department published the
We invited parties to comment on the
On October 7, 2002, the Department informed petitioners that it was rejecting its case brief with respect to YUSCO, filed on September 18, 2002, which contained new and untimely-filed information. On October 9, 2002, petitioners submitted a revised case brief concerning YUSCO, which excluded certain new factual information.
Under section 751(a)(3)(A) of the Act, the Department may extend the deadline for completion of an administrative review if it determines that it is not practicable to complete the review within the statutory time limit. On October 8, 2002, the Department extended the time limit for the final results to December 6, 2002.
For purposes of this administrative review, the products covered are certain stainless steel sheet and strip in coils. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject sheet and strip is a flat-rolled product in coils that is greater than 9.5 mm in width and less than 4.75 mm in thickness, and that is annealed or otherwise heat treated and pickled or otherwise descaled. The subject sheet and strip may also be further processed (
The merchandise subject to this review is classified in the
Excluded from the scope of this review are the following: (1) sheet and strip that is not annealed or otherwise heat treated and pickled or otherwise descaled, (2) sheet and strip that is cut to length, (3) plate (
In response to comments by interested parties, the Department has determined that certain specialty stainless steel products are also excluded from the scope of this review. These excluded products are described below.
Flapper valve steel is defined as stainless steel strip in coils containing, by weight, between 0.37 and 0.43 percent carbon, between 1.15 and 1.35 percent molybdenum, and between 0.20 and 0.80 percent manganese. This steel also contains, by weight, phosphorus of 0.025 percent or less, silicon of between 0.20 and 0.50 percent, and sulfur of 0.020 percent or less. The product is manufactured by means of vacuum arc remelting, with inclusion controls for sulphide of no more than 0.04 percent and for oxide of no more than 0.05 percent. Flapper valve steel has a tensile strength of between 210 and 300 ksi, yield strength of between 170 and 270 ksi, plus or minus 8 ksi, and a hardness (Hv) of between 460 and 590. Flapper valve steel is most commonly used to produce specialty flapper valves in compressors.
Also excluded is a product referred to as suspension foil, a specialty steel product used in the manufacture of suspension assemblies for computer disk drives. Suspension foil is described as 302/304 grade or 202 grade stainless steel of a thickness between 14 and 127 microns, with a thickness tolerance of plus-or-minus 2.01 microns, and surface glossiness of 200 to 700 percent Gs. Suspension foil must be supplied in coil widths of not more than 407 mm, and with a mass of 225 kg or less. Roll marks may only be visible on one side, with no scratches of measurable depth. The material must exhibit residual stresses of 2 mm maximum deflection, and flatness of 1.6 mm over 685 mm length.
Certain stainless steel foil for automotive catalytic converters is also excluded from the scope of this review.
Permanent magnet iron-chromium-cobalt alloy stainless strip is also excluded from the scope of this review. This ductile stainless steel strip contains, by weight, 26 to 30 percent chromium, and 7 to 10 percent cobalt, with the remainder of iron, in widths 228.6 mm or less, and a thickness between 0.127 and 1.270 mm. It exhibits magnetic remanence between 9,000 and 12,000 gauss, and a coercivity of between 50 and 300 oersteds. This product is most commonly used in electronic sensors and is currently available under proprietary trade names such as “Arnokrome III.”
Certain electrical resistance alloy steel is also excluded from the scope of this review. This product is defined as a non-magnetic stainless steel manufactured to American Society of Testing and Materials (“ASTM”) specification B344 and containing, by weight, 36 percent nickel, 18 percent chromium, and 46 percent iron, and is most notable for its resistance to high temperature corrosion. It has a melting point of 1390 degrees Celsius and displays a creep rupture limit of 4 kilograms per square millimeter at 1000 degrees Celsius. This steel is most commonly used in the production of heating ribbons for circuit breakers and industrial furnaces, and in rheostats for railway locomotives. The product is currently available under proprietary trade names such as “Gilphy 36.”
Certain martensitic precipitation-hardenable stainless steel is also excluded from the scope of this review. This high-strength, ductile stainless steel product is designated under the Unified Numbering System (“UNS”) as S45500-grade steel, and contains, by weight, 11 to 13 percent chromium, and 7 to 10 percent nickel. Carbon, manganese, silicon and molybdenum each comprise, by weight, 0.05 percent or less, with phosphorus and sulfur each comprising, by weight, 0.03 percent or less. This steel has copper, niobium, and titanium added to achieve aging, and will exhibit yield strengths as high as 1700 Mpa and ultimate tensile strengths as high as 1750 Mpa after aging, with elongation percentages of 3 percent or less in 50 mm. It is generally provided in thicknesses between 0.635 and 0.787 mm, and in widths of 25.4 mm. This product is most commonly used in the manufacture of television tubes and is currently available under proprietary trade names such as “Durphynox 17.”
Finally, three specialty stainless steels typically used in certain industrial blades and surgical and medical instruments are also excluded from the scope of this review. These include stainless steel strip in coils used in the production of textile cutting tools (
In the
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the “Issues and Decision Memorandum” (“
In our
We disregarded sales below cost for both YUSCO and Chia Far during the course of the review.
Based on our analysis of comments received, we have made changes in the margin calculations for Chia Far. The changes to the margin calculations are listed below:
We determine that the following percentage margin exists for the period July 1, 2000 through June 30, 2001:
The Department will determine, and the Customs Service shall assess, antidumping duties on all appropriate entries. In accordance with 19 CFR 351.212(b)(1), we have calculated an exporter/importer (or customer)-specific assessment rate for merchandise subject to this review. The Department will issue appropriate assessment instructions directly to the Customs Service within 15 days of publication of these final results of review. We will direct the Customs Service to assess the resulting assessment rates against the entered customs values for the subject merchandise on each of the importer's/customer's entries during the review period. For duty-assessment purposes, we will calculate importer-specific assessment rates by dividing the dumping margins calculated for each importer by the total entered value of sales for each importer during the period of review.
The following deposit requirements will be effective upon publication of this notice of final results of administrative review for all shipments of stainless steel sheet and strip in coils from Taiwan entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(1) of the Act: (1) The cash deposit rates for YUSCO, Chia Far and Tung Mung will be the rates shown above; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in these or any previous reviews conducted by the Department, the cash deposit rate will be the “all others” rate, which is 12.12 percent.
These deposit requirements shall remain in effect until publication of the final results of the next administrative review.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties or countervailing duties occurred and the subsequent assessment of double antidumping duties or countervailing duties.
This notice also serves as a reminder to parties subject to administrative protective orders (“APOs”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing this determination and notice in accordance with sections 751(a)(1) and 771(i) of the Act.
National Oceanic and Atmospheric Administration (NOAA).
Notice.
The Department of Commerce, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Written comments must be submitted on or before February 11, 2003.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at dHynek@doc.gov).
Requests for additional information or copies of the information collection instrument and instructions should be directed to Michael Travis, Department of Commerce, NOAA, National Marine Fisheries Service, 9721 Executive Center Drive North, St, Petersburg, FL 33702-2439, (727)570-5335.
NMFS proposes to collect information on fishing vessel expenses and earnings on a voluntary and continuous basis in the Gulf of Mexico offshore shrimp fishery in order to conduct socioeconomic analyses that will: improve fishery management making in that fishery; satisfy NMFS' legal mandates under Executive Order 12866, the Magnuson-Stevens Fishery Conservation and Management Act (U.S.C. 1801 et. seq.), the Regulatory Flexibility Act, the Endangered Species Act, and the National Environmental Policy Act; and quantify achievement of the performances measures in the NMFS Strategic Operating Plans. Used in conjunction with catch and effort data already being collected in this fishery as part of its dealer reporting program, as well as Coast Guard and fishing permit data on vessel characteristics, this data will be used to assess how fishermen will be impacted by and respond to any regulation likely to be considered by fishery managers. In addition, this data will be used to determine how fishing communities will be impacted by proposed fishing regulations. In the program's first year, the program will only cover vessels that primarily port in the state of Texas, with vessels from the other Gulf States being included in the second year.
Data will be collected using personal interviews and a formal survey instrument. Compared to phone interviews and mail surveys, personal interviews have been shown to generally produce higher response rates and higher quality data. Interviews will be conducted once each year in regards to the previous year's activities. Vessel owners will be asked questions pertaining to the variable costs of their fishing operations, such as price and amount of fuel used, price and amount of ice used, groceries, processing/selling fees, and labor costs. Vessel owners will also be asked questions regarding their vessel's annual or fixed costs, such as expenditures for vessel repair and maintenance, gear repair and maintenance, fishing licenses and permits, insurance, dock fees, repayment on boat and business loans, office expenses and so forth. Vessel owners will also be asked questions pertaining to the capital investment in their vessels, such as purchase price, cost of subsequent investments in the vessel and its fishing technology, and current market or replacement value. Finally, vessel owners will be asked questions regarding their socio-demographic status, such as household size, income, dependence on fishing, alternative employment opportunities, level of fishing experience, age, education level, ethnicity/race, marital status, and so forth. In instances where vessels are not operated by the owner, socio-demographic data will be solicited from both the owner and captain. Though unknown at this time, it is assumed that nearly 50 percent of these vessels are operated by hired captains.
Estimated Total Annual Burden Hours: 135.
Estimated Total Annual Cost to Public: $0.
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 (including hours and cost) 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.
Comments submitted in response to this notice 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.
National Oceanic and Atmospheric Administration (NOAA).
Notice.
The Department of Commerce, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Written comments must be submitted on or before February 11, 2003.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to David Holts, Southwest Fishery Science Center, 8604 La Jolla Shores Drive, P.O. Box 271, La Jolla, CA 92038-0271 (phone 858-546-7186).
The National Oceanic and Atmospheric Administrations's Southwest Fishery Science Center operates a billfish resource and
A paper form the size of a postcard is used.
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 (including hours and cost) 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.
Comments submitted in response to this notice 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.
National Oceanic and Atmospheric Administration (NOAA).
Notice.
The Department of Commerce, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Written comments must be submitted on or before February 11, 2003.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW, Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed Dr. Rodney Weiher, U.S. Dept. of Commerce/NOAA/PSP, Room 6117, 14th and Constitution Ave NW, Washington DC, 20234. (or via Internet at
The purpose of this data collection is to provide information on the value of current and improved hurricane forecasts to specific segments of the U.S. population. The study will measure total economic values for current hurricane forecasts and improved hurricane forecasts. This effort is designed to provide information on the uses and values of hurricane forecasts in order to improve product design and delivery systems as well as information for managers on the value of undertaking programs to improve hurricane forecasting capabilities.
This effort will involve development of extensive knowledge about how hurricane forecasts are perceived, understanding the implications of alternative forecast improvement actions, designing original survey instruments, interviewing of a large number of respondents (1200-1500), and conducting formal statistical analysis of the data. A regionally-oriented survey will be conducted using stated-preferences methods. Cognitive interviews will be used in survey development to examine individuals' understanding of hurricane forecasts and the words and meanings they may use to discuss hurricanes. The interviews will be used to examine the relative importance of hurricane forecast attributes, to assess the presentation of information on hurricane forecasts, and developing approaches for eliciting economic values for improvements in hurricane forecasting.
Up to 96 one-on-one cognitive interviews will be conducted. In addition, one pretest of the full survey instrument will be tested for a response of up to 100 usable observations. The final survey instrument will be administered to a sample of up to 1500 people.
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 (including hours and cost) 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.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection;
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Issuance of permit.
Notice is hereby given that Ms. Tracey Mueller, Mote Marine Laboratory, Sea Turtle Conservation and Research Program, Sarasota, FL has been issued a permit to take threatened and endangered green turtles (
The permit and related documents are available for review upon written request or by appointment in the following office(s):
Dr. Tammy Adams or Ruth Johnson, (301)713-2289.
On April 19, 2002, notice was published in the
The permit authorizes annual takes of 150 juvenile and subadult green turtles, 100 juvenile and sub-adult loggerhead, 150 juvenile and sub-adult Kemp's ridley, and 5 juvenile and sub-adult hawksbill turtles by capture, tagging, blood and tissue sampling for a five year population assessment of the juvenile sea turtles inhabiting Charlotte Harbor on the west coast of Florida. Up to 10 green, 10 Kemp's ridley, 10 loggerhead, and 5 hawksbill turtles will also be collected annually incidental to the Center for Shark Research gill netting for sharks in the areas of Pine Island Sound and the Gulf waters near Crystal River, FL. These turtles will be measured, flipper tagged and released. In the second through fifth years of the permit, up to 5 green and/or Kemp's ridley turtles will also have satellite tags attached.
Issuance of this permit, as required by the ESA, was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of the endangered species which is the subject of this permit, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Issuance of permit amendment.
Notice is hereby given that Mr. Thomas F. Norris, Science Applications International Corp., 3990 Old Town Avenue, Suite 105A, San Diego, California 92110 has been issued an amendment to scientific research Permit No. 995-1608.
The amendment and related documents are available for review upon written request or by appointment in the following office(s):
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713-2289; fax (301)713-0376;
Northwest Region, NMFS, 7600 Sand Point Way NE, BIN C15700, Bldg. 1, Seattle, WA 98115-0700; phone (206)526-6150; fax (206)526-6426;
Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213; phone (562)980-4001; fax (562)980-4018; and
Protected Species Coordinator, Pacific Area Office, NMFS, 1601 Kapiolani Blvd., Rm, 1110, Honolulu, HI 96814-4700; phone (808)973-2935; fax (808)973-2941.
FOR FURTHER INFORMATION CONTACT: Dr. Tammy Adams or Ruth Johnson, (301)713-2289.
On December 21, 2000, notice was published in the
The amended permit authorizes takes of up to 11 each of blue, fin, and humpback whales per year by attachment of scientific instruments, photo-identification, and behavioral observation and up to 20 whales of each species by harassment incidental to these activities.
Issuance of this amendment, as required by the ESA was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of the endangered species which is the subject of this
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Issuance of permit.
Notice is hereby given that National Marine Mammal Laboratory, 7600 Sand Point Way N.E., BIN C15700, Seattle, WA, 98115 has been issued a permit to take Alaskan harbor seals and spotted seals for purposes of scientific research.
The permit and related documents are available for review upon written request or by appointment in the following office(s):
Carrie Hubard or Ruth Johnson, (301)713-2289.
On July 12, 2002, notice was published in the
Permit No. 782-1676-00 authorizes aerial surveys and live captures of harbor seals and spotted seals in Alaskan waters. Annually, 1000 seals of each species may be captured, sampled, and released. Sampling includes measuring, weighing, flipper punch and tag, pulling vibrissae, and blood sampling. All seals will have a VHF tag applied either as a separate unit or, where possible, embedded in another type of tag. Subsets of the captured animals will also receive time-depth-recorders (TDR), satellite-linked TDRs, blubber/muscle biopsies, and/or still/video packages. The permit also authorizes the incidental harassment of an additional 3500 seals in association with capturing operations and scat collection. Over the course of the 5 year permit, 50 seals may be inadvertently captured a second time. Maximum accidental injury or mortality is three animals per species per year.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Consideration will be given to all comments received by January 13, 2003.
Written comments and recommendations on the proposed information collection should be sent to Ms. Zeiher at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.
Written requests for copies of the information collection proposal should be sent to Mr. Cushing, WHS/DIOR, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302.
Department of Defense.
Notice of Advisory Committee meeting.
The Defense Science Board Task Force on Seabasing will meet in closed session on December 11-12, 2002; January 27-28, 2003; February 25-26, 2003; and March 25-26, 2003, at Strategic Analysis Inc., 3601 Wilson Boulevard, Arlington, VA. The Task Force will assess how seabasing of expeditionary forces can best serve the nation's defense needs through at least the first half of the 21st century.
The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Defense Science Board Task Force will examine the broadest range of alternatives for seabasing of expeditionary forces and be guided by: The expected naval environment for the next 20-50 years; the role of naval forces in enabling access for joint forces through the world's littorals; assets and technologies needed to establish a robust and capable
In accordance with Section 10(d) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, these meetings will be closed to the public.
Due to critical mission requirements, there is insufficient time to provide timely notice required by Section 10(a)(2) of the Federal Advisory Committee Act and Subsection 101-6.1015(b) of the GSA Final Rule on Federal Advisory Committee Management, 41 CFR Part 101-6, which further requires publication at least 15 calendar days prior to the first meeting of the Task Force on Seabasing scheduled for December 11-12, 2002.
Department of Defense.
Notice of Advisory Committee meeting data change.
On Friday, November 29, 2002 (67 FR 71144), the Department of Defense announced closed meetings of the Defense Science Board Task Force on Joint Experimentation. The meeting scheduled for December 18, 2002, has been rescheduled for January 9-10, 2003; it will be held at Strategic Analysis Inc., 3601 Wilson Boulevard, Suite 600, Arlington, VA.
Department of the Army, DoD.
Notice.
In accordance with 37 CFR 404.6 and 404.7, announcement is made of the availability for licensing of U.S. Patent Application No. 10/159,984 entitled “Teledentistry Consult Management System and Method,” filed June 3, 2002. Foreign rights are also available (PCT/US02/17197). The United States Government, as represented by the Secretary of the Army, has rights in this invention.
Commander, U.S. Army Medical Research and Materiel Command, ATTN: Command Judge Advocate, MCMR-JA, 504 Scott Street, Fort Detrick, Frederick, MD 21702-5012.
For patent issues, Ms. Elizabeth Arwine, Patent Attorney, (301) 619-7808. For licensing issues, Dr. Paul Mele, Office of Research & Technology Assessment, (301) 6196664, both at telefax (301) 619-5034.
The invention relates generally to the field of telemedicine and, more particularly, to systems, methods and articles of manufacture for facilitating consultation/communication between referring and consulting providers in the field of dentistry.
Department of the Army, DoD
Notice.
Notice is given of the names of members of a Performance Review Board for the Department of the Army.
December 5, 2002.
Marilyn Ervin, U.S. Army Senior Executive Service Office, Assistant Secretary of the Army, Manpower & Reserve Affairs, 111 Army Pentagon, Washington, DC 20310-0111.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service performance review boards. The boards shall review and evaluate the initial appraisal of senior executives' performance by supervisors and make recommendations to the appointing authority or rating official relative to the performance of these executives.
(a) The members of the Performance Review Board for the U.S. Army Chief of Staff are:
1. MG Lawrence R. Adair, Assistant G-1.
2. MG Dorian Anderson, Commander, Total Army Personnel Command.
3. BG Harry Axson, Director, Military Personnel Policy.
4. Mr. Brian Barr, Technical Director.
5. Ms. Jean M. Bennett, Director, Resources and Infrastructure.
6. Mr. Vernon Bettencourt, Director, Analysis and Chief, Information Office.
7. Mr. Joseph R. Billman, Director of Program Development.
8. MG Robert W. Chesnut, Assistant Deputy Chief of Staff, G-3 (Mobilization).
9. MG Peter Chiarelli, Director, Operations, Readiness, and Mobilization.
10. MG Claude V. Christianson, Assistant Deputy Chief of Staff, G-4.
11. Dr. Craig E. College, Assistant Deputy Chief of Staff for Programs.
12. Mr. William F. Crain, Technical Director.
13. BG Bruce Davis, Deputy Director, Operations, Readiness, and Mobilization.
14. Mr. Thomas Dillon, Director, Counterintelligence, Foreign Disclosure, and Security.
15. MG B. Sue Dueitt, Director, Personnel Transformation.
16. Mr. Terrance M. Ford, Assistant Deputy Chief of Staff, G-2.
17. MG James J. Grazioplene, Director, FD.
18. LTG Benjamin S. Griffin, G-8.
19. Mr. James Gunlicks, Deputy Director, Training.
20. BG Dennis Hardy, Director, Force Management.
21. MG David Huntoon, Director, Strategy, Plans and Policy.
22. BG Kenneth W. Hunzeker, Deputy Director, PAE.
23. BG Jerome Johnson, Director of Plans, Operations and Readiness.
24. LTG John M. Le Moyne, Deputy Chief of Staff, G-1.
25. Mr. Mark R. Lewis, Director of Plans, Resources & Operations.
26. Ms. Maureen T. Lischke, PEO for Information Systems & Chief Information Officer.
27. MG James Lovelace, Assistant Deputy Chief of Staff, G3.
28. Mr. Wendell Lunceford, Director, Army Model and Simulation Office.
29. LTG Charles S. Mahan, Jr., Deputy Chief of Staff, G-4.
30. BG Jesus A. Mangual, Director of Force Projection and Distribution.
31. Mr. John W. Matthews, Director, Army Records Management and Declassification Activity.
32. MG David F. Melcher, Director, PAE.
33. Mr. William P. Neal, Associate Director of Force Projection and Distribution.
34. LTG Robert W. Noonan, Jr., Deputy Chief of Staff for Intelligence.
35. Mr. Mark J. O'Konski, Director of Logistics Integration Agency.
36. Mr. Eric A. Orsini, Special Assistant to the DCS, G-4.
37. BG(P) Elbertt N. Perkins, Director, DOI.
38. BG Steve Schook, Director, Human Resource and Policy.
39. Ms. Donna L. Shands, Associate Director for Sustainment.
40. Dr. Zita Simutis, Director, Manpower & Personnel Research Laboratory & Associate Director, ARI.
41. Mr. David L. Snyder, Deputy Asst Sec of the Army (Civ Personnel Policy).
42. Mr. John C. Speedy, III, Deputy Director, Strategy, Plans and Policy.
43. Mr. Lewis S. Steenrod, Director of Modernization.
44. Mr. James J. Streilein, Director, Army Evaluation Center.
45. Ms. Elizabeth B. Throckmorton, Assistant Deputy Asst Sec of the Army (Civilian Personnel Policy).
46. MG James Thurman, Director, Training.
47. Mr. Donald C. Tison, Deputy Director, Program Analysis and Evaluation.
48. Mr. Edgar B. Vandiver, III, Director, Center for Army Analysis.
49. BG Lloyd T. Waterman, Director of Sustainment.
50. Mr. Daniel F. Wiener, II, Chief Information Officer.
(b) The members of the Performance Review Board for the U.S. Army, Office of the Secretary of the Army are:
1. Dr. Benson D. Adams, Special Assistant to the ASA(IE) for Policy and Economic Analysis.
2. Dr. A. Michael Andrews, II Deputy Asst Secretary for Research & Technology/Chief Scientist.
3. Mr. William A. Armburuster, DASA for Privatization and Partnership.
4. Ms. Diane J. Armstrong, Director, Resource Integration.
5. MG William L. Bond, Deputy for Systems Management.
6. Mr. David Borland, Deputy CIO/G-6.
7. MG Stephen W. Boutelle, Director, IONS.
8. Mr. Fredrick R. Budd, Director, Single Agency Manager for Pentagon Information Technology Services.
9. Mr. Delbert F. Bunch, Deputy Program Manager for Chemical Demilitarization Operations.
10. Ms. Kathryn A. Condon, Interagency Coordinator of Military Support to Civil Authorities.
11. Mr. James C. Cooke, Special Assistant for Systems.
12. LTG Peter M. Cuviello, CIO/G-6.
13. Mr. Donald L. Damstetter, Jr., DASA (Plans, Programs & Resources).
14. Mr. Daniel B. Denning, PDASA (M&RA) & DASA (TR&M).
15. Mr. Thomas Druzgal, Deputy Auditor General, Acquisition and Material Management.
16. Mr. George S. Dunlop, Deputy ASA (Legislation).
17. Mr. Raymond J. Fatz, Deputy Assistant Secretary of the Army for Environment, Safety, and Occupational Health.
18. Mr. Patrick J. Fitzgerald, Deputy Auditor General, Policy and Operations Management.
19. MG Warren L. Freeman, Director, DC National Guard.
20. Mr. Ernest J. Gregory, Principal DASA (Financial Mgt & Comptroller).
21. Ms. Judity A. Guenther, Director of Investments.
22. MG Lynn Hartsell, Director, Operations & Support.
23. Mr. Jack E. Hobbs, Project Dir, Army Workload & Performance Systems.
24. Mr. Walter W. Hollis, Deputy Under Secretary of the Army (Operations Research).
25. Mr. Joel B. Hudson, Administrative Assistant to the Secretary of the Army.
26. Mr. Craig D. Hunter, DASA (Defense Exports and Cooperation).
27. Dr. Daphne K. Kamely. Special Assistant to the Deputy Assistant Secretary of the Army for Environment, Safety, and Occupational Health.
28. Mr. Stephen E. Keefer, Deputy Auditor General, Installations Management.
29. Mr. John A. Kelley, Special Assistant to ASA(IE) for Asset Management.
30. Mr. Thomas E. Kelley, III, Special Assistant to the Secretary of the Army for Science & Technology.
31. Mr. John R. Kohler, Director of Business & Investments.
32. Mr. Charles A. Krohn, Principal Deputy to the Chief of Public Affairs (Media Relations),
33. Ms. Joann H. Langston, Competition Advocate of the Army.
34. Mr. John W. McDonald, Deputy Under Secretary of the Army.
35. Mr. John P. McLaurin, III, DASA (Military Personnel Mgt. & EO Policy).
36. Mr. John L. Miller, Director for Business Resources.
37. Ms. Joyce E. Morrow, Deputy Auditor General, Forces and Financial Management.
38. Mr. Levator Norsworthy, Jr., Deputy General Counsel (Acquisition).
39. Mr. Eric A Orsini, Deputy ASA (Logistics).
40. Ms. Tracey L. Pinson, Director of Small & Disadvantage Business Utilization.
41. Mr. Geoffrey G. Prosch, Principal DASA (Installation & Environment).
42. Mr. Francis E. Reardon, Auditor General.
43. Mr. Matt Reres, Deputy General Counsel (Ethics and Fiscal).
44. BG Velma L. Richardson, Deputy CG NETCOM (FWD).
45. Ms. Sandra R. Riley, Deputy Administrative Assistant/Executive Director, Headquarters Services—Washington.
46. BG Lewis S. Roach, Deputy for Services & Operations & US Army Services & Operations Agency.
47. Mr. Nels Running, DUSA (IA/Commemoration of 50th Ann Korean War).
48. Mr. Luther L. Santiful, Director of Equal Employment Opportunity/Civil Works.
49. Mr. Richard G. Sayre, Special Assistant for Systems.
50. Mr. Karl F. Schneider, DASA (Army Review Boards Agency).
51. MG John L. Scott, Chief Integration Officer.
52. Mr. C Russell H. Shearer, Special Assistant to ASA (IE).
53. MG Jerry L. Sinn, Deputy ASA (Budget).
54. Mr. Douglas Sizelove, Assistant Deputy Under Secretary of the Army (Operations Research).
55. Mr. James J. Smyth, Deputy ASA (Project Planning and Review).
56. Mr. David L. Snyder, Deputy ASA (Civilian Personnel Policy).
57. Dr. Barbara J. Sotirin, Acting Director, Research & Laboratory Management.
58. Mr. Earl H. Stockdale, Jr., Deputy General Counsel (Civil Works and Environment).
59. Dr. Larry B Stotts, Director for Technology.
60. Mr. Thomas W. Taylor, Senior Deputy General Counsel.
61. Ms. Elizabeth B. Throckmorton, Assistant DASA (Civilian Personnel Policy).
62. Ms. Claudia L. Tornblom, Deputy ASA (Management and Budget).
63. Mr. Michael L. Vajda, Director, Civilian Personnel Operations Center Management Agency.
64. Mr. Patrick J. Wakefield, DASA (Chemical Demilitarization) (Advisory).
65. Mr. C. Richard Whiston, Special Assistant to Secretary of the Army for Business Transformation.
66. Mr. Joseph W. Whitaker, Jr., DASA (Installations & Housing) (Advisory).
67. Miss Sarah F. White, DASA (Force Mgt, Manpower & Reserve Affairs).
68. Mr. Avon N. Williams, Principal Deputy General Counsel.
69. Mr. Robert J. Winchester, Assistant for Intelligence Liaison.
70. Mr. Robert W. Young, Deputy for Cost Analysis.
(c) The members of the Performance Review Board for the U.S. Army, Office of the Surgeon General are:
1. MG Kenneth L. Farmer, Deputy Surgeon General.
2. Dr. Charles N. Davidson, Director, US Army Nuclear & Chemical Agency.
3. Dr. James J. Streilein, Director, Army Evaluation Center.
(d) The members of the Performance Review Board for the U.S. Mission to the North Atlantic Treaty Organization are:
1. Mr. Alfred G. Volkman, Director, International Cooperation, OUSD, AT&L.
2. Mr. Barry Pavel, Director for Strategy, OSD.
3. Mr. Bernd McConnell, Director of the Office of Foreign Disaster Assistance, USAID.
4. Ms. Pamela Frazier, Foreign Policy Advisor to Chief of Staff, AF/Department of State.
Defense Logistics Agency, DOD.
Proposed solicitation for cost sharing cooperative agreement applications.
On March 17, 1999, the Defense Logistics Agency (DLA) issued a solicitation for cooperative agreement applications (SCAA) to assist state and local governments and other nonprofit eligible entities in establishing or maintaining procurement technical assistance centers (PTACs) pursuant to chapter 142, title 10, United States Code. These centers help business firms market their goods and service to the Department of Defense (DoD), other federal agencies, and state and/or local government agencies. Cooperative agreement awards made as a result of applications submitted in response to this solicitation contained provisions for the award of additional option awards through 2002. DLA now intends to issue another solicitation as a follow-on action to the March 17, 1999, SCAA in order to maintain continuity of the Procurement Technical Assistance Program. This solicitation, when issued, will govern the submission of applications for calendar years 2003 through 2007, inclusive. This proposed SCAA is available for review on the Internet Web site:
You are invited to submit written comments concerning this proposed SCAA to: Headquarters, Defense Logistics Agency, Office of Small and Disadvantaged Business Utilization, 8727 John J. Kingman Road, Suite 1127, Ft. Belvoir, VA 22060-6221. Attn: Grants Officer.
All comments must be received by January 31, 2003, in order for them to be considered. DLA intends to post the proposed SCAA, when finalized, on the Internet in early March 2003. A future notice to be published in the
Ms. Diana Maykowskyj at (703) 767-1656.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of intent.
A combined Feasibility Report and joint Environmental Impact Statement/Environmental Impact Report (EIS/EIR) will be prepared to satisfy the requirements of the National Environmental Policy Act and the California Environmental Quality Act. The U.S. Army Corps of Engineers (Corps), Sacramental District, will serve as the Federal lead agency for the EIS with The Reclamation Board of the State of California (the Board), the non-federal sponsor, serving as the State lead agency for the EIR. The combined Feasibility Report and joint EIS/EIR will evaluate the environmental effects of a potential flood damage reduction and ecosystem restoration project at Hamilton City. The Hamilton City Flood Damage Reduction and Ecosystem Restoration is the first site-specific evaluation to be initiated as a result of the Sacramento and San Joaquin River Basins Comprehensive Study conducted by the Corps and the Board. Concurrently with the release of this notice of intent (NOI), the Board is issuing a notice of preparation (NOP) to initiate the CEQA process.
Scoping and public involvement activities were conducted under the original NOI issued for the Comprehensive Study. A series of scoping and outreach meetings were held in February through May 1998, November through December 1998, February 1999, June 1999, October through November 2001, and August through September 2002. Development of the EIS/EIR for the Comprehensive Study was at a programmatic level with the preliminary site-specific evaluation for Hamilton City Flood Damage Reduction and Ecosystem Restoration packaged as an attachment to the main programmatic document. The Comprehensive Study has since discontinued the environmental documentation effort and therefore this NOI is being submitted to establish that the Feasibility Report and EIS/EIR for Hamilton City Flood Damage Reduction
Questions about the combined Feasibility Report and joint EIS/EIR can be answered by Erin Taylor at (916) 557-6862 or by mail at U.S. Army Corps of Engineers, Planning Division, ATTN: Erin Taylor, 1325 J Street, Sacramento, CA 95814-2922, or e-mail:
The combined Feasibility Report and joint EIS/EIR will evaluate ways to reduce the risk of flooding and restore the Sacramento River's connection with its flood plain, natural flood plain processes, and riparian and associated flood plain habitat.
Alternatives include the no-action, reinforcing the existing levee, several setback levee alignments at some distance from the river, and flood-proofing or relocating structures at risk of flooding, with different habitat configurations and methods of establishment. Maximum area of potential effect is estimated to be 2,600 acres currently held by a combination of private, State, and Federal agencies. Fee title and/or conservation and flood easements would likely be required to implement any project. The Corps will conduct site-specific hydrologic, hydraulic and geotechnical analyses, to determine the most suitable potential levee alignments and the feasibility of repairing the existing levee in place. The Feasibility Study will focus on the economic feasibility and will run a risk analysis of the alternatives. Ecosystem restoration would consist of either planting native habitat or allowing native habitats to establish naturally in the area between any new levee and the river. Selection of a preferred alternative will depend on the result of these studies and the desires of the local community.
a. This notice re-initiates the scoping process whereby the Corps and the Board will identify the scope of issues to be addressed in the EIS/EIR and identify the significant environmental issues related to the flood damage reduction and ecosystem restoration at Hamilton City. The Corps and the Board have initiated a process of involving Federal, State, and local agencies, and concerned individuals under the Comprehensive Study.
b. Significant issues to be analyzed in depth include; agricultural resources, air quality, biological resources, cultural resources, geology and soils, hazardous, toxic, and radioactive materials, hydrology and water quality, and land use.
Community meeting will be held during scoping, after the release of the draft EIS/EIR, and after release of the final EIS/EIR. A public scoping meeting will be held the week of January 6, 2003. The purpose of the meeting is to explain the NOI/NOP, and to solicit suggestions, recommendations, and comments to help refine the issues, measures, and alternatives to be addressed in the EIS/EIR. The public is asked to submit any issues (points of concern, dispute or disagreement) regarding potential effects of the proposed action or alternatives by mail to Corps (see
The draft EIS/EIR is scheduled to be available for public review and comment in August 2003. The comment period on the draft EIS/EIR will be 45 days from the date the notice of availability is published in the
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of intent.
The U.S. Army Corps of Engineers (Corps) is preparing a Draft Programmatic Environmental Impact Statement (EIS) for the Upper Mississippi River Comprehensive Plan to identify problems, opportunities, and potential measures to reduce flood damages in the floodplains of the Upper Mississippi and Illinois Rivers. A Programmatic EIS will be prepared to address potential effects of any recommendations for further action resulting from this study effort, and to provide a broad review of general issues for incorporation by reference in subsequent National Environmental Policy Act (NEPA) documents, if future actions are undertaken as a result of recommendations in the Comprehensive Plan.
Questions about the proposed action and Draft Programmatic EIS can be answered by: David R. Gates, U.S. Army Corps of Engineers, St. Louis District (CEMVS-PM-F), 1222 Spruce Street, St. Louis, MO 63103, telephone (314) 331-8478, or by Charlene Carmack, U.S. Army Corps of Engineeers, Rock Island District (CEMVR-PM-A), Clock Tower Building, P.O. Box 2004, Rock Island, IL 61204-2004, telephone (309) 794-5570.
1. Section 459 of the Water Resources Development Act of 1999 directed the Secretary of the Army to develop a plan to address water resource and related land resource problems in the study area in the interest of systemic flood damage reduction. Section 459 also directed the Secretary to submit a report to Congress detailing the results of this planning effort and addressing recommendations for authorization of further Federal actions or follow-on studies concerning systemic flood control.
The Comprehensive Plan will be developed as a collaborative effort among three Corps Districts (St. Paul, Rock Island, and St. Louis); other Federal agencies (including the Federal Emergency Management Agency [FEMA], the U.S. Fish and Wildlife Service [USFWS], the Natural Resources Conservation Service (NRCS), the U.S. Environmental Protection Agency [USEPA], the U.S. Geological Survey [USGS], and the U.S. Department of Agriculture [USDA]); the States of Illinois, Iowa, Minnesota, Missouri, and Wisconsin; and appropriate non-Federal organizations. The plan will identify future management actions and make recommendations for systemic improvements that provide flood damage reduction and associated environmental benefits.
2. Alternatives, including both structural and nonstructural measures, will be identified and investigated for their potential to accomplish systemic flood damage reduction. It is anticipated that between three to five systemic flood damage reduction alternatives will be formated and evaluated for their potential to contribute to National Ecosystem Development.
3.
An initial set of public meetings (open house format) was held September 9-12 in St. Louis, MO; Quincy, IL; Peoria, IL; and Dubuque, IA. These meetings were announced in mailed newsletters (also posted on the study Web site
4. The scoping process is expected to continue through December 2002 to facilitate early input to the NEPA process and identify significant issues to be evaluated in depth in the Programmatic EIS.
5. Based on current study schedules, the Draft Programmatic EIS is anticipated to be available for public review late in the first quarter of Calendar Year 2004.
Department of Education.
The Leader, Regulatory Management Group, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before February 11, 2003.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Written requests for information should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651 or to the e-mail address
Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her e-mail address
Department of Education.
The Leader, Regulatory Management Group, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before February 11, 2003.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Written requests for information should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651 or to the e-mail address
Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her e-mail address
Department of Education.
The Leader, Regulatory Management Group, Office of the Chief Information Officer invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before January 13, 2003.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Lauren Wittenberg, Desk Officer, Department of Education, Office of Management and Budget, 725 17th Street, NW., Room 10235, New Executive Office Building, Washington, DC 20503 or should be electronically mailed to the internet address
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
This information collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1890-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.
Written requests for information should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651 or directed to her e-mail address
Department of Energy, DOE.
Notice.
The Defense Nuclear Facilities Safety Board Recommendation 2002-2, concerning weapons Laboratory support of the DOE nuclear complex at Department of Energy Defense Nuclear Facilities was published in the
Comments, data, views, or arguments concerning the Secretary's response are due on or before January 6, 2003.
Send comments, data, views, or arguments concerning the Secretary's response to: Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004.
Ms. Karen L. Boardman, Director, Office of Complex Readiness, Albuquerque Operations Office, Pennsylvania & H Street, Kirtland Air Force Base, Albuquerque, NM 87116.
Department of Energy.
Notice.
The Defense Nuclear Facilities Safety Board Recommendation 2002-1, concerning quality assurance for safety-related software at Department of Energy Defense Nuclear Facilities was published in the
Comments, data, views, or arguments concerning the Secretary's response are due on or before January 6, 2003.
Send comments, data, views, or arguments concerning the Secretary's response to: Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004.
Mr. Raymond J. Hardwick, Jr., Associate Deputy Assistant Secretary for Operations, Office of Corporate Safety Assurance, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585.
Requests for copies of EPA comments can be directed to the Office of Federal Activities at (202) 564-7167. An explanation of the ratings assigned to draft environmental impact statements (EISs) was published in FR dated April 12, 2002 (67 FR 17992).
Environmental Protection Agency (EPA).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C., App.2) notification is hereby given that the Environmental Protection Agency, Office of Research and Development (ORD), Board of Scientific Counselors (BOSC), will hold an Executive Committee meeting.
The meeting will be held on January 9-10, 2003. On Thursday, January 9th, the meeting will begin at 1 p.m., and will recess at 5:30 p.m. On Friday, January 10th, the meeting will reconvene at 9 a.m. and will adjourn at approximately 4 p.m. All times noted are eastern time.
The meeting will be held at the Lowe's L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024.
Agenda items to include, but not be limited to: Consultation on ORD's Homeland Security Research Strategy, Briefing on EPA's Report on the Environment, Discussion of BOSC Future Issues and Plans, and BOSC Communications Ad-Hoc Committee Report Update.
Anyone desiring a draft BOSC agenda may fax their request to Shirley R. Hamilton (202) 565-2444. The meeting is open to the public. Any member of the public wishing to make a presentation at the meeting should contact Shirley Hamilton, Designated Federal Officer, Office of Research and Development (8701R), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or by telephone at (202) 564-6853. In general, each individual making an oral presentation will be limited to a total of three minutes.
Shirley R. Hamilton, Designated Federal Officer, U.S. Environmental Protection Agency, Office of Research and Development, National Center for Environmental Research (MC 8701R), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, (202) 564-6853.
Environmental Protection Agency.
Notice of proposed settlement.
The United States Environmental Protection Agency is proposing to enter into an Administrative Order on Consent pursuant to section 122(h)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended regarding the New Hanover County Burn Pit Superfund Site located in Wilmington, New Hanover County, North Carolina. This agreement is made and entered into by EPA and by Axel Johnson, Inc., Sprague Energy Corporation, and Unocal Corporation (“Settling Parties”). EPA will consider public comments on the proposed settlement for 30 days. EPA may withdraw from or modify the proposed settlement should such comments disclose facts or considerations which indicate the proposed settlement is inappropriate, improper, or inadequate.
Copies of the proposed settlement are available from: Ms. Paula V. Batchelor, U.S. EPA, Region 4, Sam Nunn Atlanta Federal Center, Waste Management Division, 61 Forsyth Street, SW., Atlanta, Georgia 30303. (404) 562-8887.
Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication.
Environmental Protection Agency (EPA).
Notice.
On October 30, 2002, EPA published in the
The Administrator is hereby providing public notice of this consent agreement and final order and providing an opportunity for interested parties to comment on the CWA portions, as required by CWA section 311(b)(6)(C), 33 U.S.C. 1321(b)(6)(C).
NEXTEL failed to prepare Spill Prevention Control and Countermeasure (”SPCC”) plans for forty-eight facilities where they stored diesel oil in above ground tanks. EPA, as authorized by CWA section 311(b)(6), 33 U.S.C. 1321(b)(6), has assessed a civil penalty for these violations. NEXTEL failed to obtain the appropriate operating permits or exemptions at eight facilities in violation of CAA section 110, 42 U.S.C. 7410, and various state implementation plan (“SIP”) requirements for emergency generators. EPA, as authorized by CAA section 113(d)(1), 42 U.S.C. 7413(d)(1), has assessed a civil penalty for these violations. NEXTEL failed to file an emergency planning notification with the State Emergency Response Commission (“SERC”) and to provide the name of an emergency contact to the Local Emergency Planning Committee (“LEPC”). NEXTEL failed to submit Material Safety Data Sheets (“MSDS”) or a list of chemicals to the LEPC, the SERC, and the fire department with jurisdiction over each facility for seventy-five facilities in violation of EPCRA section 311, 42 U.S.C. 11021. At sixty-six facilities, NEXTEL failed to submit an Emergency and Hazardous Chemical Inventory form to the LEPC, the SERC, and the fire department with jurisdiction over each facility in violation of EPCRA section 312, 42 U.S.C. 11022. EPA, as authorized by EPCRA section 325, 42 U.S.C. 11045, has assessed a civil penalty for these violations. NEXTEL failed to make a hazardous waste determination and improperly disposed of hazardous waste at one facility in violation of 9 VAC 20-60-261(A), (40 CFR 261.5(g)(1) and (g)(3)). NEXTEL violated RCRA section 9003(d), 42 U.S.C. 6991b(d) and 30 TAC sections 334 and 37.801, when the insurance policy for underground storage tanks failed to use the terms “corrective action” or “sudden, non-sudden or accidental release” to describe coverage for four facilities. At one facility NEXTEL failed to notify the State or local agency or department of the existence of an underground storage tank in violation of RCRA section 9002(a), 42 U.S.C. 6991(a)(1). NEXTEL failed to follow all of the relevant underground storage tank regulations in violation of RCRA section 9003, 42. U.S.C. 6991b at one facility.
Comments are due on or before January 13, 2003.
Send written comments to the Docket Office, Enforcement and Compliance Docket and Information Center (2201T), Docket Number EC-2002-021, U.S. Environmental Protection Agency, EPA West, 1200 Pennsylvania Avenue NW., Room B133, Washington, DC 20460 (in triplicate if possible.)
Please use a font size no smaller than 12. Comments may also be sent electronically to
In person, deliver comments to U.S. Environmental Protection Agency, EPA West, 1301 Constitution Avenue, NW., Room B133, Washington, DC 20460. Parties interested in reviewing docket information may do so by calling (202) 566-1512 or (202) 566-1513. A reasonable fee may be charged by EPA for copying docket materials.
Beth Cavalier, Multimedia Enforcement Division (2248-A), U.S. Environmental Protection Agency, 1200 Pennsylvania
NEXTEL Communications, Inc., its subsidiaries, and NII Holdings, Inc., collectively referred to as “NEXTEL”, are telecommunications companies incorporated in the States of Delaware, Georgia, and Texas. NEXTEL is located at 2001 Edmond Halley Drive, Reston, Virginia, 20191 and NII Holdings, Inc. is located at 10700 Parkridge Boulevard, Suite 600, Reston, Virginia, 20191. NEXTEL disclosed, pursuant to the EPA “Incentives for Self-Policing: Discovery, Disclosures, Correction and Prevention of Violations” (“Audit Policy”), 65 FR 19618 (April 11, 2000), that they failed to prepare SPCC plans for forty-eight facilities where they stored diesel oil in above ground storage tanks, in violation of the CWA section 311(b)(3) and 40 CFR part 112. NEXTEL disclosed that for eight facilities they had failed to obtain operating permits or exemptions in violation of CAA section 110, 42 U.S.C. 7410, and various SIP requirements for emergency generators. NEXTEL disclosed that at seventy-two facilities they had failed to file emergency planning notifications with the SERC and failed to provide the name of an emergency contact to the LEPC, in violation of EPCRA sections 302 and 303, 42 U.S.C. 11002 and 11003. NEXTEL further disclosed that at seventy-five facilities they had failed to submit MSDS or a list of chemicals to the LEPC, SERC, and the fire departments with jurisdiction over the facilities, in violation of EPCRA section 311, 42 U.S.C. 11021; and that at sixty-six facilities had failed to submit an Emergency and Hazardous Chemical Inventory to the LEPC, SERC, and fire departments with jurisdiction over the facilities, in violation of EPCRA section 312, 42 U.S.C. 11022. At four facilities NEXTEL failed to ensure that the language in their financial assurance insurance policies for underground storage tanks was exactly as required by regulation, in violation of 30 TAC sections 334 and 37.801 and RCRA section 9003(d), 42 U.S.C. 6991b(d). NEXTEL violated RCRA section 9002(a)(1), 42 U.S.C. 6991(a)(1) when it failed to notify the state of the existence of an underground storage tank at one facility; and NEXTEL violated RCRA section 9003, 42 U.S.C. section 6991b and all of the relevant underground storage tank regulations at one facility. NEXTEL failed to make a hazardous waste determination and improperly disposed of hazardous waste at one facility in violation of 9-VAC 20-60-261(A).
Pursuant to 40 CFR 22.45(b)(2)(iii), the following is a list of facilities at which NEXTEL self-disclosed violations of CWA section 311(b)(3): 3719 East LaSalle St., Phoenix, AZ; 984 Walsh Ave., Santa Clara, CA; 475 14th Street, Oakland, CA; 11423 Sunrise Gold Circle, Rancho Cordova, CA; 17275 Derian Ave., Irvine, CA; 5996 Gleason Drive, Dublin, CA; 11175 Inland Ave., Mira Loma, CA; 9800 East Easter Ave., Englewood, CO; 10002 Park Meadows Drive, Lone Tree, CO; 4643 South Ulster Street, Denver, CO; 333 Inverness Drive South, Englewood, CO; 1370 Park Central Blvd., Pompano Beach, FL; 200 Avenue B, NW., Winter Haven, FL; 1101 N. Keller Road, Orlando, FL; 1150 Emma Oaks Trail, Lake Mary, FL; 400 Embassy Row, Atlanta, GA; 5952 Peachtree Industrial Blvd., Norcross, GA; 5295 Brookhollow Parkway, Norcross, GA; 2975 Breakinridge Blvd., Duluth, GA; 4150 Shackleford Rd., Norcross, GA; 880 Ashbury Drive, Buffalo Grove, IL; 40 Hartwell Ave., Lexington, MA; 135 Forbes Blvd., Mansfield MA; 11900 Bournefield Way, Silver Spring, MD; 7249 National Drive, Hanover, MD; 39200 Schoolcraft Rd., Livonia, MI; 6435 Hix Road, Westland, MI; 11322 Lackland Road, St. Louis, MO; 610 Industrial Ave., Greensboro, NC; 2 Industrial Road, Fairfield, NJ; One South Street, Garden City, NY; 175 Clearbrook Road, Elmsford, NY; 400 Bursca Drive, Building 400, Bridgeville, PA; 401 North Broad Street, Philadelphia, PA; 901 Jefferson Blvd., Norristown, PA; 4740 Perrin Creek, San Antonio, TX; 4407 Alpha Road, Farmers Branch, TX; 1600 Eberhardt Road, Temple, TX; 1412 East North Belt, Houston, TX; 1766 Old Meadow Road, McLean, VA; 421 Butler Farm Road, Hampton, VA; 400 Butler Farm Road, Hampton, VA; 593 Herndon Parkway, Herndon, VA; 2001-2003 Edmund Halley Drive, Reston, VA; 1505 Farm Credit Drive, McLean, VA; 11710 118th Avenue, NE., Kirkland, WA; 1400 NE McWilliams Road, Bremerton, WA. These facilities are not required to obtain water permits for these requirements.
In addition, violations of EPCRA sections 302, 303, 311 and/or 312 were reported at facilities in the following states: Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington. Violations of CAA section 110 were reported at facilities in Arizona, California, Kansas, New Jersey and Pennsylvania. Violations of RCRA section 9003(d) were reported in California and Illinois, and violations of RCRA section 9003(d) and 30 TAC sections 334 and 37.801 were reported in Texas. A violation of RCRA section 9002(a)(1) was reported in Pennsylvania. In Virginia, NEXTEL reported a violation of 9 VAC 20-6—261(A).
EPA determined that NEXTEL met the criteria set out in the Audit Policy for a 100% waiver of the gravity component of the penalty. As a result, EPA proposes to waive the gravity based penalty ($1,994,810) and proposes a settlement penalty amount of thirty-five thousand and four dollars ($35,004). This is the amount of the economic benefit gained by NEXTEL, attributable to their delayed compliance with the CWA, CAA, RCRA, and EPCRA regulations. NEXTEL Communications, Inc. has agreed to pay this amount. EPA and NEXTEL negotiated and signed an administrative consent agreement, following the Consolidated Rules of Practice, 40 CFR 22.13(b), on October 18, 2002 (
Under CWA section 311(b)(6)(A), 33 U.S.C. 1321 (b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of the CWA section 311(b)(3), 33 U.S.C. 1321(b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA section 311(j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $137,500 by EPA. Class II proceedings under CWA section 311(b)(6) are conducted in accordance with 40 CFR part 22.
Under CAA section 113(d), the Administrator may issue an administrative order assessing a civil penalty against any person who has violated an applicable implementation plan or any other requirement of the Act, including any rule, order, waiver, permit or plan. Proceedings under CAA
Under EPCRA section 325, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable emergency planning or right to know requirements, or any other requirement of the Act. Proceedings under EPCRA section 325 are conducted in accordance with 40 CFR part 22.
Under RCRA section 3008, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable hazardous waste requirements, or any other requirement of the Act. Proceedings under RCRA section 3008 are conducted in accordance with 40 CFR part 22.
Under RCRA section 9006, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable underground storage tank requirements, or any other requirement of the Act. Proceedings under RCRA section 9006 are conducted in accordance with 40 CFR part 22.
The procedures by which the public may comment on a proposed Class II penalty order, or participate in a Clean Water Act Class II penalty proceeding, are set forth in 40 CFR 22.45. The deadline for submitting public comment on this proposed final order is January 13, 2003. All comments will be transferred to the Environmental Appeals Board (“EAB”) of EPA for consideration. The powers and duties of the EAB are outlined in 40 CFR 22.4(a).
Pursuant to CWA section 311(b)(6)(C), EPA will not issue an order in this proceeding prior to the close of the public comment period.
Environmental Protection Agency (EPA).
Notice.
EPA has entered into a consent agreement with ADT Security Services, Inc. (“ADT”) to resolve violations of the Clean Water Act (”CWA”), the Clean Air Act (“CAA”), and the Emergency Planning and Community Right-to-Know Act (“EPCRA”) and their implementing regulations.
The Administrator is hereby providing public notice of this consent agreement and final order and providing an opportunity for interested persons to comment on the CWA portions, as required by CWA section 311(b)(6)(C), 33 U.S.C. 1321(b)(6)(C).
ADT failed to prepare Spill Prevention Control and Countermeasure (“SPCC”) plans for eight facilities where they stored diesel oil in above ground tanks. EPA, as authorized by CWA section 311(b)(6), 33 U.S.C. 1321(b)(6), has assessed a civil penalty for these violations. ADT failed to obtain the appropriate operating permits or exemptions at seven facilities in violation of CAA section 110, 42 U.S.C. 7410, and various state implementation plan (“SIP”) requirements for emergency generators. EPA, as authorized by CAA section 113(d)(1), 42 U.S.C. 7413(d)(1), has assessed a civil penalty for these violations. ADT failed to file an emergency planning notification with the State Emergency Response Commission (“SERC”) and to provide the name of an emergency contact to the Local Emergency Planning Committee (“LEPC”). ADT failed to submit Material Safety Data Sheets (“MSDS”) or a list of chemicals to the LEPC, the SERC, and the fire department with jurisdiction over each facility for ninety-two facilities in violation of EPCRA section 311, 42 U.S.C. 11021. At ninety-two facilities, ADT failed to submit an Emergency and Hazardous Chemical Inventory form to the LEPC, the SERC, and the fire department with jurisdiction over each facility in violation of EPCRA section 312, 42 U.S.C. 11022. EPA, as authorized by EPCRA section 325, 42 U.S.C. 11045, has assessed a civil penalty for these violations.
Comments are due on or before January 13, 2003.
Send written comments to the Docket Office, Enforcement and Compliance Docket and Information Center (2201T), Docket Number EC-2002-020, U.S. Environmental Protection Agency, EPA West, 1200 Pennsylvania Avenue NW., Room B133, Washington, DC 20460 (in triplicate if possible.)
Please use a font size no smaller than 12. Comments may also be sent electronically to
In person, deliver comments to U.S. Environmental Protection Agency, EPA West, 1301 Constitution Avenue, NW., Room B133, Washington, DC 20460. Parties interested in reviewing docket information may do so by calling (202) 566-1512 or (202) 566-1513. A reasonable fee may be charged by EPA for copying docket materials.
Beth Cavalier, Multimedia Enforcement Division (2248-A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone (202) 564-3271; fax: (202) 564-9001; e-mail:
ADT Security Services, Inc. a security services company incorporated in the State of Delaware and located at One Town Center Road, Boca Raton, Florida 33064, disclosed, pursuant to the EPA “Incentives for Self-Policing: Discovery, Disclosures, Correction and Prevention of Violations” (“Audit Policy”), 65 FR 19618 (April 11, 2000), that they failed to prepare SPCC plans for eight facilities where they stored diesel oil in above ground storage tanks, in violation of the CWA section 311(b)(3) and 40 CFR part 112. ADT disclosed that for seven facilities they had failed to obtain operating permits or exemptions in violation of CAA section 110, 42 U.S.C. 7410, and various SIP requirements for emergency generators. ADT disclosed that at sixty-eight facilities they had failed to file emergency planning notifications with the SERC and failed to provide the name of an emergency contact to the LEPC, in violation of EPCRA section 302, 42 U.S.C. 11002. ADT further disclosed that at ninety-two facilities they had failed to submit MSDS' or a list of chemicals to the LEPC, SERC, and the fire departments with jurisdiction over the facilities, in violation of EPCRA section 311, 42 U.S.C. 11021; and that at ninety-two facilities had failed to submit an
Pursuant to 40 CFR 22.45(b)(2)(iii), the following is a list of facilities at which ADT self-disclosed violations of CWA section 311(b)(3): 5400 West Rosecrans Avenue, Hawthorne, California; 14200 Exposition Avenue, Aurora, Colorado; 9000 Town Center Parkway, Bradenton, Florida; 1052 South Powerline Road, Deerfield, Florida; 9512 Sunbeam Center Drive, Jacksonville, Florida; 7805 NW 97th Terrace, Kansas City, Missouri; 502 Fortune Drive, Papillion, Nebraska; and 285 Thruway Park Drive, West Henrietta, New York. These facilities are not required to obtain water permits for the requirements relating to the SPCC violations disclosed.
In addition, ADT self-disclosed violations of EPCRA sections 302 and/or sections 311 and 312 at facilities located in the following states: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Nevada, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, and the District of Columbia. ADT self-disclosed violations of CAA section 110 at facilities located in California.
EPA determined that ADT met the criteria set out in the Audit Policy for a 100% waiver of the gravity component of the penalty. As a result, EPA proposes to waive the gravity based penalty ($1,914,965) and proposes a settlement penalty amount of thirty-one thousand, seven hundred and forty-one dollars ($31,741). This is the amount of the economic benefit gained by ADT, attributable to their delayed compliance with the SPCC, CAA and EPCRA regulations. ADT Security Services, Inc. has agreed to pay this amount. EPA and ADT negotiated and signed an administrative consent agreement, following the Consolidated Rules of Practice, 40 CFR 22.13(b), on October 18, 2002 (
Under CWA section 311(b)(6)(A), 33 U.S.C. 1321 (b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of the CWA section 311 (b)(3), 33 U.S.C. 1321 (b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA section 311 (j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $137,500 by EPA. Class II proceedings under CWA section 311(b)(6) are conducted in accordance with 40 CFR part 22.
Under CAA section 113(d), the Administrator may issue an administrative order assessing a civil penalty against any person who has violated an applicable implementation plan or any other requirement of the Act, including any rule, order, waiver, permit or plan. Proceedings under CAA section 113(d) are conducted in accordance with 40 CFR part 22.
Under EPCRA section 325, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable emergency planning or right to know requirements, or any other requirement of the Act. Proceedings under EPCRA section 325 are conducted in accordance with 40 CFR part 22.
The procedures by which the public may comment on a proposed Class II penalty order, or participate in a Clean Water Act Class II penalty proceeding, are set forth in 40 CFR 22.45. The deadline for submitting public comment on this proposed final order is January 13, 2003. All comments will be transferred to the Environmental Appeals Board (“EAB”) of EPA for consideration. The powers and duties of the EAB are outlined in 40 CFR 22.4(a).
Pursuant to CWA section 311(b)(6)(C), EPA will not issue an order in this proceeding prior to the close of the public comment period.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, 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 (44 U.S.C. chapter 35). Currently, the FDIC is soliciting comments concerning an information collection titled “Certification of Compliance with Mandatory Bars to Employment.”
Comments must be submitted on or before February 11, 2003.
Interested parties are invited to submit written comments to Tamara R. Manly, Management Analyst (Consumer and Compliance Unit), (202) 898-7453, Legal Division, Room MB-3109, Attention: Comments/Legal, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429. All comments should refer to “Certification of Compliance with Mandatory Bars to Employment.” Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7 a.m. and 5 p.m. (Internet address:
Tamara R. Manly, at the address identified above.
Proposal to renew the following currently approved collection of information:
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the collection should be modified prior to submission to OMB for review and approval.
Comments submitted in response to this notice also will be summarized or included in the FDIC's requests to OMB for renewal of this collection. All comments will become a matter of public record.
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 December 30, 2002.
Board of Governors of the Federal Reserve System, December 9, 2002.
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 Web site 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 January 10, 2003.
Board of Governors of the Federal Reserve System, December 9, 2002.
Administration on Aging, HHS.
Notice.
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by January 13, 2003.
Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Allison Herron Eydt, Desk Officer for AoA.
Saadia Greenberg, Office of Evaluation, Administration on Aging, Room 5607, Washington, DC 20201, (202) 357-3554.
In compliance with 44 U.S.C. 3507, AoA has submitted the following proposed collection of information to OMB for review and clearance.
State Program Reports provide state totals of the number of persons served for each type of service under the Older Americans Act Title III and Title VII programs as well as the number units of services provided and some characteristics of the clients. Information is also reported on expenditures for each type of service, staffing levels of state and area agencies on aging.
AoA estimates the burden of this collection of information as approximately 1 hour per state agency.
In 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) 498-1210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. Written comments should be received within 30 days of this notice.
Competence in the ILO system is demonstrated by physicians who have completed a NIOSH approved educational seminar (A Reader) or have passed the NIOSH B Reader certification examination (B Reader). The ILO has recently completed a revision of its radiographic classification system (ILO 2000) that will soon be published. As a result, modifications of the B Reader examinations and related training activities and materials will be needed. These revisions provide an opportunity to evaluate the current B Reader Program by surveying A and B Readers. The survey responses from these physicians will be used to develop a workshop agenda and contract specifications to improve the B Reader Program. The annual burden for this data collection is 617 hours.
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) 498-1210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503. Written comments should be received within 30 days of this notice.
Influenza Surveillance at CDC consists of four components: U.S. Sentinel Physician Network, State and Territorial Epidemiologist Reports, 122 Cities Mortality Report, and the WHO/NRVESS Laboratory Reports. Each of the 50 states as well as the District of Columbia participate in at least one of the CDC's four surveillance components, however, additional surveillance activities within the states are currently unclear. In order to develop or enhance current Influenza surveillance activities at CDC and prepare for the future, including possible pandemics, it is crucial that we are aware of any existing surveillance systems at the state level. We are proposing a survey of state health departments, specifically each state's Influenza Surveillance Coordinator in order to ascertain the nature of flu surveillance in his/her state as well as how prepared the state is for things to come. The data collected will be used to improve and/or enhance national surveillance efforts.
The questionnaire that will be used focuses on state surveillance systems as well as pandemic preparedness. Questions will be asked regarding current surveillance including: Sentinel Physicians Systems, Nursing home surveillance, and School Absenteeism. The annual burden hours are estimated to be 27.
This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health, of the Department of Health and Human Services, has been renewed for a 2-year period extending through November 30, 2004.
For further information, contact Lewis V. Wade, Ph.D., Executive Secretary, Mine Safety and Health Research Advisory Committee, Centers for Disease Control and Prevention, of the Department of Health and Human Services, HHH Building, 200 Independence Avenue, SW., Room 715-H, M/S P-12, Washington, DC 20201. Telephone 202/401-2192, fax 202/260-4464, e-mail
The Director, Management Analysis and Services office has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by December 31, 2002. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on January 8, 2003, and between approximately 1 p.m. and 2 p.m. on January 9, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before December 31, 2002, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Tara P. Turner at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA.” Elsewhere in this issue of the
Submit written or electronic comments concerning this guidance by March 13, 2003.
Submit written requests for single copies on a 3.5″ diskette of the draft guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA,” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818. See the
Submit written comments concerning this guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Carole C. Carey, Center for Devices and Radiological Health (HFZ- 450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609.
Elsewhere in this issue of the
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on special controls for the arrhythmia detector and alarm. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
In order to receive “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (1363) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
You may obtain a copy of the draft guidance from the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer. Updated on a regular basis, the CDRH home page includes device safety alerts,
Interested persons may submit to Dockets Management Branch (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO
Submit written or electronic comments on this guidance at any time. General comments on agency guidances are welcome at any time.
Submit written requests for single copies on a 3.5” diskette of the guidance document entitled “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818. See the
Submit written comments concerning this guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the docket number found in brackets in the heading of this document. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
William A. Noe, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609, ext. 174.
In the
In the
Interested persons were invited to comment on the draft guidance by May 13, 2002. FDA received two comments on the draft guidance document. The comments, from manufacturers, suggested that the draft guidance does not cite current voluntary consensus standards applicable to the devices subject to this guidance. FDA considered the comments and revised the guidance where we believe appropriate. FDA also clarified the description of the risks to health, in order to relate the risks more directly to the recommended mitigation measures.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO
In order to receive “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO
Persons interested in obtaining a copy of the guidance may also do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts,
The premarket notification information collections addressed in the guidance have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) under OMB control number 0910-0120. The labeling provisions addressed in the guidance have been approved by OMB under the PRA under OMB control number 0910-0485.
Interested persons may submit to the Dockets Management Branch (see
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.
Mark Johnston, room 7266, Department of Housing and Urban Development, 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 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Shirley Kramer, Division of Property Management, Program Support Center, HHS, room 58-41, 5600 fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Notice is hereby given in accordance with section 552b of title 5, United States Code, that a meeting of the John H. Chafee Blackstone River Valley National Heritage Corridor Commission will be held on Thursday, November 21, 2002.
The Commission was established pursuant to Public Law 99-647. The purpose of the Commission is to assist federal, state and local authorities in the development and implementation of an integrated resource management plan for those lands and waters within the Corridor.
The meeting will convene at 7 p.m. at Leicester Town Hall located at 3 Washburn Square in Leicester, MA for the following reasons:
1. Approval of Minutes.
2. Chairman's Report.
3. Executive Director's Report.
4. Financial Budget.
5. Public Input.
It is anticipated that about twenty-five people will be able to attend the session in addition to the Commission members.
Interested persons may make oral or written presentations to the Commission or file written statements. Such requests should be made prior to the meeting to: Michael Creasey, Executive Director, John H. Chafee Blackstone River Valley National Heritage Corridor Commission, One Depot Square, Woonsocket, RI 02895. Tel.: (401) 762-0250.
Further information concerning this meeting may be obtained from Michael Creasey, Executive Director of the Commission at the aforementioned address.
Bureau of Indian Affairs, Interior.
Notice.
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) invites comments on two information collection requests which will be renewed. The two collections are: Class III Gaming Procedures, 1076-0149, and Tribal Revenue Allocation Plans, 1076-0150.
Submit your comments and suggestions on or before February 11, 2003, to be assured of consideration.
Comments should be sent to: George Skibine, Bureau of Indian Affairs, Office of Indian Gaming Management, Mail Stop 4543-MIB, 1849 C Street, NW., Washington, DC 20240.
Interested persons may get copies of the information collection requests without charge by contacting George Skibine at 202-219-4066 or facsimile number 202-273-3153.
The Paperwork Reduction Act of 1995 provides an opportunity for interested parties to comment on proposed information collection requests. The Bureau of Indian Affairs, Office of Indian Gaming Management is proceeding with this public comment period as the first step in getting a normal information collection clearance from the Office of Management and Budget (OMB). Each request contains (1) type of review, (2) title, (3) summary of the collection, (4) respondents, (5) frequency of collection, (6) reporting and recordkeeping requirements.
Please note that we will not sponsor nor conduct, and you need not respond to, a request for information unless we display the OMB control number and the expiration date.
The Bureau of Indian Affairs solicits comments in order to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the bureau, including whether the information will have practical utility;
(2) Evaluate the bureau's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility and clarity of the information to be collected; and
(4) Minimize the burden of the collection of the information on those who are to respond.
Any public comments received will be addressed in the Bureau of Indian Affairs' submission of the information collect request to the Office of Management and Budget.
All comments will be available for public review during regular business hours. There may be an instance when we decide to withhold information, but if you wish us to withhold your name and address, you must state this prominently at the beginning of your comment. We will honor your request to the extent allowed by law. We will not consider anonymous comments, and we will make public all comments from businesses and from individuals who represent businesses.
Bureau of Land Management, Interior.
Temporary Emergency Closure of Public Land in Uintah County, Utah.
Notice is hereby given that the Vernal Field Office is re-issuing a temporary emergency closure of public land in Uintah County, Utah, effective January 1, 2003. This order temporarily closes 1,320 acres of public land to public land to public use and entry. This temporary closure area encompasses the following public land:
The authorized officer has determined that the underground methane generation occurring at the abandoned White River Oil Shale Mine is a safety hazard making the facility and surrounding area unsafe for human occupation of activity. The closure area effects the above described public land presently encumbered by the abandoned White River Oil Shale Mine, ancillary support facilities, and associated ventilation shafts. The closure prohibits all use, entry, or access onto the affected public lands; however, the access restriction may be waived under extraordinary circumstances where limited, short term, emergency access is warranted and appropriate clearances and authorization are obtained from the authorized officer.
If BLM authorizes emergency access, it will be conditioned on the following provisions:
All persons entering and leaving the closure area must be accompanied by personnel from the BLM's Vernal Field Office and only after BLM has determined that the area is safe for a site visit.
All persons allowed emergency access into the closure area must waive and release all direct and indirect claims that my occur against the United States for liability for any loss, damage, personal injury, or death that may occur as a result of their access to the closure area and will indemnify and hold harmless the United States. All such incidents shall immediately be reported to the BLM Vernal Field Office.
The purpose of this closure is to protect human life, ensure public safety, and prevent human contact with a known hazardous situation. A map of the area affected by this closure is on file and may be viewed at the BLM Vernal Field Office.
The closure order is effective from January 1, 2003, through December 31, 2004, unless it is rescinded or modified by the authorized officer before that date.
This closure is done under the authority of 43 CFR 8364.1. Persons violating this closure shall be subject to the penalties provided in 43 CFR 8360.0-7, including a fine not to exceed $1,000.00 and/or imprisonment not to exceed one year.
The BLM Vernal Field office, 170 South 500 East, Vernal, Utah 84078, (435) 781-4400.
Bureau of Land Management, Interior.
Notice of meetings.
The Colorado Canyons National Conservation Area (CCNCA) Advisory Council will hold its first monthly meeting of 2003 on January 9, 2003. The meeting will begin at 3 p.m. and will be held at the Mesa County Administration Building; 544 Rood Avenue, Grand Junction, CO; in the main floor Multipurpose Room. Throughout the remainder of calendar year 2003, the CCNCA Advisory Council meetings will be held the first Thursday of each month in the same location and at the same time. The CCNCA was established on October 24, 2000, when the Colorado Canyons National Conservation Area and Black Ridge Wilderness Act of 2000 (the Act) was signed by the President. The Act required that the CCNCA Advisory
January 9, 2002.
For further information or to provide written comments, please contact Greg Gnesios, Bureau of Land Management (BLM), 2815 H Road, Grand Junction, Colorado 81506; Telephone (970) 244-3049; e-mail
The CCNCA Advisory Council will meet on Thursday, January 9, 2003, at the Mesa County Administration Building; 544 Rood Avenue, Grand Junction, CO; in the main floor Multipurpose Room, Grand Junction, Colorado, beginning at 3 p.m. The agenda topics for this meeting are:
(1) The re-election of council officials.
(2) Recommendations from working groups.
(3) Land health recommendations.
(4) Public comment period.
(5) Agenda for next meeting.
Beginning February 2003 the CCNCA Advisory Council meetings will be held monthly on the first Thursday of each month at the same time and location. The dates for these meetings are February 6, 2003; March 6, 2003; April 3, 2003; May 1, 2003; June 5, 2003; July 3, 2003; August 7, 2003; September 4, 2003; October 2, 2003; November 6, 2003; and December 4, 2003.
Topics of discussion for future meetings will include recommendations on management alternatives, including the preferred management alternative, potential environmental consequences of all identified alternatives, completion of the draft resource management plan, partnerships, interpretation, adaptive management, socioeconomics, and other issues as appropriate.
All meetings will be open to the public and will include a time set aside for public comment. Interested persons may make oral statements at the meetings or submit written statements at any meeting. Per-person time limits for oral statements may be set to allow all interested persons an opportunity to speak.
Summary minutes of all Council meetings will be maintained at the Bureau of Land Management Office in Grand Junction, Colorado. They are available for public inspection and reproduction during regular business hours within 30 days of the meeting. In addition, minutes and other information concerning the CCNCA Advisory Council can be obtained from the CCNCA website at:
Department of Interior, Bureau of Land Management, California Desert District.
Notice of amendment to the California Desert Conservation Area (CDCA) Plan and effective date for off-road vehicle trail (route of travel) designations in the Western Colorado Desert (WECO) portion of Imperial County, California.
Written protests on the Proposed Plan Amendment will be accepted if received by January 13, 2003. Instructions for filing protests are contained below under
The Proposed Plan Amendment establishes or revises off-road vehicle designations of areas and trails (routes of travel) in accordance with part 43 Code of Federal Regulations subpart 8342. Trails (routes of travel) for inclusion in the State of California's Discovery Trail System and a segment of the Juan Bautista de Anza National Historic Trail are identified and authorized. The proposed designations pertain to public lands addressed by the California Desert Conservation Area Plan in the Western Colorado Desert (WECO) portion of Imperial County that lie west of the Imperial Sand Dunes Recreation Management Area.
The proposed amendment and environmental assessment are available for review on line at
Arnold Schoeck, Bureau of Land Management, 1661 South 4th Street, El Centro, CA 92243; (760) 337-4441.
The Bureau of Land Management published in the
Any person who has participated in the plan amendment process and has an interest that is or may be adversely affected by the proposed amendment may protest such approval or amendment. A protest may raise only those issues that were submitted for the record during the planning process. Protests must be filed in writing with the BLM Director in accordance with 43 CFR 1610.5-2:
(i) The name, mailing address, telephone number and interest of the person filing the protest;
(ii) A statement of the issue or issues being protested;
(iii) A statement of the part or parts of the plan or amendment being protested;
(iv) A copy of all documents addressing the issue or issues that were submitted during the planning process by the protesting party or an indication of the date the issue or issues were discussed for the record; and
(v) A concise statement explaining why the State Director's decision is believed to be wrong. The decision of the Director on any protest shall be the final decision for the Department of the Interior.
Mailing address for filing a protest:
Bureau of Reclamation, Interior.
Notice of temporary closure to motorized vehicles.
The Bureau of Reclamation's (Reclamation) New Melones Resource Office will temporarily close a portion of Shell Road to public vehicle traffic beginning December 15, 2002, and continuing through approximately April 15, 2003. The exact re-opening date will depend upon weather and resource conditions. The portion of Shell Road to be closed passes through Section 20, R14E, T1N, and continues through Section 19, R14E, T1N, MD Meridian, on property owned and managed by Reclamation. This section of the road passes through the Peoria Wildlife Mitigation Area, as defined in the Final Report, New Melones Lake Fish and Wildlife Resources Report, October 1991, page 16. The entire 2,500-acre Peoria Wildlife Mitigation Area will now be off-limits to public vehicular access—with the exception of authorized parking areas and turnarounds located outside new gates to be established at the closure points on both ends of Shell Road on Reclamation property.
The closure will be effective December 15, 2002, through approximately April 15, 2003. Exact re-opening date will be dependant upon weather and resource conditions.
A map is available for inspection at Reclamation's New Melones Lake Visitor Center, located at 6850 Studhorse Flat Road, Sonora, California 95370. The map may be viewed between the hours of 10 a.m. and 4 p.m. daily. To have a map mailed to your address, send your request to the above address, Attention: Shell Road Temporary Closure Map Request.
Reclamation, Mid-Pacific Region Public Affairs Office, at 916-978-5100 or Reclamation, New Melones Resource Office, 209-536-9094. Written comments will be accepted regarding this temporary closure now through December 15, 2002. Please send written comments to: Bureau of Reclamation, Attn: Jeff Laird, 6850 Studhorse Flat Road, Sonora, California 95370; Fax: 209-536-9652; e-mail:
This action is being taken under 43 CFR Part 423 to protect public safety and prevent additional resource degradation. Reclamation will prohibit public vehicle traffic on Shell Road and off-road throughout the Peoria Wildlife Area during the winter months in an effort to protect sensitive resources and preserve the existing roadway, which has become severely eroded and unsafe. Significant maintenance will be required to return the road to a safe condition for public vehicles. Vegetation damage, habitat destruction, erosion and sedimentation, and related resource impacts are increasing in this area. Natural resources continue to be damaged and public safety compromised by illegal actions including target shooting, poaching, off-road driving, fires, littering, dumping of large debris and hazardous materials, poaching, vandalism, and illegal camping.
Planning for a draft Shell Road Corridor Management Plan to address these and other issues is currently in progress. By closing Shell Road temporarily this winter, further damage can be avoided while plans for improvements are devised and needed maintenance is performed.
Public access by foot, horseback, and bicycle will not be impeded. The area will remain open to authorized public recreational activities including but not limited to legal hunting, hiking, rock climbing, horseback riding, bicycling, wildlife viewing, and sightseeing. Parking and turnaround areas will be located outside new gates to be established at the closure points on both ends of Shell Road on Reclamation property. Signage will be installed to notify the public of the closure.
Exceptions to the vehicle closure will include Reclamation Operations and Maintenance personnel, law enforcement and fire department officers, and other agencies, entities, and individuals who have received express written authorization from Reclamation to enter the closure areas.
This order is posted in accordance with 43 CFR part 423.3(b). Violation of this prohibition or any prohibition listed in 43 CFR part 423 is punishable by fine or imprisonment for not more than six months or both.
Bureau of Reclamation, Interior.
Notice of change.
The Water Resources Planning Act of 1965 and the Water Resources Development Act of 1974 require an annual determination of a discount rate for Federal water resources planning. The discount rate for Federal water resources planning for fiscal year 2003 is 5.875 percent. Discounting is to be used to convert future monetary values to present values.
This discount rate is to be used for the period October 1, 2002, through and including September 30, 2003.
James R. Handlon, Economist, Office of Policy, Washington DC 20240; telephone: (202) 513-0603.
Notice is hereby given that the interest rate to be used by Federal agencies in the formulation and evaluation of plans for water and related land resources is 5.875 percent for fiscal year 2003.
This rate has been computed in accordance with Section 80(a), Pub. L. 93-251 (88.Stat. 34) and 18 CFR 704.39, which: (1) Specify that the rate shall be based upon the average yield during the preceding fiscal year on interest-bearing marketable securities of the United States which, at the time the computation is made, have terms of 15 years or more remaining to maturity (average yield is rounded to nearest one-eighth percent); and (2) provide that the rate shall not be raised or lowered more than one-quarter of 1 percent for any year. The Treasury Department calculated the specified average to be 5.477 percent. Rounding this average yield to the nearest one-eighth percent is 5.500 percent, which exceeds the permissible one-quarter of 1 percent change from fiscal year 2002 to 2003. Therefore, the change is limited to one-quarter of 1 percent.
The rate of 5.875 percent shall be used by all Federal agencies in the formulation and evaluation of water and related land resources plans for the
October 22, 2002.
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of this ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation contact Darrin King on 202-693-4129 or e-mail:
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ETA, Office of Management and Budget, Room 10235, Washington, DC 20503 (202-395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* Enhance the quality, utility, and clarity of the information to be collected; and
* Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of this ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation, contact Darrin King on (202) 693-4129 or e-mail:
Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, Office of Disability Employment Policy, Office of Management and Budget, Room 10235, Washington, DC 20503 (202) 395-7316), within 30 days from the date of this publication in the
The OMB is particularly interested in comments which:
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* Enhance the quality, utility, and clarity of the information to be collected; and
* Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Employment and Training Administration, DOL.
Notice.
The U.S. Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a pre-clearance 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. 35069(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 Interagency Federal Agency Team from the Departments of Labor, Education, Health and Human Services, Agriculture, and Housing and Urban Development is soliciting comments concerning the proposed reinstatement of the Workforce Investment Act: Final Unified State Planning Guidance (OMB Control No. 1205-0407), should states desire to submit a modification to their current plan. A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below.
Maria Flynn, Office of One-Stop Operations/ATTN: Dolores Hall-Beran, U.S. Department of Labor, 200 Constitution Avenue, NW., Room S-4231, Washington, DC 20210: (202) 693-3045 (phone) (this is not a toll-free number); e-mail at
Section 501 of the Workforce Investment Act (Public Law 105-220) provides the Governor of the state the option to submit a strategic Unified State Plan for two or more of the activities or programs listed in section 501(b)(2) of the Act, which include secondary vocational education programs authorized under the Carl D. Perkins Vocational and Applied Technology Education Act, programs authorized under the title I of the Rehabilitation Act of 1973, other programs administered by Federal agencies other than the Department of Labor (DOL) as well as title I of WIA and other programs administered by DOL. The Unified Planning process provides an opportunity for states to maximize joint planning and coordination among a variety of programs and activities. States have the option of submitting a single plan for up to 16 Federal education and training programs. The Unified Plan outlines a 5-year strategy for the statewide workforce investment system of the State.
Acting on behalf of the Secretaries from each agency whose program is included in the Plan, senior managers from these respective agencies, complete a comprehensive coordinated review of the Unified State Plan modification submitted by the Governor. Based upon this review, the appropriate Secretaries of the federal agencies listed above, make a determination of whether the Plan or its modification is consistent with each program or activities' governing legislation. If no outstanding issues are noted, the Unified Plan modification is approved; if deficiencies are noted, the Governor is advised that the state must submit clarification or additional information. Modifications to the Unified Plan during the 5-year period undergo a comparable review and determination followed by a letter indicating approval or the need for additional information or clarification.
Reauthorization of the Workforce Investment Act is scheduled for 2003. The Administration is in the process of developing a reauthorization proposal which may impact the Unified Planning Process.
Since the original publication date, several of the Interagency Federal staff contact information listed in Section C (Programs and Activities) of the Unified Planning Guidance has changed. Should State staff require information on the programs and activities listed WIA section 501(b)(2), please note the following new contact information:
—Secondary Vocational Education Programs (Perkins III/Secondary);
—Postsecondary Vocational Education (Perkins II/Postsecondary;
—Tech-Prep Education (Title II of Perkins III); and
—Activities authorized under Title II of WIA (Adult Education and Family Literacy Programs):
—Activities authorized under Title I (Workforce Investment Activities for Adults, Dislocated Workers and Youth or WIA Title I):
—Activities authorized under chapter 2 of title II of the Trade Act of 1974 as amended (Trade Act Programs):
—Programs authorized under the Wagner-Peyser Act (Employment Service):
—Programs authorized under State unemployment compensation laws (Unemployment Insurance):
—Programs authorized under title V of the Older Americans Act of 1965 (Senior Community Service Employment Program, or SCSEP):
—Programs authorized under chapters 41 and 42 of Title 38, U.S.C., and 20 CFR parts 1001 and 1005 (Veterans Programs, including Veterans Employment, Disabled Veterans' Outreach Program and Local Veterans' Employment Representative Programs):
—Training activities funded by HUD under the Community Development Block Grants (CDBG) and Public Housing Programs:
—Programs authorized under the Community Services Block Grant Act (Community Services Block Grant, or CSBG):
Section 501 of the Workforce Investment Act (Public Law 105-220) provides the Governor of the state the option to submit a strategic Unified State Plan for two or more of the activities or programs listed in section 501(b)(2) of the Act. The Unified State Planning Guidance Instructions outlines a strategy for the submission of a unified plan for the statewide workforce investment system that meets the requirements of Title V of the Act. This reinstatement is needed in order for state governments to submit modifications to their Unified State Plan. These modifications may be needed in order to keep the Plan a viable, living document over its five-year life. The Act gives states the authority to modify WIA Plans at any time and the recently issued Training and Employment Guidance Letter No. 4-02 encourages states to use the unified planning guidance to move from stand-alone planning to a unified planning process. This reinstatement is needed in order for state governments to have available the document used during their initial submission of State Plans, should the state need to submit a modification to its existing Plan.
The Department of Labor is particularly interested in comments which:
(1) 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;
(2) 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; (3) Enhance the quality, utility, and clarify the information to be collected; and
(4) 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, (
Comments submitted in response to this comment request will be summarized and/or included in the request for the Office of Management and Budget's approval of the information collection request; they will also become a matter of public record.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #57327S, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), Subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit # 56585O, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with Section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #60381N, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #58534G, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, Title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #56175H, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #56739M, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #59511H, Aleknagik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of State of Alaska Commercial Fisheries Entry Commission Permit #64708K, Clarks Point, Alaska.
The workers stopped fishing in July of 2001, more than one year from the September 5, 2002, petition date. Section 223(b)(1) of the Trade Act of 1974, as amended, provides that a certification may not apply to a worker whose separation from employment occurred more than one year prior to the date the petition was filed.
Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of State of Alaska Commercial Fisheries Entry Commission Permit #55914X, Twin Hills, Alaska.
The workers stopped fishing in July of 2001, more than one year from the September 5, 2002, petition date. Section 223(b)(1) of the Trade Act of 1974, as amended, provides that a certification may not apply to a worker whose separation from employment occurred more than one year prior to the date the petition was filed.
Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #58675X, Goodnews Bay, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #56790R, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #68167V, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement
Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #55153C, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #56946A, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit # 59194H, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #66280G, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #65811Q, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002, in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit # 57803W, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #55724E, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #55022I, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #57464Q, Ekwok, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #55836U, Ekwok, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #67876N, Egegik, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #59609H, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), Subchapter D, Chapter 2, Title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #64514S, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #55694F, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #59541A, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #61907L, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit # 58284V, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
Pursuant to Title V of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182) concerning transitional adjustment assistance, hereinafter called NAFTA-TAA and in accordance with section 250(a), subchapter D, chapter 2, title II, of the Trade Act of 1974, as amended (19 U.S.C. 2273), an investigation was initiated on September 5, 2002 in response to a petition filed by the Bristol Bay Native Association on behalf of Bristol Bay salmon fishermen, State of Alaska Commercial Fisheries Entry Commission Permit #61292S, Dillingham, Alaska.
The petitioner has requested that the petition be withdrawn. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
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
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 the 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 their 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 by 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 the 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 Regional 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, DC 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.
The U.S. Nuclear Regulatory Commission (the Commission) has granted the request of Arizona Public Service Company (the licensee) to withdraw its application dated September 26, 2002, and its supplement dated October 23, 2002, for proposed amendment to Facility Operating License No. NPF-41 for the Palo Verde Nuclear Generating Station, Unit No. 1, located in Maricopa County, Arizona.
The proposed amendment would have revised the definition of steam generator tube inspection in Section 5.5.9, “Steam Generator (SG) Tube Surveillance Program,” of the Technical Specifications.
The Commission had previously issued Notices of Consideration of Issuance of Amendment published in the
For further details with respect to this action, see the application for amendment dated September 26, 2002, and its supplement dated October 23, 2002; the licensee's letter dated November 19, 2002; and the staff's letter of November 22, 2002. Documents may be examined, and/or copied for a fee, at the NRC's Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the internet at the NRC Web site,
For the Nuclear Regulatory Commission.
Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) has published a final plant-specific Supplement 7 to the Generic Environmental Impact Statement (GEIS), NUREG-1437, regarding the renewal of operating licenses NPF-4 and NPF-7 for the North Anna Power Station, Units 1 and 2, for an additional 20 years of operation. The North Anna Power Station units are operated by Virginia Electric and Power Company (VEPCo). North Anna Power Station is located on the southern shore of Lake Anna, Louisa County, Virginia. Possible alternatives to the proposed action (license renewal) include no action and reasonable alternative methods of power generation.
In Section 9.3 of the report:
Based on (1) the analysis and findings in the Generic Environmental Impact Statement for License Renewal of Nuclear Plants, NUREG-1437; (2) the Environmental Report submitted by VEPCo; (3) consultation with Federal, State, and local agencies; (4) the staff's own independent review; and (5) the staff's consideration of public comments, the recommendation of the staff is that the Commission determine that the adverse environmental impacts of license renewal for North Anna Power Station, Units 1 and 2, are not so great that preserving the option of license renewal for energy planning decision-makers would be unreasonable.
The final Supplement 7 to the GEIS is available electronically for public inspection in the NRC Public Document Room (PDR) located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, or from the Publicly Available Records (PARS) component of NRC's Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at
Mr. Andrew J. Kugler, License Renewal and
For the Nuclear Regulatory Commission.
Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) has published a final plant-specific Supplement 6 to the Generic Environmental Impact Statement (GEIS), NUREG-1437, regarding the renewal of operating licenses DPR-32 and DPR-37 for the Surry Power Station, Units 1 and 2, for an additional 20 years of operation. The Surry Power Station units are operated by Virginia Electric and Power Company (VEPCo). Surry Power Station is located on the Gravel Neck Peninsula in Surry County, Virginia. Possible alternatives to the proposed action (license renewal) include no action and reasonable alternative methods of power generation.
As discussed in Section 9.3 of the report:
Based on (1) the analysis and findings in the Generic Environmental Impact Statement for License Renewal of Nuclear Plants, NUREG-1437; (2) the Environmental Report submitted by VEPCo; (3) consultation with Federal, State, and local agencies; (4) the staff's own independent review; and (5) the staff's consideration of public comments, the recommendation of the staff is that the Commission determine that the adverse environmental impacts of license renewal for Surry Power Station, Units 1 and 2, are not so great that preserving the option of license renewal for energy planning decision-makers would be unreasonable.
The final Supplement 6 to the GEIS is available electronically for public inspection in the NRC Public Document Room (PDR) located at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, or from the Publicly Available Records (PARS) component of NRC's Agency wide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at
Mr. Andrew J. Kugler, License Renewal and Environmental Impacts Program, Division of Regulatory Improvement Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Mr. Kugler may be contacted at 301-415-2828 or by writing to: Andrew J. Kugler, U.S. Nuclear Regulatory Commission, MS O-12D1, Washington, DC 20555.
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of interest rates and assumptions.
This notice informs the public of the interest rates and assumptions to be used under certain Pension Benefit Guaranty Corporation regulations. These rates and assumptions are published elsewhere (or can be derived from rates published elsewhere), but are collected and published in this notice for the convenience of the public. Interest rates are also published on the PBGC's Web site (
The required interest rate for determining the variable-rate premium under part 4006 applies to premium payment years beginning in December 2002. The interest assumptions for performing multiemployer plan valuations following mass withdrawal under part 4281 apply to valuation dates occurring in January 2003.
Harold J. Ashner, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.)
Section 4006(a)(3)(E)(iii)(II) of the Employee Retirement Income Security Act of 1974 (ERISA) and § 4006.4(b)(1) of the PBGC's regulation on Premium Rates (29 CFR part 4006) prescribe use of an assumed interest rate (the “required interest rate”) in determining a single-employer plan's variable-rate premium. The required interest rate is the “applicable percentage” (currently 100 percent) of the annual yield on 30-year Treasury securities for the month preceding the beginning of the plan year for which premiums are being paid (the “premium payment year”). (Although the Treasury Department has ceased issuing 30-year securities, the Internal Revenue Service announces a surrogate yield figure each month—based on the 30-year Treasury bond maturing in February 2031—which the PBGC uses to determine the required interest rate.)
The required interest rate to be used in determining variable-rate premiums for premium payment years beginning in December 2002 is 4.96 percent.
The following table lists the required interest rates to be used in determining variable-rate premiums for premium payment years beginning between January 2002 and December 2002.
The PBGC's regulation on Duties of Plan Sponsor Following Mass Withdrawal (29 CFR part 4281) prescribes the use of interest assumptions under the PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044). The interest assumptions applicable to valuation dates in January 2003 under part 4044 are contained in an amendment to part 4044 published elsewhere in today's
Upon written request, copy available from: Securities and Exchange Commission, Office of Filings and Information Services, Washington, DC 20549.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
•
Form N-54A (17 CFR 274.53) is a notification of election to the Commission to be regulated as a business development company. A company making such an election only has to file a form N-54A once.
It is estimated that approximately four respondents per year file with the Commission a form N-54A. Form N-54A requires approximately 0.5 burden hours per response resulting from creating and filing the information required by the form. The total burden hours for form N-54A would be 2.0 hours per year in the aggregate. The estimated annual burden of 2.0 hours represents an increase of 1.0 hour over the prior estimate of 1.0 hour. The increase in burden hours is attributable to an increase in the number of respondents from three to four.
•
Form N-54C (17 CFR 274.54) is a notification to the Commission that a company withdraws its election to be regulated as a business development company. Such a company only has to file a form N-54C once.
It is estimated that approximately eight respondents per year file with the Commission a form N-54C. Form N-54C requires approximately 1 burden hour per response resulting from creating and filing the information required by the form. The total burden hours for form N-54C would be 8 hours per year in the aggregate. The estimated annual burden of 8 hours represents a decrease of 4 hours over the prior estimate of 12 hours. The decrease in burden hours is attributable to a decrease in the number of respondents from 12 to eight.
•
Certain companies may have to make a filing with the Commission before they are ready to elect on form N-54A to be regulated as a business development company.
It is estimated that zero respondents per year file with the Commission a form N-6F. Form N-6F requires approximately 0.5 burden hours per response resulting from creating and filing the information required by the form. The total burden hours for form N-6F would be 0 hours per year in the aggregate but we are requesting one hour for administrative purposes. The estimated annual burden of 1.0 hour represents no change from the prior estimate of 1.0 hour.
The estimates of average burden hours for forms N-54A, N54-C and N-6F are made solely for the purposes of the Act and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms.
Written comments are invited on: (a) Whether the proposed collections of information are 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 collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Kenneth A. Fogash, Acting Associate Executive Director/CIO, Office of Information Technology, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549.
Drivetime Automotive Group, Inc. (formerly known as Ugly Duckling Corporation), a Delaware corporation (“Issuer”), has filed an application with the Securities and Exchange Commission (“Commission”), pursuant to section 12(d) of the Securities Exchange Act of 1934 (“Act”)
The Issuer stated in its application that it has met the requirements of Amex rule 18 by complying with all applicable laws in State of Delaware, in which it is incorporated, and with the Amex's rules governing an issuer's voluntary withdrawal of a security from listing and registration.
The Board of Directors (“Board”) of the Issuer unanimously approved a resolution on November 13, 2002, to withdraw the Issuer's Securities from listing on the Amex. The Board of the Issuer took such action based on the limited trading volume in the Securities and the costs associated with listing its Securities on the Amex. In addition, the Issuer states pursuant to the indentures under which the Securities were issued, it is not required to maintain the listing of its Securities on the Amex.
The Issuer's application relates solely to the withdrawal of the Securities from listing on the Amex and shall not affect its obligation to be registered under section 12(g) of the Act.
Any interested person may, on or before December 30, 2002, submit by letter to the Secretary of the Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609, facts bearing upon whether the application has been made in accordance with the rules of the Amex and what terms, if any, should be imposed by the Commission for the protection of investors. The Commission, based on the information submitted to it, will issue an order granting the application after the date mentioned above, unless the Commission determines to order a hearing on the matter.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Telesolf Corp., an Arizona corporation, (“Issuer”), has filed an application with the Securities and Exchange Commission (“Commission”), pursuant to section 12(d) of the Securities Exchange Act of 1934 (“Act”)
The Board of Directors (“Board”) of the Issuer approved a resolution on November 4, 2002, to withdraw its Security from listing on the Exchange. In making the decision to withdraw its Security from the PCX, the Board considered the following: (i) The number of stockholders of record (54 holders of record as of October 14, 2002), (ii) the limited trading volume in the Security; and (iii) the cost associated with maintaining a listing on the Exchange. The Issuer's Security has traded on the OTC Bulletin Board since October 24, 2002.
The Issuer stated in its application that it has met the requirements of PCX rule 5.4(b) by complying with all applicable laws in effect in the State of Arizona, in which it is incorporated, and with the PCX's rules that govern the removal of securities from listing and registration on the Exchange. The Issuer's application relates solely to the withdrawal of the Security from listing on the PCX and shall not affect its obligation to be registered under section 12(g) of the Act.
Any interested person may, on or before December 30, 2002, submit by letter to the Secretary of the Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609, facts bearing upon whether the application has been made in accordance with the rules of the PCX and what terms, if any, should be imposed by the Commission for the protection of investors. The Commission, based on the information submitted to it, will issue an order granting the application after the date mentioned above, unless the commission determines to order a hearing on the matter.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On September 12, 2002, the National Association of Securities Dealers, Inc. (“NASD”), through its subsidiary, The Nasdaq Stock Market. Inc. (“Nasdaq”), 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 was published for comment in the
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.
In addition, the Commission finds that the proposed rule change is consistent with Section 15A(b)(5) of the Act
The Commission notes that this fee applies to members and non-members equally.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to adopt PCX rules 6.37(a)(5) and 6.37(c)(4), and amend commentary .05 to PCX rule 6.37 to require options market makers to vocalize a legal-width, two-sided market for a minimum of 10 contracts whenever a floor broker enters a trading crowd and calls for a market in an option series that is one of the 120 most actively traded equity options.
The text of the proposed rule change appears below. New text is in italics.
Rule 6.37(a)—No change.
(b) Appointment as a Primary Market Maker.—No change.
(1)-(4)—No change.
(c) In Classes of Option Contracts Other Than Those to Which Appointed.—No change.
(1)-(3)—No change.
(d)-(f)—No Change.
Commentary .05—Whenever a Floor Broker enters a trading crowd and calls for a market in any class and series at that post, each Market Maker present at the post where the option is traded is obligated, at a minimum, to make a market for one contract
In its filing with the Commission, PCX included statements concerning the purpose of, and basis for, the proposed rule change, as amended, 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 III below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to modify PCX rule 6.37 to provide that, subject to certain conditions, whenever a floor broker enters a trading crowd and calls for a market, certain market makers present at the trading post will be obligated to vocalize a two-sided, legal-width market for a minimum of 10 contracts. This obligation would apply to: (a) Market makers who have executed a transaction in the issue, but not those who have been assigned contracts by the Order Book Official pursuant to PCX rule 6.37, commentary .05, on either the day of the floor broker's call for a market or on the previous business day;
The Exchange would determine whether an equity option ranks in the top 120 most active, nationally-traded issues, based on volume statistics reported by the Options Clearing Corporation.
The Exchange represents that the proposed rule change is intended to enhance the quoting obligations of Exchange market makers. Currently, when floor brokers enter a trading crowd and request a market, market makers are only required to make a market for one contract.
The Exchange believes that the proposed rule change, as amended, is consistent with section 6(b) of the Act,
PCX does not believe that the proposed rule change, as amended, would 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, as amended, were neither solicited nor received.
Within 35 days of the date of publication of this notice in the
(A) By order approve such proposed rule change, as amended; or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act. Specifically, the Commission solicits comments on whether the proposal would have a detrimental effect on competition and liquidity on the Exchange. The Commission notes that the proposal to increase the quote size obligations for Top 120 options would apply to all market makers that have executed a trade on the same or previous day that a floor broker requests a market in a particular Top 120 option. The Commission understands that PCX market makers have continuous market making obligations in those options for which they have a primary appointment.
Persons making written submissions should file six copies thereof with the Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609. Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of the filing will also be available for inspection and copying at the principal offices of the Exchange. All submissions should refer to File No. SR-PCX-2002-55 and should be submitted by January 3, 2003.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Canadian National Railway Company (CN) has filed a notice of exemption under 49 CFR 1152 Subpart F—
CN has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) any potential overhead traffic can be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements at 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the discontinuance shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on January 14, 2003, unless stayed pending reconsideration. Petitions to stay and formal expressions of intent to file an OFA under 49 CFR 1152.27(c)(2),
A copy of any petition filed with the Board should be sent to CN's representative: Michael J. Barron, Jr., Counsel for Canadian National Railway Company, Canadian National/Illinois Central, 455 North Cityfront Plaza Drive, Chicago, IL 60611-5317.
If the verified notice contains false or misleading information, the exemption is void
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Martin Marietta Materials, Inc. (MMM), a noncarrier, has filed a verified notice of exemption to continue in control of Alamo North Texas Railroad Corporation (Alamo North) upon Alamo North's becoming a Class III railroad.
The transaction was scheduled to be consummated on or after November 20, 2002, the effective date of the exemption (7 days after the notice was filed).
At the time this notice was filed, MMM indirectly controlled two railroads, Fredonia Valley Railroad, Inc., operating in Kentucky, and Alamo Gulf Coast Railroad Co., operating in Texas.
MMM states that: (i) The railroads do not connect with each other or any railroad in their corporate family; (ii) the continuance in control is not part of a series of anticipated transactions that would connect the railroads with each other or any railroad in their corporate family; and (iii) the transaction does not involve a Class I carrier. Therefore, the transaction is exempt from the prior approval of 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 the labor protection for transactions under sections 11324 and 11325 that involve only Class III rail carriers. Because this transaction involves Class III rail carriers only, the Board, under the statute, may not impose labor protective conditions for this transaction.
If the verified notice contains false or misleading information, the exemption is void
An original and ten copies of all pleadings referring to STB Finance Docket No. 34266, 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 Fritz R. Kahn, P.C., 1920 N Street, NW., 8th Floor, Washington, DC 20036-1601.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Puget Sound & Pacific Railroad (PSPR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to lease and operate approximately 1.85 miles of rail line from Union Pacific Railroad Company extending between milepost 2.41 at Blakeslee Junction, WA, and milepost 4.26 at Raisch, WA.
Because PSPR's projected annual revenues will exceed $5 million, PSPR certified to the Board on November 8, 2002, that, on October 2, 2002, it had posted the required notice of intent to undertake the proposed transaction at the workplace of the employees on the affected line and had served a copy of the notice of intent on the national offices of all labor unions with employees on the rail line.
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34213, 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 Gary A. Laakso, Vice President Regulatory Counsel, Puget Sound & Pacific Railroad, 5300 Broken Sound Boulevard NW., Boca Raton, FL 33487 and Louis E. Gitomer, 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.
On November 25, 2002, CHS Holdings, Inc. (CHS) filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the provisions of 49 U.S.C. 10903 to abandon its entire line of railroad extending from milepost 177.44 to the end of the line at milepost 179.55, a distance of 2.11 miles, in Pembina County, ND. The line traverses U.S. Postal Service Zip Code 58271 and includes no stations.
The line does not contain federally granted rights-of-way. Any documentation in CHS's possession will be made available promptly to those requesting it.
In this proceeding, CHS is proposing to abandon a line that constitutes its entire rail system. CHS seeks to extinguish its common carrier obligation and, following abandonment of the line, to operate it as a private carrier. When issuing abandonment authority for a railroad line that constitutes the carrier's entire system, the Board does not impose labor protection, except in specifically enumerated circumstances.
By issuance of this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by March 14, 2003.
Any offer of financial assistance (OFA) under 49 CFR 1152.27(b)(2) will be due no later than 10 days after service of a decision granting the petition for exemption. Each OFA must be accompanied by a $1,100 filing fee.
All interested persons should be aware that, following abandonment of rail service and salvage of the line, the line may be suitable for other public use, including interim trail use. Any request for a public use condition under 49 CFR 1152.28 or for trail use/rail banking under 49 CFR 1152.29 will be due no later than January 2, 2003. Each trail use request must be accompanied by a $150 filing fee.
All filings in response to this notice must refer to STB Docket No. AB-845X and must be sent to: (1) Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423-0001; and (2) Fritz R. Kahn, 1920 N Street, NW., 8th Floor, Washington, DC 20036-1601. Replies to the CHS petition are due on or before January 2, 2003.
Persons seeking further information concerning abandonment and discontinuance procedures may contact the Board's Office of Public Services at (202) 565-1592 or refer to the full abandonment or discontinuance regulations at 49 CFR part 1152. Questions concerning environmental issues may be directed to the Board's Section of Environmental Analysis (SEA) at (202) 565-1552. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.]
An environmental assessment (EA) (or environmental impact statement (EIS), if necessary) prepared by SEA will be served upon all parties of record and upon any agencies or other persons who commented during its preparation. Other interested persons may contact SEA to obtain a copy of the EA (or EIS). EAs in these abandonment proceedings normally will be made available within 60 days of the filing of the petition. The deadline for submission of comments on the EA will generally be within 30 days of its service.
Board decisions and notices are available on our Web site at “
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 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 January 13, 2003 to be assured of consideration.
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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau of Alcohol, Tobacco and Firearms is soliciting comments concerning the Labeling and Advertising Requirements Under the Federal Alcohol Administration Act.
Written comments should be received on or before February 11, 2003 to be assured of consideration.
Direct all written comments to Bureau of Alcohol, Tobacco and Firearms, Linda Barnes, 650 Massachusetts Avenue, NW., Washington, DC 20226; (202) 927-8930.
Requests for additional information or copies of the form(s) and instructions should be directed to Edward A. Reisman, Alcohol Labeling and Formulation Branch, 650 Massachusetts Avenue, NW., Washington, DC 20226; (202) 927-8485.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
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 comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3507. The Office of Thrift Supervision within the Department of the Treasury will submit the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. Today, OTS is soliciting public comments on the proposal.
Submit written comments on or before February 11, 2003.
Send comments, referring to the collection by title of the proposal or by OMB approval number, to Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552; send a facsimile transmission to (202) 906-6518; or send an e-mail to
You can request additional information about this proposed information collection from Elizabeth C. Baltierra, Program Analyst (Compliance), Compliance Policy, (202) 906-6540, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552.
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the approval process, we invite comments on the following information collection.
Comments should address one or more of the following points:
a. Whether the proposed collection of information is necessary for the proper performance of the functions of OTS;
b. The accuracy of OTS's estimate of the burden of the proposed information collection;
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 information technology.
We will summarize the comments that we receive and include them in the OTS request for OMB approval. All comments will become a matter of public record. In this notice, OTS is soliciting comments concerning the following information collection.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
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 comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3507. The Office of Thrift Supervision within the Department of the Treasury will submit the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. Today, OTS is soliciting public comments on the proposal.
Submit written comments on or before February 11, 2003.
Send comments, referring to the collection by title of the proposal or by OMB approval number, to Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552; send a facsimile transmission to (202) 906-6518; or send an e-mail to
You can request additional information about this proposed information collection from Sheila Reid, Program Analyst (Compliance), Compliance Policy, (202) 906-6315, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552.
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the approval process, we invite comments on the following information collection.
Comments should address one or more of the following points:
a. Whether the proposed collection of information is necessary for the proper performance of the functions of OTS;
b. The accuracy of OTS's estimate of the burden of the proposed information collection;
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 information technology.
We will summarize the comments that we receive and include them in the OTS request for OMB approval. All comments will become a matter of public record. In this notice, OTS is
(b) In fulfilling its mission, the Commission shall consider the following issues and such other issues relating to the Postal Service as the Commission determines appropriate:
(i) the role of the Postal Service in the 21st century and beyond;
(ii) the flexibility that the Postal Service should have to change prices, control costs, and adjust service in response to financial, competitive, or market pressures;
(iii) the rigidities in cost or service that limit the efficiency of the postal system;
(iv) the ability of the Postal Service, over the long term, to maintain universal mail delivery at affordable rates and cover its unfunded liabilities with minimum exposure to the American taxpayers;
(v) the extent to which postal monopoly restrictions continue to advance the public interest under evolving market conditions, and the extent to which the Postal Service competes with private sector services; and
(vi) the most appropriate governance and oversight structure for the Postal Service.
(b) Members of the Commission shall serve without any compensation for their work on the Commission. Members appointed from among private citizens of the United States, however, while engaged in the work of the Commission, may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in Government service (5 U.S.C. 5701-5707), to the extent funds are available.
(c) The Commission shall have a staff headed by an Executive Director.
(d) The Commission, with the concurrence of the Secretary of the Treasury, may establish subcommittees, consisting of Commission members, as appropriate, to aid in its work.
(e) Consistent with such guidance as the President or, on the President's behalf, the Secretary of the Treasury, may provide, the Commission shall exchange information with and obtain advice from Members of Congress; Federal, State, local, and tribal officials; commercial, nonprofit, and residential users of the United States Postal Service; and others, as appropriate, including through public hearings.
(f) Insofar as the Federal Advisory Committee Act, as amended, may apply to the Commission, any functions of the President under that Act, except for those in section 6 of that Act, shall be performed by the Secretary of the Treasury, in accordance with the guidelines that have been issued by the Administrator of General Services.
(g) Nothing in this order shall be construed to impair or otherwise affect the functions of the Director of the Office of Management and Budget relating to budget, administrative, or legislative proposals.
(b) The Commission shall terminate 30 days after submitting its report and in no event later than August 30, 2003.
Securities and Exchange Commission.
Proposed rule.
The Securities and Exchange Commission (“SEC” or “Commission”) is proposing amendments to its existing requirements regarding auditor independence to enhance the independence of accountants that audit and review financial statements and prepare attestation reports filed with the Commission. The proposed rules recognize the critical role played by audit committees in the financial reporting process and the unique position of audit committees in assuring auditor independence. As directed by section 208(a) of the Sarbanes-Oxley Act of 2002, we are proposing rules to: Revise the Commission's regulations related to the non-audit services that, if provided to an audit client, would impair an accounting firm's independence; define the circumstances whereby an issuer's audit committee can and should pre-approve all audit and allowable non-audit services provided to the issuer by the auditor of an issuer's financial statements; prohibit partners on the audit engagement team from providing audit services to the issuer for more than five consecutive years; prohibit an accounting firm from auditing an issuer's financial statements if certain members of management of that issuer had been members of the accounting firm's audit engagement team within the one-year period preceding the commencement of audit procedures; and require that the auditor of an issuer's financial statements report certain matters to the issuer's audit committee, including “critical” accounting policies used by the issuer.
In addition to the provisions required by the Act, we also are proposing rules defining an accountant as not being independent from an audit client if any partner, principal or shareholder of the accounting firm who is a member of the engagement team received compensation based on any service provided or sold to that client other than audit, review and attest services. Further, we proposed to amend and require additional disclosures to investors of information related to the audit and non-audit services provided by, and fees paid by the issuer to, the auditor of the issuer's financial statements.
Comments should be received on or before January 13, 2003.
You should send three copies of your comments to Jonathan G. Katz, Secretary, U.S. Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC, 20549-0609. You also may submit your comments electronically to the following address:
Samuel L. Burke, Associate Chief Accountant, or Robert E. Burns, Chief Counsel, at (202) 942-4400, Office of the Chief Accountant, or, with respect to questions about investment companies, Brian D. Bullard, Chief Accountant, at (202) 942-0590, Division of Investment Management, U.S. Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549.
We are proposing to add rule 2-07 to Regulation S-X
On July 30, 2002, the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act” or “the Act”) was enacted.
As directed by the Sarbanes-Oxley Act, the proposed rules focus on key aspects of auditor independence:
Title II of the Sarbanes-Oxley Act adds new subsections (g) through (l) to section 10A of the Securities Exchange Act of 1934 as follows:
• Section 201 adds subsection (g), which specifies that a number of non-audit services are prohibited. Many of these services were previously prohibited by the Commission's independence standards adopted in November 2000 (with some exceptions and qualifications).
• Section 201 also adds subsection (h) and requires that non-audit services that are not prohibited under the Sarbanes-Oxley Act and the Commission's rules be subject to pre-approval by the registrant's audit committee. These proposed rules specify the requirements
• Section 202 adds subsection (i), which requires an audit committee to pre-approve allowable non-audit services and specifies certain exceptions to the requirement to obtain pre-approval. These proposed rules specify the requirements of the registrant's audit committee for pre-approving non-audit services by the auditor of the registrant's financial statements.
• Section 203 adds subsection (j), which establishes mandatory rotation of the engagement partner, and the reviewing (or “concurring”) partner every five years. These proposed rules expand the number of engagement personnel covered by the rotation requirement and clarify the “time out” period.
• Section 204 adds subsection (k), which requires that the auditor report on a timely basis certain information to the audit committee. In particular, the Sarbanes-Oxley Act requires that the auditor report to the audit committee on a timely basis (a) all critical accounting policies used by the registrant, (b) alternative accounting treatments that have been discussed with management along with the potential ramifications of using those alternatives, and (c) other written communications provided by the auditor to management, including a schedule of unadjusted audit differences.
• Section 206 adds subsection (l) addressing certain conflict of interest provisions. The Sarbanes-Oxley Act prohibits an accounting firm from performing audit services for a registrant if certain key members of management have recently been employed in an audit capacity by the audit firm. These proposed rules clarify which members of management are covered by these conflict of interest rules.
In addition to the mandate under title II of the Act, these proposed rules address situations where partners, principals, or shareholders of the firm who work on the audit of a company are compensated for selling non-audit services to the same audit client.
As noted above, the proposed rules establish and clarify the important roles and responsibilities of registrant audit committees as well as the registrant's independent accountant.
We have proposed a separate rule under Exchange Act section 10A (240.10A-2) to implement section 3(b)(1) of the Sarbanes-Oxley Act and clarify that our rules implementing title II of Sarbanes-Oxley not only define conduct that impairs independence but also constitute separate violations under the Exchange Act. We have otherwise drafted the proposed rules (except for the proxy disclosure changes) as part of Regulation S-X, and propose to place them among the current auditor independence provisions. These provisions are generally based on whether an accountant is “independent” in the conduct of the audit. We are considering changing the format from rules defining actions that impair the auditor's independence to rules prohibiting such actions and placing them with other Exchange Act rules. The Act supplemented section 10A of the Exchange Act and gave us express authority to adopt rules to implement these new statutory provisions. Among the reasons to move these rules under that provision is to: (1) Organize the related statutory and regulatory provisions more logically, and (2) make explicit that violations would be punishable as Exchange Act violations, as contemplated by sections 3(b)(1) and 208 of the Sarbanes-Oxley Act, with all the remedies available for Exchange Act violations, including penalties. Even if we were to move the rules out of Regulation S-X, we would intend for these provisions also to remain professional standards of independence. If we move them to be Exchange Act rules, we are considering a new provision in Regulation S-X that would state that a violation of these rules would also render the auditor not independent under Regulation S-X. Violations of these provisions could therefore also result in professional discipline in the event of a violation and cause the issuer's financial statement to fail to conform to Regulation S-X.
We seek comment on this alternative approach. We recognize that auditors have traditionally looked to Regulation S-X as the place where rules relating to audits are placed, and we do not intend to make reference to and compliance with the rules more difficult. We seek comment on whether any conforming changes in other parts of the securities laws would be necessary if we adopted these rules and made them Exchange Act rules. We also seek comment on whether any of the current auditor independence rules or definitions under Regulation S-X, the substance of which we do not propose to change in light of the Sarbanes-Oxley Act, should also be made into Exchange Act rules, or conversely, whether any of the particular proposed or existing rules relating to audits should stay in Regulation S-X even if all or most of the remaining proposed rules are adopted as Exchange Act rules.
The Commission's existing rules deem a firm to not be independent with respect to an audit client if a former partner, principal, shareholder, or professional employee of an accounting firm
Consistent with section 206 of the Sarbanes-Oxley Act, we propose adding a restriction on employment with audit clients by former employees of the accounting firm. The Act specifies that an accounting firm cannot perform an audit for a registrant:
Consistent with that directive, we propose that the employment of audit engagement team
As discussed later in this release, the term “financial reporting oversight role” refers to any individual who has direct responsibility for oversight over those
The concept of a “cooling-off” period before an auditor can take a position at the audit client was previously considered by the Independence Standards Board.
An audit firm's independence is impaired with respect to an audit client that employs a former firm professional who could, by reason of his or her knowledge of and relationships with the audit firm, adversely influence the quality or effectiveness of the audit, unless the firm has taken steps that effectively eliminate such risk.
Independence Standards Board's Standard No. 3 specifically notes that additional caution is warranted when it has been less than one year since the professional disassociated him or herself from the firm.
The Act specifies that the cooling off period must be one year. Under our proposed rules, the prohibition would commence one year prior to the earlier of either when the accountant began the current fiscal year's audit or when the accountant began review procedures necessary to conduct a timely review of the registrant's quarterly financial information associated with the current fiscal year. The measurement period is based upon the year the former employee commenced initial employment. For example, if audit engagement team member A last worked on the audit engagement on January 31, 2002 (audit report filed with the Commission on February 19, 2002), and joined audit client B on September 1, 2003, and the review procedures for B commenced on February 20, 2003, the accounting firm would not lose its independence with respect to the audit client since audit engagement team member A did not participate as an audit engagement team member subsequent to February 19, 2002. With respect to determining commencement dates, generally accepted auditing standards require that an audit engagement be properly planned. As such, procedures associated with the planning of the engagement constitute the commencement of an audit.
The Commission is also considering whether it should provide an exemption from these requirements for companies meeting certain criteria, in order to address the practical difficulties that some companies to hire qualified personnel. The criteria might include the available pool of candidates for a position, the size of the company, and the audit committee's role in ensuring the independence of the auditor.
• Is the one-year cooling-off period sufficiently long to achieve an appearance of independence by the accounting firm? If not, what period would be appropriate?
• Is the term audit engagement team sufficiently clear? If not, what changes would improve the description to describe the group of accountants who would be covered?
• Is the phrase commencement of the audit sufficiently clear? If not, what changes would improve the description? Is that the appropriate time to mark the commencement of the period? Is there a better mark?
• Is the phrase commencement of review procedures sufficiently clear? If not, what changes would improve the description?
• Is it appropriate that the cooling-off period provisions apply to employment relationships involving audit engagement team members and their audit clients? Should the requirements be limited to audit clients who are issuers as defined in section 205 of the Act?
• Are the appropriate officers covered by the proposed rule? If not, which additional individuals should be subject to the cooling-off period provision? For example, should national office personnel who would be excluded under the proposal be included?
• Should the proposed rules apply equally to large firms/companies as small firms/companies? Would the proposed rules impose a cost on smaller issuers that is disproportionate to the benefits that would be achieved? Why or why not? Should there be an exemption to this requirement for smaller businesses?
• The “cooling off” period applies to all entities in the investment company complex. Is this too broad? Why or why not?
• Should the Commission include exceptions subject to certain criteria? If so, what should these criteria be?
Section 201(a) of the Sarbanes-Oxley Act adds new section 10A(g) to the Securities Exchange Act of 1934. This section states that it shall be unlawful for a registered public accounting firm that performs an audit of an issuer's financial statements (and any person associated with such a firm) to provide to that issuer, contemporaneously with the audit, any non-audit service, including nine services set forth in the Act. There is an exception, however, for “any non-audit service, including tax services, that is not described” as a prohibited service “only if” the service has been pre-approved by the issuer's audit committee. The nine prohibited non-audit services included in the Act are:
• Bookkeeping or other services related to the accounting records or financial statements of the audit client;
• Financial information systems design and implementation;
• Appraisal or valuation services, fairness opinions, or contribution-in-kind reports;
• Actuarial services;
• Internal audit outsourcing services;
• Management functions or human resources;
• Broker or dealer, investment adviser, or investment banking services;
• Legal services and expert services unrelated to the audit; and
• Any other service that the Board
Many of these services are already the subject of our rules. As explained more fully below, we interpret the legislative history as indicating (1) Congress did not intend the rules to contain broad categorical exceptions and (2) the scope of the prohibited services should be judged against three basic principles. Those three broad principles are that an auditor cannot (1) audit his or her own work, (2) perform management functions, or (3) act as an advocate for the client. To do so would impair the auditor's independence.
Under section 201(b) of the Act, the Board,
The Senate Report on the bill that was the primary foundation for the Act,
The intention of this provision is to draw a clear line around a limited list of non-audit services that accounting firms may not provide to public company audit clients because their doing so creates a fundamental conflict of interest for the accounting firms. The list is based on simple principles. An accounting firm, in order to be independent of its audit client, should not audit its own work, which would be involved in providing bookkeeping services, financial information systems design, appraisal or valuation services, actuarial services, and internal audit outsourcing services to an audit client. The accounting firm should not function as part of management or as an employee of the audit client, which would be required if the accounting firm provides human resources services such as recruiting, hiring, and designing compensation packages for the officers, directors, and managers of an audit client. The accounting firm should not act as an advocate of the audit client, which would be involved in providing legal and expert services to an audit client in legal, administrative, or regulatory proceedings, or serving as a broker-dealer, investment adviser, or investment banker to an audit client, which places the auditor in the role of promoting a client's stock or other interests.
In statements made on the floor of the Senate on July 25, 2002, the day the Senate passed the final bill, Senator Sarbanes discussed the auditor independence provisions in the bill and stated, in part:
What has happened in recent years is that the fees earned from the consulting work have dwarfed the fees earned from the auditors, which inevitably leads to concerns that punches be pulled on the audit to accommodate the significant and remunerative involvement on the consulting side. Certain enumerated consulting practices are therefore not allowed, with the exception that a case-by-case exemption can be obtained from the oversight board that this legislation establishes.* * *
Senator Gramm has suggested that the conference report should be changed to give the SEC or the Oversight Board authority to grant broad categorical exemptions from the list of non-audit services that section 201 of the bill prohibits registered public accounting firms to provide to public company audit clients. Such a change, in my view, would weaken one of the fundamental objectives of the conference report: to draw a bright line around a limited list of non-audit services that accounting firms may not provide to public company audit clients because their doing so creates a fundamental conflict of interest for the accounting firms.
This list is based on a set of simple principles:
A public company auditor, in order to be independent,
A public company auditor
A public company auditor, to be independent,
A public company auditor
The exemptive authority provided to the Board is intentionally narrow to apply to individual cases where the application of the statutory requirement would impose some extraordinary hardship or circumstance that would merit an exemption consistent with the protection of the public interest and the protection of investors. But the fundamental presumption of the provision is that these non-audit services, by their very nature, present a conflict of interest for an accounting firm if provided to a public company audit client.* * *
The conference report chose not to follow the approach of imposing a complete prohibition on the provision of non-audit services to audit clients. Instead it chose the approach of identifying the non-audit services which by their very nature pose a conflict of interest and should be prohibited.* * *
In my view granting broad exemption authority to the Oversight Board or the SEC to permit these non-audit services would undermine the separation the conference report is intended to establish.
The Commission last amended its auditor independence rules in November 2000. In so doing, the Commission identified many of the same services included in the Act that would impair an auditor's independence. In doing so, after public comment, the Commission included certain exceptions and qualifications to these services in those rules. As part of that rulemaking, the Commission utilized concepts similar to those expressed in the Senate Report in evaluating independence matters. Rule 2-01 of Regulation S-X
The Commission had proposed more restrictive independence rules in June 2000.
It seems clear that Congress did not intend to codify unchanged the current auditor independence rules, as the Commission adopted them in November 2000. In Senator Sarbanes' statements, quoted above, he notes the debate with Senator Gramm about the use of “categorical exemptions” from the prohibitions in the Act and states that the Act was not intended to give the Commission “broad exemption authority.” We assume, therefore, that Congress intended the Commission to revise its existing rules, at a minimum, to eliminate categorical exceptions and exemptions.
We note that the terms used by Congress could be construed very broadly. We nevertheless believe that Congress did not intend to ban any service that could conceivably fall within one of the prohibited categories of services. Both the language in the Act and the legislative history argue against such a broad construction. Each service as properly interpreted would be banned; however, proper interpretation must be made in light of the three basic principles. For example, the statute prohibits “expert” services. A broad interpretation of this prohibition could lead one to conclude that almost all services provided by a certified public accountant (CPA) could be considered to be “expert” services. For example, tax services would seem to be among the services that are provided by an “expert.” However, it is clear that Congress did not wish to ban all expert services because the Act specifically provided for an auditor to be able to perform certain services, including tax services, if the audit committee approves them in advance.
Both the Senate Report and Senator Sarbanes' statements on the Senate floor describe each service as fulfilling one of the enumerated “simple principles.” In the Senate Report, these principles are that an accounting firm should not (1) audit its own work, (2) function as a part of management or as an employee of the audit client, or (3) act as an advocate of the audit client. In his July 25th floor statement, Senator Sarbanes added a fourth principle, the notion that an accounting firm should not be a promoter of the issuer's stock or other financial interests.
We therefore propose to amend the auditor independence rules to remove categorical exemptions and to define each term in the list of prohibitions in section 201(a) of the Act in relation to the “simple principle” that is at the foundation of that prohibition. In doing so, we intend to prohibit any service or scenario that reasonably could create one or more of the conflicts identified in the principles.
The proposed rules, like our current independence requirements, govern non-audit services provided by an accountant to an audit client during the audit and professional engagement period.
The proposed rule does not provide an all-inclusive list of the services that are incompatible with proposed rule 2-01(b). Whether the provision of a non-audit service not specified in the proposed rule impairs an accountant's independence will be measured against the four general principles set forth in the preliminary note to rule 2-01 and the “simple principles” in the legislative history noted above.
• Are there other non-audit services that are incompatible with rule 2-01(b) or that raise independence concerns? If so, what are they, and why do they raise independence concerns?
• Is the meaning of the general principles sufficiently clear?
Currently, an auditor's independence is impaired if the auditor provides bookkeeping services to an audit client except in limited situations, such as in an emergency or where the services are provided in a foreign jurisdiction and certain conditions are met.
The proposed rules utilize the existing definition of bookkeeping or other services, which focuses on the provision of services involving: (1) Maintaining or preparing the audit client's accounting records, (2) preparing financial statements that are filed with the Commission or the information which forms the basis of financial statements filed with the Commission, (3) preparing or originating source data underlying the audit client's financial statements.
When an accounting firm provides bookkeeping services for an audit client, the firm may be put in the position of later auditing the accounting firm's work. If, during an audit, an auditor must audit the bookkeeping work performed by his or her accounting firm, it is questionable that the auditor could, or that a reasonable investor would believe that the auditor could, remain objective and impartial. If the auditor found an error in the bookkeeping, the auditor could well be under pressure not to raise the issue with the client if raising the issue could jeopardize the firm's contract with the client for bookkeeping services or result in heightened litigation risk for the firm. In addition, keeping the books is a management function, the performance of which leads to an inappropriate mutuality of interests between the auditor and the audit client.
We understand that auditors are sometimes asked to prepare statutory financial statements for foreign companies, and these are not filed with us. Consistent with the Commission's existing rules, an accountant's independence would be impaired where
• Should the definition of bookkeeping be further clarified? If so, how?
• Does the definition cover all the bookkeeping services that would impair an accountant's independence?
• Should an auditor be permitted to provide bookkeeping services to an audit client if it is not reasonably likely that the results of those services will be subject to audit procedures during the audit of the client's financial statements? Why or why not?
• Is the standard of reasonably likely sufficiently clear? If not, should we use some other standard? If so, what standard should we use?
• Is the phrase “preparing statutory statements which form the basis of U.S. GAAP statements” sufficiently clear? If not, how might the phrase be revised?
Currently, paragraph (c)(4)(ii) identifies certain information technology services that, if provided to an audit client, impair the accountant's independence. The proposed rules identify the information technology services that would impair the auditor's independence. Under paragraph (c)(4)(ii)(A) of the proposed rule, an accountant is not independent if the accountant directly or indirectly operates or supervises the operation of the audit client's information system or manages the audit client's local area network or information system. Further, paragraph (c)(4)(ii)(B) of the proposed rule provides that an accountant is
By “significant” to the financial statements taken as a whole, we refer to information that is reasonably likely to be material to the financial statements of the audit client. Since materiality determinations may not be complete before financial statements are generated, the audit client and accounting firm by necessity will need to evaluate the general nature of the information rather than only system output during the period of the audit engagement. An accountant, for example, would not be independent of an audit client for which it designed an integrated Enterprise Resource Planning (“ERP”) system.
Operating, designing or implementing systems affecting the financial statements may place the auditor in a management role, or result in the accountant auditing his or her own work or attesting to the effectiveness of internal control systems designed or implemented by that accountant.
• Is an auditor's independence impaired when the auditor helps select or test computer software and hardware systems that generate financial data used in or underlying the financial statements? Why or why not?
• Whether a system is used to generate information that is “significant” to the audit client's financial statements may depend on the size of the engagement. Does the magnitude as a percentage of either audit fees or total fees of the fees for such services make a difference on whether performance of the service impairs independence?
Under the Commission's current independence rules, an accountant is deemed to lack independence when providing appraisal or valuations services, fairness opinions, or contribution-in-kind reports for audit clients. However, the current rules contain certain exemptions that we propose to eliminate.
Appraisal and valuation services include any process of valuing assets, both tangible and intangible, or liabilities. They include valuing, among other things, in-process research and development, financial instruments, assets and liabilities acquired in a merger, and real estate. Fairness opinions and contribution-in-kind reports are opinions and reports in which the firm provides its opinion on the adequacy of consideration in a transaction.
Providing these services to audit clients raises several auditor independence concerns. When it is time to audit the financial statements, the accountant could likely end up reviewing his or her own work, including key assumptions or variables that underlie an entry in the financial statements. Also, where the appraisal methodology involves projection of future results of operations and cash flows, some believe that the accountant that prepares the projection could have a mutuality of interest with the client in attaining forecast results.
Our proposals do not prohibit an accounting firm from providing such services for non-financial reporting (
The proposed rule does not limit an accounting firm from utilizing its own valuation specialist to review the work done by the audit client itself or an independent, third-party specialist employed by the audit client, provided the audit client or the client's specialist (and not the specialist used by the accounting firm) provides the technical expertise that the client uses in determining the required amounts recorded in the client financial statements. In those instances, because a third party or the audit client is the source of the financial information subject to the review or audit, the accountant will not be reviewing or auditing his or her own work. Additionally, the quality of the audit may be improved where specialists are utilized in such situations.
• Does providing valuation or appraisal services that are unrelated to the financial statements, such as for certain regulatory purposes, impair an accountant's independence?
• Does providing valuation or appraisal services for tax purposes impair an accountant's independence?
• Are there certain types of appraisal or valuation services, or certain instances in which they are provided, that do not raise auditor independence concerns? Are there circumstances in which an accounting firm may be required by law or regulation to provide such services, either in the United States or abroad?
• Should we provide an exemption for such services provided to a foreign private issuer by its accountant where local law requires such services (
• The Commission staff, when providing interpretations of the application of the auditor independence rules to contribution in-kind reports, has worked with foreign jurisdictions to accommodate the statutory requirements in those jurisdictions.
The current rules generally bar auditors only from providing actuarial services related to insurance company policy reserves and related accounts. Consistent with our approach to implementing the Act, we are proposing to broaden this prohibition by providing that the accountant is not independent if the auditor provides any advisory service involving the amounts recorded in the financial statements and related accounts for the audit client where it is reasonably likely that the results of these services will be subject to audit procedures during an audit of the audit client's financial statements because providing these services may cause an accountant later to audit his or her own work. Additionally, accountants providing these services assume a key management task. Stated differently, to perform these services would violate two of the three basic principles espoused in the legislative history of the Act. In addition, actuarially oriented advisory services may affect amounts reflected in some company's financial statements, such as an insurance company's financial statements. The proposed rules provide that the accountant may utilize his or her own actuaries to assist in conducting the audit provided the audit client uses its own actuaries or third-party actuaries to provide management with the primary actuarial capabilities.
• Are there certain circumstances under which an accountant can provide actuarial services to an audit client without impairing independence?
• Have we appropriately described the actuarial services prohibited by the Act?
Our current rules allow a company to outsource part of its internal audit function to the independent audit firm subject to certain exemptions. For example, smaller businesses are exempted from the internal audit outsourcing prohibition because there have been concerns about the potentially disproportionate impact on such companies. The line between performing management functions and performing an audit is not always clear. Some companies “outsource” internal audit functions by contracting with an outside source to perform, among other things, all or part of their audits of internal controls. As emphasized by the Committee of Sponsoring Organizations (“COSO”), internal auditors play an important role in evaluating and monitoring a company's internal control system.
Since the external auditor generally will rely, at least to some extent, on the internal control system when conducting the audit of the financial statements,
Proposed rule 2-01(c)(4)(v) provides that an auditor is not independent when the auditor performs internal audit services related to the internal accounting controls, financial systems, or financial statements, for an audit client. This does not include nonrecurring evaluations of discrete items or programs that are not in substance the outsourcing of the internal audit function. It also does not include operational internal audits unrelated to the internal accounting controls, financial systems, or financial statements.
We are concerned about the effect of the proposed rule on small businesses that have no internal audit department or staff. Smaller firms may not have sufficient need for full-time internal auditors but nonetheless, may need some services that internal auditors typically provide, which they obtain from their external auditors. We understand that, unless these companies can turn to their external auditors, the work may not be done at all or only at a significant cost to the company because the company would have to engage a separate accounting firm to provide these services.
• Is the definition of the “internal audit function” sufficiently clear?
• We solicit comment on whether an exception should be provided for small
• Does it impair an auditor's independence if the auditor does not provide to the client outsourcing services related to the internal audit function of the audit client, but rather performs individual audit projects for the client?
• Are there safeguards that can be established by the auditor that would allow the audit client to outsource the internal audit function to the auditor without impairing its independence?
• Would it impair the auditor's independence if the auditor performs only operational audits that are unrelated to the internal controls, financial systems, or financial statements?
• Is additional guidance necessary to distinguish the services that would be prohibited under this proposed rule from those services that would be permitted as operational audits?
We are not proposing any significant change to our current rule on management functions. Proposed rule 2-01(c)(4)(vi) provides that an accountant's independence is impaired with respect to an audit client for which the accountant acts, temporarily or permanently, as a director, officer, or employee of an audit client, or performs any decision-making, supervisory, or ongoing monitoring functions for the audit client. This provision is consistent with the provisions of existing rule 2-01(c)(4)(vi).
We believe, however, that provided the auditor does not act as an employee or perform management functions, services in connection with the assessment of internal accounting and risk management controls as well as providing recommendations for improvements do not impair an auditor's independence. Accountants must gain an understanding of their audit clients' systems of internal accounting controls when conducting an audit in accordance with generally accepted auditing standards.
At the same time, we recognize that when an auditor designs and implements its audit client's internal accounting and risk management control systems, some believe that the auditor will lack objectivity if called upon to audit financial statements that are derived, at least in part, from data from those systems or when reporting on those controls or on management's assessment of those controls. As such, we believe that design and implementation of internal accounting and risk management controls are fundamentally different from obtaining an understanding of the controls and testing the operation of the controls which is an integral part of any audit of the financial statements of a company. Likewise, design and implementation of these controls is different from recommending improvements in the internal accounting and risk management controls of an audit client.
Because of this fundamental difference, we believe that designing and implementing internal accounting and risk management controls impairs the auditor's independence because it places the auditor in the role of management. Conversely, obtaining an understanding of, assessing effectiveness of, and recommending improvements to the internal accounting and risk management controls is fundamental to the audit process and does not impair the auditor's independence.
• Do services related to designing or implementing internal accounting controls and risk management controls result in the auditor auditing his or her own work? Would such services impair an auditor's independence when the auditor is required to issue an opinion on the effectiveness of the control systems that he or she designed or implemented?
• Do services related to assessing or recommending improvements to internal accounting controls and risk management controls result in the auditor auditing his or her own work? Would such services impair an auditor's independence when the auditor is required to issue an attestation report on the effectiveness of the control systems that he or she has assessed or evaluated for effectiveness?
• We request comment on whether there are circumstances under which an accounting firm can perform or assume management functions or responsibilities for an audit client without impairing independence?
Our current rules deem an auditor to lack independence when performing certain human resources functions, and we do not propose any significant change to those rules. Consistent with our current rules, proposed rule 2-01(c)(4)(vii) provides that an auditor's independence is impaired with respect to an audit client when the auditor searches for or seeks out prospective candidates for managerial, executive or director positions; acts as negotiator on the audit client's behalf, such as determining position, status, compensation, fringe benefits, or other conditions of employment; or undertakes reference checks of prospective candidates. Under the proposed rule, an auditor's independence also is impaired when the auditor advises an audit client about the design of its management or organizational structure, when it engages in psychological testing, or other formal testing or evaluation programs, or recommends or advises the audit client to hire a specific candidate for a specific job.
Assisting management in human resource selection or development places the auditor in the position of having an interest in the success of the employees that the auditor has selected, tested, or evaluated. Accordingly, observers may perceive that an auditor would be reluctant to suggest the possibility that those employees failed to perform their jobs appropriately, or at least reasonable investors might perceive the auditor to be reluctant, because doing so would require the auditor to acknowledge shortcomings in its human resource service. The auditor also would have other incentives not to report such employees' ineffectiveness, including that the auditor would identify and be identified with the recruited employees.
• Are there additional types of human resource and employee benefit services that impair an auditor's independence?
• Would an auditor's independence be impaired if the auditor provided personnel hiring assistance for only non-executive or non-financial personnel?
• Does it impair an auditor's independence if the auditor provides consultation with respect to the compensation arrangements of the company's executives?
Our current rules deem an auditor to lack independence when performing brokerage or investment advising services for an audit client.
Selling—directly or indirectly—an audit client's securities is incompatible with the auditor's responsibility of assuring the public that the company's financial condition is fairly and accurately presented. When an accountant, in any capacity, recommends to anyone (including non-audit clients) that they buy or sell the securities of an audit client or an affiliate of the audit client, the accountant has an interest in whether those recommendations were correct. That interest could affect the audit of the client whose securities, or whose affiliate's securities, were recommended. These concepts are echoed in the “simple principles” included in the legislative history to the Sarbanes-Oxley Act.
Broker-dealers
• We solicit comment on the scope of the proposal. Are there other securities professional services that the rule should expressly identify as impairing independence?
• Would an auditor's independence be impaired if the auditor acted as a securities analyst covering the sector or industry of an audit client?
• Should we adopt rules that would clarify when the auditor is acting as an unregistered broker-dealer? If so, what should those rules be?
Our current rule states that an auditor is deemed to lack independence when he or she provides legal services to an audit client. The proposed rule provides that an accountant is not independent of an audit client if the accountant provides any service to the audit client that, under circumstances in which the service is provided, could be provided only by someone licensed, admitted or otherwise qualified to practice law in the jurisdiction in which the service is provided. The proposed rules would apply to foreign and U.S. accounting firms equally, minimizing the instances where legal services are provided by the auditor to the audit client.
A lawyer's core professional obligation is to advance clients' interests. Rules of professional conduct require the lawyer to “represent a client zealously and diligently within the bounds of the law.”
We recognize that there may be implications for some foreign registrants from this proposal. For example, we understand that in some jurisdictions it is mandatory that someone licensed to practice law perform tax work, and that an accounting firm providing such services, therefore, would be deemed to be providing legal services. Accordingly, we are interested in understanding the implications of this proposal on foreign private issuers.
• Are there any particular legal services that should be exempted from the rule?
• Would making the rule's application depend upon the jurisdiction in which the service is provided leave the rule subject to any
• Should there be any exception for legal services provided in foreign jurisdictions? For example, in some countries only a law firm may provide tax services. Should a foreign accounting firm be permitted to provide, through an affiliated law firm, tax or other services that a U.S. accounting firm could provide to a U.S. audit client without impairing the firm's independence? Why or why not?
• Should there be an exception for legal services provided to issuers in foreign jurisdictions? Should any such exception be tailored to avoid undermining the purpose of the restriction? For example, could fees for legal services be limited to a small percentage (
• Should any such exception have a “sunset” provision that would both allow foreign private issuers a transition period and allow the Commission to review the situation regarding legal services?
Our current rules do not provide that an auditor is deemed to lack independence when providing expert services to an audit client. The Act, however, includes expert services in the list of prohibited services. As discussed earlier, the legislative history, particularly related to expert services, is focused on the auditor's role when serving in an advocacy capacity. Our proposed rules interpret the legislative prohibition in light of the three basic principles of independence discussed previously.
During the Senate Floor debate, Senator Sarbanes stated, “A public company auditor, to be independent, should not act as an advocate of its audit client (as it would if it provided legal and expert services to an audit client in judicial or regulatory proceedings).”
Clients retain experts to lend authority to their contentions in various proceedings by virtue of the expert's specialized knowledge and experience. The provision of expert services by the accountant may create the appearance that the accountant is acting as the client's advocate in pursuit of the client's interests. The appearance of advocacy (and the corresponding appearance of mutual interest) created by providing expert services is sufficient to deem the accountant's independence impaired.
Our prohibition on the provision of expert services would include providing consultation and other services to an audit client's legal counsel in connection with litigation, administrative or regulatory proceedings. As discussed above in the context of the provision of legal services, legal counsel have an ethical duty to “represent a client zealously and diligently within the bounds of the law” and to “take whatever lawful and ethical measures are required to vindicate a client's cause or endeavor.”
The prohibition on providing “expert” services included in this rule proposal covers services that result in the accounting firm's specialized knowledge, experience and expertise being used to support the contentions of the audit client in various adversarial proceedings. Therefore, under our proposed rule, an auditor's independence would be impaired if the auditor were engaged by the audit client's legal counsel to provide expert witness or other services, including accounting advice, opinions, or forensic accounting services, in connection with the client's participation in a legal, administrative, or regulatory proceeding. For example, an auditor could not provide forensic accounting services to the audit client's legal representative in connection with an investigation by the Commission's Division of Enforcement. Nor could an accounting firm appear as an expert witness in a utility rate setting proceeding in support of an audit client's request for an increase in fees.
Our proposals, however, would not prohibit an auditor from assisting the audit committee in fulfilling its responsibilities in connection with the financial reporting process.
10. Did the company commit to learn the truth, fully and expeditiously? Did it do a thorough review of the nature, extent, origins and consequences of the conduct and related behavior? Did management, the Board or committees consisting solely of outside directors oversee the review? Did company employees or outside persons perform the review? If outside persons, had they done other work for the company? Where the review was conducted by outside counsel, had management previously engaged such counsel? Were scope limitations placed on the review? If so, what were they?
Report of Investigation Pursuant to Section 21(a) of the Securities Exchange Act of 1934 and Commission Statement on the Relationship of Cooperation to Agency Enforcement Decisions, Accounting and Auditing Enforcement Release (“AAER”) No. 1470 (Oct. 23, 2001).
Depending on the conduct at issue, it may be necessary for a company to engage an accountant to conduct a forensic accounting review or audit. While our proposal does not set forth independence requirements for forensic consultants, consistent with the principles we set forth in October 2001, we will consider the objectivity of the forensic accountant as to the issues being investigated in assessing whether to credit the forensic work.
In this regard, our proposals also would not prohibit an auditor from testifying as a fact witness to its audit work for a particular audit client. In those instances, the auditor is merely
• Are there circumstances in which providing audit clients with expert services in legal, administrative, or regulatory filings or proceedings should not be deemed to impair independence?
• Should an auditor be permitted to serve as a non-testifying expert for an audit client in connection with a proceeding?
• Is the definition of prohibited expert services appropriate? Why or why not?
• Is the distinction between advocacy and providing appropriate assistance to an audit committee sufficiently clear?
Section 201 of the Sarbanes-Oxley Act identifies specific categories of non-audit services that are prohibited for accounting firms to provide for their audit clients. Additionally, the Act specifies that the audit committee must pre-approve all non-prohibited non-audit services. In particular, the Act states that:
A registered public accounting firm may engage in any non-audit service,
Nothing in these proposed rules is intended to prohibit an accounting firm from providing tax services to its audit clients when those services have been pre-approved by the client's audit committee. As discussed in our previously proposed rules
While we do not define “tax services,” we understand that tax services can include a range of activities including the preparation of tax returns, tax compliance, tax planning, tax recovery, and other tax-related services. In addition, many engagements will require that an auditor review the tax accrual that is included in the financial statements. Reviewing tax accruals is part of audit services and is not, in and of itself, deemed to be a tax compliance service.
Classifying a service as a “tax service” however, does not mean that the service may not be within one of the categories of prohibited services or may not result in an impairment of independence under rule 2-01(b). The accounting firm and the registrant's audit committee should consider, for example, whether the proposed non-audit service is an allowable tax service or constitutes a prohibited legal service or expert service. As part of this process, the accounting firm and the audit committee should be mindful of the three basic principles which cause an auditor to lack independence with respect to an audit client: (1) The auditor cannot audit his or her own work, (2) the auditor cannot function as a part of management, and (3) the auditor cannot serve in an advocacy role for the client.
We also are considering whether special considerations apply when the auditor provides a tax opinion for the use of a third party in connection with a business transaction between the audit client and the third party. The tax opinion may be vital in the audit client's efforts to induce the third party to enter into the transaction, particularly when the transaction is tax-driven. Under those circumstances, the auditor may be acting as an advocate for the audit client by actively promoting the client's interests.
• We request comment on whether providing tax opinions, including tax opinions for tax shelters, to an audit client or an affiliate of an audit client under the circumstances described above would impair, or would appear to reasonable investors to impair, an auditor's independence.
• Are there tax services that should be prohibited by the Commission's independence rules?
• Is it meaningful to categorize tax services into permitted and disallowed activities? If so, what categories and related definitions would make the demarcation meaningful?
Section 301 of the Sarbanes-Oxley Act specifies that the audit committee has the responsibility for appointment, compensation, and oversight of the work of the company's audit firm. In that capacity, the audit committee has the responsibility for evaluating and determining that the audit engagement team has the competence necessary to conduct the audit engagement in accordance with GAAS.
The Sarbanes-Oxley Act also requires rotation of certain audit partners on a five-year basis in order to continue to provide audit services for a registrant. Section 203 of the Sarbanes-Oxley Act of 2002 specifies that:
It shall be unlawful for a registered public accounting firm to provide audit services to an issuer if the lead (or coordinating) audit partner (having primary responsibility for the audit), or the audit partner responsible for reviewing the audit, has performed audit services for that issuer in each of the 5 previous fiscal years of that issuer.
The concept of audit partner
The Sarbanes-Oxley Act clearly specifies that the lead audit partner and reviewing partner should serve on the engagement in that capacity for no more than five consecutive years. The Commission is proposing rules to clarify the five-year rotation requirement specified in the Sarbanes-Oxley Act.
As noted above, existing SECPS membership requirements stipulate that a rotated partner may not serve on the audit engagement for two consecutive years following rotation.
With respect to determining which partners, principals and shareholders should be included, the proposed rules would go beyond the minimum specified by the Act. As noted above, the Act requires that the lead or coordinating audit partner and the audit partner responsible for reviewing the audit rotate every five years. Clearly, the lead partner as well as the concurring review partner perform critical functions that affect the conduct and effectiveness of the engagement. However, in many larger engagements, the engagement team will include more than just the lead partner and the concurring review partner. Obviously, the larger the registrant and the more diversified the registrant's activities, the more likely that the engagement team will include multiple partners, principals or shareholders.
While under this proposal, firms would be required to rotate multiple partners in these situations, nothing in this proposal is intended to imply that all partners would need to be rotated at the same time. Indeed, we would expect that firms would stagger the rotation of partners to ensure that the engagement team continues to have appropriate expertise to allow the audit engagement to be conducted in accordance with GAAS.
Partners, principals or shareholders who are members of the audit engagement team
Since most registrants are taxable entities, an assessment of the registrant's tax provision accounted for in accordance with GAAP
In many cases, registrants have complex business transactions and other situations which may require that the engagement team consult with the accounting firm's national office or others on technical issues. Partners assigned to “national office” duties (which can include both technical accounting and centralized quality control functions) who may be consulted on specific accounting issues related to a client are not considered members of the audit engagement team even though they may consult on client matters regularly.
In addition to the audit, registrants are required to have their quarterly financial information subjected to a timely review by the accounting firm. Such review is typically conducted according to the provisions required by generally accepted auditing standards.
Under the proposed rules, a partner performing audit, review or attest services to an investment company could only do so if they had not performed such services for any entity within the investment company complex, as defined in rule 2-01(f)(14) of Regulation S-X during the previous five consecutive years. For example, the proposed rule would prohibit a partner from rotating between two separate investment company issuers within an investment company complex. The proposed rule also would prohibit a partner from rotating between an investment company issuer and any other entity within the investment company complex.
While we are proposing that all partners on the engagement team who perform a continuing audit function be subject to the partner rotation requirements, we are interested in understanding the implications of this proposed requirement on audit firms. For example, it has been suggested by some that the need for the audit firm to rotate its audit partners might be obviated by having a second audit firm periodically perform a forensic audit to evaluate the work of the existing auditor, the condition of the company's internal controls, the company's accounting and reporting practices, and other matters. Forensic audits are typically conducted by specialized accountants and are designed to go beyond the scope of a financial statement audit. Indeed, forensic audits are typically conducted when there is already reason to suspect wrongdoing or fraud. Some believe that having a separate set of examiners conduct periodic forensic audits would encourage financial statement auditors to take greater responsibility for the detection of fraud and illegal acts when auditing financial statements due to the fact that another set of auditors would be critically evaluating their role. Additionally, forensic audits conceivably could give the audit committees a tool to better evaluate the quality of the financial statement auditors.
A possible consequence of the auditor rotation requirement is that some firms may be unable staff the audit engagement team with sufficient partners who are qualified to understand some of the difficult issues that the audit client faces. This may be particularly true in industries where there are specialized transactions, regulatory processes, or accounting principles. Nonetheless, the auditor is required to conduct the audit in accordance with generally accepted auditing standards. In particular, the third general standard requires that the auditor exercise due professional care in the conduct of the audit (
• Should the Commission adopt rules requiring that issuers engage forensic auditors periodically to evaluate the work of the financial statement auditors? If so, how often should the forensic auditors be engaged? What should be the scope of the forensic auditors' work? Would doing so obviate the need to require partner rotation for the audit firm? Alternatively, could the company obtain the necessary expertise by engaging other outside consultants? If so, what type of consultants should it engage?
• Would the establishment of rules requiring companies to engage forensic auditors periodically provide an opportunity to other firms to enter the market to provide these services?
• Should the Commission establish requirements for firms conducting forensic audits? If so, what should those requirements be?
• Should issuers be given a choice between engaging forensic auditors periodically and having the audit partners on their engagement team be subject to the rotation requirements? Why or why not?
• What are the costs and benefits of engaging forensic auditors to evaluate the work of the financial statement audit firm?
• This proposed rule would apply to the audits of the financial statements of “issuers.” Should the Commission consider applying this rule to a broader population such as audits of the financial statements of “audit clients” as defined in 2-01(f)(6) of Regulation S-X? Why or why not?
• For organizations other than investment companies, the rotation requirements would apply to significant subsidiaries of issuers. Should a different approach be considered? Is so, what approach would be appropriate?
• Should the rotation requirements apply to all partners on the audit engagement team? If not, which partners should be subject to the requirements?
• Is the proposed guidance sufficiently clear as to which audit engagement team partners would be covered by the rule? Is the proposed approach appropriate? If not, how can it be improved?
• Is the exclusion of certain “national office partner” personnel from the rotation requirements appropriate?
• Is the guidance on national office partners who are exempted from the rotation requirements sufficiently clear?
• Is the distinction between a member of the engagement team and a national office partner who consults regularly (or even continually) on client matters sufficiently clear?
• Should certain partners performing non-audit services for the client in connection with the audit engagement be excluded from the rotation requirements?
• Should additional personnel (such as senior managers) be included within the mandatory rotation requirements?
• Is it appropriate to provide transitional relief where the proposed rules are more restrictive that the provisions of the Sarbanes-Oxley Act?
• Are there situations in foreign jurisdictions that extended partner rotation could be modified with additional safeguards or limitations that would recognize the jurisdictional requirements as well as logistical limitations that may exist?
• Should the rotation requirements be different for small firms? What changes would be appropriate and why? If so, how should small firms be defined?
• Would the proposed rules impose a cost on smaller firms that is disproportionate to the benefits that would be achieved?
• Is the five-year “time out” period necessary or appropriate? Would some shorter time period be sufficient, such as two, three or four years? Should there be different “time out” periods based on a partner's role in the audit process?
• If a partner rotates off an engagement after fewer than five years, should the “time out” period also be reduced? Why or why not? If so, how much should the reduction in the time out period be?
• Are the partner rotation requirements, as proposed, for investment company issuer's or other entities in the investment company complex too broad? Should we only prohibit a partner from rotating between investment company issuers within the same investment company complex? Why or why not?
• The proposed rules would not require all partners on the audit engagement team to rotate at the same time. Should it? Why or why not?
The proposed rules recognize the critical role played by audit committees in the financial reporting process and the unique position of audit committees in assuring auditor independence. An effective audit committee may enhance the auditor's independence by, among other things, providing a forum apart from management where the auditors may discuss their concerns. It may facilitate communications among the board of directors, management, internal auditors and independent accountants. An audit committee also may enhance auditor independence from management by appointing, compensating and overseeing the work of the independent auditors.
The audit committee should approve the engagement of the independent accountant to audit the issuer and its subsidiary's financial statements and have ongoing communications with the accountant. The proposals would require that the audit committee pre-approve all permissible non-audit services and all audit, review or attest engagements required under the securities laws. The proposals require that either:
• Before the accountant is engaged by the audit client to provide services other than audit, review or attest services, the audit client's audit committee expressly approve the particular engagement; or
• Any such engagement be entered into pursuant to detailed pre-approval policies and procedures established by the audit committee and the audit committee is informed on a timely basis of each service.
As provided in the Sarbanes-Oxley Act, the proposed rules recognize audit services to be broader than those services required to perform an audit pursuant to generally accepted auditing standards. For example, the Act identifies services related to the issuance of comfort letters and services related to statutory audits required for insurance companies for purposes of state law as audit services.
The audit committee also would have the sole authority to pre-approve the engagement of the company's independent accountant to expressly perform particular non-audit services. The audit committee also could establish policies and procedures provided they are detailed as to the particular service and designed to safeguard the continued independence of the auditor. Additionally, the Sarbanes-Oxley Act allows for one audit committee member to pre-approve the service.
Unlike other issuers, the investment adviser to the investment company issuer will generally engage the issuer's accountant to perform non-auditing services that might impact the accountant's independence. The proposed rule would require pre-approval not only of the non-auditing services provided to the investment company issuer, but also require pre-approval by the investment company issuer's audit committee of the non-auditing services provided to the investment adviser of an investment company issuer and any entity controlling, controlled by, or under common control with the investment adviser that provides services to the investment company. The proposed rule would not, however, require the audit committee of an investment company to approve the auditing or non-auditing services provided: (i) To another investment company registrant within an investment company complex as defined in rule 2-01(f)(14); (ii) to a sub-adviser that primarily provides portfolio management services and is under the direction of another investment adviser; and (iii) to other entities within the investment company complex that do not provide services to the fund.
Under the proposed rule, the investment company's audit committee would be able to establish policies and procedures for pre-approving non-auditing services provided not only to the investment company issuer, but also its investment adviser and related entities that provide services to the fund. The proposed rule would permit, for purposes of determining whether a non-auditing service meets the
Also, as discussed later in this release, these provisions are supplemented as a result of the proposed proxy disclosure requirements. We believe that disclosure of the procedures the audit committee uses to pre-approve audit services will provide investors valuable information that may be used to evaluate the relationships that exist between the auditor and the audit client.
• Should the Commission create other exceptions (beyond the
• Is allowing the audit committee to engage an auditor to perform non-audit services by policies and procedures, rather than a separate vote for each service, appropriate? If so, how do we ensure that audit committees have rigorous, detailed procedures and do not, in essence, delegate that authority to management?
• Should more or fewer aspects be left to the discretion of the audit committee?
• Are there specific matters that should be communicated to or considered by the audit committee prior to its engaging the auditor?
• What, if any, audit committee policies and procedures should be mandated to enhance auditor independence, interaction between auditors and the audit committee, and communications between and among audit committee members, internal audit staff, senior management and the outside auditor?
• Our proposed rules do not contain exemptions for foreign filers. Are there legal or regulatory impediments which may make it difficult for certain foreign filers to comply? If so, what safeguards can these foreign filers employ to ensure that they comply with the proposed rules?
• Our proposed rules requiring the audit committee to pre-approve non-audit services to be provided by the company's auditor do not contain an exemption for foreign filers. Are there legal or regulatory impediments which may make it difficult for certain foreign filers to comply? If so, what safeguards can these foreign filers employ to ensure that there is an authorization process to
• In addition to legal or regulatory impediments, are there practical impediments which would make it difficult for certain foreign filers to comply with the pre-approval requirements? If so, what are these impediments? What safeguards can such an entity establish to better implement the proposed rules (which is to separate the decision to engage the auditor for non-audit services from management)?
• Should the Commission provide additional specific guidance to assist audit committees when deliberating auditor independence issues? What topics would be helpful?
• Our proposed rules would require the audit committee of an investment company to pre-approve the non-auditing services provided by the accountant of the investment company to the investment company's investment adviser and any entity controlling, controlled by, or under common control with the investment adviser that provides services to the investment company. Should the audit committee of an investment company registrant be required to approve any non-auditing services provided to the investment adviser and any entity controlled, controlled by, or under common control with the investment adviser that provides services to the fund? Should the scope of the pre-approval requirement be expanded or narrowed? Why or why not?
• Under the proposed rules, the pre-approval of non-auditing services would permit, for purposes of determining whether a non-auditing service meets the
• This proposed rule would apply to “issuers.” Should the Commission consider applying this rule to a broader population such as “audit clients” as defined in 2-01(f)(6) of Regulation S-X? Why or why not?
• In addition to the requirement that a majority of the directors who are not interested persons of the registered investment company appoint the independent accountant of a registered investment company under the Investment Company Act of 1940, the proposed rules would also require the audit committee of an investment company to separately approve the accountant. For registered investment companies, who should approve the selection of the accountant,
We propose to amend the auditor independence rules to address the practice of auditors being compensated by their firms for selling non-audit services to their audit clients. The new rule would provide that an accountant is not independent if, at any point during the audit and professional engagement period,
Some accounting firms offer their professionals cash bonuses and other financial incentives to sell products or services, other than audit, review, or attest services to audit clients. We view such incentive programs as inconsistent with the independence and objectivity of external auditors that is necessary for them to maintain, both in fact and in appearance. The Commission believes that any partner, principal or shareholder who is a member of the audit engagement team could be influenced adversely as a result of the economic benefits that may be derived by promoting the firm's non-audit services to audit clients. We are concerned that an auditor might be viewed as compromising accounting judgments in order not to jeopardize the potential for increased income from sales of non-audit services.
“Compensation,” as used in the proposed rule, would include any form of income or monetary benefit distributed to the partner, principal or shareholder. Compensation would be based on the performance or sale of non-audit services if the partner, principal, or shareholder were financially rewarded in any way for the performance or sale of such services. For example, this provision would result in accounting firms removing the sale of non-audit services to a partner's audit clients from the criteria used to allocate partnership “units” to that partner. It also would apply to any other vehicle used in determining compensation for any partner, principal or shareholder who is a member of the engagement team. This provision also reinforces the position that accountants at the partner level should be viewed as skilled professionals and not as conduits for the sale of non-audit services. This proposal recognizes and focuses on the need for independence of the most senior members of the engagement team as well as the accounting firm.
• We seek comments on all aspects of incentive compensation for audit partners, principals and shareholders and on the following:
• What economic impact will our proposal have on the current system of partnership compensation in accounting firms?
• Are there other approaches that should be considered with respect to compensation packages that pose a concern about auditor independence? If so, what are they?
• Would the proposed rule change be difficult to put into practice? If so, why? How could it be changed to be more effectively applied?
• Should managers, supervisors or staff accountants who are members of the audit engagement team also be covered by this proposal?
• Does this proposal cover the appropriate time period or should a measure other than the audit and professional engagement period be considered?
• Does the proposed rule cover the entire component of an audit partner's compensation that gives rise to independence concerns?
• Will this compensation limitation disproportionately affect some firms because of their size or compensation structure? If so, how may we accomplish our goal while taking these differences into account?
• Our proposal references compensation based on the performance or sale of non-audit services. Is there a better test that permits partners to participate in the overall success of the firm while addressing the influence that such services might have on a particular auditor-client relationship?
The term “accountant” currently is defined under the rules of the Commission as a “certified public accountant or public accountant performing services in connection with an engagement for which independence is required.”
Under the existing rules of the Commission, accounting role and financial reporting oversight role were included as a single definition. However, because the proposed rules that require a cooling-off period relate only to those performing a financial reporting oversight role, the Commission proposes to define separately “accounting role” and “financial reporting oversight role.” As proposed, the term “accounting role” refers to a role where a person can or does exercise more than minimal influence over the contents of the accounting records or over any person who prepares the accounting records. All persons in a “financial reporting oversight role” (defined below) are also in an “accounting role.” However, persons in an accounting role include individuals in clerical positions responsible for accounting records (
• Is this proposed definition sufficiently clear? If not, what changes would make the definition clearer and more operational?
The term “financial reporting oversight role” refers to a role in which an individual has direct responsibility or oversight of those who prepare the registrant's financial statements and related information (
• Is this proposed definition sufficiently clear? If not, what changes would make the definition clearer and more operational?
Section 205 of the Sarbanes-Oxley Act defines an audit committee as:
A committee (or equivalent body) established by and amongst the board of directors of an issuer for the purpose of overseeing the accounting and financial reporting processes of the issuer and audits of the financial statements of the issuer.
The audit committee serves as an important body, serving the interests of investors, to help ensure that the registrant and its auditors fulfill their responsibilities under the securities laws. Because the definition of an audit committee includes the entire board of directors if no such committee of the board exists, these rules do not require registrants to establish audit committees.
Some companies do not have boards of directors and therefore do not have audit committees. For example, some limited liability companies and limited partnerships that do not have a corporate general partner may not have an oversight body that is the equivalent of an audit committee. We do not propose to exempt these entities from the proposed requirements. Rather, such issuers should look through each general partner of the limited partnerships acting as general partner until a corporate general partner or an individual general partner is reached. With respect to a corporate general partner, the registrant should look to the audit committee of the corporate general partner or to the full board of directors as fulfilling the role of the audit committee. With respect to an individual general partner, the registrant should look to the individual as fulfilling the role of the audit committee.
We do, however, propose to exempt asset-backed issuers
• Some registrants may not have designated boards of directors or audit committees (
• Our proposed rules exempt unit investment trusts and asset-backed issuers from the rule requiring the audit committee to approve auditing and non-auditing services. Should unit investment trusts and asset-backed issuers be subject to these requirements? If so, given that unit investment trusts and asset-backed issuers are not actively managed, who should be responsible for approving the auditing and non-auditing services? Are there other, similar entities that should be exempt from the pre-approval requirements?
• Are the existing definitions in Regulation S-X and rule 2-01 of Regulation S-X of audit client, issuer, and subsidiary sufficiently clear?
Section 204 of the Sarbanes-Oxley Act directs the Commission to issue rules requiring timely reporting of specific information by auditors to audit committees. We are proposing to amend Regulation S-X to require each public accounting firm registered with the Public Company Accounting Oversight Board that audits an issuer's financial statements to report, prior to the filing of such report with the Commission, to the issuer or registered investment
We believe that this section of the Sarbanes-Oxley Act and these proposed rules largely codify current requirements under Generally Accepted Auditing Standards (“GAAS”) for auditors of public companies to discuss matters with management and audit committees. We further believe that specifying the timing of these communications will facilitate more open dialogue between auditors and audit committees.
Certain specific oral or written communications with audit committees are currently required by GAAS, including:
(1) Methods used to account for significant unusual transactions,
(2) Effects of significant accounting policies in controversial or emerging areas for which there is a lack of authoritative guidance or consensus,
(3) Process used by management in formulating particularly sensitive accounting estimates and the basis for the auditor's conclusions regarding the reasonableness of those estimates,
(4) Material audit adjustments proposed and immaterial adjustments not recorded by management,
(5) Auditor's judgments about the quality of the company's accounting principles, and
(6) Disagreements with management over the application of accounting principles, the basis for management's accounting estimates, and the disclosures in the financial statements.
Auditors are required under GAAS to provide these communications in a timely manner but not necessarily before the issuance of the audit report.
• In light of the requirements for the CEO and CFO to certify information in the company's periodic filings,
We are proposing rules requiring communication by auditors to audit committees of all critical accounting policies and practices. This communication can be oral or written. In December 2001, we issued cautionary advice regarding each issuer disclosing in the Management's Discussion and Analysis
Prior to finalizing and filing annual reports, audit committees should review the selection, application and disclosure of critical accounting policies. Consistent with auditing standards, audit committees should be apprised of the evaluative criteria used by management in their selection of the accounting principles and methods. Proactive discussions between the audit committee and the company's senior management and auditor about critical accounting policies are appropriate.
In May 2002, the Commission proposed rules to require disclosures that would enhance investors' understanding of the application of companies' critical accounting policies.
Auditors may want to read and refer to the December 2001 Cautionary Guidance as well as the May 2002 proposed rules as a guide to determining the types of matters that should be communicated to the audit committee under this proposed rule. We do not propose to require that those discussions follow a specific form or manner, but we expect, at a minimum, that the discussion of critical accounting estimates and the selection of initial accounting policies will include the reasons why certain estimates or policies are or are not considered critical and how current and anticipated future events impact those determinations. In addition, we anticipate that the communications regarding critical accounting policies will include an assessment of management's disclosures along with any significant proposed modifications by the auditors that were not included.
• Should the auditor be required to provide additional information to the audit committee regarding the company's critical accounting policies?
• When should the communication take place?
• Should the auditor be required to provide the communication in writing?
• Is it appropriate that investment companies would be subject to the rules regarding critical accounting policies?
We recognize that the complexity of financial transactions results in accounting answers that are often the subject of significant debate between management and the auditors. We believe that these discussions of accounting alternatives that occur between management and the auditors should be shared with the audit committee in their oversight role. The report by the Senate Committee on Banking, Housing, and Urban Affairs on the bill that later became the foundation for the Sarbanes-Oxley Act, in addressing section 204, stated, in part:
The Committee believes that it is important for the audit committee to be aware of key assumptions underlying a company's financial statements and of disagreements that the auditor has with management. The audit committee should be informed in a timely manner of such disagreements, so that it can independently review them and intervene if it chooses to do so in order to assure the integrity of the audit.
Therefore, we are proposing rules requiring communication, either orally or in writing, by auditors to audit committees of alternative accounting treatments of financial information within GAAP that have been discussed with management, including the ramifications of the use of such alternative treatments and disclosures and the treatment preferred by the accounting firm. This proposed rule is intended to cover recognition, measurement, and disclosure considerations related to the accounting for specific transactions as well as general accounting policies.
We believe that communications regarding specific transactions should identify, at a minimum, the underlying facts, financial statement accounts impacted, and applicability of existing corporate accounting policies to the transaction. In addition, if the accounting treatment proposed does not comply with existing corporate accounting policies, or if an existing corporate accounting policy is not applicable, then an explanation of why the existing policy was not appropriate or applicable and the basis for the selection of the alternative policy should be discussed. Regardless of whether the accounting policy selected preexists or is new, the entire range of alternatives available under GAAP that were discussed by management and the auditors would be communicated along with the reasons for not selecting those alternatives. If the accounting treatment selected is not the preferred method in the auditor's opinion, we would expect that the reasons why the auditor's preferred method was not selected by management also would be discussed.
Communications regarding general accounting policies would focus on the initial selection of and changes in significant accounting policies, as required by AU § 380, and would include the impact of management's judgments and accounting estimates, as well as the auditor's judgments about the quality of the entity's accounting principles. The discussion of general accounting policies would include the range of alternatives available under GAAP that were discussed by management and the auditors along with the reasons for selecting the chosen policy. If an existing accounting policy is being modified, then the reasons for the change would also be communicated. If the accounting policy selected is not the auditor's preferred policy, then we would expect the discussions to include the reasons why the auditor considered one policy to be preferred but that policy was not selected by management.
The separate discussion of critical accounting policies and estimates is not considered a substitute for communications regarding general accounting policies, since the discussion about critical accounting policies and estimates might not encompass any new or changed general accounting policies and estimates. Likewise, this discussion of general accounting policies and estimates is not intended to dilute the communications related to critical accounting policies and estimates, since the issues affecting critical accounting policies and estimates, such as sensitivities of assumptions and others, may be tailored specifically to events in the current year, and the selection of general accounting policies and estimates should consider a broad range of transactions over time.
• Is the discussion of which accounting policies require communication with the audit committee sufficiently clear?
• Should additional matters be required to be communicated to the audit committee? If so, which matters?
• Is it appropriate that investment companies would be subject to the proposed rules regarding alternative accounting treatments?
We understand written communications between auditors and management range from formal documents, such as engagement letters, to informal correspondence, such as administrative items. We also acknowledge that not all forms of written communications provided to management also are provided to the audit committee. The decision whether to provide written communications to the audit committee is subjective and is influenced by auditing standards. Our proposed rule is intended to clarify the substance of information that would be provided by auditors to audit committees to facilitate auditor and management oversight by those committees. We anticipate that the proposed rule would result in auditors and audit committees having more robust discussions of accounting and auditing matters.
The Sarbanes-Oxley Act specifically cites the management letter and schedules of unadjusted differences as examples of material written communications to be provided to audit committees. Examples of additional written communications that we expect would be considered material to an issuer include:
• Management representation letter;
• Reports on observations and recommendations on internal controls;
• Schedule of material adjustments and reclassifications proposed, and a listing of adjustments and reclassifications not recorded, if any;
• Engagement letter;
• Independence letter.
These examples are not exhaustive, and auditors are encouraged to critically consider what additional written communications should be provided to audit committees.
The Act requires that the aforementioned communications should be timely reported to the audit committee. For purposes of the requirements of this provision, the proposed rule specifies that the proposed communications between the
The timing of these communications is intended to occur before any audit report is filed with the Commission pursuant to the securities laws. We believe that this proposed rule will ensure that these communications occur prior to filing of annual reports and proxy statements, as well as prior to filing registration statements and other periodic or current reports when audit reports are included.
• Should the timing of these communications be required to occur before any audit report is filed with the Commission or at some other time?
• Should these communications regarding critical accounting policies be required to be in writing? If so, why?
• Should we include specific instructions within the proposed rule regarding the nature of communications of critical accounting policies? If so, what instructions should be provided and why?
• Do these required communications fulfill existing GAAS requirements? If not, why?
• Should these communications regarding alternative accounting treatments be required to be in writing? If so, why?
• Do these required communications fulfill the statutory requirements? If not, why?
• Should the minimum requirements for discussion of alternative accounting treatments be expanded or reduced? If so, how?
• Should the list of recommended other communications be expanded or reduced? If so, what specific items should be added and why?
• Should the list of recommended other communications be required to be communicated to the audit committee? Why or why not?
• Are the appropriate entities included under the term “issuer” appropriate? If not, what entities should be included or excluded?
• Is it appropriate that investment companies are required to make these communications to their audit committees? Why or why not?
• This proposed rule would apply to “issuers.” Should the Commission consider applying this rule to a broader population such as “audit clients” as defined in 2-01(f)(6) of Regulation S-X? Why or why not?
To allow investors to be better able to evaluate the independence of the auditor of a company's financial statements in which they invest, the proxy disclosure rules currently require that a registrant disclose the professional fees it paid to its principal independent accountant in the most recent fiscal year. We propose to change both the types of fees that must be detailed and the years of service that are covered by the disclosure.
We are proposing these changes partly in response to public comment on this disclosure since we adopted the requirement in 2000. For example, the definition of “Audit Fees” restricts the fees reportable in that category to the services necessary only to complete the basic audit, sign the audit opinion and perform the required quarterly reviews. This category was intended to include fees for only those services specifically required under GAAS.
We recognize that there are certain accounting, audit, assurance and related services that accountants, in effect, must perform for their audit clients. Presently, registrants are required to combine fees for those services with fees paid for consulting and present the aggregate in the “All Other Fees” category. We recognize that this framework may make it difficult for shareholders to distinguish between fees for services traditionally performed by the accounting firm's auditors and fees for services performed by the accounting firm's consulting division. Some reporting companies have sought to add clarity by including further subcategories under “All Other Fees” to provide greater detail.
While the proposed rules continue to require issuers to disclose fees paid to the principal accountant for audit services, we are expanding the types of fees that should be included in this category. In addition to including fees for services necessary to perform an audit or review in accordance with GAAS,
We believe that the addition of a new category, “Audit-Related Fees,” will enable registrants to present the audit fee relationship with the principal accountant in a more transparent fashion. In general, Audit-Related Fees are assurance and related services that are traditionally performed by the independent accountant. More specifically, these services would include, among others: employee benefit plan audits, due diligence related to mergers and acquisitions, accounting assistance and audits in connection with proposed or consummated acquisitions, internal control reviews, consultation concerning financial accounting and reporting standards.
We also believe it is appropriate to add transparency regarding a second category of fees: “Tax Fees.” Tax services traditionally have been viewed as closely related to audit services and as not being in conflict with an auditor's independence. However, such services would be subject to pre-approval by the audit committee. The review of a registrant's tax accruals and reserves is a task that requires extensive knowledge about the audit client—knowledge that has already been assimilated by the audit and tax professionals. In many public companies, the fee for tax services is substantial in relation to other services. Investors may benefit from being able to consider those fees
The category of “All Other Fees” would remain unchanged from the existing rule, except that to the extent that financial information systems implementation and design exist they would be disclosed as a component of “All Other Fees.”
Thus, this proposal would add two new categories to the disclosures: (1) Audit-related fees and (2) tax fees. This proposal also would eliminate one of the current categories: financial information technology consulting fees. This category would be eliminated under this proposal because under the section of the proposal addressing nonaudit services, auditors would no longer be permitted to provide most of these consulting services to audit clients. Thus, the Commission believes that this disclosure of fees paid in this category would no longer be necessary.
For comparison purposes, two dollar amounts would be shown under each one of the four categories—one for each of the two most recent fiscal years. Each amount reported would represent the aggregate of all fees billed by the principal independent accountant that is appropriate to that category in one of those two years. As we note in the proposed Item, registrants also are required to describe each subcategory of services comprising the fees included in the “audit related” and “all other fees” categories.
The disclosures of the percentage of audit services that are not provided by permanent, full-time employees of the independent public accounting firm remain unchanged from previous rules.
We propose to require that registrants filing proxy statements disclose any policies and procedures developed by the audit committee of the board of directors concerning pre-approval of the independent accountant to perform both audit and non-audit services. Section 202 of the Sarbanes-Oxley Act states the pre-approval requirements for all auditing and non-audit services, with exceptions provided for
The proposed disclosure would set out in detail the audit committee's policies and procedures for engaging the independent accountant to perform services other than audit, review and attest services. We expect registrants to provide clear, concise and understandable descriptions of the policies and procedures. Alternatively, registrants could include a copy of those policies and procedures with the proxy statement delivered to investors and filed with the Commission. Either method should allow shareholders to obtain a complete and accurate understanding of the audit committee's policies and procedures. We expect the policies and procedures would address auditor independence oversight functions in a prudent and responsible manner. Additionally, these procedures would describe, if applicable, the specific processes in place that permit and monitor activities meeting the
We also believe investors would benefit from knowing what percentage of the fees reported in each of the “Audit-Related Fees,” “Tax Fees,” and “All Other Fees” categories were pre-approved by the audit committee pursuant to the policies and procedures instituted by the audit committee. That disclosure would provide insight into the extent to which the audit committee takes an active, direct role in considering each category of non-audit fee engagements.
The Sarbanes-Oxley Act requires the Commission to promulgate rules requiring companies to disclose the required information together with periodic reports required pursuant to sections 13(a) and 15(d) of the Exchange Act. In accordance with this mandate, we propose to require the new disclosures in a company's annual report. However, because we believe that this information is relevant to a decision to vote for a particular director or to elect, approve or ratify the choice of an independent public accountant, we propose to require this disclosure in a company's proxy statement on schedule 14A or information statement on schedule 14C. Because the information is proposed to be included in part III of annual reports on forms 10-K and 10-KSB, domestic companies would be able to incorporate the required disclosures from the proxy or information statement into the annual report.
Our intent is that this information be made available to investors of all registrants. However, not all registrants are required to file proxy statements. Thus, consistent with the provisions in the Act, registrants that do not issue proxy statements would be required to include appropriate disclosures in their annual filing included in form 10-K, form 10-KSB, 20-F, form 40-F and proposed form N-CSR as appropriate. For the reasons noted previously in this release, we propose to exempt asset-backed issuers and unit investment trusts from such disclosure requirements.
In addition, we propose to require parallel disclosure for registered management investment companies (“funds”) in annual reports on proposed form N-CSR.
Closed-end funds registered on national securities exchanges, however, are required to hold an annual meeting to elect directors under the rules of the exchanges.
• Is the proxy statement the appropriate location for this disclosure? If not, why?
• Should we permit incorporation by reference into the company's annual report?
• Would expansion of the proxy disclosure of professional fees paid to the independent auditor from three categories to four provide more useful information to investors?
• Are the new categories of disclosure appropriate? Are they well defined, or should they be more accurately defined? Should there be additional (or fewer) categories?
• Is disclosure of two years of fees appropriate? Should the proposed additional fee disclosures be expanded to three years or remain at one year?
• What, if any, additional information about professional fees would be useful to investors?
• For a registrant not subject to the proxy disclosure rules, such as foreign private issuers, should we require that the same disclosures be placed in annual reports?
• Is there any additional disclosure concerning the activities of audit committees that would be beneficial to investors?
• Should companies be required to provide the information in their quarterly reports? Should it be required that the information be included in other filings such as form 10-Q or 10-QSB?
• Should registered investment companies be required to provide the information in their semi-annual report to shareholders on proposed form N-CSR?
• Registered investment companies are required to provide disclosure of audit fees billed for the registrant only, but are required to disclose other types of fees in the aggregate for the registrant, its investment adviser, and certain other parties.
• If we adopt such a requirement, should we require or permit registrants to recalculate and report fees already disclosed for more than two years so that all fee information is consistently reported and available?
While much of the current proposal implements title II of the Act, we are also proposing changes which go beyond the provisions of the Act. In those areas, we are proposing that the provisions would be effective upon adoption of final rules. However, for those situations, we are considering the appropriate timing for the implementation of final rules and how best to allow for an orderly transition as a result of the new requirements imposed by the proposals. We are considering whether the application of some of these provisions should be delayed to a later date. For example, we are considering transition provisions related to the rules concerning audit partner rotation, audit committee communications, disclosures of fees paid to auditors, and partner compensation.
• Would a period of time beyond the adoption date of the final rules be necessary or appropriate for compliance with the final rules by smaller companies or companies with whose securities currently are not listed or quoted? If so, which rules should we consider a delayed effective date?
• How should an effective date be determined with respect to each amendment?
• Are there special considerations that we should take into account in providing a transition period for foreign private issuers?
• We invite any interested person wishing to submit written comments on the proposals or any matters that may impact the proposals, to do so. We specifically request comments from investors, issuers, and accounting firms.
• We solicit comment on each component of the proposals.
• Would the proposals related to audit committees and partner compensation help alleviate the pressure that clients may place on engagement partners or accounting firms to acquiesce to the clients' views on accounting issues? What are some of the other scenarios where such pressures might exist?
Certain provisions of the proposed amendments to Regulation S-X, schedule 14A and forms 10-K, 10-KSB, 20-F, 40-F and proposed form N-CSR contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
The titles for the collections of information are: “Regulation S-X”; “Proxy Statements—Regulation 14A and Schedule 14A”; “Form 10-K”; “Form 10-KSB”; “Form 20-F”; “Form 40-F”; and “Form N-CSR under the Investment Company Act of 1940 and Securities Exchange Act of 1934, Certified Shareholder Report.”
Regulation S-X (OMB Control No. 3235-0009) is the central repository for rules related to the form and content of financial statements filed with the Commission. Regulation S-X, however, does not direct registrants to file financial statements or to collect financial data. Regulation S-X indicates
As required by section 204 of the Sarbanes-Oxley Act, we are proposing to amend Regulation S-X to require each public accounting firm registered with the Public Company Accounting Oversight Board that audits an issuer's financial statements to report to the issuer's audit committee (1) all critical accounting policies and practices used by the issuer, (2) alternative accounting treatments within GAAP that have been discussed with management, including the ramifications of the use of the alternative treatments and the treatment preferred by the accounting firm, and (3) other material written communications between the accounting firm and management of the issuer such as any management letter or schedule of “unadjusted differences.” The required reports need not be in writing but the report would be required to be presented to the audit committee before the auditor's report on the financial statements is filed with the Commission.
We believe that auditing standards currently require discussions between the auditors and the audit committee of significant unusual, controversial, or emerging accounting policies, of the process used by management to select certain estimates, and of disagreements over certain accounting matters.
Because of these GAAS and legal provisions, we believe that adoption of the proposed rules regarding auditor reports to audit committees would not increase significantly the burden hours on accounting firms or registrants.
Schedule 14A
Item 9 of schedule 14A requires the disclosure of certain information regarding the registrant's relationship with the independent auditor of the company's financial statements when there is a solicitation relating to (1) a meeting at which directors to the company's board of directors are to be elected (or the solicitation of consents or authorizations in lieu of such a meeting) or (2) the election of the auditor, or the approval or ratification of the company's selection of the auditor. We are proposing to amend paragraph (e) of item 9 to provide more detailed information regarding the categories of fees paid by the registrant to the auditor and to inform investors about the critical role that audit committees play in assuring the auditor's independence. We believe that the proposed disclosure would allow investors to better assess an auditor's independence and the certain activities of an audit committee.
Item 9(e) currently requires disclosure of fees billed by the auditor in the last fiscal year, with the fees broken down into three categories: Audit fees, financial information systems design and implementation fees, and all other fees. The proposals would add disclosure of two categories (tax fees and audit-related fees), while eliminating one category (financial information systems design and implementation), and require disclosure of one more past year of each of these fees. Because these fees are already being disclosed, repeating the prior year's disclosures for comparison purposes should not increase significantly a registrant's compliance burden. In addition, breaking tax fees and audit-related fees out of the “all other” category of fees currently being disclosed should not result in any significant incremental burden.
Under the proposals, registrants also would be required to disclose any policies and procedures adopted by an audit committee to be followed for auditor engagements for services other than audit, review and attest services in the event that the audit committee does not expressly pre-approve the particular engagements. In addition, the proposals would require registrants to disclose what percentage of fees in each of the categories noted above (audit, audit-related, tax, and other) relate to engagements that were pre-approved by the audit committee.
We estimate that the incremental disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours on each of the 7,661 filers of schedule 14A, or an aggregate 15,322 additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. We further estimate that approximately 75% of the extra burden hours, or approximately 11,492 hours, would be expended by internal staff and the remaining 25%, or 3,830 hours, would be for outside legal costs associated with reviewing the proposed disclosures. Assuming that outside legal costs would be an average of $300 per hour, the aggregate annual legal costs would be $1,149,000. Similarly, we estimate that these proposed disclosures would
The proposed disclosure generally should be presented in a company's proxy statement in accordance with item 9(e) of schedule 14A, and incorporated by reference into the form 10-K (OMB Control No. 3235-0063). Some companies that file forms 10-K, however, are not subject to the proxy disclosure requirements. These companies would, therefore, now be required to present the required disclosures in the form 10-K. We do not believe, however, that the disclosures would be burdensome to these companies because the information to be disclosed (fees billed to the company by the auditor in the last fiscal year, with the fees broken down into certain categories) should be readily available to the company.
We estimate that the incremental disclosure of fees, the audit committee's olicies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours per year on each of the 8,484 filers of form 10-K. Six thousand six hundred and seventy-six (6,676) of those filers, however, would provide the information under schedule 14A and 209 of those filers would provide the information under schedule 14C.
Form 10-KSB (OMB Control No. 3235-0420) is the annual report filed with the Commission by “small businesses issuers.” A “small business issuer” is an entity that (1) has revenues of less than $25,000,000, (2) is a U.S. or Canadian issuer, (3) is not an investment company, and (4) if a majority owned subsidiary, the parent corporation is also a small business issuer. An entity is not a “small business issuer,” however, if the aggregate market value of its outstanding voting and non-voting common stock held by non-affiliates is $25,000,000 or more.
We estimate that the incremental disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours per year on each of the 3,820 filers of form 10-KSB. Nine hundred and eighty-five (985) of those filers, however, would provide the information under schedule 14A and 255 of those filers would provide the information under schedule 14C. The burden hours for the disclosure by these filers has been assigned to schedule 14A and schedule 14C, respectively. The burden imposed on the remaining 2,580 filers is being assigned to form 10-KSB. This results in 5,160 (2 hours x 2,580 filers) additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. We further estimate that approximately 75% of the extra burden hours, or approximately 3,870 hours, would be expended by internal staff and the remaining 25%, or 1,290 hours, would be for outside legal costs associated with reviewing the proposed disclosures. Assuming that outside legal costs would be an average of $300 per hour, the aggregate annual legal costs would be $387,000.
4. Annual Reports by Foreign Private Issuers on Form 20-F
Form 20-F (OMB Control No. 3235-0288) is used for the registration of securities of foreign private issuers pursuant to sections 12(b) or 12(g) of the Exchange Act and annual and transition reports filed with the Commission pursuant to sections 13(a) or 15(d) of the Exchange Act.
Foreign private issuers generally are not subject to the proxy disclosure requirements and, therefore, would be required to present the required disclosures on form 20-F. We do not believe, however, that these disclosures would be burdensome to these companies because the information to be disclosed (fees billed to the company by the auditor in the last fiscal year, with the fees broken down into certain categories) should be readily available to the company.
We estimate that the incremental disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours per year on each of the 1,194 filers of form 20-F, or 2,388 additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. We further estimate that approximately 25% of the extra burden hours, or approximately 597 hours, would be expended by internal staff and the remaining 75%, or 1,791 hours, would be for outside legal costs associated with reviewing the proposed disclosures because this form is prepared by foreign private issuers who rely more heavily on outside counsel for assistance. Assuming that outside legal costs would be an average of $300 per hour, the aggregate annual legal costs would be $537,300.
Form 40-F is used by certain Canadian issuers to register securities with the Commission pursuant to section 12(b) or section 12(g) and for reports pursuant to section 15(d) of the Exchange Act. A Canadian issuer may use the form if it is subject to the reporting requirements solely by reason of having filed a registration statement on form F-7, F-8, F-9, F-10, or F-80 under the Securities Act of 1933. A Canadian issuer also may use the form if it has a reporting obligation under the Exchange Act and (1) the issuer is incorporated under the laws of Canada or any Canadian province or territory, (2) the issuer is a foreign private issuer
Canadian companies that file form 40-F generally are not subject to the proxy disclosure requirements and, therefore, would be required to present the required disclosures on form 40-F. We do not believe, however, that these disclosures would be burdensome to these companies because the information to be disclosed (fees billed to the company by the auditor in the last fiscal year, with the fees broken down into certain categories) should be readily available to the company.
We estimate that the incremental disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours per year on each of the 134 filers of form 40-F, or 268 additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. Consistent with our treatment of foreign private issuers filing form 20-F, we further estimate that approximately 25% of the extra burden hours, or approximately 67 hours, would be expended by internal staff and the remaining 75%, or 201 hours, would be for outside legal costs associated with reviewing the proposed disclosures. Assuming that outside legal costs would be an average of $300 per hour, the aggregate annual legal costs would be $60,300.
We issued a release proposing form N-CSR on August 30, 2002, pursuant to section 30 of the Investment Company Act (15 U.S.C. 80a-29) and sections 13 and 15(d) of the Exchange Act (15 U.S.C. 78m and 78o(d)). The proposed disclosure would be required in a registered management investment company's annual report on proposed form N-CSR. We estimate that the additional disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, 1.5 additional burden hours per year on each of the anticipated 3,700 filers of proposed form N-CSR. This results in 5,550 (1.5 hours x 3,700 filers) additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. We estimate that the cost of these burden hours would $81 per hour, resulting in aggregate internal costs of $449,550.
Pursuant to 44 U.S.C. 3506(c)(2)(B), we solicit comments to: (1) Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the Commission's estimates of the burden of the proposed collections of information; (3) determine whether there are ways to enhance the quality, utility, and clarity of the information to be collected; and (4) evaluate whether there are ways to minimize the burden of the collections of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Persons submitting comments on the collection of information requirements should direct the comments to the Office of Management and Budget, Attention: Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Washington, DC 20503, and should send a copy to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609, with reference to File No. S7-49-02. Requests for materials submitted to OMB by the Commission with regard to these collections of information should be in writing, refer to File No.S7-49-02, and be submitted to the Securities and Exchange Commission, Records Management, Office of Filings and Information Services. OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this release. Consequently, a comment to OMB is assured of having its full effect if OMB receives it within 30 days of publication.
We are sensitive to the costs and benefits imposed by our rules, and we have identified certain costs and benefits of these proposals. Additionally, certain of these costs are imposed by Congressional mandate through the enactment of the Sarbanes-Oxley Act. We request comments on all aspects of this cost-benefit analysis, including the identification of any additional costs or benefits. We encourage commenters to identify and supply relevant data concerning the costs or benefits of the proposed amendments.
The Sarbanes-Oxley Act was enacted on July 30, 2002. Title II to that Act adds sections 10A(g) through 10A(l) to the Securities Exchange Act of 1934 (“Exchange Act”) and requires that the Commission, within 180 days of enactment, adopt rules to carry out each of those sections.
The proposed rules, in general, would:
• Revise the Commission's regulations related to the non-audit services that, if provided to an audit client, would impair an accounting firm's independence
• Require that an issuer's audit committee pre-approve all audit and non-audit services provided to the issuer by the auditor of an issuer's financial statements
• Prohibit any partner on the audit engagement team from providing audit services to the issuer for more than five consecutive years
• Prohibit an accounting firm from auditing an issuer's financial statements if certain members of management of that issuer had been members of the accounting firm's audit engagement team within the one-year period preceding the commencement of audit procedures
• Require that the auditor of an issuer's financial statements report certain matters to the issuer's audit committee, including “critical” accounting policies used by the issuer
• Require disclosures to investors of information related to the audit and non-audit services provided by, and fees paid by the issuer to, the auditor of the issuer's financial statements.
In addition, under the proposed rules, an accountant would not be independent from an audit client if any partner, principal or shareholder of the accounting firm who is a member of the engagement team received compensation based directly on any service provided or sold to that client other than audit, review and attest services. We believe that accounting firms should discontinue compensating these individuals for “cross-selling” services. While many of these proposed rules would respond directly to the provisions of title II of the Sarbanes-Oxley Act, certain of these proposals would go beyond the specific provisions of the Act to more fully address what we believe to be the Congressional intent. These provisions include:
• Our proposal requiring any partner on the audit engagement team be subject to the rotation requirements;
• Requiring a one-year cooling-off period for all audit client's employment of engagement team personnel; and
• Our proposal to limit an audit partner from receiving compensation for recommending non-audit services to an audit client.
Potential benefits resulting from the proposed amendments include increased investor confidence in the independence of auditors, in the audit process, and in the reliability of reported financial information. As discussed below, clearer auditor independence regulations should provide investors with comfort that auditors are placing the interests of investors over financial or personal incentives. Proposed rules mandating that auditors communicate certain matters to audit committees should benefit investors by enhancing the opportunities for meaningful audit committee oversight of the financial reporting process. Investors also would benefit from the enhanced disclosure of the non-audit services provided by, and fees paid to, the accounting firm that audits and reviews the company's financial statements, and from better disclosure of the audit committee's role in approving the provision of non-audit services by the accounting firm that audits the company's financial statements. We believe that these factors could improve the efficiency of the markets and result in a lower cost of capital.
The amendments would facilitate the independence of the auditor from management in the following ways.
• Providing clearer definition of the lines of non-audit services that would impair an auditor's independence;
• Requiring that each engagement of the auditor to perform audit or non-audit services for the company be pre-approved by the audit committee, which serves as the representative of investors;
• Requiring the “rotation” of partners on the audit engagement to assure a periodic fresh look at the accounting and auditing issues presented in the engagement;
• Providing that the auditor's independence would be impaired if revenues to the accounting firm from the sale of non-audit services or products to a company were directly paid to any partner, principal, or shareholder of the firm who works on the audit of that company's financial statements. This provision should decrease the appearance of any pressure on the audit engagement partner to appease management during the audit process in order to facilitate sales of non-audit services and increase the appearance and reality of auditor independence; and
• Requiring a “cooling off” period between working on the audit engagement team and joining the client as a member of management in order to assure that personal relationships and the new member of management's knowledge of the audit plan do not negatively impact the audit process.
Strengthening auditor independence should provide investors with more comfort that the auditors would play their “gatekeeper” role in companies” financial reporting and provide further assurance that the true financial condition of companies is reflected in their financial reporting thereby allowing public companies less costly access to the capital markets.
The proposed rules would require that each public accounting firm registered with the Public Company Accounting Oversight Board that audits an issuer's financial statements report to the issuer's audit committee (1) All critical accounting policies and practices used by the issuer, (2) alternative accounting treatments within GAAP that have been discussed with management, including the ramifications of the use of the alternative treatments and the treatment preferred by the accounting firm, and (3) other material written communications between the accounting firm and management of the issuer such as any management letter or schedule of “unadjusted differences.”
The report by the Senate Committee on Banking, Housing, and Urban Affairs on the bill that later became the foundation for the Sarbanes-Oxley Act, in addressing the need for such reports from the auditor to the audit committee, stated, in part:
The Committee believes that it is important for the audit committee to be aware of key assumptions underlying a company's financial statements and of disagreements that the auditor has with management. The audit committee should be informed in a timely manner of such disagreements, so that it can independently review them and intervene if it chooses to do so in order to assure the integrity of the audit.
Almost eight months before passage of the Sarbanes-Oxley Act, in December 2001, we issued cautionary advice regarding each issuer disclosing in the Management Discussion and Analysis
Prior to finalizing and filing annual reports, audit committees should review the selection, application and disclosure of critical accounting policies. Consistent with auditing standards, audit committees should be apprised of the evaluative criteria used by management in their selection of the accounting principles and methods. Proactive discussions between the audit committee and the company's senior
We continue to believe that such communications are appropriate and facilitate the audit committee's oversight of the financial reporting process. Investors should benefit by the audit committee being in a position to challenge what it may view as novel or aggressive use of GAAP to enhance reports of the company's financial results or financial condition.
The rules proposed in May 2002 provide additional information about the application of critical accounting policies, including “critical accounting estimates” and the initial adoption of material accounting policies. Auditors may want to refer to these proposed rules,
Investors would receive more detailed information about:
• Any policies and procedures adopted by an audit committee that are designed to assure that the provision of non-audit services and products by the auditor do not impair the auditor's independence,
• The fees paid by the registrant to the auditor in each of the last two years for audit, audit-related, tax, and all other services, and
• The percentage of fees in each of those categories that were pre-approved by the audit committee.
The proposed disclosures will afford investors greater visibility into those aspects of the auditor-client relationship. Providing better, more complete information in cases where non-audit services occur allows investors to determine for themselves whether there are concerns related to the auditor's independence. It also may allow investors to ask more direct and useful questions of management and directors regarding their decisions to engage the auditors for such services.
The proposed rules specify that audit partners that are compensated for cross-selling non-audit services are not independent. This would further enhance the independence of the audit function since the audit partner's focus would be on the conduct of the audit rather than on efforts to sell other services to management. The danger inherent in compensation to audit partners for cross-selling non-audit services is that it might create a temptation for auditors to compromise the quality of the audit in order to maintain their relationship with clients to whom they hope to cross-sell such services.
Changes in our auditor independence regulations may impose costs on accounting firms and on any issuers that engage, or would like to consider engaging, the auditor of an issuer's financial statements to perform non-audit services.
(a)
The current auditor independence rules state that the performance of certain non-audit services will impair an auditor's independence. The proposed rules, in some cases, would redefine the limits of those services and would add one more item, “expert services,” to the list of prohibited services. These changes could impact the competitive markets for these services. Issuers would be precluded from engaging auditors to perform certain services in the categories of internal audit services, financial systems design and implementation services, appraisal and valuation services, actuarial services, and others, that may be performed under the current rules. These companies may incur costs from having to use a separate vendor for such services resulting in the possible loss of any synergistic benefits of having a single provider for both audit and non-audit services. In particular, the loss of company-specific information that might flow from the non-audit team to the audit engagement team, or vice versa, could in some instances lower the quality of either service. Issuers also may incur costs locating a new vendor and developing a business relationship with that vendor. In addition, issuers may incur costs from not being able to retain their preferred provider of non-audit services, if that preferred provider happens to also be their auditor. The difference in value between a preferred provider and a second choice may be substantial, particularly if the preferred provider has relatively unique service offerings or service offerings that are particularly well suited to the needs of the issuer.
Accounting firms may lose one or more sources of revenue if the proposed rules are adopted because they would no longer be able to sell certain non-audit services to their audit clients. We believe, however, that in view of the statements by the largest four accounting firms, and others, that they would no longer provide internal audit outsourcing services and financial system design and implementation services to audit clients,
(b)
Inadvertent violations of the Act and the proposed rules that would add to the costs of the rules also may be mitigated by the de minimus exception to the pre-approval requirement.
We also believe that as a result of the Commission's audit committee disclosure requirements adopted in 1999,
(c)
Costs associated with the periodic replacement of partners might include more frequent company-specific training, conducted by both the accounting firm and the company, as new partners join the team auditing that company's financial statements. For example, the new partners would need to learn the company's accounting and financial reporting procedures, controls and personnel. The proposed rules also might result in incremental costs related to some partners being required to relocate from one part of the country to another.
The costs related to these proposed rules would vary based on the proximity of an accounting firm's audit clients, the concentration of the firm's practice within an industry, and the availability of partners to whom the work may be redistributed, and similar factors.
Smaller firms that do not have sufficient partners to replace the partners on an audit engagement team may be particularly affected by the proposed rules in that they would have to accept more partners into the firm or lose the audit engagement.
It is difficult to calculate the costs associated with this portion of the proposed rules. However, it is likely that these costs may be passed on to issuers in the form of higher audit fees. As noted below, we request comments on the anticipated costs associated with all aspects of the proposed rules.
(d)
Currently, when a former professional employee of an accounting firm joins an audit client within one year of leaving the firm, and the individual has significant interaction with the accounting firm's audit engagement team, professional standards require the accounting firm to perform procedures to assure that the individual's knowledge of, or relationships with, the accounting firm do not adversely influence the quality of the audit.
Costs might occur, however, from the company being required to delay the hiring, or not being able to hire, the individual that it believes is the most qualified person to perform a “financial reporting oversight role” at the company. This may add to recruitment costs or less efficient operations. Such costs are difficult to estimate and would vary from one company to another.
(e)
Under the proposed rules, each public accounting firm registered with the Public Company Accounting Oversight Board that audits an issuer's financial statements must report to the issuer's audit committee (1) all critical accounting policies and practices used by the issuer, (2) alternative accounting treatments within GAAP that have been discussed with management, including the ramifications of the use of the alternative treatments and the treatment preferred by the accounting firm, and (3) other material written communications between the accounting firm and management of the issuer such as any management letter or schedule of “unadjusted differences.”
Because of existing GAAS and legal provisions,
The existing proxy disclosure rules require disclosure of all professional fees billed by the principal auditor in the last fiscal year, with the fees broken down into three categories: audit fees, financial information systems design and implementation fees, and all other fees. The proposals would divide the disclosure into two more categories—tax fees and audit-related fees—and add disclosure of one more year of these fees while eliminating separate disclosure of fees related to financial information systems design and implementation. The proposals also would require companies that do not file proxy statements to file this information with the Commission in their annual reports on forms 10-K and 10-KSB, foreign private issuers to file the information on form 20-F, certain Canadian issuers to file the information on form 40-F, and registered management investment companies to file the information on proposed form N-CSR.
Registrants also would be required to disclose the audit committee's policies and procedures for approval of auditor engagements, and the percentage of fees in each of the four categories noted above (audit, audit-related, tax, and all other) that were pre-approved by the audit committee during each of the last two fiscal years.
Based on the staff's experience, we believe that the additional disclosure contemplated by the proposed rules would require, on average, approximately one-half of a page in a company's proxy statement or annual report. A financial printing company informed the staff that adding one-half of a page in the proxy statement would not be likely to increase the printing cost to the company because that much more text normally can be incorporated without increasing the page length by reformatting the document.
For the purposes of the Paperwork Reduction Act, we have estimated that the incremental disclosure of fees, the disclosure of the audit committees policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee would impose, on average, two additional burden hours for each of the 7,661 filers of schedule 14A, or an aggregate annual burden of 15,322 additional burden hours. We estimate that most of this time would relate to consideration and review of the disclosures of the audit committee's policies and procedures. We further estimate that approximately 75% of the extra burden hours, or approximately 11,492 hours, would be expended by internal staff and the remaining 25%, or 3,830 hours, would be for outside legal costs associated with reviewing the proposed disclosures. Assuming that the internal staff costs the company an average of $125 per hour,
For those registrants who would be providing the information on form 10-K, we estimated for the purposes of the Paperwork Reduction Act that the incremental disclosure of fees, the audit committee's policies and procedures for approval of audit engagements, and the percentage of fees pre-approved by the audit committee, would impose, on average, two additional burden hours per year on each of the 8,484 filers of form 10-K.
For smaller companies that file forms 10-KSB
Using a similar analysis, we estimated an increase of 2,388 burden hours and $537,300 in annual legal costs (2,388 x .75 x $300) for form 20-F. This produces an estimate of $298,500 (2,388 hours x $125 per hour) for internal costs, or a total cost of $835,800 ($537,300 + $298,500) for such filers. For form 40-F filers, we estimated an increase of 268 burden hours and $60,300 in annual legal costs (200 x .25 x $300). This produces an estimate of $33,500 (268 hours x $125 per hour) for internal costs, or a total cost of $93,800 ($60,300 + $33,500).
As noted above, we request comments on all aspects of this cost-benefit analysis, including the identification of any additional costs or benefits. We encourage commenters to identify and supply relevant data concerning the costs or benefits of the proposed amendments. We request comments, including supporting data, on the magnitude of the costs and benefits mentioned in this section.
• Are there any other costs or benefits that we have not identified? For example, would the additional duties on audit committees increase the cost of maintaining those committees? Would the amount of compensation demanded by audit committee members increase? Would there be a shortage of potential audit committee members that would lead to higher costs related to finding and retaining such members? Would the cost of officer/director liability insurance increase? Please describe any such costs and provide relevant data.
• Are there additional costs related to the proposed disclosures? If there are, please identify them and provide supporting data.
• We request comments on the reasonableness of the burden hour, cost estimates, and underlying assumptions related to the proposed disclosures.
• Will the prohibition of certain non-audit services impose greater costs on companies? If so, what will those costs be and how significant will those costs be?
• How much cost will issuers incur from not being able to retain their preferred providers of non-audit service, when that preferred provider happens to also be their auditor?
• What will be the impact, if any, on audit fees from the proposal to prohibit certain non-audit services?
• Are there any economies of scope that will be lost due to implementation of the auditor independence rules?
• Are there any economies of scale that will be lost due to implementation of the auditor independence rules?
For purposes of the Small Business Regulatory Enforcement Fairness Act of
Section 23(a)(2) of the Exchange Act
• Given that only larger clients have more than two partners as part of the audit process, would this provision impose higher costs on mid-tier firms?
In addition, section 2(b) of the Securities Act of 1933,
One possible adverse impact on capital formation may come from additional costs related to audit committees. Although the proposed rules do not require companies to have audit committees, many companies may choose to establish such committees to facilitate application of the rules. Additional costs may be associated with forming such committees and, if necessary, recruiting and retaining independent directors to serve on those committees.
We believe, however, that investors need to have confidence in the independence of auditors and in the integrity of the financial information that fuels our securities markets. The proposals are designed to bolster investor confidence in the securities markets by strengthening auditor independence, improving the transparency of the role of corporate audit committees, and enhancing the reliability and credibility of financial statements of public companies. Accordingly, on the whole, the proposals should promote capital formation and market efficiency.
• We request comment on the anti-competitive effects of the proposals.
• The possible effects of our rule proposals on efficiency, competition, and capital formation are difficult to quantify. We request comment on these matters in connection with our proposed rules.
This Initial Regulatory Flexibility Act Analysis has been prepared in accordance with 5 U.S.C. 603. It relates to proposed revisions to Regulation S-X and to item 9 of schedule 14A, and to forms 10-K, 10-KSB, 20-F, 40-F and proposed form N-CSR. The proposals would strengthen the Commission's requirements regarding the independence of auditors and related disclosures.
The proposed rules generally implement a congressional mandate. Some of the proposals, although not specifically required by the statute, are designed to implement the intent of the Sarbanes-Oxley Act and to assure investors that independent auditors critically are examining reported financial information. The proposed rules should provide greater assurance to investors that independent auditors are performing their public responsibilities and that the financial information published by registrants and issuers is reliable.
The proposed rules, in general, would:
• Revise the Commission's regulations related to the non-audit services that, if provided to an audit client, would impair an accounting firm's independence;
• Require that an issuer's audit committee pre-approve all audit and non-audit services provided to the issuer by the auditor of an issuer's financial statements;
• Prohibit any partner on the audit engagement team from providing audit services to the issuer for more than five consecutive years;
• Prohibit an accounting firm from auditing an issuer's financial statements if certain members of management of that issuer had been members of the accounting firm's audit engagement team within the one-year period preceding the commencement of audit procedures;
• Require that the auditor of an issuer's financial statements report certain matters to the issuer's audit committee, including “critical” accounting policies used by the issuer;
• Require disclosures to investors of information related to the audit and non-audit services provided by, and fees paid by the issuer to, the auditor of the issuer's financial statements.
In addition, under the proposed rules, an accountant would not be independent from an audit client if any partner, principal or shareholder of the accounting firm who is a member of the engagement team received compensation based on any service provided or sold to that client other than audit, review and attest services.
Our objectives are to implement title II of the Sarbanes-Oxley Act in order to increase investor confidence in the independence of auditors, in the audit process, and in the reliability of reported financial information.
We are proposing amendments to Regulation S-X and item 9 of schedule 14A and to forms 10-K, 10-KSB, 20-F, 40-F and proposed form N-CSR under the authority set forth in sections 3(a) and 208 of the Sarbanes-Oxley Act; schedule A and sections 7, 8, 10, 19 and 28 of the Securities Act, sections 3, 10A, 12, 13, 14, 17, 23 and 36 of the Exchange Act, sections 5, 10, 14 and 20 of the Public Utility Holding Company Act of 1935, sections 8, 30, 31 and 38 of the Investment Company Act of 1940, and sections 203 and 211 of the Investment Advisers Act of 1940.
The proposals would affect small registrants and small accounting firms that are small entities. Exchange Act rule 0-10(a)
For purposes of the Investment Company Act, rule 0-10
Our rules do not define “small business” or “small organization” for purposes of accounting firms. The Small Business Administration defines small business, for purposes of accounting firms, as those with under $6 million in annual revenues.
The vast majority of registrants are audited by one of the four largest accounting firms, which clearly are not small entities. Nonetheless, changes in the auditor independence regulations may impose compliance requirements, recordkeeping and reporting requirements on small accounting firms and on any small registrant that engages, or would like to consider engaging, the auditor of an issuer's financial statements to perform non-audit services.
(a)
According to the information available to the staff in 2000, however, approximately 12,600 registrants did not purchase any consulting services from the auditor of their financial statements, and 4,100 registrants reported purchasing such services.
(b)
There are reasons to believe that many small entities currently have audit committees.
(c)
Costs associated with the periodic replacement of partners might include more frequent company-specific training because new partners joining the audit engagement team would need to learn the company's accounting and financial reporting procedures, controls and personnel. The proposed rules also might result in incremental costs related to some partners being required to relocate from one part of the country to another.
Smaller firms that do not have sufficient partners to make the required replacements of the partners on an audit engagement team may be particularly affected by the proposed rules. These small accounting firms might have to accept more qualified partners into the firm or lose the audit engagement.
(d)
(e)
Some small accounting firms might have a relatively small number of partners, principals or shareholders of the firm available to serve each client. Such firms might not have personnel, other than the partner in charge of the audit of a small company's financial statements, with sufficient expertise to market and provide non-audit services to that company. In such cases, the proposed rule might result in a small company being forced to find another provider for those services. This might result in increased costs related to small entities locating and engaging additional service providers, and might decrease revenues to small accounting firms.
Under the proposed rules, each public accounting firm registered with the Public Company Accounting Oversight Board that audits an issuer's financial statements must report to the issuer's audit committee (1) all critical accounting policies and practices used by the issuer, (2) alternative accounting treatments within GAAP that have been discussed with management, including the ramifications of the use of the alternative treatments and the treatment preferred by the accounting firm, and (3) other material written communications between the accounting firm and management of the issuer such as any management letter or schedule of “unadjusted differences.”
Auditing standards currently require discussions between the auditors and the audit committee of significant unusual, controversial, or emerging accounting policies, of the process used by management to select certain estimates, and of disagreements over certain accounting matters. Further, audit committees generally are aware of management's letter making representations to the auditors, which the auditor uses in conducting the audit of the issuer's financial statements, and the auditors' letters to management on reportable conditions in internal controls and other matters. Also, due to enactment of section 401 of the Sarbanes-Oxley Act, all material adjustments identified by the auditor should be reflected in the issue's financial statements and, therefore, there should be no material “unadjusted differences.”
Because of these GAAS and legal provisions, we believe that adoption of the proposed rules regarding auditor reports to audit committees will not significantly increase costs, including costs for small accounting firms and small registrants. Some costs may be incurred, however, to the extent communications would be required before the auditor's report is filed with the Commission.
Currently, disclosure is required in proxy and information statements of the fees billed in the most recent fiscal year under the categories of audit fees, information systems design and implementation fees, and all other fees. The proposals would require disclosure of the fees billed in each of the two most recent years, instead of the current requirement for disclosure of only the most recent year's fees. The proposals also would add the categories of tax fees and audit-related fees but eliminate separate disclosure of information systems design and implementation form the current list of audit fees, information systems design and implementation fees, and all other fees. The proposed rules also would require disclosure of the percentage of fees in each category that were pre-approved by the audit committee as opposed to being entered into under the audit committee's policies and procedures. Finally, the proposals would extend the disclosure requirements to all entities filing forms 10-K, 10-KSB, 20-F, 40-F and proposed form N-CSR.
The proposed rules would require all entities filing forms 10-K, 10-KSB, 20-F, 40-F and proposed form N-CSR to include the disclosure either in the proxy or information statement or, if the company does not issue a proxy or information statement, in forms 10-K, 10-KSB, 20-F, 40-F or proposed form N-CSR. The proposed rules, therefore, might require small entities to spend additional time and incur additional costs in preparing disclosures. Small entities also might incur costs to set up procedures to monitor the activities of the audit committee in order to collect and record the information to be disclosed under the proposed rules.
The Commission is not aware of any rules that duplicate, overlap, or conflict with the proposed rules.
The Regulatory Flexibility Act directs us to consider significant alternatives that would accomplish the stated objective, while minimizing any significant adverse impact on small entities. In connection with the proposed amendments, we considered the following alternatives:
1. The establishment of differing compliance or reporting requirements or timetables that take into account the resources of small entities;
2. The clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities;
3. The use of performance rather than design standards; and
4. An exemption from coverage of the proposed amendments, or any part thereof, for small entities.
We do not propose to exempt small business issuers from the proposals because Congress indicated that any exemptions should be on a case-by-case basis and not by categories. We, nevertheless, are considering whether any exception or classifications for small businesses would be appropriate and consistent with the Sarbanes-Oxley Act. We believe investors in small companies, however, just as investors in large companies, would want and benefit from the proposed revisions in the auditor independence rules and enhanced communications between the auditor and the audit committee.
The proposed rules are designed to enhance auditors' independence and the reliability and credibility of financial statements for all public companies. Currently, we do not believe that it is feasible to further clarify, consolidate, or simplify the proposed rules for small entities. We are particularly mindful of the implications of our proposed rules on the provision of bookkeeping and internal controls services, as well as auditor rotation and cooling-off period requirements for small firms. We invite comments on these and all other issues.
We encourage the submission of comments with respect to any aspect of this Initial Regulatory Flexibility Analysis. Specifically, we request comments regarding the number of small entities that may be affected by the proposed rules, and the existence or nature of the potential impact on those small entities. We also seek comments on how to quantify the number of small accounting firms that would be affected by the proposals, and how to quantify the impact of the proposed rules on those firms.
Commenters are requested to describe the nature of any impact and provide empirical data supporting the extent of the impact. Such comments will be considered in the preparation of the Final Regulatory Flexibility Analysis, if the proposed rules are adopted, and will be placed in the same public file as comments on the proposed rules.
The Commission proposes to amend the “Codification of Financial Reporting Policies” announced in Financial Reporting Release No. 1 (April 15, 1982):
By amending section 602 to add a new discussion at the end of that section under the Financial Reporting Release Number (FR-64) assigned to the adopting release and including the text in the adopting release that discusses the final rules, which, if the proposals are adopted, would be substantially similar to section III of this release.
The Codification is a separate publication of the Commission. It will not be published in the Code of Federal Regulations.
We are proposing amendments to rules 2-01 and 2-07 of Regulation S-X, item 9 of schedule 14A, forms 10-K, 10-KSB, 20-F and 40-F, and proposed form N-CSR under the authority set forth in schedule A and sections 7, 8, 10, 19 and 28 of the Securities Act, sections 3, 10A, 12, 13, 14, 17, 23 and 36 of the Exchange Act, sections 5, 10, 14 and 20 of the Public Utility Holding Company Act of 1935, sections 8, 30, 31 and 38 of the Investment Company Act of 1940, and sections 203 and 211 of the Investment Advisers Act of 1940 and sections 3(a) and 208 of the Sarbanes-Oxley Act.
Accountants, Accounting.
Broker-dealers, Issuers, Securities.
Reporting and recordkeeping requirements, Securities.
Investment companies, Reporting and recordkeeping requirements, Securities.
In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for part 210 continues to read as follows:
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77aa(25), 77aa(26), 78c, 78j-1, 78l, 78m, 78n, 78o(d), 78q, 78u-5, 78w(a), 78ll, 78mm, 79e(b), 79j(a), 79n, 79t(a), 80a-8, 80a-20, 80a-29, 80a-30, 80a-37(a), 80b-3, 80b-11 unless otherwise noted.
2. Section 210.2-01 is amended by:
a. Revising paragraph (c)(2)(iii);
b. Revising paragraph (c)(4);
c. Adding paragraph (c)(6);
d. Adding paragraph (c)(7);
e. Adding paragraph (c)(8);
f. Revising paragraph (f)(1);
g. Revising paragraph (f)(3); and
h. Adding paragraph (f)(17).
The revisions and additions read as follows:
(c) * * *
(2) * * *
(iii)
(A) A former partner, principal, shareholder, or professional employee
(1) Does not influence the accounting firm's operations or financial policies;
(
(
(
(
(B) A former partner, principal, shareholder, or professional employee of an accounting firm is in a financial reporting oversight role at an audit client, unless the individual:
(
(
(
(4)
(i)
(A) Maintaining or preparing the audit client's accounting records;
(B) Preparing the audit client's financial statements that are filed with the Commission or form the basis of financial statements filed with the Commission; or
(C) Preparing or originating source data underlying the audit client's financial statements.
(ii)
(B) Designing or implementing a hardware or software system that aggregates source data underlying the financial statements or generates information that is significant to the audit client's financial statements or other financial information systems taken as a whole.
(iii)
(iv)
(v)
(vi)
(vii)
(B) Engaging in psychological testing, or other formal testing or evaluation programs;
(C) Undertaking reference checks of prospective candidates for an executive or director position;
(D) Acting as a negotiator on the audit client's behalf, such as determining position, status or title, compensation, fringe benefits, or other conditions of employment; or
(E) Recommending, or advising the audit client to hire, a specific candidate for a specific job (except that an accounting firm may, upon request by the audit client, interview candidates and advise the audit client on the candidate's competence for financial accounting, administrative, or control positions).
(viii)
(ix)
(x)
(6)
(i) An issuer as defined in section 10A(f) of the Securities Exchange Act of 1934 (15 U.S.C. 78j-1(f)) when an audit engagement team partner, principal or shareholder performs audit, review or attest services for that issuer or any significant subsidiaries as defined in 17 CFR 210.1-02(w), as a partner, principal or shareholder in each of the five previous fiscal years of the issuer or any significant subsidiaries and continues to serve as a partner, principal or shareholder on the audit engagement team. Following five consecutive years where audit, review or attest services have not been provided to that issuer or any significant subsidiaries by the aforementioned partners, principals or shareholders such partners, principals or shareholders again may perform audit, review or attest services for the audit client.
(ii) An entity that is part of an investment company complex as defined in 17 CFR 210.2-01(f)(14) when any audit engagement team partner, principal or shareholder performs audit, review or attest services for any entity in the investment company complex, as a partner, principal or shareholder in
(7)
(i) In connection with audit, review and attest reports required under the securities laws, the issuer's or registered investment company's audit committee pre-approves all such engagements;
(ii) For engagements other than those specified in paragraph (c)(7)(i) of this section, in accordance with section 10A(i) of the Securities Exchange Act of 1934, either:
(A) Before the accountant is engaged by the issuer or its subsidiaries, or the registered investment company or its subsidiaries, to render the service, the engagement is approved by the issuer's or registered investment company's audit committee; or
(B) The engagement to render the service is entered into pursuant to pre-approval policies and procedures established by the audit committee of the issuer or registered investment company, provided the audit committee is informed of each service.
(C) Notwithstanding paragraphs (c)(7)(ii)(A) and (B) of this section, the pre-approval requirement is waived with respect to the provision of services covered under paragraph (c)(7)(ii) of this section provided:
(
(
(
(iii) In addition, a registered investment company's audit committee pre-approves its accountant's engagements under paragraph (c)(7)(ii) of this section with the registered investment company's investment adviser (not including a sub-adviser whose role is primarily portfolio management and is sub-contracted or overseen by another investment adviser) and any entity controlling, controlled by, or under common control with the investment adviser that provides services to the registered investment company in accordance with paragraphs (c)(7)(ii)(A) through (C) of this section, except that with respect to paragraph (c)(7)(ii)(C)(
(8)
(f)(1)
(3)(i)
(ii)
(17)
3. By adding § 210.2-07 to read as follows:
(a) Each registered public accounting firm that performs for an audit client that is an issuer (as defined in section 10A(f) of the Securities Exchange Act of 1934 (15 U.S.C. 78j-1(f))), other than an issuer that is an Asset-Backed Issuer as defined in § 240.13a-14(g) and § 240.15d-14(g) of this chapter, or an investment company registered under section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8), other than a unit investment trust as defined by section 4(2) of the Investment Company Act of 1940 (15 U.S.C. 80a-4(2)), any audit required under the securities laws shall report, prior to the filing of such audit report with the Commission, to the audit committee of the issuer or registered investment company:
(1) All critical accounting policies and practices to be used;
(2) All alternative treatments of financial information within Generally Accepted Accounting Principles that have been discussed with management of the issuer or registered investment company, including:
(i) Ramifications of the use of such alternative disclosures and treatments; and
(ii) The treatment preferred by the registered public accounting firm;
(3) Other material written communications between the registered public accounting firm and the management of the issuer or registered investment company, such as any management letter or schedule of unadjusted differences.
(b) [Reserved]
4. The authority citation for part 240 continues to read as follows:
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78o, 78p, 78q, 78s, 78u-5, 78w, 78x, 78ll, 78mm, 79q, 79j, 79n, 79t(a), 80a-8, 80a-20, 80a-29, 80a-30, 80a-37(a), 80b-4, 80b-11, unless otherwise noted.
5. Section 240.10A-2 is added to read as follows:
It shall be unlawful for an auditor not to be independent under § 210.2-01(c)(2)(iii)(B), 2-01(c)(4), 2-01(c)(6), 2-01(c)(7) and 2-07.
6. Section 240.14a-101 is amended by revising paragraph (e) of item 9 to read as follows:
Item 9.
(e)(1) Disclose, under the caption
(2) Disclose, under the caption
(3) Disclose, under the caption
(4) Disclose, under the caption
(5)(i) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(ii) Disclose the percentage of fees described in each of paragraphs (e)(2) through (e)(4) of this section that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (c)(7)(ii)(B) and, (c)(7)(ii)(C), of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B) and (C)).
(6) If greater than 50 percent, disclose the percentage of hours expended on the principal accountant's engagement to audit the registrant's financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant's full-time, permanent employees.
For purposes of item 9(e)(2), (3), (4), and (5)(ii) registrants that are investment companies must disclose fees billed for services rendered to the registrant, the registrant's investment adviser (not including any sub-adviser whose role is primarily portfolio management and is subcontracted with or overseen by another investment adviser), and any entity controlling, controlled by, or under common control with the adviser that provides services to the registrant.
7. The authority citation for part 249 is amended by revising the citations, § 249.220f, § 249.240f, § 249.310 and § 249.310b and a citation for § 249.331 is added in numerical order to read as follows:
15 U.S.C. 78a
Section 249.220f is also issued under secs. 3(a), 202, 302, 404 and 407, Pub. L. No. 107-204, 116 Stat. 745.
Section 249.240f is also issued under secs. 3(a), 202, 302, 404 and 407, Pub. L. No. 107-204, 116 Stat. 745.
Section 249.310 is also issued under 15 U.S.C. 78m, 78o(d) and 78w(a) and secs. 3(a), 202 and 302, Pub. L. No. 107-204, 116 Stat. 745.
Section 249.310b is also issued under secs. 3(a), 202 and 302, Pub. L. No. 107-204, 116 Stat. 745.
Section 249.331 is also issued under secs. 3(a), 202, and 302, Pub. L. No. 107-204, 116 Stat. 745.
8. Amend form 20-F (referenced in § 249.220f) by adding paragraph (d) to item 15 to read as follows:
The text of form 20-F does not, and this amendment will not, appear in the Code of Federal Regulations.
Item 15.
(d) Principal Accountant Fees and Services.
(1) Disclose, under the caption
(2) Disclose, under the caption
(3) Disclose, under the caption
(4) Disclose, under the caption
(5)(i) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(ii) Disclose the percentage of fees described in each of paragraphs (e)(2) through (e)(4) of this section that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (c)(7)(ii)(B), and (c)(7)(ii)(C), of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B) and (C)).
(6) If greater than 50 percent, disclose the percentage of hours expended on the principal accountant's engagement to audit the registrant's financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant's full-time, permanent employees.
1. You do not need to provide the information called for by this item 15(d) unless you are using this form as an annual report.
2. A registrant that is an Asset-Backed Issuer (as defined in § 240.13a-14(g) and § 240.15d-14(g) of this chapter) is not required to disclose the information required by this item.
9. Amend form 40-F (referenced in § 249.240f) by adding paragraph (10) to general instruction B to read as follows:
The text of form 40-F does not, and this amendment will not, appear in the Code of Federal Regulations.
B. Information To Be Filed on This Form.
(10) Principal Accountant Fees and Services.
(1) Disclose, under the caption
(2) Disclose, under the caption
(3) Disclose, under the caption
(4) Disclose, under the caption
(5)(i) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(ii) Disclose the percentage of fees described in each of paragraphs (e)(2) through (e)(4) of this section that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (c)(7)(ii)(B), and (c)(7)(ii)(C), of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B) and (C)).
(6) If greater than 50 percent, disclose the percentage of hours expended on the principal accountant's engagement to audit the registrant's financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant's full-time, permanent employees.
1. You do not need to provide the information called for by this instruction B.(10) unless you are using this form as an annual report.
2. A registrant that is an Asset-Backed Issuer (as defined in § 240.13a-14(g) and § 240.15d-14(g) of this chapter) is not required to disclose the information required by this instruction B.(10).
10. Amend form 10-K (referenced in § 249.310) by:
a. Redesignating item 16 of part IV as item 17 of part IV, and
b. Adding new item 16 to part III.
The addition reads as follows:
The text of form 10-K does not, and this amendment will not, appear in the Code of Federal Regulations.
Furnish the information required by item 9(e) of schedule 14A (§ 240.14a-101 of this chapter).
(1) Disclose, under the caption
(2) Disclose, under the caption
(3) Disclose, under the caption
(4) Disclose, under the caption
(5)(i) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(ii) Disclose the percentage of fees described in each of paragraphs (e)(2) through (e)(4) of this section that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (c)(7)(ii)(B), and (c)(7)(ii)(C), of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B) and (C)).
(6) If greater than 50 percent, disclose the percentage of hours expended on the principal accountant's engagement to audit the registrant's financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant's full-time, permanent employees.
A registrant that is an Asset-Backed Issuer (as defined in § 240.13a-14(g) and § 240.15d-14(g) of this chapter) is not required to disclose the information required by this item.
11. Amend form 10-KSB (referenced in § 249.310b) by adding item 16 to part III to read as follows:
The text of form 10-KSB does not, and this amendment will not, appear in the Code of Federal Regulations.
Furnish the information required by item 9(e) of schedule 14A (§ 240.14a-101 of this chapter).
(1) Disclose, under the caption
(2) Disclose, under the caption
(3) Disclose, under the caption
(4) Disclose, under the caption
(5)(i) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(ii) Disclose the percentage of fees described in each of paragraphs (e)(2) through (e)(4) of this section that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (c)(7)(ii)(B), and (c)(7)(ii)(C), of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B) and (C)).
(6) If greater than 50 percent, disclose the percentage of hours expended on the
A registrant that is an Asset-Backed Issuer (as defined in § 240.13a-14(g) and § 240.15d-14(g) of this chapter) is not required to disclose the information required by this item.
12. The authority citation for part 274 is revised to read as follows:
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78
Section 274.128 is also issued under secs. 3(a), 202, and 302, Pub. L. 107-204, 116 Stat. 745.
13. By amending form N-CSR (referenced in §§ 249.331 and 274.128).
a. By revising general instruction D;
b. By redesignating items 5 and 6 as items 6 and 7; and
c. By adding a new item 5.
The revisions and additions read as follows:
The text of form N-CSR does not, and this amendment will not, appear in the Code of Federal Regulations.
D. Incorporation by Reference.
A registrant may incorporate by reference information required by items 5 and 7(b). No other items of the form shall be answered by incorporating any information by reference. The information required by item 5 may be incorporated by reference from the registrant's definitive proxy statement (filed or required to be filed pursuant to Regulation 14A (17 CFR 240.14a-1
(a) Disclose, under the caption
(b) Disclose, under the caption
(c) Disclose, under the caption
(d) Disclose, under the caption
(e)(1) Disclose the audit committee's pre-approval policies and procedures described in paragraph (c)(7)(ii) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)).
(2) Disclose the percentage of fees described in each of paragraphs (b) through (d) of this item that were approved by the audit committee pursuant to each of the paragraphs (c)(7)(ii)(A), (B), and (C) of rule 2-01 of Regulation S-X (17 CFR 210.2-01(c)(7)(ii)(A), (B), and (C)).
(f) If greater than 50 percent, disclose the percentage of hours expended on the principal accountant's engagement to audit the registrant's financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant's full-time, permanent employees.
1. The information required by this item 5 is only required in a report on this form N-CSR that is required by item 7(a) to include a copy of an annual report transmitted to stockholders.
2. For purposes of paragraphs (b), (c), (d) and (e)(2) of this item, registrants must disclose fees billed for services rendered to the registrant, the registrant's investment adviser (not including any sub-adviser whose role is primarily portfolio management and is subcontracted with or overseen by another investment adviser), and any entity controlling, controlled by, or under common control with the adviser that provides services to the registrant.
By the Commission.
Office of Governmentwide Policy, GSA.
Final rule.
The General Services Administration (GSA) is revising the Federal Management Regulation (FMR) to complete the transfer of coverage on real property policies from the Federal Property Management Regulations (FPMR) to the FMR. In addition to this regulatory action that amends the FMR, another final rule is being published today in the
Effective December 13, 2002.
Stanley C. Langfeld, Director, Real Property Policy Division, Office of Governmentwide Policy, General Services Administration, by phone at (202) 501-1737 or by e-mail at
As part of GSA's regulatory improvement initiative, GSA published a final rule that created FMR parts 102-71 through 102-82 (41 CFR parts 102-71 through 102-82), entitled “Real Property Policies,” in the
Public Law 107-217 was enacted on August 21, 2002, to revise and codify without substantive change certain laws related to public buildings, property, and works in Title 40 of the United States Code. GSA will update the legal citations in FMR parts 102-71 through 102-83 to reflect this new law in a separate regulatory action.
The General Services Administration (GSA) has determined that this final rule is not a significant regulatory action for the purposes of Executive Order 12866.
This final rule is not required to be published in the
The Paperwork Reduction Act does not apply because this final rule does not impose reporting, recordkeeping or information collection requirements which require the approval of the Office of Management and Budget pursuant to 44 U.S.C. 3501
This final rule is exempt from Congressional review under 5 U.S.C. 801 since it relates solely to agency management and personnel.
Administrative practice and procedure, Blind, Concessions, Federal buildings and facilities, Fire prevention, Government property management, Homeless, Individuals with disabilities, Location of space, Occupational safety and health, Parking, Real property acquisition, Security measures, Surplus Government property, Utilities.
40 U.S.C. 486(c).
The following definitions apply to GSA's real property policies:
(1) Has been adopted and promulgated by a nationally recognized standards-producing organization under procedures whereby those interested and affected by it have reached substantial agreement on its adoption, or
(2) Was formulated through consultation by appropriate Federal agencies in a manner which afforded an opportunity for diverse views to be considered.
(1) Any building which is suitable for office and/or storage space for the use of one or more Federal agencies or mixed ownership corporations, such as Federal office buildings, post offices, customhouses, courthouses, border inspection facilities, warehouses, and any such building designated by the President. It also includes buildings of this sort that are acquired by the Federal Government under the Administrator's installment-purchase, lease-purchase, and purchase-contract authorities.
(2)
(i) On the public domain.
(ii) In foreign countries.
(iii) On Indian and native Eskimo properties held in trust by the United States.
(iv) On lands used in connection with Federal programs for agricultural, recreational, and conservation purposes.
(v) On or used in connection with river, harbor, flood control, reclamation or power projects, or for chemical manufacturing or development projects, or for nuclear production, research, or development projects.
(vi) On or used in connection with housing and residential projects.
(vii) On military installations.
(viii) On Department of Veterans Affairs installations used for hospital or domiciliary purposes.
(ix) Excluded by the President.
(1) Any interest in land, together with the improvements, structures, and fixtures located thereon (including prefabricated movable structures, such as Butler-type storage warehouses and quonset huts, and housetrailers with or without undercarriages), and appurtenances thereto, under the control of any Federal agency, except:
(i) The public domain;
(ii) Lands reserved or dedicated for national forest or national park purposes;
(iii) Minerals in lands or portions of lands withdrawn or reserved from the public domain which the Secretary of the Interior determines are suitable for disposition under the public land mining and mineral leasing laws;
(iv) Lands withdrawn or reserved from the public domain but not including lands or portions of lands so withdrawn or reserved which the Secretary of the Interior, with the concurrence of the Administrator of General Services, determines are not suitable for return to the public domain for disposition under the general public land laws because such lands are substantially changed in character by improvements or otherwise; and
(v) Crops when designated by such agency for disposition by severance and removal from the land.
(2) Improvements of any kind, structures, and fixtures under the control of any Federal agency when designated by such agency for disposition without the underlying land (including such as may be located on the public domain, on lands withdrawn or reserved from the public domain, on lands reserved or dedicated for national forest or national park purposes, or on lands that are not owned by the United States) excluding, however, prefabricated movable structures, such as Butler-type storage warehouses and quonset huts, and housetrailers (with or without undercarriages).
(3) Standing timber and embedded gravel, sand, or stone under the control of any Federal agency whether designated by such agency for disposition with the land or by severance and removal from the land, excluding timber felled, and gravel, sand, or stone excavated by or for the Government prior to disposition.
Recreational activities include, but are not limited to, the operations of gymnasiums and related facilities.
Regional Officer, within the meaning of part 102-74, subpart D of this chapter, means the Federal official designated to supervise the implementation of the Public Buildings Cooperative Use Act's occasional use provisions. The Federal official may be an employee of GSA or a Federal agency that has delegated authority from GSA to supervise the implementation of the Public Buildings Cooperative Use Act's occasional use provisions.
(1) Which is an integral part of real property or is related to, designed for, or specially adapted to the functional or productive capacity of the real property and the removal of which would significantly diminish the economic value of the real property. Normally,
(2) Which is determined by the Administrator of General Services to be related to the real property.
40 U.S.C. 486(c), (d) and (e).
40 U.S.C. 486(c); Sec. 3(c), Reorganization Plan No. 18 of 1950 (40 U.S.C. 490 note); Sec. 1'201(b), E.O. 12072, 43 FR 36869, 3 CFR, 1978 Comp., p. 213.
The real property policies contained in this part apply to Federal agencies, including the General Services Administration (GSA)/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services.
When seeking to acquire space, Federal agencies should first seek space in Government-owned and Government-leased buildings. If suitable Government-controlled space is unavailable, Federal agencies must acquire real estate and related services in an efficient and cost effective manner.
Federal agencies, upon approval from GSA, may provide real estate acquisition and related services, including leasing (with or without purchase options), building and/or site purchase, condemnation, and relocation assistance. For information on the design and construction of Federal facilities, see part 102-76 of this chapter.
Yes, after considering the availability of GSA-controlled space and determining that no such space is available to meet its needs, Federal agencies must extend priority consideration to available space in buildings under the custody and control of the United States Postal Service (USPS) in fulfilling Federal agency space needs, as specified in the “Agreement Between General Services Administration and the United States Postal Service Covering Real and Personal Property Relationships and Associated Services,” dated July 1985.
Executive agencies must comply with the location policies in this part and part 102-83 of this chapter.
Prior to acquiring, constructing, or leasing space, Federal agencies must comply with the provisions of section 110(a) of the National Historic Preservation Act of 1966, as amended, (16 U.S.C. 470h-2(a)), regarding the use of historic properties. Federal agencies can find guidance on protecting, enhancing and preserving historic and cultural property in part 102-78 of this chapter.
No, a prospectus is not required if the dollar value of a project does not exceed the prospectus threshold. The Public
Such projects require approval by the Senate and the House of Representatives if the dollar value exceeds the prospectus threshold. In order to obtain this approval, prospectuses for such projects must be submitted to GSA and the Administrator of General Services will transmit the proposed prospectuses to Congress for consideration by the Senate and the House of Representatives.
Federal agencies may consider leases of privately owned land and buildings only when needs cannot be met satisfactorily in Government-controlled space and one or more of the following conditions exist:
(a) Leasing is more advantageous to the Government than constructing a new building, or more advantageous than altering an existing Federal building;
(b) New construction or alteration is unwarranted because demand for space in the community is insufficient, or is indefinite in scope or duration; or
(c) Federal agencies cannot provide for the completion of a new building within a reasonable time.
No, Federal agencies possessing independent statutory authority to acquire leased space are not subject to GSA authority and, therefore, are not subject to the requirements of this part.
Federal agencies must acquire leases on the most favorable basis to the Federal Government, with due consideration to maintenance and operational efficiency, and at charges consistent with prevailing market rates for comparable facilities in the community.
Federal agencies, upon approval from GSA, may enter into lease agreements with any person, partnership, corporation, or other public or private entity, provided that such lease agreements do not bind the Government for periods in excess of twenty years (40 U.S.C. 490(h)(1)). Federal agencies may not enter into lease agreements with persons who are barred from contracting with the Federal Government (
Yes, the limitations on leasing certain types of space are as follows:
(a) In general, Federal agencies may not lease any space to accommodate computer and telecommunications operations; secure or sensitive activities related to the national defense or security; or a permanent courtroom, judicial chamber, or administrative office for any United States court, if the average annual net rental cost of leasing such space would exceed the prospectus threshold (40 U.S.C. 606(e)).
(b) However, Federal agencies may lease such space if the Administrator of General Services first determines that leasing such space is necessary to meet requirements which cannot be met in public buildings and then submits such determination to the Committee on Environment and Public Works of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives in accordance with 40 U.S.C. 606(e).
Yes, executive agencies must acquire leased space by negotiation, except where the sealed bid procedure is required by the Competition in Contracting Act of 1984 (CICA), as amended (41 U.S.C. 253(a)).
Federal agencies, upon approval from GSA, must perform all functions of leasing building space, and land incidental thereto, for their use except as provided in this subpart.
No one, except the Contracting Officer or his or her designee, may contact lessors, offerors, or potential offerors concerning space leased or to be leased for the purpose of making oral or written representation or commitments or agreements with respect to the terms of occupancy of particular space, tenant improvements, alterations and repairs, or payment for overtime services.
Yes, upon request, GSA may perform, on a reimbursable basis, all functions of leasing building space, and land incidental thereto, for Federal agencies possessing independent statutory authority to lease space. However, GSA reserves the right to accept or reject reimbursable leasing service requests on a case-by-case basis.
Federal agencies must apply the contingent fee policies in 48 CFR 3.4 to all negotiated and sealed bid contracts for the acquisition of real property by lease. Federal agencies must appropriately adapt the representations and covenants required by that subpart for use in leases of real property for Government use.
The heads of Federal agencies must:
(a) Cooperate with and assist the Administrator of General Services in carrying out his responsibilities respecting office buildings and space;
(b) Take measures to give GSA early notice of new or changing space requirements;
(c) Seek to economize their requirements for space; and
(d) Continuously review their needs for space in and near the District of Columbia, taking into account the feasibility of decentralizing services or activities which can be carried on elsewhere without excessive costs or significant loss of efficiency.
Yes, executive agencies must obtain full and open competition among suitable locations meeting minimum Government requirements, except as otherwise provided by CICA (41 U.S.C. 253).
When acquiring leasehold interests in buildings to be constructed for Federal Government use, executive agencies must:
(a) Establish detailed building specifications before agreeing to a contract that will result in the construction of a building;
(b) Use competitive procedures;
(c) Inspect every building during construction to ensure that the building complies with the Government's specifications;
(d) Evaluate every building after completion of construction to determine that the building complies with the Government's specifications; and
(e) Ensure that any contract that will result in the construction of a building contains provisions permitting the Government to reduce the rent during any period when the building does not comply with the Government's specifications.
Yes, Federal agencies must give a price preference to space in historic properties when acquiring leased space using either the lowest price technically acceptable or the best value tradeoff source selection processes.
Federal agencies must give a price evaluation preference to space in historic properties as follows:
(a) First to suitable historic properties within historic districts, a 10 percent price preference.
(b) If no suitable historic property within an historic district is offered, or the 10 percent preference does not result in such property being the lowest price technically acceptable offer, the Government will give a 2.5 percent price preference to suitable non-historic developed or undeveloped sites within historic districts.
(c) If no suitable non-historic developed or undeveloped site within an historic district is offered, or the 2.5 percent preference does not result in such property being the lowest price technically acceptable offer, the Government will give a 10 percent price preference to suitable historic properties outside of historic districts.
(d) Finally, if no suitable historic property outside of historic districts is offered, no historic price preference will be given to any property offered.
When award will be based on the best value tradeoff source selection process, which permits tradeoffs among price and non-price factors, the Government will give a price evaluation preference to historic properties as follows:
(a) First to suitable historic properties within historic districts, a 10 percent price preference.
(b) If no suitable historic property within an historic district is offered or remains in the competition, the Government will give a 2.5 percent price preference to suitable non-historic developed or undeveloped sites within historic districts.
(c) If no suitable non-historic developed or undeveloped site within an historic district is offered or remains in the competition, the Government will give a 10 percent price preference to suitable historic properties outside of historic districts.
(d) Finally, if no suitable historic property outside of historic districts is offered, no historic price preference will be given to any property offered.
Agencies may consider leasing with a purchase option at or below fair market value, consistent with the lease-purchase scoring rules, when one or more of the following conditions exist:
(a) The purchase option offers economic and other advantages to the Government and is consistent with the Government's goals;
(b) The Government is the sole or major tenant of the building, and has a long-term need for the property; or
(c) Leasing with a purchase option is otherwise in the best interest of the Government.
All Federal agencies must follow the budget scorekeeping rules for leases, capital leases, and lease-purchases identified in appendices A and B of OMB Circular A-11. (For availability,
Federal agencies may perform for themselves all functions necessary to acquire leased space in buildings and land incidental thereto when:
(a) The authority may be delegated (see § 102-72.30(b) on the different types of delegations related to real estate leasing);
(b) The space may be leased for no rental, or for a nominal consideration of $1 per annum, and is limited to terms not to exceed 1 year;
(c) Authority has been requested by an executive agency and a specific delegation has been granted by the Administrator of General Services;
(d) A categorical delegation has been granted by the Administrator of General Services for space to accommodate particular types of agency activities, such as military recruiting offices or space for certain county level agricultural activities. A listing of categorical delegations is found at § 102-73.150; or
(e) The required space is found by the Administrator of General Services to be wholly or predominantly utilized for the special purposes of the agency to occupy such space and is not generally suitable for use by other agencies. Federal agencies must obtain prior approval from the GSA regional office having jurisdiction for the proposed leasing action, before initiating a leasing action involving 2,500 or more square feet of such special purpose space. GSA's approval must be based upon a finding that there is no vacant Government-owned or leased space available that will meet the agency's requirements. Agency special purpose space delegations can be found in §§ 102-73.165 through 102-73.220.
A categorical space delegation is a standing delegation of authority from the Administrator of General Services to a Federal agency to acquire a type of space identified in § 102-73.150 subject to limitations in this part.
Subject to the limitations cited in §§ 102-73.225 through 102-73.235, all Federal agencies are authorized to acquire the types of space listed in § 102-73.150 and, except where otherwise noted, may lease space for
Federal agencies can use categorical space delegations to acquire:
(a) Space to house antennas, repeaters, or transmission equipment;
(b) Depots, including, but not limited to, stockpiling depots and torpedo net depots;
(c) Docks, piers, and mooring facilities (including closed storage space required in combination with such facilities);
(d) Fumigation areas;
(e) Garage space (may be leased only on a fiscal year basis);
(f) Greenhouses;
(g) Hangars and other airport operating facilities including, but not limited to, flight preparation space, aircraft storage areas, and repair shops;
(h) Hospitals, including medical clinics;
(i) Housing (temporary), including hotels (does not include quarters obtained pursuant to temporary duty travel or employee relocation);
(j) Laundries;
(k) Quarantine facilities for plants, birds, and other animals;
(l) Ranger stations;
(m) Recruiting space for the armed forces (lease terms, including all options, limited to 5 years);
(n) Schools directly related to the special purpose function(s) of an agency;
(o) Specialized storage/depot facilities, such as cold storage; self-storage units; and lumber, oil, gasoline, shipbuilding materials, and pesticide materials/equipment storage (general purpose warehouse type storage facilities not included); and
(p) Space for short-term use (such as conferences and meetings, judicial proceedings, and emergency situations).
An agency special purpose space delegation is a standing delegation of authority from the Administrator of General Services to specific Federal agencies to lease their own special purpose space (identified in §§ 102-73.165 through 102-73.220), subject to limitations in this part.
Subject to the limitations on annual rental amounts, lease terms, and leases on parking spaces cited in §§ 102-73.225 through 102-73.235, the agencies listed below are authorized to acquire special purpose space associated with that agency and, except where otherwise noted, may lease such space for terms, including all options, of up to 20 years. The agencies and types of space subject to special purpose space delegations are specified in §§ 102-73.165 through 102-73.220.
The Department of Agriculture is delegated the authority to lease the following types of space:
(a) Cotton classing laboratories (lease terms, including all options, limited to 5 years);
(b) Land (if unimproved, may be leased only on a fiscal year basis);
(c) Miscellaneous storage by cubic foot or weight basis;
(d) Office space when required to be located in or adjacent to stockyards, produce markets, produce terminals, airports, and other ports (lease terms, including all options, limited to 5 years);
(e) Space for agricultural commodities stored in licensed warehouses and utilized under warehouse contracts; and
(f) Space utilized in cooperation with State and local governments or their instrumentalities (extension services) where the cooperating State or local government occupies a portion of the space and pays a portion of the rent.
The Department of Commerce is delegated authority to lease the following types of space:
(a) Space required by the Census Bureau in connection with conducting the decennial census (lease terms, including all options, limited to 5 years);
(b) Laboratories for testing materials, classified or ordnance devices, calibration of instruments, and atmospheric and oceanic research (lease terms, including all options, limited to 5 years);
(c) Maritime training stations;
(d) Radio stations;
(e) Land (if unimproved, may be leased only on a fiscal year basis); and
(f) National Weather Service meteorological facilities.
The Department of Defense is delegated authority to lease the following types of space:
(a) Air Force—Civil Air Patrol Liaison Offices and land incidental thereto when required for use incidental to, in conjunction with, and in close proximity to airports, including aircraft and warning stations (if unimproved, land may be leased only on a fiscal year basis; for space, lease terms, including all options, limited to 5 years);
(b) Armories;
(c) Film library in the vicinity of Washington, DC;
(d) Mess halls;
(e) Ports of embarkation and debarkation;
(f) Post exchanges;
(g) Postal Concentration Center, Long Island City, NY;
(h) Recreation centers;
(i) Reserve training space;
(j) Service clubs; and
(k) Testing laboratories (lease terms, including all options, limited to 5 years).
The Department of Energy is delegated authority to lease facilities housing the special purpose or special location activities of the old Atomic Energy Commission.
The Federal Communications Commission is delegated authority to lease monitoring station sites.
The Department of Health and Human Services is delegated authority to lease laboratories (lease terms, including all options, limited to 5 years).
The Department of the Interior is delegated authority to lease the following types of space:
(a) Space in buildings and land incidental thereto used by field crews of the Bureau of Reclamation, Bureau of Land Management, and the Geological Survey in areas where no other Government agencies are quartered (unimproved land may be leased only on a fiscal year basis); and
(b) National Parks/Monuments Visitors Centers consisting primarily of
The Department of the Justice is delegated authority to lease the following types of space:
(a) U.S. marshals office in any Alaska location (lease terms, including all options, limited to 5 years);
(b) Border Patrol Offices similar in character and utilization to police stations, involving the handling of prisoners, firearms, and motor vehicles, regardless of location (lease terms, including all options limited to 5 years);
(c) Space used for storage and maintenance of surveillance vehicles and seized property (lease terms, including all options, limited to 5 years);
(d) Space used for review and custody of records and other evidentiary materials (lease terms, including all options, limited to 5 years); and
(e) Space used for trial preparation where space is not available in Federal buildings, Federal courthouses, USPS facilities, or GSA-leased buildings (lease terms limited to not more than 1 year.)
The Office of Thrift Supervision is delegated authority to lease space for field offices of Examining Divisions required to be located within Office of Thrift Supervision buildings or immediately adjoining or adjacent to such buildings (lease terms, including all options, limited to 5 years).
The Department of Transportation is delegated authority to lease the following types of space (or real property):
(a) Land for the Federal Aviation Administration (FAA) at airports (unimproved land may be leased only on a fiscal year basis);
(b) General purpose office space not exceeding 10,000 square feet for the FAA at airports in buildings under the jurisdiction of public or private airport authorities (lease terms, including all options, limited to 5 years);
(c) Space for the U.S. Coast Guard oceanic unit, Woods Hole, MA; and
(d) Space for the U.S. Coast Guard port security activities.
The Department of Treasury is delegated authority to lease the following types of space:
(a) Space and land incidental thereto for the use of the Comptroller of the Currency, as well as the operation, maintenance and custody thereof (if unimproved, land may be leased only on a fiscal year basis; lease term for space, including all options, limited to 5 years); and
(b) Aerostat radar facilities necessary for U.S. Custom Service mission activities.
The Department of Veterans Affairs is delegated authority to lease the following types of space:
(a) Guidance and training centers located at schools and colleges; and
(b) Space used for veterans hospitals, including outpatient and medical-related clinics, such as drug, mental health, and alcohol.
In accordance with section 7(a) of the Public Buildings Act of 1959, as amended (40 U.S.C. 606), Federal agencies must submit a prospectus to the Administrator of General Services for leases involving a net annual rental, excluding services and utilities, in excess of the prospectus threshold provided in 40 U.S.C. 606. Agencies must be aware that prospectus thresholds are indexed and change each year.
Pursuant to GSA's long-term authority contained in section 210(h)(1) of the Federal Property and Administrative Services Act of 1949, as amended, (40 U.S.C. 490(h)(1)), agencies delegated the authorities outlined herein may enter into leases for the term specified in the delegation. In those cases where agency special purposes space delegations include the authority to acquire unimproved land, the land may be leased only on a fiscal year basis.
Federal agencies that need parking must utilize available Government-owned or leased facilities. Federal agencies must make inquiries regarding availability of such Government-controlled space to GSA regional offices and document such inquiries. If no suitable Government-controlled facilities are available, an agency may use its own procurement authority to acquire parking by service contract.
Agencies may consider purchase of buildings on a case-by-case basis when one or more of the following conditions exist:
(a) It is economically more beneficial to own and manage the property;
(b) There is a long-term need for the property;
(c) The property is an existing building, or a building nearing completion, that can be purchased and occupied within a reasonable time; or
(d) When otherwise in the best interests of the Government.
Yes, when purchasing buildings, agencies must comply with the location policies in this part and part 102-83 of this chapter.
Agencies must locate proposed Federal buildings on sites that are most advantageous to the United States. Executive agencies must consider factors such as whether the site will contribute to economy and efficiency in the construction, maintenance, and operation of the individual building, and how the proposed site relates to the Government's total space needs in the community. Prior to acquiring, constructing, or leasing buildings (or sites for such buildings), Federal agencies must use, to the maximum extent feasible, historic properties available to the agency. In site selections, executive agencies must consider Executive Orders 12072 (3 CFR, 1978 Comp., p. 213) and 13006 (40 U.S.C. 601a note). In addition, executive agencies must consider all of the following:
(a) Maximum utilization of Government-owned land (including excess land) whenever it is adequate, economically adaptable to requirements and properly located, where such use is consistent with the provisions of part 102-75, subpart B, of this chapter.
(b) A site adjacent to or in the proximity of an existing Federal building which is well located and is to be retained for long-term occupancy.
(c) The environmental condition of proposed sites prior to purchase. The sites must be free from contamination, unless it is otherwise determined to be in the best interests of the Government to purchase a contaminated site (
(d) Purchase options to secure the future availability of a site.
(e) All applicable location policies in this part and part 102-83 of this chapter.
Federal agencies must follow the land acquisition policy in the Uniform Relocation Assistance and Real Property Acquisition Policies Act, 42 U.S.C. 4651-4655, that:
(a) Encourages and expedites the acquisition of real property by agreements with owners;
(b) Avoids litigation, including condemnation actions, where possible and relieves congestion in the courts;
(c) Provides for consistent treatment of owners; and
(d) Promotes public confidence in Federal land acquisition practices.
To facilitate land acquisition, Federal agencies must:
(a) Obtain one appraisal on each parcel, tract, or other real property;
(b) Pay a property owner (or occupant) or deposit payment in the registry of the court before requiring the owner to surrender the property;
(c) Provide property owners (and occupants) at least 90-days notice of displacement before requiring anyone to move. If a Federal agency permits the owner to keep possession for a short time after acquiring the owner's property, Federal agencies must not charge rent in excess of the property's fair rental value to a short-term occupier;
(d) Try to negotiate with owners on the price;
(e) Appraise the real property before starting negotiations and give the owner (or the owner's representative) the opportunity to accompany the appraiser during the inspection; and
(f) Establish an amount estimated to be the just compensation before starting negotiations and promptly offer to acquire the property for this full amount.
Yes, Federal agencies must provide the owner with a written statement of this amount and summarize the basis for it. When it's appropriate, Federal agencies must separately state the just compensation for the property to be acquired and damages to the remaining real property.
The summary statement must:
(a) Identify the real property and the estate or interest the Federal agency is acquiring;
(b) Identify the buildings, structures, and other improvements the Federal agency considers part of the real property for which just compensation is being offered;
(c) State that the Federal agency based the estimate of just compensation on the Government's estimate of the property's fair market value. If only part of a property or less than a full interest is being acquired, Federal agencies must explain how they determined the just compensation for it; and
(d) State that the Government's estimate of just compensation is at least as much as the property's approved appraisal value.
Yes, Federal agencies must acquire at least an equal interest in all buildings, structures, or other improvements on the real property they are acquiring, including those that the Government require to be removed or those that will interfere with the proposed use of the property.
If a tenant has the right or obligation to remove these buildings, structures, or other improvements at the end of his term, Federal agencies must determine the total just compensation for the property and pay the tenant the greater of two values:
(a) The fair market value of buildings, structures, or other improvements the tenant must remove.
(b) The contributive fair market value of the tenant's improvements to the entire property's fair market value. This value will be at least as much as the value of items the tenant must remove.
Yes, Federal agencies must not:
(a) Duplicate any payment to the tenant otherwise authorized by law; and
(b) Pay a tenant unless the landowner disclaims all interests in the tenant's improvements. In consideration for any such payment, the tenant must assign, transfer, and release to the Federal agency all of its right, title, and interest in the improvements. The tenant may reject such payment under this subpart and obtain payment for its property interests according to other sections of applicable law.
Federal agencies must:
(a) Reimburse property owners for all reasonable expenses actually incurred for recording fees, transfer taxes, documentary stamps, evidence of title, boundary surveys, legal descriptions of the real property, and similar expenses needed to convey the property to the Federal Government;
(b) Reimburse property owners for all reasonable expenses actually incurred for penalty costs and other charges to prepay any existing, recorded mortgage that a property owner entered into in good faith and that encumbers the real property;
(c) Reimburse property owners for all reasonable expenses actually incurred for the prorated part of any prepaid real property taxes that cover the period after the Federal Government gets title to the property or effective possession of it, whichever is earlier; and
(d) Whenever possible, directly pay the costs identified in this section, so property owners will not have to pay them and then seek reimbursement from the Government.
Federal agencies must pay reasonable expenses for attorneys, appraisals, and engineering fees that a property owner incurs because of a condemnation proceeding, if any of the following are true:
(a) The court's final judgment is that the Federal agency cannot acquire the real property by condemnation.
(b) The Federal agency abandons the condemnation proceeding other than under an agreed-on settlement.
(c) The court renders a judgment in the property owner's favor in an inverse condemnation proceeding or the Federal agency agrees to settle such proceeding.
Federal agencies, upon approval from GSA, must provide appropriate relocation assistance under the Uniform Relocation Assistance and Real Property Acquisition Policies Act (42 U.S.C. 4651-4655) to eligible owners and tenants of property purchased for use by Federal agencies in accordance with the implementing regulations found in 49 CFR part 24 . Appropriate relocation assistance means that the Federal agency must pay the displaced person for actual:
(a) Reasonable moving expenses (in moving himself, his family, and business);
(b) Direct losses of tangible personal property as a result of moving or discontinuing a business;
(c) Reasonable expenses in searching for a replacement business or farm; and
(d) Reasonable expenses necessary to reestablish a displaced farm, nonprofit organization, or small business at its new site, but not to exceed $10,000.
9. Part 102-74 is revised to read as follows:
40 U.S.C. 486(c); E.O. 12191, 45 FR 7997, 3 CFR, 1980 Comp., p 138.
The real property policies contained in this part apply to Federal agencies, including the GSA/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services.
Executive agencies must manage, operate and maintain Government-owned and leased buildings in a manner that provides for quality space and services consistent with their operational needs and accomplishes overall Government objectives. The management, operation and maintenance of buildings and building systems must:
(a) Be cost effective and energy efficient;
(b) Be adequate to meet the agencies' missions;
(c) Meet nationally recognized standards; and
(d) Be at an appropriate level to maintain and preserve the physical plant assets, consistent with available funding.
Occupants of facilities under the custody and control of Federal agencies must:
(a) Cooperate to the fullest extent with all pertinent facility procedures and regulations;
(b) Promptly report all crimes and suspicious circumstances occurring on federally controlled property first to the regional law enforcement organization and other designated law enforcement agencies, and then through internal agency channels;
(c) Provide training to employees regarding protection and responses to emergency situations; and
(d) Make recommendations for improving the effectiveness of protection in Federal facilities.
Occupancy services are:
(a) Building services (see § 102-74.35);
(b) Concession services; and
(c) Conservation programs.
Executive agencies, upon approval from GSA, must manage, administer and enforce the requirements of agreements (such as Memoranda of Understanding) and contracts that provide for the delivery of occupancy services.
Executive agencies must provide occupancy services that substantially conform to nationally recognized standards. As needed, executive agencies may adopt other standards for buildings and services in federally-controlled facilities to conform to statutory requirements and to implement cost-reduction efforts.
Executive agencies, upon approval from GSA, must provide:
(a) Building services such as custodial, solid waste management (including recycling), heating and cooling, landscaping and grounds maintenance, tenant alterations, minor repairs, building maintenance, integrated pest management, signage, parking, and snow removal, at appropriate levels to support Federal agency missions; and
(b) Arrangements for raising and lowering the United States flags at appropriate times. In addition, agencies must display P.O.W. and M.I.A. flags at locations specified in 36 U.S.C. 902 on P.O.W./M.I.A. flag display days.
Concession services are any food or snack services provided by a Randolph-Sheppard Act vendor, commercial contractor or nonprofit organization (see definition in § 102-71.20 of this chapter), in vending facilities such as:
(a) Vending machines;
(b) Sundry facilities;
(c) Prepackaged facilities;
(d) Snack bars; and
(e) Cafeterias.
Federal agencies, upon approval from GSA, must provide concession services where building population supports such services and when the availability of existing commercial services is insufficient to meet Federal agency needs. Prior to establishing concessions, Federal agencies must ensure that:
(a) The proposed concession will be established and operated in conformance with applicable policies, safety, health and sanitation codes, laws, regulations,
(b) Sufficient funds are legally available to cover all costs for which the Government may be responsible; and
(c) All contracts will be financially self-supporting and not compete with nearby commercial enterprise.
No, Public Law 104-52, Section 636, prohibits the sale of tobacco products in vending machines in Government-owned and leased space. The Administrator of GSA or the head of an Agency may designate areas not subject to the prohibition, if minors are prohibited and reports are made to the appropriate committees of Congress.
Commercial vendors and nonprofit organizations must operate vending facilities, including cafeterias, under a contractual arrangement with Federal agencies.
With certain exceptions, the Randolph-Sheppard Act (20 U.S.C. 107
Except for cafeterias, Randolph-Sheppard Act vendors must obtain a permit from a Federal agency prior to operating vending facilities. Randolph-Sheppard Act vendors operating a cafeteria must have a contractual agreement with a Federal agency.
In every permit for a vending facility, Federal agencies must describe the vending facility location and indicate:
(a) The name of the applicant State licensing agency;
(b) That the permit is issued for an indefinite period of time subject to suspension or termination on the basis of non-compliance with agreed upon terms;
(c) That the Government will not charge the State licensing agency for normal cleaning, maintenance and repair of the building structure in and immediately adjacent to the vending facility areas;
(d) That the State licensing agency is responsible for the costs associated with properly installing, cleaning, replacing, repairing, maintaining, and removing vending facilities and vending facility equipment;
(e) That blind licensees may sell newspapers, periodicals, publications, confections, tobacco products, foods, beverages, chances for any lottery authorized by State law and conducted by an agency of a State within such State, and other articles or services that the State licensing agency and the Government determine to be suitable for a particular location;
(f) That the blind licensee's articles and services may be dispensed automatically or manually and may be prepared on or off the premises;
(g) That the blind licensee is prohibited from selling tobacco products in vending machines in Government-owned and leased space, unless the Administer of General Services designates areas not subject to the prohibition;
(h) That vending facilities must be operated in compliance with applicable health, sanitation and building codes or ordinances;
(i) That the vendor must not install, modify, relocate, remove, or renovate vending facilities without the prior written approval and supervision of the Federal agency buildings manager and the State licensing agency;
(j) That the State licensing agency must pay for relocations that it initiates;
(k) That the Federal agency must pay for relocations that it initiates; and
(l) That the Federal agency must pay for all plumbing, electrical and mechanical costs related to the renovation of existing facilities.
State licensing agencies must:
(a) Prescribe necessary procedures so that when they select vendors and employees for vending facilities no discrimination occurs because of sex, race, age, creed, color, national origin, physical or mental disability, or political affiliation;
(b) Take the necessary action to assure that vendors do not discriminate against any persons in furnishing, or refusing to furnish, to such person or persons the use of any vending facility, including any and all services, privileges, accommodations, and activities provided thereby; and
(c) Take the necessary action to assure that vendors comply with Title VI of the Civil Rights Act of 1964 and the GSA regulations issued pursuant thereto.
The State licensing agency must attempt to resolve day-to-day problems pertaining to the operation of the vending facility in an informal manner with the participation of the blind vendor and the Federal agency building's manager.
Federal agencies must report in writing any unresolved vendor issues concerning the terms of the permit, the Randolph-Sheppard Act, or the regulations in this part to the State licensing agency supervisory personnel, so that the issues may be formally addressed and resolved.
Federal agencies, upon approval from GSA, must report to the Secretary of Education at the end of each fiscal year:
(a) The total number of applications for vending facility locations received from State licensing agencies;
(b) The number of applications approved;
(c) The number of applications denied;
(d) The number of applications still pending;
(e) The total amount of vending machine income collected; and
(f) The amount of such vending machine income disbursed to the State licensing agency in each State.
Yes, Randolph-Sheppard Act vendors must meet the same contract performance requirements as commercial or nonprofit cafeteria operators.
Conservation programs are programs that improve energy and water efficiency and promote the use of solar and other renewable energy. These programs must promote and maintain an effective source reduction activity (reducing consumption of resources such as energy, water, and paper), resource recovery activity (obtaining materials from the waste stream that can be recycled into new products), and reuse activity (reusing same product before disposition, such as reusing unneeded memos for scratch paper).
Asset services include repairs (other than those minor repairs identified in § 102-74.35(a)), alterations and modernizations for real property assets. Typically, these are the type of repairs and alterations necessary to preserve or enhance the value of the real property asset.
Executive agencies, upon approval from GSA, must provide asset services such as repairs (in addition to those minor repairs identified in § 102-74.35(a)), alterations, and modernizations for real property assets. For repairs and alterations projects for which the estimated cost exceeds the prospectus threshold, Federal agencies must follow the prospectus submission and approval policy identified in this part and part 102-73 of this chapter.
Executive agencies must provide asset services that maintain continuity of Government operations, continue efficient building operations, extend the useful life of buildings and related building systems, and provide a quality workplace environment that enhances employee productivity.
No, a prospectus is not required to be submitted before emergency alterations can be performed. Federal agencies must immediately alter a building if the alteration protects people, buildings, or equipment; saves lives; and/or avoids further property damage. Federal agencies can take these actions in an emergency before GSA submits a prospectus on the alterations to the Committees for Public Works. GSA must submit a prospectus as soon as possible after the emergency.
A project which is to be financed in whole or in part from funds appropriated to the requesting agency may be performed without a prospectus if:
(a) Payment is made from agency appropriations that are not subject to Section 7 of the Public Buildings Act of 1959 (40 U.S.C. 606); and
(b) GSA's portion of the cost, if any, does not exceed the prospectus threshold.
Yes, if requested by a Federal agency, GSA will prepare a prospectus for a reimbursable alteration project.
The Administrator of General Services selects construction and alteration projects to be performed.
The Administrator selects projects based on a continuing investigation and survey of the public building needs of the Federal Government. These projects must be equitably distributed throughout the United States, with due consideration given to each project's comparative urgency.
Federal agencies identifying a need for construction or alteration of a public building must provide information, such as a description of the work, location, estimated maximum cost, and justification to the Administrator of General Services.
The Administrator of General Services must submit prospectuses for public building construction or alteration projects to the congressional committees for public buildings oversight for approval.
Federal agencies must:
(a) Comply with the energy conservation guidelines in 10 CFR part 436 (Federal Energy Management and Planning Programs); and
(b) Observe the energy conservation policies cited in this part.
Federal agencies must ensure that:
(a) Lights and equipment are turned off when not needed;
(b) Ventilation is not blocked or impeded; and
(c) Windows and other building accesses are closed during the heating and cooling seasons.
Federal agencies must ensure that existing Federal facilities meet the energy standards prescribed by the American Society of Heating, Refrigerating, and Air Conditioning Engineers and the Illuminating Engineering Society of North American in ASHRAE/IES Standard 90A-1980, as amended by the Department of Energy. Federal agencies must apply these energy standards where they can be achieved through life cycle, cost effective actions.
Yes, the Federal agency buildings manager may grant exceptions to the foregoing policies in this subpart to enable agencies to accomplish their missions more effectively and efficiently.
Yes, Federal agencies must ensure that all new lease contracts are in conformance with the policies prescribed in this subpart. Federal agencies must administer existing lease contracts in accordance with these policies to the maximum extent feasible.
Except where special circumstances exist, Federal agencies must maintain illumination levels at:
(a) 50 foot-candles at work station surfaces, measured at a height of 30 inches above floor level, during working hours (for visually difficult or critical tasks, additional lighting may be authorized by the Federal agency buildings manager);
(b) 30 foot-candles in work areas during working hours, measured at 30 inches above floor level;
(c) 10 foot-candles, but not less than 1 foot-candle, in non-work areas, to ensure safety during working hours (normally this will require levels of 5 foot-candles at elevator boarding areas, minimum of 1 foot-candle at the middle of corridors and stairwells as measured at the walking surface, 1 foot-candle at the middle of corridors and stairwells as measured at the walking surface, and 10 foot-candles in storage areas); and
(d) Levels essential for safety and security purposes, including exit signs and exterior lights.
Within the limitations of the building systems, Federal agencies must:
(a) Operate heating and cooling systems in the most overall energy efficient and economical manner;
(b) Maintain temperatures to maximize customer satisfaction by conforming to local commercial equivalent temperature levels and operating practices;
(c) Set heating temperatures no higher than 55 degrees Fahrenheit during non-working hours;
(d) Not provide air-conditioning during non-working hours, except as necessary to return space temperatures to a suitable level for the beginning of working hours;
(e) Not permit reheating, humidification and simultaneous heating and cooling; and
(f) Operate building systems as necessary during extreme weather conditions to protect the physical condition of the building.
Federal agencies are prohibited from operating portable heaters, fans, and other such devices in Government-controlled facilities unless authorized by the Federal agency building's manager.
During working hours in periods of heating and cooling, Federal agencies must provide ventilation in accordance with ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality where physically practical. Where not physically practical, Federal agencies must provide the maximum allowable amount of ventilation during periods of heating and cooling and pursue opportunities to increase ventilation up to current standards. ASHRAE Standard 62 is available from ASHRAE Publications Sales, 1791 Tullie Circle NE, Atlanta, GA 30329-2305.
Federal agencies, upon approval of GSA, must report to the DOE the energy consumption in buildings, facilities, vehicles, and equipment within 45 calendar days after the end of each quarter as specified in the DOE Federal Energy Usage Report DOE F 6200.2 Instructions.
In accordance with Executive Order 12191, “Federal Facility Ridesharing Program” (3 CFR, 1980 Comp., p. 138), executive agencies must actively promote the use of ridesharing (carpools, vanpools, privately-leased buses, public transportation, and other multi-occupancy modes of travel) by personnel working at Federal facilities to conserve energy, reduce congestion, improve air quality, and provide an economical way for Federal employees to commute to work.
To promote ridesharing at Federal facilities, agencies must:
(a) Establish an annual ridesharing goal for each facility;
(b) Report to the Administrator of General Services by June 1 of each year the goals established, the means developed to achieve those goals and the progress achieved; and
(c) Cooperate with State and local ridesharing agencies where such agencies exist.
The head of each agency must submit to GSA by June 1 of each year a report that includes:
(a) The name, address, title, and telephone number of the agencywide Employee Transportation Coordinator (ETC);
(b) A narrative on actions taken and barriers encountered in promoting ridesharing within the agency;
(c) Information on any noticeable facility achievements; and
(d) A copy of instructions issued to the agency's facility ETC's for implementing the Federal Facility Ridesharing Program.
Agencies must send their Federal Facility Ridesharing Reports to the Office of Real Property (MP), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Yes, facilities with less than 100 full-time employees or less than 100 full-time employees on the largest shift are not required to submit an annual report. Agencies must not subdivide buildings, groups of buildings or worksites for the purpose of meeting the exception standards.
The Designated Official (as defined in § 102-71.20 of this chapter) is responsible for developing, implementing and maintaining an Occupant Emergency Plan (as defined in § 102-71.20 of this chapter). The Designated Official's responsibilities include establishing, staffing and training an Occupant Emergency Organization with agency employees. Federal agencies, upon approval from GSA, must assist in the establishment and maintenance of such plans and organizations.
Yes, all occupant agencies of a facility must fully cooperate with the Designated Official in the implementation of the emergency plans and the staffing of the emergency organization.
Federal agencies, upon approval from GSA, must:
(a) Provide emergency program policy guidance;
(b) Review plans and organizations annually;
(c) Assist in training of personnel;
(d) Otherwise ensure proper administration of Occupant Emergency Programs (as defined in § 102-71.20 of this chapter);
(e) Solicit the assistance of the lessor in the establishment and implementation of plans in leased space; and
(f) Assist the Occupant Emergency Organization (as defined in § 102-71.20 of this chapter) by providing technical personnel qualified in the operation of utility systems and protective equipment.
The decision to activate the Occupant Emergency Organization must be made by the Designated Official, or by the designated alternate official. After normal duty hours, the senior Federal official present must represent the Designated Official or his/her alternates and must initiate action to cope with emergencies in accordance with the plans.
The Designated Official must make a decision to activate the Occupant Emergency Organization based upon the best available information, including:
(a) An understanding of local tensions;
(b) The sensitivity of target agency(ies);
(c) Previous experience with similar situations;
(d) Advice from the Federal agency building's manager;
(e) Advice from the appropriate Federal law enforcement official; and
(f) Advice from Federal, State, and local law enforcement agencies.
The Designated Official must initiate action to evacuate or relocate occupants in accordance with the plan by sounding the fire alarm system or by other appropriate means when there is immediate danger to persons or property, such as fire, explosion or the discovery of an explosive device (not including a bomb threat).
The Designated Official must initiate appropriate action according to the plan when there is advance notice of an emergency.
Federal agencies, upon approval from GSA, must provide for any necessary regulation and policing of parking facilities, which may include:
(a) The issuance of traffic rules and regulations;
(b) The installation of signs and markings for traffic control. (Signs and markings must conform with the Manual on Uniform Traffic Control Devices published by the Department of Transportation);
(c) The issuance of citations for parking violations; and
(d) The immobilization or removal of illegally parked vehicles.
When the use of parking space is controlled as in § 102-74.265, all privately-owned vehicles other than those authorized to use designated visitor or service areas must display a parking permit. This requirement may be waived in parking facilities where the number of available spaces regularly exceeds the demand for such spaces.
Yes, Federal agencies, upon approval from GSA, may authorize lessors or parking management contractors to manage, regulate and police parking facilities.
Federal agencies must not permit privately-owned vehicles converted for propane carburetion to enter underground parking facilities unless the owner provides to the occupant agency and the Federal agency building's manager the installer's certification that the installation methods and equipment comply with National Fire Protection Association (NFPA) Standard No. 58.
Federal agencies must reserve official parking spaces, in the following order of priority, for:
(a) Official postal vehicles at buildings containing the U.S. Postal Service's mailing operations.
(b) Federally-owned vehicles used to apprehend criminals, fight fires and handle other emergencies.
(c) Private vehicles owned by Members of Congress (but not their staffs).
(d) Private vehicles owned by Federal judges (appointed under Article III of the Constitution), which may be parked in those spaces assigned for the use of the Court, with priority for them set by the Administrative Office of the U.S. Courts.
(e) Other federally-owned and leased vehicles, including those in motor pools or assigned for general use.
(f) Service vehicles, vehicles used in child care center operations and vehicles of patrons and visitors. (Federal agencies must allocate parking for handicapped visitors whenever an agency's mission requires visitor parking.)
(g) Private vehicles owned by employees, using spaces not needed for official business.
Yes, Federal agencies may allow employees to use parking spaces not required for official needs.
The Federal agency buildings manager must determine the total number of spaces available for employee parking. Typically, Federal agencies must make a separate determination for each parking facility. However, in major metropolitan areas, Federal agencies may determine that allocations by zone would make parking more efficient or more equitably available.
The Federal agency buildings manager must allocate space available for employee parking among occupant agencies on an equitable basis, such as by allocating such parking in proportion to each agency's share of building space, office space or total employee population, as appropriate. In certain cases, Federal agencies may allow a third party, such as a board composed of representatives of agencies sharing space, to determine proper parking allocations among the occupant agencies.
Federal agencies must assign available parking spaces to their employees using the following order of priority:
(a) Severely handicapped employees (see definition in § 102-71.20 of this chapter).
(b) Executive personnel and persons who work unusual hours.
(c) Vanpool/carpool vehicles.
(d) Privately-owned vehicles of occupant agency employees that are regularly used for Government business at least 12 days per month and that qualify for reimbursement of mileage and travel expenses under Government travel regulations.
(e) Other privately-owned vehicles of employees, on a space-available basis. (In locations where parking allocations are made on a zonal basis, GSA and affected agencies may cooperate to issue additional rules, as appropriate.)
Federal agencies must take all feasible measures to improve the utilization of parking facilities, including:
(a) The conducting of surveys and studies;
(b) The periodic review of parking space allocations;
(c) The dissemination of parking information to occupant agencies;
(d) The implementation of parking incentives that promote ridesharing;
(e) The use of stack parking practices, where appropriate; and
(f) The employment of parking management contractors and concessionaires, where appropriate.
Pursuant to Executive Order 13058, “Protecting Federal Employees and the Public From Exposure to Tobacco Smoke in the Federal Workplace” (3 CFR, 1997 Comp., p. 216), it is the policy of the executive branch to establish a smoke-free environment for Federal employees and members of the public visiting or using Federal facilities. The smoking of tobacco products is prohibited in all interior space owned, rented or leased by the executive branch of the Federal Government, and in any outdoor areas under executive branch control in front of air intake ducts.
Yes, this smoking policy does not apply in:
(a) Designated smoking areas that are enclosed and exhausted directly to the outside and away from air intake ducts, and are maintained under negative pressure (with respect to surrounding spaces) sufficient to contain tobacco smoke within the designated area. Agency officials must not require workers to enter such areas during business hours while smoking is ongoing;
(b) Any residential accommodation for persons voluntarily or involuntarily residing, on a temporary or long-term basis, in a building owned, leased or rented by the Federal Government;
(c) Portions of federally-owned buildings leased, rented or otherwise provided in their entirety to nonfederal parties;
(d) Places of employment in the private sector or in other non-Federal governmental units that serve as the permanent or intermittent duty station of one or more Federal employees; and
(e) Instances where an agency head establishes limited and narrow exceptions that are necessary to accomplish agency missions. Such exceptions must be in writing, approved by the agency head, and to the fullest extent possible provide protection of nonsmokers from exposure to environmental tobacco smoke. Authority to establish such exceptions may not be delegated.
Agency heads have the responsibility to determine which areas are to be smoking and which areas are to be nonsmoking areas. In exercising this responsibility, agency heads will give appropriate consideration to the views of the employees affected and/or their representatives and are to take into consideration the health issues involved. Nothing in this section precludes an agency from establishing more stringent guidelines. Agencies in multi-tenant buildings are encouraged to work together to identify designated smoking areas.
Agency heads must evaluate the need to restrict smoking at doorways and in courtyards under executive branch control to protect workers and visitors from environmental tobacco smoke, and may restrict smoking in these areas in light of this evaluation.
Agency heads are responsible for monitoring and controlling areas designated for smoking and for ensuring that these areas are identified by proper signs. Suitable uniform signs reading “Designated Smoking Area” must be furnished and installed by the occupant agency.
Federal agency building's managers must furnish and install suitable, uniform signs reading “No Smoking Except in Designated Areas” on or near entrance doors of buildings subject to this section. It is not necessary to display a sign in every room of each building.
This smoking policy applies to the judicial branch when it occupies space in buildings controlled by the executive branch. Furthermore, the Federal Chief Judge in a local jurisdiction may be deemed to be comparable to an agency head and may establish exceptions for Federal jurors and others as indicated in § 102-74.320(e).
Yes, where there is an exclusive representative for the employees, Federal agencies must meet their obligations under the Federal Service Labor-Management Relations Act (5 U.S.C. 7101
To the maximum extent feasible, Federal agencies must manage facilities in accordance with the accident and fire prevention requirements identified in § 102-80.80 of this chapter.
Each occupant agency must:
(a) Participate in at least one fire drill per year;
(b) Maintain a neat and orderly facility to minimize the risk of accidental injuries and fires;
(c) Keep all exits, accesses to exits and accesses to emergency equipment clear at all times;
(d) Not bring hazardous, explosive or combustible materials into buildings unless authorized by appropriate agency officials and by GSA and unless protective arrangements determined necessary by GSA have been provided;
(e) Ensure that all draperies, curtains or other hanging materials are of non-combustible or flame-resistant fabric;
(f) Ensure that freestanding partitions and space dividers are limited combustible, and their fabric coverings are flame resistant;
(g) Cooperate with GSA to develop and maintain fire prevention programs that ensure the maximum safety of the occupants;
(h) Train employees to use protective equipment and educate employees to take appropriate fire safety precautions in their work;
(i) Ensure that facilities are kept in the safest condition practicable, and conduct periodic inspections in accordance with Executive Order 12196 and 29 CFR part 1960;
(j) Immediately report accidents involving personal injury or property damage, which result from building system or maintenance deficiencies, to the Federal agency building's manager; and
(k) Appoint a safety, health and fire protection liaison to represent the occupant agency with GSA.
The rules in this subpart apply to all property under the authority of the General Services Administration and to all persons entering in or on such property. Each occupant agency shall be responsible for the observance of these rules and regulations. Federal agencies must post the notice in the Appendix to this part at each public entrance to each Federal facility.
Federal agencies may, at their discretion, inspect packages, briefcases and other containers in the immediate possession of visitors, employees or other persons arriving on, working at, visiting, or departing from Federal property. Federal agencies may conduct a full search of a person and the vehicle the person is driving or occupying upon his or her arrest.
Federal agencies must:
(a) Close property to the public during other than normal working hours. In those instances where a Federal agency has approved the after-normal-working-hours use of buildings or portions thereof for activities authorized by subpart D of this part, Federal agencies must not close the property (or affected portions thereof) to the public.
(b) Close property to the public during working hours only when situations require this action to ensure the orderly conduct of Government business. The designated official under the Occupant Emergency Program may make such decision only after consultation with the buildings manager and the highest ranking representative of the law enforcement organization responsible for protection of the property or the area. The designated official is defined in § 102-71.20 of this chapter as the highest ranking official of the primary occupant agency, or the alternate highest ranking offical or designee selected by mutual agreement by other occupant agency officials.
(c) Ensure, when property or a portion thereof is closed to the public, that admission to the property, or the affected portion, is restricted to authorized persons who must register upon entry to the property and must, when requested, display Government or other identifying credentials to Federal police officers or other authorized individuals when entering, leaving or while on the property. Failure to comply with any of the applicable provisions is a violation of these regulations.
All persons entering in or on Federal property are prohibited from:
(a) Improperly disposing of rubbish on property;
(b) Willfully destroying or damaging property;
(c) Stealing property;
(d) Creating any hazard on property to persons or things; or
(e) Throwing articles of any kind from or at a building or the climbing upon statues, fountains or any part of the building.
Persons in and on property must at all times comply with official signs of a prohibitory, regulatory or directory nature and with the lawful direction of Federal police officers and other authorized individuals.
All persons entering in or on Federal property are prohibited from loitering, exhibiting disorderly conduct or exhibiting other conduct on property which:
(a) Creates loud or unusual noise or a nuisance;
(b) Unreasonably obstructs the usual use of entrances, foyers, lobbies, corridors, offices, elevators, stairways, or parking lots;
(c) Otherwise impedes or disrupts the performance of official duties by Government employees; or
(d) Prevents the general public from obtaining the administrative services provided on the property in a timely manner.
Except for the vending or exchange of chances by licensed blind operators of vending facilities for any lottery set forth in a State law and authorized by section 2(a)(5) of the Randolph-Sheppard Act (20 U.S.C. 107
(a) Participating in games for money or other personal property;
(b) Operating gambling devices;
(c) Conducting a lottery or pool; or
(d) Selling or purchasing of numbers tickets.
Except in cases where the drug is being used as prescribed for a patient by a licensed physician, all persons entering in or on Federal property are prohibited from:
(a) Being under the influence, using or possessing any narcotic drugs, hallucinogens, marijuana, barbiturates, or amphetamines; or
(b) Operating a motor vehicle on the property while under the influence of alcoholic beverages, narcotic drugs, hallucinogens, marijuana, barbiturates, or amphetamines.
Except where the head of the responsible agency or his or her designee has granted an exemption in writing for the appropriate official use of alcoholic beverages, all persons entering in or on Federal property are prohibited from being under the influence or using alcoholic beverages. The head of the responsible agency or his or her designee must provide a copy of all exemptions granted to the buildings manager and the highest ranking representative of the law enforcement organization, or other authorized officials, responsible for the security of the property.
All persons entering in or on Federal property are prohibited from soliciting commercial or political donations, vending merchandise of all kinds, displaying or distributing commercial advertising, or collecting private debts, except for:
(a) National or local drives for funds for welfare, health or other purposes as authorized by 5 CFR part 950, entitled “Solicitation Of Federal Civilian And Uniformed Service Personnel For Contributions To Private Voluntary Organizations,” and sponsored or approved by the occupant agencies;
(b) Concessions or personal notices posted by employees on authorized bulletin boards;
(c) Solicitation of labor organization membership or dues authorized by occupant agencies under the Civil Service Reform Act of 1978 (Pub. L. 95-454); and
(d) Lessee, or its agents and employees, with respect to space leased for commercial, cultural, educational, or recreational use under the Public Buildings Cooperative Use Act of 1976 (40 U.S.C. 490(a)(16)). Public areas of GSA-controlled property may be used for other activities in accordance with subpart D of this part.
All persons entering in or on Federal property are prohibited from:
(a) Distributing free samples of tobacco products in or around Federal buildings, under Public Law 104-52, Section 636.
(b) Posting or affixing materials, such as pamphlets, handbills, or flyers, on bulletin boards or elsewhere on GSA-controlled property, except as authorized in § 102-74.410, or when these displays are conducted as part of authorized Government activities.
(c) Distributing materials, such as pamphlets, handbills or flyers, unless conducted as part of authorized Government activities. This prohibition does not apply to public areas of the property as defined in § 102-71.20 of this chapter. However, any person or organization proposing to distribute materials in a public area under this section must first obtain a permit from the building's manager as specified in subpart D of this part. Any such person or organization must distribute materials only in accordance with the provisions of subpart D of this part. Failure to comply with those provisions is a violation of these regulations.
Except where security regulations apply or a Federal court order or rule prohibits it, persons entering in or on Federal property may take photographs of:
(a) Space occupied by a tenant agency for non-commercial purposes only with the permission of the occupying agency concerned;
(b) Space occupied by a tenant agency for commercial purposes only with written permission of an authorized official of the occupying agency concerned; and
(c) Building entrances, lobbies, foyers, corridors, or auditoriums for news purposes.
Except seeing eye dogs, other guide dogs and animals used to guide or assist handicapped persons, persons may not bring dogs or other animals on Federal property for other than official purposes.
All vehicle drivers entering or while on Federal property:
(a) Must drive in a careful and safe manner at all times;
(b) Must comply with the signals and directions of Federal police officers or other authorized individuals;
(c) Must comply with all posted traffic signs;
(d) Must comply with any additional posted traffic directives approved by the GSA Regional Administrator, which will have the same force and effect as these regulations;
(e) Are prohibited from blocking entrances, driveways, walks, loading platforms, or fire hydrants; and
(f) Are prohibited from parking on Federal property without a permit. Parking without authority, parking in unauthorized locations or in locations reserved for other persons, or parking contrary to the direction of posted signs is prohibited. Vehicles parked in violation, where warning signs are posted, are subject to removal at the owner's risk and expense. Federal agencies may take as proof that a motor vehicle was parked in violation of these regulations or directives as prima facie evidence that the registered owner was responsible for the violation.
No person entering or while on Federal property may carry or possess explosives, or items intended to be used to fabricate an explosive or incendiary device, either openly or concealed, except for official purposes.
Federal law prohibits the possession of firearms or other dangerous weapons in Federal facilities and Federal court facilities by all persons not specifically authorized by Title 18, United States Code, Section 930. Violators will be subject to fine and/or imprisonment for periods up to five (5) years.
Federal agencies must not discriminate by segregation or otherwise against any person or persons because of race, creed, sex, color, or national origin in furnishing or by refusing to furnish to such person or persons the use of any facility of a public nature, including all services, privileges, accommodations, and activities provided on the property.
A person found guilty of violating any rule or regulation in this subpart while on any property under the charge and control of the U.S. General Services Administration shall be fined under title 18 of the United States Code, imprisoned for not more than 30 days, or both.
No rule or regulation in this subpart may be construed to nullify any other Federal laws or regulations or any State and local laws and regulations applicable to any area in which the property is situated (section 205(c), 63 Stat. 390; 40 U.S.C. 486(c)).
This subpart establishes rules and regulations for the occasional use of public areas of public buildings for cultural, educational and recreational activities as provided by the Public Buildings Cooperative Use Act of 1976 (Pub. L. 94-541).
Yes, any person or organization wishing to use a public area must file an application for a permit from the Federal agency buildings manager.
Applicants must submit the following information:
(a) Their full names, mailing addresses and telephone numbers;
(b) The organization sponsoring the proposed activity;
(c) The individual(s) responsible for supervising the activity;
(d) Documentation showing that the applicant has authority to represent the sponsoring organization; and
(e) A description of the proposed activity, including the dates and times during which it is to be conducted and the number of persons to be involved.
Yes, if an applicant proposes to use a public area to solicit funds, the applicant must certify, in writing, that:
(a) The applicant is a representative of and will be soliciting funds for the sole benefit of a religion or religious group; or
(b) The applicant's organization has received an official ruling of tax-exempt status from the Internal Revenue Service under 26 U.S.C. 501; or, alternatively, that an application for such a ruling is still pending.
Federal agencies must issue permits within 10 working days following the receipt of the completed applications, unless the permit is disapproved in accordance with § 102-74.500.
Yes, a permit may not be issued for a period of time in excess of 30 calendar days, unless specifically approved by the regional officer (as defined in § 102-71.20 of this chapter). After the expiration of a permit, Federal agencies may issue a new permit upon submission of a new application. In such a case, applicants may incorporate by reference all required information filed with the prior application.
Federal agencies will issue permits on a first-come, first-served, basis when more than one permit is requested for the same area and times.
Before approving a permit application, Federal agencies must coordinate with their law enforcement organization if a permit involves demonstrations or activities that may lead to civil disturbances.
Yes, Federal agencies may disapprove any permit application or cancel an issued permit if:
(a) The applicant has failed to submit all information required under § 102-74.470 and § 102-74.475, or has falsified such information;
(b) The proposed use is a commercial activity as defined in § 102-71.20 of this chapter;
(c) The proposed use interferes with access to the public area, disrupts official Government business, interferes with approved uses of the property by tenants or by the public, or damages any property;
(d) The proposed use is intended to influence or impede any pending judicial proceeding;
(e) The proposed use is obscene within the meaning of obscenity as defined in 18 U.S.C. 1461-65; or
(f) The proposed use violates the prohibition against political solicitations in 18 U.S.C. 607.
Upon disapproving an application or canceling a permit, Federal agencies must promptly:
(a) Notify the applicant or permittee of the reasons for the action; and
(b) Inform the applicant or permittee of his/her appeal rights under § 102-74.510.
A person or organization may appeal the disapproval of an application or cancellation of an issued permit by notifying the regional officer (as defined in § 102-71.20 of this chapter), in writing, of the intent to appeal within 5 calendar days of the notification of disapproval or cancellation.
Yes, during the appeal process, the affected person or organization and the Federal agency buildings manager will have an opportunity to state their positions on the issues, both verbally and in writing.
The regional officer must affirm or reverse the GSA building manager's decision, based on the information submitted, within 10 calendar days of the date on which the regional officer received notification of the appeal. If the decision is not rendered within 10 days, the application will be considered to be approved or the permit validly issued. The regional officer will promptly notify the applicant or permittee and the building's manager of the decision and the reasons therefor.
Yes, Federal agencies may reserve certain time periods for use of public areas:
(a) For official Government business; or
(b) For maintenance, repair, and construction.
Permittees may use public areas during or after regular working hours of Federal agencies, provided that such uses will not interfere with Government business. When public areas are used by permittees after normal working hours, Federal agencies must lock, barricade or identify by signs, as appropriate, all adjacent areas not approved for such use to restrict permittees' activities to approved areas.
Federal agencies may provide to permittees at no cost:
(a) Space; and
(b) Services normally provided at the building in question during normal hours of building operation, such as security, cleaning, heating, ventilation, and air-conditioning. The regional officer must approve an applicant's request to provide its own services, such as security and cleaning, prior to permit approval.
Permittees must reimburse Federal agencies for services over and above those normally provided during normal business hours. Federal agencies may provide the services free of charge if the cost is insignificant and if it is in the public's interest.
Permittees must not make alterations to public areas, except with the prior written approval of the Federal agency building's manager. Federal agencies must not approve such alterations unless the Federal agency determines that the proposed alterations to a building should be made to encourage and aid in the proposed use. Permittees making alterations must ensure the safety of users and prevent damage to property.
Permittees are responsible for furnishing items such as tickets, audio-visual equipment, and other items, which are necessary for the proposed use.
Permittees are subject to all rules and regulations governing conduct on Federal property as set forth in subpart C of this part. In addition, a permittee must:
(a) Not misrepresent his or her identity to the public;
(b) Not conduct any activities in a misleading or fraudulent manner;
(c) Not discriminate on the basis of race, creed, color, disability, sex or national origin in conducting activities;
(d) Not distribute any item, nor post or otherwise affix any item, for which prior written approval under § 102-74.415 has not been obtained;
(e) Not leave leaflets or other materials unattended on the property;
(f) Not engage in activities that would interfere with the preferences afforded blind licensees under the Randolph-Sheppard Act (20 U.S.C. 107); and
(g) Display identification badges while on Federal property, if engaging in the solicitation of funds as authorized by § 102-74.475. Each badge must indicate the permittee's name, address, telephone number, and organization.
Yes, Federal agencies reserve the right to advise the public through signs or announcements of the presence of any permittees and of their non-affiliation with the Federal Government.
In accordance with 40 U.S.C. 490(i), Federal agencies must comply with the real property policies in this subpart governing the installation, repair and replacement of sidewalks around buildings, installations, properties, or grounds under the control of executive agencies and owned by the United States.
No, the Federal Government must fund the cost of installing, repairing, and replacing sidewalks. Funds appropriated to the agency for installation, repair, and maintenance, generally, must be available for expenditure to accomplish the purposes of this subpart.
Upon approval from GSA, Federal agencies may:
(a) Authorize the appropriate State or local government to install, repair and replace sidewalks, or arrange for this work, and reimburse them for this work; or
(b) Contract or otherwise arrange and pay directly for installing, repairing and/or replacing sidewalks.
Federal agencies, giving due consideration to State and local standards and specifications for sidewalks, decide when to install, repair or replace a sidewalk. However, Federal agencies may prescribe other standards and specifications for sidewalks whenever necessary to achieve architectural harmony and maintain facility security.
Applicability (41 CFR 102-74.365). The rules in this subpart apply to all property under the authority of the General Services Adminstration and to all persons entering in or on such property. Each occupant agency shall be responsible for the observance of these rules and regulations. Federal agencies must post the notice in the Appendix to part 102-74 at each public entrance to each Federal facility.
Inspection (41 CFR 102-74.370). Federal agencies may, at their discretion, inspect packages, briefcases and other containers in the immediate possession of visitors, employees or other persons arriving on, working at, visiting, or departing from Federal property. Federal agencies may conduct a full search of a person and the vehicle the person is driving or occupying upon his or her arrest.
Admission to Property (41 CFR 102-74.375). Federal agencies must:
(a) Close property to the public during other than normal working hours. In those instances where a Federal agency has approved the after-normal-working-hours use of buildings or portions thereof for activities authorized by subpart D of this part, Federal agencies must not close the property (or affected portions thereof) to the public.
(b) Close property to the public during working hours only when situations require this action to ensure the orderly conduct of Government business. The designated official under the Occupant Emergency Program may make such decision only after consultation with the buildings manager and the highest ranking representative of the law enforcement organization responsible for protection of the property or the area. The designated official is defined in § 102-71.20 of this chapter as the highest ranking official of the primary occupant agency, or the alternate highest ranking offical or designee selected by mutual agreement by other occupant agency officials.
(c) Ensure, when property or a portion thereof is closed to the public, that admission to the property, or the affected portion, is restricted to authorized persons who must register upon entry to the property and must, when requested, display Government or other identifying credentials to Federal police officers or other authorized individuals when entering, leaving or while on the property. Failure to comply with any of the applicable provisions is a violation of these regulations.
Preservation of Property (41 CFR 102-74.380). All persons entering in or on Federal property are prohibited from:
(a) Improperly disposing of rubbish on property;
(b) Willfully destroying or damaging property;
(c) Stealing property;
(d) Creating any hazard on property to persons or things;
(e) Throwing articles of any kind from or at a building or the climbing upon statues, fountains or any part of the building.
Conformity with Signs and Directions (41 CFR 102-74.385). Persons in and on property must at all times comply with official signs of a prohibitory, regulatory or directory nature and with the lawful direction of Federal police officers and other authorized individuals.
Disturbances (41 CFR 102-74.390). All persons entering in or on Federal property are prohibited from loitering, exhibiting disorderly conduct or exhibiting other conduct on property which:
(a) Creates loud or unusual noise or a nuisance;
(b) Unreasonably obstructs the usual use of entrances, foyers, lobbies, corridors, offices, elevators, stairways, or parking lots;
(c) Otherwise impedes or disrupts the performance of official duties by Government employees; or
(d) Prevents the general public from obtaining the administrative services provided on the property in a timely manner.
Gambling (41 CFR 102-74.395). Except for the vending or exchange of chances by licensed blind operators of vending facilities for any lottery set forth in a State law and authorized by section 2(a)(5) of the Randolph-Sheppard Act (20 U.S.C. 107
(a) Participating in games for money or other personal property;
(b) Operating gambling devices;
(c) Conducting a lottery or pool; or
(d) Selling or purchasing of numbers tickets.
Narcotics and Other Drugs (41 CFR 102-74.400). Except in cases where the drug is being used as prescribed for a patient by a licensed physician, all persons entering in or on Federal property are prohibited from:
(a) Being under the influence, using or possessing any narcotic drugs, hallucinogens, marijuana, barbiturates, or amphetamines; or
(b) Operating a motor vehicle on the property while under the influence of alcoholic beverages, narcotic drugs, hallucinogens, marijuana, barbiturates, or amphetamines.
Alcoholic Beverages (41 CFR 102-74.405). Except where the head of the responsible agency or his or her designee has granted an exemption in writing for the appropriate official use of alcoholic beverages, all persons entering in or on Federal property are prohibited from being under the influence or using alcoholic beverages. The head of the responsible agency or his or her designee must provide a copy of all exemptions granted to the buildings manager and the highest ranking representative of the law enforcement organization, or other authorized officials, responsible for the security of the property.
Soliciting, Vending and Debt Collection (41 CFR 102-74.410). All persons entering in or on Federal property are prohibited from soliciting commercial or political donations; vending merchandise of all kinds; displaying or distributing commercial advertising, or collecting private debts, except for:
(a) National or local drives for funds for welfare, health or other purposes as authorized by 5 CFR part 950, entitled “Solicitation of Federal Civilian And Uniformed Service Personnel For Contributions To Private Voluntary Organizations,” and sponsored or approved by the occupant agencies;
(b) Concessions or personal notices posted by employees on authorized bulletin boards;
(c) Solicitation of labor organization membership or dues authorized by occupant agencies under the Civil Service Reform Act of 1978 (Public Law 95-454); and
(d) Lessee, or its agents and employees, with respect to space leased for commercial, cultural, educational, or recreational use under the Public Buildings Cooperative Use Act of 1976 (40 U.S.C. 490(a)(16)). Public areas of GSA-controlled property may be used for other activities in accordance with subpart D of this part.
Posting and Distributing Materials (41 CFR 102-74.415). All persons entering in or on Federal property are prohibited from:
(a) Distributing free samples of tobacco products in or around Federal buildings, under Public Law 104-52, Section 636.
(b) Posting or affixing materials, such as pamphlets, handbills, or flyers, on bulletin boards or elsewhere on GSA-controlled property, except as authorized in § 102-74.410, or when these displays are conducted as part of authorized Government activities.
(c) Distributing materials, such as pamphlets, handbills, or flyers, unless conducted as part of authorized Government activities. This prohibition does not apply to public areas of the property as defined in § 102-71.20 of this chapter. However, any person or organization proposing to distribute materials in a public area under this section must first obtain a permit from the building manager as specified in subpart D of this part. Any such person or organization must distribute materials only in accordance with the provisions of subpart D of this part. Failure to comply with those provisions is a violation of these regulations.
Photographs for News, Advertising, or Commercial Purposes (41 CFR 102-74.420). Except where security regulations apply or a Federal court order or rule prohibits it, persons entering in or on Federal property may take photographs of:
(a) Space occupied by a tenant agency for non-commercial purposes only with the permission of the occupying agency concerned;
(b) Space occupied by a tenant agency for commercial purposes only with written permission of an authorized official of the occupying agency concerned; and
(c) Building entrances, lobbies, foyers, corridors, or auditoriums for news purposes.
Dogs and Other Animals (41 CFR 102-74.425). Except seeing eye dogs, other guide dogs and animals used to guide or assist handicapped persons, persons may not bring dogs or other animals on Federal property for other than official purposes.
Vehicular and Pedestrian Traffic (41 CFR 102-74.430). All vehicle drivers entering or while on Federal property:
(a) Must drive in a careful and safe manner at all times;
(b) Must comply with the signals and directions of Federal police officers or other authorized individuals;
(c) Must comply with all posted traffic signs;
(d) Must comply with any additional posted traffic directives approved by the GSA Regional Administrator, which will have the same force and effect as these regulations;
(e) Are prohibited from blocking entrances, driveways, walks, loading platforms, or fire hydrants; and
(f) Are prohibited from parking on Federal property without a permit. Parking without authority, parking in unauthorized locations or in locations reserved for other persons, or parking contrary to the direction of posted signs is prohibited. Vehicles parked in violation, where warning signs are posted, are subject to removal at the owner's risk and expense. Federal agencies may take as proof that a motor vehicle was parked in violation of these regulations or directives as prima facie evidence that the registered owner was responsible for the violation.
Explosives (41 CFR 102-74.435). No person entering or while on property may carry or possess explosives, or items intended to be used to fabricate an explosive or incendiary device, either openly or concealed, except for official purposes.
Weapons (41 CFR 102-74.440) Federal law prohibits the possession of firearms or other dangerous weapons in Federal facilities and Federal court facilities by all persons not specifically authorized by Title 18, United States Code, Section 930. Violators will be subject to fine and/or imprisonment for periods up to five (5) years.
Nondiscrimination (41 CFR 102-74.445). Federal agencies must not discriminate by segregation or otherwise against any person or persons because of race, creed, sex, color, or national origin in furnishing or by refusing to furnish to such person or persons the use of any facility of a public nature, including all services, privileges, accommodations, and activities provided on the property.
Penalties (41 CFR 102-74.450). A person found guilty of violating any rule or regulation in subpart C of this part while on any property under the charge and control of the U.S. General Services Administration shall be fined under title 18 of the United States Code, imprisoned for not more than 30 days, or both.
Impact on Other Laws or Regulations (41 CFR 102-74.455). No rule or regulation in this subpart may be construed to nullify any other Federal laws or regulations or any State and local laws and regulations applicable to any area in which the property is situated (section 205(c), 63 U.S. Statutes, 390; 40 U.S.C. 486(c)).
Federal law prohibits the possession of firearms or other dangerous weapons in
10. Part 102-75 is revised to read as follows:
40 U.S.C. 486(c), 483(a), and 484; E.O. 12512, 50 FR 18453, 3 CFR, 1985 Comp., p. 340.
The real property policies contained in this part apply to Federal agencies, including the General Services Administration (GSA)/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services. Federal agencies with authority to dispose of real property under the Federal Property and Administrative Services Act of 1949, as amended, will be referred to as “disposal agencies” in this part. Except in rare instances where GSA delegates disposal authority to a Federal agency, the “disposal agency” as used in this part refers to GSA.
Disposal agencies must provide, in a timely, efficient, and cost effective manner, the full range of real estate services necessary to support their real property utilization and disposal needs. Landholding agencies must survey the real property under their custody or control to identify property that is not utilized, underutilized, or not being put to optimum use. Disposal agencies must have adequate procedures in place to promote the effective utilization and disposal of such real property.
Disposal agencies must provide real property disposal services for real property assets under their custody and control, such as the utilization of excess property, surveys, and the disposal of
Federal agencies with independent disposal authority are encouraged to obtain utilization, disposal, and related services from those agencies with expertise in real property disposal, such as GSA, as allowed by 31 U.S.C. 1535 (the Economy Act), so that they can remain focused on their core mission.
Landholding agencies' responsibilities concerning the utilization of excess property are to:
(a) Achieve maximum use of their real property, in terms of economy and efficiency, to minimize expenditures for the purchase of real property;
(b) Increase the identification and reporting of their excess real property; and
(c) Fulfill its needs for real property, so far as practicable, by utilization of real property determined excess by other agencies, pursuant to the provision of this part, before it purchases nonfederal real property.
Disposal agencies' responsibilities concerning the utilization of excess property are to:
(a) Provide for the transfer of excess real property among Federal agencies, to mixed-ownership Government corporations, and to the municipal government of the District of Columbia; and
(b) Resolve conflicting requests for transferring real property that the involved agencies cannot resolve.
In accordance with Executive Order 12512, the Administrator of General Services is responsible for providing Governmentwide policy, oversight, and guidance for Federal real property management. The Administrator of General Services must issue standards, procedures, and guidelines for surveying the real property holdings of executive agencies on a continuing basis to identify properties which are not utilized, are underutilized, or are not being put to optimum use. In addition, the Administrator must develop survey reports describing any property or portion thereof which, in his or her judgment, is not utilized, is underutilized, or is not being put to optimum use, and which should be reported as excess property. These provisions are presently limited to fee-owned properties and supporting leaseholds and lesser interests located within the States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa, Guam, the Trust Territory of the Pacific Islands, and the Virgin Islands.
Each executive agency must identify unneeded Federal property using the following standards:
(a) Not utilized.
(b) Underutilized.
(c) Not being put to optimum use.
(1) Irregularly or intermittently by the accountable executive agency for current program purposes of that agency; or
(2) For current program purposes that can be satisfied with only a portion of the property.
(1) Even though used for current program purposes, the nature, value, or location of the property is such that it could be utilized for a different and significantly higher and better purpose; or
(2) The costs of occupying are substantially higher than other suitable properties that could be made available through transfer, purchase, or lease with total net savings to the Government, after considering property values, costs of moving, occupancy, operational efficiency, environmental effects, regional planning, and employee morale.
A landholding agency's responsibilities concerning real property utilization surveys are to:
(a) Survey real property under its control (
(b) Maintain its inventory of real property at the absolute minimum consistent with economical and efficient conduct of the affairs of the agency; and
(c) Promptly report to GSA real property that it has determined to be excess.
It is important that each executive agency notify the disposal agency of its real property needs in order to determine whether the excess or surplus property of another agency is available which would meet its need and prevent the unnecessary purchase or lease of real property.
Yes, executive agencies are not required to notify the disposal agency when an agency's proposed acquisition of real property is dictated by such factors as exact geographical location, topography, engineering, or similar characteristics which limit the possible use of other available property. For example, executive agencies are not required to notify disposal agencies concerning the acquisition of real property for a dam site, reservoir area, or the construction of a generating plant or a substation, since specific lands are needed, which limit the possible use of other available property. Therefore, no
In every case of a proposed transfer of excess real property, the most important consideration is the validity and appropriateness of the requirement upon which the proposal is based. Also, a proposed transfer must not establish a new program which has never been reflected in any previous budget submission or congressional action. Additionally, a proposed transfer must not substantially increase the level of an agency's existing programs beyond that which has been contemplated in the President's budget or by the Congress.
Before requesting a transfer of excess real property, an executive agency must:
(a) Screen its own property holdings to determine whether the new requirement can be met through improved utilization of existing real property; however, the utilization must be for purposes that are consistent with the highest and best use of the property under consideration;
(b) Review all real property under its accountability which it has been permitted or outleased and terminate the permit or lease for any property, or portion thereof, suitable for the proposed need if termination is not prohibited by the terms of the permit or lease.
(c) Utilize property that is or can be made available under § 102-75.80(a) or (b) for the proposed need in lieu of requesting a transfer of excess real property and reassign the property, when appropriate;
(d) Ensure that the appraised fair market value of the excess real property proposed for transfer will not substantially exceed the probable purchase price of other real property which would be suitable for the intended purpose;
(e) Limit the size and quantity of excess real property to be transferred to the actual requirements and separate, if possible, other portions of the excess installation for possible disposal to other agencies or to the public; and
(f) Consider the design, layout, geographic location, age, state of repair, and expected maintenance costs of excess real property proposed for transfer; agencies must be able to demonstrate that the transfer will be more economical over a sustained period of time than the acquisition of a new facility specifically planned for the purpose.
Yes, but only on a temporary basis with the condition that the property will be released for further Federal utilization or disposal as surplus property at an agreed upon time when the transfer is arranged.
GSA may temporarily assign or direct the use of such excess real property to the requesting agency. See § 102-75.240.
Yes, GSA can authorize the use of excess real property for an approved program. See § 102-75.240.
An agency holding unneeded land withdrawn or reserved from the public domain must submit to the appropriate GSA regional office a Report of Excess Real Property (Standard Form 118), with appropriate Schedules A, B, and C, only when:
(a) It has filed a notice of intention to relinquish with the Department of the Interior (43 CFR part 2372,
(b) The Department of the Interior has notified the agency that the Secretary of the Interior has determined that the lands are not suitable for return to the public domain for disposition under the general public land laws because the lands are substantially changed in character by improvements or otherwise; and
(c) The Department of the Interior provides a report identifying whether or not any other agency claims primary, joint, or secondary jurisdiction over the lands and whether its records show that the lands are encumbered by rights or privileges under the public land laws.
In such cases, the Department of the Interior must:
(a) Notify the appropriate GSA regional office of such a determination; and
(b) Authorize the landholding agency to identify in the Standard Form 118 any minerals in the land that the Department of the Interior determines to be unsuitable for disposition under the public land mining and mineral leasing laws.
Transfers of real property must be made only under the authority of the Federal Property and Administrative Services Act of 1949, unless the Administrator of General Services determines in each case that the transfer provisions of any such other law are consistent with the authority conferred by this Act. The provisions of this section shall not apply to transfers of real property authorized to be made by section 602(d) of the Act or by any special statute which directs or requires an executive agency to transfer or convey specifically described real property in accordance with the provisions of that statute.
Yes, landholding agencies must prepare reports of excess real property and related personal property on:
(a) Standard Form (SF) 118, Report of Excess Real Property, and accompanying Standard Form 118a, Buildings Structures, Utilities, and Miscellaneous Facilities, Schedule A;
(b) Standard Form 118b, Land, Schedule B; and
(c) Standard Form 118c, Related Personal Property, Schedule C.
Yes, in all cases where Government-owned land is reported excess, executive agencies must include a title report, prepared by a qualified employee of the landholding agency, documenting the Government's title to the property.
When completing the title report, agencies must include:
(a) The description of the property;
(b) The date title vested in the United States;
(c) All exceptions, reservations, conditions, and restrictions, relating to the title;
(d) Detailed information concerning any action, thing, or circumstance that occurred from the date the United States acquired the property to the date of the report which in any way affected or may have affected the United States' right, title, and interest in and to the real property (including copies of legal comments or opinions discussing the manner in which and the extent to which such right, title, or interest may have been affected). In the absence of any such action, thing, or circumstance, a statement to that effect must be made a part of the report;
(e) The status of civil and criminal jurisdiction over the land that is peculiar to the property by reason of it being Government-owned land. In the absence of any special circumstances, a statement to that effect must be made a part of the report;
(f) Detailed information regarding any known flood hazards or flooding of the property, and, if the property is located in a flood-plain or on wetlands, a listing of restricted uses (along with the citations) identified in Federal, State, or local regulations as required by Executive Orders 11988 and 11990 of May 24, 1977;
(g) The specific identification and description of fixtures and related personal property that have possible historic or artistic value;
(h) The historical significance of the property and whether the property is listed, is eligible for, or has been nominated for listing in the National Register of Historic Places or is in proximity to a property on the National Register. If the landholding agency is aware of any effort by the public to have the property listed on the National Register, it must also include this information;
(i) A description of the type, location, and condition of asbestos incorporated in the construction, repair, or alteration of any building or improvement on the property (
(j) A statement indicating whether or not, during the time the property was owned by the United States, any hazardous substance activity, as defined by regulations issued by the Environmental Protection Agency at 40 CFR part 373, took place on the property. Hazardous substance activity includes situations where any hazardous substance was stored for one year or more, known to have been released, or disposed of on the property. Agencies reporting such property shall review the regulations issued by the Environmental Protection Agency at 40 CFR part 373 for details on the information required.
If hazardous substance activity took place on the property, the reporting agency must include information on the type and quantity of such hazardous substance and the time at which such storage, release, or disposal took place. The reporting agency must also advise the disposal agency if all remedial action necessary to protect human health and the environment with respect to any such hazardous substance activity was taken before the date the property was reported excess. If such action was not taken, the reporting agency must advise the disposal agency when such action will be completed or how the agency expects to comply with CERCLA in the disposal. See §§ 102-75.340 and 102-75.345.
If no hazardous substance activity took place, the reporting agency must include the following statement:
The (reporting agency) has determined, in accordance with regulations issued by the Environmental Protection Agency at 40 CFR part 373, that there is no evidence indicating that hazardous substance activity took place on the property during the time the property was owned by the United States.
Executive agencies must provide:
(a) A legible, reproducible copy of all instruments in possession of the agency which affect the United State's right, title, or interest in the property reported or the use and operation of such property (including agreements covering and licenses to use, any patents, processes, techniques, or inventions). If it is impracticable to transmit the abstracts of title and related title evidence, agencies must provide the name and address of the custodian of such documents in the title report referred to in § 102-75.120;
(b) Any appraisal reports indicating or providing the fair market value or the fair annual rental of the property if requested by the disposal agency; and
(c) A certification by a responsible person that the property does or does not contain polychlorinated biphenyl (PCB) transformers or other equipment regulated by the Environmental Protection Agency (EPA) under 40 CFR part 761 if requested by the disposal agency. If the property does contain any equipment subject to EPA regulation under 40 CFR part 761, the certification must include the landholding agency's assurance that each piece of equipment is now and will continue to be in compliance with the EPA regulations until disposal of the property.
Yes, GSA must review each report of excess to ascertain whether the report was prepared according to the provisions of this part. GSA must notify the landholding agency, in writing, whether the report is acceptable or other information is needed within 15 calendar days after receipt of the report.
When GSA determines that a report is adequate, GSA will accept the report and inform the landholding agency of the acceptance date. However, the landholding agency must, upon request, promptly furnish any additional information or documents relating to the property required by GSA to accomplish a transfer or a disposal.
Where GSA determines that a report is insufficient, GSA will return the report and inform the landholding agency of the facts and circumstances that make the report insufficient. The landholding agency must promptly take appropriate action to submit an acceptable report to GSA. If the landholding agency is unable to submit an acceptable report, the property will be removed from under the provisions of §§ 102-75.940 and 102-75.965. However, GSA may accept the report of excess on a conditional basis and identify what deficiencies in the report must be corrected in order for the report to gain full acceptance.
Prefabricated movable structures such as Butler-type storage warehouses, quonset huts, and housetrailers (with or without undercarriages) reported to GSA along with the land on which they are located may, at GSA's discretion, be designated for disposition as personal property for off-site use or as real property for disposal with the land.
Related personal property may, at the disposal agency's discretion, be designated as personal property for disposal purposes. In making this designation for items having possible historic or artistic value, the disposal agency must ensure that Federal agencies, including the Smithsonian Institution (see § 102-36.60 of this chapter), are afforded the opportunity of obtaining them through personal property channels for off-site use for preservation and display off-site. Fixtures such as murals and fixed sculpture that have exceptional historical or artistic value may be designated for disposition by severance for off-site use. In making such designations, consideration must be given to such factors as whether the fixtures can be removed without seriously affecting the value of the realty and whether a ready disposition can be made of the severed fixtures.
When a structure is to be demolished, any fixtures or related personal property therein may, at the disposal agency's discretion, be designated for disposition as personal property where a ready disposition can be made of these items. As indicated in § 102-75.165, particular consideration should be given to designating items having possible historical or artistic value as personal property.
Before property can be transferred among Federal agencies, to mixed-ownership Government corporations, and to the municipal government of the District of Columbia, GSA must determine that:
(a) The transfer is in the best interest of the Government;
(b) The requesting agency is the appropriate agency to hold the property; and
(c) The proposed land use will maximize use of the real property, in terms of economy and efficiency, to minimize expenditures for the purchase of real property.
Landholding agencies may, without notifying GSA, transfer excess real property that they use, occupy, or control under a lease, permit, license, easement, or similar instrument when—
(a) The lease or other instrument is subject to termination by the grantor or owner of the premises within nine months;
(b) The remaining term of the lease or other instrument, including renewal rights, will provide for less than nine months of use and occupancy; or
(c) The lease or other instrument provides for use and occupancy of space for office, storage, and related facilities, which does not exceed a total of 2,500 square feet.
In those instances, landholding agencies must transfer property following the policies in this subpart.
The transferee agency must pay an amount equal to the property's fair market value (determined by the Administrator);
(a) Where the transferor agency has requested the net proceeds of the transfer pursuant to section 204(c) of the Act; or
(b) Where either the transferor or transferee agency (or organizational unit affected) is subject to the Government Corporation Control Act (31 U.S.C. 841) or is a mixed-ownership Government corporation, or the municipal government of the District of Columbia.
As may be agreed upon by GSA and the corporation, the transferee agency must pay an amount equal to—
(a) The estimated fair market value of the property; or
(b) The corporation's book value of the property.
Where the transfer is for the purpose of upgrading facilities (
Transfers may be made without reimbursement by the transferee agency only if—
(a) Congress has specifically authorized the transfer without reimbursement, or
(b) The Administrator, with the approval of the Director of the Office of Management and Budget (OMB), has approved a request for an exception from the 100 percent reimbursement requirement.
The request must include an explanation of how granting the exception would further essential agency program objectives and at the same time be consistent with Executive Order 12512, Federal Real Property Management, dated April 29, 1985. The transferee agency must attach the explanation to the Request for Transfer of Excess Real and Related Personal Property (GSA Form 1334) prior to submitting the form to GSA. The
Agency heads must endorse requests for exceptions to the 100 percent reimbursement requirement.
Agencies must submit all requests for exception from the 100 percent reimbursement requirement to the appropriate GSA regional property disposal office.
The Administrator must review all requests for exception from the 100 percent reimbursement requirement. If the Administrator approves the request, it is then submitted to OMB for final concurrence. If OMB approves the request, then GSA may complete the transfer.
The agency requesting the property will assume responsibility for protection and maintenance costs where the disposal of the property is deferred for more than 30 days from the date OMB receives the request for an exception to the 100 percent reimbursement requirement. If the request is denied, the requesting agency may pay the fair market value for the property or withdraw its request. If the request is withdrawn, responsibility for protection and maintenance cost will return to the landholding agency at that time.
Yes, disposal agencies may transfer excess property to the Senate, the House of Representatives, and the Architect of the Capitol and any activities under his or her direction, pursuant to the provisions of section 602(e) of the Federal Property and Administrative Services Act of 1949. The amount of reimbursement for such transfer must be the same as would be required for a transfer of excess property to an executive agency under similar circumstances.
Yes, whenever GSA determines that it is more advantageous to assign property temporarily rather than permanently, it may do so. If the space is for office, storage, or related facilities, GSA will determine the length of the assignment/reassignment. Agencies are required to reimburse the landholding agency (or GSA, if GSA has become responsible for seeking an appropriation for protection and maintenance expenses) (see § 102-75.970) for protection and maintenance expenses. GSA may also temporarily assign/reassign excess real property for uses other than storage, office or related facilities. In such cases, the agency receiving the temporary assignment may be required to pay a rental or users charge based upon the fair market value of the property, as determined by GSA. If the property will be required by the agency for a period of more than 1 year, it may be transferred on a conditional basis, with an understanding that the property will be reported excess at an agreed upon time (
Landholding agencies, upon approval from GSA, may grant rights for nonfederal interim use of excess property reported to GSA, when it is determined that such excess property is not required for the needs of any Federal agency and when the interim use will not impair the ability to dispose of the property.
Disposal agencies must dispose of surplus real property:
(a) In the most economical manner consistent with the best interests of the Government; and
(b) Ordinarily for cash, consistent with the best interests of the Government.
Disposal agencies must obtain from GSA a determination that there is no further Federal need or requirement for their excess real property and this property is surplus to the needs of the Federal Government. After receiving this determination, disposal agencies, upon approval from GSA, must expeditiously make the surplus property available for acquisition by State and local governmental units and nonprofit institutions (see § 102-75.350) or for sale by public advertising, negotiation, or other disposal action. Disposal agencies must consider the availability of real property for public purposes on a case-by-case basis, based on highest and best use and estimated fair market value. Where hazardous substance activity is identified,
Disposal agencies may dispose of surplus real property by exchange for privately owned property for property management considerations such as boundary realignment or for providing access. Disposal agencies may also dispose of surplus real property by exchange for privately owned property where authorized by law, when the requesting Federal agency receives approval from the Office of Management and Budget and the appropriate oversight committees and where the transaction offers substantial economic or unique program advantages not otherwise obtainable by any other acquisition method.
Yes, conveyance documents must identify all agreements and representations concerning restrictions and conditions affecting the property's future use, maintenance, or transfer.
Yes, antitrust laws must be considered in any case in which there is contemplated a disposal to any private interest of:
(a) Real and related personal property which has an estimated fair market value of $3 million or more; or
(b) Patents, processes, techniques, or inventions, irrespective of cost.
The Attorney General determines whether the proposed disposal would
The disposal agency must promptly provide the Attorney General with notice of any such proposed disposal and the probable terms or conditions, as required by section 207 of the Federal Property and Administrative Services Act of 1949. If notice is given by any disposal agency other than GSA, a copy of the notice must also be provided simultaneously to the GSA regional office in which the property is located. Upon request, a disposal agency must furnish information that the Attorney General believes to be necessary in determining whether the proposed disposition or any other disposition of surplus real property violates or would violate any of the antitrust laws.
No, advice from the Attorney General must be received before disposing of real property.
Except for disposals specifically authorized by special legislation, disposals of real property must be made only under the authority of the Federal Property and Administrative Services Act of 1949. However, the Administrator of General Services can evaluate, on a case-by-case basis, the disposal provisions of any other law to determine consistency with the authority conferred by the Act. The provisions of this section do not apply to disposals of real property authorized to be made by section 602(d) of the Act or by any special statute which directs or requires an executive agency named in the law to transfer or convey specifically described real property in accordance with the provisions of that statute.
The disposal agency:
(a) May extend credit in connection with any disposal of surplus property when it determines that credit terms are necessary to avoid reducing the salability of the property and potential obtainable price;
(b) Must administer and manage the credit disposal and any related security;
(c) May enforce, adjust, or settle any right of the Government with respect to extending credit in a manner and with terms that are in the best interests of the Government; and
(d) Must include provisions in the conveyance documents that obligate the purchaser, where a sale is made upon credit, to obtain the disposal agency's prior written approval before reselling or leasing the property. The disposal agency must ensure that the purchaser's credit obligations to the United States are fulfilled before approving the resale of the property.
Generally, yes, appraisals are required for all real property disposal transactions, except when:
(a) An appraisal will serve no useful purpose (
(b) The estimated fair market value of property to be offered on a competitive sale basis does not exceed $300,000.
For all real property transactions requiring appraisals, agencies must obtain, as appropriate, an appraisal of either the fair market value or the fair annual rental value of the property available for disposal.
Agencies must use only experienced and qualified real estate appraisers familiar with the types of property to be appraised when conducting the appraisal. When an appraisal is required for negotiation purposes, the same standard applies. However, agencies may authorize other methods of obtaining an estimate of the fair market value or the fair annual rental when the cost of obtaining that data from a contract appraiser would be out of proportion to the expected recoverable value of the property.
Yes, appraisers are authorized to consider the effect of historic covenants on the fair market value, if the property is on or eligible for the National Register of Historic Places.
Yes, appraisals, appraisal reports, appraisal analyses, and other pre-decisional appraisal documents are confidential and can only be used by authorized Government personnel who can substantiate the need to know this information. Appraisal information must not be divulged prior to the delivery and acceptance of the deed. Any persons engaged to collect or evaluate appraisal information must certify that:
(a) They have no direct or indirect interest in the property; and
(b) The report was prepared and submitted without bias or influence.
Landholding agencies should provide all persons interested in the acquiring available surplus property with the opportunity to make a complete inspection of the property, including any available inventory records, plans, specifications, and engineering reports that relate to the property. These inspections are subject to any necessary national security restrictions and are subject to the disposal agency's rules. (See §§ 102-75.335 and 102-75.985.)
All offers to purchase or lease must be in writing, accompanied by any required earnest money deposit, using the form prescribed by the disposal agency. In addition to the financial terms upon which the offer is predicated, the offer must set forth the willingness of the offeror to abide by the terms, conditions, reservations, and restrictions upon which the property is offered, and must contain such other information as the disposal agency may request.
Where the existence of asbestos on the property has been brought to the attention of the disposal agency by the Report of Excess Real Property (Standard Form 118) information provided (see § 102-75.125), the disposal agency must incorporate this information (less any cost or time estimates to remove the asbestos-containing materials) into any offer to purchase and conveyance document and include the following wording:
(a) The Purchaser is warned that the property offered for sale contains asbestos-containing materials. Unprotected or unregulated exposures to asbestos in product manufacturing, shipyard, and building construction workplaces have been associated with asbestos-related diseases. Both the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) regulate asbestos because of the potential hazards associated with exposure to airborne asbestos fibers. Both OSHA and EPA have determined that such exposure increases the risk of asbestos-related diseases, which include certain cancers and which can result in disability or death.
(b) Bidders (Offerors) are invited, urged and cautioned to inspect the property to be sold prior to submitting a bid (offer). More particularly, bidders (offerors) are invited, urged and cautioned to inspect the property as to its asbestos content and condition and any hazardous or environmental conditions relating thereto. The disposal agency will assist bidders (offerors) in obtaining any authorization(s) which may be required in order to carry out any such inspection(s). Bidders (Offerors) shall be deemed to have relied solely on their own judgment in assessing the overall condition of all or any portion of the property including, without limitation, any asbestos hazards or concerns.
(c) No warranties either express or implied are given with regard to the condition of the property including, without limitation, whether the property does or does not contain asbestos or is or is not safe for a particular purpose. The failure of any bidder (offeror) to inspect, or to be fully informed as to the condition of all or any portion of the property offered, will not constitute grounds for any claim or demand for adjustment or withdrawal of a bid or offer after its opening or tender.
(d) The description of the property set forth in the Invitation for Bids (Offer to Purchase) and any other information provided therein with respect to said property is based on the best information available to the disposal agency and is believed to be correct, but an error or omission, including but not limited to the omission of any information available to the agency having custody over the property and/or any other Federal agency, shall not constitute grounds or reason for nonperformance of the contract of sale, or any claim by the Purchaser against the Government including, without limitation, any claim for allowance, refund, or deduction from the purchase price.
(e) The Government assumes no liability for damages for personal injury, illness, disability or death, to the Purchaser, or to the Purchaser's successors, assigns, employees, invitees, or any other person subject to Purchaser's control or direction, or to any other person, including members of the general public, arising from or incident to the purchase, transportation, removal, handling, use, disposition, or other activity causing or leading to contact of any kind whatsoever with asbestos on the property which is the subject of this sale, whether the Purchaser, its successors or assigns has or have properly warned or failed properly to warn the individual(s) injured.
(f) The Purchaser further agrees that in its use and occupancy of the property it will comply with all Federal, State, and local laws relating to asbestos.
Where the existence of hazardous substance activity has been brought to the attention of the disposal agency by the Report of Excess Real Property (Standard Form 118) information provided (
(a) Notice of all hazardous substance activity identified as a result of a complete search of agency records by the landholding agency;
(b) A statement, certified by a responsible landholding agency official in the report of excess, that all remedial actions necessary to protect human health and the environment with regard to such hazardous substance activity have been taken (this is not required in the offer to purchase or conveyance document in the case of a transfer of property under the authority of section 120(h)(3)(C) of CERCLA, or the Early Transfer Authority);
(c) A commitment, on behalf of the United States, to return to correct any hazardous condition discovered after the conveyance that results from hazardous substance activity prior to the date of conveyance; and
(d) A reservation by the United States of a right of access in order to accomplish any further remedial actions required in the future.
In the case where the purchaser or grantee is a potentially responsible party (PRP) with respect to hazardous substance activity on the property under consideration, the United States is no longer under a general obligation to certify that the property has been successfully remediated, or to commit to return to the property to address contamination that is discovered in the future. Therefore, the statements of responsibility and commitments on behalf of the United States referenced in § 102-75.340 should not be used. Instead, language should be included in the offer to purchase and conveyance document that is consistent with any agreement that has been reached between the landholding agency and the PRP with regard to prior hazardous substance activity.
Based on a highest and best use analysis, disposal agencies may make surplus real property available to State and local governments and certain nonprofit institutions at up to 100 percent public benefit discount for public benefit purposes. Some examples of such purposes are education, health, park and recreation, the homeless, historic monuments, public airports, highways, correctional facilities, ports, and wildlife conservation. The implementing regulations for these conveyances are found in this subpart.
Executive agencies must include in the offer to purchase and conveyance documents the non-discrimination clause in § 102-75.360 for public benefit conveyances.
The wording of the non-discrimination clause must be as follows:
The Grantee covenants for itself, its heirs, successors, and assigns and every successor in interest to the property hereby conveyed, or any part thereof, that the said Grantee and such heirs, successors, and assigns shall not discriminate upon the basis of race, color, religion, or national origin in the use, occupancy, sale, or lease of the property, or in their employment practices conducted thereon. This covenant shall not apply, however, to the lease or rental of a room or rooms within a family dwelling unit; nor shall it apply with respect to religion to premises used primarily for religious purposes. The United States of America shall be deemed a beneficiary of this covenant without regard to whether it remains the owner of any land or interest therein in the locality of the property hereby conveyed and shall have the sole right to enforce this covenant in any court of competent jurisdiction.
Yes, disposal agencies must notify State entities and Government agencies of the availability of a surplus power transmission line and right-of-way.
Yes, section 13(d) of the Surplus Property Act of 1944 (50 U.S.C. App. 1622(d)), and section 602(a) of the Federal Property and Administrative Services Act of 1949, allows any State or political subdivision, or any State or Government agency or instrumentality to certify to the disposal agency that a surplus power transmission line and the right-of-way acquired for its construction is needed to meet the requirements of a public or cooperative power project.
Generally, once a State or political subdivision certifies that it needs a surplus power transmission line and the right-of-way, the disposal agency may sell the property to the state, or political subdivision thereof, at the fair market value. However, if a sale of a surplus transmission line cannot be accomplished because of the price to be charged, or other reasons, and the certification by the State or political subdivision is not withdrawn, the disposal agency must report the facts involved to the Administrator of General Services, to determine what further action will or should be taken to dispose of the property.
Yes, power transmission lines and rights-of-way not disposed of by sale for fair market value may be disposed of following other applicable provisions of this part, including, if appropriate, reclassification by the disposal agency.
Yes, the disposal agency must notify eligible public agencies that property currently used as or suitable for use as a public airport under the Surplus Property Act of 1944, as amended, has been determined to be surplus. A copy of the landholding agency's Report of Excess Real Property (Standard Form 118, with accompanying schedules) must be transmitted with the copy of the surplus property notice sent to the appropriate regional office of the FAA. The FAA must furnish an application form and instructions for the preparation of an application to eligible public agencies upon request.
Yes, section 13(g) of the Surplus Property Act of 1944 (49 U.S.C. 47151) authorizes the disposal agency to convey or dispose of surplus airport property to a State, political sub-division, municipality, or tax-supported institution for use as a public airport.
For the purposes of this part, surplus airport property is any surplus real property including improvements and personal property included as a part of the operating unit that the Administrator of the Federal Aviation Administration (FAA) deems is:
(a) Essential, suitable, or desirable for the development, improvement, operation, or maintenance of a public airport, as defined in the Federal Airport Act, as amended (49 U.S.C. 1101); or
(b) Reasonably necessary to fulfill the immediate and foreseeable future requirements of the grantee for the development, improvement, operation, or maintenance of a public airport, including property needed to develop sources of revenue from non-aviation businesses at a public airport. Approval for non-aviation revenue-producing areas shall be given only for such areas as are anticipated to generate net proceeds which do not exceed expected deficits for operation of the aviation area applied for at the airport.
No, if the Administrator of General Services determines that a property's highest and best use is industrial, then the property must be classified as such for disposal without regard to the public benefit conveyance provisions of this subpart.
As soon as possible after receiving the copy of the surplus notice, the Federal Aviation Administration must inform the disposal agency of its determination. Then, the FAA must provide assistance to any eligible public agency known to have a need for the property for a public airport so that the public agency may develop a comprehensive and coordinated plan of use and procurement for the property.
After an eligible public agency submits a plan of use and application, the disposal agency must transmit two copies of the plan and two copies of the application to the appropriate FAA regional office. The FAA must promptly submit a recommendation to the disposal agency for disposal of the property for a public airport or must inform the disposal agency that no such recommendation will be submitted.
The head of the disposal agency, or his or her designee, may convey property approved by the FAA for use as a public airport to the eligible public agency, subject to the provisions of the Surplus Property Act of 1944, as amended.
Any airport property that the FAA does not recommend for disposal as a public airport must be disposed of in accordance with other applicable provisions of this part. However, the disposal agency must first notify the landholding agency of its inability to dispose of the property for use as a public airport. In addition, the disposal agency must allow the landholding agency 30 days to withdraw the property from surplus or to waive any future interest in the property for public airport use.
The FAA Administrator has the sole responsibility for enforcing compliance with the terms and conditions of disposals. The FAA is also responsible for the reforming, correcting, or amending of any disposal instrument; granting releases; and any action necessary for recapturing the property, using the provisions of the Act of October 1, 1949, 63 Stat. 700, and section 1402(c) of the Federal Aviation Act of 1958, 72 Stat. 807 (50 U.S.C. App. 1622a-1622c).
If property that was conveyed for use as a public airport is revested in the United States for noncompliance with the terms of the disposal, or other cause, the Administrator of the FAA must be accountable for the property and must report the property to GSA as excess property following the provisions of this part.
No, the Airport and Airway Development Act of 1970 (49 U.S.C. sec. 47151 through sec. 47153) (Airport Act of 1970) does not apply to the transfer of airports to State and local agencies. The transfer of airports to State and local agencies may be made only under section 13(g) of the Surplus Property Act of 1944 which is continued (in effect) by the Act. Only property which the landholding agency determines cannot be reported excess to GSA for disposal under the Act, but nevertheless may be made available for use by a State or local public body as a public airport without being inconsistent with the Federal program of the landholding agency, may be conveyed under the Airport Act of 1970. In the latter instance, this act may be used to transfer non-excess land for airport development purposes providing it does not constitute an entire airport. An entire, existing and established airport can only be disposed of to a State or eligible local government under section 13(g) of the Surplus Property Act of 1944.
Disposal agencies must notify State and areawide clearinghouses and eligible public agencies that property which may be conveyed for use as a historic monument has been determined to be surplus. A copy of the landholding agency's Report of Excess Real Property (Standard Form 118) with accompanying schedules must be transmitted with the copy of each notice that is sent to the appropriate regional or field offices of the National Park Service (NPS) of the Department of the Interior.
A disposal agency may convey surplus real and related personal property for use as a historic monument, without monetary consideration, to any State, political subdivision, instrumentality thereof, or municipality, for the benefit of the public provided the Secretary of the Interior has determined that the property is suitable and desirable for such use.
Only property conforming with the recommendation of the Advisory Board on National Parks, Historic Sites, Buildings, and Monuments shall be determined to be suitable or desirable for use as a historic monument.
The disposal agency may authorize the use of historic monuments conveyed under section 203(k)(3) of the Act or the Surplus Property Act of 1944, as amended, for revenue-producing activities if the Secretary of the Interior:
(a) Determines that the activities, described in the applicant's proposed program of use, are compatible with the use of the property for historic monument purposes;
(b) Approves the grantee's plan for repair, rehabilitation, restoration, and maintenance of the property;
(c) Approves the grantee's plan for financing the repair, rehabilitation, restoration, and maintenance of the property. The Department of the Interior must not approve the plan unless it provides that all income in excess of costs of repair, rehabilitation, restoration, maintenance and a specified reasonable profit or payment that may accrue to a lessor, sublessor, or developer in connection with the management, operation, or development of the property for revenue producing activities, is used by the grantee, lessor, sublessor, or developer, only for public historic preservation, park, or recreational purposes; and
(d) Examines and approves the grantee's accounting and financial procedures for recording and reporting on revenue-producing activities.
Upon request, the disposal agency must furnish eligible public agencies with adequate preliminary property information and, with the landholding agency's cooperation, provide assistance to enable public agencies to obtain adequate property information.
Eligible public agencies must submit the original and two copies of the completed application to acquire real property for use as a historic monument to the appropriate regional or field offices of the National Park Service (NPS) of the Department of the Interior (DOI), which will forward one copy of the application to the appropriate regional office of the disposal agency.
The National Park Service must promptly:
(a) Submit the Secretary of the Interior's determination to the disposal agency; or
(b) Inform the disposal agency that no such recommendation will be submitted.
The head of the disposal agency or his or her designee may convey to an eligible public agency surplus property determined by the Secretary of the Interior to be suitable and desirable for use as a historic monument for the benefit of the public and for compatible revenue-producing activities subject to the provisions of section 203(k)(3) of the Act.
The Secretary of the Interior has the responsibility for enforcing compliance with the terms and conditions of such a disposal. DOI is also responsible for reforming, correcting, or amending any disposal instrument; granting releases; and any action necessary for recapturing the property using the provisions of section 203(k)(4) of the Act. The actions are subject to the approval of the head of the disposal agency.
In such a case, the DOI must notify the appropriate GSA Public Buildings Service regional office immediately by letter when title to the historic property is to be revested in the United States for noncompliance with the terms and conditions of disposal or for other cause. The notification must cite the legal and administrative actions that the DOI must take to obtain full title and possession of the property. In addition, it must include an adequate description of the property, including any improvements constructed since the original conveyance to the grantee. After receiving a statement from the DOI that title to the property is proposed for revesting, GSA will review the statement and determine if title should be revested. If GSA, in consultation with the Department of Interior, determines that the property should be revested, DOI must submit a Report of Excess Real Property (SF 118) to GSA. GSA will review and act upon the SF 118, if acceptable. However, the grantee must provide protection and maintenance of the property until the title reverts to the Federal Government, including the period of the notice of intent to revert. Such protection and maintenance must, at a minimum, conform to the standards prescribed in the GSA Customer Guide to Real Property Disposal.
The disposal agency must notify eligible public agencies that surplus property is available for educational and/or public health purposes. The notice must require that any plans for an educational or public health use, resulting from the development of the comprehensive and coordinated plan of use and procurement for the property, must be coordinated with ED or HHS, as appropriate. The notice must also let eligible public agencies know where to obtain the applications, instructions for preparing them, and where to submit the application. The requirement for educational or public health use of the property by an eligible public agency is contingent upon the disposal agency's approval, under § 102-75.515, of a recommendation for assignment of Federal surplus real property received from ED or HHS. Further, any subsequent transfer is subject to the approval of the head of the disposal agency as stipulated under section 203(k)(1) (A) or (B) of the Act and referenced in § 102-75.535.
Yes, ED or HHS may notify eligible nonprofit institutions that such property has been determined to be surplus. Notices to eligible nonprofit institutions must require eligible nonprofit institutions to coordinate any request for educational or public health use of the property with the appropriate public agency responsible for developing and submitting a comprehensive and coordinated plan of use and procurement for the property.
The head of the disposal agency or his designee may:
(a) Assign to the Secretary of the Department of Education (ED) for disposal under section 203(k)(1) of the Act surplus real property, including buildings, fixtures, and equipment, as recommended by the Secretary as being needed for school, classroom, or other educational use; or
(b) Assign to the Secretary of Health and Human Services (HHS) for disposal under section 203(k)(1) of the Act such surplus real property, including buildings, fixtures, and equipment situated thereon, as recommended by the Secretary as being needed for use in the protection of public health, including research.
Yes, eligible nonprofit organizations will only receive surplus real property for an educational or public health use if the disposal agency approves or grants the assignment request from either ED or HHS. The disposal agency will also consider other uses for available surplus real property, taking into account the highest and best use determination. Any subsequent transfer is subject to the approval of the head of the disposal agency as stipulated under section 203(k)(1)(A) or (B) of the Act and referenced in this part.
The ED and HHS must notify the disposal agency if it has an eligible applicant interested in acquiring the property within 30 calendar days after the date of the surplus notice. Then, after the 30-day period expires, ED or HHS has 30 calendar days to review and approve an application and request assignment of the property, or inform the disposal agency that no assignment request will be forthcoming.
When an eligible public agency submits a plan of use for property for an educational or public health requirement, the disposal agency must transmit two copies of the plan to the regional office of ED or HHS, as appropriate. The ED or HHS must submit to the disposal agency, within 30 calendar days after the date the plan is transmitted, a recommendation for assignment of the property to the Secretary of ED or HHS, or must inform the disposal agency, within the 30-calendar day period, that a recommendation will not be made for assignment of the property to ED or HHS, as appropriate. If, after
Any assignment recommendation that the Department of Education or the Department of Health and Human Services submits to the disposal agency must provide complete information concerning the educational or public health use, including:
(a) Identification of the property;
(b) The name of the applicant and the size and nature of its program;
(c) The specific use planned;
(d) The intended public benefit allowance;
(e) The estimate of the value upon which such proposed allowance is based; and
(f) An explanation if the acreage or value of the property exceeds the standards established by the Secretary.
Landholding agencies must cooperate to the fullest extent possible with representatives of ED or HHS in their inspection of such property and in furnishing information relating to the property.
In the absence of an approved application from ED or HHS to convey the property for educational or public health purposes, which must be received within the 30 calendar day time limit, the disposal agency will proceed with other disposal actions.
After receiving the disposal agency's assignment letter, ED or HHS must furnish the disposal agency with a Notice of Proposed Transfer within 30 calendar days. If the disposal agency approves the proposed transfer within 30 days of receiving the Notice of Proposed Transfer, ED or HHS may prepare the transfer documents and proceed with the transfer. The Department of Education or the Department of Health and Human Services must take all necessary actions to accomplish the transfer within 15-calendar days beginning when the disposal agency approves the transfer. The ED or HHS must furnish the disposal agency two conformed copies of deeds, leases or other instruments conveying the property under section 203(k)(1) (A) or (B) of the Act and all related documents containing restrictions or conditions regulating the future use, maintenance or transfer of the property.
The ED or HHS, as appropriate, is responsible for enforcing compliance with the terms and conditions of transfer. The ED or HHS is also responsible for reforming, correcting, or amending any transfer instruments; granting releases; and for taking any necessary actions for recapturing the property using or following the provisions of section 203(k)(4) of the Act. These actions are subject to the approval of the head of the disposal agency. The ED or HHS must notify the disposal agency of its intent to take any actions to recapture the property. The notice must identify the property affected, describe in detail the proposed action, and state the reasons for the proposed action.
In each case of repossession under a terminated lease or reversion of title for noncompliance with the terms or conditions of sale or other cause, ED or HHS must, prior to repossession or reversion of title, provide the appropriate GSA regional property disposal office with an accurate description of the real and related personal property involved using SF 118, Report of Excess Real Property, and the appropriate schedules. After receiving a statement from ED or HHS that the property is proposed for revesting, GSA will review the statement and determine if title should be revested. If GSA, in conjunction with the ED or HHS, determines that the property should be revested, ED or HHS must submit a SF 118 to GSA. The GSA will review and act upon the SF 118, if acceptable. However, the grantee must provide protection and maintenance for the property until the title reverts to the Federal Government, including the period of any notice of intent to revert. Such protection and maintenance must, at a minimum, conform to the standards prescribed in the GSA Customer Guide to Real Property Disposal.
Property for self-help housing or housing assistance (which is separate from the program under Title V of the McKinney-Vento Homeless Assistance Act covered in subpart H of this part) is property for low-income housing opportunities through the construction, rehabilitation, or refurbishment of housing, under terms that require that:
(a) Any individual or family receiving housing or housing assistance must contribute a significant amount of labor toward the construction, rehabilitation, or refurbishment; and
(b) Dwellings constructed, rehabilitated, or refurbished must be quality dwellings that comply with local building and safety codes and standards and must be available at prices below prevailing market prices.
The head of the disposal agency, or designee, may assign, at his/her discretion, surplus real property, including buildings, fixtures, and equipment to the Secretary of the Department of Housing and Urban Development (HUD).
The disposal agency must notify eligible public agencies that surplus property is available. The notice must require that any plans for self-help housing or housing assistance use resulting from the development of the comprehensive and coordinated plan of use and procurement for the property must be coordinated with HUD. Eligible public agencies may obtain an application form and instructions for preparing and submitting the application from HUD.
Yes, the requirement for self-help housing or housing assistance use of the property by an eligible public agency or nonprofit organization is contingent upon the disposal agency's approval under § 102-75.585 of HUD's assignment recommendation/request. Any subsequent transfer is subject to the approval of the head of the disposal agency as stipulated under section 203(k)(6)(B) of the Act and referenced in § 102-75.605.
If the recommendation is not approved, the disposal agency must also notify the Secretary of HUD and then may proceed with other disposal action.
The HUD notifies eligible nonprofit organizations, following guidance in the GSA Customer Guide to Real Property Disposal. Such notices must require eligible nonprofit organizations to:
(a) Coordinate any requirement for self-help housing or housing assistance use of the property with the appropriate public agency; and
(b) Declare to the disposal agency an intent to develop and submit a comprehensive and coordinated plan of use and procurement for the property.
The HUD must notify the disposal agency within 30 calendar days after the date of the surplus notice. Then, after the 30-day period expires, HUD has 30 calendar days to review and approve an application and request assignment or inform the disposal agency that no assignment request is forthcoming.
When an eligible public agency submits a plan of use for property for a self-help housing or housing assistance requirement, the disposal agency must transmit two copies of the plan to the appropriate HUD regional office. The HUD must submit to the disposal agency, within 30 calendar days after the date the plan is transmitted, a recommendation for assignment of the property to the Secretary of HUD, or must inform the disposal agency, within the 30-calendar day period, that a recommendation will not be made for assignment of the property to HUD. If, after considering other uses for the property, the disposal agency approves the assignment recommendation from HUD, it must assign the property by letter or other document to the Secretary of HUD. The disposal agency must furnish to the landholding agency a copy of the assignment, unless the landholding agency is also the disposal agency. If the disposal agency disapproves the recommendation, the disposal agency must likewise notify the Secretary of HUD.
Any assignment recommendation that HUD submits to the disposal agency must set forth complete information concerning the self-help housing or housing assistance use, including:
(a) Identification of the property;
(b) Name of the applicant and the size and nature of its program;
(c) Specific use planned;
(d) Intended public benefit allowance;
(e) Estimate of the value upon which such proposed allowance is based; and
(f) An explanation, if the acreage or value of the property exceeds the standards established by the Secretary.
Landholding agencies must cooperate to the fullest extent possible with HUD representatives in their inspection of such property and in furnishing information relating to such property.
In the absence of an approved application from HUD for self-help housing or housing assistance use, which must be received within the 30-calendar day time limit specified therein, the disposal agency must proceed with other disposal action.
After receiving the disposal agency's assignment letter, HUD must furnish the disposal agency with a Notice of Proposed Transfer within 30 calendar days. If the disposal agency approves the proposed transfer within 30 calendar days of receiving the Notice of Proposed Transfer, HUD may prepare the transfer documents and proceed with the transfer. The Department of Housing and Urban Development must take all necessary actions to accomplish the transfer within 15 calendar days beginning when the disposal agency approves the transfer. The HUD must furnish the disposal agency two conformed copies of deeds, leases or other instruments conveying the property under section 203(k)(6) of the Act and all related documents containing restrictions or conditions regulating the future use, maintenance or transfer of the property.
The HUD is responsible for enforcing compliance with the terms and conditions of transfer. The HUD is also responsible for reforming, correcting, or amending any transfer instrument; granting releases; and for taking any necessary actions for recapturing the property using the provisions of section 203(k)(4) of the Act. These actions are subject to the approval of the head of the disposal agency. The HUD must notify the head of the disposal agency of its intent to take action to recapture the property. The notice must identify the property affected, describe in detail the proposed action, and state the reasons for the proposed action.
The HUD maintains responsibility for properties previously conveyed under section 414(a) of the 1969 HUD Act. Property transferred to an entity other than a public body and used for any purpose other than that for which it was sold or leased within a 30-year period must revert to the United States. If the property was leased, then the lease terminates. The appropriate Secretary (HUD or Department of Agriculture) and the Administrator (GSA) can approve the new use of the property after the first 20 years of the original 30-year period has expired.
In each case of repossession under a terminated lease or reversion of title for noncompliance with the terms or
The head of the disposal agency or his or her designee is authorized to assign to the Secretary of the Interior for disposal under section 203(k)(2) of the Act, surplus real property, including buildings, fixtures, and equipment as recommended by the Secretary as being needed for use as a public park or recreation area for conveyance to a State, political subdivision, instrumentalities, or municipality.
The disposal agency must notify established State, regional, or metropolitan clearinghouses and eligible public agencies that surplus property is available for use as a public park or recreation area. The disposal agency must transmit the landholding agency's Report of Excess Real Property (SF 118, with accompanying schedules) with the copy of each notice sent to a regional or field office of the National Park Service (NPS) of the Department of the Interior.
Upon request, DOI must furnish eligible public agencies with an application form to acquire property for permanent use as a public park or recreation area and preparation instructions for the application.
The DOI must notify the disposal agency if it has an eligible applicant interested in acquiring the property within 30 calendar days from the date of the surplus notice.
Landholding agencies must cooperate to the fullest extent possible with DOI representatives in their inspection of the property and in furnishing information relating to the property.
Within 30 calendar days after the expiration of the 30-calendar day period specified in § 102-75.640, DOI must submit to the disposal agency an assignment recommendation along with a copy of the application or inform the disposal agency that a recommendation will not be made for assignment of the property.
Any recommendation submitted by DOI must provide complete information concerning the plans for use of the property as a public park or recreation area, including:
(a) Identification of the property;
(b) The name of the applicant;
(c) The specific use planned; and
(d) The intended public benefit allowance.
If DOI does not approve any applications or does not submit an assignment recommendation to convey the property for public park or recreation purposes, the disposal agency must proceed with other disposal action.
If, after considering other uses for the property, the disposal agency approves the assignment recommendation from DOI, it must assign the property by letter or other document to the Secretary of the Interior. The disposal agency must furnish to the landholding agency a copy of the assignment, unless the landholding agency is also the disposal agency. If the recommendation is disapproved, the disposal agency must likewise notify the Secretary.
After receiving the disposal agency's assignment letter, the Secretary of the Interior must provide the disposal agency with a Notice of Proposed Transfer within 30 calendar days. If the disposal agency approves the proposed transfer within 30 calendar days, the Secretary may proceed with the transfer. The DOI must take all necessary actions to accomplish the transfer within 15 calendar days after the expiration of the 30-calendar day period provided for the disposal agency to consider the notice. The DOI may place the applicant in possession of the property as soon as practicable in order to minimize the Government's expense of protection and maintenance of the property. As of the date the applicant takes possession of the property, or the date it is conveyed, whichever occurs first, the applicant must assume responsibility for care and handling and all risks of loss or damage to the property, and has all obligations and liabilities of ownership. The DOI must furnish the disposal agency two conformed copies of deeds, leases, or other instruments conveying property under section 203(k)(2) of the Act and related documents containing reservations, restrictions, or conditions regulating the future use, maintenance or transfer of the property.
Where appropriate, the disposal agency may make the assignment subject to DOI requiring the grantee or recipient to bear the cost of any out-of-pocket expenses necessary to accomplish the transfer, such as for surveys, fencing, security of the remaining property or otherwise.
The deed of conveyance of any surplus real property transferred for public park and recreation purposes under the Act must require that the property be used and maintained for the purpose for which it was conveyed in
The Secretary of the Interior is responsible for enforcing compliance with the terms and conditions of transfer. The Secretary is also responsible for reforming, correcting, or amending any transfer instrument; granting releases; and for recapturing any property following the provisions of section 202(k)(4) of the Act. These actions are subject to the approval of the head of the disposal agency. The DOI must notify the head of the disposal agency of its intent to take or recapture the property. The notice must identify the property affected, describe in detail the proposed action, including the reasons for the proposed action.
The DOI must notify the appropriate GSA regional office immediately by letter when title to property transferred for use as a public park or recreation area is to be revested in the United States for noncompliance with the terms or conditions of disposal or for other cause. The notification must cite the legal and administrative actions that the Department must take to obtain full title and possession of the property. In addition, it must include an adequate description of the property, using the SF 118 and the appropriate schedules. After receiving notice from DOI that title to the property is proposed for revesting, GSA will review the statement and determine if title should be revested. If GSA, in consultation with DOI, determines that the property should be revested, DOI must submit a SF 118 to GSA. The GSA will review and act upon the SF 118, if acceptable. However, the grantee must provide protection and maintenance for the property until the title reverts to the Federal Government, including the period of any notice of intent to revert. Such protection and maintenance must, at a minimum, conform to the standards prescribed in the GSA Customer Guide to Real Property Disposal.
Section 218 of the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, authorizes the disposal agency to transfer surplus real property to a State agency to provide replacement housing under title II of the Act for persons who are or will be displaced by Federal or federally assisted projects.
After receiving the surplus notice, any Federal agency needing property for replacement housing for displaced persons may solicit applications from eligible State agencies.
Federal agencies must notify the disposal agency within 30 calendar days after the date of the surplus notice if an eligible State agency is interested in acquiring the property under section 218 of the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970.
Both landholding and disposal agencies must cooperate, to the fullest extent possible, with Federal and State agency representatives in their inspection of the property and in furnishing information relating to the property.
Federal agencies must advise the disposal agency and request transfer of the property to the selected State agency within 30 calendar days after the expiration of the 30-calendar-day period specified in § 102-75.705.
Any request submitted by a Federal agency must be in the form of a letter addressed to the appropriate GSA Public Buildings Service regional property disposal office.
Any transfer request must include:
(a) Identification of the property by name, location, and control number;
(b) The name and address of the specific State agency and a copy of the State agency's application or proposal;
(c) A certification by the appropriate Federal agency official that the property is required to house displaced persons authorized by section 218; that all other options authorized under title II of the Act have been explored and replacement housing cannot be found or made available through those channels; and that the Federal or federally assisted project cannot be accomplished unless the property is made available for replacement housing;
(d) Any special terms and conditions that the Federal agency deems necessary to include in conveyance instruments to ensure that the property is used for the intended purpose;
(e) The name and proposed location of the Federal or federally assisted project which is creating the requirement;
(f) Purpose of the project;
(g) Citation of enabling legislation or authorization for the project, when appropriate;
(h) A detailed outline of steps taken to obtain replacement housing for displaced persons as authorized under title II of the Act; and
(i) Details of the arrangements that have been made to construct replacement housing on the surplus property and to ensure that displaced persons will be provided housing in the development.
If the disposal agency does not receive a request for assignment or transfer of the property under § 102-75.715, then the disposal agency must proceed with other appropriate disposal actions.
If, after considering other uses for the property, the disposal agency
Yes, the State agency is required to bear the costs of any out-of-pocket expenses necessary to accomplish the transfer, such as costs of surveys, fencing, or security of the remaining property.
If the request is not approved, the disposal agency must notify the Federal agency requesting the transfer. The disposal agency must furnish a copy of the notice of disapproval to the landholding agency.
Under section 203(p)(1) of the Act, the head of the disposal agency or designee may, in his or her discretion, convey, without monetary consideration, to any State, or to those governmental bodies named in the Act, or to any political subdivision or instrumentality, surplus real and related personal property for:
(a) Correctional facility purposes, if the Attorney General has determined that the property is required for such purposes and has approved an appropriate program or project for the care or rehabilitation of criminal offenders;
(b) Law enforcement purposes, if the Attorney General has determined that the property is required for such purposes; and
(c) Emergency management response purposes, including fire and rescue services, if the Director of the Federal Emergency Management Agency has determined that the property is required for such purposes.
The disposal agency must provide prompt notification to the Office of Justice Programs (OJP), Department of Justice (DOJ), and the Federal Emergency Management Agency (FEMA) that surplus property is available. The disposal agency's notice or notification must include a copy of the landholding agency's Report of Excess Real Property (SF 118), with accompanying schedules.
The OJP or FEMA must send notices of availability to the appropriate State and local public agencies. The notices must state that OJP or FEMA, as appropriate, must coordinate and approve any planning involved in developing a comprehensive and coordinated plan of use and procurement for the property for correctional facility, law enforcement, or emergency management response use. The notice must also state that public agencies may obtain application forms and preparation instructions from OJP or FEMA.
The OJP defines “law enforcement” as “any activity involving the control or reduction of crime and juvenile delinquency, or enforcement of the criminal law, including investigative activities such as laboratory functions as well as training.”
Yes, the disposal agency must approve a determination, under § 102-75.795, by DOJ that identifies surplus property required for correctional facility use or for law enforcement use before an eligible public agency can obtain such property for correctional facility or law enforcement use.
Yes, the disposal agency must approve a determination, under § 102-75.795, by FEMA that identifies surplus property required for emergency management response use before an eligible public agency can obtain such property for emergency management response use.
The OJP or FEMA must notify the disposal agency within 30 calendar days after the date of the surplus notice if there is an eligible applicant interested in acquiring the property. After that 30-calendar day period expires, OJP or FEMA then has another 30 days to review and approve an appropriate program and notify the disposal agency of the need for the property. If no application is approved, then OJP or FEMA must notify the disposal agency that there is no requirement for the property within the 30-calendar day period allotted for review and approval.
Any determination that DOJ or FEMA submits to the disposal agency must provide complete information concerning the correctional facility, law enforcement, or emergency management response use, including:
(a) Identification of the property;
(b) Certification that the property is required for correctional facility, law enforcement, or emergency management response use;
(c) A copy of the approved application which defines the proposed plan of use; and
(d) The environmental impact of the proposed correctional facility, law enforcement, or emergency management response use.
Both landholding and disposal agencies must cooperate to the fullest extent possible with Federal and State agency representatives in their inspection of such property and in furnishing information relating to the property.
If, after considering other uses for the property, the disposal agency approves the assignment request by DOJ or FEMA, the disposal agency must convey the property to the appropriate grantee. The disposal agency must proceed with other disposal action if it does not approve the assignment request, if DOJ or FEMA does not submit an assignment request, or if the disposal agency does not receive the determination within the 30 calendar days specified in § 102-75.780. The disposal agency must notify OJP or FEMA 15 days prior to any announcement of a determination to either approve or disapprove an application for correctional, law enforcement, or emergency management response purposes and must furnish to OJP or FEMA a copy of the conveyance documents.
The deed of conveyance of any surplus real property transferred under the provisions of section 203(p)(1) of the Act must provide that all property be used and maintained for the purpose for which it was conveyed in perpetuity. If the property ceases to be used or maintained for that purpose, all or any portion of the property must, at the option of the United States, revert to the United States in its existing condition. The deed of conveyance may contain additional terms, reservations, restrictions, and conditions the Administrator of General Services determines to be necessary to safeguard the United States' interests.
The Administrator of General Services is responsible for enforcing compliance with the terms and conditions of disposals. The GSA is also responsible for reforming, correcting, or amending any disposal instrument; granting releases; and any action necessary for recapturing the property following the provisions of section 203(p)(3) of the Act.
Upon discovery of any information indicating a change in use, OJP or FEMA must:
(a) Notify GSA; and
(b) Upon request, make a redetermination of continued appropriateness of the use of a transferred property.
The OJP or FEMA must, prior to the repossession, provide the appropriate GSA regional property disposal office with an accurate description of the real and related personal property involved. The OJP or FEMA must use the SF 118, Report of Excess Real Property, and the appropriate schedules for this purpose. After receiving a statement from OJP or FEMA that the title to the property is proposed for revesting, GSA will review the statement and determine if title should be revested. If GSA, in consultation with OJP or FEMA, determines that the property should be revested, OJP or FEMA must submit a SF 118 to GSA. The GSA will review and act upon the SF 118, if applicable. However, the grantee must provide protection and maintenance for the property until the title reverts to the Federal Government, including the period following any notice of intent to revert. Such protection and maintenance must, at a minimum, conform to the standards prescribed in the GSA Customer Guide to Real Property Disposal.
Under section 203(q)(1) of the Act, the Administrator of General Services, the Secretary of the Department of Defense (in the case of property located at a military installation closed or realigned pursuant to a base closure law), or their designee, may assign to the Secretary of the Department of Transportation (DOT) for conveyance, without monetary consideration, to any State, or to governmental bodies, any political subdivision, municipality, or instrumentality, surplus real and related personal property, including buildings, fixtures, and equipment situated on the property, that DOT recommends as being needed for the development or operation of a port facility.
The disposal agency must notify established State, regional or metropolitan clearinghouses and eligible public agencies that surplus real property is available for the development or operation of a port facility. The disposal agency must transmit a copy of the notice to DOT and a copy of the landholding agency's Report of Excess Real Property (SF 118 and supporting schedules).
Surplus notices to eligible public agencies must state:
(a) That public agencies must coordinate any planning involved in the development of the comprehensive and coordinated plan of use and procurement of property, with DOT, the Secretary of Labor, and the Secretary of Commerce;
(b) That any party interested in acquiring the property for use as a port facility must contact the Department of Transportation, Maritime Administration, for the application and instructions;
(c) That the disposal agency must approve a recommendation from DOT before it can assign the property to DOT (see § 102-75.905); and
(d) That any subsequent conveyance is subject to the approval of the head of the disposal agency as stipulated under section 203(q)(2) of the Act and referenced in § 102-75.865.
The DOT must notify the disposal agency within 30 calendar days after the date of the surplus notice if there is an eligible applicant interested in acquiring the property. After that 30-calendar day period expires, DOT then has another 30 calendar days to review and approve applications and notify the disposal agency of the need for the property. If no application is approved, then DOT must notify the disposal agency that there is no requirement for the property within the same 30-calendar day period allotted for review and approval.
Whenever an eligible public agency has submitted a plan of use for a port facility requirement, the disposal agency must transmit two copies of the plan to DOT. The DOT must either submit to the disposal agency, within 30 calendar days after the date the plan is transmitted, a recommendation for assignment of the property to DOT, or inform the disposal agency, within the
Any assignment recommendation that DOT submits to the disposal agency must provide complete information concerning the contemplated port facility use, including:
(a) An identification of the property;
(b) An identification of the applicant;
(c) A copy of the approved application, which defines the proposed plan of use of the property;
(d) A statement that DOT's determination (that the property is located in an area of serious economic disruption) was made in consultation with the Secretary of Labor;
(e) A statement that DOT approved the economic development plan, associated with the plan of use of the property, in consultation with the Secretary of Commerce; and
(f) A copy of the explanatory statement, required under section 203(q)(3)(c) of the Act.
Landholding agencies must cooperate to the fullest extent possible with DOT representatives and the Secretary of Commerce in their inspection of such property, and with the Secretary of Labor in affirming that the property is in an area of serious economic disruption, and in furnishing any information relating to such property.
If DOT does not submit an assignment recommendation or if it is not received within 30 calendar days, the disposal agency must proceed with other disposal action.
If, after considering other uses for the property, the disposal agency approves the assignment recommendation from DOT, the disposal agency must assign the property by letter or other document to DOT. If the disposal agency disapproves the recommendation, the disposal agency must likewise notify DOT. The disposal agency must furnish to the landholding agency a copy of the assignment, unless the landholding agency is also the disposal agency.
After receiving the assignment letter from the disposal agency, DOT must provide the disposal agency with a Notice of Proposed Transfer within 30 calendar days after the date of the assignment letter. If the disposal agency approves the proposed transfer within 30 calendar days of the receipt of the Notice of Proposed Transfer, DOT may prepare the conveyance documents and proceed with the conveyance. The DOT must take all necessary actions to accomplish the conveyance within 15 calendar days after the expiration of the 30-calendar day period provided for the disposal agency to consider the notice. DOT must furnish the disposal agency two conformed copies of the instruments conveying property and all related documents containing restrictions or conditions regulating the future use, maintenance, or transfer of the property.
The DOT is responsible for enforcing compliance with the terms and conditions of conveyance, including reforming, correcting, or amending any instrument of conveyance; granting releases; and taking any necessary actions to recapture the property following the provisions of section 203(q)(4) of the Act. Any of these actions are subject to the approval of the head of the disposal agency. The DOT must notify the head of the disposal agency of its intent to take any proposed action, identify the property affected, and describe in detail the proposed action, including the reasons for the proposed action.
In each case of a repossession by the United States, DOT must, at or prior to reversion of title, provide the appropriate GSA regional property disposal office, with a SF 118 and accompanying schedules. After receiving a statement from DOT that title to the property is proposed for revesting, GSA will review the statement and determine if title should be revested. If GSA, in consultation with DOT, determines that the property should be revested, DOT must submit a SF 118 to GSA. The GSA will review and act upon the SF 118, if acceptable. However, the grantee must provide protection and maintenance for the property until the title reverts to the Federal Government, including the period following the notice of intent to revert. Such protection and maintenance must, at a minimum, conform to the standards prescribed in the GSA Customer Guide to Real Property Disposal.
Executive agencies may conduct negotiated sales only when:
(a) The estimated fair market value of the property does not exceed $50,000;
(b) Bid prices after advertising are unreasonable (for all or part of the property) or were not independently arrived at in open competition;
(c) The character or condition of the property or unusual circumstances make it impractical to advertise for competitive bids and the fair market value of the property and other satisfactory terms of disposal are obtainable by negotiation;
(d) The disposals will be to States, Commonwealth of Puerto Rico, possessions, political subdivisions, or tax-supported agencies therein, and the estimated fair market value of the property and other satisfactory terms of disposal are obtainable by negotiations. Negotiated sales to public bodies can only be conducted if a public benefit, which would not be realized from a competitive sale, will result from the negotiated sale; or
(e) Negotiation is otherwise authorized by the Federal Property and Administrative Services Act of 1949 or other law, such as disposals of power transmission lines for public or cooperative power projects.
Executive agencies must:
(a) Obtain such competition as is feasible in all negotiations of disposals and contracts for disposal of surplus property; and
(b) Prepare and transmit an explanatory statement if the fair market value of the property exceeds $700,000, identifying the circumstances of each disposal by negotiation for any real property specified in 40 U.S.C. 484(e)(6)(A), to the appropriate committees of the Congress in advance of such disposal.
Executive agencies must include in the offer to purchase and conveyance
The wording of the excess profits clause should be as follows:
(a) This covenant shall run with the land for a period of 3 years from the date of conveyance. With respect to the property described in this deed, if at any time within a 3-year period from the date of transfer of title by the Grantor, the Grantee, or its successors or assigns, shall sell or enter into agreements to sell the property, either in a single transaction or in a series of transactions, it is covenanted and agreed that all proceeds received or to be received in excess of the Grantee's or a subsequent seller's actual allowable costs will be remitted to the Grantor. In the event of a sale of less than the entire property, actual allowable costs will be apportioned to the property based on a fair and reasonable determination by the Grantor.
(b) For purposes of this covenant, the Grantee's or a subsequent seller's allowable costs shall include the following:
(1) The purchase price of the real property;
(2) The direct costs actually incurred and paid for improvements which serve only the property, including road construction, storm and sanitary sewer construction, other public facilities or utility construction, building rehabilitation and demolition, landscaping, grading, and other site or public improvements;
(3) The direct costs actually incurred and paid for design and engineering services with respect to the improvements described in (b)(2) of this section; and
(4) The finance charges actually incurred and paid in conjunction with loans obtained to meet any of the allowable costs enumerated above.
(c) None of the allowable costs described in paragraph (b) of this section will be deductible if defrayed by Federal grants or if used as matching funds to secure Federal grants.
(d) In order to verify compliance with the terms and conditions of this covenant, the Grantee, or its successors or assigns, shall submit an annual report for each of the subsequent 3 years to the Grantor on the anniversary date of this deed. Each report will identify the property involved in this transaction and will contain such of the following items of information as are applicable at the time of submission:
(1) A statement indicating whether or not a resale has been made;
(2) A description of each portion of the property that has been resold;
(3) The sale price of each such resold portion;
(4) The identity of each purchaser;
(5) The proposed land use; and
(6) An enumeration of any allowable costs incurred and paid that would offset any realized profit.
(e) The Grantor may monitor the property and inspect records related thereto to ensure compliance with the terms and conditions of this covenant and may take any actions which it deems reasonable and prudent to recover any excess profits realized through the resale of the property.
A negotiated sale for economic development purposes means that the public body purchasing the property will develop or make substantial improvements to the property with the intention of reselling or leasing the property in parcels to users to advance the community's economic benefit. This type of negotiated sale is acceptable where the expected public benefits to the community are greater than the anticipated proceeds derived from a competitive public sale.
The disposal agency must prepare an explanatory statement of the circumstances of each of the following proposed disposals by negotiation:
(a) Any real property that has an estimated fair market value in excess of $700,000, except that any real property disposed of by lease or exchange is subject only to paragraphs (b) through (d) of this section;
(b) Any real property disposed of by lease for a term of 5 years or less, if the estimated fair annual rent is in excess of $100,000 for any of such years;
(c) Any real property disposed of by lease for a term of more than 5 years, if the total estimated rent over the term of the lease is in excess of $700,000; or
(d) Any real property or real and related personal property disposed of by exchange, regardless of value, or any property disposed in which any part of the consideration is real property.
Yes, the disposal agency is not required to prepare an explanatory statement for property authorized to be disposed of without advertising by any provision of law other than section 203(e) of the Act.
Yes, disposal agencies must retain a copy of the explanatory statement in their files.
Disposal agencies must submit each explanatory statement to the Administrator of General Services for review and transmittal by letter from the Administrator of General Services to the Committees on Government Operations and any other appropriate committees of the Senate and House of Representatives. Disposal agencies must include in the submission to the Administrator of General Services any supporting data that may be relevant and necessary for evaluating the proposed action.
Yes, GSA must furnish copies of its transmittal letters to the committees of the Congress (see § 102-75.920) to the disposal agency.
If there is no objection, the disposal agency may consummate the sale on or after 35 days from the date the Administrator of General Services transmitted the explanatory statement to the committees. If there is an objection, the disposal agency must resolve objections with the appropriate congressional committee or subcommittee before consummating the sale.
Disposal agencies must make available by competitive public sale any surplus property that is not disposed of by public benefit discount conveyance or by negotiated sale. Awards must be made to the responsible bidder whose bid will be most advantageous to the Government, price and other factors considered.
Yes, landholding agencies may allow organizations to use surplus real
(a) The lease or permit does not exceed one year and is revocable with not more than a 30-day notice by the disposal agency;
(b) The use and occupancy will not interfere with, delay, or impede the disposal of the property; and
(c) The agency executing the agreement is responsible for the servicing of such property.
GSA's policy is to:
(a) Manage excess and surplus real property, including related personal property, by providing only those minimum services necessary to preserve the Government's interest and realizable value of the property considered;
(b) Place excess and surplus real property in productive use through interim utilization, provided, that such temporary use and occupancy do not interfere with, delay, or retard its transfer to a Federal agency or disposal; and
(c) Render safe or destroy aspects of excess and surplus real property which are dangerous to the public health or safety.
The landholding agency is responsible for paying taxes or payments in lieu of taxes (in the event of subsequent enactment of legislation by Congress authorizing such payments on Government-owned property not legally assessable), rents, and insurance premiums and other obligations pending transfer or disposal.
The landholding agency is responsible for all expense to the Government and for the supervision of the decontamination of excess and surplus real property that has been contaminated with hazardous materials of any sort. Extreme care must be exercised in the decontamination, management, and disposal of contaminated property in order to prevent such properties from becoming a hazard to the general public. The landholding agency must inform the disposal agency of any and all hazards involved relative to such property in order to protect the general public from hazards and to preclude the Government from any and all liability resulting from indiscriminate disposal or mishandling of contaminated property.
Yes, landholding agencies may make improvements or alterations which involve rehabilitation, reconditioning, conversion, completion, additions, and replacements in structures, utilities, installations, and land improvements, in those cases where disposal cannot be accomplished without such improvements or alterations. However, agencies must not enter into commitments concerning improvements or alterations without GSA's prior approval.
The landholding agency remains responsible and accountable for excess and surplus real property, including related personal property, and must perform the protection and maintenance of such property pending transfer to another Federal agency or disposal. Guidelines for protection and maintenance of excess and surplus real property are in the GSA Customer Guide to Real Property Disposal. The landholding agency is responsible for complying with the requirements of the National Oil and Hazardous Substances Pollution Contingency Plan and initiating or cooperating with others in the actions prescribed for the prevention, containment, or remedy of hazardous conditions.
Generally, the landholding agency is responsible for the cost of protection and maintenance of the property pending transfer or disposal for at least 12 months, but not more than 15 months. However, the landholding agency is responsible for providing and funding protection and maintenance during the period of delay if the landholding agency:
(a) Requests deferral of the disposal;
(b) Continues to occupy the property beyond the excess date to the detriment of orderly disposal; or
(c) Otherwise takes actions which result in a delay in the disposition.
If the property is not transferred to a Federal agency or disposed of during the period mentioned in § 102-75.970, the disposal agency must pay or reimburse the landholding agency for protection and maintenance expense of such property from and after the expiration date of said period, only if:
(a) There is a written agreement between the landholding agency and the disposal agency specifying the maximum amount of protection and maintenance expense that the disposal agency is responsible for; and
(b) Appropriations have been made by Congress to the disposal agency in an amount sufficient to make such payment or reimbursement.
If there is no written agreement (between the landholding agency and the disposal agency) or no Congressional appropriation to the disposal agency, the landholding agency is responsible for all protection and maintenance expenses, without any right of contribution or reimbursement from the disposal agency.
Yes, the landholding agency must cooperate with the disposal agency in showing the property to prospective transferees or purchasers. Unless extraordinary expenses are incurred in showing the property, the landholding agency must absorb the entire cost of such actions.
Yes, subject to the restrictions in this subpart, any Federal agency having control of real property which has no commercial value or for which the
(a) Abandon or destroy Government-owned improvements and related personal property located on privately owned land;
(b) Destroy Government-owned improvements and related personal property located on Government-owned land; abandonment of such property is not authorized; or
(c) Donate to public bodies any Government-owned real property (land and/or improvements and related personal property), or interests therein.
No, property which is dangerous to public health or safety must be made harmless or have adequate safeguards in place before it can be abandoned, destroyed, or donated to public bodies.
No property shall be abandoned, destroyed, or donated by a Federal agency under § 102-75.920, unless a duly authorized official of that agency determines, in writing, that:
(a) The property has no commercial value; or
(b) The estimated cost of its continued care and handling exceeds the estimated proceeds from its sale.
Only a duly authorized official of that agency not directly accountable for the subject property can make the determination.
A reviewing authority must approve determinations made under § 102-75.1000 before any such disposal, whenever all the property proposed to be disposed of by a Federal agency has a current estimated fair market value of more than $50,000.
Yes, Federal agencies must obtain prior concurrence of GSA before donating to public bodies:
(a) Improvements on land or related personal property having a current estimated fair market value in excess of $250,000; and
(b) Land, regardless of cost.
Yes, any public body receiving donated improvements on land or related personal property must pay the disposal costs associated with the donation, such as dismantling, removal, and the cleaning up of the premises.
A Federal agency may not abandon or destroy improvements on land or related personal property unless a duly authorized official of that agency finds, in writing, that donating the property is not feasible. This written finding is in addition to the determination prescribed in §§ 102-75.1000, 102-75.1005, and 102-75.1010. If donating the property becomes feasible at any time prior to actually abandoning or destroying the property, the Federal agency must donate it.
No, Federal agencies may not abandon or destroy property in a manner which is detrimental or dangerous to public health or safety or which will infringe on the rights of other persons.
Yes, GSA must concur on an agency's abandonment or destruction of improvements on land or related personal property prior to abandoning or destroying such improvements on land or related personal property—
(a) Which are of permanent type construction; or
(b) The retention of which would enhance the value of the underlying land, if it were to be made available for sale or lease.
Except as provided in § 102-75.1045, a Federal agency must not abandon or destroy improvements on land or related personal property until after it has given public notice of the proposed abandonment or destruction. This notice must be given in the area in which the property is located, must contain a general description of the property to be abandoned or destroyed, and must include an offering of the property for sale. A copy of the notice must be given to the GSA regional property disposal office for the region in which the property is located.
Yes, property can be abandoned or destroyed without public notice if—
(a) Its value is so low or the cost of its care and handling so great that retaining the property in order to post public notice is clearly not economical;
(b) Health, safety, or security considerations require its immediate abandonment or destruction; or
(c) The assigned mission of the agency might be jeopardized by the delay, and a duly authorized Federal agency official finds in writing, with respect to paragraph (a), (b), or (c) of this section, and a reviewing authority approves this finding. The finding must be in addition to the determinations prescribed in §§ 102-75.1000, 102-75.1005, 102-75.1010 and 102-75.1025.
Yes, this subpart does not apply to surplus property assigned for disposal to educational or public health institutions pursuant to section 203(k) of the Act.
GSA delegates to the Secretary of Defense the authority to determine that Federal agencies do not need Department of Defense controlled excess real property and related personal property having a total estimated fair market value, including all the component units of the property, of less than $50,000; and to dispose of the property by means deemed most advantageous to the United States.
The Secretary must conduct a Federal screening to determine that there is no further Federal need or requirement for the property.
No, although the authority in this delegation must be used following the Federal Property and Administrative Services Act of 1949 and its implementing regulations.
Yes, the Secretary of Defense may redelegate the authority delegated in § 102-75.1055 to any officer or employee of the Department of Defense.
GSA delegates authority to the Secretary of Agriculture to determine that Federal agencies do not need USDA-controlled excess real property and related personal property having a total estimated fair market value, including all the component units of the property, of less than $50,000; and to dispose of the property by means deemed most advantageous to the United States.
The Secretary must conduct a Federal screening to determine that there is no further Federal need or requirement for the property.
No, although the authority in this delegation must be used following the Federal Property and Administrative Services Act of 1949 and its implementing regulations.
Yes, the Secretary of Agriculture may redelegate authority delegated in § 102-75.1075 to any officer or employee of the Department of Agriculture.
GSA delegates authority to the Secretary of the Interior to:
(a) Maintain custody, control, and accountability for mineral resources in, on, or under Federal real property which the Administrator or his designee occasionally designates as currently utilized, excess, or surplus to the Government's needs;
(b) Dispose of mineral resources by lease and to administer those leases which are made; and
(c) Determine that Federal agencies do not need Department of the Interior controlled excess real property and related personal property with an estimated fair market value, including all components of the property, of less than $50,000; and to dispose of the property by means most advantageous to the United States.
Yes, the Secretary of the Interior may redelegate this authority to any officer, official, or employee of the Department of the Interior.
Under this authority, the Secretary of the Interior is responsible for:
(a) Maintaining proper inventory records, as head of the landholding agency;
(b) Monitoring the minerals as necessary, as head of the landholding agency, to ensure that no unauthorized mining or removal of the minerals occurs;
(c) Securing any appraisals deemed necessary by the Secretary;
(d) Coordinating with all surface landowners, Federal or otherwise, to ensure no unnecessary interference with the surface use;
(e) Ensuring that the damaged or disturbed lands are restored after removal of the mineral deposits;
(f) Notifying the Administrator of General Services when the disposal of all marketable mineral deposits is complete;
(g) Complying with the applicable environmental laws and regulations, including the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321,
(h) Forwarding promptly to the Administrator of General Services copies of any agreements executed under this authority; and
(i) Providing the Administrator of General Services with an annual accounting of the proceeds received from leases executed under this authority.
The GSA delegates authority to the Secretary of the Interior, the Secretary of Health and Human Services, and the Secretary of Education to transfer and to retransfer to each other, upon request, any of the property of either agency which is being used and will continue to be used in the administration of any functions relating to the Native Americans. The term
This authority must be used only in connection with property which the appropriate Secretary determines:
(a) Comprises a functional unit;
(b) Is located within the United States; and
(c) Has an acquisition cost of $100,000 or less, provided that the transfer or retransfer does not include property situated in any area which is recognized as an urban area or place as identified by the most recent decennial census.
No, screening is not required because it would accomplish no useful purpose,
Yes, transfers/retransfers under this delegation can be at no cost or without consideration, except:
(a) Where funds programmed and appropriated for acquisition of the property are available to the Secretary requesting the transfer or retransfer; or
(b) Whenever reimbursement at fair market value is required by subpart B of this part (entitled “Utilization of Excess Real Property”.)
The Secretary requesting the transfer or retransfer must certify in writing that no funds are available to acquire the property. The Secretary transferring or retransferring the property may make any determination necessary that would otherwise be made by GSA to carry out the authority contained in this delegation.
Yes, the Secretary of the Interior, the Secretary of Health and Human Services, and the Secretary of Education may redelegate any of the authority contained in this delegation to any officers or employees of their respective departments.
Any Federal agency receiving an offer of a conditional gift of real property for a particular defense purpose within the purview of the Act of July 27, 1954, must notify the appropriate GSA regional office and must submit to GSA a recommendation indicating whether the Government should accept or reject the gift. Nothing in this subpart shall be construed as applicable to the acceptance of gifts under the provisions of other laws. The GSA must:
(a) Consult with the interested agencies before it may accept or reject such conditional gifts of real property on behalf of the United States or before it transfers such conditional gifts of real property to an agency; and
(b) Advise the donor and the agencies concerned of the action taken with respect to acceptance or rejection of the conditional gift and of its final disposition.
Prior to notifying the appropriate GSA regional property disposal office, the receiving Federal agency must acknowledge receipt of the offer in writing and advise the donor that the offer will be referred to the appropriate GSA regional property disposal office. The receiving agency must not indicate acceptance or rejection of the gift on behalf of the United States at this time. The receiving agency must provide a copy of the acknowledgment with the notification and recommendation to the GSA regional property disposal office.
When GSA determines that the gift is acceptable and can be accepted and used in the form in which it was offered, GSA must designate an agency and transfer the gift without reimbursement to this agency to use as the donor intended.
The GSA can determine whether or not a gift of property can and should be converted to money. After conversion, GSA must deposit the funds with the Treasury Department for transfer to an appropriate account which will best effectuate the intent of the donor, in accordance with Treasury Department procedures.
(1) An individual or family that lacks a fixed, regular, and adequate nighttime residence; and
(2) An individual or family that has a primary nighttime residence that is:
(i) A supervised publicly or privately operated shelter designed to provide temporary living accommodations (including welfare hotels, congregate shelters, and transitional housing for the mentally ill);
(ii) An institution that provides a temporary residence for individuals intended to be institutionalized; or
(iii) A public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings. This term does not include any individual imprisoned or otherwise detained under an Act of the Congress or a State law.
(a) This part applies to Federal real property which has been designated by Federal landholding agencies as unutilized, underutilized, excess or surplus, and is, therefore, subject to the provisions of title V of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11411).
(b) The following categories of properties are not subject to this subpart (regardless of whether they may be unutilized or underutilized):
(1) Machinery and equipment.
(2) Government-owned, contractor-operated machinery, equipment, land, and other facilities reported excess for sale only to the using contractor and subject to a continuing military requirement.
(3) Properties subject to special legislation directing a particular action.
(4) Properties subject to a court order.
(5) Property not subject to survey requirements of Executive Order 12512 (April 29, 1985).
(6) Mineral rights interests.
(7) Air Space interests.
(8) Indian Reservation land subject to section 202(a)(2) of the Federal Property and Administrative Service Act of 1949, as amended.
(9) Property interests subject to reversion.
(10) Easements.
(11) Property purchased in whole or in part with Federal funds if title to the property is not held by a Federal landholding agency as defined in this part.
(a)
(1) HUD will request descriptive information on properties sufficient to make a reasonable determination, under the criteria described below, of the suitability of a property for use as a facility to assist the homeless.
(2) HUD will direct landholding agencies to respond to requests for information within 25 days of receipt of such requests.
(b)
(1) Was included in a list of suitable properties published that year by HUD; and
(2) Remains available for application for use to assist the homeless, or has become available for application during that year.
(c)
(d)
(a)
(b)
(c)
(d)
(1) The suitability determination for a particular piece of property, and the reasons for that determination; and
(2) The landholding agency's response to the determination pursuant to the requirements of § 102-75.1190(a).
(e)
(f)
(2) Requests for review of a determination of unsuitability may be made only by representatives of the homeless, as defined in § 102-75.1160.
(3) The request for review must specify the grounds on which it is based,
(4) Upon receipt of a request to review a determination of unsuitability, HUD will notify the landholding agency that such a request has been made, request that the agency respond with any information pertinent to the review, and advise the agency that it should refrain from initiating disposal procedures until HUD has completed its reconsideration regarding unsuitability.
(i) HUD will act on all requests for review within 30 days of receipt of the landholding agency's response and will notify the representative of the homeless and the landholding agency in writing of its decision.
(ii) If a property is determined suitable as a result of the review, HUD will request the landholding agency's determination of availability pursuant to § 102-75.1190(a), upon receipt of which HUD will promptly publish the determination in the
(a) Each landholding agency must submit a report to GSA of properties it determines excess. Each landholding agency must also provide a copy of HUD's suitability determination, if any, including HUD's identification number for the property.
(b) If a landholding agency reports a property to GSA which has been reviewed by HUD for homeless assistance suitability and HUD determined the property suitable, GSA will screen the property pursuant to § 102-75.1180(g) and will advise HUD of the availability of the property for use by the homeless as provided in § 102-75.1180(e). In lieu of the above, GSA may submit a new checklist to HUD and follow the procedures in § 102-75.1180(c) through § 102-75.1180(g).
(c) If a landholding agency reports a property to GSA which has not been reviewed by HUD for homeless assistance suitability, GSA will complete a property checklist, based on information provided by the landholding agency, and will forward this checklist to HUD for a suitability determination. This checklist will reflect any change in classification,
(d) Within 30 days after GSA's submission, HUD will advise GSA of the suitability determination.
(e) When GSA receives a letter from HUD listing suitable excess properties in GSA's inventory, GSA will transmit to HUD within 45 days a response which includes the following for each identified property:
(1) A statement that there is no other compelling Federal need for the property and, therefore, the property will be determined surplus; or
(2) A statement that there is further and compelling Federal need for the property (including a full explanation of such need) and that, therefore, the property is not presently available for use to assist the homeless.
(f) When an excess property is determined suitable and available and notice is published in the
(g) Upon submission of a Report of Excess to GSA, GSA may screen the property for Federal use. In addition, GSA may screen State and local governmental units and eligible nonprofit organizations to determine interest in the property in accordance with current regulations. (
(h) The landholding agency will retain custody and accountability and will protect and maintain any property which is reported excess to GSA as provided in § 102-75.965.
(a) All properties, buildings, and land will be determined suitable unless a property's characteristics include one or more of the following conditions:
(1)
(2)
(3)
(4)
(5)
(6)
(a) Within 45 days after receipt of a letter from HUD pursuant to § 102-75.1170(a), each landholding agency must transmit to HUD a statement of one of the following:
(1) In the case of unutilized or underutilized property:
(i) An intention to declare the property excess;
(ii) An intention to make the property available for use to assist the homeless; or
(iii) The reasons why the property cannot be declared excess or made available for use to assist the homeless. The reasons given must be different than those listed as suitability criteria in § 102-75.1185.
(2) In the case of excess property that had previously been reported to GSA:
(i) A statement that there is no compelling Federal need for the property and that, therefore, the property will be determined surplus; or
(ii) A statement that there is a further and compelling Federal need for the property (including a full explanation of such need) and that, therefore, the property is not presently available for use to assist the homeless.
(a) No later than 15 days after the last-45 day period has elapsed for receiving responses from the landholding agencies regarding availability, HUD will publish in the
(1) Properties that are suitable and available.
(2) Properties that are suitable and unavailable.
(3) Properties that are suitable and to be declared excess.
(4) Properties that are unsuitable.
(b) Information about specific properties can be obtained by contacting HUD at the following toll free number: 1-800-927-7588.
(c) HUD will transmit to the ICH a copy of the list of all properties published in the
(d) No later than February 15 of each year, HUD shall publish in the
(e) HUD shall publish an annual list of properties determined suitable, but that agencies reported unavailable, including the reasons such properties are not available.
(f) Copies of the lists published in the
(a)
(2) If a written expression of interest to apply for suitable property for use to assist the homeless is received by HHS within the 60-day holding period, such property may not be made available for any other purpose until the date HHS or the appropriate landholding agency has completed action on the application submitted pursuant to that expression of interest.
(3) The expression of interest should identify the specific property, briefly describe the proposed use, include the name of the organization, and indicate whether it is a public body or a private, nonprofit organization. The expression of interest must be sent to the Division of Health Facilities Planning (DHFP) of the Department of Health and Human Services at the following address: Director, Division of Health Facilities Planning, Public Health Service, room 17A-10, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. The HHS will notify the landholding agency (for unutilized and underutilized properties) or GSA (for excess and surplus properties) when an expression of interest has been received for a particular property.
(4) An expression of interest may be sent to HHS any time after the 60-day holding period has expired. In such a case, an application submitted pursuant to this expression of interest may be approved for use by the homeless if:
(i) No application or written expression of interest has been made under any law for use of the property for any purpose; and
(ii) In the case of excess or surplus property, GSA has not received a bona fide offer to purchase that property or advertised for the sale of the property by public auction.
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(c)
(d)
(e)
(2) HHS will evaluate each completed application within 25 days of receipt and will promptly advise the applicant of its decision. Applications are evaluated on a first-come, first-serve basis. HHS will notify all organizations that have submitted expressions of interest for a particular property regarding whether the first application received for that property has been approved or disapproved. All applications will be reviewed on the basis of the following elements, which are listed in descending order of priority, except that paragraphs (e)(2)(iv) and (e)(2)(v) of this section are of equal importance:
(i)
(ii)
(iii)
(iv)
(v)
(3) Additional evaluation factors may be added as deemed necessary by HHS. If additional factors are added, the application packet will be revised to include a description of these additional factors.
(4) If HHS receives one or more competing applications for a property within 5 days of the first application, HHS will evaluate all completed applications simultaneously. The HHS will rank approved applications based on the elements listed in § 102-75.1200(e)(2) and notify the landholding agency, or GSA, as appropriate, of the relative ranks.
(a)
(2) The landholding agency maintains the discretion to decide the following:
(i) The length of time the property will be available. (Leases and permits will be for a period of at least one year, unless the applicant requests a shorter term.)
(ii) Whether to grant use of the property via a lease or permit.
(iii) The terms and conditions of the lease or permit document.
(b)
(2) Prior to assignment to HHS, GSA may consider other Federal uses and other important national needs; however, in deciding the disposition of surplus real property, GSA will generally give priority of consideration to uses to assist the homeless. The GSA may consider any competing request for the property made under section 203(k) of the Federal Property and Administrative Services Act of 1949 (40 U.S.C. 484(k)) (education, health, public park or recreation, and historic monument uses) that is so meritorious and compelling that it outweighs the needs of the homeless, and HHS may likewise consider any competing request made under subsection 203(k)(1) (education and health uses) of that law.
(3) Whenever GSA or HHS decides in favor of a competing request over a request for property for homeless assistance use as provided in paragraph (b)(2) of this section, the agency making the decision will transmit to the appropriate committees of the Congress an explanatory statement which details the need satisfied by conveyance of the surplus property, and the reasons for determining that such need was so meritorious and compelling as to outweigh the needs of the homeless.
(4)
(c)
The landholding agency will defer, for 20 days after the date that notice of a property is published in the
(a) At the end of the 60-day holding period described in § 102-75.1200(a), HHS will notify GSA, or the landholding agency, as appropriate, if an expression of interest has been received for a particular property. Where there is no expression of interest, GSA or the landholding agency, as appropriate, will proceed with disposal in accordance with applicable law.
(b) Upon advice from HHS that all applications have been disapproved, or if no completed applications or requests for extensions have been received by HHS within 90 days from the date of the last expression of interest, disposal may proceed in accordance with applicable law.
40 U.S.C. 486(c) (in furtherance of the Administrator's authorities under 40 U.S.C. 601-619 and elsewhere as included under 40 U.S.C. 490(a) and (c)); E.O. 12411, 48 FR 13391, 3 CFR, 1983 Comp., p. 155; E.O. 12512, 50 FR 18453, 3 CFR, 1985 Comp., p. 340.
16 U.S.C. 470 h-2; 40 U.S.C. 486(c) and 490(a).
Yes, Executive Order 13006 requires executive agencies that have a mission requirement to locate in an urban area to give first consideration to space in historic buildings and districts inside central business areas. Agencies may give a price preference of up to 10 percent to space in historic buildings and districts, in accordance with §§ 102-73.115 and 102-73.120 of this chapter.
40 U.S.C. 486(c); E.O. 12411, 48 FR 13391, 3 CFR, 1983 Comp., p. 155; and E.O. 12512, 50 FR 18453, 3 CFR, 1985 Comp., p. 340.
The real property policies contained in this part apply to Federal agencies, including the GSA/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services.
Executive agencies must provide a quality workplace environment that supports program operations, preserves the value of real property assets, meets the needs of the occupant agencies, and provides child care and physical fitness facilities in the workplace when adequately justified. An executive agency must promote maximum utilization of Federal workspace, consistent with mission requirements, to maximize its value to the Government.
Executive agencies must provide assignment and utilization services that will maximize the value of Federal real property resources and improve the productivity of the workers housed therein.
Executive agencies must promote the optimum use of space for each assignment at an economical cost to the Government, provide quality workspace that is delivered and occupied in a timely manner, and assign space based on mission requirements.
Yes, in accordance with 40 U.S.C. 490b, Federal agencies can allot space in Federal buildings to individuals or entities who will provide child care services to Federal employees if such:
(a) Space is available;
(b) Agency determines that such space will be used to provide child care services to children of whom at least 50 percent have one parent or guardian who is a Federal Government employee; and
(c) Agency determines that such individual or entity will give priority for available child care services in such space to Federal employees.
Yes, in accordance with 5 U.S.C. 7901, Federal agencies can allot space in Federal buildings for establishing fitness programs.
Federal agencies must address the following elements in their planning effort for establishing fitness programs:
(a) A survey indicating employee interest in the program;
(b) A three-to five-year implementation plan demonstrating long-term commitment to physical fitness/health for employees;
(c) A health related orientation, including screening procedures, individualized exercise programs, identification of high-risk individuals, and appropriate follow-up activities;
(d) Identification of a person skilled in prescribing exercise to direct the fitness program;
(e) An approach that will consider key health behavior related to degenerative disease, including smoking and nutrition;
(f) A modest facility that includes only the essentials necessary to conduct a program involving cardiovascular and muscular endurance, strength activities, and flexibility;
(g) Provision for equal opportunities for men and women, and all employees, regardless of grade level.
Yes, in accordance with 12 U.S.C. 1770, Federal agencies may allot space in Federal buildings to Federal credit unions without charge for rent or services if:
(a) At least 95 percent of the membership of the credit union to be served by the allotment of space is composed of persons who either are presently Federal employees or were Federal employees at the time of admission into the credit union, and members of their families; and
(b) Space is available.
Federal agencies may provide without charge to Federal credit union services such as:
(a) Lighting;
(b) Heating and cooling;
(c) Electricity;
(d) Office furniture;
(e) Office machines and equipment;
(f) Telephone service (including installation of lines and equipment and other expenses associated with telephone service); and
(g) Security systems (including installation and other expenses associated with security systems).
Executive agencies, when acquiring or utilizing federally owned and leased space under the Federal Property and Administrative Services Act of 1949, as amended, must promote efficient utilization of space. Where there is no Federal agency space need, executive agencies must make every effort to maximize the productive use of vacant space through the issuance of permits, licenses or leases to nonfederal entities to the extent authorized by law.
Yes, Federal agencies must:
(a) First utilize space in Government-owned and Government-leased buildings.
(b) If there is no suitable space in Government-owned and Government-leased buildings, utilize space in buildings under the custody and control of the U.S. Postal Service.
(c) If there is no suitable space in buildings under the custody and control of the U.S. Postal Service, agencies may acquire real estate by lease, purchase, or construction, as specified in part 102-73 of this chapter.
Yes, Federal agencies must assume responsibility for the preservation of the historic properties they own or control. Prior to acquiring, constructing or leasing buildings, agencies must use, to the maximum extent feasible, historic properties already owned or leased by the agency (16 U.S.C. 470h-2).
Federal agencies electing to establish a public access defibrillation program in a Federal facility must follow the guidelines, entitled “Guidelines for Public Access Defibrillation Programs in Federal Facilities,” which can be obtained from the Office of Real Property (MP), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
40 U.S.C. 486(c) and 490.
The real property policies contained in this part apply to Federal agencies, including the General Services Administration (GSA)/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services. The responsibilities for safety and environmental management under this part are intended to apply to GSA or those Federal agencies operating in GSA space pursuant to a GSA delegation of authority.
The basic safety and environmental management policies for real property are that Federal agencies must:
(a) Provide for a safe and healthful work environment for Federal employees and the visiting public;
(b) Protect Federal real and personal property;
(c) Promote mission continuity;
(d) Provide reasonable safeguards for emergency forces if an incident occurs;
(e) Assess risk;
(f) Make decisionmakers aware of risks; and
(g) Act promptly and appropriately in response to risk.
Federal agencies have the following responsibilities concerning the assessment and management of asbestos:
(a) Inspect and assess buildings for the presence and condition of asbestos-containing materials. Space to be leased must be free of all asbestos containing materials, except undamaged asbestos flooring in the space or undamaged boiler or pipe insulation outside the space, in which case an asbestos management program conforming to Environmental Protection Agency (EPA) guidance must be implemented;
(b) Manage in-place asbestos that is in good condition and not likely to be disturbed;
(c) Abate damaged asbestos, and asbestos likely to be disturbed. Federal agencies must perform a pre-alteration asbestos assessment for activities that may disturb asbestos;
(d) Not use asbestos in new construction, renovation/modernization or repair of their owned or leased space. Unless approved by GSA, Federal agencies must not obtain space with asbestos through purchase, exchange, transfer, or lease, except as identified in paragraph (a) of this section; and
(e) Communicate all written and oral asbestos information about the leased space to tenants.
Federal agencies have the following responsibilities concerning the abatement of radon in space when radon levels exceed current EPA standards:
(a) Retest abated areas and make lessors retest, as required, abated areas to adhere to EPA standards; and
(b) Test non-public water sources (in remote areas for projects such as border stations) for radon according to EPA guidance. Radon levels that exceed current applicable EPA standards must be mitigated. Federal agencies must retest, as required, to adhere to EPA standards.
Federal agencies must assess indoor air quality of buildings as part of their safety and environmental facility assessments. Federal agencies must respond to tenant complaints on air quality and take appropriate corrective action where air quality does not meet applicable standards.
Federal agencies have the following responsibilities concerning lead in buildings:
(a) Test space for lead-based paint in renovation projects that require sanding, welding or scraping painted surfaces.
(b) Not remove lead based paint from surfaces in good condition.
(c) Test all painted surfaces for lead in proposed or existing child care centers.
(d) Abate lead-based paint found in accordance with Department of Housing and Urban Development (HUD) Lead-Based Paint Guidelines, available by writing to HUD USER, PO Box 6091, Rockville, MD, 20850.
(e) Test potable water for lead in all drinking water outlets.
(f) Take corrective action when lead levels exceed the HUD Guidelines.
Federal agencies' responsibilities concerning the monitoring of hazardous materials and wastes are:
(a) Monitor the transport, use, and disposition of hazardous materials and waste in buildings to provide for compliance with GSA, Occupational Safety and Health Administration (OSHA), Department of Transportation, EPA, and applicable State and local requirements. In addition to those operating in GSA space pursuant to a delegation of authority, tenants in GSA space must comply with these requirements.
(b) In leased space, include in all agreements with the lessor requirements that hazardous materials kept in leased space are kept and maintained according to applicable Federal, State, and local environmental regulations.
Federal agencies have the following responsibilities concerning the management of underground storage tanks in real property:
(a) Register, manage and close underground storage tanks, including heating oil and fuel oil tanks, in accordance with GSA, EPA, and applicable State and local requirements.
(b) Require the party responsible for tanks they use but don't own to follow these requirements and to be responsible for the cost of compliance.
Federal agencies must follow the standards issued by the Interagency Committee on Seismic Safety in Construction (ICSSC) as the minimum level acceptable for use by Federal agencies in assessing the seismic safety of their owned and leased buildings and in mitigating unacceptable seismic risks in those buildings.
Yes, Federal agencies must identify and estimate safety and environmental management risks and appropriate risk reduction strategies for buildings. Federal agencies occupying as well as operating buildings must identify any safety and environmental management risks and report or correct the situation, as appropriate. Federal agencies must use the applicable national codes and standards as a guide for their building operations.
Yes, Federal agencies must manage the execution of risk reduction projects in buildings they operate. Federal agencies must identify and take appropriate action to eliminate hazards and regulatory noncompliance.
Yes, Federal agencies must evaluate facilities to comply with GSA's safety and environmental program and applicable Federal, State and local environmental laws and regulations. Federal agencies should conduct these evaluations in accordance with schedules that are compatible with repair and alteration and leasing operations.
Federal agencies have the following responsibilities concerning the investigation of incidents, such as fires, accidents, injuries, and environmental incidents in buildings they operate:
(a) Investigate all incidents regardless of severity.
(b) Form Boards of Investigation for incidents resulting in serious injury, death, or significant property losses.
Yes, Federal agencies must inform their tenants of the condition and management of their facility safety and environment. Agencies operating GSA buildings must report any significant facility safety or environmental concerns to GSA.
Federal agencies must assess required environmental issues throughout planning and project development so that the environmental impacts of a project are considered during the decision making process.
Federal agencies must:
(a) Comply with the occupational safety and health standards established in the Occupational Safety and Health Act (OSHA) of 1970 (Pub. L. 91-596); Executive Order 12196; 29 CFR part 1960, and applicable safety and environmental management criteria identified in this part;
(b) Not expose occupants and visitors to unnecessary risks;
(c) Provide safeguards that minimize personal harm, property damage, and impairment of Governmental operations, and that allow emergency forces to accomplish their missions effectively.
(d) Follow accepted fire prevention practices in operating and managing buildings;
(e) To the maximum extent feasible, comply with one of the nationally recognized model building codes and with other nationally recognized codes in their construction or alteration of each building in accordance with 40 U.S.C. 619.
(f) Use the applicable national codes and standards as a guide for their building operations.
Federally owned buildings are generally exempt from State and local code requirements in fire protection; however, in accordance with 40 U.S.C. 619, each building constructed or altered by a Federal agency must be constructed or altered, to the maximum extent feasible, in compliance with one of the nationally recognized model building codes and with other nationally recognized codes. Leased buildings are subject to local code requirements and inspection.
Yes, the Fire Administration Authorization Act of 1992 (Pub. L. 102-522) requires sprinklers or an equivalent level of safety in certain types of Federal employee office buildings, Federal employee housing units, and federally assisted housing units.
Yes, the Act applies to all Federal agencies and all federally owned and leased buildings in the United States.
The performance objective of the automatic sprinkler system is that it must be capable of protecting human lives. Sprinklers should be capable of controlling the spread of fire and its effects beyond the room of origin. A functioning sprinkler system should activate prior to the onset of flashover.
The equivalent level of life safety evaluation is to be performed by a qualified fire protection engineer. The analysis should include a narrative discussion of the features of the building structure, function, operational support systems and occupant activities that impact fire protection and life safety. Each analysis should describe potential reasonable worst case fire scenarios and their impact on the building occupants and structure. Specific issues that must be addressed include rate of fire growth, type and location of fuel items, space layout, building construction, openings and ventilation, suppression capability, detection time, occupant notification, occupant reaction time, occupant mobility, and means of egress.
To be acceptable, the analysis must indicate that the existing and/or proposed safety systems in the building provide a period of time equal to or greater than the amount of time available for escape in a similar building complying with the Act. In conducting these analyses, the capability, adequacy, and reliability of all building systems impacting fire growth, occupant knowledge of the fire, and time required to reach a safety area will have to be examined. In particular, the impact of sprinklers on the development of hazardous conditions in the area of interest will have to be assessed.
Yes, the following are three options for establishing that an equivalent level of safety exists:
(a) In the first option, the margin of safety provided by various alternatives is compared to that obtained for a code complying building with complete sprinkler protection. The margin of safety is the difference between the available safe egress time and the required safe egress time. Available safe egress time is the time available for evacuation of occupants to an area of safety prior to the onset of untenable conditions in occupied areas or the egress pathways. The required safe egress time is the time required by occupants to move from their positions at the start of the fire to areas of safety. Available safe egress times would be developed based on analysis of a number of assumed reasonable worst case fire scenarios including assessment of a code complying fully sprinklered building. Additional analysis would be used to determine the expected required safe egress times for the various scenarios. If the margin of safety plus an appropriate safety factor is greater for an alternative than for the fully sprinklered building, then the alternative should provide an equivalent level of safety.
(b) A second alternative is applicable for typical office and residential scenarios. In these situations, complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire size to no more than 1 megawatt (950 Btu/sec), and prevent flames from leaving the room of origin. The times required for each of these conditions to occur in the area of interest must be determined. The shortest of these three times would become the time available for escape. The difference between the minimum time available for escape and the time required for evacuation of building occupants would be the target margin of safety. Various alternative protection strategies would have to be evaluated to determine their impact on the times at which hazardous conditions developed in the spaces of interest and the times required for egress. If a combination of fire protection systems provides a margin of safety equal to or greater than the target margin of safety, then the
(c) As a third option, other technical analysis procedures, as approved by the responsible agency head, can be used to show equivalency.
Analytical and empirical tools, including fire models and grading schedules such as the Fire Safety Evaluation System (Alternative Approaches to Life Safety, NEPA 101A) should be used to support the life safety equivalency evaluation. If fire modeling is used as part of an analysis, an assessment of the predictive capabilities of the fire models must be included. This assessment should be conducted in accordance with the American Society for Testing and Materials Standard Guide for Evaluating the Predictive Capability of Fire Models (ASTM E 1355).
The head of the agency responsible for physical improvements in the facility or providing Federal assistance or a designated representative will determine the acceptability of each equivalent level of safety analysis. The determination of acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of the fire scenarios for the facility, and the reasonableness of the assumed maximum probable loss. Agencies should maintain a record of each accepted equivalent level of safety analysis and provide copies to fire departments or other local authorities for use in developing prefire plans.
A qualified fire protection engineer must perform the equivalent level of safety analysis.
A
(a) An engineer having an undergraduate or graduate degree from a college or university offering a course of study in fire protection or firesafety engineering, plus a minimum of 4 years work experience in fire protection engineering;
(b) A professional engineer (P.E. or similar designation) registered in Fire Protection Engineering; or
(c) A professional engineer (P.E. or similar designation) registered in a related engineering discipline and holding Member grade status in the International Society of Fire Protection Engineers.
40 U.S.C. 318a, 486(c) and 490.
In a June 28, 1995, Presidential Policy Memorandum for Executive Departments and Agencies, entitled, “Upgrading Security at Federal Facilities” (see the Weekly Compilation of Presidential Documents, vol. 31, p. 1148), the President directed that executive agencies must, where feasible, upgrade and maintain security in facilities they own or lease under their own authority to the minimum standards specified in the Department of Justice's June 28, 1995 study entitled “Vulnerability Assessment of Federal Facilities.” The study may be obtained by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA, 15250-7954.
No, the minimum standards specified in the Department of Justice's June 28, 1995 study entitled “Vulnerability Assessment of Federal Facilities” identifies the minimum-security standards that agencies must adhere to for all existing owned and leased Federal facilities. As specified in § 102-81.25, new federally owned and leased facilities must be designed to meet the standards identified in the document entitled “Interagency Security Committee Security Design Criteria for New Federal Office Buildings and Major Modernization Projects,” dated May 28, 2001. The security design criteria for new facilities takes into consideration technology developments, new cost consideration, the experience of practitioners applying the criteria, and the need to balance security requirements with public building environments that remain lively, open, and accessible.
No, the Interagency Security Committee Security Design Criteria:
(a) Apply to new construction of general purpose office buildings and new or lease-construction of
(b) Do not apply to airports, prisons, hospitals, clinics, and ports of entry, or to unique facilities such as those classified by the Department of Justice Vulnerability Assessment Study as Level V. Nor will the criteria overrule existing Federal laws and statutes, and other agency standards that have been developed for special facilities, such as border stations and child care centers.
Anyone who applies for employment (including volunteer positions) at a child care facility, located on federally controlled property (including federally leased property), must reveal any arrests and convictions on the job application.
40 U.S.C. 486(c); E.O. 12072; and E.O. 13006
The real property policies contained in this part apply to Federal agencies, including the GSA/Public Buildings Service (PBS), operating under, or subject to, the authorities of the Administrator of General Services.
Each executive agency is responsible for identifying its geographic service area and the delineated area within which it wishes to locate specific activities, consistent with its mission and program requirements, and in accordance with all applicable statutes, regulations and policies.
Yes, Federal agencies must follow the hierarchy of consideration identified in § 102-79.55 of this chapter.
Delineated area means the specific boundaries within which space will be obtained to satisfy an agency space requirement.
Each Federal agency is responsible for identifying the delineated area within which it wishes to locate specific activities, consistent with its mission and program requirements, and in accordance with all applicable laws, regulations, and Executive Orders.
Yes, Federal agencies must also consider real estate, labor, and other operational costs and applicable local incentives when identifying the delineated area.
In accordance with the Competition in Contracting Act of 1984 (CICA), as amended (41 U.S.C. 253(a)), executive agencies must consider whether restricting the delineated area for obtaining leased space to the central business area will provide for adequate competition when acquiring leased space. Where an executive agency determines that the delineated area must be expanded beyond the CBA in order to provide adequate competition, the agency may expand the delineated area in consultation with local officials. Executive agencies must continue to include the CBA in such expanded areas.
Federal agencies conducting the procurement must approve the final delineated area for site acquisitions and lease actions and must confirm that the final delineated area complies with the requirements of all applicable laws, regulations, and Executive Orders.
The GSA Public Buildings Service provides guidance in their Customer Guide to Real Property on the process for appealing GSA's decisions and recommendations concerning delineated areas.
In the Rural Development Act, as amended, Congress directs Federal agencies to develop policies and procedures to give first priority to the location of new offices and other Federal facilities in rural areas. The intent of the Act is to revitalize and develop rural areas and help foster a balance between rural and urban America.
Rural area means a city, town, or unincorporated area that has a population of 50,000 inhabitants or less, other than an urbanized area immediately adjacent to a city, town, or unincorporated area that has a population in excess of 50,000 inhabitants, as specified in the Rural Development Act, as amended.
An urbanized area is a statistical geographic area defined by the Census Bureau, consisting of a central place(s) and adjacent densely settled territory that together contain at least 50,000 people, generally with an overall population density of at least 1,000 people per square mile.
Yes, executive agencies must give first priority to the location of new offices and other facilities in rural areas in accordance with the Rural Development Act (7 U.S.C. 2204b-1), unless their mission or program requirements call for locations in an urban area. First priority to the location of new offices and other facilities in rural areas must be given in accordance with the hierarchy specified in § 102-79.55 of this chapter.
Executive Order 12072, entitled “Federal Space Management,” requires all executive agencies that have a mission requirement to locate in an urban area to give first consideration to locating Federal facilities in central business areas, and/or adjacent areas of similar character, to use them to make downtowns attractive places to work, conserve existing resources, and encourage redevelopment. It also directs executive agencies to consider opportunities for locating cultural, educational, recreational, or commercial activities within the proposed facility.
Executive Order 13006, entitled “Locating Federal Facilities on Historic Properties in Our Nation's Central Cities,” requires all executive agencies that have a mission requirement to locate in an urban area to give first consideration to locating Federal facilities in historic buildings and districts within central business areas. It also directs executive agencies to remove regulatory barriers, review their policies, and build new partnerships with the goal of enhancing participation in the National Historic Preservation program.
No, Executive Orders 12072 and 13006 only apply to agencies looking for space in urban areas.
After an agency identifies its geographic service area and delineated area within which it wishes to locate specific activities are in an urban area (
(a) Consider agency-controlled historic properties within historic districts inside central business areas when locating Federal operations, in accordance with Executive Order 13006 (which, by reference, also incorporates the requirements in Executive Order 12072 and the Rural Development Act of 1972);
(b) Then consider agency-controlled developed or undeveloped sites within historic districts, if no suitable agency-controlled historic property specified in paragraph (a) of this section is available;
(c) Then consider agency-controlled historic properties outside of historic districts, if no suitable agency-controlled site exists within a historic district as specified in paragraph (b) of this section;
(d) Then consider non-historic agency-controlled properties, if no suitable agency-controlled historic properties outside of historic districts exist as specified in paragraph (c) of this section;
(e) Then consider historic properties under the custody and control of the U.S. Postal Service, if there is no available space in non-historic agency-controlled properties specified in paragraph (d) of this section.
(f) Then consider non-historic properties under the custody and control of the U.S. Postal Service, if there is no available space in historic properties under the custody and control of the U.S. Postal Service specified in paragraph (e) of this section.
If no suitable space in non-historic buildings under the custody and control of the U.S. Postal Service is available, agencies may then acquire real estate by purchase, lease, or construction, in accordance with FMR part 102-73.
Yes, if an agency has a specific location need to be in an urban area,
Central cities are those central cities defined by OMB in OMB Bulletin No. 99-04 or succeeding OMB Bulletin.
If an agency has a need to be in a specific urban area that is not a central city in a metropolitan area, then the agency must give first consideration to locating in a historic building in a historic district in the CBA of the appropriate metropolitan area. If no such space is available, agencies must give consideration to locating in a non-historic building in a historic district in the CBA of the appropriate metropolitan area. If no such space is available, agencies must give consideration to locating in a historic building outside of a historic district in the CBA of the appropriate metropolitan area. If no such space is available, agencies should give consideration to locating in a non-historic building outside of a historic district in the CBA of the appropriate metropolitan area.
Yes, Federal agencies must give a price preference when acquiring space via either the lowest price technically acceptable or the best value tradeoff source selection process. See part 102-73 of this chapter for additional guidance.
Office of Governmentwide Policy, GSA.
Final rule.
The General Services Administration (GSA) is transferring coverage on real property policies to the Federal Management Regulation (FMR). A final rule published in the
December 13, 2002.
Stanley C. Langfeld, Director, Real Property Policy Division, at (202) 501-1737.
To promote efficient management of Government assets, which is the Federal Property and Administrative Services Act's original intent, GSA is improving its regulatory system by establishing the Federal Management Regulation (FMR) as the successor regulation to the Federal Property Management Regulations (FPMR). The FMR will contain a refined set of policies and regulatory requirements on managing property and administrative services. Non-regulatory guidance, procedures, information, and standards now in the FPMR is being removed from the regulation and will be available in separate documents, such as customer service guides, handbooks, brochures, Internet Web sites, and FMR bulletins.
The General Services Administration (GSA) has determined that this final rule is not a significant regulatory action for the purposes of Executive Order 12866.
This final rule is not required to be published in the
The Paperwork Reduction Act does not apply because this final rule does not impose reporting, recordkeeping or information collection requirements which require the approval of the Office of Management and Budget pursuant to 44 U.S.C. 3501,
This final rule is also exempt from Congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.
Acquisition of real property, Administrative practices and procedures, Concessions, Crime, Federal buildings and facilities, Fire prevention, Government real property management, Location of space, Public utilities, Safety and environmental management, Security measures, Vending facility program for blind persons.
40 U.S.C. 486(c); Executive Order 12191 dated February 1, 1980; Sec. 205(c), 63 Stat. 390.
For information on Federal facility ridesharing,
40 U.S.C. 486(c).
For information on fire protection (firesafety) engineering,
E.O. 12072, Sec. 1-201(b), 43 FR 36869.
For information on acquisition of real property,
40 U.S.C. 486(c); 40 U.S.C. 490 (The Federal Property and Administrative Services Act of 1949, as amended, Sec. 205(c) and 210, 63 Stat. 377); and 40 U.S.C. 601-619 (The Public Buildings Act of 1959, as amended); Pub. L. 92-313.
For information on construction and alteration of public buildings,
40 U.S.C. 486(c); The Federal Property and Administrative Services Act of 1949, as amended, Sec. 205(c), 63 Stat. 390.
For information on management of buildings and grounds,
40 U.S.C. 486(c); The Federal Property and Administrative Services Act of 1949, as amended, Sec. 205(c), 63 Stat. 390.
For information on public utilities,
40 U.S.C. 486(c); The Federal Property and Administrative Services Act of 1949, as amended, Sec. 205(c), 63 Stat. 390.
For information on utilization and disposal of real property,
For information on location of space,
Centers for Disease Control and Prevention, Office of Inspector General, HHS.
Interim final rule.
This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. This document also contains delegations of authority to the Office of Inspector General concerning civil money penalties. The interim final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts. In addition and in accordance with the Agricultural Bioterrorism Protection Act of 2002, the Department of Agriculture is establishing, by separate regulation, standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. This action is necessary to protect animal and plant health, and animal and plant products.
The interim final rule is effective as of February 7, 2003. However, for dates of specific applicability see § 73.0. Written comments must be submitted on or before February 11, 2003. The final rule will be published after consideration of the comments.
Select Agent Program, Centers for Disease Control and Prevention, 1600 Clifton Rd., E-79, Atlanta, GA 30333. Comments may be e-mailed to:
Minh Thomas, Select Agent Program, Centers For Disease Control and Prevention, 1600 Clifton Rd., MS E-79, Atlanta Ga. 30333. (404) 498-2259.
This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of certain biological agents and toxins (referred to below as select agents and toxins). This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications. The Act requires an interim final rule and mandates its effective date and transition provisions. The new regulations are set forth in a new 42 CFR part 73 (referred to below as the part 73 regulations).
The part 73 regulations implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188 (referred to below as the Act).
In general, the entities regulated under the part 73 regulations are academic institutions and biomedical centers; commercial manufacturing facilities (the pharmaceutical industry); federal, state, and local laboratories, including clinical and diagnostic laboratories; and research facilities.
Based on provisions of the Act (42 U.S.C. 262a, note), the part 73 regulations supersede the regulations at 42 CFR 72.6 (referred to below as the § 72.6 regulations). The § 72.6 regulations, which became effective April 15, 1997, established certain shipping and handling requirements on laboratory facilities that send or receive “select agents.” In addition to regulating transfers, the part 73 regulations, among other things, cover the “possession and use” of select agents and toxins and include requirements for security risk assessments conducted by Department of Justice. The Act bolstered the authority to protect against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts.
The Act gives the Department of Agriculture (referred to below as USDA) the authority and responsibility for regulating activities regarding select agents and toxins to protect animal and plant health and animal and plant products. The Act gives the Department of Health and Human Services (referred to below as HHS) the authority and responsibility for regulating activities regarding select agents and toxins to protect the public health and safety. Some of the select agents and toxins regulated under this part are also regulated by USDA under 9 CFR part 121. The select agents and toxins subject to regulation by both agencies are identified as “overlap” select agents and toxins and those regulated solely by HHS are identified as HHS select agents and toxins. The Act provides for interagency coordination between the two departments regarding overlap select agents and toxins.
In addition to explaining information discussed above, § 73.2 explains that the part 73 regulations do not apply in two types of situations. Paragraph (b) states that the part 73 regulations do not set requirements for the exportation of select agents or toxins. The Department of Commerce has primary responsibility for regulating the exportation of microorganisms and toxins at 15 CFR. Paragraph (c) states that the part 73 regulations do not set requirements for the transportation in commerce of select agents or toxins. The Department of Transportation has primary responsibility for regulating the transportation of such select agents and toxins as hazardous materials under 49 CFR parts 171 through 180. Other agencies may also have authority over microorganisms that are exported or transported. For example, FDA regulates unapproved products used in clinical trials and such products would be subject to FDA's provisions as well as the provisions of the Department of Commerce or the Department of Transportation. The regulation only lists the agencies with primary authority over transportation and exports.
The provisions of § 73.3, consistent with the intent of the Act, provide that entities and individuals are allowed to conduct activities regulated by the part 73 regulations only if they are conducted for a lawful purpose and in accordance with the part 73 regulations.
The HHS select agents and toxins are listed in § 73.4 and the overlap select agents and toxins are listed in § 73.5.
In a notice of intent to issue regulations published in the
We prepared the list for the notice of intent to issue regulations after receiving extensive input from a group of scientists from 21 Federal government entities. We made all of the determinations discussed below in response to the comments based on recommendations from the same group of scientists.
The Act (42 U.S.C. 262a (a)(1)(B)) provides the following criteria that the HHS Secretary must consider for establishing the list:
• The effect on human health of exposure to the agent or toxin;
• The degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;
• The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and
• Any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate.
The interim final rule does not make distinctions concerning children or other specific populations because we are unaware of any basis for making such distinctions.
The notice did not include “viruses causing hantavirus pulmonary syndrome” and “yellow fever virus” on the list of select viruses. One commenter, without providing reasons, asserted that they should be included on the list. We have not included them on the list in the interim final rule. “Viruses causing hantavirus pulmonary syndrome” are difficult to propagate and there is a lack of data establishing laboratory acquired infections. Also, there is an available and effective vaccine for “Yellow fever virus.”
The notice included “Monkeypox virus” on the list of select viruses. One commenter indicated that it is not easily transmissible to humans, there is no indication that this agent has ever been chosen as a potential bioweapon, and this agent has not been demonstrated to result in high levels of mortality. We have included “Monkeypox virus” on the list of non-overlap viruses. Monkeypox has similarities with smallpox virus in that monkeypox has a similar clinical presentation, causes similar mortality rates as observed in recent outbreaks, is highly infectious when aerosolized, and is reported to have chains of transmission for several generations.
The notice included “Herpes B virus” on the list of select viruses. Six commenters indicated that it should be deleted based on assertions that there is no indication that this agent has ever been chosen as a potential bioweapon, the agent has not been shown to be easily transmissible to humans, the agent has not been demonstrated to result in high levels of mortality, and there is little evidence in the literature of true aerosol transmission of the naturally occurring virus. With changes to reflect current taxonomic classification and nomenclature, we have included it on the list of HHS agents and toxins as “Cercopithecine herpesvirus 1 (Herpes B virus)” based on the scientific data that it is lethal to humans, can be replicated in large concentrations, and can cause infection via the aerosol route.
The notice did not include “Camelpox” on the list of select viruses. One commenter asserted that “Camelpox” should be included on the list based on the assertion that recent publications have raised concerns about its potential use as a biological weapon. We have not included “Camelpox” on the list because it has not been associated with human illness or disease.
The notice included “Variola major (smallpox)” on the list of select viruses. One commenter requested that we change “Variola major (smallpox)” to “Variola major and variola minor associated viruses including alastrim.” We have made this change by including “Variola major virus (Smallpox virus) and Variola minor (Alastrim)” on the list of HHS select agents and toxins. “Variola minor virus,” also known as “Variola Alastrim,” is another virus that causes smallpox and like “Variola major virus” is highly infectious and lethal and can be spread by inhalation.
The notice included “
The notice did not include “
The notice did not include “aflatoxins” on the list of select toxins. One commenter asserted, without reasons, that these organisms should be included on the list. We have not included them on the list because the acute toxicity is too low to pose a significant mass casualty threat.
The notice included “Shigatoxin and Shiga-like toxins” on the list of select toxins. One commenter asserted that a change is needed in the reference to “Shiga-like toxins” to clarify that it does not include analogous proteins that are not toxic, and another commenter similarly asserted that the same term should identify or at least quantify the specific “Shiga-like toxins” to be included. We agree with the commenters and clarified the list of select toxins to include “Shigatoxin and Shiga-like ribosome inactivating proteins.”
In the notice, certain toxins were on the list of select toxins only if the aggregate amount were more than a specified amount. Three commenters argued in favor of the principle that a toxin should be listed without distinctions regarding amounts. One commenter asserted that the aggregate amounts for toxins are too low and do not take into account the vastly different toxicities of these listed materials. We made no changes based on these comments. The Act (42 U.S.C. 262a (a)(1)(A)) states that the list is to include those toxins that have the potential to pose a severe threat to public health and safety. We believe that the specified toxins at levels below the threshold levels do not meet the Act's criteria for inclusion. Further, as evidenced by the different amounts for certain toxins, we did take into account the different toxicities of toxins.
One commenter recommended that the list of toxins include only those with an LD
One commenter asserted that the “Botulinum neurotoxins” should be included only if quantities are greater than 13 milligrams and the listing for “
With respect to the listing in the notice of “full-length” nucleic acids, commenters raised concern that the deletion of one nucleic acid would not constitute “full-length” even though capable of causing harm similar to a “full-length.” We agree with the commenters and changed the listings to exclude only those forms that are not capable of yielding infectious and/or replication-competent forms of any of the viruses listed (accordingly, forms such as microarrays are not on the list).
Regarding the proposed regulation of “Nucleic acids (synthetic or naturally derived) of Variola major virus (smallpox virus) and Variola minor virus (Alastrim) that are 100 nucleotides or more in length,” one commenter noted that Variola virus shares many conserved nucleic acid sequences with other Orthopoxviruses (
The provisions of §§ 73.4 and 73.5 include procedures for excluding attenuated strains of select agents and toxins upon a determination that they do not meet the Act's criteria for inclusion,
Paragraph (a) of § 73.6 states that an entity is exempt from the provisions of this part, other than § 73.14 (transfer), if all of the following apply:
• The only activities conducted by the entity that are subject to the part 73 regulations concern select agents or toxins that are contained in specimens or in isolates from the specimens presented for diagnosis, verification, or proficiency testing;
• Upon identification as the result of diagnosis or verification, the entity immediately reports to HHS any of the following: Variola major virus (Smallpox virus) and Variola minor (Alastrim),
• The entity reports as required under Federal, State, or local law, to appropriate authorities;
• After diagnosis, verification, or proficiency testing, the entity either transfers the specimens or isolates from the specimens to a facility eligible for receiving them, or destroys them on-site by autoclaving, incineration, or by means of a sterilization or neutralization process sufficient to cause inactivation;
• The entity transfers or destroys those select agents or toxins used for diagnosis or verification within seven calendar days after identification, unless directed otherwise by the Federal Bureau of Investigation or other law enforcement entity after consultation with the HHS Secretary;
• The entity transfers or destroys those select agents or toxins used for proficiency testing within 90 calendar days after receipt; and
• The entity prepares a record of the identification and transfer or destruction on CDC Form 0.1318, submits the completed form to the HHS Secretary within seven calendar days after the transfer or destruction, and maintains a copy of the record for a period of three years.
The provisions of this exemption meet the requirements of the Act (42 U.S.C. 262a (g)(1)). The Act mandates such an exemption for diagnosis, verification, or proficiency testing regarding select agents and toxins. It also requires reporting to HHS and when required under Federal, State, or local law, to other appropriate authorities, and further requires the agents or toxins to be transferred or destroyed after use.
This requirement that the entity immediately reports to HHS upon identification of any of biological agents listed in § 73.6 (a)(2) is warranted because HHS has determined that these pose the greatest risk to public health and safety and national security.
Allowing seven calendar days for transfer or destruction for select agents or toxins identified through diagnosis or verification and 90 calendar days for transfer or destruction of select agents or toxins used for proficiency testing will provide sufficient time to accomplish the intended purpose.
The requirements that the entity must notify HHS within seven calendar days after identification and maintain the record of notification, provide a means for documenting that the transfer or destruction actually occurred. We request comment on the sufficiency of the 7-day and 90-day requirements for the transfer or destruction of the select agent or toxin after identification.
Paragraph (b) of § 73.6 states that unless the HHS Secretary issues an order to an entity making specific provision of this part applicable to protect the public health and safety, products that are, bear, or contain listed select agents or toxins that are cleared, approved, licensed, or registered under any of the following laws are exempt from the provisions of the part 73 regulations insofar as their use is only for the approved purposes and meets the requirements of such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262);
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
This exemption is mandated by the Act (42 U.S.C. 262a (g)(2)).
Paragraph (c) of § 73.6 states that the HHS Secretary may exempt on a case-by-case basis an investigational product that is, bears, or contains a listed select agent or toxin from the requirements of the regulations when such product is being used in an investigation authorized under a Federal Act referred to above in the discussion concerning § 73.6 (b) and additional regulation under this part is not necessary to protect public health and safety. Paragraph (c) also sets forth application provisions and requires the HHS Secretary to make a determination within 14 calendar days after receipt of the application if the application meets certain requirements.
The Act specifically provides for this exemption, including the time frame for
Paragraph (d) of § 73.6 states that the HHS Secretary may temporarily exempt an entity from the requirements of the regulations, in whole or in part, based on a determination that the exemption is necessary to provide for the timely participation of the entity in response to a domestic or foreign public health emergency. Paragraph (d) further provides that the exemption may not exceed 30 calendar days, except that the HHS Secretary may grant one extension of an additional 30 calendar days. In addition, it sets forth application provisions.
The Act specifically provides for this exemption, including the time limits (42 U.S.C. 262a (g)(3)).
Paragraph (e) of § 73.6 states that upon request of the USDA Secretary, after the granting by the USDA Secretary of an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 based on a finding that there is an agricultural emergency, the HHS Secretary may temporarily exempt an entity from the applicability of the requirements of this part, in whole or in part, to provide for the timely participation of the entity in response to the agricultural emergency. Paragraph (e) further provides that the exemption may not exceed 30 calendar days, except that upon the request of the USDA Secretary, the HHS Secretary may grant one extension of an additional 30 calendar days.
The Act specifically provides for this exemption, including the time limits (42 U.S.C. 262a (g)(4)).
Paragraph (a) of § 73.7 states that an entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless the entity has been granted a certificate of registration by HHS or USDA. This reflects requirements in the Act (42 U.S.C. 262a (d)).
Paragraph (b) contains information concerning the submission of an application for a certificate of registration to HHS or USDA and sets forth the information required to be included in the application. The requested information is needed to determine whether an applicant is eligible for a certificate of registration by meeting the requirements of the part 73 regulations. The requested information is necessary to make a preliminary determination if the entity meets the requirements of this part. We are requesting comments on the information required in the application for registration.
Paragraph (c) explains that an application that covers any HHS select agent or toxin (regardless of whether it also covers overlap select agents or toxins) must be submitted to HHS and an application that covers only overlap select agents or toxins may be submitted either to HHS or USDA. This reflects the intent of the Act to provide joint jurisdiction over activities and avoid unnecessary burden regarding overlap select agents and toxins (7 U.S.C. 8411). Regardless of which agency receives the application regarding an overlap select agent or toxin, both agencies will provide input before a determination is made to grant or deny a certificate of registration.
Paragraph (d) provides that a certificate of registration will be valid only for the specific select agents and toxins and the specified activities and locations consistent with the information upon which the certificate of registration or amendment was granted. This requirement reflects the conclusion that each situation for conducting activities involving select agents and toxins is unique, and HHS or USDA can only issue a certificate of registration based on the information submitted.
Paragraph (d) also provides that the Responsible Official of an agency must get prior approval by promptly notifying the HHS Secretary in writing in accordance with § 73.21, if any change occurs in any information submitted in the application for the certificate of registration or amendments. This includes modifications to the list of individuals approved under § 73.8, changes in area of work, or changes in protocols or objectives of studies. This requirement is necessary to enable HHS to ensure that the entity continues to meet the requirements of the part 73 regulations.
Paragraph (d) contains provisions for obtaining amendments to a certificate of registration to add select agents or toxins or to change specified activities or locations.
Paragraph (e) contains provisions for granting a certificate of registration if the requirements of the part 73 regulations are met. Paragraph (e) also notes, consistent with the discussion above, that HHS will issue a certificate of registration or amendment for an HHS overlap select agent or toxin only if the USDA Secretary concurs that the requirements for obtaining a certificate of registration or amendment under 9 CFR part 121 have been met.
Paragraph (f) provides that a certificate of registration will cover activities at only one general physical location (a building or a complex of buildings at a single mailing address). This is designed to ensure that the Responsible Official is not over-extended and will be able to perform the activities required under § 73.9.
Paragraph (g) provides that a certificate of registration will be valid for up to three years. This will allow for varied expiration dates and thereby lessen the subsequent administrative burden regarding the processing of renewals. We are seeking comments on this time period for renewal of a registration.
Paragraph (h) provides that an entity must provide notice in writing to the HHS Secretary in accordance with § 73.21 at least five business days before destroying a select agent or toxin, if the destruction is for the purpose of discontinuing activities with an agent or toxin covered by a certificate of registration. This will allow the HHS Secretary to observe the destruction or take other action as appropriate.
Paragraph (a) of § 73.8 states that an entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless the entity and any individual who owns or controls the entity are approved by the HHS Secretary or the USDA Secretary based on security risk assessments by the Attorney General. Paragraph (b) of § 73.8 states that an individual may not have access to a select agent or toxin unless approved by the HHS Secretary or the USDA Secretary based on a security risk assessment by the Attorney General. These security risk assessments are required by the Act (42 U.S.C. 262a (e)).
Based on specific authority in the Act, paragraph (a) provides that the security risk assessment requirements do not apply to Federal, State, or local governmental agencies (42 U.S.C. 262a (e)), but the security risk assessments do apply to the Responsible Official and other individuals working for such agencies.
Paragraph (c) sets forth procedures for obtaining the security risk assessments.
Paragraph (d) restates the criteria in the Act for disapproving entities and individuals (42 U.S.C. 262a (e)). The Act states that “restricted persons,” as defined in 18 U.S.C. 175b, may not be granted access to select agents and toxins (42 U.S.C. 262a (e)). A restricted person is a person who:
• Is under indictment for a crime punishable by imprisonment for a term exceeding 1 year;
• Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
• Is a fugitive from justice;
• Is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));
• Is an alien illegally or unlawfully in the United States;
• Has been adjudicated as a mental defective or has been committed to any mental institution;
• Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or
• Has been discharged from the Armed Services of the United States under dishonorable conditions.
In addition, the HHS Secretary may deny or limit access if the individual is reasonably suspected by any Federal law enforcement or intelligence agency of: Committing a crime set forth in section 2332b(g)(5) of title 18 U.S.C.; knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331of such title18) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power (as defined in section 1801 of title 50 U.S.C.
Consistent with specific provisions in the Act, paragraph (e) also allows for limited approvals (42 U.S.C. 262a (e)).
Paragraph (f) provides that unless a shorter period is granted under paragraph (e), an approval for an entity or individual will be valid for three years unless terminated sooner at the request of the entity or individual, or terminated for cause.
Paragraph (g) implements specific provisions of the Act for requesting the Attorney General to expedite the security risk assessment process and for expediting the HHS Secretary's review process (42 U.S.C. 262a (e)). The Act allows expedited processing only for individuals (not entities). Expedited processing will be given to those cases showing good cause (
Under § 73.9, an entity conducting regulated activities must identify and authorize an individual as the Responsible Official. The Responsible Official must:
• Be approved for access to biological agents and toxins under § 73.8;
• Be familiar with the requirements of the part 73 regulations, and
• Have authority and responsibility to ensure that the requirements of the part 73 are met, on behalf of the entity.
These requirements regarding a Responsible Official are necessary to ensure management oversight of the implementation of the part 73 regulations and to establish a point of contact.
This section also provides for the designation of Alternate Responsible Officials to conduct the duties of the Responsible Official. The Responsible Official may identify one or more individuals, any of whom may serve as the Alternate Responsible Official when the Responsible Official is unavailable. The Responsible Official and all individuals identified to serve as the Alternate Responsible Official must meet all of the qualifications for a Responsible Official.
We recommend that the Responsible Official and Alternate Responsible Officials be either biosafety officers or senior management officials of the entity, or both. Although we understand that some entities have limited staff, to help foster objectivity we strongly recommend where feasible that the Responsible Official should not be an individual actually using, working with, or transferring or receiving the select agents and toxins.
Paragraph (a) of § 73.10 states that an entity subject to the provisions of the part 73 regulations must develop and implement a safety plan that:
• Considers the biosafety standards and requirements appropriate for BSL2, 3, or 4 operations,
• Meets the specific requirements for handling toxins found in 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories' and/or 29 CFR 1910.1200, “Hazard Communication,” whichever applies.
• Considers the requirements for handling toxins found in Appendix I in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories.”
• Considers the requirements for handling genetic elements, recombinant nucleic acids, and
These provisions are designed to implement the mandate in the Act to establish safety provisions commensurate with the risk the biological agent or toxin poses to the public health and safety (42 U.S.C. 262a (b)). Both BMBL and the NIH Guidelines provide for graded requirements based on the level of hazard posed by the specific agents and toxins. The work with these agents and toxins are classified into biosafety levels (BSL 1 through 4) based on their hazards and the quantities being handled. As the level of risk increases, the guidelines impose more stringent requirements for safety practices. These guidelines are accepted standards in the biomedical sector. In addition, grants that are awarded for funding improvements to public health agencies mandate compliance with the NIH Guidelines. Similarly, new grants from NIH to fund research on select agents and toxins mandate compliance with the NIH guidelines. Consequently, we expect that entities subject to this rule either are complying with these guidelines or are making provisions to comply. Further, these are essentially the same requirements imposed on entities under the § 72.6 regulations. We are seeking comments on the incorporation of these guidelines as requirements.
Paragraph (b) of § 73.10 states that:
• The Responsible Official must conduct regular inspections of the laboratory where select agents and toxins are stored or used to ensure compliance with all of the procedures and protocols of the safety plan,
• The results of these inspections must be documented, and
• Any problems identified during inspections must be addressed.
These provisions are added to help ensure that the safety provisions are met.
The concerns that prompted this rule and its authorizing statute are not limited to the Select Agents listed herein. Laboratory manipulation of microbes can alter their characteristics, either intentionally or inadvertently, so as to increase their virulence, pathogenicity, or host range or alter their mode of transmission or route of exposure in ways that increase risks to human, animal, or plant health. In particular, the resulting modified organisms could present risks equal to or even greater than the current select agents and toxins.
In recognition of this prospect, and to protect public health and safety and ensure security, paragraph (c) states that an entity may not conduct the following experiments unless approved by the HHS Secretary, after consultation with experts:
• Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
• Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD
This is to ensure that these categories of experiments with select agents and toxins involving recombinant DNA (as defined in the NIH Guidelines) are conducted only if safe to do so.
Also, we have reserved paragraph (d) for possible future specification of additional types of experiments that might warrant stringent scrutiny in the interest of safety; and we hereby request comments concerning what additional experiments, regardless if regulated under the part 73 regulations, might warrant such attention. In particular, we request comments addressing issues concerning experiments with biological agents that could possibly increase their virulence or pathogenicity; change their natural mode of transmission, route of exposure, or host range in ways adverse to human, animal, or plant health; result in the deliberate transfer of a drug resistant trait or a toxin-producing capability to a microorganism by means that do not involve recombinant DNA techniques; or involve research with Variola major virus and Variola minor virus (
The provisions of § 73.11 require entities subject to the provisions of the part 73 regulations to develop and implement a security plan establishing policy and procedures that ensure the security of areas containing select agents and toxins. The provisions of § 73.11 are designed to meet these objectives and the Act's mandate to establish security requirements for the purpose of protecting the public health and safety (42 U.S.C.262a (e)). We invite comments on these provisions, and are particularly interested in views on whether the provisions are sufficient to meet the purposes stated above.
The provisions of § 73.12 state that entities required to register under the part 73 regulations must develop and implement an emergency response plan. The requirements for the plan are designed to ensure that entities plan ahead to be ready to take appropriate action to deal with any hazard that could arise.
We also note that if the entity has prepared and implemented an emergency response plan or is part of a larger institution's plan developed under other Federal, State, or local emergency response planning laws (
The provisions of § 73.13 state that an entity required to register under this part must provide information and training on safety and security for working with select agents or toxins on a timely basis to each individual approved for access under § 73.8 and each unapproved individual working in, or visiting, areas where select agents and toxins are handled or stored. The criteria in § 73.13 are designed, consistent with the Act's mandate concerning training (42 U.S.C. 262a (b), to ensure that individuals understand the hazards and how to deal with them.
We also note that if the entity has an existing training program under OSHA or other government or entity programs, that training program, with any necessary amendments, may be used to meet the requirements of § 73.13.
The transfer provisions in § 73.14, consistent with specific provisions of the Act (42 U.S.C. 262a (b)), state that a select agent or toxin may not be transferred from one entity to another entity within the United States (regardless of whether the transfer is interstate or intrastate), or received by an entity in the United States from an entity outside the United States, unless the transfer meets specified requirements. The transfer provisions are designed to ensure that select agents and toxins are shipped only to recipients that have authority to use or possess them. Also, the transfer provisions are designed to ensure that HHS and the participants monitor the shipments and that any problems are quickly reported to HHS so that any required action could be taken.
The provisions of § 73.15 set forth record keeping requirements concerning the list of approved individuals, inventories, access to agents and toxins, and areas where agents are used. These requirements are designed to allow determinations concerning compliance with the requirements of the part 73 regulations and to help assign what action should be taken if an emergency were to arise. Some of the requirements concerning quantities apply only to toxins since quantity data concerning replicating organisms may not be meaningful. We invite comments on these requirements.
The part 73 regulations at § 73.16 set forth inspection provisions that apply during the time an application is pending and any time when a certificate
Consistent with the mandate in the Act, § 73.17 sets forth requirements for reporting thefts, losses, or releases of select agents or toxins (42 U.S.C. 262a (g)(8) and (j)). This is intended to determine responsibility for reporting and to help ensure that the appropriate information is reported so that effective and timely responses can be made.
To implement requirements of the Act (42 U.S.C. 262a (e)(7)), § 73.18 provides that an entity may obtain review of a decision denying or revoking a certificate of registration under 73.7 and the affected entity or individual may obtain review of a decision denying or revoking approval under 73.8. To help ensure timely resolution of disputes, the request for such review must be submitted in writing within 30 calendar days after the adverse decision. Under this section, the request for review must state the factual basis for the review, which will be carried out in accordance with 42 U.S.C. 262a(e)(7). Where the adverse decision is in whole or in part based upon notification by the Attorney General under 42 U.S.C. 262a(e)(3), the request for review will be forwarded to the Attorney General for the Attorney General's review and final notification to the HHS Secretary.
A discussion regarding the authority for, and the implementation of, civil money penalties by the Office of Inspector General is set forth below under the heading “Civil money penalties.”
The provisions of § 73.20 are informational. They note that the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) provides specific criminal penalties for violation of provisions of the part 73 regulations. They also note that other criminal penalties may apply for violation of the part 73 regulations.
Paragraphs (a), (b), and (c) of § 73.21 explain how to obtain forms and how to submit applications, requests, notifications, and other information under the part 73 regulations.
To help ensure the timely resolution of matters, paragraph (d) of § 73.21 sets forth a mechanism for considering applications or requests to be abandoned if the applicant or requester fails to respond within 30 calendar days (or within such time period agreed upon by the applicant or requester and the HHS Secretary) to an HHS request for additional information.
The provisions of § 73.0 include a phase-in period for certain requirements to allow entities to comply without causing disruption or termination of research or educational projects.
The phase-in for entities that on February 7, 2003, already were conducting activities under a certificate of registration issued under § 72.6 of this chapter or already were lawfully possessing select agents and toxins are as follows:
1. On and after February 7, 2003, the following provisions of part 73 are applicable: § 73.1 Definitions; § 73.2 Purpose and scope; § 73.3 General prohibition; § 73.4 HHS select agents and toxins; § 73.5 Overlap select agents and toxins; § 73.6 Exemptions from requirements under this part; § 73.9 Responsible Official; § 73.10 Safety; § 73.12 Emergency response; § 73.13 Training, but only those training provisions relating to safety and emergency response; § 73.15 Records; § 73.16 Inspections; § 73.17 Notification for theft, loss, or release; § 73.18 Administrative review; § 73.19 Civil money penalties; § 73.20 Criminal penalties; and § 73.21 Submissions and forms.
2. Before conducting activities subject to the interim final during the period from March 12, 2003, through November 11, 2003, such an entity must have submitted to HHS or USDA an application package under § 73.7 certifying compliance with the provisions referred to in (1) above.
3. Before conducting activities subject to the interim final during the period from March 12, 2003, through April 11, 2003, such an entity must have submitted applications for security risk approvals under § 73.8 to the Attorney General for the entity, the Responsible Official, and any individual who owns or controls the entity.
4. On and after March 12, 2003, such an entity must comply with the transfer requirements in § 73.14.
5. On and after April 12, 2003, such an entity must comply with the requirement to obtain security risk approvals under § 73.8 for the entity, the Responsible Official, and any individual who owns or controls the entity.
6. Before conducting activities subject to the interim final during the period from April 12, 2003, through June 11, 2003, such an entity must have submitted applications for security risk approvals under § 73.8 for all individuals with access to select agents and toxins.
7. On and after June 12, 2003, such an entity must comply with the requirement to obtain security risk approvals under § 73.8 for all individuals with access to select agents and toxins.
8. Before conducting activities subject to the interim final during the period from June 12, 2003, through September 11, 2003, such an entity must comply with the requirement in § 73.11 to develop a security plan.
9. On and after September 12, 2003, such an entity must fully comply with the provisions of § 73.11, including the provisions regarding the implementation of a security plan, and must fully comply with the provisions of § 73.13, including the training provisions relating to security.
10. On and after November 12, 2003, such an entity must comply with the requirement in § 73.7 to obtain a certificate of registration.
11. Such an entity also remains:
• Subject to the registration provisions of the § 72.6 regulations until November 12, 2003, when superseded by § 73.7;
• Subject to the security provisions regarding development of a security plan until June 12, 2003, when superseded by the requirement to develop a security plan under § 73.11;
• Subject to the security provisions of the § 72.6 regulations regarding implementation of a security plan until September 12, 2003, when superseded by the requirement to fully comply with § 73.11;
• Subject to the training provisions of the § 72.6 regulations related to security until September 12, 2003, when superseded by the requirement to fully comply with § 73.13; and
• Subject to the transfer provisions of the § 72.6 regulations until March 12, 2003, when superseded by § 73.14.
The following is a timeline of the registration phase-in period that is described in the previous paragraph:
We have also provided a more limited phase-in for entities that on February 7, 2003, were not already conducting activities under a certificate of registration issued under § 72.6 of this chapter and were not already lawfully possessing select agents as follows:
(1) On and after February 7, 2003, the following sections are applicable: §§ 73.1 through 73.6 (definitions, purpose and scope, general prohibition, HHS select agents and toxins, overlap select agents and toxins, exemptions from requirements under this part); §§ 73.8 through 73.10 (Security risk assessments, Responsible Official, Safety); §§ 73.12 through 73.21 (emergency response, training, transfers, records; inspections; notification for theft, loss, or release; administrative review; civil money penalties; criminal penalties; and submissions and forms) and must hold a valid permit under 9 CFR part 122 and/or 42 CFR part 71.54.
(2) On and after September 12, 2003, the provisions of § 73.11 (security) are applicable.
(3) On and after November 12, 2003, the provisions of § 73.7 (registration) are applicable.
(4) During the period from February 7, 2003, through November 11, 2003, such an entity may not conduct activities regulated under this part unless the entity has submitted to HHS or USDA an application package under § 73.7 certifying compliance with the provisions referred to in paragraph (b)(2) of this section.
In 1981, Congress enacted the civil money penalty statute, section 1128A of the Social Security Act (42 U.S.C. 1320a-7a), as one of several administrative remedies to combat increases in fraud and abuse. The civil money penalty law authorized the HHS Secretary and the Inspector General to impose civil money penalties and program exclusions on individuals and entities whose wrongdoing caused injury to HHS programs or their beneficiaries. Since 1981, the civil money penalty provisions have been expanded to apply by reference to numerous types of fraudulent and abusive activities.
The Act specifically authorized civil money penalties against any individual or other person violating the part 73 regulations (42 U.S.C. 262a (i)). The Act incorporates by reference many of the provisions of section 1128A of the Social Security Act. As a result, and in accordance with section 1128A(j)(2) of the Social Security Act, the Office of the Inspector General may impose a civil money penalty in an amount not exceeding $250,000 in the case of an individual, and up to $500,000 in the case of any other person, who violates the Act. Accordingly, to address this new civil money penalty authority, we added provisions to the part 73 regulations at § 73.19 and are amending 42 CFR parts 1003 as follows:
• In § 1003.100, Basis and purpose, we are revising paragraph (a), redesignating paragraph (b)(3) to read as (b)(4), and adding a new paragraph (b)(3), stating the broad purpose of this new civil money penalty authority.
• In § 1003.101, Definitions, we are adding a definition for the term “Select agents and toxins” consistent with the definition in the part 73 regulations.
• In § 1003.102, Basis for CMPs and assessments, we are redesignating existing paragraphs (d) and (e) to read respectively as paragraphs (e) and (f), and adding a new paragraph (d) to cross-reference the implementing regulations and the OIG's authority to impose penalties for determined violations.
• In § 1003.103, Amount of penalty, we are adding a new paragraph (l) to address the $250,000/$500,000 maximum penalty amounts.
The OIG specifically seeks public comments on the possible inclusion of specific mitigating and aggravating factors in considering penalty amounts.
The Act (42 U.S.C. 262a (h)) prohibits the disclosure under the Freedom of Information Act (5 U.S.C. 552) of certain information concerning registrations; transfer documentation; safeguard and security measures; notifications of
The Act requires this document to be published as an interim final rule (42 U.S.C. 262a, note).
The Centers for Disease Control and Prevention (referred to below as the CDC) has determined that the Paperwork Reduction Act (44 U.S.C. Chapter 35) applies to the data collection activities in this Interim Final Rule. In compliance with the Paperwork Reduction Act, CDC publishes a list of information collection requests under review by the Office of Management and Budget (OMB). To request more information on the proposed data collection or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer at (404) 498-1210.
CDC is proposing to collect this information through the use of five separate forms. These forms are: (1) Application for Registration; (2) Facility Notification Form; (3) Request for Exemption; (4) Transfer of Select Agent Form; and (5) Clinical and Diagnostic Laboratory Reporting Form.
The Application for Registration (CDC Form 0.1319) will be used by facilities to register with CDC. The Application for Registration requests facility information, a list of select agents and toxins in use, possession, or for transfer by the facility, characterization of the select agent, and laboratory information. This form is a modification of an existing form approved under OMB Control No. 0920-0199. Estimated average time to complete this form is 3 hours, 45 minutes for an entity with one principal investigator working with one select agent. CDC estimates that entities will need an additional 45 minutes for each additional investigator or select agent. This is an increase of 1 hour, 45 minutes over the previous form due to new reporting requirements for security and identification of those individuals the entity has designated to have a legitimate need to handle or use select agents or toxins.
Facilities must amend their registration if certain changes occur in the information submitted to the HHS Secretary. To apply for an amendment to a certificate of registration, an entity must obtain the relevant portion of the application package and submit the information requested in the package to CDC. Estimated time to amend a registration package is 60 minutes.
The Facility Notification Form (CDC Form 0.1316) must be completed by facilities whenever there is release of a select agent or theft or loss of a select agent. This is a new form. Estimated average time to complete this form is 60 minutes.
The Request for Exemption Form (CDC Form 0.1317) will be used by facilities that are using select agents or toxins in investigational new drug testing or in cases of public health emergency. This is a new form. Estimated average time to complete this form is 70 minutes.
The Transfer of Select Agent Form (CDC Form EA-101) will be used by facilities requesting transfer of a select agent or toxin to their facilities and by the facility transferring the agent. This is a modification of an existing form approved under OMB Control No. 0920-0199. Estimated average time to complete this form is 1 hour, 45 minutes. This is an increase of 75 minutes due to procedural changes.
The Clinical and Diagnostic Laboratory Exemption Report (CDC Form 0.1318) will be used by clinical and diagnostic laboratories to notify the HHS Secretary that select agents or toxins identified as the result of diagnosis or proficiency testing have been properly disposed of. This is a new form. Estimated average time to complete this form is 60 minutes.
In addition to the standardized forms, the part 73 regulations also outline situations in which an entity must notify or make a request of the HHS Secretary in writing and CDC is requesting OMB approval to collect this information. The regulation states that an entity must notify the HHS Secretary in writing at least five business days before destroying select agents or toxins. The estimated time to gather the information and submit this notification is 30 minutes. An entity may also apply to the HHS Secretary for an expedited review of an individual by the Attorney General. To apply for this expedited review, an entity must submit a request in writing to the HHS Secretary establishing the need for such action. The estimated time to gather the information and submit this request is 30 minutes. Entities should be aware that CDC is not developing standardized forms to use in these situations. Rather, the entity should provide the information as requested in the appropriate section of the regulation.
As part of the safety requirements of this regulation, the Responsible Officer is required to conduct regular inspections (at least annually) of the laboratory where the select agents and toxins are stored. The results of these inspections must be documented. CDC estimates that, on the average, such documentation will take one hour.
Finally, as part of the safety requirements of this regulation, the entity is required to record the identity of the individual trained, the date of training, and the means used to verify that the employee understood the training. Estimated time for this documentation is 2 hours per principal investigator.
An entity or an individual may request administrative review of a decision denying or revoking certification of registration in writing within 30 calendar days after the adverse decision. This request should include a statement of the factual basis for the review. CDC estimates the time to prepare and submit such a request is four hours.
Finally, an entity must implement a system to ensure that certain records
The total annualized burden for this data collection is 30,777 hours.
This document has been reviewed by the Office of Management and Budget under Executive Order 12866.
In the course of developing the rule, CDC considered the rule's costs and benefits. CDC's analysis is summarized below.
The entities generally fall into one of four categories: academic institutions and biomedical centers; commercial manufacturing facilities (the pharmaceutical industry); federal, state, and local laboratories, including clinical and diagnostic laboratories; and research facilities. Based on the initial notifications, academic institutions and commercial facilities comprise 81 percent of the regulated entities.
The expected registered entities are estimated to have about 20,000 staff that will be required to submit information to the Attorney General for approval. In general, entities limit access to select agents or toxins to a far smaller population than their overall workforce. In most cases, this smaller population is composed of scientific staff. The number of employees directly handling select agents or toxins typically ranges from approximately three individuals at smaller commercial and state entities to more than one hundred researchers at some large academic institutions. On average, commercial entities authorize approximately 12 individuals to work with select agents or toxins. Similarly, at state entities the average number of authorized employees is estimated at about 15. Authorized populations at research institutes and at federal entities are larger, with approximately 25 employees handling select agents or toxins on average. Academic institutions have the largest staff directly working with select agents or toxins, averaging almost 40 authorized persons per entity.
There is wide variation in current security practices, although there is a correlation between BSL levels and security levels. For example, BSL-3 laboratories tend to have more security than BSL-2 laboratories. Nevertheless, even for laboratories of the same type or BSL level, some variation exists. There also appears to be systematic variation across laboratories of different types. In general, security is relatively strong at federal laboratories, research institutes, and commercial laboratories; security practices at academic institutions and state laboratories are more variable.
Most entities (approximately 70 percent) have a training program in place that addresses the safety of staff that is in proximity to or handling select agents. Of the remaining entities (that do not have a standard safety training program in place), some of them train people on the job as necessary for the employee to learn some skills or improve his or her proficiency. All commercial entities have a standardized safety training program in place—at the very least for the technical staff that work in the laboratories. The vast majorities of entities (85 percent) have a system in place to record and monitor the inventory of select agents or toxins.
Because many of the laboratories that will register under this rule are already substantially in compliance with the practices required, the costs of the rule are limited. The median annualized cost of the rule is estimated to range from $9,300 to $201,000 (annualized over 20 years). The estimated first year cost of the rule ranges from $23,400 for a small commercial entity with a BSL 3 lab to $730,400 for a medium university with a BSL2-3 lab. The total annualized cost of the rule is estimated to be $41 million.
Most of the cost of the rule (over 60 percent) is attributable to four initial activities: limiting access to select agents and work areas; developing and implementing a security plan; developing and implementing a safety plan; and obtaining risk assessments for existing staff.
The impacts resulting from the October 2001 anthrax attacks provide an example of the costs that a limited release could incur. The anthrax attacks caused five fatalities and 17 illnesses, disrupted business and government activities, closed substantial parts of the postal service, and caused widespread apprehension and changes in behavior. Costs included more than $23 million to decontaminate one Senate office building; approximately $2 billion in revenues lost to the postal service, and as much as $3 billion in additional costs to the postal service for cleanup of contamination and procurement of mail-sanitizing equipment. Substantial costs due to lost productivity throughout the economy and from ongoing costs of the investigations into the incident are additional impacts.
Implementation of the interim final rule will provide a means of determining where select agents and toxins are located; ensure that their transfer, storage, and use can be tracked; provide for the screening of personnel with access to such agents or toxins; and require that entities in possession of such agents or toxins develop and implement effective means of biosafety and physical security. The benefit of these provisions is a reduced likelihood of either an accidental or intentional release of select agents and toxins and the consequent avoidance of costs associated with such a release.
In large part, the rule establishes common sense rules that already should be followed by entities conducting activities under the rule. Moreover, any costs of compliance should not be significant. The annualized cost on small entities would not exceed one percent of sales or revenue stream and the initial cost would not exceed three percent of sales or revenue stream. A copy of the economic analysis, “Regulatory Impact Analysis, 42 CFR part 73, Select Biological Agents and Toxins, Interim Final Rule,” is available from on the CDC Web site at
Therefore, the HHS Secretary hereby certifies that the interim final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532 that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This rule would have no consequential effect on State, local, or tribal governments.
Biologics, Packaging and containers, Penalties, Reporting and recordkeeping requirements, Transportation.
Administrative practice and procedure, Fraud, Grant programs-health, Health facilities, Health professions, Maternal and child health, Medicaid, Medicare, Penalties, Social security.
42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a)
(a) For those entities that on February 7, 2003, were conducting activities under a certificate of registration issued under § 72.6 of this chapter, or were lawfully possessing select agents and toxins, the provisions of part 73 and § 72.6 of this chapter are applicable as follows:
(1) On and after February 7, 2003, the following sections are applicable: §§ 73.1 through 73.6 (definitions, purpose and scope, general prohibition, HHS select agents and toxins, overlap select agents and toxins, exemptions from requirements under this part); § 73.9 (Responsible Official); § 73.10 (Safety); § 73.12 (emergency response); and §§ 73.15 through 73.21 (records; inspections; notification for theft, loss, or release; administrative review; civil money penalties; criminal penalties; and submissions and forms).
(2) On and after February 7, 2003, the provisions of § 73.13 concerning training related to safety and emergency response are applicable; and on and after September 12, 2003, the remaining provisions of § 73.13, including those concerning training related to security, are applicable.
(3) On and after March 12, 2003, the provisions of § 73.14 (transfers) are applicable.
(4) On and after April 12, 2003, the provisions of § 73.8 regarding security risk assessments for the entity, the Responsible Official, and any individual who owns or controls the entity are applicable; and on and after June 12, 2003, the remainder of § 73.8 (including the provisions regarding individual risk assessments for other than the Responsible Official or any individual who owns or controls the entity) is applicable.
(5) On and after June 12, 2003, the provisions of § 73.11 regarding the development of a security plan are applicable, and on and after September 12, 2003, the remainder of the provisions of § 73.11, including the provisions regarding the implementation of a security plan, is applicable.
(6) On and after November 12, 2003, the provisions of § 73.7 (registration) are applicable.
(b) The following also applies to those entities that on February 7, 2003, already were conducting activities under a certificate of registration issued
(1) During the period from March 12, 2003, through November 11, 2003, such an entity may not conduct activities regulated under this part unless the entity has submitted to HHS or USDA an application package under § 73.7 certifying compliance with the provisions referred to in paragraph (a)(1) of this section and the provisions in § 73.13 concerning training related to safety and emergency response.
(2) During the period from March 12, 2003, through April 11, 2003, such an entity may not conduct activities regulated under this part unless the entity has submitted applications for approval under § 73.8 (security risk assessment) to the Attorney General for the entity, the Responsible Official, and any individual who owns or controls the entity.
(3) During the period from April 12, 2003, through June 11, 2003, such an entity may not conduct activities regulated under this part unless the entity has submitted applications for approval under § 73.8 (security risk assessments) to the Attorney General for all individuals (other than the Responsible Official and any individual who owns or controls the entity) with access to select agents and toxins.
(4) Such an entity remains:
(i) Subject to the registration provisions of § 72.6 of this chapter until November 12, 2003, when superseded by § 73.7;
(ii) Subject to the security provisions of § 72.6 of this chapter regarding development of a security plan until June 12, 2003, when superseded by the requirement to develop a security plan under § 73.11;
(iii) Subject to the security provisions of § 72.6 of this chapter regarding implementation of a security plan until September 12, 2003, when superseded by the requirement to fully comply with § 73.11;
(iv) Subject to the training provisions of § 72.6 of this chapter related to security until September 12, 2003, when superseded by the training provisions of § 73.13 relating to security; and
(v) Subject to the transfer provisions of § 72.6 of this chapter until March 12, 2003, when superseded by § 73.14.
(c) For those entities that on February 7, 2003, were not already were conducting activities under a certificate of registration issued under § 72.6 of this chapter and were not already lawfully possessing select agents and toxins, the provisions of part 73 are applicable as follows:
(1) On and after February 7, 2003, the following sections are applicable: §§ 73.1 through 73.6 (definitions, purpose and scope, general prohibition, HHS select agents and toxins, overlap select agents and toxins, exemptions from requirements under this part); §§ 73.8 through 73.10 (Security risk assessments, Responsible Official, Safety); §§ 73.12 through 73.21 (emergency response, training, transfers, records; inspections; notification for theft, loss, or release; administrative review; civil money penalties; criminal penalties; and submissions and forms) and must hold a valid permit under 9 CFR part 122 and/or 42 CFR part 71.54.
(2) The provisions of § 73.11 are applicable on and after September 12, 2003.
(3) On and after November 12, 2003, the provisions of § 73.7 (registration) are applicable.
(4) During the period from February 7, 2003, through November 11, 2003, such an entity may not conduct activities regulated under this part unless the entity has submitted to HHS or USDA an application package under § 73.7 certifying compliance with the provisions referred to in paragraph (b)(2) of this section.
For purposes of this part:
(a) This part sets forth requirements regarding the possession or use in the United States, receipt from outside the United States, or transfer within the United States, of select agents and toxins. The requirements are designed to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). The Act was
(b) This part does not set requirements for the exportation of select agents or toxins. The Department of Commerce has primary responsibility for regulating the exportation of microorganisms and toxins in Title 15 of the Code of Federal Regulations.
(c) This part does not set requirements for the transportation in commerce of select agents or toxins. The Department of Transportation has primary responsibility for regulating the transportation of such select agents and toxins as hazardous materials under 49 CFR parts 171 through 180.
An entity or individual may not possess or use in the United States, receive from outside the United States, or transfer within the United States, a select agent or toxin unless such activities are conducted for a lawful purpose and in accordance with the provisions of this part. Registration, exclusions, and exemptions are automatically revoked when any event occurs that results in an entity or individual no longer being eligible.
Except for exclusions under paragraph (f) of this section, the viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms specified in paragraphs (a) through (e) of this part are HHS select agents and toxins.
(a) Viruses:
(1) Crimean-Congo haemorrhagic fever virus.
(2) Ebola viruses.
(3) Cercopithecine herpesvirus 1 (Herpes B virus).
(4) Lassa fever virus.
(5) Marburg virus.
(6) Monkeypox virus.
(7) South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito).
(8) Tick-borne encephalitis complex (flavi) viruses (Central European Tick-borne encephalitis, Far Eastern Tick-borne encephalitis [Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever]).
(9) Variola major virus (Smallpox virus) and Variola minor virus (Alastrim).
(b) Bacteria:
(1)
(2)
(3)
(c) Fungi:
(d) Toxins:
(1) Abrin.
(2) Conotoxins.
(3) Diacetoxyscirpenol.
(4) Ricin.
(5) Saxitoxin.
(6) Tetrodotoxin.
(7) Shiga-like ribosome inactivating proteins.
(e) Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms:
(1) Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (d) of this section if the nucleic acids:
(i) Are in a vector or host chromosome;
(ii) Can be expressed
(iii) Are in a vector or host chromosome and can be expressed
(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) through (d) of this section that have been genetically modified.
(f) Exclusions:
(1) This section does not include any select agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) This section does not include non-viable select agent organisms or nonfunctional toxins.
(3) Paragraph (a) of this section does not include the vaccine strain of Junin virus (Candid #1).
(4) Paragraph (d) of this section does not include the following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified: 100 mg of Abrin; 100 mg of Conotoxins; 1,000 mg of Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of Shiga-like ribosome inactivating proteins; or 100 mg of Tetrodotoxin.
(5) The HHS Secretary may exclude from this section attenuated strains of HHS select agents or toxins upon a determination that they do not pose a severe threat to the public health and safety. To apply for an exclusion an applicant must submit a request in writing in accordance with § 73.21 to the HHS Secretary establishing that the attenuated strain or toxin is eligible for exclusion. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. An exclusion will be effective upon notification to the applicant. Exclusions will be published in the notice section of the
Except for exclusions under paragraph (f) of this section, the viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic acids, and recombinant organisms specified in paragraphs (a) through (e) of this part are overlap select agents and toxins.
(a) Viruses:
(1) Eastern Equine Encephalitis virus.
(2) Nipah and Hendra Complex viruses.
(3) Rift Valley fever virus.
(4) Venezuelan Equine Encephalitis virus.
(b) Bacteria:
(1)
(2)
(3)
(4)
(5)
(6)
(7) Botulinum neurotoxin producing species of
(8)
(9)
(c) Fungi:
(d) Toxins:
(1) Botulinum neurotoxins.
(2)
(3) Shigatoxin.
(4) Staphylococcal enterotoxins.
(5) T-2 toxin.
(e) Genetic elements, recombinant nucleic acids, and recombinant organisms:
(1) Select agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the select agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (d) of this section if the nucleic acids:
(i) Are in a vector or host chromosome;
(ii) Can be expressed
(iii) Are in a vector or host chromosome and can be expressed
(3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) through (d) of this section that have been genetically modified.
(f) Exclusions:
(1) This section does not include any select agent or toxin that is in its naturally occurring environment provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) This section does not include non-viable select agent organisms or nonfunctional toxins.
(3) Paragraph (a) does not include the vaccine strain of Rift Valley fever virus (MP-12) or Venezuelan Equine encephalitis virus vaccine strain TC-83.
(4) Paragraph (d) of this section does not include the following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified: 0.5 mg of Botulinum neurotoxins; 5 mg of Staphylococcal enterotoxins; 100 mg of
(5) The HHS Secretary, after consultation with the USDA Secretary, may exclude from this section attenuated strains of overlap select agents or toxins upon a determination that they do not pose a severe threat to the public health and safety and do not meet the criteria in 9 CFR part 121 for inclusion. To apply for an exclusion, an applicant must submit a request in writing in accordance with § 73.21 to the HHS Secretary or the USDA Secretary in accordance with 9 CFR part 121, establishing that the attenuated strain is eligible for exclusion. In response to an application submitted to the HHS Secretary, the HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. An exclusion will be effective upon notification to the applicant. Exclusions will be published in the notice section of the
(a) An entity is exempt from the provisions of this part, other than § 73.14 (transfer), provided that all of the following apply:
(1) The only activities conducted by the entity that are subject to this part concern select agents or toxins that are contained in specimens or in isolates from specimens presented for diagnosis, verification, or proficiency testing;
(2) Upon identification of a select agent or toxin as the result of diagnosis or verification, the entity immediately reports to the HHS Secretary by telephone, facsimile, or e-mail in accordance with § 73.21 any of the following: Variola major virus (Smallpox virus) and Variola minor (Alastrim),
(3) The entity reports as required under Federal, State, or local law, to appropriate authorities;
(4) After the diagnosis, verification, or proficiency testing, the entity either transfers the specimens or isolates containing a select agent or toxin from the specimens to a facility eligible for receiving them under this part, or destroys them on-site by autoclaving, incineration, or by a sterilization or neutralization process sufficient to cause inactivation;
(5) The entity transfers or destroys those select agents or toxins used for diagnosis or testing within seven days after identification, unless directed otherwise by the Federal Bureau of Investigation or other law enforcement entity after consultation with the HHS Secretary; and
(6) The entity transfers or destroys those select agents or toxins used for proficiency testing within 90 days after receipt; and
(7) The entity prepares a record of the identification and transfer or destruction on CDC Form 0.1318, submits the completed form to the HHS Secretary in accordance with § 73.21 within seven days after identification, and maintains a copy of the record for a period of three years.
(b) Unless the HHS Secretary issues an order to an entity making specific provisions of this part applicable to protect the public health and safety, products that are, bear, or contain listed select agents or toxins that are cleared, approved, licensed, or registered under any of the following laws, are exempt from the provisions of this part insofar as their use is only for the approved purpose and meets the requirements of such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. 262);
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
(c) The HHS Secretary may exempt from the requirements of this part on a case-by-case basis an investigational product that is, bears, or contains a select agent or toxin, when such product is being used in an investigation authorized under a Federal Act referred to in paragraph (b) of this section and additional regulation under this part is not necessary to protect public health and safety. To apply for an exemption an applicant must submit to the HHS Secretary in accordance with § 73.21 a completed CDC Form 0.1317 certifying that the product is being used in an investigation authorized under a Federal Act referred to in paragraph (b) of this section, and that additional regulation under this part is not necessary to protect public health and safety. The HHS Secretary shall make a determination regarding the application within 14 calendar days after receipt, provided the application meets all of the requirements of this section and the application establishes that the investigation has been authorized under the cited Act. The HHS Secretary will provide a written decision granting the request, in whole or in part, or denying the request. The applicant must notify the HHS Secretary when an authorization for an investigation no longer exists. This exemption automatically ceases when such authorization is no longer in effect.
(d) The HHS Secretary may temporarily exempt an entity from the requirements of this part, in whole or in part, based on a determination that the exemption is necessary to provide for the timely participation of the entity in
(e) Upon request of the USDA Secretary, after the USDA Secretary has granted an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 based on a finding that there is an agricultural emergency, the HHS Secretary may temporarily exempt an entity from the applicability of the requirements of this part, in whole or in part, to provide for the timely participation of the entity in response to the agricultural emergency. With respect to the emergency, the exemption under this part may not exceed 30 days, except that upon the request of the USDA Secretary, the HHS Secretary may grant one extension of an additional 30 days.
(a) An entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless the entity has been granted a certificate of registration by the HHS Secretary or the USDA Secretary.
(b) To apply for a certificate of registration an entity must:
(1) Obtain a registration application number from the HHS Secretary and then apply for approval under § 73.8 for the entity, the Responsible Official, and any individual who owns or controls the entity; and
(2) In accordance with § 73.21, submit the information requested to the HHS Secretary or the USDA Secretary as specified in the registration application package [CDC Form 0.1319]. Information submitted will be used to determine whether the applicant would be eligible to conduct activities under this part. Minimum information required includes:
(i) Identification information (
(ii) The name, source, and characterization information on select agents and toxins included in the registration, and quantities held at the time of the application;
(iii) The location, including building and room and floor plans for each building and room, where each select agent or toxin will be stored or used;
(iv) Information addressing safety, security, emergency response plans, and training, including descriptions of any equivalent measures adopted pursuant to § 73.11(d);
(v) The name, position, and identification information regarding the Responsible Official, including the identification number assigned by the Attorney General for compliance with § 73.8;
(vi) A list of individuals who will need access to select agents and toxins;
(vii) A certification statement signed by the Responsible Official attesting to the accuracy of the information submitted; and
(viii) Any other information necessary for the determination.
(c) An application that covers any HHS select agents or toxins (regardless of whether it also covers overlap select agents or toxins) must be submitted to the HHS Secretary in accordance with § 73.21. An application that covers only overlap select agents or toxins may be submitted to either the HHS Secretary or the USDA Secretary.
(d) A certificate of registration will be valid only for the specific select agents and toxins, and the specified activities and locations that are consistent with the information provided by the entity upon which the certificate of registration or amendment was granted. The Responsible Official must promptly notify the HHS Secretary in writing in accordance with § 73.21, if a change occurs in any information submitted to the HHS Secretary in the application for the certificate of registration or amendments. This includes modifications to the list of individuals approved under § 73.8, changes in area of work, or changes in protocols or objectives of studies. To apply for an amendment to a certificate of registration to add select agents or toxins or to change specified activities or locations, an entity must obtain the relevant portion of the registration application package and submit the information requested in the package to the agency that issued the certificate of registration. The package must be submitted to the appropriate address specified in the package.
(e) In response to an application to the HHS Secretary for a certificate of registration or amendment for select agents and toxins, the HHS Secretary will issue a certificate of registration or amendment if it is determined that the stated activities would be lawful (based on information submitted by the applicant or otherwise obtained by the HHS Secretary) and meet the requirements of this part. Otherwise, the application for a certificate of registration or amendment will be denied. The HHS Secretary will issue a certificate of registration or amendment for an overlap select agent or toxin only if the USDA Secretary concurs that the requirements for obtaining a certificate of registration or amendment under 9 CFR part 121 have been met. The determination of whether a certificate of registration or amendment will be granted may be contingent upon inspection or submission of additional information.
(f) A certificate of registration will cover activities at only one general physical location (a building or a complex of buildings at a single mailing address).
(g) Unless terminated sooner in accordance with this paragraph, a certificate of registration will be valid for up to three years. To obtain a new certificate of registration an entity must submit a new application. (Note: To help ensure timely processing of an application for a certificate of registration or amendment, the applicant should submit the application at least eight weeks prior to the expiration date.)
(1) The HHS Secretary will terminate a certificate of registration based on a determination that the recipient no longer conducts activities covered by the certificate.
(2) Also, the HHS Secretary may terminate a certificate of registration based on a security risk assessment under § 73.8 or failure to comply with the provisions of this part, and may take such action immediately if necessary to protect the public health or safety. Upon such termination, any select agent or toxin in the possession of the entity must be destroyed or transferred as directed by the HHS Secretary.
(h) An entity must provide notice in writing to the HHS Secretary in accordance with § 73.21 at least five business days before destroying a select agent or toxin, if the destruction would be for the purpose of discontinuing activities with a select agent or toxin covered by a certificate of registration. This will allow the HHS Secretary to observe the destruction or take other action as appropriate.
(a) An entity may not possess or use in the United States, receive from outside the United States, or transfer within the United States, any select agent or toxin unless approved by the HHS Secretary or the USDA Secretary based on a security risk assessment by the Attorney General. This paragraph does not apply to Federal, State, or local governmental agencies, but does apply to the Responsible Official and others working for or otherwise acting on behalf of such agencies.
(b) An entity may not provide an individual access to a select agent or toxin and an individual may not access a select agent or toxin, unless the individual is approved by the HHS Secretary or the USDA Secretary, based on a security risk assessment by the Attorney General.
(c) To obtain a security risk assessment under this section, an entity must submit to the Attorney General the information requested for the entity, the Responsible Official, any individual who owns or controls the entity, and any other individuals required to obtain approval under this section. The determinations regarding approval will be made by the agency that is responsible for making determinations regarding the corresponding certificate of registration. An entity will receive prompt notice of action taken in response to a request for approval for the entity, the Responsible Official, and individuals. An individual will receive prompt notice of a denial of approval.
(d) The Attorney General will conduct a security risk assessment on entities and individuals whose identifying information is properly submitted. Based on the security risk assessment, the Attorney General will notify the HHS Secretary if the Attorney General identifies any entity, individual who owns or controls the entity, or any other individual who is:
(1) A restricted person under 18 U.S.C. 175b; or
(2) Reasonably suspected by any Federal law enforcement or intelligence agency of:
(i) Committing a crime specified in 18 U.S.C. 2332b(g)(5);
(ii) Having a knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or
(iii) Being an agent of a foreign power (as defined in 50 U.S.C. 1801).
(e) The HHS Secretary will deny or revoke access to any select agent or toxin to an entity or individual identified by the Attorney General as a restricted person under paragraph (d)(1). The HHS Secretary will deny or revoke access to any select agent or toxin to an entity or individual identified by the Attorney General as meeting the criteria of paragraph (d)(2) unless determined by the HHS Secretary to be warranted in the interest of the public health and safety or national security. For individuals meeting the criteria of paragraph (d)(2) the HHS Secretary may provide a limited approval for a specified time based upon the finding that circumstances warrant such action in the interest of the public health and safety or national security.
(f) Unless a shorter period is granted under paragraph (e) of this section, an approval for an entity or individual under this section will be valid for five years unless terminated sooner. The HHS Secretary may terminate an approval for an entity or an individual based on a request from the entity or individual, a security risk assessment under this section, or a failure to comply with the provisions of this part, and may take such action immediately if necessary to protect the public health and safety, or national security.
(g) The HHS Secretary will request the Attorney General to expedite the review process for an individual and will take action to expedite the HHS Secretary's review process for an individual upon a showing of good cause (
(a) As a condition of conducting activities regulated under this part, an entity must identify and authorize an individual as the Responsible Official. The Responsible Official may identify one or more individuals, any of whom may serve as the Alternate Responsible Official when the Responsible Official is unavailable. The Responsible Official and all individuals identified to serve as the Alternate Responsible Official must meet all of the qualifications for a Responsible Official. The Responsible Official and all Alternate Responsible Officials must:
(1) Be approved under § 73.8;
(2) Be familiar with the requirements of this part; and
(3) Have authority and responsibility to ensure that the requirements of this part are met, on behalf of the entity.
(b) For purposes of this part, the Alternate Responsible Official acting in the absence of the Responsible Official may conduct all of those activities required under this part to be performed by the Responsible Official.
(c) The Responsible Official is responsible for ensuring compliance with the regulations, including:
(1) Developing and implementing safety, security and emergency response plans in accordance with § 73.10—§ 73.12;
(2) Allowing only approved individuals to have access to select agents or toxins in accordance with § 73.8 and § 73.11;
(3) Providing appropriate training for safety, security and emergency response in accordance with § 73.13;
(4) Transferring select agents or toxins in accordance with § 73.14;
(5) Providing timely notice of any theft, loss, or release of a select agent or toxin in accordance with § 73.13;
(6) Maintaining detailed records of information necessary to give a complete accounting of all activities related to select agents or toxins in accordance with § 73.15.
(7) The reporting of the identification of a select agent or toxin as a result of diagnosis, verification or proficiency testing in accordance with § 73.6.
(a) An entity subject to the provisions of this part, must develop and implement a safety plan. In developing a safety plan, an entity should consider:
(1) The biosafety standards and requirements for BSL 2, 3, or 4 operations, as they pertain to the respective select agents, that are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories,” including all appendices except Appendix F. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 371954, Pittsburgh, Pennsylvania, 75250-7954 or call in the Washington, DC metropolitan area 202-512-1800 or outside that area call toll free 1-866-512-1800. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. This publication is also available on the CDC Web site at
(2) The specific requirements for handling toxins found in 29 CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories” and/or 29 CFR 1910.1200, “Hazard
(3) For provisions of the safety plan relating to genetic elements, recombinant nucleic acids and recombinant organisms, the “NIH Guidelines for Research Involving Recombinant DNA Molecules,” (NIH Guidelines). This includes, among other things, provisions regarding risk assessment, physical containment, biological containment, and local review and applies to all recombinant DNA research, regardless of funding. Copies may be obtained from the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia, 30333. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia. The “NIH Guidelines for Research Involving Recombinant DNA Molecules,” is also available on the CDC Web site at
(b) The Responsible Official or his or her designee must conduct regular inspections (at least annually) of the laboratory where select agents and toxins are stored or used to ensure compliance with all of the procedures and protocols of the safety plan. The results of these inspections must be documented, and any deficiencies identified during inspections must be corrected.
(c) An entity may not conduct the following experiments unless approved by the HHS Secretary after consultation with experts:
(1) Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.
(d) [Reserved]
(a) An entity must develop and implement a security plan establishing policy and procedures that ensure the security of areas containing select agents and toxins. The security plan must be based on a systematic approach in which threats are defined, vulnerabilities are examined, and risks associated with those vulnerabilities are mitigated with a security systems approach.
(b) The plan must:
(1) Describe inventory control procedures, minimal education and experience criteria for those individuals with access to select agents or toxins, physical security, and cyber security;
(2) Contain provisions for routine cleaning, maintenance, and repairs; provisions for training personnel in security procedures; provisions for securing the area (
(3) Describe procedures for loss or compromise of keys, passwords, combinations, etc.;
(4) Contain procedures for reporting suspicious persons or activities, loss or theft of listed agents or toxins, release of listed agents or toxins, or alteration of inventory records;
(5) Contain provisions for the control of access to containers where listed agents and toxins are stored; and procedures for reporting and removing unauthorized persons;
(6) Contain provisions for ensuring that all individuals with access, including workers and visitors, understand security requirements and are trained and equipped to follow established procedures;
(7) Establish procedures for reporting and removing unauthorized persons; and
(8) Establish procedures for securing the area when individuals approved under § 73.8 are not present (
(c) The security plan must be reviewed by the RO at least annually and after any incident.
(d) With respect to areas containing select agents and toxins, the entity must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security as the provisions below:
(1) Allow unescorted access only to individuals who have been approved under § 73.8 and who are performing a specifically authorized function during hours required to perform the defined job (including delivery to an outside shipping agent for transportation in commerce);
(2) Allow individuals not approved under § 73.8 to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by individuals approved under § 73.8;
(3) Provide for the control of access to containers where select agents and toxins are stored by requiring freezers, refrigerators, cabinets, and other containers where stocks of select agents and toxins are stored to be locked (
(4) Require the inspection of all packages upon entry to and exit from the area;
(5) Establish a protocol for intra-entity transfers, including provisions for ensuring that the packaging, and movement from a laboratory to another laboratory or from a laboratory to a shipping place, is conducted under the supervision of an individual approved under § 73.8;
(6) Require that each approved individual under 73.8 does not share with any other person, his or her unique means (
(7) Require that each individual approved under § 73.8 report any of the following immediately to the Responsible Official:
(i) Any loss or compromise of their keys, passwords, combinations, etc.;
(ii) Any suspicious persons or activities;
(iii) Any loss or theft of select agents or toxins;
(iv) Any release of select agents or toxins; and
(v) Any sign that inventory and use records of select agents or toxins have been altered or otherwise compromised.
(e) The entity must separate areas where select agents and toxins are stored or used from the public areas of the buildings.
(f) Upon termination of the use, a select agent or toxin must be
(1) Securely stored in accordance with the requirements of this section;
(2) Transferred to another registered facility in accordance with § 73.14; or
(3) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.
(a) An entity required to register under this part must develop and implement an emergency response plan that meets the requirements of OSHA Hazardous waste operations and emergency response standard at 29 CFR 1910.120. Nothing in this section is to supersede or preempt the enforcement of the emergency response requirements
(b) The emergency response plan must be coordinated with any entity-wide plans. The plan must address such events as bomb threats, severe weather (hurricanes, floods), earthquakes, power outages, and other natural disasters or emergencies.
(c) The emergency response plan must address the following:
(1) The hazards associated with the use of the select agents and toxins;
(2) Any hazards associated with response actions that could lead to a spread of a select agent or toxin;
(3) Planning and coordination with outside parties;
(4) Personnel roles, lines of authority, training, and communication;
(5) Emergency recognition and prevention;
(6) Safe distances and places of refuge;
(7) Site security and control;
(8) Evacuation routes and procedures;
(9) Decontamination;
(10) Emergency medical treatment and first aid;
(11) Emergency alerting and response procedures;
(12) Critique of response and follow-up;
(13) Personal protective and emergency equipment; and
(14) Special procedures needed to address the hazards of specific agents.
(a) An entity required to register under this part and falls outside of the OSHA Bloodborne Pathogen Standard 29 CFR 1910.1030(a) must provide information and training on safety and security for working with select agents and toxins to each individual approved for access under § 73.8 and each unapproved individual working in, or visiting, areas where select agents and toxins are handled or stored. The information and training must meet the requirements of this section and must ensure that all individuals who work in, or visit, the areas understand the hazards of select agents and toxins present in the area.
(b) The entity must provide information and training at the time of an individual's initial assignment to a work area where select agents or toxins are present and prior to assignments involving new exposure situations. The entity must provide refresher training annually.
(c) The Responsible Official must provide appropriate training in safety, containment, and security to all individuals with access to areas where select agents and toxins are handled or stored.
(d) In lieu of initial training for those individuals already involved in handling select agents or toxins, the Responsible Official may certify in writing that the individual has the required knowledge, skills, and abilities to safely carry out the duties and responsibilities.
(e) The entity must ensure that each individual with access to areas where select agents or toxins are handled or stored received and understood the training required by this section unless certified under paragraph (d) of this section. The entity must record the identity of the individual trained, the date of training, and the means used to verify that the employee understood the training.
A select agent or toxin may not be transferred from one entity to another entity within the United States (regardless of whether the transfer is interstate or intrastate), or received by an entity in the United States from an entity outside the United States, unless:
(a) The sender:
(1) Has a certificate of registration that covers the transfer of the particular select agent or toxin to be transferred,
(2) Meets the exemption requirements under § 73.6 (a) for the particular select agent or toxin to be transferred, or
(3) Is transferring the select agent or toxin from outside the United States (and all import requirements are met);
(b) The recipient has a certificate of registration that includes the particular select agent or toxin to be transferred;
(c) Prior to the transfer, the recipient and sender completes CDC Form EA-101, and the recipient submits to the HHS Secretary in accordance with § 73.21 a completed CDC Form EA-101.
(d) CDC has authorized the transfer based on the finding that the recipient has a certificate of registration covering the transfer of the select agent or toxin;
(e) The sender complies with all applicable laws concerning packaging and shipping;
(f) The Responsible Official of the recipient provides a completed paper copy or facsimile transmission of CDC Form EA-101 to the sender and to the HHS Secretary within 2 business days of receipt of the select agent or toxin; and
(g) The recipient immediately reports to the HHS Secretary if the select agent or toxin has not been received within 48 hours after the expected delivery time, or if the package received containing select agents or toxins has been leaking or was otherwise damaged.
(h) When the select agents or toxins are consumed or destroyed after a transfer, the recipient must within five business days report such fact to the HHS Secretary in accordance with § 73.21 on a CDC Form EA-101.
This section does not cover transfers within an entity when the sender and the recipient are covered by the same certificate of registration.
The Responsible Official must maintain complete records relating to the activities covered by this Part. Such records include:
(a) An entity required to register under this part must maintain an up-to-date, accurate list of the individuals approved under § 73.8 for access to select agents and toxins.
(b) The entity must maintain an accurate, current inventory of each select agent and toxin held. The inventory records must include the following information for each select agent and toxin:
(1) The name, characteristics, and source data;
(2) The quantity held on the date of the first inventory (toxins only);
(3) The quantity acquired, the source, and date of acquisition;
(4) The quantity, volume, or mass destroyed or otherwise disposed of and the date of each such action;
(5) The quantity used and date(s) of the use (toxins only);
(6) The quantity transferred, the date of transfer, and individual to whom it was transferred (this includes transfers within an entity when the sender and the recipient are covered by the same certificate of registration);
(7) The current quantity held (toxins only);
(8) Any select agent or toxin lost, stolen, or otherwise unaccounted for; and
(9) A written explanation of any discrepancies.
(c) The entity must maintain the following records:
(1) For access to the select agents or toxins:
(i) The name of each individual who has accessed any select agent or toxin;
(ii) The select agent or toxin used;
(iii) The date when the select agent or toxin was removed, if removed from long-term storage or holdings for stock cultures;
(iv) The quantity removed (toxins only);
(v) The date the select agent or toxin was returned to the long-term storage or holdings for stock cultures; and
(vi) The quantity returned (toxins only);
(2) For access to the area where select agents are used or stored:
(i) The name of each individual who has accessed the area;
(ii) The date and time the individual entered the area;
(iii) The date and time the individual left the area; and
(iv) For individuals not approved under § 73.8, the individual approved under § 73.8 who accompanied the unapproved individual into the area.
(d) The entity must implement a system to ensure that all records and databases created under paragraphs (b) and (c) of this section are accurate, and that the authenticity of records may be verified.
(e) The entity must create a record concerning inspections conducted under § 73.10(b).
(f) Safety, security, and emergency response plans.
(g) Training records.
(h) Transfer documents (CDC Form EA-101) and permits.
(i) Safety and security incident reports.
(j) The entity must maintain all records created under this part for three years.
The HHS Secretary, without prior notification and with or without cause, shall be allowed to inspect any site at which activities regulated by this part are conducted and shall be allowed to inspect and copy any records relating to the activities covered by this part.
(a) Upon discovery of a theft or loss of a select agent or toxin, an entity required to register under this part must immediately notify the HHS Secretary and State and local law enforcement. The notification must be reported to the HHS Secretary by either telephone, facsimile, or e-mail in accordance with § 73.21.
(b) Thefts or losses must be reported whether the select agent or toxin is subsequently recovered or the responsible parties are identified.
(c) When reporting a theft or loss, the entity must provide the following information:
(1) The name of the select agent or toxin and any identifying information (
(2) An estimate of the quantity lost or stolen;
(3) An estimate of the time during which the theft or loss occurred; and
(4) The location (building, room) from which the theft or loss occurred.
(d) The entity shall immediately notify the HHS Secretary and State and local public health agencies of any release of a select agent or toxin causing occupational exposure or release outside of the primary containment barriers. The report must be made to the HHS Secretary by telephone, facsimile, or e-mail in accordance with § 73.21.
(e) When reporting a release, the entity must provide the following information:
(1) The name of the select agent or toxin and any identifying information (
(2) An estimate of the quantity released;
(3) The time and duration of the release;
(4) The environment into which the release occurred (
(5) The location (building, room) from which the release occurred;
(6) The number of individuals potentially exposed at the facility.
(7) Actions taken to respond to the release; and
(8) Hazards posed by the release.
(f) Within seven calendar days of theft, loss, or release, the entity must submit a follow-up report in writing to the HHS Secretary on CDC Form 0.1316 in accordance with § 73.21.
An entity may obtain review of a decision denying or revoking a certificate of registration under § 73.7 and the affected entity or individual may obtain review of a decision denying or revoking approval under § 73.8 by requesting such review in writing within 30 calendar days after the adverse decision. The request for review must state the factual basis for the review, which will be carried out in accordance with 42 U.S.C. 262a(e)(7). Where the adverse decision is in whole or in part based upon notification by the Attorney General under 42 U.S.C. 262a (e)(3), the request for review will be forwarded to the Attorney General for the Attorney General's review and final notification to the HHS Secretary.
(a) The Inspector General of the Department of Health and Human Services is delegated authority to conduct investigation and to impose civil money penalties against any individual or entity in accordance with regulations in 42 CFR part 1003 for violation of the regulations in this part, as authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). The delegation of authority includes all powers contained in section 6 of the Inspector General Act of 1978 (5 U.S.C. App.).
(b) The administrative law judges in, assigned to, or detailed to the Departmental Appeals Board (DAB) have been delegated authority to conduct hearings and to render decisions with respect to the imposition of civil money penalties, as authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188). This delegation includes, but is not limited to, the authority to administer oaths and affirmations, to subpoena witnesses and documents, to examine witnesses, to exclude or receive and give appropriate weight to materials and testimony offered as evidence, to make findings of fact and conclusions of law, and to determine the civil money penalties to be imposed.
(c) The DAB of the Department of Health and Human Services is delegated authority to make final determinations with respect to the imposition of civil money penalties for violations of the regulations of this part.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) provides specific criminal penalties for violation of provisions of this part. This is in addition to any other criminal penalties that would apply for violation of provisions of this part.
(a) CDC forms referred to in this part, including registration application packages, may be obtained on the Select Agent Program Web site at
(b) Applications, requests, notifications, and other information required to be submitted to the HHS Secretary in writing, but not required to be on a form, unless otherwise specified, must be submitted to the Select Agent Program, Center for Disease Control and Prevention, 1600 Clifton Road, NE., Mail Stop E 79, Atlanta, Georgia 30333, or by e-mail at
(c) Information not required to be submitted to the HHS Secretary on a form may be submitted to the Select Agent Program, Center for Disease Control and Prevention, 1600 Clifton
(d) If an application or request submitted to the HHS Secretary is incomplete or additional information is needed to allow the decision maker to make a determination, the HHS Secretary will notify the applicant or requester in writing of the deficiency and request additional information. If the applicant or requester fails to respond within 30 calendar days (or within such time period agreed upon by the applicant or requester and the HHS Secretary) the application or request will be deemed abandoned.
(e) You may request forms or other information from the USDA at the following address: APHIS, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 40, Riverdale, MD 20737-1231.
42 U.S.C. 262a, 1302, 1320-7, 1320a-7a, 1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).
(a)
(b)
(1) Provides for the imposition of civil money penalties and, as applicable, assessments against persons who—
(xiv) Have submitted, or caused to be submitted, certain prohibited claims, including claims for services rendered by excluded individuals employed by or otherwise under contract with such person, under one or more Federal health care programs;
(xv) Violate the Federal health care programs' anti-kickback statute as set forth in section 1128B of the Act; or
(xvi) Violate the provisions of part 73 of this chapter, implementing section 351A(b) and (c) of the Public Health Service Act, with respect to the possession and use within the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins in use, or transfer of listed biological agents and toxins.
For purposes of this part:
(b) The OIG may impose a penalty and, where authorized, an assessment against any person (including an insurance company in the case of paragraphs (b)(5) and (b)(6) of this section) whom it determines in accordance with this part—
(16) Is involved in the possession or use in the United States, receipt from outside the United States, or transfer within the United States, of select agents and toxins in violation of part 73 of this chapter as determined by the HHS Secretary, in accordance with sections 351A(b) and (c) of the Public Health Service Act.
(l) For violations of section 351A(b) or (c) of the Public Health Service Act and 42 CFR part 73, the OIG may impose a penalty of not more than $250,000 in the case of an individual, and not more than $500,000 in the case of any other person.
Animal and Plant Health Inspection Service, USDA.
Interim rule and request for comments.
In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are establishing, by regulation, standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. This action is necessary to protect animal and plant health, and animal and plant products.
This interim rule is effective on February 11, 2003. We will consider all comments that we receive on or before February 11, 2003.
You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 02-088-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 02-088-1. If you use e-mail, address your comment to
You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.
APHIS documents published in the
For information concerning the regulations in 7 CFR part 331, contact Dr. Robert Flanders, Chief, Pest Permit Evaluations Branch, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236, (301) 734-5930.
For information concerning the regulations in 9 CFR part 121, contact Dr. Denise Spencer, Senior Staff Veterinarian, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231, (301) 734-3277.
On June 12, 2002, the President signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188). Title II of Pub. L. 107-188, “Enhancing Controls on Dangerous Biological Agents and Toxins” (sections 201 through 231), provides for the regulation of certain biological agents and toxins by the Department of Health and Human Services (subtitle A, sections 201-204) and the Department of Agriculture (subtitle B, sections 211-213), and provides for interagency coordination between the two departments regarding overlap agents and toxins (subtitle C, section 221). Subtitle D (section 231) provides for criminal penalties regarding certain biological agents and toxins. For the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC) has been designated as the agency with primary responsibility for implementing the provisions of the Act; the Animal and Plant Health Inspection Service (APHIS) is the agency fulfilling that role for the Department of Agriculture (USDA).
In subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002,” referred to below as the Act ), section 212(a) provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that she determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act further requires (under section 213(b)) that all persons in possession of any listed biological agent or toxin must, within 60 days of the publication of that interim rule, notify the Secretary of such possession.
In accordance with these statutory requirements, on August 12, 2002, we published in the
Under section 212 of the Act, the Secretary must also provide by regulation for the establishment and enforcement of standards and procedures governing the possession, use, and transfer of listed biological agents and toxins in order to protect animal and plant health, and animal and plant products. Specifically, sections 212(b) and (c) require that the Secretary:
• Establish and enforce safety procedures for listed agents and toxins, including measures to ensure proper training and appropriate skills to handle agents and toxins, and proper laboratory facilities to contain and dispose of agents and toxins;
• Establish and enforce safeguard and security measures to prevent access to listed agents and toxins for use in domestic or international terrorism or for any other criminal purpose;
• Establish procedures to protect animal and plant health, and animal and plant products, in the event of a transfer or potential transfer of a listed agent or toxin in violation of the safety procedures and safeguard and security measures established by the Secretary; and
• Ensure appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.
This interim rule establishes the regulations required under the Act. To accomplish this, we are amending 7
Both 7 CFR part 331 and 9 CFR part 121 begin with sections that discuss the effective dates of the regulations, §§ 331.0 and 121.0, respectively. Pursuant to section 213(c) of the Act, the Secretary must, not later than 180 days after the Act's enactment, promulgate an interim final rule establishing the standards and procedures governing the possession, use, and transfer of listed biological agents and toxins that shall take effect 60 days after the date on which the rule is promulgated. However, the Act also requires that the interim final rule include timeframes for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents or toxins listed pursuant to section 212(a)(1) and that were underway as of the effective date of such rule.
Accordingly, in 7 CFR 331.0 and 9 CFR 121.0 we provide that the regulations in both parts are effective on February 11, 2003. On and after that date, any individual or entity possessing, using, or transferring any listed agent or toxin must be in compliance with the provisions of each part.
However, to minimize the disruption of research or educational projects (
In recognition of the potential delays in registering individuals and entities under these regulations during the first year of implementation and the subsequent delay of research, we will also afford additional time to reach full compliance with the regulations to individuals and entities who do not currently possess listed agents or toxins. Therefore, we provide that any individual or entity who does not possess listed agents or toxins by the effective date of these regulations, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of these regulations that are applicable for current possessors at the time of application, as provided in paragraphs (a) through (e) of 7 CFR 331.0 and 9 CFR 121.0.
In paragraph (a) of both parts, we set forth the transfer provisions that will be applicable during the phase-in period. Specifically, we provide that, during the period from February 11, 2003, to November 12, 2003, listed agents or toxins may only be transferred to an individual or entity that is not registered under 7 CFR part 331 or 9 CFR part 121 if the individual or entity has been issued a permit by the APHIS Administrator (the Administrator) under 7 CFR part 330 or 9 CFR 122 to import or move interstate that specific agent or toxin. Since some individuals or entities may not have been issued a permit prior to the effective date of these regulations, we further provide that an individual or entity may apply for a permit. In addition to the permit required under 7 CFR part 330 or 9 CFR 122, an individual or entity will also be required to submit APHIS Form 2041, in accordance with §§ 331.13(c) and 121.14(c), respectively.
Because USDA permits do not cover intrastate movement, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with 7 CFR part 331 or 9 CFR part 121.
With regard to overlap agents and toxins, we provide that from February 11, 2003, to November 12, 2003, listed overlap agents or toxins may only be transferred to an individual or entity not registered under 9 CFR part 121 using the permit provisions described above or, if the individual or entity is registered under CDC's select agent program for that specific overlap agent or toxin, in accordance with CDC's regulations in 42 CFR part 72. The regulations in 42 CFR part 72 cover all inter-entity transfers of “select agents,” which include overlap agents and toxins, whether interstate or intrastate. We note, however, that CDC's regulations in 42 CFR part 72 will be superseded by CDC's new select agent regulations in 42 CFR part 73 on March 12, 2003, and, thereafter, listed overlap agents or toxins may be transferred to an individual or entity not registered under 9 CFR part 121 or 42 CFR part 73 using the permit provisions described above.
In paragraph (b) of both parts, we require that the responsible official submit the registration application package by March 12, 2003, as required in 7 CFR 331.8 and 9 CFR 121.9. In addition, we require that the responsible official submit to the United States Attorney General (the Attorney General) the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.
Paragraph (c) of both parts requires the responsible official to submit to the Attorney General by April 11, 2003, the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need and the appropriate training and skills to handle or use listed agents or toxins. We note that these individuals must have received appropriate training in biosafety and/or containment, in accordance with 7 CFR 331.12 or 9 CFR 121.13.
We recognize that developing and implementing the security section of the Biocontainment and Security Plan (7 CFR 331.11) or the Biosafety and Security Plan (9 CFR 121.12) may require additional time to consult with security experts and to obtain the necessary funding. Therefore, in paragraph (d) of both parts, we provide that the responsible official will have until June 12, 2003, to submit the security section of the plan to APHIS or, for overlap agents or toxins, to APHIS or CDC. Then the responsible official has until September 12, 2003, to implement that security plan and provide security training in accordance with 7 CFR 331.12 or 9 CFR 121.13.
Finally, by November 12, 2003, the registration application process must be complete and the entity must be in full compliance with the regulations.
In 7 CFR 331.1 and 9 CFR 121.1, we define the terms used in the regulations. In our August 2002 interim rule establishing the regulations, we defined the terms
In this interim rule, we are removing the definition of
Therefore, we use the term
To be consistent with CDC, we are also removing the definition of
Furthermore, in 9 CFR part 121, we are revising the definition of
In this interim rule, we define the terms
To clarify the transfer provisions in the regulations, we define
In 7 CFR 331.1, we also define
In 9 CFR 121.1, we also define
To facilitate understanding of the regulations, both 7 CFR 331.2 and 9 CFR 121.2 discuss the purpose and scope of the regulations. Specifically, 7 CFR 331.2(a) states that part 331 sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to plant health or plant products, while 9 CFR 121.2(a) states that part 121 sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to both human and animal health, or to animal health or animal products. Both 7 CFR 331.2(a) and 9 CFR 121.2(a) note that the purpose of the regulations is to ensure the safe handling of such agents or toxins, and to protect against the use of such agents or toxins in domestic or international terrorism or for any other criminal purpose.
In 7 CFR 331.2(b) and 9 CFR 121.2(b), we further provide that any individual or entity that possesses, uses, or transfers any listed agent or toxin must register in accordance with §§ 331.6 and 121.7, respectively. In order for an entity to register, each entity must designate an individual who has the authority and control to ensure compliance with the regulations to be the responsible official. It is the responsible official who must complete and submit the registration application package to APHIS or, for overlap agents or toxins, to APHIS or CDC. As part of registration, the responsible official, the entity, and, where applicable, the
Finally, 7 CFR 331.2(c) and 9 CFR 121.2(c) state that the responsible official is responsible for ensuring compliance with the safety procedures in the regulations, including implementing the Biocontainment and Security Plan (7 CFR 331.11) or the Biosafety and Security Plan (9 CFR 121.12); providing the proper training to individuals that handle or use listed agents or toxins; and providing proper laboratory facilities to contain and dispose of such agents or toxins. In addition, the responsible official is responsible for ensuring compliance with the safeguard and security measures in the regulations, including restricting access to only those individuals who have a legitimate need to handle or use agents or toxins and who have been approved to handle or use such agents or toxins, and transferring listed agents or toxins only to registered individuals or entities.
In our August 2002 interim rule, we established the initial lists of biological agents and toxins required under section 212(a)(1) of the Act. In this interim rule, we are amending the lists of biological agents and toxins in both 7 CFR 331.3 and 9 CFR 121.3.
We have made several changes to 7 CFR 331.3. In 7 CFR 331.3(a), we have amended the entry for
In addition, we have added several provisions that limit the applicability of the regulations in part 331. First, in 7 CFR 331.3(b) we provide that any biological agent or toxin listed in that section that is in its naturally occurring environment will not be subject to the requirements of part 331, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. We have included this provision because we believe that it would be impractical to regulate a biological agent or toxin that is in its naturally occurring environment. Listed agents or toxins could be found in castor beans or corn going to market, for example, and it would be impractical to apply these regulations in such cases.
Second, in 7 CFR 331.3(c) we provide that biological agents or toxins that meet certain criteria do not have the potential to pose a severe threat to plant health or to plant products. Thus, an individual or entity that only possesses, uses, or transfers an agent or toxin that meets any of the following criteria will not be subject to the requirements of this part: (1) Nonviable agents that are, bear, or contain listed agents or toxins; or (2) genetic elements or subunits of listed agents or toxins, if the genetic elements or subunits are not capable of causing disease.
We have also made several changes to the list in 9 CFR 121.3 to be consistent with CDC and to reflect changes in scientific nomenclature. In June 2002, CDC convened an interagency working group to review its list of 36 select agents, some of which are the overlap agents that are listed in our regulations, and develop recommendations regarding possible changes to that list. Because that process was in its initial stages at the time we published the August 2002 interim rule that established the list of biological agents and toxins, the list of overlap agents and toxins reflected the select agent list promulgated by CDC in October 1996. The interagency working group has since submitted its recommendations to CDC.
Based on the interagency working group's recommendations, we have removed aflatoxin from the list of overlap agents and toxins in § 121.3(b), and we have moved Nipah virus from the animal agent and toxin list to the overlap agent and toxin list. In addition, we have added Botulinum neurotoxin producing species of
Due to changes in scientific nomenclature, in 9 CFR 121.3(b) we have replaced the entry for equine morbillivirus (Hendra virus) with Hendra virus; replaced
In 9 CFR 121.3(c), we have adopted CDC's provisions regarding genetic elements, recombinant nucleic acids, and recombinant organisms to be consistent with CDC's list of overlap agents and toxins.
To clarify that we are regulating the agent that causes disease rather than the disease itself and to be consistent with CDC's approach, in 9 CFR 121.3(d) we have replaced the entry for avian influenza (highly pathogenic) with avian influenza virus (highly pathogenic); replaced African swine fever with African swine fever virus; replaced classical swine fever with classical swine fever virus; replaced malignant catarrhal fever with malignant catarrhal fever virus (exotic); replaced Peste des petits ruminants with Peste des petits ruminants virus; replaced sheep pox with sheep pox virus; and replaced vesicular stomatitis (exotic) with vesicular stomatitis virus (exotic).
In addition, in 9 CFR 121.3(d) we have replaced the entry for Newcastle disease virus (exotic) with Newcastle disease virus (VVND) to make it clear that we are regulating only velogenic strains.
Moreover, in 9 CFR 121.3 we have added several provisions that limit the applicability of the regulations in part 121. First, in 9 CFR 121.3(e) we provide that any biological agent or toxin listed in that section that is in its naturally occurring environment will not be subject to the requirements of part 121, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. We have included this provision because we believe that it would be impractical to regulate a biological agent or toxin that is in its naturally occurring environment. Listed agents or toxins could be found in cattle or infected humans, for example, and it would be impractical to apply these regulations in such cases.
Second, in 9 CFR 121.3(f) we provide that biological agents or toxins that meet certain criteria do not have the potential to pose a severe threat to both human and animal health, or to animal health or animal products. Therefore, an individual or entity possessing, using, or transferring an agent or toxin that meets any of the following criteria will not be subject to the requirements of part 121:
(1) Nonviable agents or fixed tissues that are, bear, or contain agents or toxins listed in § 121.3. However, we note that the importation and interstate movement of these nonviable agents and fixed tissues are still subject to the permit requirements under 9 CFR part 122; or
(2) Genetic elements or subunits of animal agents or toxins listed in § 121.3(d), if the genetic elements or subunits are not capable of causing disease. However, we note that the importation and interstate movement of these genetic elements or subunits of listed agents or toxins are still subject to
(3) Overlap toxins under the control of a principal investigator (or equivalent), if the total aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins (types A-G), 100 mg of
Finally, in 9 CFR 121.3(g) we have established a procedure by which an individual or entity may request a determination by the Administrator that an attenuated strain of a biological agent does not pose a severe threat to both human and animal health, or to animal health or animal products. This provision is necessary because some attenuated strains of a biological agent may not pose a severe threat to both human and animal health, or to animal health or animal products. Therefore, by definition, such attenuated strains would be excluded from the list of biological agents or toxins in § 121.3.
Accordingly, 9 CFR 121.3(h) provides that an individual or entity may request review by the Administrator to determine whether or not a specific attenuated strain poses a severe threat to both human and animal health, or to animal health or animal products. For overlap agents, an individual or entity may request review by APHIS or CDC. If APHIS or CDC determines that a specific attenuated strain does not pose a severe threat to human and animal health, or to animal health or animal products, and the individual or entity in possession of that particular attenuated strain will not be subject to the requirements of part 121. We note, however, that this determination will be limited to the specific attenuated strain and to the specific activities involving that attenuated strain.
APHIS or CDC will notify the applicant and publish a notice in the
Section 212(a)(2) of the Act requires that the lists of biological agents and toxins be reviewed and republished biennially, or more often as needed, and revised as necessary. In addition, the Act requires that, when determining whether to include an agent or toxin, the Secretary shall consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups. To accomplish this, we may hold public meetings to provide the opportunity for Federal departments and agencies and scientific experts to comment on the lists in 7 CFR 331.3 and 9 CFR 121.3.
Section 212(g)(1) of the Act explicitly sets forth the exemptions for overlap agents and toxins. The exemptions for overlap agents and toxins in 9 CFR 121.4 match the provisions in the Act. We set forth similar provisions for exemptions for plant agents and toxins in 7 CFR 331.4 and animal agents and toxins in 9 CFR 121.5.
In accordance with section 212(g)(1)(B) of the Act, 9 CFR 121.4(a) provides that clinical or diagnostic laboratories and other entities possessing, using, or transferring overlap agents or toxins that are contained in specimens presented for diagnosis or verification will be exempt from the requirements of part 121, provided that the identification of such agents or toxins is immediately reported to the APHIS or CDC, and to other appropriate authorities when required by Federal, State, or local law; and, within 7 days after identification, such agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. We further provide that a copy of the completed form must be maintained for 3 years.
Based on information provided by CDC and APHIS’ National Veterinary Services Laboratories (NVSL), and taking into consideration the threat posed by listed agents and toxins, we believe that 7 days will provide ample time after identification to inactivate the agent or toxin, or to make transfer arrangements and to transfer the agent or toxin.
To be consistent with the exemptions for overlap agents and toxins, in 7 CFR 331.4(a) and 9 CFR 121.5(a) we have adopted this exemption for diagnostic laboratories (the term clinical laboratories is not applicable to the plant-related regulations in 7 CFR part 331 or the animal-related regulations in 9 CFR part 121). We note, however, that diagnostic laboratories and other entities will still be required to obtain a permit under 7 CFR part 330 and 9 CFR part 122 to import and move interstate any listed agent or toxin.
In 7 CFR 331.4(a), 9 CFR 121.4(a), and 9 CFR 121.5(a), we further provide that, during agricultural emergencies or outbreaks, or in endemic areas, the Administrator may require less frequent reporting. For example, during an outbreak, we may allow biweekly reporting of identifications of a specific agent. In such cases, we will inform the diagnostic laboratories or other entities of this temporary change to the notification requirements.
In 9 CFR part 121, we also provide an exemption for clinical or diagnostic laboratories and other entities conducting proficiency testing. Specifically, in 9 CFR 121.4(b) we provide that clinical or diagnostic laboratories and other entities possessing, using, or transferring overlap agents or toxins that are contained in specimens presented for proficiency testing will be exempt from the requirements of part 121, provided that the identification of such agents or toxins, and their derivatives, is reported to the APHIS or CDC and to other appropriate authorities when required by Federal, State, or local law; and within 90 days of receipt of the agents or toxins, the agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. We further provide that a copy of the completed form must be maintained for 3 years.
Paragraph (a) of 9 CFR 121.5 contains the same exemption provision for animal agents or toxins that are contained in specimens presented for proficiency testing. Based on information provided by NVSL, which conducts such proficiency testing, we believe that 90 days will provide ample time to run the necessary tests for any listed agent or toxin.
We wish to emphasize that a clinical or diagnostic laboratory, or other entity, will be exempt only if it satisfies the specific requirements of these exemptions. Clinical or diagnostic laboratories and other entities must register in accordance with the regulations if they wish to maintain a viable agent or active toxin as a positive control. This is consistent with the “fundamental premise of the [Act]—that all those who maintain possession of a [listed biological agent or toxin] must register and be subject to appropriate security and safety requirements.” (H.R. Conf. Rep. No. 107-481, at 122 (2002)).
Pursuant to section 212(g)(1)(C) of the Act, the regulations in 9 CFR part 121 provide exemptions for products that are, bear, or contain agents or toxins that have been cleared, approved, licensed, or registered under certain Federal laws. Generally, we believe that it is unnecessary to impose additional regulation on products that have been cleared, approved, licensed, or
Accordingly, for overlap agents or toxins and animal agents or toxins, 9 CFR part 121 (§§ 121.4(c) and 121.5(e), respectively) provides that, unless the Administrator by order determines that additional regulation of a specific product is necessary to protect animal health, or animal products, an individual or entity possessing, using, or transferring products that are, bear, or contain agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131
In addition, in 9 CFR 121.4(d) we provide that an individual or entity possessing, using, or transferring investigational products that are, bear, or contain overlap agents or toxins may be exempt from the requirements of this part if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal health or animal products. An individual or entity possessing, using, or transferring such investigational products may apply for an exemption from the requirements of this part by submitting APHIS Form 2042 to APHIS or CDC. Given the time sensitivity of investigational or clinical trials, the Administrator shall make a determination regarding an exemption within 14 days after receipt of the application and notification that the investigation has been authorized under a Federal law.
We have added a similar provision for experimental products in 9 CFR 121.5(f). However, because it is not required by the Act, in § 121.5(f) we did not stipulate that the Administrator will make a determination regarding an exemption within 14 days after receipt of the application and notification that the investigation has been authorized under a Federal law. We did not include this provision in order to give the Administrator the discretion to take longer than 14 days to make a determination, when necessary. However, we expect that the Administrator will make determinations regarding such exemptions in a timely manner.
Furthermore, in 9 CFR 121.5(c) we provide that an individual or entity receiving diagnostic reagents and vaccines that are, bear, or contain listed agents or toxins, also known as high consequence livestock pathogens or toxins, that are produced at USDA diagnostic facilities will be exempt from the requirements of part 121. These diagnostic reagents and vaccines are products that would be cleared, approved, licensed, or registered pursuant to the Virus-Serum-Toxin Act (21 U.S.C. 151-159), but for the fact that they are produced by USDA.
In accordance with section 212(g)(1)(D) of the Act, 9 CFR 121.4(e) provides that the Administrator may exempt an individual or entity from the requirements of the regulations, in whole or in part, for 30 days if it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap agent or toxin. The Administrator may extend the exemption once for an additional 30 days, as deemed necessary.
In 9 CFR 121.4(f), we set forth a similar provision for public health emergencies. Specifically, § 121.4(f) provides that, upon request of the Secretary of Health and Human Services, the Administrator may exempt an individual or entity from the requirements of the regulations, in whole or in part, for 30 days if the Secretary of Health and Human Services has granted an exemption for a public health emergency involving an overlap agent or toxin. The Administrator may extend the exemption once for an additional 30 days, as deemed necessary.
Finally, section 212(g)(2) of the Act provides that the Secretary may grant exemptions from the applicability of the regulations if the Secretary determines that such exemptions are consistent with protecting animal or plant health and animal or plant products. This general exemption authority affords the Secretary more discretion to exempt plant and animal agents and toxins than overlap agents and toxins, since the Act specifically sets forth the exemptions for overlap agents and toxins.
Accordingly, 7 CFR 331.4(b) and 9 CFR 121.5(f) indicate that the Administrator may grant exemptions from the requirements of these parts upon a showing of good cause and a determination that it is consistent with protecting animal or plant health and animal or plant products. For example, such exemptions may be granted for agricultural emergencies involving plant or animal agents or toxins. An individual or entity may request in writing an exemption from the requirements of the regulations.
In accordance with section 212(d) of the Act, 7 CFR 331.5(a) and 9 CFR 121.6(a) require that, unless exempted under those parts, an individual or entity possessing, using, or transferring listed agents or toxins must register with APHIS. Section 121.6(a) of 9 CFR part 121 further requires that an individual or entity possessing, using, or transferring overlap agents or toxins must register with APHIS or CDC.
We note that Congress expected that most registrants would be public and private entities, rather than individuals. (H.R. Conf. Rep. No. 107-481, at 125 (2002)). Thus, 7 CFR 331.5(b) and 9 CFR 121.6(b) indicate that, to apply for a certificate of registration, each entity must designate an individual to be the responsible official. The responsible official must have the authority and control to ensure compliance with the regulations. The responsible official must complete and sign the registration application package, and will be the individual contacted by APHIS or CDC if any questions arise concerning the application or subsequent compliance. As part of registration, the responsible official and the entity will be subject to a security risk assessment by the Attorney General.
While most registrants are likely to be entities, both 7 CFR 331.5(b) and 9 CFR 121.6(b) provide that, in the event that an individual applies for and is granted a certificate of registration, we will consider the individual to be the responsible official.
We wish to emphasize that it is the entity's responsibility to designate the appropriate individual to be the responsible official (i.e., an individual who has the authority and control to
Furthermore, we note that a certificate of registration will apply to only one general physical location (
Although not contemplated by the Act, we recognize that there may be times when the responsible official is unavailable. Since some functions may only be performed by the responsible official (
To apply for a certificate of registration, 7 CFR 331.8(a) and 9 CFR 121.9(a) provide that the responsible official must submit all of the information and documentation required in the registration application package to APHIS, including the name, source, and characterization data for each agent or toxin to be registered, as required by section 212(d)(2) of the Act. For overlap agents or toxins, the responsible official must submit all of the information and documentation required in the registration package to either APHIS or CDC. The responsible official must submit the registration application package to APHIS in cases where he/she is seeking registration for either plant and animal agents or toxins, and overlap agents or toxins.
In 7 CFR 331.6(b) and 9 CFR 121.7(b), we provide that APHIS may issue a certificate of registration upon:
(1) Approval of the responsible official; the alternate responsible official, where applicable; the entity; and, where applicable, the individual who owns or controls the entity following a security risk assessment by the Attorney General. As provided for by the Act, we may waive the security risk assessment of the entity and the individual who owns or controls such entity for Federal, State, or local governmental agencies;
(2) Approval of the containment and security of the entity (7 CFR 331.6) or approval of the biosafety, containment, and security of the entity (9 CFR 121.7). For plant-related agents or toxins, the entity's containment and security procedures must be commensurate with the risk of the agent or toxin, given its intended use. Similarly, for overlap and animal agents or toxins, the entity's biosafety, containment, and security procedures must be commensurate with the risk of the agent or toxin, given its intended use. APHIS will review the Biocontainment and Security Plan or the Biosafety and Security Plan, as applicable, and may inspect and evaluate the premises and records to determine compliance with the regulations and the biosafety and/or containment and security requirements. For overlap agents and toxins, APHIS or CDC will review the Biosafety and Security Plan, and may inspect and evaluate the premises and records to determine compliance with the regulations and the biosafety and/or containment and security requirements; and
(3) A determination by the Administrator that the individual or entity seeking to register has a lawful purpose to possess, use, or transfer such agents or toxins.
Furthermore, 9 CFR 121.7(c) provides that APHIS and CDC will review applications for registration and amendments to a certificate of registration for overlap agents or toxins, and a certificate of registration or amendment to a certificate of registration will only be issued if APHIS and CDC concur.
As indicated in 7 CFR 331.6(c) and 9 CFR 121.7(d), a certificate of registration will be valid for only specific agents or toxins, and specific activities and locations. A certificate of registration may cover more than one listed agent or toxin, and it may be amended to cover additional listed agents or toxins. A responsible official may request an amendment to a certificate of registration by submitting the relevant pages from the registration application package to the agency that issued the certificate of registration, either APHIS or CDC.
Furthermore, under 7 CFR 331.6(d) and 9 CFR 121.7(e), a certificate of registration may be amended to reflect changed circumstances (
There may be instances where a responsible official wishes to discontinue possessing, using, or transferring one or more agents or toxins for which they are registered. In those instances, 7 CFR 331.5(e) and 9 CFR 121.6(f) state that the responsible official may inactivate the agent or toxin or he/she may transfer the agent or toxin to a registered individuals or entities. The responsible official must notify APHIS or, for overlap agents, APHIS or CDC, 5 business days prior to the planned inactivation so that we may have the opportunity to observe the inactivation of the agents or toxins. APHIS or CDC will notify the responsible official if we wish to observe the inactivation of the agents or toxins.
Finally, 7 CFR 331.6(f) and 9 CFR 121.7(g) indicate that a certificate of registration will be valid for a maximum of 3 years. To minimize the administrative burden associated with this new registration program, initially we will assign expiration dates ranging from 24 to 36 months to stagger the dates for renewing registration. Upon renewal, we expect that all certificates of registration will be valid for 3 years.
Section 212(e)(6)(A) of the Act provides that an individual who seeks to register shall be subject to a database check by the Attorney General. Section 212(e)(6)(B) goes on to provide that other persons (
Pursuant to section 212(e)(3) of the Act, upon receipt of the names and identifying information of those seeking to register, the Attorney General will use criminal, immigration, national security, and other electronic databases for the purpose of identifying whether the individuals are within any of the categories described in 18 U.S.C. 175b (relating to restricted persons). According to 18 U.S.C. 175b, the term “restricted person” means an individual who:
(A) Is under indictment for a crime punishable for a term exceeding 1 year;
(B) Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
(C) Is a fugitive from justice;
(D) Is an unlawful user of any controlled substance (as defined in
(E) Is an alien illegally or unlawfully in the United States;
(F) Has been adjudicated as a mental defective or has been committed to any mental institution;
(G) Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State, pursuant to section 6(j) of the Export Administration Act of 1979 (50 U.S.C. App. 2405(j), section 620A of chapter 1 of part M of the Foreign Assistance Act of 1961 (22 U.S.C. 2371), or section 40(d) of chapter 3 of the Arms Export Control Act (22 U.S.C. 2780(d)), has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or
(H) Has been discharged from the Armed Services of the United States under “dishonorable conditions.”
Section 212(e)(3) of the Act further provides that the Attorney General will use criminal, immigration, national security, and other electronic databases for the sole purpose of identifying whether the individuals are reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801.
Accordingly, in 7 CFR 331.7(a) and 9 CFR 121.8(a) we provide that APHIS may deny an application for registration or revoke registration if the Attorney General identifies the individual as within any of the categories described in the previous paragraphs.
With regard to overlap agents or toxins, 9 CFR 121.8(b) provides that APHIS or CDC will deny an application for registration or revoke registration if the Attorney General identifies the individual as a “restricted person” as described in 18 U.S.C. 175b. APHIS or CDC may deny an application for registration or revoke registration if the Attorney General identifies the individual as within any of the remaining categories described above.
Furthermore, in keeping with the safety and security requirements of the Act, in 7 CFR 331.7(a) and 9 CFR 121.8(a), we provide that APHIS may deny an application for registration or revoke registration if the responsible official does not have a lawful purpose to possess, use, or transfer listed agents or toxins; the responsible official is an individual who handles or uses listed agents or toxins and he/she does not have the necessary training or skills to handle such agents or toxins; the entity does not meet the biosafety and/or containment and security requirements prescribed by the Administrator; there are egregious or repeated violations of the biosafety, containment, or security requirements; or the Administrator determines that such action is necessary to protect animal or plant health, and animal or plant products.
We may summarily revoke or suspend registration for any of the reasons set forth in 7 CFR 331.7(a) and in paragraphs (a) and (b) of 9 CFR 121.8. In accordance with 7 CFR 331.7(c) and 9 CFR 121.8(d), we will notify the responsible official in writing if an application for registration is denied or a certificate of registration is revoked or suspended. For overlap agents or toxins, APHIS or CDC will provide the necessary notification.
Finally, both parts provide that denial of an application for registration, revocation of registration, and suspension of registration may be appealed under §§ 331.16 and 121.17, respectively.
To facilitate compliance with the regulations, 7 CFR 331.9 and 9 CFR 121.10 both set out the responsibilities of the responsible official. Specifically, the regulations indicate the responsible official is responsible for:
• Developing and implementing a Biocontainment and Security Plan or a Biosafety and Security Plan, as applicable;
• Allowing only approved individuals within the entity to have access to listed agents or toxins;
• Providing appropriate training in biosafety and/or containment and security procedures for all personnel;
• Transferring agents or toxins only to registered individuals or entities;
• Ensuring that all visitors are informed of and follow the entity's security requirements and procedures;
• Notifying APHIS or, for overlap agents, APHIS or CDC, of changes in circumstances;
• Providing timely notice of any theft, loss, or release of a biological agent or toxin; and
• Maintaining detailed records of information necessary to give a complete accounting of all of the entity's activities related to agents or toxins.
In addition, both parts provide that the responsible official for a diagnostic laboratory or other entity possessing, using, or transferring listed agents or toxins that are contained in specimens presented for diagnosis must immediately report the identification of such agents or toxins to the Administrator and to other appropriate authorities when required by Federal, State, or local law. Furthermore, both parts provide that the Administrator may require less frequent reporting during agricultural emergencies or outbreaks, or in endemic areas. We are adopting these reporting requirements because this information will help us to identify outbreaks and to monitor activities related to listed agents and toxins.
Finally, to be consistent with CDC, we have adopted the CDC's approach on experiments involving recombinant DNA. We believe this provision will address concerns about laboratory manipulation of microbes that alter their characteristics (
Accordingly, in 9 CFR 121.10(c) we provide that a responsible official must ensure that the following experiments are not conducted unless approved by the Administrator, after consultation with experts:
(1) Experiments utilizing recombinant DNA that involve the deliberate transfer of a pathogenic trait or drug resistance trait to biological agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture; and
(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxins lethal for vertebrates at an LD
In addition, we request comments concerning what additional experiments, regardless if regulated under these regulations, might warrant similar scrutiny in the interest of safety. In particular, we request comments addressing issues concerning experiments with biological agents that could possibly increase their virulence or pathogenicity, change their natural mode of transmission, route of exposure, or host range in ways adverse to human, animal, or plant health; or result in the deliberate transfer a drug resistant trait or a toxin-producing capability to a microorganism by means that do not involve recombinant DNA techniques. We also request comments regarding the form oversight should
Section 212(e)(1) of the Act provides that the Secretary shall establish appropriate safeguard and security requirements for persons possessing, using, or transferring biological agents or toxins commensurate with the risk such agent poses to animal and plant health, and animal and plant products (including the risk of use in domestic or international terrorism). Section 212(e)(2)(A) goes on to state that the regulations must include provisions to ensure that the registered person provides access to listed agents and toxins to only those individuals whom the registered person has determined have a legitimate need to handle or use such agents or toxins. In addition, section 212(b)(1)(A) requires that the Secretary establish and enforce safety procedures for agents and toxins, including measures to ensure proper training and appropriate skills to handle such agents and toxins.
Accordingly, 7 CFR 331.10(a) and 9 CFR 121.11(a) provide that an individual may not have access to biological agents or toxins listed in §§ 331.3 and 121.3, respectively, unless approved by APHIS or, for overlap agents, APHIS or CDC. Both parts require the responsible official to ensure that only approved individuals within the entity have access to listed agents or toxins. In addition, the responsible official must request such access for only those individuals who have a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins.
We recognize that a responsible official may want to minimize the number of individuals who require access approval. Accordingly, we reiterate that such approval is necessary only for those individuals who have a legitimate need to
To ensure that individuals who handle or use listed agents or toxins have the appropriate training and skills, 7 CFR 331.10(c) requires that the responsible official must provide appropriate training in containment and security procedures to all individuals with access to agents and toxins in accordance with 7 CFR 331.12. Similarly, 9 CFR 121.11(c) requires that the responsible official must provide appropriate training in biosafety and/or containment and security procedures to all individuals with access to agents and toxins in accordance with 9 CFR 121.13.
Furthermore, the responsible official must provide APHIS with information about the individual's training and skills, such as a curriculum vitae for principal investigators and researchers, and a description of training completed by support personnel (7 CFR 331.10(e) and 9 CFR 121.11(e)).
In order to obtain access approval for an individual, section 212(e)(2)(B) of the Act requires that the responsible official submit the names and identifying information for those individuals deemed to have a legitimate need to handle or use listed agents or toxins to the Secretary and the Attorney General, promptly after determining the individuals need access, and periodically thereafter, not less frequently than once every 5 years. We note that the screening of employees working with agents or toxins is the primary responsibility of the responsible official, not the individual employee. (H.R. Conf. Rep. No. 107-481, at 125 (2002)).
Both 7 CFR 331.10(d) and 9 CFR 121.11(d) indicate that, for each individual identified by the responsible official as having a legitimate need to handle or use listed agents or toxins, the responsible official must submit that individual's name and identifying information to APHIS and the Attorney General. Paragraph (d) of 9 CFR 121.11 further provides that, for overlap agents, the responsible official must submit this information to either APHIS or CDC and the Attorney General.
Pursuant to section 212(e)(3) of the Act, upon receipt of the names and identifying information, the Attorney General will use criminal, immigration, national security, and other electronic databases for the purpose of identifying whether the individuals are within any of the categories described in 18 U.S.C. 175b (relating to restricted persons). Section 212(e)(3) of the Act further provides that the Attorney General will use criminal, immigration, national security, and other electronic databases for the purpose of identifying whether the individuals are reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801.
In 7 CFR 331.10(h) and 9 CFR 121.11(h), we provide that we may deny or limit access of an individual to listed agents or toxins if the Attorney General identifies the individual as within any of the categories described in the previous paragraph. This is consistent with the requirements in section 212(e)(2)(C)(i) of the Act.
With regard to overlap agents or toxins, 9 CFR 121.11(i) provides that APHIS or CDC will deny an individual access to overlap agents or toxins if the Attorney General identifies the individual as a “restricted person” as described in 18 U.S.C. 175b. APHIS or CDC may deny or limit access of an individual if the Attorney General identifies the individual as within any of the remaining categories described above.
Furthermore, in keeping with the safety and security requirements of the Act, both 7 CFR 331.10(h) and 9 CFR 121.11(h) provide that we may deny or limit access if the individual does not have a legitimate need to handle listed agents or toxins; the individual does not have the necessary training or skills to handle listed agents or toxins; or the Administrator determines that such action is necessary to protect animal or plant health or animal or plant products.
The Administrator will determine what constitutes limited access on a case-by-case basis. The determination will take into consideration all the facts at hand and be commensurate with the risks posed by the agent or toxin. Generally, we expect that an individual granted limited access will only be allowed to handle or use an agent or toxin under the direct supervision of an approved individual.
Section 212(e)(3)(C) of the Act provides that the Attorney General will
Accordingly, both 7 CFR 331.10(g) and 9 CFR 121.11(g) provide that we will notify the responsible official if an individual is granted full or limited access, or denied access, to biological agents or toxins, and we will notify the individual if he/she is denied access or granted only limited access to such agents or toxins. Paragraph (g) of 9 CFR 121.11 further provides that, for overlap agents or toxins, APHIS or CDC will provide the necessary notification.
Pursuant to section 212(e)(5) of the Act, 7 CFR 331.10(f) and 9 CFR 121.11(f) indicate that we may expedite the access approval process for individuals upon request by the responsible official and a showing of good cause, such as public health or agricultural emergencies, national security, impending expiration of a research grant, or a short-term visit by a prominent researcher. We note, however, that the Act specifically provides that expedited review is not available for individuals or entities seeking to register (section 212(e)(6)).
Both 7 CFR 331.10(j) and 9 CFR 121.11(k) provide that access approval for individuals is valid for 5 years and, thereafter, the responsible official shall request access approval every 5 years for as long as the individual needs access to such agents or toxins. This is consistent with the requirements of the Act.
In 7 CFR 331.10(k) and 9 CFR 121.11(l), we further provide that the responsible official must immediately notify APHIS or, for overlap agents or toxins, APHIS or CDC, when an individual's access to listed agents or toxins is terminated by the entity and the reasons therefore. We believe this information will be relevant to any subsequent determinations to allow that individual access to listed agents or toxins.
Section 212(e)(7)(A)(i) of the Act requires that the regulations provide for an opportunity for review by the Secretary, when requested by the individual involved, of a determination to deny that individual access to listed agents or toxins. Thus, 7 CFR 331.10(i) and 9 CFR 121.11(j) provide that an individual may appeal the Administrator's decision to deny or limit access to biological agents or toxins, in accordance with §§ 331.16 and 121.17, respectively.
Sections 212(b) and (c) of the Act require that the Secretary establish and enforce safety procedures for listed agents and toxins, including measures to ensure proper training and appropriate skills to handle agents and toxins, and proper laboratory facilities to contain and dispose of agents and toxins. In addition, sections 212(b) and (c) of the Act require that the Secretary establish and enforce safeguard and security measures to prevent access to listed agents and toxins for use in domestic or international terrorism or for any other criminal purpose. Pursuant to section 212(e)(1), the safeguard and security requirements must be commensurate with the risk posed by the agent or toxin.
Because different agents and toxins pose differing degrees of risk, depending on factors such as their escape potential and availability of a suitable habitat (for plant-related agents) and transmission and effect of exposure to the agent or toxin (for overlap and animal agents or toxins), we believe that it would be counterproductive to attempt to prepare a detailed list of prescriptive requirements for entities (
Accordingly, 7 CFR 331.11 requires that, as a condition of registration, an individual or entity must develop and implement a Biocontainment and Security Plan. Similarly, 9 CFR 121.12 requires that, as a condition of registration, an individual or entity must develop and implement a Biosafety and Security Plan. The titles and provisions of the plans are different because the agents listed under 7 CFR 331.3 do not pose a severe threat to human health and, therefore, it is unnecessary to require that the plant-related plan address personnel safety and health.
In 7 CFR 331.11, we provide that the plan must contain sufficient information and documentation to describe the containment procedures and the security systems and procedures. The plan's containment and security provisions must be commensurate with the risk posed by the agent or toxin, given its intended use.
Similarly, in 9 CFR 121.12 we provide that the plan must contain sufficient information and documentation to describe the biosafety and containment procedures, and the security systems and procedures. The plan's biosafety, containment, and security provisions must be commensurate with the risk posed by the agent or toxin, given its intended use.
Pursuant to section 212(e)(9) of the Act, we will provide technical assistance and guidance upon request to help individuals and entities develop their plans.
In 7 CFR 331.11(a)(1), we provide that the plan's containment procedures must be sufficient to contain the agent or toxin (
We expect that a number of the individuals or entities seeking to register under these regulations will have previously been issued permits under 7 CFR part 330 or 9 CFR part 122, or will have been registered under CDC's select agent regulations in 42 CFR part 72 and thus will have appropriate biosafety and/or containment procedures already in place. It is likely that these biosafety and/or containment procedures will meet the requirements of the regulations or could be easily modified to meet the requirements of the regulations. Therefore, we encourage individuals or entities seeking to register to make use of existing biosafety and/or containment procedures, and to modify such procedures as necessary.
In 7 CFR 331.11(a)(2) and 9 CFR 121.12(a)(2), we further provide that the security systems and procedures must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the threat posed by the agent or toxin. This site-specific risk assessment should involve a threat assessment and risk analysis in which threats are defined, vulnerabilities examined, and risks associated with those vulnerabilities are identified.
The security systems and procedures must be tailored to address site-specific characteristics and requirements, ongoing programs, and operational needs and must mitigate the risks identified in the risk assessment. The
Moreover, with respect to areas containing listed agents or toxins, an entity or individual must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security as the provisions below:
• Allow unescorted access only to approved individuals who are performing a specifically authorized function during hours required to perform that job;
• Allow individuals not approved under 7 CFR 331.10 or 9 CFR 121.11 to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by approved individuals;
• Provide for the control of access to containers where listed agents and toxins are stored by requiring that such containers be locked when not in the direct view of an approved individual and by using other monitoring measures, as needed;
• Require the inspection of all packages upon entry and exit;
• Establish a protocol for intra-entity transfers, including provisions for ensuring that the packaging and movement, is conducted under the supervision of an approved individual;
• Require that approved individuals do not share with any other person their unique means of accessing the area or listed agents or toxins; and
• Require that approved individuals immediately report any of the following to the responsible official: Any loss or compromise of keys, passwords, combinations, etc.; any suspicious persons or activities; any loss or theft of listed agents or toxins; any release of a listed agent or toxin; and any sign that inventory and use records for listed agents and toxins have been altered or otherwise compromised.
We recommend that security experts be consulted to ensure that the individual or entity develops security systems and procedures that will meet the requirements of this section. However, we recognize that this may not be possible in every instance. Therefore, we reiterate that we will provide technical assistance and guidance upon request.
In 7 CFR 331.11(a)(3) and 9 CFR 121.12(a)(3), we also require that the plans include incident response plans for containment breach, security breach, inventory violations, non-biological incidents such as workplace violence, and cybersecurity breach. Under 7 CFR 331.11(a)(3), the incident response plans must address containment, inventory control, and notification of managers and responders; while under 9 CFR 121.12(a)(3) the incident response plans must address containment, personnel safety and health, inventory control, and notification of managers and responders. As discussed above, it is unnecessary for 7 CFR 331.11(a)(3) to address personnel safety and health because the plant-related agents do not pose a severe threat to human health.
Finally, to ensure that the Biocontainment and Security Plan continues to meet the entity's containment and security needs, in 7 CFR 331.11(b) we require that the plan be reviewed, performance tested, and updated annually. The plan must also be reviewed and revised, as necessary, after any incident. We include these same requirements in 9 CFR121.12(b) in order to ensure that the Biosafety and Security Plan continues to meet the entity's biosafety, containment, and security needs.
To ensure that individuals who handle or use listed agents or toxins have the appropriate training and skills, 7 CFR 331.12(a) provides that the responsible official must provide appropriate training in containment and security procedures to all individuals with access to listed agents and toxins while 9 CFR 121.13(a) provides that the responsible official must provide appropriate training in biosafety, containment, and security procedures to all individuals with access to listed agents and toxins. These provisions are different because the agents listed under 7 CFR 331.3 do not pose a severe threat to human health and, therefore, it is unnecessary to require that the plant-related plan address personnel safety and health.
Both 7 CFR 331.12 and 9 CFR 121.13 provide that the responsible official must provide information and training to an individual at the time the individual is assigned to work with a listed agent or toxin. In addition, the responsible official must provide refresher training annually.
In accordance with 212(b) of the Act, 7 CFR 331.13 and 9 CFR 121.14 set forth the transfer requirements for biological agents and toxins. Both 7 CFR 331.13 and 9 CFR 121.14 provide that a listed biological agent or toxin may only be transferred to individuals or entities registered to possess, use, or transfer that particular agent or toxin. However, the sender of an agent or toxin may be an individual or entity that has a certificate of registration for the agent or toxin, an individual or entity that is exempt from the requirements of the regulations, or an individual or entity located outside of the United States. Biological agents or toxins may only be transferred under the conditions in each section and must be authorized by APHIS or, for overlap agents or toxins, by APHIS or CDC, prior to the transfer.
Both 7 CFR 331.13(a) and 9 CFR 121.14(a) incorporate the existing permit requirements under the plant pest regulations in 7 CFR part 330 and the organisms and vectors regulations in 9 CFR part 122, respectively. We believe the current permitting systems provided for by the existing plant pest and organisms and vectors regulations will complement the requirements under these new regulations, and will provide additional protections for the transfer of listed agents and toxins. We do not expect that these permit requirements will be burdensome, since permits for listed biological agents or toxins issued under 7 CFR part 330 and 9 CFR part 122 are valid for up to 1 year and can be renewed.
Thus, §§ 331.13(a) and 121.14(a) provide that, in addition to the permit required under 7 CFR part 330 or 9 CFR part 122, respectively, biological agents or toxins may only be imported or moved interstate with the prior authorization of APHIS or, for overlap agents or toxins, APHIS or CDC. To obtain such authorization, the sender and the responsible official for the recipient must complete and submit APHIS Form 2041 to APHIS or CDC, in accordance with §§ 331.13(c) and 121.14(c).
Furthermore, under 7 CFR 331.12(b), plant agents or toxins listed in 7 CFR 331.3 may be moved intrastate only with the prior authorization of APHIS,
To track the actual transfer of the agents and toxins, we are adopting CDC's transfer process to be consistent with CDC and because a number of regulated parties are already familiar with this transfer process. This transfer process is designed to provide an accurate record of the transfer; such information may be crucial in the event of a criminal or epidemiological investigation.
Both 7 CFR 331.13(c) and 9 CFR 121.14(c) set out the transfer process and procedures (APHIS Form 2041). Specifically, both parts provide that, prior to each transfer, the sender and the responsible official for the recipient must complete APHIS Form 2041. Then the sender must submit the form to APHIS or, for overlap agents or toxins, to APHIS or CDC.
After reviewing the form, APHIS will authorize the transfer based on a finding that the recipient has a certificate of registration covering the transfer of the listed agent or toxin. For overlap agents and toxins, APHIS or CDC will authorize the transfer based on a finding that the recipient has a certificate of registration covering the transfer of the listed agent or toxin.
To confirm the transfer, 7 CFR 331.13(c)(3) and 9 CFR 121.14(c)(3) provide that the responsible official for the recipient must notify the agency authorizing the transfer (either APHIS or CDC) and the sender upon receipt of the agent or toxin by mailing or faxing a completed APHIS Form 2041 to APHIS or CDC within 2 business days.
Furthermore, 7 CFR 331.13(c)(4) and 9 CFR 121.14(c)(4) provide that the recipient must notify APHIS or, for overlap agents, APHIS or CDC, immediately if the agent or toxin has not been received within 48 hours after the expected delivery or if the package containing the agent or toxin is leaking or has been damaged.
Finally, both 7 CFR 331.13(d) and 9 CFR 121.14(d) provide that the sender must comply with all applicable laws governing packaging and shipping.
Although not contained in this interim rule, pursuant to section 212(b) of the Act, we note that APHIS has incident response procedures in place to protect animal and plant health and animal and plant products in the event of a transfer or potential transfer in violation of the safety procedures and safeguard and security measures established by these regulations. Generally, these incident response procedures consist of coordinating with appropriate Federal, State, and local agencies; communicating with stakeholders, industry partners, and diagnostic laboratories about the potential threat; elevating surveillance; and communicating with international agencies, if necessary.
The recordkeeping requirements in 7 CFR 331.14 and 9 CFR 121.15 are designed to document an entity's compliance with the regulations and to satisfy the investigational needs of APHIS and the Attorney General, in accordance with section 212 of the Act. In 7 CFR 331.14 and 9 CFR 121.15, we provide that the responsible official must maintain complete records of information necessary to give an accounting of all of the activities related to agents or toxins listed in §§ 331.3 and 121.3, respectively. Such records must include the Biocontainment and Security Plan or the Biosafety and Security Plan, as applicable; a current list of all individuals with access to agents or toxins; training records for such individuals; accurate and current inventory records (including source and characterization data); permits and transfer documents (APHIS Form 2041) issued by APHIS or, for overlap agents and toxins, APHIS or CDC; security records (
We require that the responsible official maintain such records for 3 years and produce such records, upon request, to APHIS or CDC inspectors, and appropriate Federal, State, or local law enforcement authorities.
Section 212(f) of the Act provides that the Secretary shall have the authority to inspect persons to ensure compliance with the regulations, including prohibitions on restricted persons and other provisions of subsection 212(e) of the Act. Accordingly, in 7 CFR 331.15(a) we require that any APHIS inspector be allowed, without previous notification, to enter and inspect the entire premises, all materials and equipment, and all records required to be maintained by the regulations. Likewise, in 9 CFR 121.16(a) we require that any APHIS or CDC inspector be allowed to conduct such inspections.
As previously noted, APHIS may inspect and evaluate the premises and records prior to issuing a certificate of registration in order to ensure compliance with the regulations (7 CFR 331.15(b) and 9 CFR 121.16(b)). APHIS or CDC may conduct such inspections for overlap agents or toxins. Once registered, inspections of the premises and records will be conducted to ensure compliance with the regulations.
The Act specifically requires notification in the event of theft, loss, or release of a biological agent or toxin. Therefore, 7 CFR 331.16(a) and 9 CFR 121.17(a) provide that the responsible official must orally notify APHIS and appropriate Federal, State, and local law enforcement agencies immediately upon discovery of the theft or loss of agents or toxins listed in §§ 331.3 and 121.3, respectively. The regulations further provide that the oral notification must be followed by a written report within 7 days. We are allowing 7 days for the submission of the written report to give the responsible official ample time to compile information and investigate the theft or loss in order to provide a more detailed report.
Similarly, 7 CFR 331.16(b) and 9 CFR 121.17(b) provide that the responsible official must orally notify APHIS immediately upon discovery that a release of a listed agent or toxin has occurred outside of the biocontainment area. As with notification of theft or loss, the regulations provide that oral notification of a release must be followed by a written report within 7 days. The regulations further provide that APHIS will notify relevant Federal, State, and local authorities, and the public, if necessary. In § 121.17(b), we additionally provide that, if the release involves an overlap agent or toxin, we will also notify the Secretary of Health and Human Services.
Section 212(e)(7)(A)(i) of the Act states that the regulations shall provide for an opportunity for review by the Secretary, when requested by the individual involved, of a determination to deny that individual access to listed agents or toxins and, when requested by the person involved, of a determination to deny or revoke registration for that person.
Accordingly, both 7 CFR 331.17 and 9 CFR 121.18 provide that an individual
Both 7 CFR 331.17 and 9 CFR 121.18 provide that the appeal must be in writing and submitted to the Administrator within 30 days of the decision. The appeal must state all of the facts and reasons upon which the individual or entity disagrees with the decision. Where the denial or revocation of registration or the denial or limitation of an individual's access approval is based solely upon an identification by the Attorney General, APHIS will forward the request for review to the Attorney General to review.
In accordance with section 212(e)(7)(A)(iii), the decision of the Administrator constitutes final agency action for purposes of 5 U.S.C. 702.
Section 212(e)(7)(A)(ii) of the Act provides that the Secretary, during a review of a determination, may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement agency.
While not reflected in the regulations, we note that the Act provides for civil and criminal penalties for violations of the regulations. Under section 212(i) of the Act, any person who violates any provision of these regulations will be subject to a civil money penalty, in addition to any other penalties that may apply under law. The civil money penalty shall not exceed $250,000 for an individual and $500,000 for any other person.
Section 231 of the Act sets out the criminal penalties for violations of the regulations. Section 231(b)(2) of the Act provides that whoever transfers a biological agent or toxin to a person who the transferor knows or has reasonable cause to believe is not registered shall be fined or imprisoned for no more than 5 years, or both. Similarly, section 231(c)(2) provides that whoever knowingly possesses a biological agent or toxin without registering under the regulations shall be fined or imprisoned no more than 5 years, or both.
Immediate action is necessary in order for USDA to comply with the requirements of Title II, subtitle B, of Pub. L. 107-188, which requires the publication of this interim rule not later than December 9, 2002. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest.
We will consider comments we receive during the comment period for this interim rule (see
This rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.
For this rule, we have prepared an economic analysis. The economic analysis provides a cost-benefit analysis as required by Executive Order 12866, as well as an analysis of the potential economic effects of this proposed rule on small entities, as required under 5 U.S.C. 603. The economic analysis is summarized below. Copies of the full analysis are available by contacting the person listed under
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188), the Secretary of Agriculture is required to provide by regulation for the establishment and enforcement of standards and procedures governing the possession and use of the listed biological agents and toxins; the establishment and enforcement of safety requirements for the transfer of listed agents and toxins; the establishment and enforcement of safeguard and security measures to prevent access to listed agents and toxins for use in domestic or international terrorism or other criminal purpose; and the establishment of procedures to protect animal and plant health, and animal and plant products, in the event of a transfer in violation of the established safety and security measures. For the Health and Human Services Department (HHS), CDC is taking similar measures related to biological agents and toxins that have the potential to adversely affect human health or human and animal health.
The Regulatory Flexibility Act requires that agencies specifically consider the economic effects of their rules on small entities. The entities most likely to be affected by this rule are those laboratories and other institutions conducting research and related activities that involve the use of listed biological agents and toxins. Most affected entities (other than Federal or State governmental entities) would be considered part of North American Industrial Classification System (NAICS) code 541710, “Research and Development in the Physical, Engineering, and Life Sciences.” Some affected entities would be considered part of NAICS 541940, “Veterinary Services;” NAICS 611310, “Colleges, Universities and Professional Schools;” NAICS 325412, “Pharmaceutical Preparation Manufacturing;” NAICS 325413, “In-Vitro Diagnostic Substance Manufacturing;” and NAICS 325414, “Biological Product (except Diagnostic) Manufacturing.”
The Small Business Administration (SBA) has established guidelines for determining when establishments are to be considered “small” under the Regulatory Flexibility Act. An entity in NAICS 541710, 325413, or 325414 is considered to be a small entity if it has 500 or fewer employees; for NAICS 325412, that threshold is 750 or fewer employees. An entity in NAICS 611310 is considered small with annual receipts/revenues of $6 million or less.
According to the 1997 Economic Census, no less
Benefits associated with this rule are the avoided losses to animals or plants that could be attacked by these organisms, and their products and markets. Losses include reduction in
The costs associated with outbreaks can be very high as is demonstrated by natural outbreaks that have occurred. For example, it has been estimated that the losses to agriculture and the food chain from the recent FMD outbreak in the United Kingdom, including the costs compensated by the government amount to about £3.1 billion ($4.7 billion). In 1999, Ekboir estimated the potential impacts of an FMD outbreak in California alone at between $8.5 and $13.5 billion.
The above cited consequences relate to natural or accidental introduction. Deliberate introduction greatly increases the probability of an agent or toxin becoming established and causing wide-ranging and devastating impacts on the economy, disruption to society, diminished confidence in public and private institutions, and possible loss of life. The perpetrators would have the advantage of controlling the time of introduction of the agent, introducing agents into remote or highly susceptible areas, multiple introductions of the same agent, or simultaneous release of different agents. Intentional introductions permit an increased probability of survival of a pathogen, the use of highly virulent strains and high concentrations of inoculum, and precise timing of release to coincide with maximal colonization potential.
Facilities that possess listed agents and toxins will be affected by this rule. Those facilities are primarily research and diagnostic facilities. They include Federal, State, and university laboratories, and commercial enterprises.
Because affected entities vary widely and the information needed to determine an individual facility's biosafety, containment and physical security situation will not be available until the registration process occurs, information on specific necessary changes at any individual facility and thus those costs are not available. However, some general observations regarding the potential costs can be made.
There are approximately 33 academic, commercial, and State and Federal government facilities that have indicated their possession of listed plant pathogens and thus affected by this rule. This information was obtained from the notifications received by Plant Protection and Quarantine, APHIS-USDA.
In addition, there are approximately 619 commercial diagnostic facilities, university research and diagnostic facilities, State and Federal diagnostic and research facilities, and others in possession of animal and/or overlap agents or toxins that are expected to be affected by this rule.
The facilities that deal with listed plant agents and toxins are academic institutions, commercial diagnostic and research facilities, and State and Federal Government facilities. Almost 60 percent of the affected facilities are academic and almost 30 percent government. The affected facilities tend to be small.
The facilities that deal with animal and overlap agents are academic, commercial, government, non-profit, and other. Twenty-nine percent of the facilities with listed agents and toxins are identified academic institutions, 45 percent as private commercial or non-profit entities, and 15 percent as government. The remaining 11 percent are not identified, but include veterinary practices. Animal and overlap agents are used primarily in diagnostic work and research.
The level of security at the facilities dealing with listed agents and toxins is currently very diverse, ranging from a locked freezer to a lock on the door to razor wire perimeter fencing, a guard post, locks or coded entry, and visitor escorts.
Clinical and diagnostic laboratories are specifically exempted from the provisions of the regulations for possessing, using, or transferring animal
Under this rule, unless exempted a person or facility shall not possess, use, or transfer any listed agent or toxin without a certificate of registration issued by APHIS or CDC. The registration process is designed to obtain critical information concerning persons or facilities in possession of certain agents or toxins, as well as the specific characteristics of the agents and toxins. Information to determine that persons seeking to register have a lawful purpose to possess, use, or transfer agents or toxins will also be required as part of the registration process. This will involve security risk assessments by the U.S. Department of Justice, and collecting and providing the required information. Also as a condition of registration, a Biocontainment and Security Plan or Biosafety and Security Plan must be developed. It is estimated that it will cost between $414 and $778 per facility to collect and provide the required information. Registration amendments are expected to cost $86 each. In addition, it is estimated that re-applying for registration will cost $299 to $459 for those facilities to re-apply, as the registration is valid for up to 3 years.
Under this rule, listed biological agents and toxins may only be transferred to persons registered to possess, use, or transfer that particular agent or toxin. However, the sender may be an individual or facility exempt from the requirements of this rule, or an individual or facility located outside the United States. Transfer must occur only with prior authorization, notification of receipt by the recipient, and notification of overdue or damaged shipments. It is estimated that complying with these requirements will cost $124 for each of an expected 6,520 transfers in a year.
Biosafety and containment requirements ensure that the combination of work practices and physical containment are proportional to the risk associated with the agent or toxin. USDA permits dealing with the listed agents and toxins already required the biosafety and containment level commensurate with the risk associated with the pathogen covered in the permit or registration. Therefore, to the extent that affected entities are already permittees, the biosafety and containment requirements of this rule will have already been required at those facilities. There are almost 400 individual permittees with listed agents and toxins representing an unknown number of facilities.
This rule will require that any facility where listed agents and toxins are held adequately provide for the physical security of the premises. This rule does not specify how security needs are to be met, only that they are adequate. Because the current level of security is very diverse, physical security components may have to be added in various quantities (including none) to meet the specific security needs of a given facility.
An example of security spending at USDA laboratories shows security upgrades at NVSL in Ames, IA, completed in 2002 cost $550,077 ($6.63/ft
The average cost per square foot of electronic portion of security for budget purposes ranges from $6.25/ft
This rule will require that all information resources related to listed biological agents and toxins have an appropriate level of protection in the system that is used to acquire, store, manipulate, manage, move, control, display, switch, interchange, receive or transmit that information. Most affected entities have a variety of compelling reasons, including regulatory requirements, for already protecting information.
Other costs associated with this rule include the costs of any additional training that may occur, record keeping, complying with the requirements for theft/loss/release notification, and appealing rulings. It is estimated that yearly recordkeeping will cost from $450 to $1,499 per registered facility. It is estimated that theft, loss, and release reporting will cost $72 for each occurrence. It is estimated that appeal requirements will cost $311 for each
Costs to APHIS that may be incurred as a result of the rule include the cost for processing facility registrations, notifications of identification of agents and toxins, exemption applications, transfer applications, theft/loss/release notifications and appeals, and performing facility inspections. It is estimated that APHIS will incur costs associated with this rule of as much as $1.5 million in the first year. Paperwork processing will cost APHIS $744,705 per year. In addition, APHIS may incur costs associated with providing technical assistance on compliance with this rule. Inspections are expected to cost between $240 and $997 per facility and occur every 3 years along with registration, or $156,000 to $650,000 for all facilities. Additional inspector training to cover the needs of this rule may be needed as well. The cost may be similar to the current level. In 2002, APHIS spent $35,480 on inspector training. Background checks or security clearances for all inspectors could be expected to cost $45,000. User fees to offset government costs will not be collected by APHIS under this rule.
Approximately 70 percent of research and development (commercial and non-profit laboratories dealing with human, animal, and plant agents), biological (except diagnostic) manufacturing, diagnostic manufacturing, pharmaceutical manufacturing, and other private establishments affected by this rule have fewer than 20 employees, and another 15 percent have between 20 and 49 employees.
For the purpose of assessing the impact of the security requirements of the rule, we make the following assumptions based on the available information on the size distribution of the affected entities:
• Eighty percent of affected facilities have an area to be secured of approximately 10,000 ft
• Five percent of affected facilities are Federal facilities and will not need security upgrades as a result of this rule;
• Fifteen percent of affected facilities have an area to be secured of approximately 30,000 ft
• Because facilities will have varying levels of existing security, security needs, and methods of meeting those needs, the average security upgrades in APHIS facilities is used as a proxy for upgrades at these facilities. (The proxy is based on upgrading to state of the art equipment, which may or may not be used at a given facility.)
Using an average budget estimate for upgrading the electronic portion of a security system of $6.25/ft
Applying a budget cost of $62,500 to the 80 percent of affected facilities with 10,000 ft
In addition, a facility could need none, some, or all of the following:
• Facility security assessment, including developing a security plan as per the rule; $8.9 million if the 80 percent with smaller spaces all need a $17,000 assessment and $2.5 million if the 15 percent with larger spaces all need a $25,000 assessment.
• Entry control equipment; includes x-ray—small unit ($28,000 per unit), x-ray—large unit ($40,000 per unit), and metal detector(s) ($20,000 per unit). Other features would entail yearly recurring costs.
• Yearly recurring costs: Off-site monitoring ($10,000 to $45,000 per year); an equipment maintenance agreement ($12,000 to $30,000 per year); and guard service—unarmed ($30.00/hr per security post), armed ($35.00/hr per security post), and a supervisor ($40.00/hr).
This rule will involve other costs to the regulated community. It is estimated that complying with the exemption and notification of identification requirements will have a total cost of $93,000 per year. The rule will also involve the costs associated with the registration requirements. It is estimated that it will cost $315,980 to collect and provide the required information. Registration amendments are expected to cost $100,964 in the first year. In addition, it is estimated that it will cost $214,809 for facilities to collect and provide the required information for re-application. Complying with the requirements concerning the transfer of listed agents and toxins could cost $808,480 per year. The rule could also entail costs for any needed upgrades to biosafety and containment, and cybersecurity. These costs are expected to be small. To the extent that affected entities are already permittees, the biosafety and containment requirements of the new act will have already been required at those facilities. Affected entities have a variety of compelling reasons, including legislation, for already protecting information. The rule also requires that a biosafety and security plan be developed. It is estimated that the development of the biosafety portion of the plan could cost
The costs to APHIS include processing facility registrations, notifications of identification of agents and toxins, exemption applications, transfer applications, theft/loss notifications, appeals, performing facility inspections, and providing technical assistance for compliance. It is estimated that this will cost as much as $1.5 million in the first year. Paperwork processing is estimated to cost APHIS $744,705 per year.
The above is given to provide perspective on the magnitude of the potential costs associated with the rule. The facilities covered in this rule can and do vary from a small laboratory contained within a larger facility to large dedicated buildings to large groups of buildings and land. Because security needs are site specific and the rule allows for site specific security solutions, the approaches and applications will be varied. Physical security measures may have to be added in various quantities (including none) to meet the specific security needs of a facility. Also, some of the impacts of this rule are somewhat offset by previous requirements, funding from other sources for upgrades that would otherwise be mandated by this rule, and flexibility in the rule that allows for site-specific needs to be met in the most cost effective manner possible.
While the costs associated with this rule could be considerable, some of those impacts are somewhat offset by previous requirements, funding from other sources for upgrades that would otherwise be mandated by this rule, and flexibility in the rule that allows for site specific needs to be met in the most cost effective manner possible. In addition, these costs are greatly outweighed by the benefits of preventing a deliberate introduction of a listed agent or toxin into the United States. Should any listed agent or toxin be intentionally introduced, the consequences would be significant as demonstrated by natural outbreaks that have occurred.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We plan to request continuation of that approval for 3 years. Please send written comments on the 3-year approval request to the following addresses: (1) Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) Docket No. 02-088-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 02-088-1 and send your comments within 60 days of publication of this rule.
This interim rule establishes regulations governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal products and plant products. Unless specifically exempted under the regulations, an individual or entity must register with APHIS or, for overlap agents or toxins, APHIS or CDC, in order to possess, use, or transfer biological agents or toxins.
To register, an individual or entity must submit a registration application package; develop and implement a Biocontainment and Security Plan or Biosafety and Security Plan, as applicable; and request access approval for individuals who have been identified as having a legitimate need to handle or use listed agents or toxins and who have the appropriate training and skills to handle or use such agents or toxins.
We are soliciting comments from the public (as well as affected agencies) concerning our information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
(Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)
Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this interim rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
Agricultural research, Laboratories, Plant diseases and pests, Reporting and recordkeeping requirements.
Agricultural research, Animal diseases, Laboratories, Medical research, Reporting and recordkeeping requirements.
Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 647 (7 U.S.C. 8401).
The regulations in this part are effective on February 11, 2003.On and after that date, any person possessing, using, or transferring any agent or toxin listed in § 331.3 must be in compliance with the provisions of this part. However, so as not to disrupt research or educational projects involving listed agents or toxins that were underway as of the effective date of this part, any person possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with this part. Any provision not specifically cited in paragraphs (a) through (f) of this section will be applicable as of February 11, 2003. In addition, any individual or entity who does not possess listed agents or toxins by the effective date of this part, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of this part that are applicable for current possessors at the time of application, as provided in paragraphs (a) through (e) of this section.
(a) During the period from February 11, 2003, to November 12, 2003, biological agents or toxins listed in § 331.3 may only be transferred to an individual or entity that is not registered under this part if the individual or entity has been issued a permit by the Administrator under part 330 of this chapter to import or move interstate that specific agent or toxin. If an individual or entity has not been issued a permit under part 330 of this chapter, the individual or entity may apply for a permit. To receive an agent or toxin, an individual or entity will also be required to submit APHIS Form 2041, in accordance with § 331.13(c). Because USDA permits do not cover intrastate movement, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with this part.
(b) By March 12, 2003, the responsible official must submit the registration application package as required in § 331.8. In addition, the responsible official must submit to the Attorney General the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.
(c) By April 11, 2003, the responsible official must submit to the Attorney General the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins, as required in § 331.10.
(d) By June 12, 2003, the responsible official must submit to APHIS the security section of the Biocontainment and Security Plan required in § 331.11.
(e) By September 12, 2003, the responsible official must implement the security section of the Biocontainment and Security Plan, as required in § 331.11, and provide security training in accordance with 7 CFR 331.12.
(f) By November 12, 2003, the registration application process must be complete and the entity in full compliance with the regulations in this part.
(1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(2) Deterioration of food, water, equipment, supplies, or material of any kind; or
(3) Deleterious alteration of the environment.
(1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(2) Any poisonous isomer or biological product, homolog, or derivative of such a substance.
(a) This part sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to plant health or to plant products. The purpose of this part is to ensure the safe handling of such agents or toxins, and to protect against the use of such agents or toxins in domestic or international terrorism or for any other criminal purpose.
(b) Accordingly, this part provides that any individual or entity that possesses, uses, or transfers any agent or toxin listed in § 331.3 must register in accordance with § 331.6. To register, each entity must designate an individual who has the authority and control to ensure compliance with the regulations to be the responsible official. The responsible official must complete and submit the registration application package to APHIS. As part of registration, the responsible official, the entity, and, where applicable, the individual who owns or controls such entity will be subject to a security risk assessment by the Attorney General.
(c) The responsible official is responsible for ensuring compliance with the safety procedures in this part, including implementing the Biocontainment and Security Plan in accordance with § 331.11, providing the proper training to individuals who handle or use agents or toxins listed in § 331.3, and providing proper laboratory facilities to contain and dispose of such agents or toxins. In addition, the responsible official is responsible for ensuring compliance with the safeguard and security measures in this part, including restricting access to only those individuals who have a legitimate need to handle or use agents or toxins and who have been approved in accordance with § 331.10, and transferring such agents or toxins only to registered individuals or entities in accordance with § 331.13.
(a) The biological agents and toxins listed in this section have been determined to have the potential to pose a severe threat to plant health or to plant products.
(b) The Administrator has determined that it would be impractical to regulate a biological agent or toxin that is in its naturally occurring environment. Therefore, any biological agent or toxin listed in this section that is in its naturally occurring environment will not be subject to the requirements of this part, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(c) The Administrator has determined that biological agents or toxins that meet any of the following criteria do not have the potential to pose a severe threat to plant health or to plant products. Therefore, an individual or entity that only possesses, uses, or transfers an agent or toxin that meets any of the following criteria will not be subject to the requirements of this part:
(1) Nonviable agents that are, bear, or contain listed agents or toxins;
(2) Genetic elements or subunits of listed agents or toxins, if the genetic elements or subunits are not capable of causing disease.
(a) Diagnostic laboratories
(1) The identification of such agents or toxins is immediately reported to the Administrator and to other appropriate authorities when required by Federal, State, or local law; and
(2) Within 7 days after identification, the agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to the Administrator.
(b) In addition to the exemption provided in paragraph (a) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting animal or plant health, and animal or plant products. An individual or entity that possesses, uses, or transfers agents or toxins may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. If there is a conflict as to any material fact, the individual or entity may request a hearing to resolve the conflict.
(a) Unless exempted under § 331.4, any individual or entity that possesses, uses, or transfers any agent or toxin listed in § 331.3 must register with APHIS.
(b) Each entity must designate an individual to be its responsible official. The responsible official must have the authority and control to ensure compliance with the regulations. The responsible official must complete and sign the registration application package, and will be the individual contacted by APHIS if any questions arise concerning the application or subsequent compliance with the regulations in this part. As part of registration, the responsible official and the entity will be subject to a security risk assessment by the Attorney General. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, APHIS will consider the individual to be the responsible official.
(c) An entity may designate an individual to be an alternate responsible official, who may act for the responsible
(a) Unless exempted under this part, an individual or entity shall not possess, use, or transfer any agent or toxin listed in § 331.3 without a certificate of registration issued by APHIS.
(b) A certificate of registration may be issued upon:
(1) Approval of the responsible official; the alternate responsible official, where applicable; the entity; and, where applicable, the individual who controls the entity following a security risk assessment by the Attorney General;
(2) Approval of the containment and security of the entity. The entity's containment and security procedures must be commensurate with the risk of the agent or toxin, given its intended use. APHIS will review the Biocontainment and Security Plan, and may inspect and evaluate the premises and records to determine compliance with the regulations and the containment and security requirements; and
(3) A determination by the Administrator that the individual or entity seeking to register has a lawful purpose to possess, use, or transfer such agents or toxins.
(c) A certificate of registration will be valid for only the specific agents or toxins listed on the certificate and specific activities and locations. A certificate of registration may cover more than one listed agent or toxin, and it may be amended to cover additional listed agents or toxins.
(d) A certificate of registration may be amended to reflect changed circumstances (
(e) If a responsible official wishes to discontinue possessing, using, or transferring a particular agent or toxin, the responsible official may inactivate the agent or toxin or he/she may transfer the agent or toxin to a registered individuals or entities in accordance with § 331.12. The responsible official must notify APHIS 5 business days prior to the planned inactivation so that we may have the opportunity to observe the inactivation of the agents or toxins. We will notify the responsible official if we wish to observe the inactivation of the agents or toxins.
(f) A certificate of registration will be valid for a maximum of 3 years.
(a) APHIS may deny an application for registration or revoke registration if:
(1) The Attorney General identifies the responsible official, entity, or the individual who owns or controls the entity as within any of the categories described in 18 U.S.C. 175b; or
(2) The Attorney General identifies the responsible official, entity, or the individual who owns or controls the entity as reasonably suspected by any Federal law enforcement or intelligence agency of:
(i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
(ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or
(iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801; or
(3) The responsible official does not have a lawful purpose to possess, use, or transfer agents or toxins listed in § 331.3; or
(4) The responsible official is an individual who handles or uses listed agents or toxins and he/she does not have the necessary training or skills to handle such agents or toxins; or
(5) The entity does not meet the containment and security requirements prescribed by the Administrator;
(6) There are egregious or repeated violations of the containment or security requirements; or
(7) The Administrator determines that such action is necessary to protect animal or plant health, and animal or plant products.
(b) APHIS may summarily revoke or suspend registration for any of the reasons set forth in paragraph (a) of this section.
(c) APHIS will notify the responsible official in writing if an application for registration is denied or a certificate of registration is revoked or suspended.
(d) Denial of an application for registration, revocation of registration, and suspension of registration may be appealed under § 331.16.
(a) To apply for a certificate of registration, an individual or entity must submit all of the information and documentation required in the registration application package to APHIS, including the name, source, and characterization data for each agent or toxin to be registered.
(b) The registration application package may be obtained by calling (301) 734-5519 or faxing a request to (301) 734-8700. It is also available on the Internet at
(a) The responsible official is responsible for ensuring compliance with the regulations, including:
(1) Developing and implementing a Biocontainment and Security Plan in accordance with § 331.11;
(2) Allowing only approved individuals within the entity to have access to any agents or toxins listed in § 331.3 in accordance with § 331.10;
(3) Providing appropriate training in containment and security procedures for all personnel in accordance with § 331.12;
(4) Transferring agents or toxins only to registered individuals or entities in accordance with § 331.13;
(5) Ensuring that all visitors are informed of and follow the entity's security requirements and procedures;
(6) Notifying APHIS of changes in circumstances in accordance with § 331.6;
(7) Providing timely notice of any theft, loss, or release of a biological agent or toxin in accordance with § 331.16;
(8) Maintaining detailed records of information necessary to give a complete accounting of all of the activities related to agents or toxins listed in § 331.3 in accordance with § 331.14.
(b) In addition to the requirements in paragraph (a) of this section, the responsible official for a diagnostic laboratory or other entity possessing, using, or transferring agents or toxins listed in § 331.3 that are contained in specimens presented for diagnosis must immediately report the identification of such agents or toxins to the Administrator and to other appropriate authorities when required by Federal, State, or local law.
(a) An individual may not have access to biological agents or toxins listed in § 331.3 unless approved by APHIS. APHIS will grant, limit, or deny access of individuals to listed agents or toxins.
(b) The responsible official is responsible for ensuring that only approved individuals within the entity have access to any agents or toxins listed in § 331.3. The responsible official must request such access for only those individuals who have a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins.
(c) The responsible official must provide appropriate training in containment and security procedures to all individuals with access to agents and toxins listed in § 331.3, in accordance with § 331.12.
(d) For each individual identified by the responsible official as having a legitimate need to handle or use listed agents or toxins, the responsible official must submit that individual's name and identifying information to APHIS and the Attorney General.
(e) In addition, the responsible official must submit information about the individual's training and skills to APHIS (
(f) APHIS may expedite the access approval process for individuals upon request by the responsible official and a showing of good cause (
(g) APHIS will notify the responsible official if an individual is granted full or limited access, or denied access to listed agents or toxins. APHIS will also notify the individual if he/she is denied access or granted only limited access.
(h) APHIS may deny or limit access of an individual to listed agents or toxins if:
(1) The Attorney General identifies the individual as within any of the categories described in 18 U.S.C. 175b;
(2) The Attorney General identifies the individual as reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801;
(3) The individual does not have a legitimate need to handle listed agents or toxins;
(4) The individual does not have the necessary training or skills to handle listed agents or toxins;
(5) The Administrator determines that such action is necessary to protect plant health or plant products.
(i) An individual may appeal the Administrator's decision to deny or limit access under § 331.15.
(j) Access approval is valid for 5 years; thereafter, the responsible official shall request renewal of access approval every 5 years for as long as the individual needs access to agents or toxins listed in § 331.3.
(k) The responsible official must immediately notify APHIS when an individual's access to listed agents or toxins is terminated by the entity and the reasons therefor.
(a) As a condition of registration, an individual or entity must develop and implement a Biocontainment and Security Plan.
(1)
(2)
(i) The site-specific risk assessment should involve a threat assessment and risk analysis in which threats are defined, vulnerabilities examined, and risks associated with those vulnerabilities are identified.
(ii) The security systems and procedures must be tailored to address site-specific characteristics and requirements, ongoing programs, and operational needs, and must mitigate the risks identified under paragraph (a)(2)(i) of this section.
(iii) The plan must describe inventory control procedures, personnel suitability for those individuals with access to agents or toxins listed in § 331.3, physical security, and cybersecurity. The plan must also contain provisions for securing the area (
(iv) With respect to areas containing listed agents or toxins, an entity or individual must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security as the provisions below:
(A) Allow unescorted access only to approved individuals who are performing a specifically authorized function during hours required to perform that job;
(B) Allow individuals not approved under § 331.10 to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by approved individuals;
(C) Provide for the control of access to containers where listed agents and toxins are stored by requiring that such containers be locked when not in the direct view of an approved individual and by using other monitoring measures, as needed;
(D) Require the inspection of all packages upon entry and exit;
(E) Establish a protocol for intra-entity transfers, including provisions for ensuring that the packaging and movement, is conducted under the supervision of an approved individual;
(F) Require that approved individuals do not share with any other person their unique means of accessing the area or listed agents or toxins; and
(G) Require that approved individuals immediately report any of the following to the responsible official:
(
(
(
(
(
(3)
(b) The Biocontainment and Security Plan must be reviewed, performance tested, and updated annually. The plan must also be reviewed and revised, as necessary, after any incident.
(a) The responsible official must provide appropriate training in containment and security procedures to all individuals with access to agents and toxins listed in § 331.3.
(b) The responsible official must provide information and training to an individual at the time the individual is assigned to work with a listed agent or toxin. The responsible official must provide refresher training annually.
Biological agents and toxins listed in § 331.3 may only be transferred to an individual or entity registered to possess, use, or transfer that particular agent or toxin. However, the sender of an agent or toxin may be an individual or entity that has a certificate of registration for the agent or toxin, an individual or entity that is exempt from the requirements of this part, or an individual or entity located outside of the United States. Biological agents or toxins may only be transferred under the conditions of this section and must be authorized by APHIS prior to the transfer.
(a)
(b)
(c)
(2) APHIS will authorize the transfer based on a finding that the recipient has a certificate of registration covering the transfer of the listed agent or toxin.
(3) The responsible official for the recipient entity must notify APHIS and the sender upon receipt of the agent or toxin by mailing or faxing a completed APHIS Form 2041 within 2 business days.
(4) The responsible official for the recipient must notify APHIS immediately if the agent or toxin has not been received within 48 hours after the expected delivery or if the package containing the agent or toxin is leaking or has been damaged.
(d) The sender must comply with all applicable laws governing packaging and shipping.
(a) The responsible official must maintain complete, up-to-date records of information necessary to give an accounting of all of the activities related to agents or toxins listed in § 331.3. Such records must include the following:
(1) The Biocontainment and Security Plan;
(2) A current list of all individuals with access to agents or toxins listed in § 331.3;
(3) Training records for individuals with access to such agents or toxins;
(4) Accurate and current inventory records (including source and characterization data);
(5) Permits and transfer documents (APHIS Form 2041) issued by APHIS;
(6) Security records (
(7) Containment and security incident reports.
(b) The responsible official must maintain such records for 3 years.
(c) All records must be produced upon request to APHIS inspectors, and appropriate Federal, State, or local law enforcement authorities.
(a) To ensure compliance with the regulations, any APHIS inspector must be allowed, without previous notification, to enter and inspect the entire premises, all materials and equipment, and all records required to be maintained by this part.
(b) Prior to issuing a certificate of registration to an entity or individual, APHIS may inspect and evaluate their premises and records to ensure compliance with the regulations and the containment and security requirements.
(a) The responsible official must orally notify APHIS and appropriate Federal, State, or local law enforcement
(b) The responsible official must orally notify APHIS immediately upon discovery that a release of an agent or toxin has occurred outside of the biocontainment area. The oral notification must be followed by a written report (APHIS Form 2043) within 7 days. Upon notification and a finding that the release poses a threat to animal or plant health, or animal or plant products, APHIS will notify relevant Federal, State, and local authorities, and the public, if necessary.
(c) The responsible official must orally notify APHIS of a theft, loss, or release of an agent or toxin by calling (301) 734-5519. A copy of APHIS Form 2043 may be obtained by writing to Biological and Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236, or by calling (301) 734-5519. APHIS Form 2043 may be mailed to the same address or faxed to (301) 734-8700.
An individual or entity may appeal a denial or revocation of registration under this part. An individual who has been denied access to listed agents or toxins or who has been granted only limited access to listed agents or toxins under this part may appeal that decision.
Secs. 211-213, Title II, Pub. L. 107-188, 116 Stat. 647 (7 U.S.C. 8401).
The regulations in this part are effective on February 11, 2003. On and after that date, any person possessing, using, or transferring any agent or toxin listed in § 121.3 must be in compliance with the provisions of this part. However, so as not to disrupt research or educational projects involving listed agents or toxins that were underway as of the effective date of this part, any person possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with this part. Any provision not specifically cited in paragraphs (a) through (f) of this section will be applicable as of February 11, 2003. In addition, any person who does not possess listed agents or toxins by the effective date of this part, but who wishes to initiate a research or educational project prior to November 12, 2003, must be in compliance with the provisions of this part that are applicable for current possessors at the time of application, as provided in paragraphs (a) through (e) of this section.
(a) During the period from February 11, 2003, to November 12, 2003, biological agents or toxins listed in § 121.3 may only be transferred to an individual or entity that is not registered under this part if:
(1) The individual or entity is registered by CDC for that specific overlap agent or toxin in accordance with 42 CFR part 72; or
(2) The individual or entity has been issued a permit by the Administrator under part 122 of this subchapter to import or move interstate that specific agent or toxin. If an individual or entity has not been issued a permit under part 122 of this subchapter, the individual or entity may apply for a permit. To receive an agent or toxin, an individual or entity will also be required to submit APHIS Form 2041, in accordance with § 121.14(c). Because USDA permits do not cover intrastate movement, unless registered by CDC under 42 CFR part 72, an individual or entity may not receive a listed agent or toxin that is being moved intrastate until that individual or entity is registered in accordance with this part.
(b) By March 12, 2003, the responsible official must submit the registration application package as required in § 121.9. In addition, the responsible official must submit to the Attorney General the names and identifying information for the responsible official; alternate responsible official, where applicable; entity; and, where applicable, the individual who owns or controls the entity.
(c) By April 11, 2003, the responsible official must submit to the Attorney General the names and identifying information for all individuals whom the responsible official has identified as having a legitimate need to handle or use listed agents or toxins, and who have the appropriate training and skills to handle such agents or toxins, as required in § 121.11.
(d) By June 12, 2003, the responsible official must submit the security section of the Biosafety and Security Plan required in § 121.12 to APHIS or, for overlap agents or toxins, to APHIS or CDC.
(e) By September 12, 2003, the responsible official must implement the security section of the Biosafety and Security Plan, as required in § 121.12, and provide security training in accordance with 9 CFR 121.13.
(f) By November 12, 2003, the registration application process must be complete and the entity in full compliance with the regulations in this part.
(1) Death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(2) Deterioration of food, water, equipment, supplies, or material of any kind; or
(3) Deleterious alteration of the environment.
(1) Any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(2) Any poisonous isomer or biological product, homolog, or derivative of such a substance.
(a) This part sets forth the requirements for possession, use, and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, or to animal products. The purpose of this part is to ensure the safe handling of such agents or toxins, and to protect against the use of such agents or toxins in domestic or international terrorism or for any other criminal purpose.
(b) Accordingly, this part provides that any individual or entity that possesses, uses, or transfers any agent or toxin listed in § 121.3 must register in accordance with § 121.7. To register, each entity must designate an individual who has the authority and control to ensure compliance with the regulations to be the responsible official. The responsible official must complete and submit the registration application package to APHIS or, for overlap agents or toxins, to APHIS or CDC. As part of registration, the responsible official, the entity, and, where applicable, the individual who owns or controls such entity will be subject to a security risk assessment by the Attorney General.
(c) The responsible official is responsible for ensuring compliance with the safety procedures in this part, including implementing the Biosafety and Security Plan in accordance with § 121.12, providing the proper training to individuals who handle or use agents or toxins listed in § 121.3, and providing proper laboratory facilities to contain and dispose of such agents or toxins. In addition, the responsible official is responsible for ensuring compliance with the safeguard and security measures in this part, including restricting access to only those individuals who have a legitimate need to handle or use agents or toxins and who have been approved in accordance with § 121.11, and transferring such agents or toxins only to registered individuals or entities in accordance with § 121.13.
(a) Except as provided in paragraphs (f) and (g) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to both human and animal health, to animal health, or to animal products.
(b)
(c) Genetic elements, recombinant nucleic acids, and recombinant organisms of overlap agents or toxins:
(1) Biological agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the biological agent viruses.
(2) Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the toxins listed in paragraph (b) of this section, if the nucleic acids:
(i) Are in a vector or host chromosome;
(ii) Can be expressed
(iii) Are in a vector or host chromosome and can be expressed in
(3) Viruses, bacteria, fungi, and toxins listed in paragraph (b) of this section that have been genetically modified.
(d)
(e) The Administrator has determined that it would be impractical to regulate a biological agent or toxin that is in its naturally occurring environment. Therefore, any biological agent or toxin listed in this section that is in its naturally occurring environment will not be subject to the requirements of this part, provided that the biological agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(f) The Administrator has determined that biological agents or toxins that meet any of the following criteria do not have the potential to pose a severe threat to both human and animal health, or to animal health or animal products. Therefore, an individual or entity that only possesses, uses, or transfers an agent or toxin that meets any of the following criteria will not be subject to the requirements of this part:
(1) Nonviable agents or fixed tissues that are, bear, or contain agents or toxins listed in this section.
(2) Genetic elements or subunits of agents or toxins listed in paragraph (d) of this section, if the genetic elements or subunits are not capable of causing disease.
(3) Overlap toxins under the control of a principal investigator (or equivalent), if the total aggregate amount does not, at any time, exceed the following amounts: 0.5 mg of Botulinum neurotoxins (types A-G), 100 mg of
(g)
(1) If APHIS or CDC determines that a specific attenuated strain does not pose a severe threat to human and animal health, or to animal health or animal products, an individual or entity will not be subject to the requirements of this part. This determination will be limited to the specific attenuated strain and to the specific activities involving that attenuated strain.
(2) An individual or entity may request a review by writing to the Administrator or, for overlap agents, by writing to the Administrator or CDC.
(3) If it is determined that a specific attenuated strain does not pose a severe threat, APHIS or CDC will notify the applicant and publish a notice in the
(4) An individual or entity may request reconsideration of an adverse decision in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies upon to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. If there is a conflict as to any material fact, the individual or entity may request a hearing to resolve the conflict.
(a) Clinical or diagnostic laboratories and other entities possessing, using, or transferring overlap agents or toxins that are contained in specimens presented for diagnosis or verification will be exempt from the requirements of this part, provided that:
(1) The identification of such agents or toxins is immediately reported to APHIS or CDC, and to other appropriate authorities when required by Federal, State, or local law; and
(2) Within 7 days after identification, the agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC.
(b) Clinical or diagnostic laboratories and other entities possessing, using, or transferring overlap agents or toxins that are contained in specimens presented for proficiency testing will be exempt from the requirements of this part, provided that:
(1) The identification of such agents or toxins, and their derivatives, is immediately reported to the APHIS or CDC, and to other appropriate authorities when required by Federal, State, or local law; and
(2) Within 90 days of receipt, the agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to APHIS or CDC. A copy of the completed form must be maintained for 3 years.
(c) Unless the Administrator by order determines that additional regulation of a specific product is necessary to protect animal or plant health, or animal or plant products, an individual or entity possessing, using, or transferring products that are, bear, or contain overlap agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131
(d) An individual or entity possessing, using, or transferring investigational products that are, bear, or contain
(1) An individual or entity possessing, using, or transferring such investigational products may apply for an exemption from the requirements of this part by submitting APHIS Form 2042 to APHIS or CDC.
(2) For investigational products authorized under any of the Federal laws specified in paragraph (c) of this section, the Administrator shall make a determination regarding an exemption within 14 days after receipt of the application and notification that the investigation has been authorized under a Federal law.
(e) The Administrator may exempt an individual or entity from the requirements of this part, in whole or in part, for 30 days if it is necessary to respond to a domestic or foreign agricultural emergency involving an overlap agent or toxin. The Administrator may extend the exemption once for an additional 30 days.
(f) Upon request of the Secretary of Health and Human Services, the Administrator may exempt an individual or entity from the requirements of this part, in whole or in part, for 30 days if the Secretary of Health and Human Services has granted an exemption for a public health emergency involving an overlap agent or toxin. The Administrator may extend the exemption once for an additional 30 days.
(a) Diagnostic laboratories and other entities possessing, using, or transferring agents or toxins that are contained in specimens presented for diagnosis or verification will be exempt from the requirements of this part, provided that:
(1) The identification of such agents or toxins is immediately reported to the Administrator and to other appropriate authorities when required by Federal, State, or local law; and
(2) Within 7 days after identification, the agents or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to the Administrator.
(b) Diagnostic laboratories and other entities possessing, using, or transferring agents or toxins that are contained in specimens presented for proficiency testing will be exempt from the requirements of this part, provided that:
(1) The identification of such agents or toxins, and their derivatives, is immediately reported to the Administrator, and to other appropriate authorities when required by Federal, State, or local law; and
(2) Within 90 days of receipt, the agent or toxins are transferred or inactivated, and APHIS Form 2040 is submitted to the Administrator. A copy of the completed form must be maintained for 3 years.
(c) An individual or entity receiving diagnostic reagents and vaccines that are, bear, or contain listed agents or toxins, also known as high consequence livestock pathogens or toxins, that are produced at USDA diagnostic facilities will be exempt from the requirements of this part.
(d) Unless the Administrator by order determines that additional regulation is necessary to protect animal health or animal products, an individual or entity possessing, using, or transferring products that are, bear, or contain listed agents or toxins will be exempt from the requirements of this part if the products have been cleared, approved, licensed, or registered pursuant to:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
(2) Section 351 of Public Health Service Act (42 U.S.C. 262);
(3) The Virus-Serum-Toxin Act (21 U.S.C. 151-159); or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 131
(e) An individual or entity possessing, using, or transferring experimental products that are, bear, or contain listed agents or toxins may be exempt from the requirements of this part if such product is being used in an investigation authorized by any Federal law and the Administrator determines that additional regulation under this part is not necessary to protect animal or plant health, and animal or plant products. An individual or entity possessing, using, or transferring such experimental products may apply for an exemption from the requirements of this part by submitting APHIS Form 2042 to APHIS.
(f) In addition to the exemptions provided in paragraphs (a) through (e) of this section, the Administrator may grant a specific exemption upon a showing of good cause and upon his or her determination that such exemption is consistent with protecting animal health and animal products. An individual or entity that possesses, uses, or transfers agents or toxins may request in writing an exemption from the requirements of this part. If granted, such exemptions are valid for a maximum of 3 years; thereafter, an individual or entity must request a new exemption. If a request for exemption is denied, an individual or entity may request reconsideration in writing to the Administrator. The request for reconsideration must state all of the facts and reasons upon which the individual or entity relies to show that the exemption was wrongfully denied. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. If there is a conflict as to any material fact, the individual or entity may request a hearing to resolve the conflict.
(a) Unless exempted under §§ 121.4 or 121.5, any individual or entity that possesses, uses, or transfers any agent or toxin listed in § 121.3 must register with APHIS or, for overlap agents or toxins, APHIS or CDC.
(b) Each entity must designate an individual to be its responsible official. The responsible official must have the authority and control to ensure compliance with the regulations. The responsible official must complete and sign the registration application package, and will be the individual contacted by APHIS or CDC if any questions arise concerning the application or subsequent compliance with the regulations in this part. As part of registration, the responsible official and the entity will be subject to a security risk assessment by the Attorney General. While most registrants are likely to be entities, in the event that an individual applies for and is granted a certificate of registration, APHIS will consider the individual to be the responsible official.
(c) An entity may designate one or more individuals to be an alternate responsible official, who may act for the responsible official when he/she is unavailable. These individuals must have the authority and control to ensure compliance with the regulations when acting as the responsible official. These individuals will also be subject to a security risk assessment by the Attorney General as part of registration.
(a) Unless exempted under §§ 121.4 or 121.5, an individual or entity shall not possess, use, or transfer any agent or toxin listed in § 121.3 without a certificate of registration issued by APHIS or CDC.
(b) A certificate of registration may be issued upon:
(1) Approval of the responsible official; the alternate responsible official, where applicable; the entity; and, where applicable, the individual who owns or controls the entity following a security risk assessment by the Attorney General;
(2) Approval of the biosafety, containment, and security of the entity. The entity's biosafety, containment, and security procedures must be commensurate with the risk of the agent or toxin, given its intended use. APHIS or CDC will review the Biosafety and Security Plan, and may inspect and evaluate the premises and records to determine compliance with the regulations and the biosafety, containment, and security requirements; and
(3) A determination by the Administrator that the individual or entity seeking to register has a lawful purpose to possess, use, or transfer such agents or toxins.
(c) For overlap agents, APHIS and CDC will review applications for registration and amendments to a certificate of registration, and a certificate of registration or amendment to a certificate of registration will only be issued if APHIS and CDC concur.
(d) A certificate of registration will be valid for only the specific agents or toxins listed in the certificate and specific activities and locations. A certificate of registration may cover more than one listed agent or toxin, and it may be amended to cover additional listed agents or toxins.
(e) A certificate of registration may be amended to reflect changed circumstances (
(f) If a responsible official wishes to discontinue possessing, using, or transferring a particular agent or toxin, the responsible official may inactivate the agent or toxin or he/she may transfer the agent or toxin to a registered individual or entity in accordance with § 121.13. The responsible official must notify APHIS or, for overlap agents or toxins, APHIS or CDC, 5 business days prior to the planned inactivation so that we may have the opportunity to observe the inactivation of the agents or toxins. APHIS or CDC will notify the responsible official if we wish to observe the inactivation of the agents or toxins.
(g) A certificate of registration will be valid for a maximum of 3 years.
(a) APHIS may deny an application for registration or revoke registration if:
(1) The Attorney General identifies the responsible official, entity, or individual who owns or controls the entity as within any of the categories described in 18 U.S.C. 175b; or
(2) The Attorney General identifies the responsible official, entity, or individual who owns or controls the entity as reasonably suspected by any Federal law enforcement or intelligence agency of:
(i) Committing a crime set forth in 18 U.S.C. 2332b(g)(5); or
(ii) Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or
(iii) Being an agent of a foreign power as defined in 50 U.S.C. 1801; or
(3) The responsible official does not have a lawful purpose to possess, use, or transfer agents or toxins listed in § 121.3; or
(4) The responsible official is an individual who handles or uses agents or toxins listed in § 121.3 and he/she does not have the necessary training or skills to handle such agents or toxins; or
(5) The entity does not meet the biosafety, containment, and security requirements prescribed by the Administrator;
(6) There are egregious or repeated violations of the biosafety, containment, or security requirements; or
(7) The Administrator determines that such action is necessary to protect animal or plant health, and animal or plant products.
(b) For overlap agents or toxins, APHIS or CDC shall deny an application for registration or revoke registration if the Attorney General identifies the responsible official, entity, or individual who owns or controls the entity as within any of the categories described in 18 U.S.C. 175b. APHIS or CDC may also deny registration or revoke registration for the reasons set forth in paragraphs (a)(2) through (a)(7) of this section.
(c) APHIS may summarily revoke or suspend registration for any of the reasons set forth in paragraphs (a) and (b) of this section.
(d) APHIS will notify the responsible official in writing if an application for registration is denied or a certificate of registration is revoked or suspended. For overlap agents or toxins, APHIS or CDC will notify the responsible official in writing if an application for registration is denied or a certificate of registration is revoked or suspended.
(e) Denial of an application for registration, revocation of registration, and suspension of registration may be appealed under § 121.17.
(a) To apply for a certificate of registration, the responsible official must submit all of the information and documentation required in the registration application package to APHIS, including the name, source, and characterization data for each agent or toxin to be registered. For overlap agents or toxins, the responsible official must submit all of the information and documentation required in the registration package to either APHIS or CDC. The responsible official must submit the registration application package to APHIS in cases where he/she is seeking registration for both animal and overlap agents and toxins.
(b) For animal agents and toxins, the registration application package may be obtained by calling (301) 734-3277 or faxing a request to (301) 734-3652. It is also available on the Internet at
(c) For overlap agents and toxins, the registration application package may be obtained by contacting APHIS, as set forth in paragraph (b) of this section, or by calling CDC at (404) 498-2255; faxing a request to (404) 498-2265; or writing to Select Agent Program, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mail Stop E 79, Atlanta, GA 30333. It is also available on the Internet at
(a) The responsible official is responsible for ensuring compliance with the regulations, including:
(1) Developing and implementing a Biosafety and Security Plan in accordance with § 121.12;
(2) Allowing only approved individuals within the entity to have access to any agents or toxins listed in § 121.3 in accordance with § 121.11;
(3) Providing appropriate training in biosafety, containment, and security procedures for all personnel in accordance with § 121.13;
(4) Transferring agents or toxins only to registered individuals or entities in accordance with § 121.14;
(5) Ensuring that all visitors are informed of and follow the entity's security requirements and procedures;
(6) Notifying APHIS or, for overlap agents or toxins, APHIS or CDC, of changes in circumstances in accordance with § 121.7;
(7) Providing timely notice of any theft, loss, or release of a biological agent or toxin in accordance with § 121.17;
(8) Maintaining detailed records of information necessary to give a complete accounting of all of the activities related to agents or toxins listed in § 121.3 in accordance with § 121.15.
(b) In addition to the requirements in paragraph (a) of this section, the responsible official for a diagnostic laboratory or other entities possessing, using, or transferring agents or toxins listed in § 121.3 that are contained in specimens presented for diagnosis must immediately report the identification of such agents or toxins to the Administrator and to other appropriate authorities when required by Federal, State, or local law.
(c) In addition to the requirements in paragraph (a) of this section, the responsible official must ensure that the following experiments are not conducted unless approved by the Administrator, after consultation with experts:
(1) Experiments utilizing recombinant DNA that involve the deliberate transfer of a pathogenic trait or drug resistance trait to biological agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxins lethal for vertebrates at an LD
(a) An individual may not have access to biological agents or toxins listed in § 121.3 unless approved by APHIS or CDC. APHIS will grant, limit, or deny access of individuals to listed agents or toxins. APHIS or CDC will grant, limit, or deny access of individuals to overlap agents or toxins.
(b) The responsible official is responsible for ensuring that only approved individuals within the entity have access to any agents or toxins listed in § 121.3. The responsible official must request such access for only those individuals who have a legitimate need to handle or use agents or toxins, and who have the appropriate training and skills to handle such agents or toxins.
(c) The responsible official must provide appropriate training in biosafety, containment, and security procedures to all individuals with access to agents and toxins listed in § 121.3.
(d) For each individual identified by the responsible official as having a legitimate need to handle or use agents or toxins, the responsible official must submit that individual's name and identifying information to APHIS and the Attorney General. For overlap agents or toxins, the responsible official must submit this information to either APHIS or CDC and the Attorney General.
(e) In addition, the responsible official must submit information about the individual's training and skills to APHIS or, for overlap agents or toxins, APHIS or CDC (
(f) APHIS may expedite the access approval process for individuals upon request by the responsible official and a showing of good cause (
(g) APHIS will notify the responsible official if an individual is granted full or limited access, or denied access to listed agents or toxins. APHIS will also notify the individual if he/she is denied access or granted only limited access. For overlap agents or toxins, APHIS or CDC will provide the necessary notification.
(h) APHIS may deny or limit access of an individual to listed agents or toxins if:
(1) The Attorney General identifies the individual as within any of the categories described in 18 U.S.C. 175b;
(2) The Attorney General identifies the individual as reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime set forth in 18 U.S.C. 2332b(g)(5); knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence; or being an agent of a foreign power as defined in 50 U.S.C. 1801;
(3) The individual does not have a legitimate need to handle listed agents or toxins;
(4) The individual does not have the necessary training or skills to handle listed agents or toxins;
(5) The Administrator determines that such action is necessary to protect animal health or animal products.
(i) For overlap agents or toxins, APHIS or CDC will deny an individual access to such agents or toxins if the Attorney General identifies the individual as within any of the categories described in 18 U.S.C. 175b. APHIS or CDC may also deny or limit access of an individual for the reasons set forth in paragraphs (f)(2) through (f)(5) of this section.
(j) An individual may appeal the Administrator's decision to deny or limit access under § 121.17.
(k) Access approval is valid for 5 years; thereafter, the responsible official shall request renewal of access approval every 5 years for as long as the individual needs access to agents or toxins listed in § 121.3.
(l) The responsible official must immediately notify APHIS or, for overlap agents or toxins, APHIS or CDC, when an individual's access to agents or toxins listed in § 121.3 is terminated by the entity and the reasons therefore.
(a) As a condition of registration, the responsible official must develop and implement a Biosafety and Security Plan.
(1)
(2)
(i) The site-specific risk assessment should involve a threat assessment and risk analysis in which threats are defined, vulnerabilities examined, and risks associated with those vulnerabilities are identified.
(ii) The security systems and procedures must be tailored to address site-specific characteristics and requirements, ongoing programs, and operational needs and must mitigate the risks identified under paragraph (a)(2)(i) of this section.
(iii) The plan must describe inventory control procedures, personnel suitability for those individuals with access to agents or toxins listed in § 121.3, physical security, and cybersecurity. The plan must also contain provisions for routine cleaning, maintenance, and repairs; provisions for securing the area (
(iv) With respect to areas containing listed agents or toxins, an entity or individual must adhere to the following security requirements or implement measures to achieve an equivalent or greater level of security as the provisions below:
(A) Allow unescorted access only to approved individuals who are performing a specifically authorized function during hours required to perform that job;
(B) Allow individuals not approved under § 121.11 to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by approved individuals;
(C) Provide for the control of access to containers where listed agents and toxins are stored by requiring that such containers be locked when not in the direct view of an approved individual and by using other monitoring measures, as needed;
(D) Require the inspection of all packages upon entry and exit;
(E) Establish a protocol for intra-entity transfers, including provisions for ensuring that the packaging and movement, is conducted under the supervision of an approved individual;
(F) Require that approved individuals do not share with any other person their unique means of accessing the area or listed agents or toxins; and
(G) Require that approved individuals immediately report any of the following to the responsible official:
(
(
(
(
(
(3)
(b) The Biosafety and Security Plan must be reviewed, performance tested, and updated annually. The plan must also be reviewed and revised, as necessary, after any incident.
(a) The responsible official must provide appropriate training in biosafety, containment, and security procedures to all individuals with access to agents and toxins listed in § 121.3.
(b) The responsible official must provide information and training to an individual at the time the individual is assigned to work with a listed agent or toxin. The responsible official must provide refresher training annually.
Biological agents and toxins listed in § 121.3 may only be transferred to individuals or entities registered to possess, use, or transfer that particular agent or toxin. However, the sender of an agent or toxin may be an individual or entity that has a certificate of registration for the agent or toxin, an individual or entity that is exempt from the requirements of this part, or an individual or entity located outside of the United States. Biological agents or toxins may only be transferred under the conditions of this section and must be authorized by APHIS or, for overlap agents or toxins, by APHIS or CDC, prior to the transfer.
(a)
(b)
(c)
(2) APHIS or CDC will authorize the transfer based on a finding that the recipient has a certificate of registration covering the transfer of the listed agent or toxin.
(3) The responsible official for the recipient must notify the agency authorizing the transfer (either APHIS or CDC) and the sender upon receipt of the agent or toxin by mailing or faxing a completed APHIS Form 2041 to APHIS or CDC within 2 business days.
(4) The responsible official for the recipient must notify APHIS or CDC immediately if the agent or toxin has not been received within 48 hours after the expected delivery or if the package containing the agent or toxin is leaking or has been damaged.
(d) The sender must comply with all applicable laws governing packaging and shipping.
(a) The responsible official must maintain complete, up-to-date records of information necessary to give an accounting of all of the activities related to agents or toxins listed in § 121.3. Such records must include the following:
(1) The Biosafety and Security Plan;
(2) A current list of all individuals with access to agents or toxins listed in § 121.3;
(3) Training records for individuals with access to such agents or toxins;
(4) Accurate and current inventory records (including source and characterization data);
(5) Permits and transfer documents (APHIS Form 2041) issued by APHIS and CDC;
(6) Security records (
(7) Biosafety, containment, and security incident reports.
(b) The responsible official must maintain such records for 3 years.
(c) All records must be produced upon request to APHIS or CDC inspectors, and appropriate Federal, State, or local law enforcement authorities.
(a) To ensure compliance with the regulations, any APHIS or CDC inspector must be allowed, without previous notification, to enter and inspect the entire premises, all materials and equipment, and all records required to be maintained by this part.
(b) Prior to issuing a certificate of registration to an entity or individual, APHIS or CDC may inspect and evaluate the premises and records to ensure compliance with the regulations and the biosafety, containment, and security requirements.
(a) The responsible official must orally notify APHIS and appropriate Federal, State, or local law enforcement agencies immediately upon discovery of the theft or loss of agents or toxins listed in § 121.3. The oral notification must be followed by a written report (APHIS Form 2043) within 7 days.
(b) The responsible official must orally notify APHIS immediately upon discovery that a release of an agent or toxin has occurred outside of the biocontainment area. The oral notification shall be followed by a written report (APHIS Form 2043) within 7 days. Upon notification and a finding that the release poses a threat to animal or plant health, or animal or plant products, APHIS will notify relevant Federal, State, and local authorities, and the public, if necessary. If the release involves an overlap agent or toxin, APHIS will also notify the Secretary of Health and Human Services.
(c) The responsible official must orally notify APHIS of a theft, loss, or release of an agent or toxin by calling (866) 994-5698. A copy of APHIS Form 2043 may be obtained by writing to National Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231; or by calling (301) 734-3277. The form is also available on the Internet at
An individual or entity may appeal a denial or revocation of registration under this part. An individual who has been denied access to listed agents or toxins or who has been granted only limited access to listed agents or toxins under this part may appeal that decision.
Pension and Welfare Benefits Administration, Department of Labor.
Notice on the Availability of the Year 2002 Form M-1.
This document announces the availability of the Year 2002 Form M-1, Annual Report for Multiple Employer Welfare Arrangements and Certain Entities Claiming Exception. A copy of this new form is attached.
Amy J. Turner, Pension and Welfare Benefits Administration, Department of Labor, at (202) 693-8335.
The Form M-1 is required to be filed under section 101(g) and section 734 of the Employee Retirement Income Security Act of 1974, as amended (ERISA), and 29 CFR 2520.101-2.
This document announces the availability of the Year 2002 Form M-1, Annual Report for Multiple Employer Welfare Arrangements (MEWAs) and Certain Entities Claiming Exception (ECEs). A copy of the new form is attached. This year's Form M-1 is substantively identical to the Year 2001 Form M-1. In addition, the filing deadlines for the Year 2002 Form M-1 parallel those for last year's form. Specifically, the Year 2002 Form M-1 is generally due March 1, 2003, with an extension until May 1, 2003 available. These Year 2002 deadlines were also previously published; they are included in the Department of Labor's regulations implementing the Form M-1 filing requirement and they were set forth in last year's Form M-1.
PWBA is committed to working together with administrators to help them comply with this filing requirement. Additional copies of the Form M-1 are available on the Internet at:
Sec. 29 U.S.C. 1024, 1027, 1059, 1132(c)(5), 1135, 1181-1183, 1185, 1185a, 1185b, 1191, 1191a, 1191b, 1191c; Sec. 101, Pub. L. 104-191, 101 Stat. 1936 (29 U.S.C. 1181); Secretary of Labor's Order No. 1-87, 52 FR 13139, April 21, 1987.
Federal Election Commission.
Final rules and transmittal of regulations to Congress.
The Federal Election Commission is issuing final rules regarding disclaimers in political communications, fraudulent solicitations, civil penalties, personal use of campaign funds, and a technical amendment under the Federal Election Campaign Act of 1971, as amended (“FECA” or “the Act”). The final rules implement portions of the Bipartisan Campaign Reform Act of 2002 (“BCRA”) that govern new requirements for disclaimers accompanying radio, television, print, and other campaign communications, expand the FECA's fraudulent misrepresentation prohibition, increase the FECA's civil penalties for violating the prohibition on contributions made in the name of another, and codify the “irrespective” test regarding the personal use of campaign funds by candidates and Federal office holders.
The Commission had planned to address BCRA-related rules for inaugural committees in this rulemaking; however, inaugural committees will now instead be addressed in a future rulemaking. Further information is provided in the supplementary information that follows.
January 13, 2003.
Mr. John C. Vergelli, Acting Assistant General Counsel, or Attorneys, Ms. Ruth Heilizer (personal use), Ms. Dawn Odrowski (fraudulent solicitations and civil penalties), or Mr. Richard Ewell (disclaimers), 999 E Street, NW., Washington, DC, 20463, (202) 694-1650 or (800) 424-9530.
The Bipartisan Campaign Reform Act of 2002 (“BCRA”), Pub. L. 107-155, 116 Stat. 81 (March 27, 2002), contains extensive and detailed amendments to the Federal Election Campaign Act of 1971 (“FECA” or “the Act”), as amended, 2 U.S.C. 431
Section 402(c)(1) of BCRA establishes a general deadline of 270 days for the Commission to promulgate regulations to carry out BCRA, which is December 22, 2002. The final rules do not apply with respect to runoff elections, recounts, or election contests resulting from the November 2002 general election. 2 U.S.C. 431 note.
Because of the brief period before the statutory deadline for promulgating these rules, the Commission received and considered public comments expeditiously. The Notice of Proposed Rulemaking (“NPRM”), on which these final rules are based, was published in the
Under the Administrative Procedures Act, 5 U.S.C. 553(d), and the Congressional Review of Agency Rulemaking Act, 5 U.S.C. 801(a)(1), agencies must submit final rules to the Speaker of the House of Representatives and the President of the Senate, and publish them in the
These final rules address changes to: disclaimer requirements for campaign communications (2 U.S.C. 441d); fraudulent misrepresentations for purposes of soliciting contributions or donations (2 U.S.C. 441h); civil penalties for a particular knowing and willful violation of FECA (2 U.S.C. 437g); permissible uses of campaign funds by candidates and officeholders (2 U.S.C. 439a); and a technical amendment to the definition of “Act” to include BCRA amendments to FECA.
Pre-BCRA, 11 CFR 100.18 defined “Act” to mean the Federal Election Campaign Act as amended by the 1974, 1976, and 1980 amendments. The final rules amend this definition to include the amendments to FECA within the Bipartisan Campaign Reform Act.
Under 2 U.S.C. 441d, certain communications must include disclaimers identifying who paid for and, where applicable, who authorized the communication. In BCRA, Congress added new specificity to these requirements, expanded the disclaimer requirement to reach disbursements to finance “any communication” made by political committees through any type of general public political advertising, and required that “electioneering communications” include disclaimers.
The Commission is implementing these statutory changes by deleting pre-BCRA 11 CFR 110.11 in its entirety, and adopting a new section 110.11 that is organized into a more easily understandable rule. As explained in detail below, revised section 110.11 incorporates many substantive provisions from the pre-BCRA version of the section.
Paragraph (a) sets out the scope of the section by specifying which communications must carry disclaimers. Under 2 U.S.C. 441d(a), as amended by Congress through BCRA section 311, disclaimers are required whenever a person makes a disbursement for an electioneering communication, whenever a political committee makes a disbursement for the purpose of financing “any communication through any broadcasting station, newspaper, magazine, outdoor advertising facility, mailing, or any other type of general public political advertising,” or whenever any person makes a disbursement for the purpose of financing “communications expressly advocating the election or defeat of a clearly identified candidate, or solicits any contribution through any broadcasting station, newspaper, magazine, outdoor advertising facility, mailing, or any other type of general public political advertising.” The descriptive list of “through any broadcasting station, newspaper, magazine, outdoor advertising facility, mailing, or any other type of general public political advertising” is similar to the language used by Congress in BCRA to describe a “public communication,” as defined in 2 U.S.C. 431(22).
The Commission noted in the NPRM that the 2 U.S.C. 441d(a) references to “communication” share a fundamental similarity with the definition of “public communication” (2 U.S.C. 431(22)) in that both contain the virtually identical and broadly inclusive phrase, “or any other type [form] of general public political advertising,” to describe what is encompassed by the respective definitions.
The Commission sought comment on whether the description of “communication” in 2 U.S.C. 441d(a) should be equated with the term “public communication,” as defined in 2 U.S.C. 431(22). The Commission noted that one effect of using the consistent terminology of “public communication” to describe the 2 U.S.C. 441d(a) communications would be that “telephone banks to the general public” would be subject to the disclaimer requirements. Another effect of using the consistent terminology of “public communication” would be to harmonize the meaning of “mailing” with “mass mailing,” and the coverage of “any broadcasting station” with “any broadcast, cable, or satellite transmission.”
The Commission received two comments on this issue. Both commenters argued that the terms “public communication” and “communication,” as used in the section 441d(a) context, should be treated as distinct terms with separate definitions. One commenter, advised against any interpretation that would have the effect of making the disclaimer requirements applicable to telephone banks. That commenter asserted that the existence of several state laws limiting or prohibiting taped phone messages are already sufficient to deter abuse in this area, and disclaimer requirements would only serve to chill speech.
The Commission does not agree with this commenter that state laws regarding taped calls are sufficient to supplant the statutory disclaimer requirement, even in those few states that do have laws limiting taped calls. Requiring a caller to identify himself or herself serves important disclosure functions consistent with Congressional intent to broaden the reach of the previous laws regarding disclaimers and would likely complement state laws limiting the use of taped calls.
The other commenter stated that treating the term “communication” in 2 U.S.C. 441d(a) the same as “public communication” would “conflate and confuse two separate concepts that Congress established to meet two distinct purposes.” That commenter also asserted that the inclusion of other forms of “general public political advertising” does not indicate that the two terms share the same meaning. The commenter supported this assertion by citing to the Commission's previous explanation that “general language following a listing of specific terms * * * does not evidence Congressional intent to include a separate and distinct term that is not listed * * *”
The Commission notes that its prior statement cited by the commenter was made in the context of a decision not to include Internet communications within the definition of “public communication.” Unlike the term “telephone bank to the general public” and the other terms listed in the BCRA definition of “public communication,” communications over the Internet were not specifically listed as one of the forms of “general public political advertising.” But while general language following a list of specific terms may not, by itself, provide sufficient evidence of Congressional intent, the Commission believes that such intent can be found where Congress has provided additional guidance as to the proper interpretation of that general language elsewhere in the same statute. In the Commission's judgment, the use of the phrase “or any other type [form] of general public political advertising,” which is used in BCRA only in the two locations specified above,
This approach also incorporates Congressional intent, apparent in 2 U.S.C. 441d(d), to regulate communications by radio and television, and the Commission's judgment that it would be unsupportable to require a disclaimer for a television communication that was broadcast, while not requiring a disclaimer for the same communication merely because it was carried on cable or satellite. It is also consistent with other uses (or proposed uses) of the term “public communication” in its regulations. The Commission has used the term “public communication” to clarify the definition of “generic campaign activity,”
In addition, by employing the term “public communication” in the section 110.11 disclaimer rules, the Commission avoids assigning different meanings to the term “mailing” in 2 U.S.C. 441d(a) and “mass mailing,” the term used in the definition of “public communication” and defined by Congress in BCRA as more than 500 pieces of substantially similar mail.
While the term “public communication” serves generally to describe the proper reach of the disclaimer rules, the Commission has decided that certain Internet-based communications also should be covered. The Commission has for years interpreted the statute to require disclaimers on electronic mail and Internet website communications.
Nonetheless, to avoid overreaching in this area, and to maintain some symmetry with the definition of “public communication,” the Commission is limiting the coverage of electronic mail to situations involving more than 500 substantially similar unsolicited communications. This approach would not require a disclaimer on electronic mail where the recipients have taken some affirmative step to be on a list used by the sender, such as responding positively to a request to be on such list. Moreover, regarding websites, the Commission is extending the disclaimer requirements only to political committee websites. This will assure, for example, that a website created and paid for by an individual will not have to include a disclaimer. At the same time, arguably, the most significant use of electronic mail and websites to conduct campaign activity will have to provide the public notice of who is responsible.
In order to incorporate the foregoing Internet-based applications in the final disclaimer rules, 11 CFR 110.11(a) provides that for purposes of the section, the term “public communication” also covers more than 500 unsolicited electronic mail communications and websites of political committees. This is the Commission's only divergence from the 11 CFR 100.26 definition of “public communication.”
The Commission notes that it has initiated a separate rulemaking regarding several Internet-related issues. The disclaimer provisions may be revisited in that rulemaking.
Paragraphs (a)(1) through (4) of the final rules in 11 CFR 110.11 enumerate the particular types of such communications to which the disclaimer requirements apply. For the reasons described above and unless otherwise specified, the term “communications” is used in the preceding sentence and the remainder of the narrative below as a shorthand reference that encompasses both “public communications” and “electioneering communications.” Throughout revised section 110.11, the word “type” is used, rather than “form,” as in the pre-BCRA version of the regulation. This change has no substantive effect and only serves to conform the regulation to the language of the statute.
In BCRA, Congress provided that “any communication” for which a political committee makes a disbursement must include a disclaimer, expanding the scope of the disclaimer requirement for political committees beyond communications constituting express advocacy and communications soliciting contributions. Compare pre- and post-BCRA versions of 2 U.S.C. 441d(a). Revised paragraph (a)(1) of section 110.11 reads, “[a]ll public communications for which a political committee makes a disbursement.”
In contrast, revised paragraph (a)(2) of section 110.11 requires that “[a]ll public communications by any person that expressly advocate the election or defeat of a clearly identified candidate” must include a disclaimer. 2 U.S.C. 441d(a). The revised rule does not substantively change the disclaimer requirement for express advocacy communications from the pre-BCRA version of the regulation because BCRA does not alter the reach of the disclaimer requirements for persons that are not political committees, except with regard to electioneering communications (
Similarly, paragraph (a)(3) of section 110.11 requires “[a]ll public communications by any person” that solicit a contribution must include a disclaimer. 2 U.S.C. 441d(a). Here, too, the revised rule does not change the disclaimer requirement for solicitations from the pre-BCRA version of the rule because BCRA makes no changes in this regard.
Congress amended 2 U.S.C. 441d(a) to require that “electioneering communications” include disclaimers. In paragraph (a)(4) of section 110.11, the Commission requires that “[a]ll electioneering communications by any person” include a disclaimer. The term “electioneering communication” is defined in 11 CFR 100.29(a).
The Internal Revenue Service (“IRS”) commented generally on the scope of the Commission's proposed rules and found no direct conflict with the Internal Revenue Code or the regulations thereunder. The IRS noted that the Commission proposed at 11 CFR 110.11(a)(1)(iii) to require a disclaimer statement for all types of “general public political advertising” by any person soliciting contributions. The IRS also requested that for the benefit of tax-exempt organizations the Commission should restate certain requirements of section 6113 of the Internal Revenue Code (26 U.S.C. 6113). The IRS stated that section 6113 provides that certain tax-exempt organizations that are not eligible to receive tax deductible charitable contributions, and whose gross annual receipts normally exceed $100,000, must disclose in an “express statement (in a conspicuous and easily recognizable format)” that contributions to the organization are not deductible for Federal income tax purposes as charitable contributions. This provision
Paragraph (b) of section 110.11 sets out the general content requirements for disclaimers, depending on who paid for the communication and, where applicable, who authorized the communication. Pre-BCRA paragraphs (a)(1)(i) and (ii) of section 110.11, which applied to communications authorized and paid for by a candidate and communications authorized by a candidate but paid for by another person, respectively, are redesignated as paragraphs (b)(1) and (2) in the revised regulation, respectively, without substantive revision.
Paragraph (b)(3) of section 110.11 applies to a communication, including any solicitation, that is not paid for or authorized by a candidate. The provisions of pre-BCRA 11 CFR 110.11(a)(1)(iii) are replaced with paragraph (b)(3), with one substantive change. In BCRA, Congress provided that a covered communication not authorized by a candidate, his or her authorized committees or agents must have a disclaimer that includes the “permanent street address, telephone number, or World Wide Web address” of the person who paid for the communication. 2 U.S.C. 441d(a)(3). Similar language is being added in paragraph (b)(3).
The Commission is not including pre-BCRA 11 CFR 110.11(a)(1)(iv) in revised section 110.11. This paragraph applied to “solicitations directed to the general public on behalf of a political committee which is not an authorized committee of a candidate” and required that these solicitations only state the name of the person who paid for the communication. In the NPRM the Commission proposed deleting paragraph (a)(1)(iv). Given that Congress amended 2 U.S.C. 441d(a) to extend the disclaimer requirements to apply “whenever a political committee makes a disbursement for the purpose of financing any communication” through any type of general public political advertisement, and given that Congress did not create a specific exception for authorization language in solicitations by unauthorized committees, the Commission is not retaining pre-BCRA 11 CFR 110.11(a)(1)(iv).
In BCRA, Congress created a number of specific requirements for disclaimers to be included in communications covered by the statute. These statutory requirements vary, depending on whether the communication is printed or broadcast through radio or television, and on whether a candidate or another person pays for the communication. 2 U.S.C. 441d(c), (d). Paragraph (c) combines the disclaimer requirements in pre-BCRA 11 CFR 110.11(a)(5) with the new requirements Congress added in BCRA.
Paragraph (c)(1) sets forth a general, “clear and conspicuous” requirement applicable to all disclaimers, regardless of the medium in which the communication is transmitted. Paragraph (c)(1) is a slightly revised version of the “clear and conspicuous” requirement in pre-BCRA 11 CFR 110.11(a)(5). The final sentence of paragraph (c)(1) provides that a disclaimer is not clear and conspicuous if it is difficult to read or hear, or if its placement is easily overlooked. This modifies the corresponding pre-BCRA provision, which was focused on print communications only, by generalizing it to apply to communications made through other media as well. This generalization is justified by BCRA's revision to section 441d, which broadened the scope of the statute. No commenters addressed this paragraph.
Several of the specific disclaimer requirements added by BCRA apply only to printed communications. 2 U.S.C. 441d(c)(1). Paragraph (c)(2) of section 110.11 implements the new statutory specifications, and also incorporates three of the print-specific provisions of pre-BCRA 11 CFR 110.11.
One commenter suggested that the pre-BCRA disclaimer regulations work well and should not be changed except where required under BCRA. For the most part, the Commission agrees, but with the recognition that Congress has in fact required a number of changes in the disclaimer provisions through BCRA. For example, the pre-BCRA requirement that a disclaimer be “clear and conspicuous” was limited to printed communications. In BCRA, Congress added a new requirement that the disclaimer in a printed communication be of “sufficient type-size to be clearly readable by the recipient of the communication.” 2 U.S.C. 441d(c)(1). Given the specificity of the statutory requirements added by BCRA, new paragraph (c)(2)(i) restates the “sufficient type size” requirement verbatim, while new paragraphs (c)(2)(ii) and (c)(2)(iii) also precisely track 2 U.S.C. 441d(c)(2) and (3), respectively.
The Commission sought comment on whether the term “sufficient type size” requires additional clarification or a “safe harbor” provision. Three commenters responded and each stated that the Commission should provide some additional guidance or “safe harbor” in the form of an “objective” standard for type size. One commenter advocated a type-size requirement related to the smallest font size of a communication, but a different commenter warned that such a requirement could be easily circumvented by reducing the type-size of one sentence, or even one word, in the communication. Two commenters also expressed concerns that a type-size requirement based on the size of the largest font size in the communication would be “unworkable” or “overly complex.” One commenter supported an approach that would set a fixed minimum type size.
The Commission shares the concerns expressed by the commenters regarding formulas fixed to the smallest or largest type size in a communication's core message text. However, the Commission is also reluctant to set one fixed minimum type size for all communications because a type size that can be easily read in a newspaper might be completely unreadable when included on a billboard or other large, printed communication. Therefore, in 11 CFR 110.11(c)(2)(i), the Commission is creating a “safe harbor” provision that establishes a fixed, twelve-point type size as a sufficient size for disclaimer text in newspapers, magazines, flyers, signs and other printed communications that are no larger than the common poster size of 24 inches by 36 inches. However, no specific safe harbor provision would apply to larger printed communications because the Commission concludes that the vast differences in the potential size and manner of display of larger printed communications would render fixed type-size examples ineffective and inappropriate. Whether a disclaimer on a larger printed communication is of sufficient type size to be clearly readable is therefore to be determined on a case-by-case basis, taking into account the vantage point from which the communication is intended to be seen or read as well as the actual size of the disclaimer text.
Paragraph (c)(2)(ii) of section 110.11 specifies that the disclaimer included in printed communications must be contained within a printed box set apart from the other contents of the communication. 2 U.S.C. 441d(c)(2). Paragraph (c)(2)(iii) specifies that the text of the disclaimer must be printed with a reasonable degree of color contrast between the background and the printed statement. 2 U.S.C. 441d(c)(3). Both of these requirements apply regardless of the size of the printed material under paragraph (c)(2)(i).
In the NPRM, the Commission sought comment on whether the statutory phrase “reasonable degree of color contrast” should be further defined, and specifically whether the color contrast for the disclaimer notice should be related to the color contrast of the core message text. One commenter drew a distinction between the statutory requirement of color contrast between the “background and printed statement,” 2 U.S.C. 441d(c)(3), and the Commission's suggestion in the narrative of the NPRM that a color contrast is required between the disclaimer text and the core message text. The Commission notes that color contrast between the disclaimer text and the core message text is not required by the statute, and is not required by the final rules. This should alleviate the commenter's concern that such an additional requirement might require three different colors (a background color, a core message text color, and a disclaimer text color), thereby effectively prohibiting simple black and white communications and possibly raising the cost for the communication. Therefore, paragraph (c)(2)(iii) addresses only the contrast between the text and background of a communication, and provides two “safe harbor” examples that, when followed, comply with the color-contrast requirement. First, paragraph (c)(2)(iii) specifies that the color contrast requirement is met if the disclaimer is printed in black text on a white background. Second, paragraph (c)(2)(iii) specifies that the color contrast requirement is met if the degree of contrast between the background color and the disclaimer text color is at least as great as the degree of contrast between the background color and the color of the largest text in the communication. Please note that these two examples do not constitute the only ways to satisfy the color contrast requirements, and that they are safe harbors, not mandatory requirements. This approach is intended to provide a clear, flexible safe harbor that will ensure that the disclaimer does not blend in with the background of the communication any more than a headline or other key part of the core message text, and thereby providing certainty to persons making communications needing disclaimers.
Paragraphs (c)(2)(iv) and (v) incorporate pre-BCRA regulatory provisions specific to print communications. Paragraph (c)(2)(iv), to which the provisions of pre-BCRA paragraph (a)(5)(i) are redesignated without substantive revision, states that a disclaimer need not appear on the front or cover page of a communication, except for communications that only contain a front face, such as billboards. Paragraph (c)(2)(v), to which the provisions of pre-BCRA paragraph (a)(5)(ii) are redesignated without substantive change, states that a communication that would require a disclaimer if distributed separately, and that is included in a package of materials, must contain the required disclaimer.
In BCRA, Congress added new requirements for disclaimers in radio and television communications paid for by candidates or persons authorized by candidates. 2 U.S.C. 441d(d)(1). Paragraph (c)(3) implements these specific statutory requirements as described below.
Paragraph (c)(3)(i) tracks the new statutory language requiring that a communication that is paid for or authorized by a candidate or the candidate's authorized committee and transmitted through radio must include an audio statement spoken by the candidate himself or herself. 2 U.S.C. 441d(d)(1)(A). The statement must identify the candidate, and state that the candidate has approved the communication.
Likewise, paragraphs (c)(3)(ii) tracks the new statutory language requiring that a communication that is paid for or authorized by a candidate or the candidate's authorized committee and transmitted through television have an oral disclaimer spoken by the candidate himself or herself. 2 U.S.C. 441d(d)(1)(B). The provision requires the candidate to identify himself or herself, and to state that he or she has approved the communication. In addition, Congress specified that the candidate must convey that message in one of two ways: through a full-screen view of the candidate making the statement or through a “clearly identifiable photographic or similar image of the candidate” that appears during the candidate's voice-over statement. Paragraph (c)(3)(ii)(A) sets forth the first option, while paragraph (c)(3)(ii)(B) sets forth the second option and provides additional guidance regarding the meaning of “clearly identifiable.” The only commenter who specifically addressed this issue suggested that the picture of the candidate should only be considered “clearly identifiable” if it is displayed in a full-screen view. However, the Commission notes that although Congress specifically required a full-screen view when the candidate is shown making the statement, Congress did not require a full-screen view for the still picture. The Commission views this as an intentional distinction that contemplated an alternative to the full-screen view. Therefore, the Commission is establishing a safe harbor provision whereby a still picture of the candidate shall be considered “clearly identifiable” if it occupies at least 80% of the vertical screen height. That size is, in the Commission's judgment, a meaningful alternative to the full-screen requirement, and complies with Congress's mandate that the picture be “clearly identifiable.”
Congress also established a third disclaimer requirement for communications paid for or authorized by a candidate and transmitted through television. In addition to the oral statement described above, each television communication must contain a “clearly readable” written statement that appears at the end of the communication “for a period of at least four seconds” with a “reasonable degree of color contrast” between the background and the disclaimer statement.
The pre-BCRA regulations provided that a written disclaimer appearing on the screen of a television communication “shall be considered clear and conspicuous if [it] appear[s] in letters equal to or greater than four (4) percent of the vertical picture height for not less than four (4) seconds.” Pre-BCRA 11 CFR 110.11(a)(5)(iii). Two commenters urged the Commission to retain the four-percent height provision as a “safe harbor.” However, the new Congressional color-contrast requirement in 2 U.S.C. 441d(d)(2)(B)(ii) renders the pre-BCRA “safe harbor” incomplete because the four-percent-for-four-seconds provision does not address color contrast.
The Commission is therefore setting forth the statutory “clearly readable”
Paragraph (c)(3)(iii)(B) sets forth the four-second duration requirement in accordance with the BCRA language. 2 U.S.C. 441d(d)(1)(B).
Paragraph 11 CFR 110.11(c)(3)(iii)(C) addresses the new color contrast requirement in BCRA, which is the third criterion used to determine whether a statement is clearly readable. Because the statute did not define “reasonable degree of color contrast,” the Commission requested comment on several different approaches. To continue the same “safe harbor” approach of pre-BCRA paragraph (a)(5)(iii), the regulations would have to describe “reasonable degree of color contrast” in an objective manner. The same commenter who addressed the color contrast issue in the context of printed communications also suggested that the Commission avoid overly complicated or cost-incurring definitions of “reasonable degree of color contrast” in the context of television communications. For the same reasons stated above with reference to the color contrast requirements for printed communications, the Commission is providing “safe harbors” for disclaimers that are printed in black text on a white background, as well as disclaimers that have at least the same degree of contrast with the background color as the degree of contrast between the background color and the color of the largest text used in the communication. 11 CFR 110.11(c)(3)(iii)(C). Either of these disclaimer formats would satisfy the color-contrast requirement, which is the third criterion used to determine whether the statement is “clearly readable.”
The Commission received no comments on the two proposed examples of spoken disclaimers that, if used by a candidate, will satisfy the requirements of paragraphs (c)(3)(i), (ii) and (iii). These examples, located in paragraph (c)(3)(iv), are not mandatory and are not the only acceptable disclaimers. Paragraph (c)(3)(iv) is intended to provide a clear “safe harbor” for candidates, authorized committees, and others required to include disclaimers in communications.
In BCRA, Congress set forth a scripted audio statement required for disclaimers in communications transmitted through radio or television and paid for by persons other than candidates or persons authorized by candidates. 2 U.S.C. 441d(d)(2). New paragraph (c)(4) tracks the statutory language by requiring the name of the political committee or other person responsible for the communication and any connected organization to be included in the communication. “Connected organization” is defined in 11 CFR 100.6. Paragraph (c)(4) also requires that communications transmitted through a telephone bank, as defined in 11 CFR 100.28, carry the same statement.
Furthermore, in the case of a television transmission, Congress required that the statement be conveyed by a “full-screen view of a representative of the political committee or other person making the statement,” or in a “voice-over” by such representative. 2 U.S.C. 441d(d)(2). The Commission sought comment on whether the regulation should specify who may represent the payor for this purpose. One commenter urged the Commission to require an officer of the organization to make the statement, rather than a volunteer or paid celebrity. In contrast, another commenter argued that any restriction on who could make the statement “would far exceed the scope of BCRA,” which allows a “representative of the committee
Finally, as with authorized television communications, the disclaimer statement for a television communication that is not authorized by any candidate must also appear in writing at the end of the communication in a clearly readable manner with a reasonable degree of color contrast between the background and the printed statement for a period of at least four seconds. 2 U.S.C. 441d(d)(2). Paragraphs 11 CFR 110.11(c)(4)(iii)(A), (B), and (C) are therefore identical to 11 CFR 110.11(c)(3)(iii)(A), (B), and (C).
Paragraph (d) of section 110.11 covers disclaimers for communications that constitute coordinated party expenditures and independent expenditures by national, state, district, and local political party committees. The relevant pre-BCRA provisions of 11 CFR 110.11(a)(2) are being redesignated as paragraph (d)(1), with one minor grammatical change and without substantive change.
Although the Commission did not propose any significant substantive changes for disclaimer requirements related to coordinated party expenditures, one commenter expressed concern that a communication paid for by a political party committee with funds subject to the 2 U.S.C. 441a(d) coordinated expenditure limits would, solely by virtue of being a 2 U.S.C. 441a(d) coordinated expenditure, be considered to be “authorized” communications subject to the requirements of 11 CFR 110.11(c)(3).
Paragraph (d)(3) covers communications that constitute independent expenditures by political party committees. It states that the disclaimer provisions apply to such communications, and that a “non-authorization notice” is required, as with any other independent expenditure communication.
The Commission is redesignating the provisions of pre-BCRA 11 CFR 110.11(a)(4), pertaining to communications that qualify as “exempt activities,” as paragraph (e) of section 110.11. In the NPRM, the Commission proposed to make only minor, non-substantive revisions. 67 FR 55351. Although not so expressly stated in the NPRM, the Commission based this proposal on the tentative conclusion that Congress did not intend, in BCRA, to overturn the Commission's longstanding approach to disclaimers for exempt activities. The Commission received no comments on this proposal.
The Commission has concluded that no substantive revisions are necessary. The Commission has, however, rewritten the paragraph to make it clear that public communications that constitute exempt activities are covered by the requirements of paragraphs (a), (b), (c)(1), and (c)(2) of section 110.11, but are not subject to the new “stand by your ad” requirements in paragraphs (c)(3) and (c)(4) of section 110.11. This revision is not intended to change the rule substantively; rather, it is only intended to clarify the rule in light of the new provisions added by BCRA.
Exceptions to the disclaimer requirements are set out in paragraph (f). The exceptions in pre-BCRA paragraphs (a)(6)(i), (ii), and (iii) are being redesignated as paragraphs (f)(1)(i), (ii), and (iii), respectively, with only grammatical, non-substantive revision.
The Commission is incorporating the provisions of pre-BCRA 11 CFR 110.11(a)(7), regarding certain communications by a separate segregated fund or its connected organization, in paragraph (f)(2), because this provision is essentially an exception. In addition, in paragraph (f)(2), the word “form” is being changed to “type.” This change has no substantive effect, and is being done only to conform to the language of the statute.
Paragraph (g) of section 110.11 continues the pre-BCRA rule pertaining to comparable rates for print advertising. That is, the contents of pre-BCRA 11 CFR 110.11(b) are being redesignated as paragraph (g). Other than the addition of a heading for the paragraph, there are no revisions to the pre-BCRA rule. Paragraph (g) tracks 2 U.S.C. 441d(b), as did its pre-BCRA predecessor. No commenters addressed this provision.
BCRA adds a subsection to the fraudulent misrepresentation statute at 2 U.S.C. 441h. The new provision, 2 U.S.C. 441h(b), prohibits a person from fraudulently misrepresenting that the person is speaking, writing or otherwise acting for, or on behalf of, a Federal candidate or political party, or an employee or agent of either, for the purpose of soliciting contributions or donations. It also prohibits persons from participating in, or conspiring to participate in, plans, schemes, or designs to make such fraudulent misrepresentations in soliciting contributions and donations. BCRA also non-substantively amends the existing fraudulent misrepresentation statute by redesignating it as subsection (a) of 2 U.S.C. 441h. The regulation implementing this provision, together with the pre-BCRA fraudulent misrepresentation regulation formerly found at 11 CFR 110.9(b),
The pre-BCRA fraudulent misrepresentation provision, now codified at 2 U.S.C. 441h(a), is aimed at fraudulent misrepresentation of campaign authority. For additional background,
Because the language and purpose of the pre-BCRA misrepresentation statute encompasses only misrepresentations by a candidate or the candidate's employee or agent, the Commission has historically been unable to take action in enforcement matters where persons unassociated with a candidate or candidate's authorized committee have solicited funds by purporting to act on behalf of a specific candidate or political party. Candidates have complained that contributions that contributors believed were going to benefit the candidate were diverted to other purposes, harming both the candidate and contributor. Consequently, the Commission has frequently included in its annual legislative recommendations to Congress a recommendation that 2 U.S.C. 441h be amended to specifically prohibit any person from fraudulently misrepresenting a candidate or political party in solicitations.
The Commission received one comment on the proposed rules to implement BCRA's fraudulent solicitation provision and to redesignate the pre-BCRA fraudulent misrepresentation rule. The commenter expressed support for combining these two provisions in a new rule. The commenter agreed that an anti-fraud provision aimed at fraudulent fundraising and applicable to a broader range of persons was needed.
The final rule at 11 CFR 110.16(a) remains unchanged from the proposed rule in the NPRM. Paragraph (a) amends the pre-BCRA fraudulent misrepresentation regulation, formerly found at 11 CFR 110.9(b), by adding the title, “In general.” This change follows BCRA, which added a similar heading to section (a) of 2 U.S.C. 441h. Technical amendments also make the wording of paragraph (a) gender-neutral. Finally, paragraph (a)(2) has been amended from the pre-BCRA rule to include the word “scheme” so that it tracks the statute.
The final rule at 11 CFR 110.16(b) tracks the statutory language in BCRA. No changes are being made from the proposed rule. Paragraph (b)(1) prohibits a person from fraudulently misrepresenting that the person speaks, writes, or otherwise acts for or on behalf of a candidate, political party, or an employee or agent of either, in soliciting contributions or donations. As used in section 110.16(b)(1), “donation” has the same meaning as in 11 CFR 300.2(e).
The Commission notes that the fraudulent misrepresentations prohibited in both 11 CFR 441h(a) and (b) and 11 CFR 110.16(a) and (b) differ from common law fraud. Unlike common law fraudulent misrepresentation, section 441h gives rise to no tort action. Section 441h is part of a Federal statute designed to address campaign finance abuses, not common law fraud.
The Supreme Court has recognized that statutes that address schemes to defraud, such as sections 441h(a)(2) and (b)(2), do not require proof of the common law requirements of “justifiable reliance” and “damages.”
Another indication that the fraudulent misrepresentations prohibited by section 441h differ from common law fraud is that section 441h(a) states that the fraudulent misrepresentation must be “on a matter which is damaging to [the misrepresented] candidate or political party.” If the statute were to require proof of damage in common law fraudulent misrepresentation, then the phrase “on a matter which is damaging” is superfluous. Courts construe statutes so “as to avoid rendering superfluous any parts thereof.”
The Act imposes civil penalties on anyone violating any portion of FECA or the Presidential Election Campaign Fund Act (“Fund Act”) or the Presidential Primary Matching Payment Account Act (“Matching Payment Act”). The Act's civil penalties, found at 2 U.S.C. 437g(a)(5), (6), and (12), are organized into two tiers of monetary penalties; one tier of penalties for violations of the Act, and a second tier of penalties for “knowing and willful” violations of the Act.
BCRA amends sections 437g(a)(5)(B) and 437g(a)(6)(C) by separating out and increasing the penalties for a subset of knowing and willful violations, namely, contributions that are made in the name of another.
Section 437g(a)(6)(C) of FECA, authorizing a court to impose civil penalties on a person who knowingly and willfully violates the Act, has been similarly amended by BCRA. Accordingly, the Commission amends 11 CFR 111.24 to implement these amendments to FECA.
Specifically, the Commission is dividing 11 CFR 111.24(a) into paragraphs (a)(1), and (a)(2)(i) and (ii). Paragraph (a)(1) contains the unchanged language of the pre-BCRA regulation for civil penalties for violations of the Act or the Fund Act or Matching Payment Act. Paragraph (a)(2) addresses “knowing and willful” violations and is further divided into paragraphs (a)(2)(i) and (ii). Paragraph (a)(2)(i) contains the unchanged language of the pre-BCRA regulation for civil penalties for knowing and willful violations of FECA or the Fund Act or the Matching Payment Act. 11 CFR 111.24(a)(2)(ii) implements BCRA's amendments to FECA increasing civil penalties for knowing and willing violations involving contributions made in the name of another. In the case of a knowing and willful violation of the prohibition on contributions in the name of another, the civil penalty is not
In BCRA, Congress deleted 2 U.S.C. 439a in its entirety, and replaced it with an entirely new section. Subsection (a) of the amended section sets forth the following four categories of “permitted uses” of campaign funds: (1) Otherwise authorized expenditures in connection with a candidate's campaign for Federal office; (2) ordinary and necessary expenses incurred in connection with a Federal officeholder's duties; (3) contributions to certain tax-exempt organizations; and (4) transfers, without limitation, to national, state or local political party committees. 2 U.S.C. 439a(a)(1) through (4). Congress also included a list of non-exhaustive,
Former 2 U.S.C. 439a was the statutory basis for the Commission's pre-BCRA “personal use” rules. It allowed candidates and Federal officeholders to use excess campaign funds to pay for ordinary and necessary expenses incurred in connection with their duties as Federal officeholders, certain contributions to tax-exempt organizations, and other lawful purposes, including transfers, without limitation, to national, state or local political party committees. The former section 439a also generally prohibited candidates and Federal officeholders from converting their excess campaign funds to personal uses.
Two pre-BCRA regulations implemented the statutory conversion-to-personal-use prohibition. 11 CFR 113.1(g)(1)(i) set out a non-exhaustive list of
In the NPRM, the Commission proposed regulations that would implement amended section 439a. The Commission also requested comments on several issues. With regard to the personal use regulations, the Internal Revenue Service commented that it saw no direct conflict between the Commission's proposals and the Internal Revenue Code or the regulations thereunder. Other comments are addressed below.
The pre-BCRA version of 2 U.S.C. 439a contained a general prohibition against the personal use of campaign funds, but did not specify any particular impermissible uses. In contrast, the Commission's pre-BCRA personal use regulations specifically defined certain uses of campaign funds or donations as
When Congress enacted BCRA, it amended 2 U.S.C. 439a(b) to include a non-exhaustive list of prohibited personal uses of campaign funds. As one of BCRA's principal sponsors explained, amended section 439a
As the Commission noted in the NPRM, pre-BCRA section 113.1(g)(1)(ii) stated that a use that would exist “irrespective” of a candidate's campaign or a Federal officeholder's duties would constitute a prohibited personal use. In BCRA, Congress codified the “irrespective” test as part of new section 439a(b)(2) (“For the purposes of paragraph (1), a contribution or donation shall be considered to be converted to personal use if the contribution or amount is used to fulfill any commitment, obligation, or expense of a person that would exist irrespective of the candidate's election campaign or individual's duties as a holder of Federal office * * *”) As the Commission explained in the NPRM, BCRA's “irrespective” test is virtually identical to the language in section 113.1(g)(1)(ii). The Commission proposed to continue to apply the “irrespective” test as it had done prior to BCRA. No comments were received specifically on this issue, although one commenter cited BCRA's “irrespective” language in the context of the commenter's analysis of the “noncampaign-related trip” language in proposed 11 CFR 113.1(g)(i)(K). (Noncampaign-related trips are discussed below.) Therefore, in the final rule, the Commission is not revising the “irrespective” test.
In BCRA, Congress deleted the phrase “in excess of any amount necessary to defray” campaign expenses from section 439a. Former section 113.1(e) defined “excess campaign funds” to mean “amounts received by a candidate as contributions which he or she determines are in excess of any amount necessary to defray his or her campaign expenditures.” In the NPRM, the Commission proposed not to change section 113.1(e), but raised the issue of whether Congress intended to eliminate the discretion of candidates and Federal
To ensure that 11 CFR part 113 is consistent with the plain language of BCRA, the Commission has decided that the term “excess campaign funds” should be dropped. Accordingly, the title of part 113, (formerly “Excess Campaign Funds and Funds Donated to Support Federal Officeholder Activities”) now reads “Campaign Funds and Funds Donated to Support Federal Officeholder Activities.” In addition, the references to the term “excess campaign funds” throughout part 113 are being deleted.
The Commission is also deleting 11 CFR 113.1(e), which previously defined “excess campaign funds” as “amounts received by a candidate as contributions which he or she determines are in excess of any amount necessary to defray his or her campaign expenditures.”
The Commission is also making the following conforming amendments. In paragraphs (e)(1)(i), (e)(5), and (f), the term “campaign funds” is being substituted for “excess campaign funds.” Lastly, the Commission is also changing “excess campaign funds” to “campaign funds” in paragraph (b), which defines “office accounts.”
Notwithstanding a principal sponsor's statement that the BCRA codifies the Commission's personal use regulations, amended section 439a failed to include two per se examples of personal use contained in 11 CFR 113.1(g). One of these, funeral, cremation or burial expenses, is being retained with significant exceptions. These would include such expenses for a candidate, employee or volunteer of authorized committees whose death arises out of, or in the course of, campaign activity. While there is no legislative history pertaining to this particular category of personal uses, it is at least a permissible construction of the BCRA to conclude that Congress deliberately excluded funeral expenses from its list of excluded uses of campaign funds. Norman J. Singer, Statutes and Statutory Construction § 47.23 (6th ed. 2000) (“When ‘include' is utilized, it is generally improper to conclude that entities not specifically enumerated are excluded. * * * It has also been assumed that when the legislature expresses things through a list, the court assumes that what is not listed is excluded.”).
In any event, limiting the use of campaign funds for funeral expenses resulting from a death that arises out of, or in the course of, campaign activity meets the Commission's “irrespective” test now codified in 2 U.S.C. 439a(b)(2). The phrase, “arises out of, or in the course of,” is a term of art employed in workers” compensation statutes and insurance contracts and would cover, for instance, deaths resulting from injuries suffered during campaign activity.
In addition, with respect to funeral expenses for authorized committee staff and volunteers who die in the course of campaign activity, public policy considerations counsel the permission of the payment of such expenses from campaign funds as campaign volunteers and staff, unlike officeholders and their staff, generally do not receive any fringe benefits that would cover the cost of funeral expenses.
In the NPRM, the Commission proposed adding a new rule, 11 CFR 113.1(g)(1)(i)(I), which would prohibit candidates from using campaign funds to pay themselves salaries or otherwise compensate themselves for income lost as a result of campaigning for Federal office. In AO 1999-1, the Commission banned the use of campaign funds to pay candidate salaries, in part because candidates would otherwise be able to spend campaign funds received as salaries for prohibited personal uses such as food, clothing, utilities, mortgages and other prohibited uses. Also, although the Commission noted that one of BCRA's principal sponsors stated that BCRA was intended to codify the Commission's current regulations but not its advisory opinions (148
The Commission sought comment as to whether or not principal campaign committees should be able to pay a candidate's salary out of campaign funds. Three commenters opposed the NPRM's proposal to prohibit the payment of candidate salaries and no commenter supported the proposal. One commenter argued that the definition of personal use does not encompass a payment to, as distinguished from an obligation of, a candidate. The same commenter also argued that because many candidates must forego salary in order to conduct the business of the campaign, a candidate who is dependent on an income is put at a severe disadvantage compared to an incumbent who is free to campaign at all times without any reduction in compensation or to an affluent challenger, who can afford to campaign without receiving any compensation.
The commenter also noted that AO 1999-1, which cites AOs 1996-34, 1995-42, and 1995-20, stated that the Commission has permitted the use of campaign funds to enable candidates and immediate family members to attend campaign events. Finally, the commenter concluded that candidates without significant resources might not be able to forego salary payments in order to run for Federal office, and recommended that the Commission promulgate a regulation permitting candidates to be paid salaries from campaign funds, with restrictions sufficient to prevent abuse.
A second commenter, citing the above-mentioned statement by one of BCRA's principal sponsors that the new law was not intended to codify the Commission's advisory opinions, asserted that the Commission lacked the authority to characterize salary payments to candidates from campaign funds as a
Finally, a third commenter, who joined in the comments of the previous two commenters, maintained that the
The Commission agrees with the commenters that the payment of a salary to a candidate is not a prohibited personal use as defined under Commission regulations since, but for the candidacy, the candidate would be paid a salary in exchange for services rendered to an employer. The Commission's personal use regulations issued on February 9, 1995 adopted the “irrespective test” in determining whether expenses would be deemed personal use. In the Explanation and Justification, the Commission explained that “if campaign funds are used for a financial obligation that is caused by campaign activity or the activities of an officeholder, that use is not personal use.” Explanation and Justification, Final Rules on Expenditures; Reports by Political Committees; Personal Use of Campaign Funds, 60 FR 7862, at 7863-7864 (Feb. 9, 1995). A salary paid to a candidate would be in return for the candidate's services provided to the campaign and the necessity of that salary would not exist irrespective of the candidacy. As the Commission has previously stated, under the Act and Commission regulations, a candidate and the candidate's campaign committee have wide discretion in making expenditures to influence the candidate's election, but may not convert excess campaign funds to personal use. 2 U.S.C. 431(9) and 439a, AOs 1992-4, 1991-2, 1988-13, 1987-2, 1987-1, 1984-42, 1984-8, 1980-138 and 1980-49. Therefore, the Commission will permit a candidate's principal campaign committee to pay a salary to the candidate, thus superseding AO 1999-1.
Advisory Opinions 2001-10, 2001-03, 2000-40, 2000-37, and 2000-12 state the Commission will permit the use of campaign funds for salary payments to a member of the candidate's family provided that that the family member is providing bona fide services to the campaign and the salary does not exceed fair market value for the services provided. Unlike the payment of salaries to members of a candidate's family, however, there need not be any showing that a candidate is providing bona fide services to the campaign; the fact that the candidate's work is valuable to his or her campaign shall be presumed.
Note that a candidate's salary does not, however, constitute a qualified campaign expense as that term is defined in 11 CFR 9002.11 and 9032.9.
The payment of salaries to candidates from campaign funds is subject to certain conditions in the final rules. First, the candidate's salary must be paid from his or her principal campaign committee only, as defined in 11 CFR 100.5(e)(1). This condition precludes the possibility of multiple salaries, and generally adds clarifying specificity.
Second, the salary payment to the candidate must not exceed the minimum annual salary for the Federal office sought. Thus, if a candidate seeks a seat held by a member of the House of Representatives or the Senate who holds a leadership position, and is thus paid more than the minimum salary payable to a member of the House of Representatives or the Senate, respectively, the candidate's salary payment shall nonetheless not exceed the lowest salary for the Federal office that he or she seeks. Any salary payment to a candidate from campaign funds in excess of the salary paid to a Federal officeholder—U.S. House, U.S. Senate, or the Presidency—shall be considered personal use.
Third, the final rule requires candidates who avail themselves of this salary provision to provide income tax records from the relevant years and other evidence of earned income upon the request of the Commission.
Fourth, payments made under this paragraph must be computed on a pro-rata basis. This is intended to prevent a candidate's principal campaign committee from paying the candidate the entire minimum annual salary for the Federal office sought by the candidate, unless he or she is a candidate, as defined by 11 CFR 100.3(a), for at least one year. Any tax payments required by the Internal Revenue Service, or state and/or local governments, are the responsibility of the candidate.
Fifth, an incumbent Federal officeholder, as defined in 11 CFR 100.5(f)(1), must not receive salary payments as a candidate from campaign funds. Otherwise, of course, such an incumbent officeholder would be receiving two salaries, one from his or her campaign and one for his or her official duties.
Sixth, under the final rules at 11 CFR 113.1(g)(1)(i)(I), the first payment of a salary from campaign funds to a candidate must be made no earlier than the filing deadline for access to the primary election ballot for Federal candidates, as determined by State law, or in those states that do not conduct primaries, on January 1 of each even-numbered year.
In making this decision, the Commission is satisfied that, because all candidate and family members' salaries will be fully disclosed to the public, those who contribute to the campaign and who support the candidate will be able to voice their approval, or
One issue on which the Commission requested comment is raised by 2 U.S.C. 439a(b)(2)(E), which specifically included a
The principal sponsors of BCRA stated that Congress had intentionally left intact the statutory provision that states that campaign funds may be used “for ordinary and necessary expenses incurred in connection with duties of the individual as a holder of Federal office.”
Another group of commenters also observed that new section 439a(a)(2) states that campaign funds may be used “for ordinary and necessary expenses incurred in connection with duties of the individual as a holder of Federal office.” This language, these commenters stated, expresses Congress's intent to allow Senators to use campaign funds for their official expenses, including fact-finding trips. These commenters also pointed out that fact-finding trips, which members would not take but for their official duties, would not occur “irrespective” of their official duties. Therefore, these trips constitute part of members' official duties and do not constitute a prohibited personal use of campaign funds.
Finally, two commenters acknowledged that 2 U.S.C. 439a(b)(2) includes a vacation or noncampaign-related trip in the list of prohibited uses. Nonetheless, they asserted that, if the Commission were to issue regulations to ban the use of campaign funds for noncampaign-related travel, it would be ignoring Congress's clear authorization in amended 2 U.S.C. 439a(a)(2) to allow the use of campaign funds for expenses incurred in connection with an individual's duties as a Federal officeholder, and the “irrespective” test, which, as stated above, is now part of amended 2 U.S.C. 439a(b)(2). They urged the Commission to construe the statute as a whole.
Other commenters also argued that the Commission should not prohibit the use of campaign funds to pay for all noncampaign-related travel, including fact-finding trips. As did the previous commenters, these commenters noted that BCRA permits the use of campaign funds “for ordinary and necessary expenses incurred in connection with duties of the individual as a holder of Federal office.” Therefore, the commenters urged the Commission not to adopt regulations defining “noncampaign-related” travel as a
Another commenter asserted that the Commission has historically treated the use of campaign funds for campaign-related travel and for officeholder travel as permissible. This commenter argued that the language of amended 2 U.S.C. 439a(a) has explicitly made this practice permissible by listing both campaign expenditures and officeholder-related expenses as acceptable uses of campaign funds. If, according to the commenter, Congress intended to change its longstanding practice, it would have done so explicitly, in its list of
A commenter stated that there is no need to change the Commission's current personal use regulations because Congress did not intend either to limit or ban an officeholder's ability to use campaign funds for officeholder travel, even if the travel is not campaign-related, such as fact-finding trips. A different commenter maintained that campaign funds should not be used for fact-finding trips. Instead, the commenter recommended that campaign funds not be used for anything other than campaign costs, such as advertising and campaign literature, with the exception of charitable contributions.
Based on Congressional guidance and the reasoning expressed in other comments concerning this matter, the Commission is not adding the “noncampaign-related trip” language to the list of
BCRA amended 2 U.S.C. 439a by including “a noncampaign-related automobile expense” in the list of
Two sets of commenters addressed this proposal. BCRA's principal sponsors stated that the Commission's proposed regulation could be read, incorrectly, to completely prohibit the use of campaign funds for any vehicle expenses (other than for
The Commission agrees with these reasons to continue to assess vehicle expenses on a case-by-case basis under 11 CFR 113.1(g)(1)(ii)(D). The text of proposed 11 CFR 113.1(g)(1)(i)(J) was identical to that of pre-BCRA 11 CFR 113.1(g)(1)(ii)(D). The Commission further notes that one of BCRA's principal sponsors explained that the “ * * * personal use * * * provision is intended to
The Commission acknowledges the BCRA's sponsors' observation that the beginning of paragraph (g)(1)(ii)(D) could be read to prohibit campaign and officeholder-related uses of vehicles funded by campaign contributions. (”Vehicle expenses, unless they are a
The Commission is making non-substantive changes to two cross-references in 11 CFR 113.1(g)(5) to the definition of “expenditure,” and to one cross-reference in 11 CFR 113.1(g)(6) to the definition of “contribution.” These citation changes conform to the reorganized regulations on “contributions” and “expenditures.” 67 FR 50582 (Aug. 5, 2002).
The Commission is revising the provision in this regulation that includes as a member of the candidate's family a person who shares a residence with the candidate. This change was not addressed in the NPRM, but is being included to clarify the intent of the regulation and to eliminate any potential conflict with the Defense of Marriage Act, 1 U.S.C. § 7. While the personal use prohibition applies to “any person,” the regulations apply special scrutiny to members of a candidate's family as potential conduits for evasion of the personal use prohibition. At the same time, the regulations recognize that a joint account shared with one or more family members may be used to pay a candidate's personal living expenses without the role of the family members in such payments being treated as a contribution. 11 CFR 113.1(g)(6)(ii).
The revised regulation recognizes that any payments to a person sharing a residence with a candidate could serve as a means of supporting the candidate's personal living expenses and thus bans gifts from the campaign to family members or persons residing with the candidate, 11 CFR 113.1(g)(4), subjects salary payments by the campaign to such persons to certain conditions, 11 CFR 113.1(g)(1)(H), and limits payments for real or personal property owned by family members and used for campaign purposes. 11 CFR 113.1(g)(1)(E)(2). Use of campaign funds for mortgage, rent or utility payments for the residence of a candidate or of a member of the candidate's family is also prohibited, 11 CFR 113.1(g)(1)(E)(1), but would not operate any differently in the case of a family member who resides with the candidate. Similarly, anyone actually residing with a candidate could pay a share of living expenses without having those payments be deemed contributions to the candidate's campaign. Finally, personal funds of candidates would include the candidate's share of any joint accounts held by the candidate and a person residing with the candidate. 11 CFR 113.1(g)(6)(ii).
The revised regulation includes any person residing with the candidate within the definition of “Members of the candidate's family.” The provision formerly included “a person who has a committed relationship with the candidate, such as sharing a residence and having mutual responsibility for each other's personal welfare or living expenses.” The “committed relationship” condition could have been read as an approximation of marriage, especially as the 1995 Explanation and Justification for this provision, 60 FR 7872 (Feb. 29, 1995), stated that persons in this committed relationship category “will be treated as the equivalent of the candidate's spouse.” This rendering of the statute appears to be prohibited by the Defense of Marriage Act, 1 U.S.C. § 7, which provides that “[i]n determining the meaning of any Act of Congress, or of any ruling, regulation, of interpretation of the various administrative bureaus and agencies of the United States, the word 'marriage' means only a legal union between one man and one woman as husband and wife, and the word 'spouse' refers only to a person of the opposite sex who is a husband or a wife.”
In addition, the Commission was concerned that a committed relationship does not represent a generally recognized legal test (for instance, most states do not recognize non-marital relationships contemplated by the “committed relationship” provision) and thus would be difficult for the Commission to ascertain and enforce if called upon to do so. The question of residence or domicile on the other hand is a factual matter that does not call upon the Commission to inquire into or make judgments about the nature of the relationship between a candidate and persons residing with the candidate.
In the NPRM, the Commission proposed new 11 CFR 113.1(g)(8), a recordkeeping requirement for campaign funds used for expenses that may be partly personal in nature. Such expenses may include vehicle, legal, meal, and travel expenses.
Given the amendments BCRA made to 2 U.S.C. 439a described above regarding the deletion of the phrase “excess campaign funds” and the amendments being made to 11 CFR 113.1, the Commission is revising section 113.2 in several respects. First, the title and the introductory portion of this section are
In the NPRM, the Commission noted that former 2 U.S.C. 439a included the phrase “for any other lawful purpose” in addition to enumerating permissible uses of excess campaign funds. BCRA amended section 439a by deleting “any other lawful purpose” from the list of permitted uses. Nonetheless, in the NPRM, the Commission proposed retaining that term in pre-BCRA 11 CFR 113.2(d). One commenter disagreed with the Commission's proposed rule and recommended that the “any other lawful purpose” language be deleted from the regulation. This commenter noted that pre-BCRA 11 CFR 113.2(d), which closely tracks the wording of section 439a, provides for four broad permissible uses of campaign funds: (1) Ordinary and necessary expenses incurred in connection with the duties of a holder of Federal office; (2) contributions to an organization described in 26 U.S.C. 170(c); (3) transfers to a national, state or local party committee; and (4) any other lawful purpose, except that such funds may not be converted to personal use, other than to defray officeholder expenses or repay loans made by the candidate for campaign purposes. Pointing out that BCRA deletes “any other lawful purpose” as an expressly permissible use of campaign funds, the commenter argued that BCRA reduces the categories of permissible uses of campaign funds from four to three. Thus, the commenter concluded that the “any other lawful purpose” language in 11 CFR 113.2(d) should be deleted and that the regulation should be revised accordingly.
The Commission concludes that the commenter's reasoning is correct, and therefore is removing and reserving paragraph (d) of former section 113.2, which referred to “any other lawful purpose.” With this revision, it is now clear that in addition to defraying expenses in connection with a campaign for federal office, campaign funds may be used only for the enumerated non-campaign purposes identified in paragraphs (a), (b), and (c) of section 113.2, and that this listing of permissible non-campaign purposes is exhaustive.
The Commission notes that, pursuant to 2 U.S.C. 432(e)(3)(B), authorized committees also may make contributions of $1,000 or less to authorized committees of other candidates. This provision was not amended by BCRA which otherwise generally increased contribution limits to $2,000 per person. Authorized committees may make contributions to organizations other than those described in section 170(c) of the Internal Revenue Code of 1986 and other authorized committees (subject to the $1,000 limit) unless those contributions are in connection with the campaign for Federal office of the authorizing candidate. In furtherance of a Federal candidate's election, that Federal candidate may contribute to state and local candidates pursuant to this section.
A provision addressing the repayment of candidate loans has been deleted from section 113.2 as part of the removal of paragraph (d). The Commission will, if necessary, address this issue in the upcoming “Millionaires' Amendment” rulemaking.
Although the Commission is not amending section 113.2(e)(1), which refers to “excess funds,” it is changing section 113.2(e)(1)(i), which refers to “any excess campaign or donated funds.” These rules permit qualified Members of Congress who served in the 102d Congress or an earlier Congress to convert to personal use the unobligated balance of their excess funds as of Nov. 30, 1989. Paragraph (e)(1) addresses “excess funds,” rather than “excess campaign funds,” and sets forth detailed instructions to determine this amount. Revised paragraph (e)(1)(i) now refers simply to “campaign funds.”
In light of Congress deleting the phrase “in excess of any amount to defray” campaign expenses from section 439a, and the Commission's revision herein to 11 CFR 113.1 and 113.2, officeholders may spend campaign funds to defray campaign expenses and expenses incurred in connection with the recipient's duties as a holder of federal office, and that such expenses may be paid in any order, at their discretion.
The Commission certifies that the attached final rules will not have a significant economic impact on a substantial number of small entities. The basis of this certification is that national, State, and local party committees of the two major political parties to which the fraudulent solicitation, disclaimers, and civil penalties rules apply are not small entities under 5 U.S.C. 601. In addition, the rules for personal use only affect individuals, not entities, and the rules for the prohibition on fraudulent solicitation do not carry an economic impact. Furthermore, the requirements of the disclaimer rules as applied to small entities are no more than what is necessary to comply with the new statute enacted by Congress, and in any event, such entities will not incur significant additional costs in complying with these requirements. The increase in civil penalties do not unduly burden small entities since a small entity would pay a civil penalty only if the entity engaged in a specific knowing and willful violation of the Act.
Elections.
Campaign funds, and political committees and parties.
Campaign funds, and political committee and parties.
Campaign funds, and political candidates.
2 U.S.C. 431, 434, 438(a)(8).
2 U.S.C. 431(8), 431(9), 432(c)(2), 437d(a)(8), 438(a)(8), 441a, 441b, 441d, 441e, 441f, 441g, 441h, and 441k.
(a)
(1) All public communications for which a political committee makes a disbursement.
(2) All public communications by any person that expressly advocate the election or defeat of a clearly identified candidate.
(3) All public communications by any person that solicit any contribution.
(4) All electioneering communications by any person.
(b)
(1) If the communication, including any solicitation, is paid for and authorized by a candidate, an authorized committee of a candidate, or an agent of either of the foregoing, the disclaimer must clearly state that the communication has been paid for by the authorized political committee;
(2) If the communication, including any solicitation, is authorized by a candidate, an authorized committee of a candidate, or an agent of either of the foregoing, but is paid for by any other person, the disclaimer must clearly state that the communication is paid for by such other person and is authorized by such candidate, authorized committee, or agent; or
(3) If the communication, including any solicitation, is not authorized by a candidate, authorized committee of a candidate, or an agent of either of the foregoing, the disclaimer must clearly state the full name and permanent street address, telephone number, or World Wide Web address of the person who paid for the communication, and that the communication is not authorized by any candidate or candidate's committee.
(c)
(1)
(2)
(i) The disclaimer must be of sufficient type size to be clearly readable by the recipient of the communication. A disclaimer in twelve (12)-point type size satisfies the size requirement of this paragraph (c)(2)(i) when it is used for signs, posters, flyers, newspapers, magazines, or other printed material that measure no more than twenty-four (24) inches by thirty-six (36) inches.
(ii) The disclaimer must be contained in a printed box set apart from the other contents of the communication.
(iii) The disclaimer must be printed with a reasonable degree of color contrast between the background and the printed statement. A disclaimer satisfies the color contrast requirement of this paragraph (c)(2)(iii) if it is printed in black text on a white background or if the degree of color contrast between the background and the text of the disclaimer is no less than the color contrast between the background and the largest text used in the communication.
(iv) The disclaimer need not appear on the front or cover page of the communication as long as it appears within the communication, except on communications, such as billboards, that contain only a front face.
(v) A communication that would require a disclaimer if distributed separately, that is included in a package of materials, must contain the required disclaimer.
(3)
(i) A communication transmitted through radio must include an audio statement by the candidate that identifies the candidate and states that he or she has approved the communication; or
(ii) A communication transmitted through television or through any broadcast, cable, or satellite transmission, must include a statement that identifies the candidate and states that he or she has approved the communication. The candidate shall convey the statement either:
(A) Through an unobscured, full-screen view of himself or herself making the statement, or
(B) Through a voice-over by himself or herself, accompanied by a clearly identifiable photographic or similar image of the candidate. A photographic or similar image of the candidate shall be considered clearly identified if it is at least eighty (80) percent of the vertical screen height.
(iii) A communication transmitted through television or through any broadcast, cable, or satellite transmission, must also include a similar statement that must appear in clearly readable writing at the end of the television communication. To be clearly readable, this statement must meet all of the following three requirements:
(A) The statement must appear in letters equal to or greater than four (4) percent of the vertical picture height;
(B) The statement must be visible for a period of at least four (4) seconds; and
(C) The statement must appear with a reasonable degree of color contrast between the background and the text of the statement. A statement satisfies the color contrast requirement of this paragraph (c)(3)(iii)(C) if it is printed in black text on a white background or if the degree of color contrast between the background and the text of the statement is no less than the color contrast between the background and the largest type size used in the communication.
(iv) The following are examples of acceptable statements that satisfy the spoken statement requirements of paragraph (c)(3) of this section with respect to a radio, television, or other broadcast, cable, or satellite communication, but they are not the only allowable statements:
(A) “I am [insert name of candidate], a candidate for [insert Federal office sought], and I approved this advertisement.”
(B) “My name is [insert name of candidate]. I am running for [insert Federal office sought], and I approved this message.”
(4)
(i) A communication transmitted through radio or television or through any broadcast, cable, or satellite transmission, must include the following audio statement, “XXX is responsible for the content of this advertising,” spoken clearly, with the blank to be filled in with the name of the political committee or other person paying for the communication, and the name of the connected organization, if any, of the payor unless the name of the connected organization is already provided in the “XXX is responsible” statement; and
(ii) A communication transmitted through television, or through any broadcast, cable, or satellite transmission, must include the audio statement required by paragraph (c)(4)(i) of this section. That statement must be conveyed by an unobscured full-screen view of a representative of the political committee or other person making the statement, or by a representative of such political committee or other person in voice-over.
(iii) A communication transmitted through television or through any broadcast, cable, or satellite transmission, must also include a similar statement that must appear in clearly readable writing at the end of the communication. To be clearly readable, the statement must meet all of the following three requirements:
(A) The statement must appear in letters equal to or greater than four (4) percent of the vertical picture height;
(B) The statement must be visible for a period of at least four (4) seconds; and
(C) The statement must appear with a reasonable degree of color contrast between the background and the disclaimer statement. A disclaimer satisfies the color contrast requirement of this paragraph (c)(4)(iii)(C) if it is printed in black text on a white background or if the degree of color contrast between the background and the text of the disclaimer is no less than the color contrast between the background and the largest type size used in the communication.
(d)
(1)(i) For a communication paid for by a political party committee pursuant to 2 U.S.C. 441a(d), the disclaimer required by paragraph (a) of this section must identify the political party committee that makes the expenditure as the person who paid for the communication, regardless of whether the political party committee was acting in its own capacity or as the designated agent of another political party committee.
(ii) A communication made by a political party committee pursuant to 2 U.S.C. 441a(d) and distributed prior to the date the party's candidate is nominated shall satisfy the requirements of this section if it clearly states who paid for the communication.
(2) For purposes of this section, a communication paid for by a political party committee, other than a communication covered by paragraph (d)(1)(ii) of this section, that is being treated as a coordinated expenditure under 2 U.S.C. 441a(d) and that was made with the approval of a candidate, a candidate's authorized committee, or the agent of either shall identify the political party that paid for the communication and shall state that the communication is authorized by the candidate or candidate's authorized committee.
(3) For a communication paid for by a political party committee that constitutes an independent expenditure under 11 CFR 100.16, the disclaimer required by this section must identify the political party committee that paid for the communication, and must state that the communication is not authorized by any candidate or candidate's authorized committee.
(e)
(f)
(i) Bumper stickers, pins, buttons, pens, and similar small items upon which the disclaimer cannot be conveniently printed;
(ii) Skywriting, water towers, wearing apparel, or other means of displaying an advertisement of such a nature that the inclusion of a disclaimer would be impracticable; or
(iii) Checks, receipts, and similar items of minimal value that are used for purely administrative purposes and do not contain a political message.
(2) For purposes of this section, whenever a separate segregated fund or its connected organization solicits contributions to the fund from those persons it may solicit under the applicable provisions of 11 CFR part 114, or makes a communication to those persons, such communication shall not be considered a type of public communication and need not contain the disclaimer required by paragraphs (a) through (c) of this section.
(g)
(1) No person who sells space in a newspaper or magazine to a candidate, an authorized committee of a candidate, or an agent of the candidate, for use in connection with the candidate's campaign for nomination or for election, shall charge an amount for the space which exceeds the comparable rate for the space for non-campaign purposes.
(2) For purposed of this section, comparable rate means the rate charged to a national or general rate advertiser, and shall include discount privileges usually and normally available to a national or general rate advertiser.
(a)
(1) Fraudulently misrepresent the person or any committee or organization under the person's control as speaking or writing or otherwise acting for or on behalf of any other candidate or political party or employee or agent thereof in a matter which is damaging to such other candidate or political party or employee or agent thereof; or
(2) Willfully and knowingly participate in or conspire to participate in any plan, scheme, or design to violate paragraph (a)(1) of this section.
(b)
(1) Fraudulently misrepresent the person as speaking, writing, or otherwise acting for or on behalf of any candidate or political party or employee or agent thereof for the purpose of soliciting contributions or donations; or
(2) Willfully and knowingly participate in or conspire to participate in any plan, scheme, or design to violate paragraph (b)(1) of this section.
2 U.S.C. 437g, 437d(a), 438(a)(8); 28 U.S.C. 2461 nt.
(a) Except as provided in 11 CFR part 111, subpart B and in paragraph (b) of this section, a civil penalty negotiated by the Commission or imposed by a court for a violation of the Act or chapters 95 or 96 of title 26 (26 U.S.C.) shall be as follows:
(1) Except as provided in paragraph (a)(2) of this section, in the case of a violation of the Act or chapters 95 or 96 of title 26 (26 U.S.C.), the civil penalty shall not exceed the greater of $5,500 or an amount equal to any contribution or expenditure involved in the violation.
(2) Knowing and willful violations.
(i) In the case of a knowing and willful violation of the Act or chapters 95 or 96 of title 26 (26 U.S.C.), the civil penalty shall not exceed the greater of $11,000 or an amount equal to 200% of any contribution or expenditure involved in the violation.
(ii) Notwithstanding paragraph (a)(2)(i) of this section, in the case of a knowing and willful violation of 2 U.S.C. 441f, the civil penalty shall not be less than 300% of the amount of any contribution involved in the violation and shall not exceed the greater of $50,000 or 1,000% of the amount of any contribution involved in the violation.
2 U.S.C. 432(h), 438(a)(8), 439a, and 441a.
(b)
(e) [Removed and reserved]
(g)
(1)(i) Personal use includes but is not limited to the use of funds in a campaign account for any item listed in paragraphs (g)(1)(i)(A) through (J) of this section:
(A) Household food items or supplies.
(B) Funeral, cremation or burial expenses except those incurred for a candidate (as defined in 11 CFR 100.3) or an employee or volunteer of an authorized committee whose death arises out of, or in the course of, campaign activity.
(C) Clothing, other than items of
(D) Tuition payments, other than those associated with training campaign staff.
(E) Mortgage, rent or utility payments—
(
(
(F) Admission to a sporting event, concert, theater or other form of entertainment, unless part of a specific campaign or officeholder activity.
(G) Dues, fees or gratuities at a country club, health club, recreational facility or other nonpolitical organization, unless they are part of the costs of a specific fundraising event that takes place on the organization's premises.
(H) Salary payments to a member of the candidate's family, unless the family member is providing
(I) Salary payments by a candidate's principal campaign to a candidate in excess of the lesser of: the minimum salary paid to a Federal officeholder holding the Federal office that the candidate seeks; or the earned income that the candidate received during the year prior to becoming a candidate. Any earned income that a candidate receives from salaries or wages from any other source shall count against the foregoing limit of the minimum salary paid to a Federal officeholder holding the Federal office that the candidate seeks. The candidate must provide income tax records from the relevant years and other evidence of earned income upon the request of the Commission. Salary shall not be paid to a candidate before the filing deadline for access to the primary election ballot for the Federal office that the candidate seeks, as determined by State law, or in those states that do not conduct primaries, on January 1 of each even-numbered year.
(J) A vacation.
(ii) The Commission will determine, on a case-by-case basis, whether other uses of funds in a campaign account fulfill a commitment, obligation or expense that would exist irrespective of the candidate's campaign or duties as a Federal officeholder, and therefore are personal use. Examples of such other uses include:
(A) Legal expenses;
(B) Meal expenses;
(C) Travel expenses, including subsistence expenses incurred during travel. If a committee uses campaign funds to pay expenses associated with travel that involves both personal activities and campaign or officeholder-related activities, the incremental expenses that result from the personal activities are personal use, unless the person(s) benefiting from this use reimburse(s) the campaign account within thirty days for the amount of the incremental expenses, and
(D) Vehicle expenses, unless they are a
(2)
(3)
(4)
(5)
(6)
(i) The payment is a donation to a legal expense trust fund established in accordance with the rules of the United States Senate or the United States House of Representatives;
(ii) The payment is made from funds that are the candidate's personal funds as defined in 11 CFR 110.10(b), including an account jointly held by the candidate and a member of the candidate's family;
(iii) Payments for that expense were made by the person making the payment before the candidate became a candidate. Payments that are compensation shall be considered contributions unless—
(A) The compensation results from
(B) The compensation is exclusively in consideration of services provided by the employee as part of this employment; and
(C) The compensation does not exceed the amount of compensation which would be paid to any other similarly qualified person for the same work over the same period of time.
(7)
(i) The spouse of the candidate;
(ii) Any child, step-child, parent, grandparent, sibling, half-sibling or step-sibling of the candidate or the candidate's spouse;
(iii) The spouse of any child, step-child, parent, grandparent, sibling, half-sibling or step-sibling of the candidate; and
(iv) A person who shares a residence with the candidate.
(8)
In addition to defraying expenses in connection with a campaign for federal office, funds in a campaign account or an account described in 11 CFR 113.3:
(d) [Removed and reserved]
(e) * * *
(1) * * *
(i) Cash assets the Member may convert any excess campaign or donated funds in an amount up to the Member's authorized committee(s)' cash on hand, determined under 11 CFR 104.3(a)(1), as of November 30, 1989, less the committee(s)' total outstanding debts as of that date.
(5) 103d Congress or later Congress: A qualified Member who serves in the 103d Congress or a later Congress may not convert to personal use any campaign or donated funds, as of the first day of such service.
(f) Nothing in this section modifies or supersedes other Federal statutory restrictions or relevant State laws that may apply to the use of campaign or donated funds by candidates or Federal officeholders.