AMERICAN BAR ASSOCIATION

SECTION OF ADMINISTRATIVE LAW AND REGULATORY PRACTICE 2006 MIDYEAR MEETING

COUNCIL MEETING Hyatt Regency Chicago

Chicago, Illinois

Saturday, February 11, 2006

8:00 a.m. – 9:00 a.m. Breakfast 9:00 a.m. – 11:20 a.m. Council Meeting

Columbus Hall K/L – East Tower, Gold Level

AGENDA 9:00 – 9:10 a.m. Call to Order

Approval of 2005 Fall Meeting Minutes TAB 1 Introduction of Persons Present 9:10 – 9:20 a.m. Report of the Chair, Kinney TAB 2A TAB 2B TAB 2C 9:20 – 9:25 a.m. Report of the Chair-Elect, Troy TAB 3A TAB 3B TAB 3C 9:25 – 9:35 a.m. Report of the ABA Board Liaison, Agrast 9:35 – 10:00 a.m. Delegates’ Report, Kaleta TAB 4 (Delegates’ Report) 10:00 –10:20 a.m. OMB Risk Assessment Proposal, Shapiro TAB 5 10:20 – 10:35 a.m. Suspension of Federal E-Rulemaking TAB 6

Initiative, Parker 10:35 – 10:50 a.m. House Committee on Issues of Concern to the Profession – National Security vs. Right to Privacy, TAB 7 Kaleta 10:50 – 10:55 a.m. Nominating Committee Report, Funk 10:55 – 11:05 a.m. Homeland Security Law Institute, Zusman 11:05 – 11:10 a.m. Second Annual Administrative Law and Regulatory TAB 8 Practice Institute, Young 11:10 – 11:20 a.m. Request to Increase Section Staffing, Kinney, May TAB 9 11:20 – 11:30 a.m. Summer Council Meeting Proposal TAB 10 Adjourn

AMERICAN BAR ASSOCIATION SECTION OF ADMINISTRATIVE LAW AND REGULATORY PRACTICE

2006 MIDYEAR MEETING

COUNCIL MEETING Hyatt Regency Chicago

Chicago, Illinois

Sunday, February 12, 2006

Columbus Hall E/F, East Tower, Gold Level 8:00am – 10:00am Breakfast Program

Federal Lobbying Disclosure: Is Reform Needed? You are encouraged to attend this program. A discussion of proposed resolutions dealing with lobbying reform will convene during the Council meeting to follow. Breakfast will be served from 8 to 8:30am, and the program will begin at 8:30am. Panelists: Craig Holman, Washington, DC William Luneberg, Pittsburgh, PA Thomas Susman, Washington, DC Michael Wittenwyler, Washington, DC

Columbus Hall K/L, East Tower, Gold Level 10:10 a.m. – Noon Council Meeting

AGENDA

10:10 – 10:15 a.m. Welcome and Introduction of Persons Present 10:15 – 10:35 a.m. Lobbying Reform resolutions, Luneberg Tab 11 10:35 – 11:00 a.m. Election Law Committee Report, Potter Tab 12 (a) Fair Vote Plan (b) Redistricting 11:00 – 11:05 a.m. Publications Committee Report, Shavers 11:05 – 11:10 a.m. Budget Report, Cohen Tab 13 11:10 – 11:15 a.m. Annual Meeting Report, Belkin Tab 14 11:15 – 11:30 a.m. Delegates’ Report continued, Kaleta, Susman 11:30 a.m. Adjourn

MINUTES OF COUNCIL MEETING SECTION OF ADMINISTRATIVE LAW & REGULATORY PRACTICE

AMERICAN BAR ASSOCIATION Marriot at Metro Center

Washington, D.C. November 19, 2005

Attendance: Chair Eleanor Kinney; Chair-Elect Dan Troy; Vice-Chair Michael Asimow; Last Retiring Chair Randy May; Section Delegates Judy Kaleta and Tom Susman; Secretary Jamie Conrad; and Council Members Bernard Bell, Nicole Bernabo (Young Lawyers Division), Myles Eastwood, Michael Herz, Kenneth Hurwitz, Katy Kunzer, Hon. Lois Oakley (Administrative Judiciary), Nina Olson, Richard Parker, Hon. Raymond Randolph (Judiciary), Luke Reynolds (Law Student Division), Ron Smith, Richard Stoll, Wendy Wagner, Consuela Washington (Legislative Branch), and Hon. Ann Young; and Board of Governors Liaison Mark Agrast. I. Administrative Chair Kinney called the meeting to order at 9:07. The August 6 and 7, 2005 minutes were approved, subject to correction of some typos identified by Jeff Lubbers. Persons present introduced themselves. II. Report of the Chair Chair Kinney reported that she thought the Fall Conference had been “terrific,” and thanked co-chairs Katy Kunzer and Sharon Levine. She also thanked Dick Stoll for enabling the dinner to be held at the Cosmos Club. She reminded participants of the Spring Meeting in Bermuda. Jack Young updated Council on the second annual Administrative Law and Regulatory Practice Institute (April 6-7, 2006), to be focused upon Lobbying. Lynne Zusman announced the Section’s First Annual Homeland Security Law Institute to be held on January 20, chaired by herself and Joe Whitley, former General Counsel to the Department of Homeland Security. Kinney noted the ABA Presidential Appointments process is now underway, and encouraged interested persons to contact Dan Troy now. Kinney expressed her desire that the Section become more involved in submitting reports and recommendations, and proposed a goal that each committee should aim to produce at least one per year. Kinney also noted that Paul Verkuil and Wendy Wagner are working on the law school essay contests and that Bill Funk is chairing the nominating committee. III. Report of the Chair-Elect

Chair-Elect Troy announced that he had chosen Austin, Texas as the location of the 2007 Spring Meeting. He requested input regarding the date of the next Fall Meeting. Troy seconded the Chair’s recommendation that committees generate reports and recommendations. He cited as examples (i) the ability of agencies to grant waivers,

which several Section members are beginning to address; and (ii) criteria for when agencies should proceed by rulemaking vs. guidance, which Dick Stoll is spearheading. IV. Report of the Vice Chair Vice Chair Asimow added that he, too, would be encouraging committees to become more active in producing recommendations and programs. He solicited reactions to having the 2008 Spring Meeting in Las Vegas. He noted that he is assisting Cynthia Drew in chairing the 2005 Midyear Meeting in Chicago, and that programs would include: 7th Circuit judges talking about judicial review; environmental law after Katrina & Rita; and lobbying issues. He said there was still time to propose a program, if one contacted him immediately. Asimow noted that our Section meetings do not generate revenues, and asked Council members to please identify corporate sponsors for the Mid-Year meeting, especially from Chicago law firms. V. Delegates’ Reports Delegate Susman referred Council members to the ABA’s Summary of Actions from the House of Delegates Annual Meeting. He indicated that the House will take up asbestos again at Midyear. He added that while the House rejected the Section Officers Conference proposals before it regarding ABA governance, there was broad recognition that some sort of changes were warranted to reflect the disproportionate contributions made by Sections (as opposed to state delegations) to the policy work of the ABA. Finally, he noted that with respect to the Midyear Meeting, he and fellow delegate Judy Kaleta would refer to the Council reports and recommendations within our expertise. VI. Federal Consent Decree Legislation Councilmember Bell described a draft report and recommendation from the Section on Dispute Resolution regarding pending federal legislation affecting consent decrees resolving litigation filed by the federal government against state and local governmental entities. He summarized his memorandum to Council, indicating that the principal concern motivating the legislation – not addressed by the report – is the anti-democratic nature of consent decrees that bind the successors of the elected officials who entered into them. But, he argued, those concerns can be adequately addressed under existing law and the current standard it establishes for modifying consent decrees. Moreover, he noted, while the current arrangement allows elected state and local officials to choose when and how to bind their successors, the pending bill would result in federal law preempting that exercise of judgment. He added that, from a policy perspective, it is more problematic when private litigants, rather than the federal government, seek to bind state and local officials, but the pending legislation does not address such cases. Bell reported that the Section on Dispute Resolution is amenable to revising its report along these lines. Secretary Conrad spoke in support of Bell’s recommendations, asking ironically why private parties should not also be able to undo consent decrees whenever they experienced a change of control. The Council thanked Bell, commenting that his memo was better than the underlying report and recommendation. Councilmember Parker noted

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that bonds also obligate the successors of the officials who issued them. Delegate Susman opined that the FRCP 60(b)(5) standard, as interpreted by the Rufo decision, may indeed be too tough, but that federal legislation may not be the ideal solution. Keith Rizzardi, speaking from the audience, expressed concern over the automatic vacatur provision of the legislation, especially its 90-day timeframe for DOJ to respond. The sense of the Council was that Bell should negotiate with the Section on Dispute Resolution to improve the report and recommendation, and to report back to Section. Ron Levin felt it would be better to say courts should be mindful of these prudential considerations regarding scope, over-breadth and over-intrusiveness, especially as identified in the findings of the report. Bell’s memo notes that states have ability to limit their own discretion to enter into consent decrees. Judge Randolph noted that the pending legislation would apply even if elected officials were reelected. VII. Proposed Changes at Social Security Administration Robin Arzt presented information to the Council on proposal from the SSAB, that a new Article I Social Security Court be created to replace the federal district courts as the court of first instance hearing appeals of final Social Security Administration decisions regarding disability claims. She urged the Section to start thinking about this issue now. The impending SSAB proposal would be consistent with a paper by Lubbers and Verkuil that recommends regional (i.e., specialty) courts. But in Arzt’s view the Veterans Court isn’t working out well. Nina Olson discussed the Tax Court and how well it does work (an Article I court, though it rides circuit). Vice-Chair Asimow noted that present ABA policy opposes creation of specialized Article I courts, but opined that it may well be time to reconsider that policy. Jodi Levine, co-chair of the Benefits Committee, said they have been considering the idea, and noted 1986 & 1992 ABA policies on point. Someone noted the virtue of involving the Veterans Affairs Committee. It was noted that the original problem was SSA non-acquiescence to judicial decisions. Kinney thanked Robin for raising this issue and asked her to keep the Council apprised of new developments in this regard. VIII. Commission on Immigration Resolutions Anna Shavers discussed these seven resolutions, and proposed that the Section consponsor three of them: Due Process & Judicial Review; Right to Counsel; and Administration of U.S. Immigration Laws. In general, the resolutions oppose things Congress has done recently, and largely restate current ABA policy. Reports supporting the resolutions have just been released and will be emailed to Council members. ABA President Greco wants to move fast on them. Chair Kinney argued that this is asking too much too late; Vice-Chair Asimow agreed. It was noted that the Administration’s position on these issues is unknown and that the Section’s liaison from the Administration did not keep us informed. The Council expressed its frustration with this situation. Shavers will spearhead consideration of the three resolutions and will report to Council in February. IX. Report from the ABA Board of Governors

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Liaison Agrast asked Council members to let him know of matters before the Board so that he can run interference for us. He noted that the Board approved the Section’s latest request to charge a nominal registration fee for Midyear Meeting CLE programs. Agrast reported that ABA membership is up to 407,000; with a plan to reach 500,000 by 2010. The ABA membership plan has been updated, and no longer discusses government lawyers as being lesser targets for membership growth. The ABA has a healthy operating surplus for the 11th consecutive year ($3.8M out of $91.4 M revenues), and projects a small surplus next year. Such surpluses are used to cushion the ABA toward the end of its three-year dues cycle. It is now at end of a three-year cycle, and the Board will have to propose a dues increase to the House in February. In its decennial governance action, the House in August voted down a plan to give sections more power relative to state bars. Conversations have now shifted to discuss how Sections can be given more power without having to wait for the next decennial governance review; since Sections do provide a disproportionately larger amount to the substantive work of HOD. Agrast noted Sections get only 6 of 37 seats on the Board currently. Chair Kinney thanked Mark for his efforts on the Section’s behalf. X. EU Project Update Chair Kinney began by thanking George Bermann for the quality of the EU program the day before. Bermann reported that the project, now two years old, is on course, though behind schedule. A closed session Thursday involved presentations on all five sections of the report, based on previously submitted preliminary draft reports. The first public conference Friday also went well. It will be a big job to finalize the report. Overall, the substance is good, but a few sections are incomplete and all are dissimilar in format. The second conference of the project will be at the University of Indiana on June 23, and will focus on pharmaceutical and food safety (and maybe environmental regulation). Neil Eisner will try to orchestrate a federal interagency forum here in DC to include EU staff. Bermann still hopes to do third and final conference in Brussels in Fall 2007 or later. He thinks the project’s funding, while modest, will be sufficient. Thanks were expressed to Charles Koch and Jim O’Reilly, co-reporters on the Project. XI. Sensitive But Unclassified Resolution Steve Vieux noted the deletion of “sole” in first sentence of recommendation, and changed “the” to “a” in the same sentence. Katy Kunzer noted that DHS is in process of developing a standard policy for designating information “SBU.” The Council debated whether some federal records not covered by FOIA should be. Judy Kaleta asked whether DHS or other agencies besides DOJ should be referenced in recommendation; Bill Funk supported the idea, Nina Olson opposed it. Judge Randolph questioned whether the report accurately reflects the timing and motivation of the Ashcroft and Card memoranda; Jim O’Reilly explained their history. Chair-Elect Troy urged the Section to take a hard look at whether current FOIA exemptions and the current classification E.O. are adequate for protecting (and sharing) information like vulnerability assessments. Delegate Susman questioned the breadth of sentiment for expanding FOIA exemptions.

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Randy May offered two nonsubstantive amendments to the resolution: adding “taking into account the sensitive nature of the information” somewhere in last sentence, and inserting “does not establish a legal” in lieu of “cannot be a”. The “Committee on Style” will address these. After a motion and second, the resolution passed unanimously with Judge Randolph abstaining. XII. Blanket Authority Letter on Constructive Removal Vice-Chair Asimow presented this letter. Council members should give edits to Michael. XIII. Annual Meeting in Hawaii Chair Kinney asked Council members to fill out a form regarding whether they will attend the Annual Meeting. Early indications are that very few Council members are planning to travel to Hawaii. Kinney asked the Council to consider whether a Council Meeting should be held beforehand somewhere in the contiguous 48 states. A concern was raised that the Council would send bad signal to the ABA if it held its own separate meeting elsewhere. The point was then made that the Section Annual Meeting (CLE programs) will be held in Hawaii no matter what, and that the issue at hand is strictly that of achieving a quorum to conduct meaningful Council business, such as consideration of resolutions before the House. The issue will be reconsidered at the Midyear meeting based on survey results. The meeting adjourned at 12:00. The Chair was applauded for ending on time.

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American Bar Association

Section of Administrative Law and Regulatory Practice

Upcoming Meetings through August 2006

February 10- 12, 2006

2006 Midyear Meeting Program Co-Chairs: Cynthia Drew and Michael Asimow Hyatt Regency Chicago

February 15, 2006

Networking for Success: 'When in Rome' -- Speaking, Looking, and Acting Like You're an Attorney

12:15pm- 1:00pm Howard University School

of Law 2900 Van Ness Street, NW

Washington, DC

February 21, 2006

2006 Outlook for Transportation Legislation Transportation Law Committee

11:30am – 1:30pm Bank of America Building,

Washington, D.C

March 2, 2006

Administrative Law Review Symposium –Cracks in the System: The Adequacy of U.S. Healthcare Regulation in a

Global Age Eleanor Kinney

1pm – 5pm American University

Washington College of Law

March 30, 2006

Defining the Judge: How the Media, Elected Officials & the Public Perceive Judges & the Judiciary

Program Chair: Hon. Jodi Levine

8am – 10am Freedom Forum,

1101 Wilson Blvd Arlington, VA

April 6-7, 2006

Second Annual Administrative Law and Regulatory Practice Institute - "Lobbying"

Program Chairs: Jack Young, Tom Susman, Otto Hetzel Wyndham Washington,

D.C.

April 28 - 30, 2006

2006 Spring Meeting Program Chair: Christine Franklin

Elbow Beach Club, Bermuda

August 4 - 6, 2006

2006 Annual Meeting Program Chair: Janet Belkin

Waikiki Beach Marriott, Honolulu, Hawaii

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Transportation Committee Quarterly

Section of Administrative Law & Regulatory Practice American Bar Association

Winter 2005 – 2006 Volume 8, Number 1

In This Issue • SAFETEA-LU

• Case Notes

• Recent Agency Appointments & Departures

• Presidential Nominations

Committee Officers Co-Chairs Tom Bolling Linda Lasley Vice Chairs David H. Coburn Neil R. Eisner C. Scott Jones Judith S. Kaleta David M. Lehrman Kevin M. McDonald William S. Morrow Jr. Scott M. Schutz Editor C. Scott Jones

Upcoming Events

• Administrative Law Section Midyear Meeting, Chicago, Illinois February 10-12. 2006.

SAFETEA-LU On August 10, 2005, after an unprecedented twelve intervening short-term extension acts since the expiration of TEA-211, the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) was enacted as Public Law 109-59. SAFETEA-LU technically provides $286.4 billion for a six-year authorization period extending from FY2004 to FY2009, but the delays in its passage effectively curtail the legislation to a four-year bill. As a practical matter SAFETEA-LU provides for approximately $244 billion in guaranteed funding authority over the course of four years and two months through fiscal year 2009 for highways, highway safety, and public transportation. The delay was caused in large part by disagreements regarding a proper overall funding level and an equitable distribution of funds among the States.

Notwithstanding the prolonged fiscal debates, SAFETEA-LU constitutes record-level spending, exceeding by a wide margin the $218 billion in funding authorized under TEA-21, which was in effect during the period FY 1998 – 2003. A majority of the $244 billion total - approximately $193.2 billion - is committed to authorizations for the Federal-aid Highway Program. SAFETEA-LU increases the number of “core” highway programs from five to six. These include interstate maintenance (IM); the national highway system (NHS); the surface transportation program (STP); bridge and bridge maintenance; congestion, mitigation and air quality (CMAQ); and the new highway safety improvement program (HSIP). Remaining highway funding goes to other programs such as federal lands highways or the equity bonus (EB) program, which some consider another “core” program.

The funds are allocated in such a manner that annual spending

increases occur each year with total spending in FY 2009 almost 23% higher than total spending in FY2005. Apart from authorizations under the Federal-aid Highway Program, Congress allotted $14.8 billion in earmarks for more than 5,000 separate high priority projects (HPPs), including the d $229 million bridge proposed to link Ketchikan, Alaska to a sparsely populated island off the coast. 2

Major SAFETEA-LU provisions include: Surface Transportation

1 The Transportation Equity Act for the 21st Century (TEA-21)(P.L. 105-206). 2 By comparison, TEA-21 contained approximately 1,849 earmarks valued at $9.4 billion.

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• “Outlook for Transportation Legislation in 2006” sponsored by the Transportation Committee, ABA Section of Administrative Law and Regulatory Practice. Washington, DC, February 21, 2006 from 11:30 -1:30 pm (lunch will be served). Reservations (202) 662-1528.

• Second Annual Administrative Law and Regulatory Practice Institute, Wyndham Washington, DC, April 6-7, 2006.

Finance, Trust Fund Budgetary Treatment, Guaranteed Funding, Changes to Revenue Aligned Budge Authority (RABA), Equity Bonus Innovation, Innovative Finance and Tolling, Highway and Commercial Vehicle Safety Programs, and Environmental Issues, such as “Streamlining.” Some of these programs build on foundations established by TEA-21; others are new. A brief description of several of these provisions follows but a detailed analysis is beyond the scope of this article. For a more detailed description, including a link to the text of the legislation, readers should visit http://www.fhwa.dot.gov/safetealu/index.htm.

Environmental Issues

Before the Department of Transportation (DOT) or any of its component modal agencies can proceed with final design, property acquisition, or construction on a project, it must comply with certain environmental review requirements, including those of the National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. § 4231 et seq.) and the Section 4(f) of the Department of Transportation Act of 1966(49 U.S.C. § 303; 23 U.S.C. § 138). NEPA requires federal agencies to consider the environmental impacts of proposed major federal actions. Section 4(f) prohibits use of publicly owned parks and recreation areas, wildlife and waterfowl refuges, and publicly or privately owned historic sites or national, state, or local significance for use in a transportation project unless there is no “prudent and feasible” alternative to do otherwise, and the project includes all possible planning to minimize harm to the resource. SAFETEA-LU contains several provisions that experimentally modify these responsibilities. Section 6009 of SAFETEA-LU permits the use of publicly owned parks and recreation areas, wildlife and waterfowl refuges if it is determined that such use would result in “de minimis impacts” to the resource, although that determination must receive concurrence from the official with jurisdiction over that resource (for example, the U.S. Fish and Wildlife Service or the local park authorities). Similarly, SAFETEA-LU permits DOT to use a publicly or privately owned historic cite if a de minimis impact determination is made in accordance with the provisions of the National Historic Preservation Act, 16 U.S.C. § 470f. However, de minimis is not specifically defined, and DOT is charged with issuing regulations within one year clarifying factors to be considered and standards to be applied in determining whether alternatives are “prudent and feasible” under the Section 4(f) requirements. Other provisions of SAFETEA-LU permit States to assume a number of responsibilities that heretofore have been the exclusive province of DOT. Section 6004 permits any State to assume responsibility for determining categorical exclusions under NEPA, provided they enter into a Memorandum of Understanding with the Secretary. Under this arrangement FHWA assumes a programmatic monitoring role. Section 6005 of SAFETEA-LU establishes a project delivery program that will permit five selected States - Alaska, California, Ohio, Oklahoma, and Texas - to assume most DOT environmental responsibilities under NEPA and other environmental laws (excluding the Clean Air Act and transportation planning requirements). The delegation

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Editor’s Note Many thanks to the Department of Transportation and its component modal administrations for maintaining the informative, user-friendly web sites from which most of the material in this newsletter has been gathered. Thanks also to Linda Lasley, Assistant Chief Counsel for Legislation and Regulation for the Federal Transit Administration and Transportation Committee Co-chair and to David Bonelli, Attorney-Advisor with the General Law Division of the National Traffic Highway Safety Administration whose draft writings on judicial developments for another ABA publication formed the basis for the Case Notes section. Any views or opinions expressed in this publication are mine alone as are any errors of fact or grammar. C. Scott Jones

authority is limited to highway projects, and States may choose to assume responsibility for only specific projects or for a broader programmatic delegation that encompasses all highway projects in the State. Section 6003 establishes another pilot program that authorizes the Secretary of DOT to allow up to five States to assume environmental responsibilities under NEPA and 4(f) for Recreational Trails and Transportation Enhancement projects. Section 6002 of SAFETEA-LU shortens to 180 days the statute of limitation for challenging certain Federal decisions. This abbreviated statute of limitations applies to a permit, license, or approval decision by a Federal agency, if the decision relates to a highway or public transportation capital project and the agency publishes a notice in the Federal Register announcing that its decision is final. The provision is intended to expedite the resolution of issues affecting transportation projects. Innovative Finance and Tolling Tolling SAFETEA-LU provides States with the increased flexibility to use tolling in order to finance infrastructure improvements as well as for purposes of managing congestion through devices such as higher priced high occupancy vehicle (HOV) lanes. For example, the Interstate System Construction Toll Pilot Program authorizes the Secretary of Transportation to permit a State or compact of States to collect tolls on an Interstate highway, bridge, or tunnel for the purpose of constructing Interstate highways. Only three such experimental projects will be permitted throughout the nation. The Interstate System Reconstruction and Rehabilitation Toll Pilot Program and Value Pricing Pilot Program were both established under TEA-21 and continued under SAFETEA-LU. The first program permits up to three Interstate tolling projects for the purpose of reconstructing or rehabilitating Interstate highway corridors that could not be adequately maintained or improved without the collection of tolls. [PL 105-178, 1216(b).] The second provides $59 million in funding through 2009 to support the costs of implementing up to 15 variable pricing pilot programs nationwide to manage congestion and benefit air quality, energy use and efficiency. Another new program, the Express Lanes Demonstration Program authorizes 15 demonstration projects through 2009 that will employ tolling as a means to manage high levels of congestion, reduce emissions in a non-attainment or maintenance area, or finance added Interstate lanes in order to reduce congestion. Public and private entities designated by a State may apply to participate and, if approved, may utilize existing or newly created tolling facilities. Tolls charged on HOV facilities under the program must use pricing that varies according to time of day or level of traffic; for non-HOV facilities, variable pricing is optional. Innovative Finance Private Activity Bonds – To provide the opportunity for new sources of investment capital to finance the nationals transportation infrastructure system, SAFETEA-LU expands bonding authority for private activity bonds by adding highway facilities and surface freight transfer facilities to a list of other activities eligible for exempt facility bonds.

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Transportation Infrastructure Finance and Innovation Act (TIFIA) – Established in TEA-21, the TIFIA program provides Federal credit assistance in order to stimulate private co-investment in nationally or regionally significant highway, rail, and transit surface transportation projects. SAFETEA-LU authorizes $610 million through 2009 to pay the subsidy cost of supporting Federal credit under TIFIA and encourages broader use of TIFIA financing by lowering the eligibility threshold to a total project cost of at least $50 million or 1/3 of a State’s annual apportionment of Federal-aid highway funds, whichever is less. State Infrastructure Banks (SIBS) – SAFETEA-LU authorizes all States to enter into cooperative agreements with the Secretary to establish infrastructure revolving funds eligible to be capitalized with Federal transportation funds authorized for fiscal years 2005-2009. SIBs provide States the ability to increase the efficiency of their transportation investment through several forms of non-grant assistance to public or private entities for eligible projects. Examples include below-market subordinate loans, interest rate buy-downs on third party loans, and guarantees and other forms of credit enhancement. FHWA maintains a helpful list of fact sheets, regulations and interim guidance associated with each provision of SAFETEA-LU that is located at http://www.fhwa.dot.gov/safetealu/reference.htm.

Case Notes In AirTrans, Inc. v. Mead the Sixth Circuit upheld the authority of the Department of Transportation (DOT) Inspector General under Section 228 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA) to obtain and execute criminal search warrants for DOT-regulated entities. 389 F.3d 594(6th Cir. 2004). In Spector v. Norwegian Cruise Line Ltd., the Supreme Court held in a 5-4 decision that Title III of the Americans with Disabilities Act (“ADA”) applies to foreign-flagged cruise lines that transport U.S. passengers to and from U.S. ports thereby resolving a split between the Courts of Appeals for the Fifth and Eleventh Circuits. 125 S. Ct. 2169 (2005). Title III of the ADA prohibits discrimination against the disabled in the enjoyment of public accommodations and specified public transportation services. 42 U.S.C. §§ 12182, 12184(a). Earlier this year the Supreme Court upheld the Michigan Motor Carrier Act in the face of two constitutional challenges to the Act. In American Trucking Ass’ns v. Mich. Public Service Comm’n, the Court held that Michigan’s $100 per truck intrastate fee is a valid exercise of the State’s police powers and not a violation of the dormant Commerce Clause of the

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U.S. Constitution, because the fee is imposed only on intrastate commerce and is applied evenhandedly to all carriers traveling from point to point within the State. 125 S. Ct. 2419, 2421 (2005). In Mid-Con Freight Systems, Inc. v. Mich. Public Service Comm’n, the Court held that the $10 per truck maximum registration fee imposed by federal law under the Single State Registration System (SSRS) does not preempt the annual $100 fee Michigan levies on trucks operating entirely in interstate commerce, because the requirements set forth in Michigan’s Statute do not concern the SSRS statute’s subject matter. 125 S. Ct. 2427 (2005). The Court also opined that because Michigan had instituted its separate fee before the SSRS existed, Michigan’s fee was not intended to circumvent limitations imposed under the federal system. Id. at 2435.

Agency Appointments & Departures FTA

Sandra K. Bushue was appointed as Deputy Administrator on January 9, 2005. Deputy Administrator Bushue most recently held the position of Vice President and Strategic Account Manager for Homeland Security for Siemens One. In this position, she was the primary contact for homeland security business opportunities at the Federal level. She also held the position of Director, Government Affairs for Transportation at Siemens where she monitored and tracked legislation. Before joining Siemens, she was the Director of Government Affairs at the law firm Holland & Knight. Before that, she held a number of positions in the Administrations of Presidents Reagan and George H.W. Bush, including serving as Director of Programs in the Office of the White House Chief of Staff. Ms. Bushue also served as Special Assistant to the Secretary at the U.S. Department of Transportation and Deputy Director of the National Commission on Intermodal Transportation. She received her B.A. degree from Eureka College, Eureka, IL and her MBA from George Mason University, Fairfax, VA.

David B. Horner was appointed as the Chief Counsel of the Federal

Transit Administration (FTA) in January 2006. Mr. Horner joined FTA from the law firm of Hunton & Williams, where he was a member of the Global Capital Markets and Mergers & Acquisitions Group in the firm’s Richmond, Virginia office. Mr. Horner holds a J.D. from Washington and Lee University School of Law, an M. Phil in Politics from Oxford University and a B.A., magna cum laude, from Kenyon College. Mr. Horner is a member of Phi Beta Kappa and the Virginia Bar.

MARAD Julie Nelson was appointed as Chief Counsel for the Maritime

Administration (MARAD) in August 2005. Immediately prior to her appointment Ms. Nelson served as General Manager and Maritime/ Contracts Attorney for Oceaneering International, Inc., an ocean engineering development group. Ms. Nelson received her J.D. and B.G.S. from Indiana University School of Law and her LL.M. in Admiralty from Tulane University School of Law, where she was a Maritime Law Fellow and Graduate Advisor

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to the Tulane Maritime Law Journal. In addition, Ms. Nelson did graduate study in European Union law and government at the Ecole National D’Administration in Paris. From 1981 – 1989 Ms. Nelson served with the U.S. Navy on active and reserve duty.

OIG Kenneth M. Mead resigned as Inspector General for the Department of

Transportation on January 23, 2006. Todd J. Zinser, the current Deputy Inspector General will assume responsibilities as head of the Office of Inspector General until the President appoints a permanent successor to Mr. Mead. Mr. Mead has served as the Inspector General of DOT since 1997 when President Clinton appointed him to the office.

PHMSA Brigham A. McCown was appointed as the first Deputy Administrator

for the Pipeline and Hazardous Materials Safety Administration (PHMSA) and is currently serving as the Acting Administrator as well. Immediately prior to assuming his current responsibilities at PHMSA, Mr. McCown served as the first Chief Counsel of the Federal Motor Carrier Safety Administration (FMCSA). Prior to joining the U.S. Department of Transportation in 2003, Mr. McCown was a member of Winstead Sechrest & Minick P.C., a Dallas-based law firm where he specialized in transportation, construction, energy, and public law issues. Mr. McCown earned a Bachelor of Arts degree in diplomacy and foreign affairs from Miami University in 1988 and a law degree from the Salmon P. Chase College of Law at Northern Kentucky University in 1997.

Joseph Ahern is currently serving as the Deputy Chief Counsel and Acting Chief Counsel of the recently created Pipeline and Hazardous Materials Safety Administration (PHMSA). Mr. Ahern joined PHMSA’s predecessor agency, the Research and Special Program Administration, as the Deputy Chief Counsel on September 19, 2004, after completing a 30-year career with the U.S. Coast Guard. Mr. Ahern graduated from the U.S. Coast Guard Academy in 1974 and from Georgetown University Law Center in 1982. Mr. Ahern is a member of the Florida and Virginia State Bars. STB

In late December 2005, Surface Transportation Board (STB) Member W. Douglas Buttrey was unanimously elected by the Board to serve as Chairman until President Bush designates a permanent Chairman for the agency. Former Chairman Roger Nober resigned his position as Chairman and Member of the United States Transportation Board effective January 3, 2006. Mr. Nober had served as the Board’s second Chairman since November 26, 2002, and for a period of 54 weeks during 2003 and 2004 served as the Board’s only member.

Also, Board Member Francis P. Mulvey was unanimously elected to serve as Vice Chairman, effective Mr. Nober’s departure from the Board.

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Presidential Nominations

On January 17, 2006, President Bush announced his intention to name the following individuals to senior level posts at the Department of Transportation:

• Tyler D. Duvall to be Assistant Secretary of Transportation for Transportation Policy. Mr. Duvall currently serves as Deputy Assistant Secretary for Transportation Policy.

• Roger Shane Karr to be Assistant Secretary of Transportation for

Governmental Affairs. Mr. Karr currently serves as Deputy Chief of Staff for the Department of Transportation.

• Nichole R. Nason to be Administrator of the National Highway

Traffic Safety Administration. Ms. Nason currently serves as Assistant Secretary of Transportation for Governmental Affairs.

• David C. Sanborn to be Administrator of the Maritime

Administration. Mr. Sanborn currently serves as Director of Operations for Europe and Latin America at DP World.

• James S. Simpson to be Federal Transit Administrator. Mr.

Simpson is currently Chairman and Chief Executive Officer of Victory Worldwide Transportation.

TOPIC: Discuss a problem or issue aris-ing at the intersection of constitutional and administrative law.

PRIZE: The winner will receive a $500 cash prize and round-trip airfare and accommo-dation to attend the Section's Fall Confer-ence in Washington, DC. At the discretion of the editorial board, the winning entry will be selected for publication in Adminis-trative and Regulatory Law News.

ELIGIBILITY: The competition is open to currently enrolled students of ABA-accredited law schools who are also mem-bers of the ABA Section of Administrative Law and Regulatory Practice.

The essay must be the student's original, unpublished work. The paper may be pre-pared to satisfy a course requirement or for other academic credit. However, the essay must be the work of the submitting student without substantial editorial input from others. Co-authored papers are ineligible. Only one essay may be submitted per en-trant.

FORMAT: Essays must not exceed 12 pages, including title, citations, and any footnotes. The text of the essay must be double-spaced, with twelve-point font and one-inch margins.

Entries should reflect the style of Adminis-trative Law News articles rather than law review style. Entrants are encouraged to review past copies available at http://www.abanet .org/adminlaw/news/backpage.html - prior to drafting their sub-missions. Citations must be embedded in text or in footnote form; essays with end-notes will be disqualified. Cites must con-form with the 18th Edition of The Blue-book: A Uniform System of Citation.

JUDGING: Entries will be judged based on the following criteria:

• Creativity and clarity of the proposal or thesis

• Organization • Quality of the analysis and research • Grammar, syntax and form

The entries will be judged anonymously by the Fellows of the ABA Section of Admin-istrative Law and Regulatory Practice.

ENTRY PROCEDURE: Each submission must include a SEPARATE COVER PAGE with the entrant's name, law school, year of study, mailing and email address, and phone number. The contestant's name and other identifying markings, such as school name, MAY NOT appear on any copy of the submitted essay. Send three copies of the essay, a digital copy in Word format on an IBM-formatted diskette or CD-ROM. Submissions must be postmarked no later than March 31, 2006 and mailed to: Ameri-can Bar Association, Admin Law Essay Competition, 740 15th Street NW, Suite 900, Washington, D.C. 20005

Section of Administrative Law and Regula-tory Practice staff will assign a random number to each entry and record this num-ber on all copies of each essay submitted. Neither the contestant's identity nor his/her academic institution will be known to the selection committee.

By submitting an entry in this contest, the entrant grants the ABA and the ABA Sec-tion of Administrative Law and Regulatory Practice permission to edit and publish the entry in the Administrative Law News.

QUESTIONS: Please direct any questions about the contest to the Section Staff Direc-tor at knightk@staff.abanet.org.

Lead Story Headline 20

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Section of Administrative Law and Regulatory Practice

2006-2007 Meeting Schedule

Committee Chair Orientation and Meet the Officers Reception Washington, DC

Tentative for September 14, 2006 Meeting followed by Reception

2006 Administrative Law Conference

October 2006 Washington, D.C.

Second Annual

Homeland Security Law Institute January 2007

Washington, D.C.

2007 Midyear Meeting February 9-11. 2007

Miami, Florida

Third Annual Administrative Law and Regulatory Practice Institute

April 2007 Washington, D.C.

2007 Spring Meeting

April 2007 Austin, Texas

2007 Annual Meeting

August 11-13, 2007 San Francisco, California

Section of Administrative Law & Regulatory Practice 740 15th Street, NW Washington, DC 20005

Sidley A

AMERICAN BAR ASSOCIATION

SECTION CHAIR-ELECTDaniel Troy

Partner,ustin Brown & Wood LLP

(202) 736-8304FAX: (202) 736-8711

Email dtroy@sidley.com

February 2, 2006

To: Administrative Law Section Committee Chairs

Fr: Dan Troy, Section Chair-Elect

Re: 2006-2007 Section Committee Appointments

I would appreciate hearing from you no later than March 31, 2006 as to whether you would like to continue serving as the Chair or Co-Chair of your respective committee in the 2006-2007 membership year. In the event that you do not wish to continue, I would appreciate your recommendations on a replacement. Please send your response to the attention of Kim Knight in the Section office, at email: knightk@staff.abanet.org. Committees are the lifeblood of our Section. I appreciate your time and consideration on this matter, and I am looking forward to a productive year as Section Chair with your assistance.

Section of Administrative Law & Regulatory Practice 740 15th Street, NW Washington, DC 20005

Sidley A

AMERICAN BAR ASSOCIATION

SECTION CHAIR-ELECTDaniel Troy

Partner,ustin Brown & Wood LLP

(202) 736-8304FAX: (202) 736-8711

Email dtroy@sidley.com

February 2, 2006

To: Administrative Law Section Fellows, Past Section Chairs, and Committee Chairs

Fr: Dan Troy, Section Chair-Elect

Re: 2006-2007 Presidential Appointments

ABA President-Elect Karen Mathis has issued a call for nominations to ABA Standing and Special Committees, Commissions, and Task Forces. The deadline for nominations is March 1, 2006.

Members are welcome to submit self-nominations at www.abanet.org/appointments. This website also contains information about the available appointments, and the entire process. If you would like me to prepare a nomination for you on behalf of the Section, please contact me as soon as possible at dtroy@sidley.com. Please also copy Kim Knight in the Section office, at knightk@staff.abanet.org.

To: Council, Section of Administrative Law and Regulatory Practice

From: Judith S. Kaleta• Thomas M. Susman

Date: February 6, 2006 Subject: DELEGATES REPORT ON RECOMMENDATIONS TO HOUSE

OF DELEGATES MEETING ON FEBRUARY 13, 2006 AND OTHER MATTERS OF INTEREST CONCERNING THE HOUSE

We are continuing with the approach we first adopted in our report for the House of Delegates 2004 Midyear Meeting in Atlanta. We are presenting the recommendations in numerical order within five categories: our Section’s recommendation, requests for co-sponsorship voted upon by the Council, recommendations we have been invited to co-sponsor, other recommendations of interest, and others. The summaries were provided by the ABA. In some instances, we have expanded upon them in a note or in our commentaries. We have also included our tentative reaction to and comments from committee members and others on recommendations we have been asked to co-sponsor and those of interest. For these two categories, the language of the resolution is in the Appendix to our report to assist in our discussion at the Council meeting. If you wish to review the full recommendations and supporting reports, they are available at http://www.abanet.org/leadership/home.html (click on “House of Delegates”). We hope this review is helpful and look forward to your ideas and reactions. Please let us know – in advance of the Council meeting, if possible – whether there is any resolution in the “of interest” or “others” categories that should be discussed by the Council in Chicago. We will be discussing these resolutions at our meeting in Chicago. We are also aware that several Sections are considering filing late reports for consideration by the House. This may include additional recommendations concerning response to Hurricanes Katrina and Rita from TIPS, immigration from Criminal Justice, and monitoring from the Task Force on Domestic Surveillance. We will have more information on these at our Council meeting.

• The views expressed herein are the personal views of Ms. Kaleta as informed by her membership in the Section and service on the Section’s Council and do not represent the views of the U.S. Department of Transportation.

MID YEAR MEETING RECOMMENDATIONS

OUR RECOMMENDATION 112 SECTION OF ADMINISTRATIVE LAW AND REGULATORY

PRACTICE Urges the Attorney General of the United States to issue a

memorandum to Freedom of Information Act (FOIA) officials at federal agencies clarifying that the designation of agency records as “sensitive but unclassified” cannot be a basis for withholding agency documents from release.

We had an inquiry from the Antitrust Section, but further follow-up did not identify any opposition. The Standing Committee on Law and National Security, however, has raised a few questions concerning whether the recommendation is drafted too narrowly (by focusing on SBU). Tom Susman, who will present the resolution to the House, is working with them to resolve any concerns and has asked for suggested language that we may want to consider at the meeting. We appreciate the efforts of Steve Vieux and Jim O’Reilly drafting this resolution.

RECOMMENDATIONS WE HAVE VOTED TO CO SPONSOR

None

REQUESTS TO CO-SPONSOR

103 STANDING COMMITTEE ON MEDICAL PROFESSIONAL LIABILITY

SECTION OF DISPUTE RESOLUTION SECTION OF LITIGATION TORT TRIAL AND INSURANCE PRACTICE SECTION

Reaffirms opposition to legislation that places a dollar limit on recoverable damages that operate to deny full compensation to a plaintiff in a medical malpractice action and opposes the creation of healthcare tribunals that would deny patients injured by medical negligence the right to request a trial by jury or the right to receive full compensation for their injuries.

NOTE: This recommendation also recognizes that the nature and extent of

damages in a medical malpractice case are triable issues of fact and should not be subject to formulas or schedules.

2

JSK: This recommendation has generated some email discussion, ranging from opposing co-sponsorship to opposing the resolution to concerns about the report accompanying the recommendation. I agree with those who do not support co-sponsorship, but do not agree that the Section should oppose this recommendation.

TMS: I would not propose we cosponsor and have not decided whether the Section should oppose.

109 SECTION OF DISPUTE RESOLUTION Supports the use of federal consent decrees that are consistent

with specified principles and opposes legislation that limits the efficacy of consent decrees when state and local governments are parties thereto.

Note: The principles are: the duration and term of the consent decree should be determined by the language of the decree; consent decrees that do not state a specific duration should remain in effect until terminated or modified by a court for good cause; and the burden of proof with respect to a motion to modify or terminate a decree should remain on the party seeking the modification or termination. JSK & TMS: As we discussed at the Fall Council meeting, this recommendation raises questions of importance to federal agencies and federalism issues. We asked Bernie Bell to work with the Dispute Resolution Section, and he will report to us on the results of his efforts.

OTHER RECOMMENDATIONS OF INTEREST

ADMINISTRATIVE PROCESS FOR ASBESTOS-RELATED INJURIES

An introductory note: Jim Flanagan, co-chair of the Adjudications Committee reviewed the first 4 commendations from TIPS and reported the following: “The TIPS proposals relate to any legislation that would establish an administrative process to compensate for asbestos-related injuries in lieu of existing state, territorial or federal tort-based litigation. The proposals specifically do not take a position on whether an administrative process should be adopted, but assert that if it were adopted, it should include the recommended provisions, which relate to adequate representation, immunity of the award from subrogation and similar claims, and that the administrative process be implemented (and private suits terminated) only when there is adequate assurance and notice that sufficient funds are available to meet expected claims, and that tort-based claims may be revived if the funds incur a shortfall. These recommendations do not present any issues for the Adjudication Committee.”

3

106A TORT TRIAL AND INSURANCE PRACTICE SECTION

Recommends that any legislation establishing an administrative process in lieu of state, territorial or federal tort-based asbestos-related claims should insure access by claimants to adequate representation in the claims process.

106B TORT TRIAL AND INSURANCE PRACTICE SECTION Recommends that any legislation establishing an administrative process in lieu of state, territorial or federal tort-based asbestos-related claims should insure that awards to claimants not be depleted by taxation or by subrogation from any private or governmental entity and should not unduly foreclose independent claims existing under state, territorial or federal law relating to safety or other obligations of employers.

106C TORT TRIAL AND INSURANCE PRACTICE SECTION Recommends that any legislation establishing an administrative

process in lieu of state, territorial or federal tort-based asbestos-related claims should contain specific provisions to insure adequate upfront financing and disclosure of certain information concerning contributors.

106D TORT TRIAL AND INSURANCE PRACTICE SECTION Recommends that any legislation establishing an administrative

process in lieu of state, territorial or federal tort-based asbestos-related claims should contain specific contingent provisions to respond to any potential occurrence of a shortfall of funds.

106E TORT TRIAL AND INSURANCE PRACTICE SECTION Supports proper care and treatment of animals as an essential part

of the response to any disaster or emergency situation as part of any emergency preparedness operational plans.

JSK: The reaction to this has been negative, not because delegates

don’t like animals, but because of an interest in ensuring that the ABA focuses on other significant emergency response matters that that may be enhanced through changes to statutes or administrative procedures. TIPS has also prepared several recommendations that they intend to present to Rules and Calendars for consideration as late filed reports. These recommendations express the ABA’s sympathy for human losses

4

resulting from Hurricanes Katrina and Rita. 106 E and related hurricane recommendations may be withdrawn or not calendared.

TMS: I don’t have anything against animals. I love animals. But I have trouble understanding why the House of Delegates should spend its time on an issue that doesn’t affect the profession, doesn’t involve legal issues or institutions, and doesn’t relate to a lawyer’s expertise. If this doesn’t go on Consent, I would probably support a motion to table but would not initiate one myself.

IMMIGRATION An introductory note: At our Fall Council meeting, Anna Shavers brought to our attention the following 7 recommendations. We had some initial discussion about the difficulty of evaluating current ABA policy and new proposals. Since that time, the Commission has revised these recommendations and the reports. The recommendations have been reviewed by the Adjudications committee. A memo from the committee co-chair Jim Flanagan is attached to our report. He notes a concern with 107D (lines 12-16.) In addition, these recommendations have been the subject of discussion among several others in Section including Ann Young, Jeff Lubbers, and Ron Levin. We have alerted the chair of the Commission on Immigration that we may have some comments to provide after our Council meets at the Mid Year meeting. We look forward to the discussion, with open minds and ready pens. 107A COMMISSION ON IMMIGRATION Right to Counsel: Supports the due process right to counsel for all

persons in removal proceedings and the availability of legal representation to all non-citizens in immigration related matters.

NOTE: The recommendation also supports expansion of the “legal

orientation program,” establishment of systems to screen and refer indigent persons and to provided legal representation, and legislation to overturn “no cost to the government” restriction on representation in removal proceedings.

107B COMMISSION ON IMMIGRATION Immigration reform: Supports a regulated, orderly and safe

immigration system that addresses the undocumented population, need for immigrant labor, value of family reunification, and the need for an effective enforcement strategy; and supports lawful permanent residence and citizenship for undocumented persons who entered the United Stated states as minors.

107C COMMISSION ON IMMIGRATION

5

Due process and judicial review: Supports adequate funding appropriations to ensure that agencies adjudicate immigration applications in a timely manner and reduce backlogs; and urges an administrative agency structure for the implementation of immigration laws that will provide non-citizens with due process protections throughout the immigration process.

JSK & TMS: Given our recent success in our recommendation on Administrative

Adjudication for the 21st century, it appears that we may have something to add to this matter. We look forward to hearing from our experts.

, 107D COMMISSION ON IMMIGRATION Administration of U.S. Immigration Laws: Supports a

transparent, user-friendly, accessible, fair and efficient system for administering immigration laws that has sufficient resources to carry out its functions in a timely manner.

Jim Flanagan writes: “[R]ecommendation (c) does raise a potential problem. It supports:

(c) vigilant enforcement against the unauthorized practice of law and ineffective assistance of counsel in immigration matters, and the development of mechanisms to ensure that substantive and procedural rights are not prejudiced for applicants for immigration relief or benefits who have been victimized by the unauthorized practice of law or ineffective assistance of counsel.

This recommendation is prompted by problems that arise because applicants are unfamiliar with the procedures, or because they rely unauthorized document preparers who fraudulently or negligently file documents that subsequently have severe adverse consequences for the applicant. Enforcement of the rules against unauthorized practice of law is important and uncontroversial. However, the remedy in the administrative process for ineffective assistance of counsel presents a difficult situation. There clearly is a need for some remedy, but any procedure that may reopen the adjudication has the potential for significant delay, and may undermine any finality in the process. The recommendation does not define the remedy, and those issues may be resolved when the procedures are defined. However, the failure to anticipate and resolve these issues will present severe problems for administrative adjudicators, and those who manage the process.”

JSK: This recommendation also supports “the development of a standardized, efficient process for the timely handling of Freedom of Information Act

6

requests for immigration matters that ensures compliance with statutory deadlines.” I defer to the expertise of my fellow delegate on this.

TMS: I am less concerned than Jim Flanagan about the need to specify remedies when advocating “vigilant enforcement.” And delays in processing FOIA requests in the immigration arena are legend, so this seems like a soft proposal in that area as well. I am not convinced we should not support but remain open to being persuaded.

107E COMMISSION ON IMMIGRATION Immigration detention: Opposes the detention of non-citizens in

immigration removal proceedings except in extraordinary circumstances, which would include a determination, following a hearing and subject to judicial review, that a person presents a threat to national security or public safety, or presents a substantial flight risk.

107F COMMISSION ON IMMIGRATION Asylum and Refugee Procedures: Supports the establishment of

laws, policies, and practices that ensure optimum access to legal protection for refugees, asylum seekers, torture victims, and others deserving of humanitarian refuge.

107G COMMISSION ON IMMIGRATION Protection for Immigrant Victims of Crimes: Supports avenues

for lawful immigration status, employment authorization, and public benefits for victims of human trafficking and other crimes including rape, torture, domestic violence, sexual assault and sexual exploitation and supports the use of Legal Services Corporation funding to provide services to such victims.

111 CENTER FOR HUMAN RIGHTS Urges bar associations through out the world to speak out in their

respective communities in support of the Rule of Law. JSK: The recommendation also would adopt a Statement of Core

Principles adopted by approximately 100 international bar presidents and leaders. The 3 core principles have already been adopted by the ABA: 1) an impartial and independent judiciary, 2) an independent legal profession, and 3) access to justice. Any controversy surrounding this will result from the last sentence of the principles: “And that these core principles shall not yield to any emergency of the moment.”

TMS: If they routinely yielded to the emergency of the moment, they would hardly be “core principles.” I would support.

7

177B BOARD OF GOVERNORS

Recommends that membership dues be increased by approximately 17% to be effective with Fiscal Year 2006-07 and further recommends that limited testing of new dues pricing concepts be allowed.

JSK: The Board of Governors unanimously voted to recommend an

increase and have been working to ensure its approval. If you have been practicing over 10 years, dues are raised from $350 to $399. And yes, someone has looked into the science of pricing, and that is why it is not $400.

OTHER RECOMMENDATIONS (Without Comment) 11-1 HOUSE RULES OF PROCEDURE

Amends Section 45.9 of the House Rules of Procedure, Law School Accreditation, as recommended by the Council of the Section of Legal Education and Admissions to the Bar.

100 SECTION OF LEGAL EDUCATION AND ADMISSIONS TO THE

BAR Concurs in the action of the Council of the Section of Legal Education and Admissions to the Bar in adopting the revisions to the Rules of Procedure for Approval of Law Schools and to Standard 103 and its Interpretations of the Standards for Approval of Law Schools.

101 STANDING COMMITTEE ON PARALEGALS

Grants approval, reapproval and extension of the term of approval to several paralegal education programs, and withdraws the approval of one program at the request of the institution.

102 SECTION OF FAMILY LAW

SECTION OF INDIVIDUAL RIGHTS AND RESPONSIBILITIES COMMISSION ON HOMELESSNESS AND POVERTY

Opposes legislation and policies that prohibit, limit or restrict placement into foster care of any child on the basis of sexual orientation of the proposed foster parent when such foster care placement is otherwise determined to be in the best interest of the child.

104A NATIONAL CONFERENCE OF COMMISSIONERS ON UNIFORM

STATE LAWS

8

Approves the Uniform Foreign-Country Money Judgments Recognition Act, promulgated by the National Conference of Commissioners on Uniform State Laws in 2005 as an appropriate Act for those States desiring to adopt the specific substantive law suggested therein.

104B NATIONAL CONFERENCE OF COMMISSIONERS ON UNIFORM

STATE LAWS

Approves the Uniform Debt-Management Services Act, promulgated by the National Conference of Commissioners on Uniform State Laws in 2005 as an appropriate Act for those States desiring to adopt the specific substantive law suggested therein.

104C NATIONAL CONFERENCE OF COMMISSIONERS ON UNIFORM

STATE LAWS

Approves the Uniform Certificate of Title Act, promulgated by the National Conference of Commissioners on Uniform State Laws in 2005 as an appropriate Act for those States desiring to adopt the specific substantive law suggested therein.

104D NATIONAL CONFERENCE OF COMMISSIONERS ON UNIFORM

STATE LAWS Approves the Uniform Assignment of Rents Act, promulgated by the National Conference of Commissioners on Uniform State Laws in 2005 as an appropriate Act for those States desiring to adopt the specific substantive law suggested therein.

105 COMMISSION ON RENAISSANCE OF IDEALISM

STANDING COMMITTEE ON PRO BONO AND PUBLIC SERVICE

SENIOR LAWYERS DIVISION SECTION OF BUSINESS LAW SECTION OF LITIGATION Urges all lawyers to contribute to the public good through

community service activities in addition to their professional responsibility to deliver pro bono service in accordance with the Model Rules of Professional Conduct Rule 6.1.

9

108A SECTION OF INDIVIDUAL RIGHTS AND RESPONSIBILITIES COUNCIL ON RACIAL AND ETHNIC JUSTICE Urges Congress to create and appropriate funds for a Commission

to study and make findings relating to the present day social, political and economic consequences of both slavery and the denial thereafter of equal justice under law for persons of African descent living in the United States and authorizes the Commission to propose public policies or governmental actions, if any, that may be appropriate to address such consequences.

108B SECTION OF INDIVIDUAL RIGHTS AND RESPONSIBILITIES Urges Congress to enact legislation to establish a process to

provide federal recognition and to restore self-determination to Native Hawaiians.

110 SECTION OF INTERNATIONAL LAW Urges the development and adoption thereafter, of a uniform law

that would permit unsworn declarations under penalty of perjury to be executed by persons located outside the United States in lieu of affidavits, verifications, or other sworn documents in state or territorial judicial proceedings, as is currently the federal practice under 28 U.S.C. §1746.

OUTLOOK FOR THE ANNUAL MEETING

There are several matters that may be considered at the annual meeting that we want to bring to your attention. First, our Election Law committee is reviewing a proposal aimed at ensuring that the winner of the popular vote in a Presidential election would also be the winner of the Electoral College vote. The Election Law Committee is seeking Section members interested in joining the discussion. We anticipate this to result in a recommendation to be considered by the House at the Annual Meeting. Second, the House of Delegates Committee on Issues of Concern to the Legal Profession will be conducting a panel presentation at the Annual Meeting on national security vs. the right to privacy. The Section has been asked to work with the committee. Several Section representatives will participate in a planning meeting with other Sections and the House Committee. Third, the Joint Commission to Evaluate the Model Code of Judicial Conduct is working on a new model code that will be brought to the House in August. If you have any interest in early involvement in any of these matters, please advise Kim Knight and us.

Your faithful Delegates, Judy Kaleta & Tom Susman

February 3, 2006

10

OFFICE OF MANAGEMENT AND BUDGET

Proposed Risk Assessment Bulletin

________________________________________________________________________

SUMMARY: As part of an ongoing effort to improve the quality, objectivity, utility, and integrity of information disseminated by the federal government to the public, the Office of Management and Budget (OMB), in consultation with the Office of Science and Technology Policy (OSTP), proposes to issue new technical guidance on risk assessments produced by the federal government.

DATES: Interested parties should submit comments to OMB’s Office of Information and

Regulatory Affairs on or before June 15, 2006.

ADDRESSES: Because of potential delays in OMB’s receipt and processing of mail,

respondents are strongly encouraged to submit comments electronically to ensure timely receipt. We cannot guarantee that comments mailed will be received before the comment closing date. Electronic comments may be submitted to: OMB_RAbulletin@omb.eop.gov. Please put the full body of your comments in the text of the electronic message and as an attachment. Please include your name, title, organization, postal address, telephone number and e-mail address in the text of the message. Please be aware that all comments are available for public inspection. Accordingly, please do not submit comments containing trade secrets, confidential or proprietary commercial or financial information, or other information that you do not want to be made available to the public. Comments also may be submitted via facsimile to (202) 395-7245.

FOR FURTHER INFORMATION CONTACT: Dr. Nancy Beck, Office of Information

and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., New Executive Office Building, Room 10201, Washington, DC, 20503. Telephone (202) 395-3093.

SUPPLEMENTARY INFORMATION: Introduction

Risk assessment is a useful tool for estimating the likelihood and severity of risks to human health, safety and the environment and for informing decisions about how to manage those risks. For the purposes of this Bulletin, the term “risk assessment” refers to a document that assembles and synthesizes scientific information to determine whether a potential hazard exists and/or the extent of possible risk to human health, safety or the environment.

The acceptance of risk assessment in health, safety, and environmental policy was enhanced

by the seminal report issued by the National Academy of Sciences (NAS) in 1983: Risk

This proposed bulletin is being released for peer review and public comment. It should not be construed to represent the official policy of the U.S. Office of Management and Budget. - 1 -

Assessment in the Federal Government: Managing the Process. The report presented a logical approach to assessing environmental, health and safety risk that was widely accepted and used by government agencies.

Over twenty years after publication of the NAS report, there is general agreement that the

risk assessment process can be improved. The process should be better understood, more transparent and more objective. Risk assessment can be most useful when those who rely on it to inform the risk management process understand its value, nature and limitations, and use it accordingly.

Many studies have supported the use of risk assessment and recommended improvements.

For example, in 1993 the Carnegie Commission on Science, Technology, and Government issued “Risk and the Environment: Improving Regulatory Decision-making.”1 In 1994, the NAS issued “Science and Judgment in Risk Assessment” to review and evaluate the risk assessment methods of EPA.2 In 1995, the Harvard Center for Risk Analysis issued “Reform of Risk Regulation: Achieving More Protection at Less Cost.”3 In 1997, the Presidential/Congressional Commission on Risk Assessment and Risk Management issued “Risk Assessment and Risk Management in Regulatory Decision-Making.”4 A series of NAS reports over the past 10 years have made useful recommendations on specific aspects and applications of risk assessment.5 The findings in these reports informed the development of this Bulletin.

OMB, in collaboration with OSTP, has a strong interest in the technical quality of agency

risk assessments because these assessments play an important role in the development of public policies at the national, international, state and local levels. The increasing importance of risk assessment in the development of public policy, regulation, and decision making requires that the

This proposed bulletin is being released for peer review and public comment. It should not be

1 Carnegie Commission on Science, Technology and Government, Risk and the Environment: Improving Regulatory Decision Making, New York, NY, June 1993. 2 National Research Council Science and Judgment in Risk Assessment, Washington DC: National Academy Press, 1994. 3 Harvard Group on Risk Management Reform, Reform of Risk Regulation: Achieving More Protection at Less Cost, Human and Ecological Risk Assessment, vol. 183, 1995, pp. 183-206. 4 Presidential/Congressional Commission on Risk Assessment and Risk Management, Vol. 2, Risk Assessment and Risk Management in Regulatory Decision-Making, hereinafter “Risk Commission Report,” 1997. 5 See, e.g., National Research Council, Health Implications of Perchlorate Ingestion,, Washington DC: National Academy Press, 2005; National Research Council, Arsenic in Drinking Water 2001 Update, Washington DC: National Academy Press, 2001; National Research Council, Toxicological Effects of Methylmercury, Washington DC: National Academy Press, 2000; National Research Council, Health Effects of Exposure to Radon, BEIR VI, Washington DC: National Academy Press, 1999; National Research Council, Science and the Endangered Species Act, Washington, DC: National Academy Press, 1995; National Research Council, Science and Judgment in Risk Assessment, Washington DC: National Academy Press, 1994; National Research Council, Issues in Risk Assessment I: Use of the Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, Washington DC: National Academy Press, 1993; National Research Council, Issues in Risk Assessment II: The Two Stage Model of Carcinogenesis, Washington DC: National Academy Press, 1993; National Research Council, Issues in Risk Assessment III: A Paradigm for Ecological Risk Assessment, Washington DC: National Academy Press, 1993; National Research Council, Pesticides in the Diet of Infants and Children, Washington DC: National Academy Press, 1993; National Academy of Engineering, Keeping Pace with Science and Engineering: Case Studies in Environmental Regulation, Washington DC: National Academy Press, 1993; National Research Council, Risk Assessment in the Federal Government: Managing the Process, Washington DC: National Academy Press, 1983.

construed to represent the official policy of the U.S. Office of Management and Budget. - 2 -

technical quality and transparency of agency risk assessments meet high quality standards. Moreover, a risk assessment prepared by one federal agency may inform the policy decisions of another federal agency, or a risk assessment prepared by one or more federal agencies may inform decisions made by legislators or the judiciary. This Bulletin builds upon the historic interest that both OMB and OSTP have expressed in advancing the state of the art of risk assessment.6

The purpose of this Bulletin is to enhance the technical quality and objectivity of risk

assessments prepared by federal agencies by establishing uniform, minimum standards. Federal agencies should implement the technical guidance provided in this Bulletin, recognizing that the purposes and types of risk assessments vary. The Bulletin builds on OMB’s Information Quality Guidelines and Information Quality Bulletin on Peer Review and is intended as a companion to OMB Circular A-4 (2003), which was designed to enhance the technical quality of regulatory impact analyses, especially benefit-cost analysis and cost-effectiveness analysis. Like OMB Circular A-4, this Bulletin will need to be updated periodically as agency practices and the peer-reviewed literature on risk assessment progress.

The audience for the Bulletin includes analysts and managers in federal agencies with

responsibilities for assessing and managing risk or conducting research on improved approaches to risk assessment. The Bulletin should also be of interest to the broad range of specialists in the private and public sectors involved in or affected by risk assessments and/or decisions about risk and safety.

Although this Bulletin addresses certain technical aspects of risk assessment, it does not

address in any detail the important processes of risk management and risk communication.7 The technical guidance provided here addresses the development of the underlying documents that may help inform risk management and communication, but the scope of this document does not encompass how federal agencies should manage or communicate risk.

Uses of Risk Assessments

Risk assessment is used for many purposes by the Federal Government. At a broad level,

risk assessments can be used for priority setting, managing risk, and informing the public and other audiences. The purpose of the assessment may influence the scope of the analytic work, the type of data collected, the choice of analytic methods, and the approach taken to reporting the findings. Accordingly, the purpose of an assessment should be made clear before the analytical work begins.

This proposed bulletin is being released for peer review and public comment. It should not be

6 See U.S. Office of Science and Technology Policy, Chemical Carcinogens: A Review of the Science and Its Associated Principles, 50 FR10371 (1985); and, U.S. Office of Management and Budget, Memorandum for the Regulatory Working Group, Principles for Risk Analysis, Jan 12, 1995. 7 National Research Council Understanding Risk: Informing Decisions in a Democratic Society, Washington DC: National Academy Press, 1996; Risk Commission Report, Volume 2, 1997; National Research Council, Improving Risk Communication, Washington DC: National Academy Press, 1989.

construed to represent the official policy of the U.S. Office of Management and Budget. - 3 -

Priority Setting Risk assessment is sometimes used as a tool to compare risks for priority-setting purposes.8

For example, in 1975 the Department of Transportation prepared a comparative assessment of traffic safety hazards related to highway and vehicle design as well as driver behavior.9 A wide range of countermeasures were compared to determine which measures would be most effective in saving lives and reducing injuries. Similarly, risk assessment models relating to food safety and agricultural health concerns may be used to rank relative risks from different hazards, diseases, or pests. In 1987 and again in 1990, the Environmental Protection Agency (EPA) prepared a comparative assessment of environmental hazards – both risks to human health and the environment – to inform the Agency’s priority setting.10 This work demonstrated that the environmental risks of greatest concern to the public often were not ranked as the greatest risks by agency managers and scientists.

Screening-level risk assessments are sometimes used as a first step in priority setting. The

purpose of the “screen” is to determine, using conservative (or worst-case) assumptions, whether a risk could exist, and whether the risk could be sufficiently serious to justify agency action. If the screening-level assessment indicates that a potential hazard is not of concern, the agency may decide not to undertake a more comprehensive assessment. If the screening-level assessment indicates that the potential hazard may be of concern, then the agency may proceed to undertake a more comprehensive assessment to estimate the risk more accurately.11

Informing Risk Management Decisions

Often, a risk assessment is conducted to help determine whether to reduce risk and, if so, to

establish the appropriate level of stringency. A wide set of standards derived from statutes, regulations, and/or case law guide regulatory agencies in making risk management decisions. In such situations, the risk management standard is known a priori based on “acceptable risk” considerations.12

Risk assessments may be used to look at risk reduction under various policy alternatives to

determine if these alternatives are effective in reducing risks. In some agency programs, the

This proposed bulletin is being released for peer review and public comment. It should not be

8 Davies, J. C. (ed), Comparing Environmental Risks: Tools for Setting Government Priorities, Resources for the Future, Washington, DC, 1996; Minard, R, State Comparative Risk Projects: A Force for Change, Northeast Center for Comparative Risk, South Royalton, Vermont, March 1993. 9 U.S. Department of Transportation, National Highway Safety Needs Report, Washington, DC, April 1976. 10 U.S. Environmental Protection Agency, Unfinished Business: A Comparative Assessment of Environmental Protection, Washington, DC, 1987; U.S. Environmental Protection Agency, Reducing Risk: Setting Priorities and Strategies for Environmental Protection, Science Advisory Board, Washington, DC, 1990. 11 National Research Council, Science and Judgment in Risk Assessment, Washington DC: National Academy Press, 1994. 12 Douglas, M, Risk Acceptability According to the Social Sciences, Russell Sage Foundation, New York, NY, 1985; Fischhoff, B, S Lichtenstein, P Slovic, SL Derby, RL Keeney, Acceptable Risk, Cambridge University Press, UK, 1981.

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results of risk assessments are an important technical input to benefit-cost analyses, which are then used to inform risk management decisions in rulemakings.13

Informing the Public

In some circumstances, risk assessments are undertaken to inform the public through education and informational programs.14 Such programs can help citizens make informed decisions in their personal lives. For example, Federal agencies alert the public about the risks of living in a home with elevated levels of radon gas, of purchasing a sport utility vehicle with a certain height-to-width ratio, and taking long-term estrogen therapy. The dissemination of public risk information, even if it is not accompanied by a regulation, can induce changes in the behavior of consumers, patients, workers, and businesses.

Sometimes, Federal agencies undertake large-scale risk assessments that are designed to

inform multiple audiences. For example, the Surgeon General’s Report on Smoking and Health has, over the years, contained a wide variety of health risk estimates. These estimates have been adopted in programs and documents disseminated by local and state governments, Federal agencies, private companies, and the public at large. In some cases, Federal scientists participate in an international effort to develop risk models that can be used to educate the public and inform decisions throughout the world.15

Types of Risk Assessments

Risk assessment is a broad term that encompasses a variety of analytic techniques that are

used in different situations, depending upon the nature of the hazard, the available data, and needs of decision makers.16 The different techniques were developed by specialists from many disciplines, including toxicology, epidemiology, medicine, chemistry, biology, engineering, physics, statistics, management science, economics and the social sciences. Most risk assessments are performed by teams of specialists representing multiple disciplines. They are often prepared by government scientists or contractors to the government.

This proposed bulletin is being released for peer review and public comment. It should not be

13 Breyer, S., Breaking the Vicious Circle: Toward Effective Risk Regulation, Harvard University Press, Cambridge, MA 1993; Hahn, RW (ed), Risks, Costs and Lives Saved: Getting Better Results from Regulation, Oxford University Press, New York, NY, 1996; Viscusi, WK, Rational Risk Policy, Clarendon Press, Oxford, UK, 1998; National Research Council, Valuing Health Risks, Costs, and Benefits for Environmental Decisionmaking, Washington, DC: National Academy Press, 1990. 14 Fischhoff, B, S Lichtenstein, P Slovic, SL Derby, RL Keeney, Acceptable Risk, Cambridge University Press, UK, 1981; Douglas, M, Risk Acceptability According to the Social Sciences, Russell Sage Foundation, New York, NY, 1985; Wilson, R, EAC Crouch, Risk-Benefit Analysis, Harvard University Press, Cambridge, MA, 2001. 15 Renn, O, White Paper on Risk Governance: Towards an Integrative Approach, International Risk Governance Council, Geneva, Switzerland, September 2005. 16 Haimes, YY, Risk Modeling, Assessment, and Management, John Wiley and Sons, New York, New York, 1998; Wilson, R, EAC Crouch, Risk-Benefit Analysis, Harvard University Press, Cambridge, MA, 2001.

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Actuarial Analysis of Real-World Human Data When large amounts of historic data from humans are available, an actuarial risk assessment

may be performed using classical statistical tools. For example, the safety risks associated with use of motor vehicles, including the risks of a vehicle’s design features, may be estimated by applying statistical tools to historic data on crashes, injuries and/or fatalities. When sufficient numbers of people have been exposed to large doses of chemicals and radiation, it may be feasible to estimate risks using health data and statistical methods. The field of epidemiology, a branch of public health and medicine, performs such assessments by combining actuarial analyses with biologic theory and medical expertise.17 The field of radiation risk assessment has been informed by epidemiology, including studies of the World War II bombings at Hiroshima and Nagasaki and more recently the experiences of workers who were exposed to radiation on the job. Estimates of the health risks of tobacco products have been generated primarily on the basis of epidemiology.

Dose-Response Analysis Using Experimental Data

Special techniques of risk assessment have been developed for settings where humans and/or

animals are exposed – intermittently or continuously – to various doses of substances.18 The adverse effects of concern may range from different types of cancer to developmental, reproductive or neurological effects. Real-world data on adverse effects in humans or wildlife may not be available because (a) adequate data have not been collected, (b) the adverse effects (e.g., certain types of leukemia) are too rare to analyze directly, (c) the exposures of concern are associated with a new technology or product, or (d) adverse effects may occur only after a long period (e.g., several decades) of exposure.

When direct real-world data on toxicity are unavailable or are inadequate, risk assessments

may be performed based on data from toxicity experiments with rodents, since rats and mice have relatively short lifetimes and are relatively inexpensive to house and feed. Toxicity experiments involving rodents, although controversial to some, have three important advantages: (1) the doses, whether administered by injection, in feed or by inhalation, can be measured precisely, (2) different doses can be applied to different groups of rodents by experimental design, and (3) pathology can be performed on rodents to make precise counts of tumors and other adverse events.

When dose-response data are available from a rodent experiment, the assessor usually faces

two critical extrapolation issues: how effects observed in rodents are relevant to people or wildlife and how effects observed at the high doses used in experiments are relevant to the low doses typically found in the environment. Techniques have been developed to perform such extrapolations and to portray the resulting uncertainty in risk estimates associated with extrapolation.

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17 Monson, R, Occupational Epidemiology, Second Edition, CRC Press, Boca Raton, Florida, 1990. 18 Rodricks, JV, Calculated Risks: The Toxicity and Human Health Risks of Chemicals in Our Environment, Cambridge, University Press, New York, NY, 1992.

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Infectious Disease and Epidemic Modeling Risk assessments of infectious agents pose special challenges since the rate of diffusion of an

infectious agent may play a critical role in determining the occurrence and severity of an epidemic. Risk assessments of the spread of the HIV virus, and the resulting cases of AIDs, were complicated by the different modes of transmission (e.g., sexual behavior, needle exchange and blood transfusion) and the analyst’s need to understand the relative size and degree of mixing of these populations.19 Scientific understanding of both biology and human behavior are critical to performing accurate risk assessments for infectious agents.

Failure Analysis of Physical Structures

One of the best known types of risk assessments addresses low-probability, high-

consequence events associated with the failure of physical structures.20 Since these events are exceedingly rare (e.g., bridge failure or a major core meltdown at a nuclear reactor), it may not be feasible to compute risks based on historic data alone. Engineers have developed alternative techniques (e.g., fault-tree analysis) that estimate both the probability of catastrophic events and the magnitude of the resulting damages to people, property and the environment. Such “probabilistic” risk assessments are now widely used in the development of safety systems for dams, nuclear and chemical plants, liquefied natural gas terminals, space shuttles and other physical structures.

Legal Authority This Bulletin is issued under statutory authority and OMB’s general authorities to oversee the

quality of agency analyses, information and regulatory actions. In the “Information Quality Act,” Congress directed OMB to issue guidelines to “provide

policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility and integrity of information” disseminated by Federal agencies. Pub. L. No. 106-554, § 515(a). The Information Quality Act was developed as a supplement to the Paperwork Reduction Act, 44 U.S.C. § 3501 et seq., which requires OMB, among other things, to “develop and oversee the implementation of policies, principles, standards, and guidelines to . . . apply to Federal agency dissemination of public information.” Moreover, Section 624 of the Treasury and General Government Appropriations Act of 2001, often called the “Regulatory Right-to-Know Act,” (Public Law 106-554, 31 U.S.C. § 1105 note) directs OMB to “issue guidelines to agencies to standardize . . . measures of costs and benefits” of Federal rules.

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19 Turner, CF., et al., AIDS: Sexual Behavior and Intravenous Drug Use, National Research Council, Washington, D.C., 1989, pp. 471-499. 20 Pate-Cornell, ME, Uncertainties in Risk Analysis: Six Levels of Treatment, Reliability Engineering and System Safety, vol. 54(2-3), 1996, pp. 95-111; Haimes, YY, Risk Modeling, Assessment, and Management, John Wiley and Sons, New York, New York, 1998.

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Executive Order 12866, 58 Fed. Reg. 51,735 (Oct. 4, 1993), establishes that OIRA is “the repository of expertise concerning regulatory issues, including methodologies and procedures that affect more than one agency,” and it directs OMB to provide guidance to the agencies on regulatory planning. E.O. 12866, § 2(b). The Order requires that “[e]ach agency shall base its decisions on the best reasonably obtainable scientific, technical, economic, or other information.” E.O. 12866, § 1(b)(7). The Order also directs that “[i]n setting regulatory priorities, each agency shall consider, to the extent reasonable, the degree and nature of risks posed by various substances or activities within its jurisdiction.” E.O. 12866, § 1(b)(4). Finally, OMB has additional authorities to oversee the agencies in the administration of their programs.

All of these authorities support this Bulletin.

The Requirements of This Bulletin This bulletin addresses quality standards for risk assessments disseminated by federal

agencies.

Section I: Definitions Section I provides definitions that are central to this Bulletin. Several terms are identical to or

based on those used in OMB’s government-wide information quality guidelines, 67 Fed. Reg. 8452 (Feb. 22, 2002), and the Paperwork Reduction Act, 44 U.S.C. § 3501 et seq.

The term “Administrator” means the Administrator of the Office of Information and

Regulatory Affairs in the Office of Management and Budget (OIRA). The term “agency” has the same meaning as in the Paperwork Reduction Act, 44 U.S.C. §

3502(1). The term “Information Quality Act” means Section 515 of Public Law 106-554 (Pub. L. No.

106-554, § 515, 114 Stat. 2763, 2763A-153-154 (2000)). The term “risk assessment” means a scientific and/or technical document that assembles and

synthesizes scientific information to determine whether a potential hazard exists and/or the extent of possible risk to human health, safety, or the environment. For the purposes of this Bulletin, this definition applies to documents that could be used for risk assessment purposes, such as an exposure or hazard assessment that might not constitute a complete risk assessment as defined by the National Research Council.21 This definition includes documents that evaluate baseline risk as well as risk mitigation activities.

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21 National Research Council Risk Assessment in the Federal Government: Managing the Process, Washington DC: National Academy Press, 1983.

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The term “influential risk assessment” means a risk assessment the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions. The term "influential" should be interpreted consistently with OMB's government-wide Information Quality Guidelines and the Information Quality Guidelines of the relevant agency. A risk assessment can have a significant economic impact even if it is not part of a rulemaking. For instance, the economic viability of a technology can be influenced by the government’s characterization of the risks associated with the use of the technology. Alternatively, the federal government's assessment of risk can directly or indirectly influence the regulatory actions of state and local agencies or international bodies.

Examples of “influential risk assessments” include, but are not limited to, assessments that

determine the level of risk regarding health (such as reference doses, reference concentrations, and minimal risk levels), safety and environment. Documents that address some but not all aspects of risk assessment are covered by this Bulletin. Specific examples of such risk assessments include: margin of exposure estimates, hazard determinations, EPA Integrated Risk Information System (IRIS) values, risk assessments which support EPA National Ambient Air Quality Standards, FDA tolerance values, ATSDR toxicological profiles, HHS/NTP substance profiles, NIOSH current intelligence bulletins and criteria documents, and risk assessments performed as part of economically significant rulemakings. Documents falling within these categories are presumed to be influential for the purposes of this Bulletin.

The term “available to the public” covers documents that are made available to the public by the agency or that are required to be disclosed under the Freedom of Information Act, 5 U.S.C. § 552.

Section II: Applicability Section II states that, to the extent appropriate, all publicly available agency risk assessments

shall comply with the standards of this Bulletin. This statement recognizes that there may be situations in which it is not appropriate for a particular risk assessment to comport with one or more specific standards contained in this Bulletin, including the general standards in Section IV, which apply to both influential and non-influential risk assessments. A rule of reason should prevail in the appropriate application of the standards in this Bulletin. For example, in a screening-level risk assessment, the analyst may be seeking to define an upper limit on the unknown risk that is not likely to be exceeded. Screening-level assessments, in this situation, would not have to meet the standard of “neither minimizing nor exaggerating the nature and magnitude of risk.” On the other hand, it is expected that every risk assessment (even screening- level assessments) will comply with other standards in Section IV. For example, it is expected that every risk assessment shall describe the data, methods, and assumptions with a high degree of transparency; shall identify key scientific limitations and uncertainties; and shall place the risk in perspective/context with other risks familiar to the target audience. Similarly, every quantitative risk assessment should provide a range of plausible risk estimates, when there is scientific uncertainty or variability.

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This Bulletin does not apply to risk assessments that arise in the course of individual agency adjudications or permit proceedings, unless the agency determines that: (1) compliance with the Bulletin is practical and appropriate and (2) the risk assessment is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings. This exclusion is intended to cover, among other things, licensing, approval and registration processes for specific product development activities. This Bulletin also shall not apply to risk assessments performed with respect to inspections relating to health, safety, or environment.

This Bulletin also does not apply to any risk assessment performed with respect to an

individual product label, or any risk characterization appearing on any such label, if the individual product label is required by law to be approved by a Federal agency prior to use. An example of this type of risk assessment includes risk assessments performed for labeling of individual pharmaceutical products. This Bulletin does apply to risk assessments performed with respect to classes of products. An example of this type of risk assessment is the risk assessment performed by FDA in their evaluation of the labeling for products containing trans-fatty acids.

Section III: Goals For each covered risk assessment, this Bulletin lays out five aspirational goals.

1. Goals Related to Problem Formulation

As a risk assessment is prepared, risk assessors should engage in an iterative dialogue with the agency decision maker(s) who will use the assessment. There will be many choices regarding the objectives, scope, and content of the assessment, and an iterative dialogue will help ensure that the risk assessment serves its intended purpose and is developed in a cost-effective manner. For example, a risk manager may be interested in estimates of population and/or individual risk and an iterative dialogue would ideally bring this to the attention of a risk assessor early in the process.

2. Goals Related to Completeness

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There is often a tension between the desire for completeness in the scientific sense and the desire for a well-defined scope that limits the inquiry to a set of practical, tractable, and relevant questions. The scope of an assessment should reflect a balance between the desire for scientific completeness and the need to provide relevant information to decision makers. The concept of considering the benefits and cost of acquiring further information (e.g., a broader scope or better data on a more narrow scope) is presented in the OMB Information Quality Guidelines, the OMB Information Quality Bulletin for Peer Review, and OMB Circular A-4.22

22 US Office of Management and Budget, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 FR 8452-8460 Feb. 22, 2002; US Office of Management and Budget, Final Information Quality Bulletin for Peer Review, 70 FR 2664-2677, Jan 14, 2005; and

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3. Goals Related to Effort Expended

The level of effort should be commensurate with the importance of the risk assessment,

taking into consideration the nature of the potential hazard, the available data, and the decision needs. For instance, if an agency is only interested in a screening-level assessment, then an assessment which explores alternative dose-response models may not be warranted.

4. Goals Related to Resources Expended

Agencies should take into account the importance of the risk assessment in gauging the

resources, including time and money, required to meet the requirements of this Bulletin.23 5. Goals Related to Peer Review and Public Participation

Agencies should consider appropriate procedures for peer review and public participation in

the process of preparing the risk assessment. When a draft assessment is made publicly available for comment or peer review, the agency is required to clarify that the report does not represent the official views of the federal government. Precise disclaimer language is recommended in OMB's Information Quality Bulletin on Peer Review. Public comments can play an important role in helping to inform agency deliberations.24 When people are engaged early in the process, the public typically has an easier time concurring with government documents and decisions which may affect them.25

Section IV: General Risk Assessment and Reporting Standards

Each risk assessment disseminated by a Federal agency is subject to OMB’s Information

Quality Guidelines and the agency’s Information Quality Guidelines. These guidelines require risk assessments to meet the three key attributes of utility, objectivity, and integrity.

This proposed bulletin is being released for peer review and public comment. It should not be

US Office of Management and Budget, Circular A-4, Sept 2003 available at: http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf. 23 See Risk Commission Report, Vol. 2, at 63 (“Deciding to go forward with a risk assessment is a risk management decision, and scaling the effort to the importance of the problem, with respect to scientific issues and regulatory impact, is crucial.”); id., at 21 (“The level of detail considered in a risk assessment and included in the risk characterization should be commensurate with the problem’s importance, expected health or environmental impact, expected economic or social impact, urgency, and level of controversy, as well as with the expected impact and cost of protective measures.”), 1997. 24 Risk Commission Report, Vol. 2, at 21 (“Stakeholders play an important role in providing information that should be used in risk assessments and in identifying specific health and ecological concerns that they would like to see addressed.” id., at 185, 1997. 25 National Research Council, Understanding Risk: Informing Decisions in a Democratic Society, Washington DC: National Academy Press, 1996.

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This Bulletin identifies six standards that apply to both influential and non-influential risk assessments. An additional seventh standard is also presented for risk assessments that are likely to be used in regulatory analysis.

1. Standards Relating to Informational Needs and Objectives

A risk assessment should clearly state the informational needs driving the assessment as well

as the objectives of the assessment. This simple requirement will ensure that readers and users are able to understand the questions the assessment sought to answer and will help to ensure that risk assessments are used for their intended purposes. This is particularly important in cases where likely users of the risk assessment are not the original intended audience for the document. For example, an explicit statement of the ranges of chemical doses for which the assessment is relevant will inform other users as to whether or not the assessment is relevant their purposes.

2. Standards Relating to Scope

Every risk assessment should clearly summarize the scope of the assessment. The statement

of scope may necessitate policy judgments made by accountable policy officials and managers as well as analysts. The scope of some assessments may be highly discretionary while others may be rigidly determined or influenced by statutory requirements, court deadlines or scarcity of available agency resources. In cases where the scope of an assessment has been restricted primarily due to external considerations beyond the agency's control, policy makers and other participants in the process should be made aware of those complicating circumstances and the technical limitations they have introduced in the agency's work product.

To begin framing the scope of a risk assessment, the first step should be to specify and

describe the agent, technology and/or activity that is the subject of the assessment. The next step entails describing the hazard of concern. In order for an assessment to be complete, the assessment must address all of the factors within the intended scope of the assessment. For example, a risk assessment informing a general regulatory decision as to whether exposure to a chemical should be reduced would not be constrained to a one-disease process (e.g., cancer) when valid and relevant information about other disease processes (e.g., neurological effects or reproductive effects) are of importance to decision making.

The third step in framing the scope of the assessment entails identifying the affected entities.

Affected entities can include populations, subpopulations, individuals, natural resources, animals, plants or other entities. If a risk assessment is to address only specific subpopulations, the scope should be very clear about this limitation. An analytic product may be incomplete when it addresses only risks to adults when there is information suggesting that children are more exposed and/or more susceptible to adverse effects than are adults.

Once the affected entities are defined, the assessment should define the exposure or event

scenarios relevant to the purpose of the assessment as well as the type of event-consequence or dose-response relationship for the exposure or event ranges that are relevant to the objectives of the risk assessment. Although scientific completeness may entail analysis of different health

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effects and multiple target populations, the search for completeness will vary depending upon the nature of the assessment. In a fault-tree analysis of nuclear power accidents, an aspect of completeness may be whether pathways to accidents based on errors in human behavior have been addressed as well as pathways to accidents based on defects in engineering design or physical processes.

When agencies ask whether a particular chemical or technology causes or contributes to a

particular disease, completeness in a scientific sense may entail consideration of evidence regarding the causative role of other factors in producing the disease of interest. For example, an assessment of radon exposure and lung cancer may need to consider the role of cigarette smoking as a potential confounding factor that influences the estimated risk of radon. Alternatively, the evidence on smoking may suggest that the risks of radon are larger for smokers than non-smokers, a so-called risk-modifying or synergistic factor. The scientific process of considering confounding and/or synergistic factors may assist policy makers in developing a broader sense of how risk can be reduced significantly and the range of decision options that need to be considered if maximum risk reduction is to be achieved. 3. Standards Related to Characterization of Risk

Every risk assessment should provide a characterization of risk, qualitatively and, whenever

possible, quantitatively.26 When a quantitative characterization of risk is provided, a range of plausible risk estimates should be provided.27 Expressing multiple estimates of risk (and the limitations associated with these estimates) is necessary in order to convey the precision associated with these estimates.

In the 1996 amendments to the Safe Drinking Water Act (SDWA), Congress adopted a basic

quality standard for the dissemination of public information about risks of adverse health effects. Under 42 U.S.C. 300g– 1(b)(3)(B), the agency is directed ‘‘to ensure that the presentation of information [risk] effects is comprehensive, informative, and understandable.’’ The agency is further directed ‘‘in a document made available to the public in support of a regulation [to] specify, to the extent practicable— (i) each population addressed by any estimate [of applicable risk effects]; (ii) the expected risk or central estimate of risk for the specific populations [affected]; (iii) each appropriate upper-bound or lower-bound estimate of risk; (iv) each significant uncertainty identified in the process of the assessment of [risk] effects and the studies that would assist in resolving the uncertainty; and (v) peer-reviewed studies known to the [agency] that support, are directly relevant to, or fail to support any estimate of [risk] effects and

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26 National Research Council, Science and Judgment in Risk Assessment, at 185, (“EPA should make uncertainties explicit and present them as accurately and fully as feasible and needed for risk management decision-making. To the greatest extent feasible, EPA should present quantitative, as opposed to qualitative, representations of uncertainty.”), Washington DC: National Academy Press, 1994. 27 See Carnegie Commission on Science, Technology and Government, Risk and the Environment: Improving Regulatory Decision Making, New York, NY, June 1993, at 87 (“Regulatory agencies should report a range of risk estimates when assessing risk and communicating it to the public. How risk estimates, whether derived from an inventory or not, are conveyed to the public significantly affects the way citizens perceive those risks. Single-value risk estimates reported to the public do not provide an indication of the degree of uncertainty associated with the estimate. Such numbers do not convey the conservative nature of some risk estimates.”).

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the methodology used to reconcile inconsistencies in the scientific data.’’ These SDWA quality standards should be met, where feasible, in all risk assessments which address adverse health effects. 4. Standards Related to Objectivity

Risk assessments must be scientifically objective, neither minimizing nor exaggerating the

nature and magnitude of the risks. On a substantive level, objectivity ensures accurate, reliable and unbiased information. When determining whether a potential hazard exists, weight should be given to both positive and negative studies, in light of each study’s technical quality. The original and supporting data for the risk assessment must be generated, and the analytical results developed, using sound statistical and research methods.

Beyond the basic objectivity standards, risk assessments subject to this Bulletin should use

the best available data and should be based on the weight of the available scientific evidence.28 The requirement for using the best available scientific evidence was applied by Congress to risk information used and disseminated pursuant to the SDWA Amendments of 1996 (42 U.S.C. 300g-1(b)(3)(A)&(B)). Under 42 U.S.C. 300g–1(b)(3)(A), an agency is directed ‘‘to the degree that an agency action is based on science,’’ to use ‘‘(i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data).’’ Agencies have adopted or adapted this SDWA standard in their Information Quality Guidelines for risk assessments which analyze risks to human health, safety, and the environment. We are similarly requiring this as a general standard for all risk assessments subject to this Bulletin.

In addition to meeting substantive objectivity standards, risk assessments must be accurate,

clear, complete and unbiased in the presentation of information about risk. The information must be presented in proper context. The agency also must identify the sources of the underlying information (consistent with confidentiality protections) and the supporting data and models, so that the public can judge for itself whether there may be some reason to question objectivity. Data should be accurately documented, and error sources affecting data quality should be identified and disclosed to users.

A risk assessment report should also have a high degree of transparency with respect to data,

assumptions, and methods that have been considered. Transparency will increase the credibility

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28 Risk Commission Report, Vol. 1, at 38 (“Because so many judgments must be based on limited information, it is critical that all reliable information be considered. Risk assessors and economists are responsible for providing decision-makers with the best technical information available or reasonably attainable, including evaluations of the weight of the evidence that supports different assumptions and conclusions.”) The Risk Commission Report provides examples of the kinds of considerations entailed in making judgments on the basis of the weight of the scientific evidence in a toxicity study: quality of the toxicity study; appropriateness of the toxicity study methods; consistency of results across studies; biological plausibility of statistical associations; and similarity of results to responses and effects in humans. Vol. 2 at 20,1997.

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of the risk assessment, and will allow interested individuals, internal and external to the agency, to understand better the technical basis of the assessment.

5. Standards Related to Critical Assumptions

Risk assessments should explain the basis of each critical assumption and those assumptions

which affect the key findings of the risk assessment. If the assumption is supported by, or conflicts with, empirical data, that information should be discussed. This should include discussion of the range of scientific opinions regarding the likelihood of plausible alternate assumptions and the direction and magnitude of any resulting changes that might arise in the assessment due to changes in key assumptions. Whenever possible, a quantitative evaluation of reasonable alternative assumptions should be provided. If an assessment combines multiple assumptions, the basis and rationale for combining the assumptions should be clearly explained.

6. Standards Related to the Executive Summary

Every risk assessment should contain an executive summary which discloses the objectives

and scope, the key findings of the assessment, and the key scientific limitations and uncertainties in the risk assessment. Presentation of this information in a helpful and concise introductory section of the report will not only foster improved communication of the findings, but will also help ensure that the risk assessment is appropriately utilized by diverse end users. Major limitations are those that are most likely to affect significantly the determinations and/or estimates of risk presented in the assessment.

The executive summary should also place the estimates of risk in context/perspective with

other risks familiar to the target audience. Due care must be taken in making risk comparisons. Agencies might want to consult the risk communication literature when considering appropriate comparisons. Although the risk assessor has considerable latitude in making risk comparisons, the fundamental point is that risk should be placed in a context that is useful and relevant for the intended audience.29

7. Standards Related to Regulatory Analysis

When a risk assessment is being produced to support or aid decision making related to regulatory analysis, there are additional standards that should be met. Risk assessors should consult OMB Circular A-4, which addresses requirements designed to improve the quality of regulatory impact analyses. For major rules involving annual economic effects of $1 billion or more, a formal quantitative analysis of the relevant uncertainties about benefits and costs is required.30 In this Bulletin, we highlight important aspects of risk assessments useful for regulatory analysis:

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29 National Research Council, Improving Risk Communication, Washington DC: National Academy Press, 1989, at 165-79; see also Risk Commission Report, Volume 1, at 4, One of the key recommendations of the Risk Commission Report was that the problems a regulation is intended to address should be placed in their “public health and ecological context.”, 1997. 30 US Office of Management and Budget, Circular A-4, Sept, 2003, available at: http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf.

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1) The scope of the risk assessment should include evaluation of alternative options, clearly

establishing the baseline risk analysis and the risk reduction alternatives that will be evaluated. When relevant, knowledge of the hazard and anticipated countermeasures should be understood in order to accurately capture the baseline risk.

2) The risk assessment should include a comparison of the baseline risk against the risk

associated with the alternative mitigation measures being considered, and describe, to the extent feasible, any significant countervailing risks caused by alternative mitigation measures.31

3) The risk assessment should include information on the timing of exposure and the onset of

the adverse effect(s) as well as the timing of control measures and the reduction or cessation of adverse effects.

4) When estimates of individual risk are developed, estimates of population risk should also

be developed. Estimates of population risk are necessary to compare the overall costs and benefits of regulatory alternatives.

5) When a quantitative characterization of risk is made available, this should include a range

of plausible risk estimates, including central estimates. A “central estimate” of risk is the mean or average of the distribution; or a number which contains multiple estimates of risk based on different assumptions, weighted by their relative plausibility; or any estimate judged to be most representative of the distribution.32 The central estimate should neither understate nor overstate the risk, but rather, should provide the risk manager and the public with the expected risk.33

Section V: Special Standards for Influential Risk Assessments In addition to the standards presented in section IV, all influential risk assessments should

meet certain additional standards. When it is not appropriate for an influential risk assessment to adhere to one or more of the standards in this section of the Bulletin, the risk assessment should contain a rationale explaining why the standard(s) was (were) not met.

1. Standard for Reproducibility

Influential risk assessments should be capable of being substantially reproduced. As

described in the OMB Information Quality Guidelines, this means that independent reanalysis of the original or supporting data using the same methods would generate similar analytical results, subject to an acceptable degree of precision. Public access to original data is necessary to satisfy

This proposed bulletin is being released for peer review and public comment. It should not be

31 Graham, J.D., Jonathan B. Wiener (eds), Risk Versus Risk: Tradeoffs in Protecting Health and the Environment, Harvard University Press, Cambridge, MA, 1995. 32 See, e.g., Holloway, CA, Decision Making Under Uncertainty: Models and Choices (1979), at 76, 214, 91-127 Theodore Colton, Statistics in Medicine (1974), at 28-31. 33 National Research Council, Science and Judgment in Risk Assessment, at 170-75, Washington DC: National Academy Press, 1994.

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this standard, though such access should respect confidentiality and other compelling considerations.34 It is not necessary that the results of the risk assessment be reproduced. Rather, someone with the appropriate expertise should be able to substantially reproduce the results of the risk assessment, given the underlying data and a transparent description of the assumptions and methodology. 2. Standard for Comparison to Other Results

By definition, influential risk assessments have a significant impact. In such situations, it is

appropriate for an agency to find and examine previously conducted risk assessments on the same topic, and compare these risk assessments to the agency risk assessment. A discussion of this comparison should be incorporated into the risk assessment.

3. Standard for Presentation of Numerical Estimates

When there is uncertainty in estimates of risk, presentation of single estimates of risk is

misleading and provides a false sense of precision. Presenting the range of plausible risk estimates, along with a central estimate, conveys a more objective characterization of the magnitude of the risks. Influential risk assessments should characterize uncertainty by highlighting central estimates as well high-end and low-end estimates of risk. The practice of highlighting only high-end or only low-end estimates of risk is discouraged.

This Bulletin uses the terms “central” and “expected” estimate synonymously. When the

model used by assessors is well established, the central or expected estimate may be computed using standard statistical tools. When model uncertainty is substantial, the central or expected estimate may be a weighted average of results from alternative models. Formal probability assessments supplied by qualified experts can help assessors obtain central or expected estimates of risk in the face of model uncertainty.35 4. Standard for Characterizing Uncertainty

Influential risk assessments should characterize uncertainty with a sensitivity analysis and,

where feasible, through use of a numeric distribution (e.g., likelihood distribution of risk for a given individual, exposure/event scenario, population, or subpopulation). Where appropriate,

This proposed bulletin is being released for peer review and public comment. It should not be

34 See US Office of Management and Budget, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 FR 8456, (“However, the objectivity standard does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections. ’’) Feb. 22, 2002. 35 National Research Council, Estimating the Public Health Benefits of Proposed Air Pollution Regulations, Washington, DC: National Academies Press, 2002; Cooke, RM, Experts in Uncertainty: Opinion and Subjective Probability in Science, Oxford University Press, New York, NY, 1991; Evans, JS, JD Graham, GM Gray, RL Sielken, A Distributional Approach to Characterizing Low-Dose Cancer Risk, Risk Analysis, vol. 14(1), 1994, pp. 25-34; Hoffman, O, S Kaplan, Beyond the Domain of Direct Observation: How to Specify a Probability Distribution that Represents the State-of-the-Knowledge About Uncertain Inputs, Risk Analysis, vol. 19(1), 1999, pp. 131-134; Morgan, MG, M Henrion, M Small, Uncertainty: A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis, Cambridge University Press, Cambridge, UK, 1990.

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this should include sufficient description so that the lower and upper percentiles and the median, mean, mode, and shape of the uncertainty distribution are apparent.

When one or more assumptions are used in a risk assessment, the assessor may evaluate how

plausible changes in the assumptions influence the results of the assessment. An assumption may be used for a variety of reasons (e.g., to address a data gap or to justify the selection of a specific model or statistical procedure). Professional judgment is required to determine what range of assumptions is plausible enough to justify inclusion in the sensitivity analysis. Sensitivity analysis is particularly useful in pinpointing which assumptions are appropriate candidates for additional data collection to narrow the degree of uncertainty in the results. Sensitivity analysis is generally considered a minimum, necessary component of a quality risk assessment report.

A model is a mathematical representation -- usually a simplified one -- of reality. Where a

risk can be plausibly characterized by alternative models, the difference between the results of the alternative models is model uncertainty. For example, when cancer risks observed at high doses of chemical exposure are extrapolated to low doses (i.e., doses below the range of empirical detection of cancer risk), a dose-response model must be employed to compute low-dose risks. Biological knowledge may be inadequate to predict the shape of the dose-response curve for cancer in the low-dose region. While it is common for risk assessors to use a model where cancer risk is proportional to dose (even at low doses), there are cases where it has been demonstrated, through huge epidemiological studies or detailed biologic data from the laboratory, that a non-linear dose-response shape is appropriate. When risk assessors face model uncertainty, they need to document and disclose the nature and degree of model uncertainty. This can be done by performing multiple assessments with different models and reporting the extent of the differences in results.36 A weighted average of results from alternative models based on expert weightings may also be informative.37

When the model used by assessors is well established, the central or expected estimate may

be computed using classical statistics. When model uncertainty is substantial, the central or expected estimate may be a weighted average of the results from alternative models.38 Judgmental probabilities supplied by scientific experts can help assessors obtain central or

This proposed bulletin is being released for peer review and public comment. It should not be

36 Holland, CH, RL Sielken, Quantitative Cancer Modeling and Risk Assessment, Prentice-Hall, Englewood Cliffs, New Jersey, 1993; Olin, S, W Farland, C Park, L Rhomberg, R Scheuplein, T Starr, J Wilson (eds), Low-Dose Extrapolation of Cancer Risks: Issues and Perspectives, International Life Sciences Institute, Washington, DC, 1995. 37 Morgan, MG, M Henrion, M Small, Uncertainty: A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis, Cambridge University Press, Cambridge, UK, 1990; Cooke, RM, Experts in Uncertainty: Opinion and Subjective Probability in Science, Oxford University Press, New York, NY, 1991; National Research Council, Estimating the Public Health Benefits of Proposed Air Pollution Regulations, Washington, DC: National Academies Press, 2002. 38 Clemen, RT, Making Hard Decisions: An Introduction to Decision Analysis, Second Edition, Duxbury Press, Pacific Grove, CA, 1996; Morgan, MG, M Henrion, M Small, Uncertainty: A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis, Cambridge University Press, Cambridge, UK, 1990; Hoffman, O, S Kaplan, Beyond the Domain of Direct Observation: How to Specify a Probability Distribution that Represents the State-of-the-Knowledge About Uncertain Inputs, Risk Analysis, vol. 19(1), 1999, pp. 131-134.

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expected estimates of risk in the face of model uncertainty.39 Central or expected estimates of risk play an especially critical role in decision analysis and cost-benefit analysis.40

Statistical uncertainty sometimes referred to as data uncertainty or parameter uncertainty

occurs when some data exist on the value of an input, but the value of the input is not known with certainty. If a sample of data exists on an input, the degree of statistical uncertainty in the input value is influenced by the size of the sample and other factors. Risk assessors should document and disclose the nature and degree of statistical uncertainty.

5. Standard for Characterizing Results

Results based on different effects observed and/or different studies should be presented to

convey how the choice of effect and/or study influences the assessment. Authors of the assessment have a special obligation to evaluate and discuss alternative theories, data, studies and assessments that suggest different or contrary results than are contained in the risk assessment. When relying on data from one study over others, the agency should discuss the scientific justification for its choice. 6. Standard for Characterizing Variability

A risk is variable when there are known differences in risk for different individuals,

subpopulations, or ecosystems. In some cases variability in risk is described with a distribution. Where feasible, characterization of variability should include sufficient description of the variability distribution so that the lower and upper percentiles and the median, mean, and mode are apparent.41 This section should also disclose and evaluate the most influential contributors to variation in risk. This characterization should reflect the different affected populations (e.g., children or the elderly), time scales, geography, and other parameters relevant to the needs and objectives of the risk assessment. If highly exposed or sensitive subpopulations are highlighted, the assessment should also highlight the general population to portray the range of variability.42

This proposed bulletin is being released for peer review and public comment. It should not be

39 Morgan, MG, M Henrion, M Small, Uncertainty: A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis, Cambridge University Press, Cambridge, UK, 1990; Cooke, RM, Experts in Uncertainty: Opinion and Subjective Probability in Science, Oxford University Press, New York, NY, 1991; Evans, JS , JD Graham, GM Gray, RL Sielken, A Distributional Approach to Characterizing Low-Dose Cancer Risk, Risk Analysis, vol. 14(1), 1994, pp. 25-34. 40 Pate-Cornell, ME, Uncertainties in Risk Analysis: Six Levels of Treatment, Reliability Engineering and System Safety, vol. 54(2-3), 1996, pp. 95-111; Clemen, RT, Making Hard Decisions: An Introduction to Decision Analysis, Second Edition, Duxbury Press, Pacific Grove, CA, 1996; Viscusi, WK, Rational Risk Policy, Clarendon Press, Oxford, UK, 1998. 41 Burmaster, DE, PD Anderson, Principles of Good Practice for the Use of Monte Carlo Techniques in Human Health and Ecological Risk Analysis, Risk Analysis, vol. 14(4), 1994, pp.477-481. 42 Cullen, AC, HC Frey, Probabilistic Techniques in Exposure Assessment: A Handbook for Dealing with Variability and Uncertainty in Models and Inputs, Plenum Press, New York, NY, 1999; Hattis, D, DE Burmaster, Assessment of Variability and Uncertainty Distributions for Practical Risk Analyses, Risk Analysis, vol. 14(5), 1994, pp.713-730; National Research Council, Human Exposure for Airborne Pollutants: Advances and Opportunities, Washington, DC: National Academies Press 1991.

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7. Standard for Characterizing Human Health Effects Since the dictionary definition of "risk" refers to the possibility of an adverse consequence or

adverse effect, it may be necessary for risk assessment reports to distinguish effects which are adverse from those which are non-adverse. Given that the capacity of science to detect effects is rapidly growing, sometimes faster than our ability to understand whether detected or predicted effects are adverse, the adversity determination is not always an obvious one.

Where human health effects are a concern, determination of which effects are adverse shall

be specifically identified and justified based on the best available scientific information generally accepted in the relevant clinical and toxicological communities.

In chemical risk assessment, for example, measuring the concentration of a chemical

metabolite in a target tissue of the body is not a demonstration of an adverse effect, though it may be a valid indicator of chemical exposure. Even the measurement of a biological event in the human body resulting from exposure to a specific chemical may not be a demonstration of an adverse effect. Adversity typically implies some functional impairment or pathologic lesion that affects the performance of the whole organism or reduces an organism's ability to withstand or respond to additional environmental challenges. In cases where qualified specialists disagree as to whether a measured effect is adverse or likely to be adverse, the extent of the differences in scientific opinion about adversity should be disclosed in the risk assessment report. In order to convey how the choice of the adverse effect influences a safety assessment, it is useful for the analyst to provide a graphical portrayal of different “safe levels” based on different effects observed in various experiments. If an unusual or mild effect is used in making the adverse-effect determination, the assessment should describe the ramifications of the effect and its degree of adversity compared to adverse effects that are better understood and commonly used in safety assessment.

Although the language in this section explicitly addresses human health endpoints, for other

endpoints, such as ecological health, it is expected that the agency would rely upon information from a relevant group of experts, such as ecologists or habitat biologists, when making determinations regarding adversity of effects.

8. Standard for Discussing Scientific Limitations

Influential risk assessments should, to the extent possible, provide a discussion regarding the

nature, difficulty, feasibility, cost and time associated with undertaking research to resolve a report’s key scientific limitations and uncertainties.

9. Standard for Addressing Significant Comments

An agency is expected to consider all of the significant comments received on a draft

influential risk assessment report. Scientific comments shall be presumed to be significant. In order to ensure that agency staff is rigorous in considering each significant comment, it is typically useful to prepare a "response-to-comment" document, to be issued with, or as part of,

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the final assessment report, to summarize the significant comments and the agency's responses to those comments. Agency responses may range from revisions to the draft report or an acknowledgement that the agency has taken a different position than the one suggested by the commenter. Where agencies take different positions than commenters, the agency response to comments should provide an explicit rationale for why the agency has not adopted the position suggested by the commenter (e.g., why the agency position is preferable or defensible).

Section VI: Updates Influential risk assessments should provide information or analysis, within the intended scope

of the assessment, which assists policy makers in determining whether more data needs to be gathered or whether the assessment can be based on the data and assumptions currently available. Since risk assessment is typically an iterative process, with risk estimates subject to refinement as additional data are gathered, it is useful for assessments to disclose how fast the relevant database and assumptions are evolving and how likely it is that the database and assumptions will be significantly different within several months or years. While risk assessments should offer insight into what additional scientific understanding might be achieved through additional data collection and/or analysis, the decisions about whether to invest in additional inquiry, whether to take interim protective steps while additional inquiry is underway, or whether to act promptly without additional inquiry are policy decisions that are beyond the scope of the risk assessment report.

Each agency should, taking into account the resources available, priorities, and the

importance of the document, consider revising its influential risk assessments as relevant and scientifically plausible information becomes available. Each agency should (1) have procedures in place that would ensure it is aware of new, relevant information that might alter a previously conducted influential risk assessment, and (2) have procedures in place to ensure that this new, relevant information is considered in the context of a decision to revise its previously conducted assessment. In addition, as relevant and scientifically plausible information becomes available, each agency shall consider updating or replacing its assumptions to reflect new data or scientific understandings.43

Section VII: Certification For each risk assessment subject to this Bulletin, the agency shall include a certification, as

part of the risk assessment document, explaining that the agency has complied with the

This proposed bulletin is being released for peer review and public comment. It should not be

43 See National Research Council, Science and Judgment in Risk Assessment, at 90, Washington DC: National Academy Press, 1994, (“Over time, the choice of defaults should have decreasing impact on regulatory decision-making. As scientific knowledge increases, uncertainty diminishes. Better data and increased understanding of biological mechanisms should enable risk assessments that are less dependent on default assumptions and more accurate as predictions of human risk.”); Risk Commission Report, Volume 2, at iv (“Agencies should continue to move away from the hypothetical . . . toward more realistic assumptions based on available scientific data.”), 1997.

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requirements of this Bulletin and the applicable Information Quality Guidelines, except as provided in Section VIII.

Section VIII: Deferral and Waiver The agency head may waive or defer some or all of the requirements of this Bulletin where warranted by compelling rationale. In each such instance, the agency shall include a statement in the risk assessment document that the agency is exercising a deferral or waiver as well as a brief explanation for the deferral or waiver. If the agency head defers the risk assessment requirements prior to dissemination, the risk assessment requirements shall be complied with as soon as practicable. A compelling rationale might cover health and safety risk assessments which are time-sensitive or need to be released due to an emergency situation. It is expected that a need for such a deferral would be an infrequent event. In the rare case of a time-sensitive necessary release, a complete risk assessment, which meets the standards set out in this Bulletin, should be provided to the public as soon as is practicable. Section IX: OIRA and OSTP Responsibilities OIRA, in consultation with OSTP, is responsible for overseeing agency implementation of this Bulletin. OIRA and OSTP shall foster learning about risk assessment practices across agencies.

Section X: Effective Date The requirements of this Bulletin apply to: (1) final public risk assessments disseminated

after 12 months following the publication of this Bulletin in final form, and (2) draft risk assessments disseminated after six months following the publication of this Bulletin in final form. These dates are necessary to ensure Federal agencies have sufficient time to both (1) become familiar with these standards and (2) incorporate these standards into ongoing risk assessments. Section XI: Judicial Review

This Bulletin is intended to improve the internal management of the Executive Branch and is not intended to, and does not create any right or benefit, substantive or procedural, enforceable at law or in equity, against the United States, its agencies or other entities, its officers or employees, or any other person.

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RISK ASSESSMENT BULLETIN I. Definitions.

For purposes of this Bulletin, the term— 1. “agency” has the same meaning as the Paperwork Reduction Act, 44 U.S.C. § 3502(1); 2. “influential risk assessment” means a risk assessment the agency reasonably can

determine will have or does have a clear and substantial impact on important public policies or private sector decisions; 3. “risk assessment” means a scientific and/or technical document that assembles and synthesizes scientific information to determine whether a potential hazard exists and/or the extent of possible risk to human health, safety or the environment.

II. Applicability.

1. To the extent appropriate, all agency risk assessments available to the public shall comply with the standards of this Bulletin.

2. This Bulletin does not apply to risk assessments performed with respect to: a. inspections relating to health, safety, or environment; b. individual agency adjudications or permit proceedings (including a registration, approval, or licensing) unless the agency determines that i. compliance with this Bulletin is practical and appropriate and ii. the risk assessment is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings; and c. an individual product label, or a risk characterization appearing on any such label, if the individual product label is required by law to be approved by a Federal agency prior to use.

III. Goals. 1. The objectives of the assessment shall be a product of an iterative dialogue between the

assessor(s) and the agency decisionmaker(s). 2. The scope and content of the risk assessment shall be determined based on the

objectives of the assessment and best professional judgment, considering the benefits and costs of acquiring additional information before undertaking the assessment.

3. The type of risk assessment prepared shall be responsive to the nature of the potential hazard, the available data, and the decision needs.

4. The level of effort put into the risk assessment shall be commensurate with the importance of the risk assessment.

5. The agency shall follow appropriate procedures for peer review and public participation in the process of preparing the risk assessment.

IV. General Risk Assessment and Reporting Standards.

Each agency risk assessment shall: 1. Provide a clear statement of the informational needs of decision makers, including the

objectives of the risk assessment. 2. Clearly summarize the scope of the assessment, including a description of:

a. the agent, technology and/or activity that is the subject of the assessment;

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b. the hazard of concern; c. the affected entities (population(s), subpopulation(s), individuals, natural

resources, ecosystems, or other) that are the subject of the assessment; d. the exposure/event scenarios relevant to the objectives of the assessment; and

e. the type of event-consequence or dose-response relationship for the hazard of concern.

3. Provide a characterization of risk, qualitatively and, whenever possible, quantitatively. When a quantitative characterization of risk is provided, a range of plausible risk estimates shall be provided.

4. Be scientifically objective: a. as a matter of substance, neither minimizing nor exaggerating the nature and magnitude of risks; b. giving weight to both positive and negative studies in light of each study’s technical quality; and c. as a matter of presentation: i. presenting the information about risk in an accurate, clear, complete and

unbiased manner; and ii. describing the data, methods, and assumptions used in the assessment

with a high degree of transparency. 5. For critical assumptions in the assessment, whenever possible, include a quantitative

evaluation of reasonable alternative assumptions and their implications for the key findings of the assessment. 6. Provide an executive summary including:

a. key elements of the assessment’s objectives and scope; b. key findings; c. key scientific limitations and uncertainties and, whenever possible, their quantitative implications; and d. information that places the risk in context/perspective with other risks familiar to the target audience.

7. For risk assessments that will be used for regulatory analysis, the risk assessment also shall include:

a. an evaluation of alternative options, clearly establishing the baseline risk as well as the risk reduction alternatives that will be evaluated;

b. a comparison of the baseline risk against the risk associated with the alternative mitigation measures being considered, and assess, to the extent feasible, countervailing risks caused by alternative mitigation measures;

c. information on the timing of exposure and the onset of the adverse effect(s), as well as the timing of control measures and the reduction or cessation of adverse effects;

d. estimates of population risk when estimates of individual risk are developed; and

e. whenever possible, a range of plausible risk estimates, including central or expected estimates, when a quantitative characterization of risk is made available.

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V. Special Standards for Influential Risk Assessments. All influential agency risk assessments shall:

1. Be “capable of being substantially reproduced” as defined in the OMB Information Quality Guidelines. 2. Compare the results of the assessment to other results published on the same topic from qualified scientific organizations. 3. Highlight central estimates as well as high-end and low-end estimates of risk when such estimates are uncertain. 4. Characterize uncertainty with respect to the major findings of the assessment including: a. document and disclose the nature and quantitative implications of model

uncertainty, and the relative plausibility of different models based on scientific judgment; and where feasible:

b. include a sensitivity analysis; and c. provide a quantitative distribution of the uncertainty. 5. Portray results based on different effects observed and/or different studies to convey how the choice of effect and/or study influences the assessment.

6. Characterize, to the extent feasible, variability through a quantitative distribution, reflecting different affected population(s), time scales, geography, or other parameters relevant to the needs and objectives of the assessment.

7. Where human health effects are a concern, determinations of which effects are adverse shall be specifically identified and justified based on the best available scientific information generally accepted in the relevant clinical and toxicological communities.

8. Provide discussion, to the extent possible, of the nature, difficulty, feasibility, cost and time associated with undertaking research to resolve a report's key scientific limitations and uncertainties.

9. Consider all significant comments received on a draft risk assessment report and: a. issue a "response-to-comment" document that summarizes the significant

comments received and the agency's responses to those comments; and b. provide a rationale for why the agency has not adopted the position suggested

by commenters and why the agency position is preferable. VI. Updates. As relevant and scientifically plausible information becomes available, each agency shall, considering the resources available, consider:

1. revising its risk assessment to incorporate such information; and 2. updating or replacing its assumptions to reflect new data or scientific understandings.

VII. Certification. For each risk assessment subject to this Bulletin, the agency shall include a certification explaining that the agency has complied with the requirements of this Bulletin and the applicable Information Quality Guidelines, except as provided in Section VIII.

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VIII. Deferral and Waiver. The agency head may waive or defer some or all of the requirements of this Bulletin where warranted by compelling rationale. In each such instance, the agency shall include a statement in the risk assessment document that the agency is exercising a deferral or waiver as well as a brief explanation for the deferral or waiver. If the agency head defers the requirements prior to dissemination, the agency shall comply with them as soon as practicable. IX. OIRA and OSTP Responsibilities. OIRA, in consultation with OSTP, shall be responsible for overseeing agency implementation of this Bulletin. OIRA and OSTP shall foster better understanding about risk assessment practices and assess progress in implementing this Bulletin. X. Effective Date. The requirements of this Bulletin apply to: (1) final public risk assessments disseminated after twelve months following the publication of this Bulletin in final form, and (2) draft risk assessments disseminated after six months following the publication of this Bulletin in final form. XI. Judicial Review. This Bulletin is intended to improve the internal management of the Executive Branch and is not intended to, and does not create any right or benefit, substantive or procedural, enforceable at law or in equity, against the United States, its agencies or other entities, its officers or employees, or any other person.

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No. 05 Monday January 9, 2006

Page A-6

ISSN 1523-567X Regulation & Law

Government Operations OMB Struggles to Deal With Objections On Capitol Hill to E-Regulation Project An ambitious plan by the Office of Management and Budget to place the federal regulatory docket on the Internet has been put on hold by congressional appropriators concerned about the cross-agency project. Lawmakers object to OMB's method for funding the project, which involves agency contributions to OMB instead of a specific appropriation from Congress. Legislation passed late last year requires OMB to provide a report to Congress justifying the expenditures by each participating agency. While OMB is rushing to complete the report, the entire process imposed by the House and Senate Appropriations committees could further delay implementation of the E-Rulemaking program for several months, according to agency officials outside of OMB. The OMB official in charge of the program, Karen Evans, who is OMB's administrator for the Office of Electronic Government and Information, downplayed the impact of the congressional action in an interview with BNA Jan. 4. She said OMB's effort to upload agency rulemaking information onto a single government Web site ( www.Regulations.gov ) would experience only a slight delay. "Congress wants better transparency and wants to have a better understanding of what we're doing in E-Government," Evans said. "We believe they're entitled to that." However, other officials involved with the program expressed a less optimistic view. One member of the governmentwide steering committee for the project said the congressional roadblock comes at a "critical point" for the three-year-old program and--if not resolved soon--could threaten the viability of the entire effort. Top OMB officials, including Evans and Deputy Director Clay Johnson, met with House and Senate appropriations committee staff Jan. 4 in an effort to resolve the impasse. How long the project will remain stalled is unclear. Language inserted into the Transportation, Treasury appropriations bill (H.R. 3058) requires agencies to obtain prior approval from both Appropriations committees before transferring funds to OMB's E-Government initiative, the umbrella program that includes the E-Rulemaking project. The measure became law Nov. 30. Lawmakers Attempt to Assert Control Congressional appropriators believe the funding restrictions are necessary in order to reassert their control over agency expenditures, said House Appropriations Committee spokesman John Scofield. The chief proponent of the legislative rider was Rep. Joseph

Knollenberg (R-Mich.), chairman of the Appropriations subcommittee on Transportation, Scofield said. "Congress believes that it is inappropriate for OMB to go hat in hand [to other agencies] to fund this program," Scofield said. "They've got to sell Congress on the plan and they didn't do a decent job before, so they tried an end run." (emphasis added by RWP) At the center of the dispute is an unorthodox funding scheme for the "E-Rulemaking" project under which federal departments and agencies must take money from their appropriated budgets and pay into a separate fund, which OMB then uses to cover the costs of the program. The projected E-Rulemaking fund will total about $12.7 million for FY 2006, if agencies are permitted to go forward with the OMB funding plan, according to OMB spokesman Alex Conant. However, in December, after the congressional restrictions were put in place, the fund contained only about $2.5 million, leaving a potential shortfall of $10.2 million. Regulations.gov currently hosts only a small percentage of the government's rulemaking dockets. Without an infusion of funds to help move additional agencies onto the site, "the system will become very brittle and lead to much consumer dissatisfaction," the steering committee member said. The congressional action "will have profound impacts on the program," the steering committee member added, and could possibly delay OMB's implementation plan for months. "It's a very big deal--very significant," the member said. The E-Rulemaking project and Regulations.gov Web site began in 2003 as part of a broader E-Government initiative by OMB that was authorized under Section 206 of the 2002 E-Government Act (H.R. 2458, S. 803). The goal is to have the regulatory dockets for all major federal rulemaking agencies, totaling about 200 in all, available for public access on the Internet by 2007. Until last year, Regulations.gov was a simple Web portal, displaying basic information about pending regulations and allowing citizens to file comments on line. Beginning in September 2005, the site was upgraded and expanded into what OMB calls the "Federal Docket Management System." The new FDMS allows citizens to view the entire rulemaking docket for a regulatory proceeding, including background materials and prior versions of the rule, as well as to view and post comments. "It's supposed to be just like being in the agency's docket room," said a former manager with the project. So far, about 31 agencies post rulemaking materials on Regulations.gov, including some larger entities such as the departments of Defense, Energy, and Homeland Security and the Environmental Protection Agency, as well as some smaller, less prominent regulatory bodies such as the Western Area Power Administration and Foreign Agricultural Service. Further Implementation on Hold Under "a very aggressive implementation plan," OMB had scheduled additional agencies to migrate onto the expanded Regulations.gov site each calendar quarter through 2007, Evans said. Because of the congressional action, that implementation plan is now on hold.

"E-Rulemaking will suspend all further agency implementation and development activities effective beginning second quarter of FY 2006," the co-chairs of OMB's E-Rulemaking Executive Committee advised in a letter sent to agencies Dec. 19. Until the budget issue is resolved, OMB will allocate funds only "to operate and maintain" the current system, the letter said. Besides the halt on adding agencies to the Web site, all employee training and efforts to improve the Web site's usability will be stopped, as well, a manager of the project said. OMB Sets Agency Funding Formulas Under the current funding mechanism, OMB calculates a funding formula for each agency, based on the size of the agency's budget and the extent of the agency's rulemaking activity, and then mandates agency payments as part of OMB's "passback"--or budget approval--for the agency during each budget cycle, a member of the steering committee said. Since the program began in 2003, EPA has served as the coordinating agency, or "managing partner" in OMB's terminology, for the project. EPA enters into a memorandum of understanding with each agency for the fund transfer, collects the funds, and manages program implementation through an outside contractor, Lockheed Martin Corp. EPA was selected to serve in that role because it was one of the first agencies to develop its own Web-based docket system, which predates Regulations.gov, according to a former manager of the EPA site. Longtime Capitol Hill Concern Congressional concern about OMB's funding scheme is long-standing, Scofield said, dating from the program's inception. While separate subcommittees made haphazard attempts to deal with the funding scheme in previous years, the language in the 2005 Transportation-Treasury appropriations bill is the first governmentwide restriction on the project, he added. The language in H.R. 3058 states: "No funds shall be available for transfers or reimbursements to the E-Government Initiatives sponsored by the Office of Management and Budget prior to 15 days following submission of a report to the Committees on Appropriations by the Director of the Office of Management and Budget and receipt of approval to transfer funds by the House and Senate Committees on Appropriations." The report mandated by the legislation must detail for each agency the amount proposed for transfer, the specific use of the funds, the relevance of that use to the agency, and a description of any activities for which funds were appropriated that will not be implemented as a result of the transfer. OMB's Evans said OMB had completed work on the report and could submit it as early as Jan. 6. Even so, she acknowledged that the project will remain on hold until OMB receives approval from the appropriations committees. "We still need to wait," she said.

OMB Official Defends Funding Scheme Evans defended OMB's funding methodology for E-Rulemaking and described submission of the report as more of a formality than a pre-condition for further spending. "Technically, [the report] is notification," she said, asserting that the Economy Act, 31 U.S.C. 1535, authorizes agencies to use funds to contract with other agencies for services. The act provides: "The head of an agency or major organizational unit within an agency may place an order with a major organizational unit within the same agency or another agency for goods or services if ... the head of the ordering agency or unit decides the order is in the best interest of the United States Government and ... the head of the agency decides ordered goods or services cannot be provided by contract as conveniently or cheaply by a commercial enterprise." "Instead of all agencies reinventing the wheel on this, we get greater economies and greater efficiencies by working as a single entity," Evans said. Asked about Evans's statement on the authority for the funding program, Scofield with the Appropriations Committee, said: "We have written a law that they need to comply with. Whether they think they have authority under another law is irrelevant." Despite the congressional concern, Evans said OMB had no plans to alter its funding mechanism for the E-Rulemaking project in the future. "We don't expect any changes," she said, "but we will work with the appropriations committees to see what is the best way to move through the [E-Government] initiatives." Not all participating agencies are happy about having to join the governmentwide regulation Web site, preferring to stick with their own Web-based docket systems, Evans acknowledged. While she declined to name specific agencies, two officials involved in the project told BNA that some managers at some of the agencies that have had their own E-Rulemaking sites for years, have expressed resentment at having to merge their E-dockets with Regulations.gov, which they view as a less sophisticated system. In addition to EPA, the Department of Transportation has a well-developed Web-based regulatory docket system. Stating the justification for consolidation, Evans said, "We are the federal government and the E-Government Act requires us to consolidate certain activities in order to achieve cost-savings, including E-Rulemaking." Delay May Allow Reassessment While OMB waits for approval from Capitol Hill to continue with the project, one government watchdog group sees a silver lining in the delay. "If it's just a funding hiccup, then this setback might be a blessing in disguise," said Robert Shull, director of regulatory policy with OMB Watch. "The FDMS is turning out to be pretty lousy--it's 'cutting edge' if we wind back the clock to ten years ago, but not up to snuff by today's standards."

He noted that the Regulations.gov site is not "user friendly" or intuitive, failing to allow bookmarking or easy switching from one page to another. Moreover, the site fails to operate properly with tools typically installed on most computers today like popup blockers. "My hope is that this interim period will be a chance for the project's administrators to see the flaws and clumsiness of the system and move the project forward in a better direction," Shull said. Taking a "big picture" view of OMB's current predicament, one observer--who was involved as a manager of the project until recently--blames much of the problem on OMB's failure to build a sustainable infrastructure for the project, both within the agencies and on Capitol Hill. "In their haste to show success, they failed to establish a proper governance structure," the former manager said. "It's like trying to build a skyscraper without a foundation." The former manager continued, "The project lacks an adequate system for funding, policies, reserve funding for contingencies--and most importantly, a shared vision with Congress." By Ralph Lindeman

Draft 5 SECOND ANNUAL

ADMINISTRATIVE LAW & REGULATORY PRACTICE INSTITUTE

LOBBYING Washington, D.C. April 6 – 7, 2006

Who Should Attend:

Every aspect of our personal lives, business and government is affected by the laws passed by Congress and regulations issued by administrative agencies. This practice-oriented program will provide practitioners, industry representatives, and government relations specialists, government attorneys and program officials, with the knowledge and techniques to navigate Congress and federal agencies from the creation of an idea through enactment. The Speakers and Panelists are among the leading lobbyists, scholars and lawyers in the field. Day 1: 9:00-9:10 I. Opening Remarks. Eleanor Kinney, Chair, Section of Administrative Law &

Regulatory Practice John Hardin Young, Program Chair 9:10-10:30 II Everything You Need to Know about the Law of Lobbying —The

Legal Ground Rules Prof. William V. Luneburg 10:45-12:00 III. Everything You Need to Know about The Art of Lobbying— The

Tactics & Techniques of an Effective lobbyist 12:15- 1:30 IV. Luncheon Speaker: 2:00-2:45 VI. Congressional Panel: Best Practices as seen by Members of

Congress

2:45-3:45 VII. Panel: The Ethical and Enforcement Dilemmas Faced by Private Practitioners, Government Lawyers and Lobbyists.

4:00-5:15 VIII. Small Group Discussions: An Examination for Private and

Government Lawyers and Lobbyists of Compliance Issues based on a Case Study Taken form Current Events

Otto Hezel & David Schnare, Coordinators

5:30- 7:00 IX.. Reception

*** Day 2: 9:00-10:00 X.. THE FELLOWS DISTINGUISHED LECTURE

A distinguished Washington practitioner will present the second annual lecture on the administrative and regulatory process relating to lobbying. The Lecture will be newsworthy and published in the Administrative Law Review. Thomas M. Susman

10:00-11:15 XI. PANEL: CONVERSATIONS WITH SEASONED

PRACTITIONERS AND LOBBYISTS: DEVELOPING A WINNING STRATEGY.

11:15-12:30 XII.. PANEL: GRASSROOTS, MEDIA, AND TECHNOLOGY IN A

LOBBYING CAMPAIGN

M e m o r a n d u m January 25, 2006 To: Administrative Law Section Council Fr: Eleanor Kinney, Section Chair Randy May, Immediate Past Section Chair

Kim Knight, Section Director Re: Recommendation to Increase Part-Time Staff Position to Full-Time We recommend that the Section commit to investing an amount up to $16,000 per annum, to provide funding for the current part-time staff position to be converted to full-time. ABA General Revenue would cover 22.5 hours (as it currently does), and the Section would cover 15 hours, totaling the standard 37.5 hour ABA work week. As currently configured the part-time position presents several obstacles for the Section:

• Inability to attract qualified employees for a long term commitment. Most job-seekers looking for part-time work at this level of salary are students, or persons who already hold a full-time job elsewhere and are looking to supplement their income with a part-time job. These people have no intention of making a long-term commitment to the job; further they have odd schedule requirements.

• Turnover causes interruptions in member service. Intermittently having to recruit and replace the part-time person takes the Section Director away from more important duties. Recruiting is very time intensive. Further, training the new person also takes a considerable amount of time given the intricacies of the ABA policies and procedures. Most recently the part-time position has remained vacant because of the lack of time available to devote to appropriately recruiting and training a new person.

In addition:

• We have been told by ABA leadership that if the Section wants to be seriously considered for receiving additional staff funding from the ABA, we should first demonstrate our own commitment by funding some salary out of the Section (which we currently do not).

The position provides the following important services for the Section:

• First point of contact for the membership and public • Support to member programs and committee projects • Maintaining the Section office (filing systems, copies of publications) • Maintaining financial reports and data • Routine updating of the Section web pages • follow-up communications with new members (welcome kit, etc.)

• getting membership, program, and book information to key events around town • Continuity of service while the Director is on travel at meetings

In addition, the full-time person will enhance the Section’s ability to deliver programs and services, as well as assist in the recruitment and retention of members. What Would it Cost the Section?

The estimated salary of the position is approximately $20 per hour. For the Section to cover 15 hours per week @ $20/hr. x 52 weeks would total $15,600. The fringe benefits (health insurance, etc.) are already covered by ABA General Revenue and would not increase.

The position is currently vacant. It was advertised during Fall 2005 and met with disappointing results in terms of a desirable part-time candidate. We would like to have the approval of the Council to convert the position to full-time prior to any advertising of the position. The sooner the position is filled, the sooner the Section will benefit.

Proposed Format for the 2006 Summer Council Meeting and Annual Meeting

Summer Council Meeting July 20-21, 2006

Washington, D.C. Thursday, July 20, 2006 1:00pm – 5:00pm Out-of-town arrivals 3:00pm – 4:00pm Publications Committee Meeting 5:30pm – 6:30pm Welcome Reception 6:30pm – 8:00pm Program/Great Debate Suggested topic: Oregon vs. Gonzales Dan Cohen has volunteered to organize the program. 8:00pm – 9:00pm Reception continues Friday, July 21, 2006 8:00am - 9:00am Council Breakfast 9:00am – 3:00pm Council Meeting with working lunch Adjourn

2006 Annual Meeting Waikiki Beach Marriott, Honolulu, Hawaii

Friday, August 4, 2006 All Day Sponsored and Co-Sponsored CLE Programs in the Presidential CLE Center 6:00pm Social Event – To Be Determined Saturday, August 5, 2006 9:00am – 10:00am Executive Committee Meeting 10:00am – Noon Council Meeting 5:00pm Opening Assembly followed by Presidential Reception

Possible Amendments to the Lobbying Disclosure Act 1. Expanding Disclosure: a. Coverage of grassroots lobbying fees and expenditures, persons paid to conduct the lobbying, and the issues as to which the lobbying has been directed. (How should covered “grassroots” lobbying be defined? Should the disclosure extend to efforts to generate lobbying that are directed at members, employees, officers or shareholders of the lobbying entity?) b. Broadened disclosure of the membership of lobbying coalitions by, for example, eliminating the current requirement that the member plan or control the lobbying activities and/or reducing the existing $10,000 monetary trigger for disclosure. (Should tax exempt entities be exempt from these disclosures?) c. Disclosure of campaign contributions by registered lobbying firms and organizations or their employee lobbyists, the recipients of those contributions, and the amounts contributed; disclosure of the official positions held by lobbyists in campaign organizations directed at the election of federal officials; disclosure of hosting or co-hosting fundraising events for officials by registrants or their lobbyists. d. Disclosure of gifts and other monies (e.g. travel expenses and payments to “honor” officials) paid by registrants or their lobbyists to or on behalf of covered executive and legislative branch officials. e. Disclosure of the names of the covered officials contacted by lobbyists, the subject matter(s) of the communications, and the dates of those communications. Some have proposed imposing disclosure requirements on the officials themselves; is this wise and workable? f. Disclosure of lobbying information on periodic reports (e.g. active lobbyists, person/entity contacted, and matter discussed) by specific issue, rather than general topic area. g. Consolidated disclosure in periodic reports of all lobbying done for a self-lobbying organization that also hires an outside firm to lobby on its behalf. h. Eliminating the Section 15 election to use IRC definitions for registration threshold and reporting purposes. i. Requiring disclosure of ALL prior executive and legislative branch “covered” positions held by lobbyists employed by the registrant. j. Requiring disclosure of the fact that the lobbyist is employed on a contingency basis (and perhaps more details related to the terms of the fee agreement).

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2. Improving Public Availability of Lobbying Information

1. Requiring quarterly, not semiannual, reports by registered lobbying firms and self-lobbying organizations.

2. Linking LDA and FEC reports to facilitate public knowledge of the link

between lobbyists and federal campaigns. There are several other changes that could be implemented without legislative amendment: 3. compatibility of House and Senate filing systems. 4. improving the search capability of the internet accessible database of registrations and reports. 5. requiring electronic filing of registrations and reports. 3. Compliance and Enforcement 1. Removing LDA administration from the Senate and House and placing it in another federal agency (e.g. the FEC) or in an independent agency. If so, should the agency have audit authority to discover whether a person should have registered or, if registered, whether it filed incomplete or false reports? 2. If administration remains in the House and Senate, a. should the Secretary of the Senate and Clerk of the House have more resources to police compliance with the Act, b. what, if anything, should be done to improve the transparency of enforcement activities by the Department of Justice, c. should civil penalties be increased (from $50,000 per violation), d. are there other changes that could facilitate and encourage aggressive (but fair) enforcement of the LDA?

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4. Other Possible Changes: Travel Rules - prohibition on lobbyist involvement or sponsorship of congressional travel - prohibition on sponsored travel - restrictions and increased disclosure of sponsored travel - restrictions and increased disclosure on air travel Gift Rules - prohibition on gifts - prohibition on lobbyist gifts - additional restrictions or limitation on gifts - additional disclosure on gifts Institutional Reforms

-public disclosure of the existence, origins, and objectives of earmark language in appropriations reports and bills

-availability of the text of legislation 72 hours in advance of any vote unless the requirement is waived by a super-majority vote or unanimous consent

-all drafts of bills should be posted on the Internet at the time they are scheduled for subcommittee or committee action.

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Comparison of the Lobbying Reform Measures,

H.R. 2412 (Rep. Meehan), S. 1398 (Sen. Feingold), H.R. 3177 (Rep. Miller), House Administration Directives (Rep. Ney)

H.R. 2412 (Meehan) S. 1398 (Feingold) H.R. 3177 (Miller) Ney Directives Increasing Lobbying Disclosure

• Quarterly reports

Yes Yes No No

• Mandatory electronic filing

Yes, of lobbyist reports. Yes, of lobbyist reports. No Yes, of lobbyist reports; congressional travel records; and congressional honoraria.

• Full Web-based disclosure

Yes Yes No Yes

• Disclosure of stealth lobbying coalitions

Yes, of members of coalitions whose primary purpose is to lobby on the specific issue.

Yes, of non-individual members of coalitions whose spending exceeds lobbying registration threshold of $20,000 every six months.

No No

• Disclosure of grassroots lobbying

Yes, of mass communications encouraging the general public to make lobbying contacts.

Yes, of mass communications encouraging the general public to make lobbying contacts.

No No

• Disclose lobbying contacts

Yes, of lobbying contacts with members and covered executive officials.

Yes, of oral communications with members and covered executive officials.

No No

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H.R. 2412 (Meehan) S. 1398 (Feingold) H.R. 3177 (Miller) Ney Directives Slowing the Revolving Door

• Extend “cooling-off period” during which you cannot lobby from the current one year

Yes, to two years for lobbying contacts for covered officials.

Yes, to two years for lobbying contacts for members, senior congressional staff and covered executive officials.

No No

• Include lobbying activity as well as lobbying contacts in “cooling-off period”

No Yes, for members and very senior executive officials.

No No

• Disclosure by officials when seeking private employment

Yes, for members and covered executive officials.

Yes, for members, senior staff and covered executive officials.

No No

• Disclosure by lobbyists of previous federal employment

Yes Yes No No

• Prohibits special privileges of members-turned-lobbyists

No Yes No No

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H.R. 2412 (Meehan) S. 1398 (Feingold) H.R. 3177 (Miller) Ney Directives

• Restricts members of Congress from influencing employment decisions of lobbying firms based on partisanship

Yes Yes No No

Curbing Excesses in Congressional Travel

• Prohibits privately-sponsored trips

No No No No

• Prohibits lobbyists from organizing trips

Yes Yes No No

• Prohibits lobbyists from participating in trips

No Yes No No

• Restricts use of corporate jets to transport members on trips

No Yes, requires member to reimburse the airfare at the charter rate rather than the current first-class airfare rate.

No No

• Requires detailed disclosure of trips

Yes Yes No No

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H.R. 2412 (Meehan) S. 1398 (Feingold) H.R. 3177 (Miller) Ney Directives

• Limits expenses on trips

Yes, at per diem rate. Yes, at per diem rate. No No

Strengthening Gift Rules

• Prohibits lobbyists from giving gifts to members

No Yes, except for gifts of very nominal value, campaign contributions, informational materials, friendship.

Yes, except for gifts of very nominal value, campaign contributions, informational materials, friendship.

No

Toughening Enforcement

• Increases penalties for violations

Yes, for reporting violations, up to $100,000; for travel violations, up to $100,000 first offense, $300,000 for second offense, $500,000 for third offense.

Yes, for reporting violations, up to $100,000.

No No

• Provides additional oversight

Yes, GAO investigation; House Administration Committee hearings; and bipartisan task force to study effectiveness of the law.

Yes, ongoing investigations by the GAO.

No No

Source: Public Citizen

Buyers Up • Congress Watch • Critical Mass • Global Trade Watch • Health Research Group • Litigation Group

Joan Claybrook, President

Detailed Comparison of Lobbying Reform Proposals from The House Republican Leadership, Sen. Reid and Democratic Leadership (S. 2180),

Sen. Feingold (S. 1398), Sens. McCain/Burns and Rep. Shays (S. 2128/H.R. 4575) and Reps. Meehan/Emanuel (H.R. 2412)

Most Recent Update: Jan. 23, 2006

Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

CAMPAIGN CONTRIBUTIONS TO POLITICIANS

CURRENT LAW • Lobbyists are subject to the same $2,100 per election contribution limit as all other individuals; $5,000 per year

to PACs; and $26,700 per year to all national party committees. Individuals are also subject to the $101,400 per election cycle aggregate limit to all candidates and committees.

• There are no restrictions on who can organize fundraising events or serve on fundraising committees, such as lobbyists.

Prohibit campaign contributions from or arranged by lobbyists

No No No No No

Prohibit lobbyists from hosting fundraising events

No No No No No

Prohibit lobbyists from bundling campaign contributions from others

No No No No No

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Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

Prohibit lobbyists from serving on officeholder fundraising committees

No No No No No

Report lobbyists’ campaign contributions

Unknown Yes, lobbyists and lobbying firms to disclose contributions to candidates, committees and Leadership PACs on their LDA reports.

No requirement for lobbyists to report contributions other than the current reporting requirement for candidates to disclose donors to the FEC.

Requires lobbyists and lobbying firms to report contributions and fundraisers hosted for candidates on their LDA reports.

No requirement for lobbyists to report contributions other than the current reporting requirement for candidates to disclose donors to the FEC.

TRAVEL RESTRICTIONS

CURRENT LAW • Congressional rules, rather than statutes, prohibit lobbyists from paying for travel for members of Congress

and their staff. • Lobbyists may arrange travel and have their clients pay for it. • Corporations and special interests may pay travel expenses for members of Congress and staff. • Corporate jets may be used for travel valued usually at lower-cost first-class airfare, rather than the actual

higher-cost charter rate. • The sponsor and cost of travel is to be reported by the member and staff shortly after the event .

Prohibit privately-sponsored trips

Yes, but only for non-campaign-related purposes.

Yes, except for sponsorship by non-profit groups with no ties to lobbyists.

No No No

Prohibit lobbyists from paying for trips

Yes, but only for non-campaign-related purposes.

Yes, but only for non-campaign-related purposes.

Yes, but only for non-campaign-related purposes.

No, but ethics rules prohibit lobbyists paying for trips.

Yes, but only for non-campaign-related purposes.

Prohibit lobbyists from organizing trips

Yes, but only for non-campaign-related purposes.

Yes, but only for non-campaign-related purposes.

Yes, but only for non-campaign-related purposes.

No Yes, but only for non-campaign-related purposes.

Prohibit lobbyists from participating in trips

No Yes, but only for non-campaign-related purposes.

Yes, but only for non-campaign-related purposes.

No No

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Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

Restrict use of corporate jets to transport members on trips

Unknown No, but requires disclosure of date, destination and owner of the jet on campaign-related and non-campaign-related trips.

Yes, requires member to reimburse the airfare at the full charter rate for campaign trips only.

Yes, requires member to reimburse the airfare at the full charter rate for campaign trips only.

No

Require detailed disclosure of trips

Unknown Yes Yes Yes Yes

Limit expenses on trips

Unknown Yes, at per diem rate. Yes, at per diem rate. Yes, at per diem rate. Yes, at per diem rate.

GIFT RULES CURRENT LAW • Congressional rules cap gifts at $50 per item and $100 per year from any individual to a member of Congress

and staff. • The value of a seat in a skybox is artificially set at below $50. • There are no special reporting requirements for gifts that are not travel related.

Prohibit lobbyists from giving gifts to members and staff

No, but restricts lawmakers from receiving gifts from each lobbyist in excess of $20 per gift, $50 aggregate per year.

Yes, including meals, tickets to sporting events and other gifts above nominal value.

Yes, including meals, tickets to sporting events and other gifts above nominal value.

No, but would require that any gift in excess of $20 value be reported. Also requires that tickets to sporting events be reported at actual market value.

No

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Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

REVOLVING DOOR

CURRENT LAW • Former members of Congress and their staff and executive branch officials may become lobbyists immediately

upon leaving public service, but are generally prohibited from making lobbying contacts with their former colleagues for one year.

• Executive branch officials are prohibited from negotiating future employment from persons with official business, unless a confidential waiver is received.

• Members of Congress are advised not to create a conflict of interest through negotiating future employment, but there is no prohibition.

• Congressional staff are required to inform members when they are negotiating future employment that may pose a conflict of interest and receive their approval.

Extend current one-year “cooling-off period” during which an individual cannot lobby

Yes, to two years for lobbying contacts for members, senior congressional staff and senior executive branch officials.

Yes, to two years for lobbying contacts for members, senior congressional staff and senior executive branch officials.

Yes, to two years for lobbying contacts for members, senior congressional staff and senior executive branch officials.

Yes, to two years for lobbying contacts for members, senior congressional staff and senior executive branch officials.

Yes, to two years for lobbying contacts for members, senior congressional staff and senior executive branch officials.

Include during “cooling-off-period” any paid lobbying activity, such as supervising others and developing lobbying strategy

No No Yes, for members and very senior executive branch officials.

No No

Disclose when seeking private employment

Unknown Yes, for members,senior staff and covered executive branch officials.

Yes, for members, senior staff and covered executive branch officials.

Yes, for members and covered executive branch officials.

Yes, for members and covered executive branch officials.

Prohibit special privileges (e.g. access to the congressional floor and gym) for members who become lobbyists

Yes Yes Yes No No

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Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

Restrict members from influencing employment decisions of lobbying firms based on partisanship

No Yes Yes No Yes

LOBBYIST DISCLOSURE

CURRENT LAW • Lobbyists file semi-annual financial disclosure reports usually in paper format that are made available on the

Internet; they are searchable only by limited fields, such as lobbyist name. • Contributions are reported to the FEC, which are difficult to track, not as part of disclosure reports filed by

lobbyists with the Senate and House. • There are no reporting requirements for bundled contributions – money raised by lobbyists from their family,

friends and colleagues. • Specific lobbying contacts with “covered” officials – members of Congress, their senior staff, or officials in the

executive branch – are not required to be disclosed. • Members of lobbying coalitions are not disclosed. • Grass-roots lobbying activity (hiring consultants, advertising, phone banks, direct mail, paid state staff, grants

to groups) is not subject to disclosure. Disclose lobbying contacts

Unknown No Yes, of oral lobbying contacts with members and senior executive branch officials.

No Yes, of oral or written lobbying contacts with members and senior executive branch officials.

File quarterly reports

Yes Yes Yes Yes Yes

Mandatory electronic filing

Unknown Yes Yes Yes Yes

Full Web-based disclosure

Unknown Yes Yes Yes Yes

6

Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

Disclose stealth lobbying coalitions

Yes Yes, of organizational members of coalitions whose spending exceeds lobbying registration threshold of $10,000 every three months.

Yes, of organizational members of coalitions whose spending exceeds lobbying registration threshold of $10,000 every three months.

Yes, of organizational members of coalitions whose spending exceeds lobbying registration threshold of $10,000 every three months.

Yes, of members of coalitions whose primary purpose is to lobby on that specific issue.

Disclose grassroots lobbying

Unknown Yes, of paid grass-roots lobbying activity for those who receive or spend more than $50,000 for lobbying in a three-month period.

Yes, of mass communications by registered lobbyists encouraging the general public to make lobbying contacts.

Yes, of any attempt by an individual paid to engage in grass-roots lobbying, a registered lobbyist or consulting firm, or leadership PAC, to influence the general public to make lobbying contacts. Large grassroots expenditures of $250,000 must be reported in 20 days.

Yes, of mass communications by registered lobbyists encouraging the general public to make lobbying contacts.

Disclose lobbyists previous federal employment

Unknown Yes Yes Yes Yes

Disclose travel and gifts received by members of Congress on their Web sites

No No No No No

Centralize the disclosure of all lobbying, travel and ethics records

No Yes No No No

7

Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

ENFORCEMENT CURRENT LAW • Monitoring reporting violations of lobbyists is the responsibility of the Secretary of the Senate and the Clerk of

the House in Congress, and the Office of Government Ethics (OGE) for the executive branch, each of which may refer violations to the Department of Justice (DOJ) for legal sanctions.

• Reporting violations are subject to a maximum penalty of $50,000. • Monitoring compliance to the travel or gift rules is the responsibility of the ethics committees in Congress,

which may assess a variety of penalties on members and staff depending on the violations, and the OGE and DOJ for the executive branch.

Create an agency with independent authority for monitoring and enforcing compliance

No, but requires greater ethics training for all members and staff by the committee.

Yes, for centralizing data collection of lobbying disclosure forms and Senate financial disclosure forms and for monitoring compliance with filing requirements.

No No No

Forfeit congressional pension if convicted of a felony

Yes No No No No

Increase penalties for violations of lobbying disclosure laws

Unknown Yes, for reporting violations, up to $100,000; for willful criminal violations, up to 5 years in prison; for corrupt criminal violations, up to 10 years in prison.

Yes, for reporting violations, up to $100,000.

Yes, for reporting violations, up to $100,000.

Yes, for reporting violations, up to $100,000; for travel violations, up to $100,000 first offense, $300,000 for second offense, $500,000 for third offense.

8

Type of Lobbyist Activity Subject to

Regulation House Republican Leadership Plan

Sen. Reid and Democratic Leadership

(S. 2180)

Sen. Feingold (S. 1398)

Sens. McCain/Burns and

Rep. Shays (S. 2128/H.R. 4575)

Reps. Meehan and Emanuel

(H.R. 2412)

CONGRESSIONAL PROCESS

CURRENT LAW • Congressional rules committees may attached “closed rules” to specific bills, which limit the time for debate,

restrict the opportunity for amendments, and/or rescind the requirement that the bills be in print prior to consideration.

• Earmarks are appropriations for special projects, often non-germane to an appropriations bill, that are frequently inserted in conference committee.

Require conference bills to be in print and available to the public 24 hours before a vote

No Yes No No No

Restrict earmarks in appropriations bills

Yes No No No No

Michael S. Greco AMERICAN BAR ASSOCIATION 321 N. Clark Street President Chicago, Illinois 60610-4714 (312) 988-5109 FAX: (312) 988-5100 TO: Chairs, Standing Committee on Election Law Section of Administrative Law Section of Individual Rights & Responsibilities FROM: Michael S. Greco SUBJ: Fair Vote Plan DATE: January 19, 2006 As you may know, the Association has long supported direct election of the President and elimination of the Electoral College. As you no doubt know, there is no realistic prospect that that change will receive serious attention in the foreseeable future. I was asked recently by former Senator Birch Bayh to meet with him about a “Fair Vote Plan” proposal being advanced by him and others as a means of ensuring that the popular vote winner would also be the Electoral College winner. Bob Evans joined me at that meeting. Attached is a follow-up memorandum that Senator Bayh, at my request, has just sent me, explaining the proposal. It is an intriguing concept and I ask that you and your Section and Committee colleagues study it with an eye toward the possibility of bringing forward a resolution to the House of Delegates in August with respect to it. I would appreciate your letting me know what interest your entity has in doing so. If you need additional information, please contact Bob Evans in the Governmental Affairs Office and he will seek to obtain it for you. Thanks in advance. cc: Honorable Birch Bayh Robert D. Evans Elizabeth Yang Kimberly Knight Tanya Terrell-Collier

2006 Hawaii Annual Meeting Showcase (General Session) Programs

Showcase Programs will be held: Thursday, August 3 – Sunday, August 6. The SOC Annual Meeting Task Force elected not to hold programs on Monday, August 7. Time Slots: 7:30 a.m. – 9:00 a.m. Section Programming 9:30 a.m. – 11:00 a.m. Showcase (General Session) Programming 11:30 a.m. – 1:00 p.m. Section Programming Showcase Program (General Session) Schedule Thursday, August 3, 2006:

• Hawaii Program • Military Tribunals Begin: National Security Champions, the International

Legal Community and Individual Rights Advocates Friday, August 4, 2006:

• Attorney-Client Privilege • Elder Law

Saturday, August 5, 2006:

• Hot Tips on Doing Business in Asia • The Response to Judicial Activism

Sunday, August 6, 2006:

• Computers: Best Practices for the Electronic Age • The Perfect Storm – Part 1: How to Prepare Your Client for a Disaster

2006 Showcase Program Schedule.doc

American Bar Association Annual Meeting August 4-8, 2006

Honolulu, HI

CLE CENTRE SUBMISSION FORM

DEADLINE FOR SUBMITTING THIS FORM TO THE PLANNING COMMITTEE:

November 11, 2005 Please submit additional sheets if necessary. Type (preferable) or print legibly.

Submitted by: Kimberly Knight – Section Director Section: Administrative Law & Regulatory Practice Firm: Address: 740 15th Street NW City/State/Zip: Washington, DC 20005 Telephone: 202-662-1665 Email: knightk@staff.abanet.org Date Time Title Description (25 -30

words) Friday, August 4th

Flexible Outsourcing, Third Party Arrangements and the Federal Regulators

Issues relating to risk management, data security, privacy, compliance management and legal liability are just a few of the topics addressed by the regulators in examinations and by consultants and other experts in drafting contracts. This session looks at what is required and how banks and their affiliated companies can comply and protect themselves.

Friday, August 4th

Flexible Lessons Learned from the Post-Katrina disaster recovery: what can lawyers do to help lessen harms next time?

CDC Speaker to cover public health concerns State speaker to cover state powers and federal assistance FEMA or DHS Senior Person to cover Emergency responder/law enforcement roles

Friday, August 4th

Flexible Whistleblowing Program Whistleblowing protections and accountability mechanisms to promote good

Withdrawn

governance and external reporting/transparency in complex organizations. Cooperative compliance programs for promoting workplace safety

Friday, August 4th

Flexible Revisions to the Model State APA Act.

The National Conference of Commissioners ("NCCUSL") has a Drafting Committee to Revise the Model State Administrative Procedures Act. The first reading will take place next summer and would be a good time to have a program at Annual.

Friday, August 4th

Flexible International Trade and Customs

Trading with our Asian partners—current perspectives on customs and trade issues.

Return this form via email by November 11, 2005

2006AnnualMeeting@abanet.org