April 12, 2001

The Honorable Fred Thompson, Chairman
Senate Governmental Affairs Committee
SD-340
Washington, D.C. 20510

Dear Mr. Chairman:

RE: John Graham OIRA Administrator Nomination

We are writing to bring to your attention our concerns about the nomination of John D. Graham as Administrator of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget, and to request your leadership in obtaining answers to critical questions about Mr. Graham’s qualifications.

Candidates nominated for OIRA Administrator deserve careful review because of the significant responsibilities handled by the office. The OIRA Administrator oversees implementation of the Paperwork Reduction Act (PRA), which addresses government-wide management of information resources including agency collection and dissemination of information and oversight of our statistical agency infrastructure. Since creation of the office, every president has given the Administrator regulatory review responsibilities, effectively controlling the regulatory output of Executive Branch agencies. With a relatively small staff and little accountability, the OIRA Administrator can have virtual control over a vast array of internal agency operations, many of which have direct impact on public health and safety and the environment.

OIRA has always been a controversial office. Over the years, it has been accused of unnecessarily delaying urgently needed safeguards, forcing agencies to severely weaken the protective value of proposed safeguards, and even blocking regulatory initiatives from being implemented. Congress has noted that OIRA has often failed to carry out the statutory mandates required by the PRA and instead focused on agency regulatory reviews. In this role, OIRA has frequently insisted that agencies change the way in which they assess the value of human life and taken other steps to change the underlying analyses demonstrating the need for regulation or even collection of information. This has led many observers to believe that OIRA has, at times, been a backdoor channel for regulated industry to make one last stand to accomplish what it was not able to achieve through agency processes such as the public notice and comment process mandated by the Administrative Procedure Act.

The recent flurry of activity by the Bush Administration to review and in some cases reverse important regulatory initiatives of the Clinton Administration reminds us of how politically charged the regulatory process has become once again.

As the Director of the Harvard Center of Risk Analysis (HCRA), for more than a decade Mr. Graham has raised a majority of the Center’s funding from industries that would be affected by the regulations and paperwork he would be reviewing and overseeing as OIRA Administrator. Over the years, these companies and trade groups have poured millions of dollars into Mr. Graham’s research and public education campaigns to oppose regulations affecting them. Such a level of support raises a host of questions about Mr. Graham’s independence and impartiality that warrant close attention by the Committee.

Specifically, we believe it is essential for the Committee to understand the extent of collaboration between Mr. Graham, HCRA and industry supporters because it will help the Committee determine:

There is one other area of inquiry that we urge the Committee to pursue: whether Mr. Graham can fairly administer the law given his public statements criticizing many of the laws he will play a role in implementing if confirmed.

For these reasons we urge the Committee to review these concerns about Mr. Graham and the Harvard Center of Risk Analysis described in the attached document and to pursue the questions outlined in it.

Sincerely,

Peg Seminario, Director Safety and Health
AFL-CIO

Charles M. Loveless, Director of Legislation
American Federation of State, County and Municipal Employees (AFSCME)

Michael F. Jacobson, Ph.D., Executive Director
Center for Science in the Public Interest

Mark Shaffer,
Senior Vice President for Programs
Defenders of Wildlife

Brent Blackwelder, President
Friends of the Earth

Alan Reuther, Legislative Director
International Union, United Automobile, Aerospace & Agricultural Implement Workers of America (UAW)

Thomas A. Wathen, Executive Vice President
National Environmental Trust

Alyssondra Campaigne, Legislative Director
Natural Resources Defense Council

Gary D. Bass, Executive Director
OMB Watch

Robert K. Musil, Ph.D., M.P.H., Executive Director
Physicians for Social Responsibility

Joan Claybrook, President
Public Citizen

Frank Clemente, Director
Public Citizen Congress Watch

Debbie Sease, Legislative Director
Sierra Club

Gene Karpinski, Executive Director
U.S. Public Interest Research Group

cc: Sen. Joseph Lieberman, Ranking Democrat
Members, Committee on Governmental Affairs

Suggested Information Request and Questions for
John D. Graham Proposed by Consumer, Environmental, Labor
and Public Health Organizations

1) Budget and Funding Sources

On October 21, 1991, Mr. Graham, Director of the Harvard Center of Risk Analysis (HCRA), wrote to the Vice President for Government Affairs at the Philip Morris Companies to seek a meeting to request $25,000 in funding for 1992 and 1993 [attached]. (Such a solicitation may have been in violation of a Harvard School of Public Health policy of not accepting tobacco money according to "Regulations Czar Prefers New Path," The New York Times, March 25, 2001 (attached).] Mr. Graham sought a contribution to "help the Center expand its public policy activities. It is important for me to learn more about risk-related challenges that you face," his letter stated.

Graham noted that the "Center has been launched primarily with gifts from the following corporations: the Amoco Company, Bethlehem Steel Corporation, British Petroleum, Chevron Corporation, The Coca Cola Company, Dow Chemical Company, Eastman Kodak Company, Exxon Corporation, General Electric Corporation, General Motors, Inland Steel Industries, Merck & Company, Mobil Oil Corporation, the Monsanto Company, Pepsico Incorporated, Rohm and Hass Company, Texaco, Union Carbide Corporation, and Westinghouse Corporation…The Center is now looking to a broader base of industrial sources to supply critical funding for the years ahead."

It appears that the Center has been quite successful at broadening its base of support over the last decade. According to HCRA’s Web site more than 100 large corporations and trade associations fund or have funded the Center since it was founded in 1989, as well as several foundations that are connected to or heavily supported by regulated industries [attached]. Moreover, recent news accounts [The New York Times, supra; "Nominees Funding at Issue, Critics of Harvard Risk Analyst See Ties to Industry," The Boston Globe, March 18, 2001 (attached)] indicate that HCRA receives at least 60 percent of its funding from regulated industries, much of which comes in unrestricted grants.

Many of these regulated companies had a direct stake in the outcome of research, reports, testimony, advisory services and public relations efforts undertaken by Mr. Graham and HCRA. HCRA’s efforts were used to question, and in many cases undermine support for, federal regulatory initiatives. Because most of the corporate and trade association support was labeled "unrestricted," or there is no indication when "restricted" grants from such entities were received, it is impossible to determine to what extent these funding sources directly sponsored Mr. Graham’s and HCRA’s work. If such direct support was provided, regardless whether labeled restricted or unrestricted, Mr. Graham would have been obliged to disclose his benefactors. In many cases he does not.

Given this high level of support to HCRA from regulated industry it is critical for the Committee on Governmental Affairs to get some baseline information about funding sources, amounts and dates of contributions. Such information will help determine to what extent Mr. Graham and HCRA have acted as a research arm, think tank, consultant, lobbyist and public relations entity pursuing an anti-regulation agenda on behalf of industries, rather than as an independent institution producing objective scholarship. We suggest that Mr. Graham be asked to provide the following information to the Committee:

2) HCRA Executive Council

HCRA’s Executive Council has 16 members [see attached list and annotated summary of their corporate and professional positions]. Nearly all of them maintain senior positions at some of America’s largest companies or trade associations, or they work for major law firms representing the interests of corporations involved in litigation related to federal regulatory matters. We believe it is worth the Committee asking the following question:

Because of the lack of transparency about, and potential conflicts of interest posed by, HCRA’s funding sources and Mr. Graham’s work on behalf of regulated industry, we urge the Committee to learn more about each of the following regulatory case examples:

3) Regulating Second-Hand Smoke

During the next few years Congress may pass and President Bush could sign into law legislation that would grant the Food and Drug Administration (FDA) authority to regulate tobacco products and their effect. Such regulations would first need to be prepared by the FDA according to requirements and guidelines established by the Office of Information and Regulatory Affairs (OIRA), under Mr. Graham’s leadership, and then be reviewed by OIRA officials and effectively approved, amended or rejected.

It appears that in the early 1990s, Mr. Graham and HCRA may have been actively involved in efforts being coordinated by the tobacco industry and Philip Morris to counter adverse government regulatory activities anticipated from an Environmental Protection Agency (EPA) assessment of the risks posed to non-smokers by environmental tobacco smoke (ETS), also known as second-hand smoke, and an Occupational Safety and Health Administration (OSHA) advanced notice of proposed rulemaking on indoor air quality.

As documented in a recent Public Citizen report, "Safeguards At Risk: John Graham and Corporate America’s Back Door to the Bush White House" [see pages 39 to 47], and the attached documents that were contained in the Philip Morris tobacco archives, the following sequence of events appears to have taken place over several years:

In light of this account, we believe the Committee would benefit from a more detailed understanding of Mr. Graham’s relationship with Philip Morris during this period. We suggest that the following questions be asked of Mr. Graham:

4) Regulating Food Safety

OIRA plays a central role in reviewing any new food safety regulations proposed by the FDA and the Department of Agriculture (USDA). On August 12, 1992, as previously noted, HCRA received a $20,000 check from Dr. Enrique J. Guardia, Vice President of Scientific Relations at Kraft General Foods, a subsidiary of Philip Morris, "to support the work of the Center, in general, and your contributions to the food safety debate (Pesticides)." [Note that Kraft Foods is listed as an unrestricted grant on the HCRA Web site.] Mr. Guardia stated that "I would like to meet from time to time to discuss topics of mutual interest."

That same day Guardia sent a second letter [attached] to Graham apparently in response to a letter Graham sent him regarding food industry support for HCRA. Graham’s letter evidently had asked Guardia for the names of other potential corporate donors for the new project and had named the sum to be solicited from the food sector as $25 million. This amount of money was so high that Guardia demurred: "You know fund raising better than I, but your request of $25 M strikes me as excessive in a year like 1992. Ask yourself whether you would not be better off asking for $10 M."

In light of this account, we believe the Committee would benefit from a more detailed understanding of Mr. Graham’s relationship with Kraft General Foods, the five other food companies (E.I. Dupont de Nemours & Company, The Coca-Cola Company, Frito-Lay, PepsiCo, Inc. and Procter & Gamble), and two trade associations (Grocery Manufacturers of America and the National Food Processors Association) that are listed as HCRA funders. Specifically, we suggest that the following questions be asked of Mr. Graham:

5) Regulating Pesticides

OIRA will play a key role in reviewing any new pesticide regulations that EPA may want to promulgate. Unfortunately, in August 1999 HCRA issued a biased and fundamentally flawed report ["Risk/Risk Tradeoffs in Pesticide Regulation: Evaluating the Public Health Effects of a Ban on Organophosphate and Carbamate Pesticides" (attached)] designed to obstruct the implementation of the unanimously passed Food Quality Protection Act (FQPA). The report used extreme assumptions to conclude that stopping the use of older, highly toxic pesticides would oddly result in an increase in premature deaths. The study suggested that implementation of the FQPA would result in banning all uses of certain pesticides, which could result in up to 1,000 premature deaths per year due to decreased food consumption. The report was criticized for its poor application of risk assessment techniques and unrealistic assumptions.

The report’s most prominent flaws are the assumptions that FQPA implementation would cause a catastrophic shortage of insecticides available to farmers and that the readily available alternative chemical and non-chemical pest control options would not be used to replace the banned pesticides. The authors assumed that EPA would ban all uses of all organophosphate (OP) and carbamate insecticides. This complete ban of more than 50 chemicals is far outside the scope of any action EPA has considered necessary to achieve the goals of the FQPA. The report’s authors acknowledge this fact, but then base their analysis on what they concede is a false assumption. They justify their decision on account of its "analytic virtue" (i.e., simplicity). The report’s assertion that alternatives are too costly is not based on any analysis of actual costs and is simply not credible.

The truth is that pesticide prices and expenditures in the U.S. are falling across the board as dozens of new products have increased competition. There are many existing, proven alternatives to high risk insecticides. The pest control industry has been developing and introducing new products in response to FQPA’s pressure to phase-out older, high-risk chemicals. Ironically, the HCRA analysis ignores the effects of market-driven innovation. The study also ignores the progress made by farmers in adopting bio-intensive Integrated Pest Management, or a least-toxic approach.

The study was funded by the American Farm Bureau Federation (see p. 35), which opposes restrictions on pesticides. The report, dubbed "The Truth from Harvard" by pesticide lobbyists, has been used to generate congressional support for rolling back FQPA’s key public health provisions, which require that manufacturers prove pesticides are safe for children and infants.

In light of this account, we urge the Committee to ask the following questions of Mr. Graham:

6) Regulating the Use of Cell Phones

During the next four years the National Highway Traffic Safety Administration (NHTSA) may decide that cellular phone usage in moving vehicles should be regulated in order to reduce accidents, injuries and death. Should such a regulation be promulgated the OIRA Administrator will play a key role in reviewing the rule for approval, but important questions have been raised about the quality of HCRA research in this area.

The "Safeguards at Risk" report (pp. 48-55) noted that Mr. Graham already has significant experience with this regulatory issue as HCRA received a $300,000 grant from AT&T Wireless Communications to assess the risks of using a cell phone while driving. In fact, in July 2000, one week after NHTSA held a public hearing on driver distraction and recommended that drivers pull over before using cell phones, Mr. Graham and HCRA published the AT&T-funded report, which concluded that further regulation of this issue was unwarranted. HCRA’s report stated that "although there is evidence that using a cellular phone while driving poses risks to both the driver and others, it may be premature to enact substantial restrictions at this time. We simply do not have enough reliable information on which to base reasonable policy." [A summary of the report, "Cellular Phones and Driving: Weighing the Risks and Benefits," is attached.]

Mr. Graham’s report, which was self-published and reviewed by 12 independent specialists chosen by Mr. Graham, came under significant criticism from the authors (Donald A. Redelmeier, M.D. and Robert J. Tibshirani, Ph.D.) of a peer-reviewed study published in 1997 in the prestigious New England Journal of Medicine [attached]. That study had concluded that the risk of car crashes is four times greater when a driver uses a cell phone. Dr. Redelmeier, the NEJM author who was also one of the 12 reviewers of the Graham study, told reporters that the "Harvard researchers left the report open to conflict-of-interest questions because they didn’t publish it in a scientific journal or take other steps to demonstrate the study’s fairness." There were numerous methodological problems with the Graham/HCRA report, according to "Safeguards at Risk."

In light of this account, we believe the following questions should be asked of Mr. Graham:


7) Regulating Air Bags

As OIRA Administrator, Mr. Graham would pass judgment on a host of regulatory proposals from the National Highway Traffic Safety Administration (NHTSA) – perhaps even a new air bag standard. But the research and advocacy Mr. Graham has done in recent years raises concerns about the quality of his analytical work and whether it has been slanted to favor HCRA contributors.

According to the report "Safeguards at Risk" [pages 2 and 56-66], in the early 1980s Graham’s research was cited by the Secretary of Transportation, Elizabeth Dole, in support of a passive restraint air bags mandate. But by March of 1997, in news appearances and testimony before the National Transportation Safety Board, Graham reversed course and argued that a new, unpublished HCRA report had convinced him that passenger air bags were not cost effective enough to justify being mandated. Graham’s research suggested that the $399,000 price tag for each life saved using passenger side air bags was too high compared to the $70,000 per life-year saved of driver side air bags.

Mr. Graham’s announcement of his new study findings, engineered with considerable media fanfare, occurred as NHTSA was preparing to issue for OIRA review a proposed rule pushed by the auto industry that would have permitted manufacturers to depower air bags.

Mr. Graham’s study came under harsh criticism by transportation safety experts because it had not been peer reviewed and it was based on questionable data. Subsequently, it was peer-reviewed by the prestigious Journal of the American Medical Association (JAMA), and the revised Graham study had reversed course [attached]. The revised study found that driver-side air bags cost only $24,000 for each life-year saved, rather than Mr. Graham’s original $70,000 estimate, and that the passenger-side air bag cost estimate had declined from $399,000 to $61,000 – a very "cost effective" estimate, according to some measures used and to Graham’s researchers. While the JAMA article indicated that funding for the JAMA study had been provided by the Centers for Disease Control to the Graham-run Harvard Injury Control Center at the Harvard School of Public Health, HCRA has received unrestricted support from the Ford Motor Company, General Motors, and the Goodyear Tire & Rubber Company.

At the same time, Mr. Graham’s Injury Control Center and HCRA released a public opinion survey ["The Airbag’s Teflon Image: A National Survey of Knowledge and Attitudes," March 17, 1997 (attached)] about Americans’ knowledge of airbags. The report’s press release contended that Americans’ widespread support for air bags was founded upon bad information. Some have speculated that the survey fit with the political strategy of the auto industry at the time, which was waging a campaign to deflect attention from the need for more advanced air bag systems by focusing on the public’s knowledge of safety issues involving air bags.

The public opinion survey did not mention who funded the 1,000 person sample. Source of funding was not noted for the NTSB testimony or the JAMA article either.

To better understand the relationship between Mr. Graham and the auto industry, we urge the Committee to pursue the following questions:


8) Regulating Dioxin

As OIRA Administrator, Mr. Graham will sit in judgment should the EPA decide to propose new regulations to control exposure to dioxin, the name given to a group of highly toxic chemicals that are produced when chlorine is burned. Since 1995 EPA has been conducting a dioxin reassessment, which is under review by the agency’s Science Advisory Board (SAB). Graham served as a consultant on the 1995 SAB Dioxin Reassessment Review Committee and until his recent resignation, was a member of the current SAB Dioxin Reassessment Review Committee.

According to the "Safeguards at Risk" report (p. 2-3, 109-110), last year EPA prepared a draft risk assessment that showed the public faces much higher risks of cancer and non-cancer health harms (infertility, immune system damage and learning disabilities) from dioxin, even at very low levels of exposure, than was previously understood. The risk assessment was based on more than 100 studies in animals and humans showing that dioxin caused cancer at low doses. More than 90 percent of dioxin exposure comes through the food we eat, especially fish, meat and dairy products.

At a meeting of the SAB in November 2000, citing only two limited outlying studies, Graham claimed that low levels of dioxin may actually protect against cancer. He urged the SAB to include in its official comments language stating that dioxin may be an "anti-carcinogen." The report noted, "Based on the transcript of the meeting, Graham wanted the SAB to tell EPA to revise its report to include the following statement: ‘It is not clear whether further reductions in background body burdens of TCDD [dioxin] will cause a net reduction in cancer incidence, a net increase in cancer incidence, or have no net change in cancer incidence.’ If EPA were to adopt this approach its dioxin risk assessment might fail to provide a basis for federal regulators to ask companies to curtail dioxin emissions." The Washington Post has reported that at the November meeting, "[a]bout a third of the 21 panel members were scientists and scholars who have worked as paid consultants to the chemical industry. They included John D. Graham -- long a critic of the notion that dioxin and cancer are linked and founder of the industry-backed Harvard Center for Risk Analysis[.]" ["Dioxin Report by EPA on Hold, Industries Oppose Finding of Cancer Link, Urge Delay," The Washington Post, April 12, 2001 (attached).]

The Safeguards at Risk report notes that HCRA has received financial support from at least 48 different dioxin producers, including incinerator companies, pulp and paper companies, cement kilns, copper smelters, PVC manufacturers, PCB producers, and the petroleum industry.

Despite the conflict of interest created by Mr. Graham’s obligation to serve as an objective expert as a consultant to the SAB and his real or perceived obligations to HCRA’s dozens of dioxin-producing supporters, Mr. Graham continued to participate in the SAB process as a vocal proponent for industry’s position. Even when two scientists – Frederica Perera and Ellen Silbergeld – recused themselves from the SAB because of their close association with environmental organizations that were pushing for tighter controls of dioxin, Mr. Graham still failed to resign. ["Expert Panel Backs EPA Dioxin Study," The Charleston Gazette, October 1, 1995 (attached)] (Perera, an environmental health sciences professor at the Columbia University School of Public Health, was a board member of the Natural Resources Defense Council. Silbergeld, an epidemiologist at the University of Maryland, was a former staffer for the Environmental Defense Fund.)

Further, in the month prior to the Science Advisory Board meeting, HCRA organized a high-profile conference on drinking water and health risks, "financed by a grant from the Chlorine Chemistry Council and the Chemical Manufacturers’ Association." [Greenpeace Report, "Dow Brand Dioxin: Dow Makes You Poison Great Things," September 1995, citing the CCC Executive Newsline, April 3, 1995 (attached).] The root source of most dioxin in the environment is produced as a byproduct of industrial chlorine chemistry.

In light of the issues described above, we recommend that the Committee ask Mr. Graham the following questions:

9) Non-Disclosure of Regulated Industry Funding

Throughout the "Safeguards at Risk" report it is suggested that Mr. Graham regularly fails to disclose the source of HCRA funding when interviewed by the media or even when testifying before Congress. With respect to congressional testimony, on at least six occasions that were reviewed, Mr. Graham failed to disclose HCRA funders, in both his written and oral testimony. Those occasions were January 31, 1995, House Committee on Science; February 2, 1995, House Subcommittee on Commerce, Trade, and Hazardous Materials and Subcommittee on Health and Environment; February 15, 1995, Senate Committee on Governmental Affairs; March 22, 1995, Senate Committee on Environment and Public Works; June 10, 1998, House Committee on Science; and April 21, 1999, Senate Committee on Governmental Affairs.

In light of these numerous instances, we urge the Committee to ask the following questions:

10) Disclosure at OIRA

The concerns raised about Mr. Graham’s funding sources and his substantive policy positions, as described above, raise important questions about his ability to be independent and impartial as OIRA Administrator. Accordingly, we suggest that Mr. Graham be asked to provide specific information to the Committee about how his actions at OIRA can be monitored for accountability purposes:

 



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