ILSI Risk Science Institute

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This stub is a work-in-progress by the journalists's group. We are indexing the millions of documents stored at the San Francisco Uni's Legacy Tobacco Archive [1] With some entries you'll need to go to this site and type into the Search panel a (multi-digit) Bates number. You can search on names for other documents also.     Send any corrections or additions to


This article is part of the Tobacco portal on Sourcewatch funded from 2006 - 2009 by the American Legacy Foundation.

The Risk Science Institute (RSI) was run as a subsidiary of the International Life Sciences Institute (ILSI) and Toxicology Forum (both of which were run by Alex Malaspina of Coca Cola) The RSI's Executive Director was Jeffrey A Foran.

It started life originally as the risk committee of the Nutrition Foundation Inc. which was merged into the ILSI in 1985. For a while it was simply called the Risk Sciences committee of the ILSI-Nutrition Foundation (ILSI-NF), but eventually it became detached as the independently run ILSI-RSI, and then just known as the Risk Science Institute (RSI).

The RSI and the Center of Risk Management appear to be organisations associated primarily with the Grocery Manufacturer's Association (GMA) However Tom Borelli's Scientific Issues division at Philip Morris had both organisations on his list of $300,000 in sponsorships (along with the ILSI and Toxicology Forum) in 1990. [2]

Toxicology Forum
Society of Toxicology
ILSI & Tox.Forum (Doc Index)
Nutrition Foundation and ILSI-NF
ILSI Risk Science Institute
Society for Risk Analysis
American College of Toxicology
Health & Environmental Science Institute
Center for Excellence in Toxicology
Alex Malaspina

Documents & Timeline

1971 Oct President Richard Nixon established a "Quality of Life" review process that involved re-evaluaton of some health and environmental regulations. Supervised by the Office of Management and Budget, the review process required the agencies to consider various regulatory alternatives and their costs when developing "significant" regulations.

However, many agencies ignored the process and the OMB’s authority was very limited. Many agencies objected to subjecting their regulatory programs to economic analysis -- estimating benefits and costs is very difficult and thus quite controversial.[3]

1974 Nov President Ford’s Executive Order 11821 established procedures for preparing Inflation Impact Statements that were designed to illuminate the economic impact of regulatory proposals, specifically their effects on productivity and competition. The driving force behind that review process was the Review Group on Regulatory Reform, a subcommittee of the Domestic Council, which was a policy-coordinating mechanism used in the Ford White House. The Review Group focused on legislative and process changes in the regulatory system. The group was cochaired by a member of the Council of Economic Advisers and the deputy counsel to the president. Senior-level officials from other parts of the administration, including the OMB, served on the group.

In July 1975, President Ford met with the members of ten independent regulatory commissions and urged them to reform their regulatory processes. Because the so-called independent agencies are not subject to the jurisdiction of presidential executive orders, President Ford and his staff tried to coax them into following the spirit, if not the letter, of his directive. Ford focused on four reforms:

  1. measuring and considering the costs and benefits of proposed regulations;
  2. reducing the backlog and delays in regulatory proceedings;
  3. suggesting changes in the legislation under which each regulatory commission operates, including deregulation where appropriate; and
  4. assuring that the consumers’ interests prevail in regulatory proceedings.

1978 Feb President Jimmy Carter established the Regulatory Analysis Review Group (RARG). That cabinet-level body was granted review authority over the most important regulations proposed. Senior officials in the Office of Management and Budget, the Council of Economic Advisers, and the White House formed the effort’s core, with the bulk of the analytical work performed by the Council on Wage and Price Stability (CWPS).

To formalize regulatory review during his administration, President Carter issued Executive Order 12044 in March 1978, replacing Ford’s Economic Impact Statement with the Regulatory Analysis. The OMB was responsible for seeing that the president’s directive was carried out and delegated to the CWPS the authority to review agency submissions. For all new regulations that would have an economic impact of $100 million or more, the program required presentation of a Regulatory Analysis prior to publishing the regulation in the Federal Register. [4]

1978 The Occupational Safety and Health Administration (OSHA) began employing economists. Although OSHA was not required by statute to consider costs and benefits when developing regulations, it did so in response to the influence of the RARG’s actions. (In 1981 the Supreme Court, in American Textile Manufacturers Institute v. Donovan, ruled that the law required OSHA to use feasibility rather than cost-benefit analysis as a basis for regulation.)

The Food and Drug Administration came under fire from the RARG when it attempted to require informational inserts with prescription drugs. The "patient packaging insert" was intended to outline the proper use of medication and possible side effects. The RARG sided with opponents of the measure (the pharmaceutical companies) who proposed an alternative, more economical means of getting such information to the consumer.{which was ..??} In 1978 Congress eliminated the Civil Aeronautics Board

1980 The Regulatory Flexibility Act of 1980, required rulemaking agencies to write regulations in a manner that would minimize the burdens on small business. Compliance with this provision was minimal. Many agencies simply attached a perfunctory statement to new rules in order to meet the law’s formal requirements. Moreover, enterprises that had been adversely affected by a regulation could not take an agency to court for violating the act. Without the ability to stand in court, businesses benefited little from the act.

The Paperwork Reduction Act of 1980 created the Office of Information and Regulatory Affairs, in the Office of Management and Budget, to supervise the enforcement of the law’s objective to reduce the burden of federal reporting requirements. The law took effect after President Carter left office. Early in 1981 President Reagan, by executive order, expanded OIRA’s mission to encompass the review of regulations promulgated by executive branch agencies.

1981 Jan - 1989 Jan 20 RONALD REAGAN PRESIDENT OF THE USA. (Democrat Congress 1981-85). Members of Congress were generally opposed to the formal imposition of the so-called Decision Sciences/Risk Assessment procedures on the regulatory agencies (EPA, FDA, CDC, OSHA, NIOSH, etc)

1981 Feb President Ronald Reagan established the Presidential Task Force on Regulatory Relief as one of his first acts after moving into the Oval Office. Regulatory reform was one of the "four pillars" of his initial program for economic recovery. The Task Force was a unit of the Executive Office of the President.

Executive Order 12291 stated, "Regulatory action shall not be undertaken unless the potential benefits to society from the regulation outweigh the potential costs to society." The presidential directive required agencies to prepare a regulatory impact analysis for each "major rule" pending, subject to review by the OIRA. A federal agency could not publish a notice of proposed rulemaking until an OIRA review was complete and its concerns had been addressed.

One of the order’s strengths was that it allowed the OIRA to identify any rule as a "major rule." It also required the regulatory agencies to demonstrate that the benefits of a proposed regulation exceeded the costs, and it gave the OIRA power to delay rulemaking to ensure that broader economic issues were appropriately addressed by the regulatory agencies prior to issuing a new regulation.

[In effect, he handed the head of the OIRA the power to strangle any health and environmental regulation by delay and a forced cost-benefit analysis on conditions that may not have any economic return. Early death of the disabled and the pensioners, for instance, is beneficial to the economy.]
[He then placed James J Tozzi, a professional corproate lobbyist, at the head of the organisation]

At an organizational level, President Reagan abolished the CWPS and transferred its regulatory review function to the OIRA. The Task Force on Regulatory Relief often acted as a court of appeals for issues on which the OIRA and the regulatory agencies could not agree. The staff director of the task force also headed the OIRA, with the rank of assistant director of the OMB. Thus, the coordination between the two groups was close and at a high level.

1981-89 The Department of Labor was especially affected with over 40 percent of its regulations initially failing to obtain approval from the OIRA. The Reagan administration also substantially reduced the staffing and budgets of the regulatory agencies. The number of full-time equivalent employees of federal regulatory agencies declined 16 percent,

1986 Nov 17-19 The American College of Toxicology has listed among its attendees: Catherine St Hilaire the new director of the ILSI Risk Science Institute (RSI). [5]

1987 An ILSI-NF draft document "Determination of No Significant Risk Level: Carcinogens."
This has 7 pages which have been edited by (probably Chief Scientist Wally Hayes) at RJ Reynolds Tobacco. He has deleted.

- Page 4 (c) which more or less says that the evidence shall conform to the specifications listed below ..." unless the chemical as known to the state to cause cancer indicates that the application of other principles is scientifically more appropriate."
[This could be used against the tobacco industry since its product was already known to cause lung cancer]
- Page 5 (4) which says that the results or the most sensitive study should be used (rather than the average, or the least sensitive)
[All industries wanted to play down the results of sensitive studies]
- Page 5 (5) which abandons the claim of thresholds - levels below which no danger is to be assumed. It promoted a linear extrapolation method which assumes that no threshold exists, because people have different sensitivities to chemicals and toxins, and sometimes they are synergistic or at least cumulative.
[This was clearly not in the interests of the tobacco industry since many of its effects seem to be synergistic, cumulative and long-term.]

There are a number of other deletions including those of public comment on proposed rules. [6]

Risk Science, Analysis & Management
Risk Assessment History/tobacco
Risk Assessment & Management Commission
Task Force on Regulatory Relief (WhiteHouse)
Delaney Clause (Food, Drug Act)
ILSI Risk Science Institute
Society for Risk Analysis
Harvard Center for Risk Analysis (HCRA)
Harvard Group on Risk Management Reform (HGRMR)
Resources for the Future
Coalition for Uniform Risk Estimation (CURE)
Institute for Regulatory Policy (IRP)

1987 July California's Proposition 65 ("Safe Drinking Water and Toxic Enforcement Act") was intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm. This appears to have triggered the development of Risk Assessment. See this July 1987 RJ Reynolds proposal to attack it via a "Workshop on Risk Assessment in Reproductive & Development Toxicology". The ILSI-RSI Director is in attendance {{Dr Catherine St. Hilaire]] [7]

Note also that the Institute is based in the political capital, of Washington DC, not in New York or any industrial center.


1989 Mar president H.W. Bush established the Council on Competitiveness, which replaced the Task Force on Regulatory Relief (also headed by the vice president). Its charter authorized it to review all federal regulations. The council intervened in many specific regulatory matters. For example, it stopped an EPA proposal that would have required municipalities to divert 25 percent of their solid waste destined for incineration into recycling programs.

1990 Apr 17-19The ILSI's Risk Science Institute has collaborated with the Environmental Protection Agency to run a symposium on Methodology for Assessing Health Risks from Complex Mixtures in Indoor Air.
The Tobacco Institute has sent Holcomb Environmental Services along to report on the conference. Larry Holcomb was second only to Gray Robertson (HBI) in his willingness to run pseudo-IAQ testing for the tobacco industry.

It is apparent from this report that the tobacco industry was NOT involved in establishing or directing this conference. It generally advocated "source control" to improve indoor air quality (a euphemism for stopping people from smoking). The author lists all the main speakers and gives an overview of their condemnation of ETS. He gives special praise to those who don't list ETS in their talks. [8]

1992 Jan Following substantial criticism by advocates of regulatory reform, President Bush placed a three month moratorium on the issuance of new regulations. During that period, agencies were called upon to evaluate existing regulations and accelerate action on initiatives that would "eliminate any unnecessary regulatory burden." Opponents of the new Bush policy charged that it "delayed, weakened, or discontinued" many environmental, health, and safety regulations.

1992 One prestigious US institution that has received funds from Philip Morris and its subsidiaries is the Harvard Center for Risk Analysis, whose former director, John Graham, has assisted Philip Morris with risk communication about environmental tobacco smoke and has on many occasions requested funds for the center. Among several other sources of corporate support, the center currently has an unrestricted grant from the Philip Morris subsidiary Kraft Foods and a restricted grant from the Risk Science Institute of the International Life Sciences Institute (ILSI).[9] [10]


1993 Feb /E Clinton administration rescinded the existing executive orders on regulatory review and abolished the Council on Competitiveness.

1993 SepClinton issued Executive Order 12866, replacing the Reagan-Bush directives and reasserting the agencies primacy in the regulatory decision-makeing process.

President Clinton reaffirmed the OMB (via OIRA) as the central agency charged with review of proposed regulations. However, because the previous Republican administrations had been criticized for allowing regulatory discussions to go on behind the closed doors of the OMB, the new executive order made the process more accessible to the public. Specifically, the OIRA must publicly identify its recommended changes for regulatory actions.

Clinton’s executive order requires the agencies to do many sensible things in the process of drafting rules, including identifying alternative ways of meeting governmental objectives, considering benefits and costs, and using market-based alternatives and performance standards. The recent reduction of ten thousand pages of environmental and pharmaceutical regulations, including the deletion of 11 percent of the total pages of EPA regulations and the rewriting of another 70 percent, is a positive result of that effort.

The EPA’s own regulatory analysis of its proposed air quality standard for ground-level ozone (smog) estimates benefits of $1.5 billion at most but with costs between $600 million and $2.5 billion.

1995 Congress was controlled by the Republicans. The House of Representatives approved a host of regulatory reform bills but only a few passed the Senate.

1995 Oct 17 Conference on Endocrine Distrupters with EPA and CREEE involvement. It was run by Jeffrey A Foran as the Executive Director of the ILSI Risk Science Institute

1996 May 6 The Environmental Protection Agency was still collaborating with the ILSI and the Risk Science Institute. This is a few selected parts of the transcript of a conference on Cancer Risk Assessment held in Virginia (Sheraton City Centre Hotel) which had been attended by Mayada Logue of Philip Morris. The Conference agenda shows panels which have some of the more corporate-friendly scientists, such as John Doull and Dennis Paustenback. the operation was run by Jeffery A Foran, the Executive Director of the Risk Science Institute. [11]

1996 Nov Research Needs on Age-related Differences in Susceptibility to Chemical Toxicants. A report of an ILSI Risk Science Institute Working group. (45 pages) [12]