Risk Assessment

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This stub is a work-in-progress by the ScienceCorruption.com 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 editor@sciencecorruption.com

In the 1980s, the companies with poisoning and polluting problems were increasingly facing regulation by the main health and environmental agencies in the USA (EPA, FDA, CDC, OSHA, NIOSH, etc.) They had two main avenues of defence:

  • Regulatory Relief: This became the catch-cry of the Reagan campaign, with its (well justified) complaint that America was being overwhelmed by minor regulations promulgated by dozens of uncontrolled agencies, which were swamping the people and the bureaucrats with mountains of unnecessary forms and licenses. This resulted in the Paperwork Reduction Act, and the rise of the Office of Information and Regulatory Affairs]] (OIRA) as part of the WhileHouse Office of Management & Budget (See James Tozzi)
  • Standards of proof: Another political ploy they tried with reasonable success was to set the standards of proof that substances were dangerously toxic at a level that was so high that it was virtually impossible for the agencies to impose meaningful regulations.

This was imposed on the regulating agencies by obligations to engage in a formalised process of Risk Analysis & Risk Assessment - which implied holding hearings and accepting contradictory evidence. The first term refers to 'analysis' based on previous knowledge of toxic substances and the ability to identify and measure those components, while the second ('assessment') assumes the experts have the honesty and ability to assess the degree of potential harm resulting from low levels of these substances, in isolation or in complex blends.

RISK SCIENCE ENTRIES
Risk Science, Analysis & Management
Risk Assessment History/tobacco
Risk Assessment & Management Commission
Task Force on Regulatory Relief (WhiteHouse)
Delaney Clause (Food, Drug Act)
RISK ORGANISATIONS
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)

These political ploys were created to fight the environmental movement (then later extended into health): both looked to be reasonable to the media and the public, because both depended on judgements of degree (which the media and the public usually didn't have) Both were used to impose delays on restricting substances while "extensive and scientific rigorous tests and measurements were made". They needed scientists to reach a public consensus, and when scientists can be hired like mercenaries, this was impossible.

This approach was favoured by corporate interests. The alternative was the common regulatory decision to use the "Precautionary Principle" when common-sense suggests that unacceptable levels of danger exists; to ban a substnce until it was proved safe.

Test of Risk Significance

The tobacco industry often complained about the use of a one-tailed test of significance in anti-smoking studies. These are approximately equivalent to using a 90 percent confidence interval to test the chance that a relative risk differs from 1.0 -- but without the second-tail. This second tail test, implies that Environmental Tobacco smoke may actually be beneficial to health in immunising the passive smoker from lung cancer -- and therefore the positives need to be offset against the perceived negatives.

Although 95 percent confidence limits are commonly used in epidemiology, 90 percent confidence intervals are often used in health studies, and are in fact standard in epidemiologic studies of agents such as radiation, which like tobacco, is a strong lung carcinogen. In putting a large emphasis on this rather minor part of the analysis, the tobacco industry ignored the importance epidemiologists put in other factors in making their causal inference -- such as consistency of association, strength of association, temporality of the association, dose-response relationship and biologic plausibility.

Executive Order

In Ronald Reagan's first term (1981-84) the Members of Congress were generally opposed to introducing Risk Assessment, Risk Analysis (and Risk Management) legislation into the agencies, so President Reagan was prevailed upon to impose these requirements by Executive Order. [2] C Boyden Gray, an heir of the RJ Reynolds Tobacco fortune, and a legal aide to Reagan, appears to have been a major proponent of the Order. In the White House, he clearly was the advisor who had knowledge and the powers to drive this attempted reguatory imposition. The chemical and tobacco industries also had many hired guns who were given the job of promoting to the public the idea that these 'new tools' were sensible and responsible measures. The suggested line was that they were replacing activist zealotry, with considered science.

In the 1980s, the USA higher education system suddenly found that it could obtain generous donations from industry and corporate sponsors to create departments and degrees in Risk Analysis/Management. Many of the younger professors of statistics, mathematics and the emerging computer sciences, overnight became lecturers on the subject. This shifted the power-base in the regulatory agencies away from those with actual experience and knowledge in health or environmental problems, to those who's expertise was in the analytical, economic and statistical areas. It especially suited those with a free-market, minimal-regulation, laissez-faire ideology.

Environmental Protection Agency

Since the aim of those boosting the use of Risk Assessment and Risk Analysis as a scientific tool for regulation of the regulators (the aim was Risk Management by discounting the degree of regulation, or disarming the agency itself), it was natural that the EPA and FDA were generally opposed to any legislative introduction of these (essentially statistical + political) proceses.

William Ruckelshaus, the Chief of the Environmental Protection Agency (EPA) once said "A risk assessment is like a captured spy. Torture it enough and it will tell you anything."

Another EPA Chief, William Reilly wrote,

"The National Research Council concluded in a 1984 report that fewer than 2 percent of the chemicals currently used for commercial purposes have been tested sufficiently for a complete health hazard assessment to be made. Adequate information to support even a partial hazard assessment is available for only 14 percent of the chemicals; for 70 percent, no information is available. Moreover, these percentages refer only to human health hazards. In general, environmental hazards are even less well understood. Never mind that there are no data. This has never stopped a dedicated risk assessor from calculating risks to the third decimal place, presenting the results as factual and reliable, then using the results to support a political decision to impose unknown risks on the public.[1]

Backfired

The concept of "Risk Assessment" doesn't appear in the tobacco documents (in the modern sense of the term) until about 1985. The EPA then siezed on it as the preferred term for its own evaluation. They performed a "Risk Assessment/Analysis" of second-hand smoke (ETS) (December 1992) and decided that it was a Group A carcinogen -- on the basis that it was essentially the same as primary breathed smoke which produces lung-cancer. The tobacco industry then fell back on the old claim that the medical literature had a 'publication bias' in that it only published bad news about tobacco, and didn't publish the good news found by industry scientists that no real health problems existed.

Delaney

The development of Risk Assessment and Risk Management as a pseudo-scientific pursuit is in direct opposition to the use of the Delaney Clause to block the sale of food-stuffs (and tobacco) which had measurable levels of substances known to be carcinogenic. The Clause forbids the government from approving food additives that are known to cause cancer in humans or animals; This amendment was made to the Federal food, Drug and Cosmetics Act in 1958 under pressure from the sponsor Rep. James J Delaney, D-NY, followed growing public concern with higher levels of pesticides and herbicides in agriculture.

During President Reagan and President HW Bush Administrations, the various food, beverage, tobacco, cosmetic and confectionary industries worked on diluting the clause, or removing it completely. However they came to recognise that most health and biomedical scientists thought the Clause should remain, or, even possibly be tightened in its applications. The EPA director, Anne M Gorsuch was given the task of selling the dilution of the Delaney Clause, but she became mired in conflicts of interest and charges of corruption. She later wrote a book attacking Reagan, saying she only did what she was asked to do. George W Bush cut the EPA's budget, and did nothing about health hazards.

Environmental Research Foundation director Peter G Montague wrote:

The chemical industry has been working relentlessly since 1975 to expand the use of risk assessment throughout government. President Clinton quietly signed Executive Order 12866 on September 30, 1993, officially embedding risk assessment in the U.S. "philosophy of regulation." Executive Order 12866 is arguably the culmination of their efforts. From the viewpoint of anyone who wants to spread chemicals into the environment, risk assessment is a marvelously useful technique: Because it is based in mathematics, most people can't even understand it, much less participate in it, so it immediately excludes most of the public from decisions. Furthermore, because it is mathematical, the result gains an aura of certainty and precision, even if it is based on "data" that are nothing more than guesses.

By providing healthy grants to universities and think-tanks, and by sponsoring chairs in Risk Assessment and Management at universities around the world, the various industries with poisoning and polluting problems have managed to entrench Risk Sciences as a legitimate academic pursuit -- where it is mainly in the province of the statisticians and mathematicians. Sometimes it hides under a pseudonym, "Biostatistics" as if the numbers and techniques used to evaluate Biological studies are somehow different to those needed for other forms of research.

Documents & Timeline

1958 The original amendment later known as the Delaney Clause/Amendment was made to the Federal Food, Drug and Cosmetic Act . The amendment prohibits the FDA from approving the use of any food additive found to cause cancer in animals or humans. It was criticized as being too restrictive by setting a zero level of risk, but in practice this only applies to a very small number of food additives. In recent years a standard known as GRAS (Generally Regarded As Safe) has been widely accepted base on outcomes, rather than measuements.

1962 The immensely influential book "Silent Spring", by Rachel Carson (1907–1964), brought to the public’s attention the results of indiscriminate use of DDT (dichlorodiphenyltrichloroethane) and other pesticides. Carson also criticized industrial society for abusing the natural environment and failing to recognize the threat to industry’s own existence when natural processes are seriously disturbed. Silent Spring launched a revolution in attitudes at all levels of society, from schoolchildren to government and industrial leaders.

1975 The chemical industry begins attacking EPA and FDA regulations and laws on health and the environment on the basis that they should use "Risk Assessment" to determine what should be regulated and what should not. It is later supported by the tobacco industry.

1977The early history of the Delaney Claus/Amendment can be found in Edward W. Lawless, TECHNOLOGY AND SOCIAL SHOCK (New Brunswick, N.J.: Rutgers University Press, 1977).

1981 Aug Ronald Reagan's EPA Administrator Anne M Gorsuch announced a restructuring of the EPA on grounds of efficiency, and a whole raft of new staff appointments. Among them was Dr John A Todhunter [3]

1981 Nov-1989 Nov President Ronald Reagan was under pressure to remove the Delaney Clause. His head of the EPA, Anne M Gorsuch was sympathetic to industry, but both she and her agency came under media scrutiny and personal attacks when it was reported that she had done secret deals with an oil company on high acceptable lead levels.

1982 Apr 15 Both the EPA staff (mainly John A Todhunter and John Hernandes) and the director, Anne Gorsuch, were under attack. Then the Inspector-General Novick swore that she had promised Thriftway, an oil refinder in New Mexico, that the EPA would lay no charge if they exceeded the EPA's lead standard (Environmental Health Letter). [4]

Gorsuch then decided not to proceed with the attempts at regulating formaldehyde, a ubiquitous chemical that causes tumors in anmials.

1982 Nov New York Times report: OSHA and NIOSH are ... barely on speaking terms.

The agencies' differences erupted into public view recently when J.Donald Millar, director of NIOSH, complained that OSHA was using flawed scientific studies in reviewing cotton dust exposure. The review could lead to relaxing standards for protecting textile workers from byssinosis, a disease caused by cotton dust. An equally pointed exchange had just ended over proposals to protect workers from formaldehyde. Mr. Millar had sent Thorne G. Auchter, OSHA's administrator, documents relating to the chemical's properties, recommending that it be regarded as a carcinogen and suggesting regulation.
In response, Mr. Auchter's assistant, Mark Cowan, said OSHA could not issue regulations to control formaldehyde exposure based upon the simple classification of the substance as a human carcinogen.
He said that in line with a Supreme Court decision on the chemical benzene, OSHA must find that a substance is also a significant risk to occupationally-exposed workers and that regulations can lessen the risk. In another letter, Mr. Millar urged Mr. Auchter to issue a temporary emergency standard for exposure to ethylene dibromide, an agricultural fumigant that he said had been shown to cause cancer and damage genes.
Mr. Auchter said the agency did not have enough information to take such action and so would handle the problem through the normal rulemaking process, which can take months or years. Then there was Niosh's protest over OSHA proposals to protect trade secrets by limiting employee access to health records and to information about chemicals.
Mr. Auchter said NIOSH's charges that his agency is not using good science in its rulemaking are a lot of hogwash. Good science, he said, is what happens when someone agrees with the results. [Source unknown]

1983 Anne Gorsuch was replaced by William D Ruckelshaus. Following this appointment the EPA decided to look at the chemicals again and moves to dilute the Delaney Clause were quietly shelved. The emphasis shifted to promoting Risk Assessment as a requirement before legislation could be enacted to limit chemical pollution in food-stuffs. [5]

[After the Gorsuch scandal a number of Gorsuch's associates also left the EPA and set up as scientific lobbyists to various industries. See Rita Lavelle (sent to prison for perjury), John A Todhunter, and John A Moore (below)]

1983-1986 The Unbearable Lightness of Politics: Climate Change Denial and Political Polarization by Robert Antonio and Robert Brulle.

Neoliberals sought to weaken the substantial network of environmental regulations and oversight agencies, created in the 1970s, and to blunt the environmental movement’s effort to strengthen this system and make it more comprehensive. In the 1970s, new neoliberal organizations, centered in the mountain states, spearheaded the “Sagebrush Rebellion” to defend property rights and oppose environmental regulation (Cawley 1993). These forces gained political traction under President Reagan, who made James Watt, a leader in the Sagebrush Rebellion, Secretary of the Interior and Anne Gorsuch EPA head.

Reagan empowered the anti-environmentalist countermovement, and forged the neoliberal Republican strategy of selecting opponents of regulation to lead environmental and other regulatory agencies, deemed to be “intrusive” and “antibusiness.”

The momentum of the Sagebrush Rebellion faded after Reagan’s first term, as Watt and Gorsuch were forced to resign due to allegations of illegal activities. [6]

1983 Mar 8 The first appearance of the business name Environ Corp. in the tobacco archives is in an Occupational Health & Safety Letter. Joseph V Rodricks is listed along with some others as an author of a report "Risk Assessments in the Federal Government: Managing the Process"

Their paper notes that the "... basic problem with risk assessment is the sparseness and uncertainty of the scientific knowledge of the health hazards addressed. Although evidence of health effects of a few chemicals, such as asbestos, has been clear, in many cases the evidence is meager and indirect. To make regulatory judgements on the basis of animal data, risk assessors must rely on a series of assumptions." [7]

1983 Sep 27 Thorne G Auchter (still at OSHA), (his partner) James J Tozzi (at Beveridge & Diamond), Wayne Valis and S John Byington are all speaking at a Toxic Torts Advocacy Institute "Toxic Torts Clearinghouse" training course. [8]

[The Toxic Torts Advocacy Institute was a tobacco, asbestos and chemical industry funded legal training ground for defence lawyers][9]

1983 Nov 25 Right-to-Know Regulations

The historic Hazard Communication standard (HCS) is issued by Congress, giving workers the right to know which chemicals they may be exposed to in their workplace and the hazards these chemicals present. Employers with hazardous chemicals in their workplaces are required to implement a program to provide information and training to workers, including the procedures used to protect workers.

1984 Mar A charge of conflict of interest was laid against former OSHA Director Thorne Auchter (later Ass.Sec of Labor) who is being examined by the FBI. ... Auchter resigned as head of OSHA to become president of the construction giant, the B.B. Anderson Companies. Earlier, he had dismissed a series of twelve OSHA violations against the same company." [2]

The New York Times said of his resignation: " OSHA Gets Tough, at Last. The previous OSHA head (a woman) was highly active but first under Thorne Auchter and then Robert Rowland, enforcement lagged. The agency cut down on workplace inspections, slowed standard-setting to a crawl.

1984 Dec 3 Bhopal Disaster

The catastrophic release of the toxic chemical methyl isocyanate (a pesticide) at Union Carbide's plant in Bhopal, India kills at least 3,800 immediately, and results in thousands of later deaths, affecting half a million people. The disaster sparks worldwide concern and prompted OSHA to inspect all U.S. facilities manufacturing or processing this chemical, and leads OSHA to increase inspections of chemical plants. (in 1985-86)

.

[Bhopal was the straw that broke the OSHA-deregulator's back. President Reagan realised that the tide of public opinion had turned against deregulation. They were no longer supporting the overall relaxation of standards that had gone on under the reign of Watt, Gorsuch, and Auchter at the OSHA.

1986 May-Mar 1989 Reagan appoints Assistant Secretary John Pendergrass to head OSHA.

John Pendergrass, an industrial hygienist by training, becomes Assistant Secretary for OSHA under President Ronald Reagan. Under his direction, the agency issues 11 safety standards and 4 health standards. He oversees a rulemaking to strengthen OSHA's standards for hundreds of toxic substances (ie. the Permissible Exposure Limits, PELS), an effort that was overturned by the courts in 1992.

1986 Thorne Auchter (ex head of the Occupational Safety and Health Administration) and James Tozzi (ex OIRA) founded the lobbying company Multinational Business Services (MBS), and its not-for-profit Federal Focus, Inc, (a 501(c)(3) non-profit 'foundation') which was funded largely by Philip Morris. Federal Focus successfully blocked the federal government from gathering data related to deaths from secondhand smoke.

The success of Federal Focus spawned dozens of 'non-profit' policy institutes and business-oriented think-tanks under the same control; among them were:

Federal Focus was the vehicle by which the tobacco industry tried to change the rules for the science of epidemiology and the political rules behind risk-management. (See Good Epidemiological Practice (GEP) and the London Principles.) [[10]]

1989 Mar 24 Exxon Valdez Oil Spill

The Exxon Valdez oil tanker spills 11 million gallons of crude oil into Alaska's Prince William Sound. OSHA sends inspectors to monitor worker protection and required safety and health training.

1989 Jul One of Anne Gorsuch's senior staff, Jack A Moore the EPA Deputy Assistant Administrator during the Reagan Administration (a toxicologist who headed the pesticide program), founded the Institute for Evaluating Health Risks based in both Washington DC and in Menlo Park California. Chevron provided the initial funding, and a dozen other oil companies, banks, and supermarket chains kicked in about $600,000 ... but this was supposedly a 'nonprofit' research organization. Moore claims that his think-tank has a "commitment to the application of independent scientific analysis of chemical exposure health risk assessments."

1990 June 25 The EPA has retaliated by using the tobacco industry's own risk assessment tactics against them. The term is vague enough to be used for any sort of evaluation. The EPA has released draft documents concerning passive smoking:

  1. a risk assessment for lung cancer in adults
  2. a risk assessment for respiratory effects in children
  3. a policy guide on ETS mitigation strategies for the workplace.

They have classified ETS as a Group A carcinogen and attributed approx 3,700 nonsmoker lung cancer death per year to ETS. It recommended total bans of separately exhausted smoking areas.

[This classification brings it under the strict limits of the Delaney Amendment]

The Tobacco Institute turned out 58 industry consultants to file objections to these conclusions. This is the strategy document circulated by the TI. They are going to

The proposed tactics to be used are discussed in full. They also explain the OSHA Regulatory Process in detail, and also explain the Labor union and AFL-CIO position. [11] [12]

1991 The Institute for Evaluating Health Risks (IEHR) undertook to check on five studies used by the EPA to rule on the likely effects that PC'Bs had on the liver. They subsequently concluded that EPA's blanket condemnation of PCBs as a cause of cancer was in error.

Also, Dr Renate D Kimbrough who was associated with IEHR, did a survey for the Illinois Department of Public Health on the blood-lead levels in Illinois children living near a Superfund site (with predictable results). [13] Later they did a study, sponsored by General Electric, concerned with the cancer risk in workers exposed to PCBs. [3]

[Jack A Moore was also, at one time, the admissions secretary to the Society of Toxicology

1991 Thorne G. Auchter, now almost a full-time tobacco lobbyist (Federal Focus, Multinational Business Services and the Institute for Regulatory Policy (IRP)) writes, Towards Common Measures: Recommendations for a Presidential Executive Order on Environmental Risk Assessment and Risk Management Policy. (Washington, D.C.: Federal Focus, Inc., 1991).

This report to Vice President Dan Quayle by a conservative think-tank, provided justification for, an Executive Order they hoped President George HW Bush would issue. Mr. Bush demurred and the order was never signed.

[Vice President Dan Quayle, who is as thick-as-a-brick, was given the job of running a "Competitiveness Council".

1991 Apr- May Philip Morris make 4 payment to Thorne Auchter for Services in February related to the EPA and OSHA.

  • Apr -- $ 1,728.37 + $1,668.20 + $4,756.80 + 1,931.50
  • May -- $1,460.50 [14]

Auchter was also a silent partner in George Carlo's science for sale operation known as Health and Environmental Sciences (HES).
Right next to the direct payments which were made to Auchter. These accounts also lists (expenses?) payments made to HES of:

  • Jan -- $4,435.00 + $ 86.95 ex
  • Mar -- $5,600.00 + $67.40 ex
  • Apr -- $5,600.00 + $67.40 ex and $8,840.00 + $65.65
  • May -- $8,840.00 + $65.65 ex
  • June -- $13,019.00 + $36.00 +$6,320.00 +$150.20
  • Aug -- $12,707.50 + $182.16 ex
  • Oct -- $6,671.50 + $175.93 ex

1991 Sep The OSHA have issed a request for information on Indoor Air Quality. This is how they begin a 'Rule making' process.

1992 Feb The 'Comment Period' at the OSHA has formally expired (re IAQ)

1992 August The OSHA has a new Administrator. [15]

1992 Aug 21 Matt Swetonic of E. Bruce Harrison has written to Betsy Annese at RJ Reynolds Tobacco about his recent contact with science lobbyist George L Carlo. Carlo had worked with Swetonic when he ran a "flying circus of Dow scientists touring the country talking about the Agent Orange issue (dioxins)" He still had a working relationship with EBH doing joint projects for various chemical industry clients.

He tells Swetonic that Auchter and Tozzi were behind the pressure on the White House to release the Executive Order imposing Risk Assessment techniques on the regulatory agencies which had been prepared, but not issued by Reagan. It was being opposed by the EPA.

Carlo suggests a campaign to get scientists to support the Order. He believes they could be mobilized to support "risk assessment reform" via a series of symposiums, and he wants RJ Reynolds to fund. [16]


1992 Dec The EPA published a risk assessment of ETS that concluded that ETS caused lung cancer in adults and respiratory problems in children -- and classified it as a Group A carcinogen. [17]

1993 July 28 John A Moore (ex EPA) Director of the Institute for Evaluating Health Risks (IEHR) appeared before a House subcommittee on Risk Assessment

He also recommended improved procedures to establish quantitative risk estimates, encouraging data development so as to eliminate over-reliance on assumptions in the absence of data, and effective use of human data. [18]


1996 March European journalist discovered that Philip Morris had a secret German laboratory with a large contingency of scientists called INBIFO who were doing research of various kinds. A speech was hurriedly prepared to provide journalists with an outline of Philip Morris's research activities. It has been cleared by the legal department under Cathy Ellis. One section says:

You are probably aware of the increasing number of publications which claim that DNA changes occur following smoke exposure. We think that this is a trend which will continue in the future and that this trend is important to us because of the possible implications on risk assessment . Therefore, our primary objective is to gain the theoretical and practical knowledge necessary to critically analyze these claims .[19]

  1. ↑ William Reilly, editor, STATE OF THE ENVIRONMENT: A VIEW TOWARD THE NINETIES. (Washington, D.C.: The Conservation Foundation, 1977), pg. 425.
  2. ↑ [Source} Health Policy Advisory Center, Health PAC Bulletin, 1984
  3. ↑ New York Times, March 10 1999, Non-Profit Organizations Receiving Corporate Funding (CSPI)
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