Short History of the ISRTP
The journal RTP first appeared in June 1981 with an opening editorial by Fred Coulston and Albert Kolbye, and articles from John Frawley, Jeff Carr, James Smeets of the EU, and the Nobelist Joshua Lederberg. The announced scope of the journal was to converge and facilitate exchanges and understanding among scientists, regulators, and he regulated industries.
The Society itself was formed on November 26, 1984. Sixty-four charter members formed the Society. The society was incorporated in Washington D.C. on January 4, 1985.
A statement of the intent and scope of the Society was formulated in a 1995 as follows:
ISRTP is dedicated to promoting the social usefulness of health and safety (H&S) regulation worldwide. Toward this objective, ISRTP recognizes the following:
- must be transparent, fair, and open to public inspection. Dogmatic and authoritarian H&S regulation has no place in open and free societies. It should not be determined in a closed process accessible only to self-appointed experts.
- Individual lives are naturally precarious. No human action is absolutely safe. Hence, no H&S regulation can guarantee absolute safety. All H&S regulations require a trade-off between costs and benefits.
- Innovative risk taking in the face of unknown and unknowable potential risks and hazards is the hallmark of human enterprise, an intrinsic feature of human character, and the essential determinant of the success of the human race. H&S regulation should not mortify human enterprise.
- H&S concerns of individuals and societies are determined by known and objectively defined risks and hazards, as well as by fears of unknown or hypothetical dangers. While the former are moderated by acts of reasoned prudence, the latter raise concerns that cannot be resolved in a fully rational context. Still, irrational fears of the unknown are the unavoidable complement of the human psyche, and such that H&S regulation is forced to address.
- H&S regulation distinguishes risk assessment and risk management. The former provides the appraisal of the extent of risks and hazards, the latter establishes the actual modalities of regulation based on cost/benefit estimates and additional considerations of policy, ethics, and social values. For regulation to be factual and fair, risk assessment must be independent and scientifically objective to the extent possible. Equal objectivity must apply in the evaluation of costs and benefits of regulatory options.
- Risks and hazards in general are not uniformly distributed in a society. Therefore, risk management decisions will also account for ethical considerations that may be different in different locales. Issues of voluntary and involuntary risks perceived versus experienced risks, present versus future risks, and other considerations will be part of local value judgments in risk management.
- The scientific method is the exclusive warrantor of objectivity in the definition and assessment of H&S hazards and risks. Science comprises research hypotheses in search of validation as well as experimentally validated knowledge. Unlike experimentally validated knowledge, non-validated hypotheses cannot contribute to practical technology or to policy formulation. At the present time, science cannot provide all validated knowledge that is necessary or desirable in H&S regulation.
- For risks and hazards that can be objectively defined, the cost/benefit tradeoff options must include the direct costs and benefits of the regulation, as well as the totality of indirect cost/benefit consequences, and the opportunity costs and benefits of marginal economic ramifications.
- Comprehensive cost/benefit estimates are not feasible for risks and hazards that remain hypothetical or conjectural. However, for such hypothetical hazards it is possible to estimate the economic cost/benefit of progressive use restrictions, and such estimates ought to inform regulatory decisions.
- Global trends point to a common world market. Although regional H&S regulatory differences will persist, it is desirable that certain fundamental principles and a common language of regulation be accepted worldwide.
- Fairness, endurance, and international acceptance demand that H&S regulation be factually objective, politically neutral, and non-partisan. ISRTP seeks to be an important voice in the construction of H&S regulation. It promotes studies, research, meetings, and debates on general and specific issues, and provides expert advice in legislative and administrative proceedings. ISRTP proclaims an international interest in H&S regulation, conscious that international offerings provide useful terms of reference and a diversity of experiences and solutions. An international dialogue on H&S regulation will improve local decisions, reduce regional differences, lift barriers to free communication and trade, and will ultimately contribute to an incremental process of civilization.
Over the years the “manifesto” has evolved into a strategic plan adopted by Society in 2003 and revised January 14, 2016, as follows:
ISRTP Strategic Plan
The purpose of the Society is to provide an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and health, and the environment.
To fulfill the Society’s Mission Statement, three objectives must be met.
- The first is identifying and prioritizing scientific issues that would affect the development, modification, or application of regulations affecting human health and safety and the environment.
- The second is identifying and engaging the policy makers and scientists who would be most concerned with developing, modifying, or applying those regulations, or affected by their development, modification, or application.
- The third is providing an open public forum promoting the evaluation and application of sound toxicologic and pharmacologic science as a basis for developing new regulations or for modifying or applying existing regulations affecting human health and safety and the environment.
Current and emerging scientific information and issues that are likely to affect either the development of new regulations or the modification or application of existing regulations in the areas of human health, safety, and/or the environment, will be identified through input from the members of the Society and others. The Council will then assign priorities to these issues on the basis of their potential impact on regulation and science.
Policy makers and scientists will be identified who would be impacted by or interested in any regulatory action that might be affected by the evaluation and application of the scientific data or principles involved with high priority issues. If an issue goes forward, These policy makers and scientists will be engaged if possible. These may be representatives of regulatory agencies, consumer or environmental organizations, and industry companies or organizations. The Society will encourage participation in its informational activities by all policy makers and scientists who have, or should have, an interest in a particular issue.
The Society will provide open public forums by sponsoring a peer-reviewed scientific journal where the results of all credible scientific investigations affecting regulation can be published, and by sponsoring conferences where issues can be fully evaluated and discussed. In sponsoring conferences, the Society recognizes the importance of outreach and cooperation with other organizations with similar goals, and will make every effort to leverage members’ participation in such organizations to forward the mission of the Society. The Society will make every effort to ensure that scientifically valid alternative viewpoints are represented in the journal and at conferences.
Additionally, the Council will consider a free-access Internet journal, which would increase the public availability of information provided. Other innovations to be considered include: special lower or no cost page charges for government, full time students, and/or consumer/environmental groups, and a special section for opinions, rather than scientific papers, which could focus on government pronouncements or other published or expressed opinions from opposing sides. Although this latter may not be science, it might help to focus issues, and identify the sound toxicologic and pharmacologic science underlying the potential regulation at issue.
A Public Awareness Committee will be assembled to identify programs to increase awareness of the Society, particularly among policy makers and scientists, as a principal source of the sound toxicologic and pharmacologic science that can serve as a basis for regulation affecting human health and safety and the environment. This committee will also identify the resources necessary to carry out these programs. The Council will then determine which programs to pursue.
A Financial Committee will be assembled to consider all potential sources of funding, including requests to foundations, membership dues, sponsorships of conferences, etc. A specific dollar goal will be given to the Committee by the Council.
The Council will review the Strategic Plan before each annual membership meeting, beginning in 2005, and will report on any changes to the Plan at the annual meeting.