History of Risk Assessment in Toxicology

Sol Bobst

• Publisher: Academic Press
• Year: 2017
• Print ISBN: 9780128095324
• eBook ISBN: 9780128095430
• Topic: Medicine
• Subtopic: Medical Theory, Practice & Reference

History of Risk Assessment in Toxicology guides the reader through the historical narrative of the evolution of risk assessment thinking in human and environmental practices. Risk assessment concepts are used in many different professional practice areas. In the health and environmental practices of risk assessment, the critical issue is often what chemical concentration in air, water, food, or a solid substance is acceptable, or considered not to result in any adverse effect.The book reviews examples from early scientific and health studies to showcase the foundations of risk assessment. The book also explores the development of risk assessment as practiced by major regulatory bodies such as the US Food and Drug Administration (FDA), the Occupational Safety & Health Administration (OSHA), and the US Environmental Protection Agency (EPA) to reveal how risk assessment has evolved in the 20th and 21st centuries.Modern technology has created opportunities in silicon in vitro, computational modeling, omics, and big data techniques to assess the toxicity of chemicals, while traditional approaches to risk assessment are being challenged with new and innovative approaches. Finally, current issues being debated and tested in risk assessment are outlined with possible future avenues suggested.- Presents the first dedicated history on the evolution of risk assessment in toxicology- Reviews the development of major US and EU regulatory bodies- Provides a context to current debates surrounding the future of risk assessment- Reviews examples from early scientific and health studies to showcase the foundations of risk assessment

Chapter 1

Prehistory of Risk Assessment

Origins of Human Tragedies and Concepts of Risk

Sol Bobst, ToxSci Advisors, Houston, TX, United States

Abstract

In modern human civilization, the devastation caused by human disease, war, and natural disasters is well documented. Some discussion of these topics is warranted in an introduction to the history of risk assessments, to set the stage of defining and understanding what risk was.

Keywords

Risk; chance; assessment; cancer; scientific methods

1.1 Introduction

In modern human civilization, the devastation caused by human disease, war, and natural disasters is well documented. Some discussion of these topics is warranted in an introduction to the history of risk assessment, to set the stage for defining and understanding what risk was. The following table below shows some of the devastating illnesses, the times they were noted, and the death toll they created.

Disease	Timeline	Death Toll
Tuberculosis	Prerecorded time	Unknown > Millions
Influenza	4000 BC–Present	Unknown > Millions
Malaria	3000 BC–Present	Unknown > Million
Bubonic plague	500/1300 AD	>25 million people
Measles	800 AD –Present	> Hundreds of thousands
Typhus	1400−1500 AD	> Hundreds of thousands
Chicken pox	1500 AD	Unknown > Millions
Yellow fever	1500 to present	> Hundreds of thousands
Small pox	1500 BC–20th century	> 7 million people (Roman Epidemic)

These tragedies and experiences helped to develop the idea of adverse outcomes and the need for responding to public health needs. While medicine would take several centuries to modernize to address sanitation in health, these human experiences are noteworthy in the development of ideas of risk.

1.2 The Mathematical Development of Risk Concepts

Before there was a concept of risk, there were concepts of the mathematical ideas around chance. Some of the first to document principles of probability include Girolamo Cardano (1500–71) who wrote a book titled Liber de Ludo Aleae (Books on Game of Chance). John Graunt published a compilation on the birth and death records in London from 1604 to 1661 titled The Natural and Political Observations made upon the Bills of Mortality. Thus, this was a historical example of how often an unwanted outcome in death or birth may happen as a rate of occurrence within a larger population, or show any trends or changes over a period of time.

1.3 Percivall Pott and Chimney Sweepers

An important milestone in any risk assessment history timeline would have to include Percivall Pott’s study of chimney sweepers and the incidence of Soot wart (skin cancer on the scrotum). It is known as the first documented case of occupationally related cancer. This work was published in 1775. By 1778, the British Parliament passed an act where children engaged in chimney sweep work should be required to take a bath at least once a week, in order to remove soot from their body, which Percivall had suggested was an associated or causative agent in the development of the warts, and if continuingly irritated, the development of scrotal cancer. The historical importance of Pott’s work was directly helpful in responding the Spinner’s Mule Cancers a little over 100 years later in 1890, where the spinner would use mineral oil in the occupation, and the soot also resulted in scrotal cancer. This helped continue a trend of associated exposure with effect, and the management of the risk by controlling the occupational environment, or by changing hygiene practices.

1.4 Industrial Smog and Regulatory Responses

The distribution of electric power that came from coal-fired power for steam, and then eletrical power plants in the early-to-late 1800s resulted in some written descriptions of London smog in the Victorian era, like that of Flora Tristan in the London Journal, who wrote in 1839: “Over every English town there hangs a pall compounded of the Ocean vapours that perpetually shroud the British Isles, and the heavy noxious fumes of the Cyclops’ cave”. Another famous documentation of industrial pollution is Monet’s painting of London looking at Parliament in 1899 that appeared to give the impression of smog. The Industrial Revolution thus caused smog conditions around many population centers globally. One well known tragedy of this smog without regulation was the great “Smog of London” which occurred from December 5–9, in 1952. This was a result of the heavy coal emissions combined with a period of cold weather, anticyclone, and windless conditions resulting in respiratory ailments that caused 4000–12,000 deaths, and over 100,000 became sick or were hospitalized with respiratory illnesses. The response was the passing of the Clean Air Act in 1956 and 1958, which provided financial incentives for individual homes to not use coal to heat their homes; it is suggested that it took up to 10 years to observe a notable change in air quality in the city of London. Air pollution continues to be a problem for major metropolitan areas, such as Beijing and other cities in China, with large industrial complexes as well as automotive traffic filling the air with particulates and other forms of soot. Air quality and regulation continues to be an challenge for policy makers and industrial/community stakeholders to manage to improve health and quality of life.

1.5 The Narrative of the History of Toxicological Risk Assessment

This book is admittedly narrow in scope, but this is also due to the fact that toxicological risk assessment is a niche practice by definition. However, the practice of risk assessment spans several industries, including food, industrial chemicals, consumer products, and pharmaceutical development. From a historical perspective, this book addresses the narrative of how legislation and risk assessment practices have developed over time. Risk assessment involves both the traditional scientific methods and development of data, and it also has a subjective element of human perception that influences how decisions are made. The book and the authors have explained the narrative of risk assessment by showing these case study examples. The narrative of this short book will illustrate to the reader how current regulations around risk assessment in the US EPA and FDA have developed, and this leads to the current topics of the emerging issues and current debates that are ongoing today, about how we as a scientific community practice risk assessment.

Further Reading

1. https://en.wikipedia.org/wiki/List_of_natural_disasters_by_death_toll.

2. Bernstein PL. Against the Gods: The Remarkable Story of Risk New York: Wiley; 1996.

3. https://en.wikipedia.org/wiki/Chimney_sweeps%27_carcinoma.

4. http://www.mytimemachine.co.uk/?p=62.

5. http://www.metoffice.gov.uk/learning/learn-about-the-weather/weather-phenomena/case-studies/great-smog.

6. https://en.wikipedia.org/wiki/Pollution_in_Chi...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• List of Contributors
• Preface
• Series Introduction
• Chapter 1. Prehistory of Risk Assessment: Origins of Human Tragedies and Concepts of Risk
• Chapter 2. Risk Assessment in the 20th Century Part I: Early Lessons in Food and Drug Safety
• Chapter 3. History of European and Global Regulation of Risk Assessment
• Chapter 4. The History of Risk Assessment Within OSHA and ACGIH: Asbestos Case Study
• Chapter 5. Risk Assessment in the 21st Century: New Technologies and Techniques