Canadian Regulatory Perspective on Next Generation Risk Assessments for Pest Control Products and Industrial Chemicals

In 2012, the Council of Canadian Academies published the expert panel on integrated testing of pesticide’s report titled: Integrating emerging technologies into chemical safety assessment. This report was prepared for the Government of Canada in response to a request from the Minister of Health and on behalf of the Pest Management Regulatory Agency. It examined the scientific status of the use of integrated testing strategies for the regulatory health risk assessment of pesticides while noting the data-rich/poor dichotomy that exists when comparing pesticide formulations to most industrial chemicals. It also noted that the adoption of integrated approaches to testing and assessment (IATA) strategies may refine and streamline testing of chemicals, as well as improve results in the future. Moreover, the experts expected to see an increase in the use of integrated testing strategies over the next decade, resulting in improved evidence-based decision-making. Subsequent to this report, there has been great advancements in IATA strategies, which includes the incorporation of adverse outcome pathways (AOPs) and new approach methodologies (NAMs). This perspective provides the first Canadian regulatory update on how Health Canada is also advancing the incorporation of alternative, non-animal strategies, using a weight of evidence approach, for the evaluation of pest control products and industrial chemicals. It will include specific initiatives and describe how this work is leading to the creation of next generation risk assessments. It also reflects Health Canada’s commitment towards implementing the 3Rs of animal testing: reduce, refine and replace the need for animal studies, whenever possible.

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Upholding the EU's Commitment to ‘Animal Testing as a Last Resort' Under REACH Requires a Paradigm Shift in How We Assess Chemical Safety to Close the Gap Between Regulatory Testing and Modern Safety Science

Alternatives to Laboratory Animals ◽

10.1177/02611929211040824 ◽

2021 ◽

pp. 026119292110408

Author(s):

Julia Fentem ◽

Ian Malcomber ◽

Gavin Maxwell ◽

Carl Westmoreland

Keyword(s):

European Commission ◽

Paradigm Shift ◽

Modern Science ◽

Transformational Change ◽

Weight Of Evidence ◽

Animal Testing ◽

Chemical Safety ◽

Policy Makers ◽

Safety Science ◽

Animal Safety

Animal use for testing chemicals under REACH continues to increase, despite advances in non-animal safety science during the past 15 years. The application of modern science and technology, and the use of ‘next generation’ weight-of-evidence assessment approaches, are embedded in EU guidance for establishing the safety of cosmetics and foods – and of the ingredients used in these products. However, this is still not the case for the regulation of chemicals. Under the new Chemicals Strategy for Sustainability, thought leaders in human health and environmental protection are calling on the European Commission to quickly embrace the benefits of modern and innovative non-animal safety science, in place of outdated animal testing, if the EU is to be a leader in safe and sustainable innovation under the European Green Deal transformational change ambitions. The European Commission also needs to enable companies to meet their legal obligation to only conduct animal testing as a last resort, by providing a more flexible, science-based and consistent regulatory framework for assuring chemical safety, which supports the integration of data from different sources. We are at a tipping point for closing the gap between regulatory chemicals testing and modern safety science. It is time to join forces, across policy makers, scientists, regulators and lawyers, to lead the paradigm shift needed to deliver what EU citizens want – namely, chemicals and products that are safe and sustainable, without resorting to animal testing.

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Concept of REACH and impact on evaluation of chemicals

Human & Experimental Toxicology ◽

10.1177/0960327107087801 ◽

2008 ◽

Vol 27 (1) ◽

pp. 5-21 ◽

Cited By ~ 28

Author(s):

H Foth ◽

AW Hayes

Keyword(s):

Safety Data ◽

Weight Of Evidence ◽

Main Task ◽

The European Union ◽

Industrial Chemicals ◽

Chemical Safety ◽

Substantial Impact ◽

Production Chain ◽

Acceptable Risks ◽

Address Data

Industrial chemicals have been in use for many decades and new products are regularly invented and introduced to the market. Also for decades, many different chemical laws have been introduced to regulate safe handling of chemicals in different use patterns. The patchwork of current regulation in the European Union is to be replaced by the new regulation on industrial chemical control, REACH. REACH stands for registration, evaluation, and authorization of chemicals. REACH entered force on June 1, 2007. REACH aims to overcome limitations in testing requirements of former regulation on industrial chemicals to enhance competitiveness and innovation with regard to manufacture safer substances and to promote the development of alternative testing methods. A main task of REACH is to address data gaps regarding the properties and uses of industrial chemicals. Producers, importers, and downstream users will have to compile and communicate standard information for all chemicals. Information sets to be prepared include safety data sheets (SDS), chemical safety reports (CSR), and chemical safety assessments (CSA). These are designed to guarantee adequate handling in the production chain, in transport and in use and to prevent the substances from being released to and distributed within the environment. Another important aim is to identify the most harmful chemicals and to set incentives to substitute them with safer alternatives. On one hand, REACH will have substantial impact on the basic understanding of the evaluation of chemicals. However, the toxicological sciences can also substantially influence the workability of REACH that supports the transformation of data to the information required to understand and manage acceptable and non acceptable risks in the use of industrial chemicals. The REACH regulation has been laid down in the main document and 17 Annexes of more than 849 pages. Even bigger technical guidance documents will follow and will inform about the rules for application and work out of dossiers. The following article gives a comprehensive overview on the concept of REACH to give deeper insight into this document. Members of the scientific community will have to define their own position as researchers, teachers, and experts to support the efforts to protect human health and the environment. The concept of REACH as well as new approaches to adapt standard testing regimes to foster a risk oriented approach in required work load to decrease animal based tests and to strengthen weight of evidence are explained in detail in this article.

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Addressing Human Variability in Next-Generation Human Health Risk Assessments of Environmental Chemicals

Environmental Health Perspectives ◽

10.1289/ehp.1205687 ◽

2013 ◽

Vol 121 (1) ◽

pp. 23-31 ◽

Cited By ~ 71

Author(s):

Lauren Zeise ◽

Frederic Y. Bois ◽

Weihsueh A. Chiu ◽

Dale Hattis ◽

Ivan Rusyn ◽

...

Keyword(s):

Health Risk ◽

Human Health ◽

Human Health Risk ◽

Environmental Chemicals ◽

Risk Assessments ◽

Next Generation ◽

Health Risk Assessments

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Assessment of hearing dysfunction induced by industrial chemicals in presence or absence of noise: A weight of evidence approach

Toxicology ◽

10.1016/j.tox.2010.08.137 ◽

2010 ◽

Vol 278 (3) ◽

pp. 374

Author(s):

Adolf Vyskocil ◽

François Lemay ◽

Tony Leroux ◽

France Gagnon ◽

Martine Gendron ◽

...

Keyword(s):

Weight Of Evidence ◽

Industrial Chemicals

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Surveying the Chemical Anthropocene

Environment and Society ◽

10.3167/ares.2021.120111 ◽

2021 ◽

Vol 12 (1) ◽

pp. 181-202

Author(s):

Yogi Hale Hendlin

Keyword(s):

Conflicts Of Interest ◽

Chemical Exposure ◽

Risk Assessments ◽

Costs And Benefits ◽

Toxic Chemical ◽

Chemical Safety ◽

Social Fabric ◽

Sociotechnical Imaginaries ◽

Financial Conflicts Of Interest ◽

Safety Assessments

Faced with the non-optional acceptance of toxic chemical artifacts, the ubiquitous interweaving of chemicals in our social fabric oft en exists out of sight and out of mind. Yet, for many, toxic exposures signal life-changing or life-ending events, phantom threats that fail to appear as such until they become too late to mitigate. Assessments of toxicological risk consist of what Sheila Jasanoff calls “sociotechnical imaginaries,” arbitrations between calculated costs and benefits, known risks and scientifically wrought justifications of safety. Prevalent financial conflicts of interest and the socially determined hazards posed by chemical exposure suggest that chemical safety assessments and regulations are a form of postnormal science. Focusing on the histories of risk assessments of pesticides such as DDT, atrazine, PFAS, and glyphosate, this article critically reviews Michel Serres’s notion of “appropriation by contamination.”

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Chapter 23. Integrated Testing Strategies and the Prediction of Toxic Hazard

In Silico Toxicology - Issues in Toxicology ◽

10.1039/9781849732093-00584 ◽

2010 ◽

pp. 584-605 ◽

Cited By ~ 5

Author(s):

M. Balls

Keyword(s):

Testing Strategies ◽

Integrated Testing ◽

Toxic Hazard

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Conclusion: The “Next Gen” Public Service

The Government-Industrial Complex ◽

10.1093/oso/9780190851798.003.0005 ◽

2018 ◽

pp. 156-178

Author(s):

Paul C. Light

Keyword(s):

Public Service ◽

Industrial Complex ◽

Next Generation ◽

Federal Employees ◽

Public Servants ◽

The Government

Chapter 5 closes the book with a discussion of the “next gen” public service. Even as Congress and the president embrace the regular reblending using the “reset and trade” system proposed in chapter 4, they must assure that the government-industrial complex embraces a continued commitment to public service, a mission that matters to the nation’s future, and a workforce that brings new vitality to aging institutions. Federal employees are going to retire in record numbers over the next decade, but their departures will not create a destructive “retirement tsunami” if Congress and the president act now to recruit and train the next generation of public servants wherever they work in the government-industrial complex.

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Alfabeticemos! Let’s Teach Literacy!

Operation Pedro Pan and the Exodus of Cuba's Children ◽

10.5744/florida/9781683401551.003.0003 ◽

2020 ◽

pp. 63-104

Author(s):

Deborah Shnookal

Keyword(s):

Education Reform ◽

Political Culture ◽

Participatory Democracy ◽

Next Generation ◽

Literacy Campaign ◽

Parents And Children ◽

The Government ◽

The Impact ◽

Hearts And Minds

The Cuban revolutionary government prioritized education reform as the key to lifting the country out of underdevelopment and creating a new political culture of participatory democracy, epitomized by the 1961 literacy campaign. Fidel Castro’s opponents, however, regarded this campaign as evidence of the “communist indoctrination” by the government of young Cubans and were therefore determined to “save” as many children as possible by sending them to Miami until Castro was ousted. This chapter takes a detailed look at how the battle for the hearts and minds of the next generation unfolded with the mobilization of 100,000 teenagers as literacy brigadistas to teach in the mountains and remote parts of the island. It examines the objectives of the campaign, the recruitment propaganda used to mobilize the Conrado Benítez brigades, how the campaign affected relations between parents and children, and the impact that participation in the campaign had on a generation of revolutionary youth.

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