THE IMPORTANCE OF LEADERSHIP

IN REGULATORY SCIENCE
Author: Johanny Pestalozzi, PhD

November 26th, 2020

AGENDA
1. About J. Pestalozzi
2. Introduction
3. Review Method
4. Key Concepts on
The Importance of
Leadership in Regulatory
Science
5. Conclusions
6. References

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INTRODUCTION Scope of leadership (modern definition)
• “ability of an individual, group or organization to "lead",
take charge or initiative, influence or guide other individuals,
teams, or entire organizations (and even an industry)”
• “to obtain their aid and support in the accomplishment of a
common task" (Western, 2019)

Scope of work of Regulatory Science (abbreviated definition)

• “Scientific and technical foundations (incl. methods, tools, and
approaches) for establishing regulations in various industries”
(Moghissi et al., 2014)
− E.g., pharmaceuticals, medical devices, and agrochemicals
(plant protection and fertilizers)
• Followed by regulatory laws & affairs, focusing on regulations’
promulgation, implementation, compliance, and enforcement
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INTRODUCTION Regulatory Regulatory Regulatory
Science Laws Affairs

• Purpose: to ensure product quality (efficacy) & safety

(health & environment)
• Stakeholders: Governmental organizations, businesses, end users,
and public
• Challenge: gap in pace & scope of implementation & substitution
− Technological innovations & knowledge transfer from
research to convert/incorporate them into policy
− Leading to economic growth & well-being in society

Scope of presentation: address the importance of leadership

as an enabler of regulatory science in the agro-chemical industry

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KEY CONCEPTS
IMPORTANCE OF LEADERSHIP IN REGULATORY SCIENCE

Concept 1 – Influence Concept 2 – Harmonization Concept 3 – Partnership

Research institutions, Coherence standards, Enable collaboration
politicians, and criteria, and between corporate,
companies in the processes governmental, and public
industry actors
• Translate into faster
• Focus on strategic approvals and • Dialogue on topics
topics availability of of social & corporate
(risk/innovation) quality products in relevance with a (multi-
• Commercial & the market disciplinary) & complex
regulatory relevance (modernization) reach
(safety and efficacy)
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 1. Databases
REVIEW METHOD Google Scholar, open access journals
(Science Direct, NCBI)
2. Keywords
leadership (regulatory science & regulation),
regulatory science, benefits of leadership,
regulatory science agrochemicals
3. Content selection
First, general interest (generation of hypotheses)
Second, narrowed down literature to key concepts
4. Documents reviewed:
First phase 25, second phase 15
5. Content production
Analysis of the literature and highlight of relevant concepts
Elaboration of a structure (Word), content compilation &
generation of slides (Power Point)

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 KEY CONCEPTS

Importance of Leadership in Regulatory Science

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Concept 1: Influence to focus on strategic topics

• Research institutions, politicians, and companies to apply innovative methods &

technologies for product/risk assessment, commercial & regulatory relevance
• Shape preventive and not reactive regulations, to avoid costs for businesses when
accidents happen (economic, social, reputational, and environmental nature)
• Patel and Miller (2012): historically, public health laws and regulations
− Established following public health tragedies
− Typically research tools & techniques to execute the laws: not synchronized with
public health needs
• Organophosphates, the most common agrochemical poison followed by herbicides
(Aggrawal, 2006)
− Organophosphate pesticides (OPP): nerve agent, inhibit acetylcholinesterase,
essential for normal function in insects, but also in humans and many other
animals (Goodman, 2011)
− Human and animal toxicity OPPs are a societal health and environmental concern Mango, a host-fruit of the Med-fly
(Goodman, 2011), e.g., malathion, an insecticide used in combating the
Mediterranean fruit fly, Med-fly (EPA, 2017)
• Key: Identify more efficient tools & techniques for risk assessment & management 8
Concept 2: Help harmonize standards, criteria, and processes
• Enable coherent standards across markets and align corporate goals with regulatory
processes & priorities and vice-versa (influence politics): faster approvals and availability
• Help investigate & define strategic regulatory management – current challenges
(Synergy Consulting, 2020):
− Lack of systematic approach for assessing the impact of pending and new
regulations on the business
− Unrealistic and unreasonable policy positions when engaging with regulators
• Agrochemical market is international in character, meeting a broad range of regulatory
requirements (even for the same products) - based on core sets of data with wide validity
(scientific evidence and evaluation) can facilitate approvals, (Rothstein et al., 1999)
− European Union (EU), Codex Alimentarius Commission (Codex), and North American
Free Trade Agreement (NAFTA) have tried to harmonize pesticide legislation:
maximum residue limits (MRLs) – but limits remain variable int. (Handford et al.,
2015)
• Key: “Globally harmonized pesticide standards would aid to increase productivity,
profits and trade, and enhance the ability to protect public health and the environment” Reichstag Building, Berlin, Germany
(Handford et al., 2015)
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Concept 3: Promote multi-sectoral partnerships
• Collaboration between corporate, governmental, and public actors
− Investment for multi-sectoral investigations and promote a direct dialogue
− Topics of social & corporate relevance, influencing the broad range of stakeholders
(considering sustainability, complexity, and multidisciplinary aspects)
• E.g., in the USA, migrant and seasonal farmworkers are the most susceptible to
organophosphate exposure
− 50% undocumented & in poverty: difficult to understand population (Villarejo, 2003)
− 70% faces linguistic barriers, cannot speak English well (NCFH, 2012)
− More likely: to suffer from chemical related ailments than the general U.S.
population & expose their families through contaminated clothing (Hansen and
Donohoe, 2003)
− Economic, social, and political barriers make passing policy and creating protective
measures less likely to occur (Quesada et al., 2017)
• Key: Comprehensive understandings of risk impact & populations most vulnerable on
chemical poisoning and how they are exposed
− Helps design regulatory measures to protect those groups (collaborative task)
Farm worker
− Prevents deaths and diseases, reduces negative headlines, and increases social
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acceptance of the organization and products, prevents possible lawsuits
 • Influence on topics of high relevance in the agrochemical industry
(due to high impact & probability risks)
CONCLUSIONS − Can be addressed in the industry to obtain a comprehensive
understanding on potential effects and how to prevent them
− Help generate preventive legislations (e.g., multi-disciplinary
research on potential behavior of certain molecules of
poisoning effect in humans and the environment)
• Facilitate a better alignment between corporate and
governmental goals
− Investigation of technologies & processes to improve
regulatory practices
− Define regulatory strategies within the organization to become
more competitive
− Helps to elaborate clear policy positions to engage with
regulators, increased success of approvals
• Promotion of collaboration among multi-sectoral stakeholders
− Improve knowledge transfer & dialogue, especially
comprehensive risk management/governance, translate into
increased product & corporate acceptance
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 Aggrawal, A., 2006. Agrochemical Poisoning, in: Tsokos, M. (Ed.), Forensic pathology reviews.
Humana Press, Totowa, NJ, pp. 261–327.
REFERENCES EPA, 2017. Malathion. Environmental Protection Agency. Archived from the original on 2017-05-
04.https://web.archive.org/web/20170504113220/https://www.epa.gov/pesticides#malathion
(accessed 23 November 2020).
Goodman, B., 2011. Pesticide Exposure in Womb Linked to Lower IQ. Health & Pregnancy. WebMD.
Archived from the original on 2011-04-24.
References
Aggrawal, A., 2006. Agrochemical Poisoning, in: Tsokos, M. (Ed.), Forensic pathology reviews.
Humana Press, Totowa, NJ, pp. 261–327.
EPA, 2017. Malathion. Environmental Protection Agency. Archived from the original on 2017-05-
04.https://web.archive.org/web/20170504113220/https://www.epa.gov/pesticides#malathion
(accessed 23 November 2020).
Goodman, B., 2011. Pesticide Exposure in Womb Linked to Lower IQ. Health & Pregnancy. WebMD.
Archived from the original on 2011-04-24.
Handford, C., Elliott, C., Campbell, K., 2015. A review of the global pesticide legislation and the scale
of challenge in reaching the global harmonization of food safety standards: Global Harmonization
of Pesticide Legislation. Integrated environmental assessment and management 11.
https://doi.org/10.1002/ieam.1635.
Hansen, E., Donohoe, M., 2003. Health issues of migrant and seasonal farmworkers. Journal of
Health Care for the Poor and Underserved. 14 (2): 153–164. doi:10.1353/hpu.2010.0790. ISSN
1049-2089.
Moghissi, A.A., Straja, S.R., Love, B.R., McBride, D.K., Stough, R.R., 2014. Innovation in Regulatory
Science: Evolution of a new scientific discipline. Technology & Innovation. 16 (2): 155–165.
doi:10.3727/194982414X14096821477027.

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 NCFH, 2012. Farmworker Health Factsheet. Archived copy (PDF). National Center For Farmworker

REFERENCES Health: Archived (PDF) from the original on 2015-09-22. Retrieved 2017-04-24.
https://web.archive.org/web/20150922001717/http://www.ncfh.org/uploads/3/8/6/8/38685
499/fs-facts_about_farmworkers.pdf (accessed 23 November 2020).
OECD, 2020. Agricultural Chemical Pesticide Registration.
https://www.oecd.org/env/ehs/pesticides-biocides/agricultural-chemical-pesticide-
registration.htm (accessed 20 November 2020).
Patel, M., Miller, M.A., 2012. Impact of regulatory science on global public health. The Kaohsiung
journal of medical sciences 28 (7 Suppl), S5-9. https://doi.org/10.1016/j.kjms.2012.05.003.
Quesada, J., Hart, L.K., Bourgois, P., 2017. Structural Vulnerability and Health: Latino Migrant
Laborers in the United States. Medical Anthropology. 30 (4): 339–362.
doi:10.1080/01459740.2011.576725.
Rothstein, H., Irwin, A., Yearley, S., McCarthy, E., 1999. Regulatory Science, Europeanization, and
the Control of Agrochemicals. Science, Technology, & Human Values 24 (2), 241–264.
https://doi.org/10.1177/016224399902400203.
Simon Shackley, B. Wynne, 1995. Global Climate Change: the Mutual Construction of an Emergent
Science-Policy Domain. Science and Public Policy 22 (4), 218–230.
Synergy Consulting, 2020. Regulatory Affairs Management.
https://www.synergyconsulting.ae/consultings/regulatory-affairs-management/ (accessed 20
November 2020).
Villarejo, D., 2003. The Health of U.S. Hired Farm Workers". Annual Review of Public Health. 24:
175–193. doi:10.1146/annurev.publhealth.24.100901.140901. PMID 12359914.
Western, S., 2019. Leadership: A critical text. London. Sage. ISBN 978-1-5264-5951-0.

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THANK YOU!
Johanny.pestalozzi@gmail.com

Contact: www.johannypestalozzi-pmc.com