Introduction
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Part 1 - Definitions to Support the National Gene Technology Scheme
Q1: What other objectives might guide the updating of definitions?
Response
Not addressed
Q2: How might we improve the regulatory flexibility of definitions within the National Gene Technology Scheme, whilst maintaining protections for human health and the environment?
Response
Not addressed
Q3: What other issues should be taken into account when considering how best to ensure that humans are not regulated as GMOs?
Response
Not addressed
Q4: Given the benefits and challenges of defining terms in legislation, what other mechanisms might be used to provide the clarity required?
Response
Not addressed
Part 2 - Risk-Proportionate Regulation Through Risk Tiering and Appropriate Regulatory Approaches
Q5: Are there any other key objectives/considerations that should be taken into account in designing a risk-proportionate approach to regulation?
Response
Key Points
RE QUESTION 5
• Principles of risk management currently used in a diverse range of management systems should be used to enhance the principles basis for risk-proportionate gene-technology regulation.
• Process oriented rather than final product-oriented hazard analysis of new breeding technologies is illustrated in recent research publications.
• The potential of new breeding technologies to give greater precision in genetic modification requires the concurrent implementation of effective quality assurance systems throughout the new product development chain.
Principles of risk management currently used in a diverse range of management systems should be used to enhance the principles basis for risk-proportionate gene-technology regulation.
The issues paper Part 2.2 lists Objectives of risk-proportionate regulation and identifies objectives as follows.
It is important that work to progress a risk-proportionate approach is guided by agreed objectives,
including that it should:
• efficiently respond to changes in scientific understandings of GMOs and the risks they may pose…
I propose an expanded revision of the objectives for risk proportionate regulation as follows:
It is important that work to progress a risk-proportionate approach is guided by agreed objectives, including that it should:
• efficiently respond to changes in scientific understandings of GMOs and the risks they may pose.
• draw on accepted principles of risk assessment and management, is structured, systematic and timely, with assurance of safety being built into each GMO by risk prevention at all stages of the development process
• respond to changes in scientific understanding of the processes in which gene technologies are used,
• …
Explicit mention of process-related risks and objectives and accumulated knowledge on management systems would assist the formulation of principles-based regulations, as these concepts have a rich history. Risk management systems are applied in many fields of engineering, technology and project management, and highly relevant general principles have emerged from this experience.
A key tool that has emerged is failure mode and effects analysis (FMEA; Montgomery 2009, Adams and Moss 2008, Luning and Marcelis 2009), which involves proactive identification of hazards, uncertainties, potential failures and errors, and systematically prioritising them according to likelihood and potential impact – the essence of risk-proportionate regulation.
This project management tool is widely used in the food industry for quality and safety assurance, primarily as the starting point of Hazard Analysis and Critical Control Points (HACCP) safety assurance systems. It has led to identification of seven essential principles of HACCP (Adams and Moss 2008, CAC 1997) that could form the backbone of a modernised principle-based approach to risk-proportionate regulation.
Key principles of HACCP used in the food industry (Adams and Moss 2008, CAC 1997) are
1) Conduct a hazard analysis.
2) Determine the Critical Control Points (CCPs).
3) Establish critical limits.
4) Establish a system to monitor control of the CCP
5) establish corrective action to be taken when monitoring indicate that a particular CCP is not under control.
6) Establish procedures to verify that the HACCP system is working effectively.
7) Establish documentation concerning all procedures and records appropriate to these principles and their application.
Standards for food safety programs (food safety management systems) that incorporates HACCP principles include the International Standards Organisation (ISO) 22000 series standards (e.g most recently ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain, but generally the ISO systems discussed in Chapter 7, 7.6 Quality assurance from a chain perspective, by Luning and Marcelis 2009).
Key elements to ensure safety.
In discussing ISO 22000 Luning and Marcellis (2009) nominate the following key elements to ensure food safety along the food supply chain as follows:
1) Prerequisite programs such as codes of good manufacturing practice and good hygienic practices.
2) Hazard analysis and critical control point principles (as listed above).
3) The monitoring procedures used in process control.
4) System management which is documented in a written manual and which includes documentation associated with food safety programs (food safety management systems).
5) Interactive communication.
Clear recognition of suitably adapted versions of these key elements as discussed below could enhance systematic assurance of the safety of new gene-technologies and lessen the chances of bias and gaps in risk management. The key elements are part of frameworks that are best practice in a variety of fields, from food manufacturing to new drug discovery; from business management practice to best government legislative practice.
Although this body of knowledge is quite extensive (See note 1), the main points can be captured succinctly and effectively. The Therapeutic Goods Administration does this well in their webpage overview of how these system management ideas are used in medical Good Manufacturing Practice ( TGA 2017 ). David Hoyle (2009) does this concisely in an introductory chapter on best management practices for business operations. Excellence Through Stewardship (2016) show how this applies to laboratory operations that use gene-technology (ETS 2016).
What could emerge from the Phase I Issues paper consultation is explicit roadmaps that take full advantage of this history of good system management practice.
Process oriented rather than final product-oriented hazard analysis of new breeding technologies is illustrated in recent research publications.
In the literature just mentioned, general principles for hazard analysis of manufacturing operations, engineering design projects, and microbial contamination of food are well described, but hazard analysis of gene-technology is less extensive.
Recent scientific publications illustrate how hazard and failure mode and effects analysis might be applied to the biological and intracellular processes that are the first stage of new gene technology deployment. These publications illustrate that the potential of new breeding technologies to give greater precision in genetic modification will require the concurrent implementation of best practices in quality assurance throughout the chain of new product development.
Young et al. 2019 illustrate how genetic process-related risk can emerge and provide context for interpreting it. Young et al. show DNA template used for homologous recombination directed repair of targeted single standard breaks can lead to unintended (foreign) inserts at the target site. Extensive use of genomic sequencing technologies and bioinformatics was needed to detect unexpected events, and third-party auditing of findings was useful.
These workers demonstrate how such risks can be mitigated (and cite Wei et al. 2018 on this). They mention mitigation by selective genetic screening of candidate progeny, and by choosing single-stranded oligodeoynucleotide repair templates in gene editing procedures. Young et al. 2019 also argue that with gene editing risks of off target changes may be small compared with (i) background mutation events (normal level of DNA replication errors) appearing in progeny each generation of natural mating, and (ii) the large numbers of single nucleotide polymorphism differences among breeds of cattle. The historical background of genetic and phenotypic variability from conventional breeding provides evidence about the boundaries of generally safe genetic variation. These are considerations which are relevant to evaluation of proportionate risk.
General principles highlighted by these reports are that (i) deployment of best laboratory management practices can mitigate risks from gene technologies, and (ii) proportionate genetic risk of new breeding technology should be judged against the unavoidable background level of risks from conventional breeding.
Note 1.
Food safely management systems are elaborated by Codex Alimentarius Commission (1997), and in several resources published by Food Standards Australia New Zealand. Australian Standard/New Zealand standard ISO 31000:2009 and Department of Health and Aging 2013 provides systematic risk management principles, and the latter document at page 18, under Guiding principles of risk analysis, elaborates many of these management principles in a gene technology context.
Excellence Through Stewardship (ETS) publications such as Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products (2016) available at https://www.excellencethroughstewardship.org/ show how these management principles relate to crop GMO development for use in agricultural applications. Module 1: Research in the Laboratory in this ETS document explains how these management principles apply to laboratory work with GMOs. The Therapeutic Goods Administration provides and overview of how these system management ideas fit into medical Good Manufacturing Practice ( https://www.tga.gov.au/good-manufacturing-practice-overview Good manufacturing practice - an overview 29 September 2017; https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products Manufacturing principles for medicinal products 2 January 2018). The book Golden Rice: The Imperiled Birth of a GMO Superfood (Regis 2019) provides an extensive narrative on the problems of misdirected regulatory objectives, highlighting the value of a systems management approach.
Bibliography
Australian Standard/New Zealand standard ISO 31000:2009. Risk Management--Principles and guidelines.
Adams M R and M O Moss 2008. Chapter 11. Controlling the microbiological quality of foods. In Food Microbiology 3rd Ed. RCH Publishing.
Codex Alimentarius Commission (CAC) 1997. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application: Annex to CAC/RCP 1-1969, Rev.3 (1997). Codex Alimentarius Commission (CACV), Geneva. http://www.fao.org/docrep/004/y1579e/y1579e03.htm
Department of Health and Aging 2013. Risk Analysis Framework Version 4 ISBN 978-1-74241-953943-5
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
Excellence Through Stewardship (ETS) 2016. Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products available at https://www.excellencethroughstewardship.org/
Food Standards Australia New Zealand (FSANZ) 2015. Food Standard Code 3.2.1 . Food Safety Programs. https://www.foodstandards.gov.au/industry/safetystandards/programs/Pages/default.aspx Webpage August 2015.
Food Standards Australia New Zealand (FSANZ) 2007. Food Safety Programs. A guide to Standard 3.2.1 Food Safety Programs.
Hoyle, David 2009. Chapter 1 Putting ISO 9000 in Context pages 1-20 in ISO 9000 Quality Systems Handbook.
International Standards Organisation (ISO) 2008. Quality management systems – Requirements. (ISO 9001:2008). International Organization for Standardization (ISO), Geneva. http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm;
ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain https://www.standards.org.au/standards-catalogue/international/iso-slash-tc--34-slash-sc--17/iso--22000-colon-2018
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019. https://www.ich.org/page/safety-guidelines accessed 26 November 2019.
Luning, P. A. and Willem J Marcelis 2009. Food Quality Management: Technological and Managerial Principle and Practices. Wageningen Academic Publishers.
Montgomery D C 2009. Chapter 2. The DMAIC problem solving process. In Statistical Quality Control: A Modern Introduction 6th Ed. John Wiley.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) 2017. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13, 01 January 2017
Regis, Ed 2019. The Imperiled Birth of a GMO Superfood, Johns Hopkins University Press.
Therapeutic Goods Administration 2017. Good manufacturing practice - an overview 29 September 2017 https://www.tga.gov.au/good-manufacturing-practice-overview
Therapeutic Goods Administration 2018 Manufacturing principles for medicinal products 2 January 2018 https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products
US Food and Drug Administration (FDA) 2018. (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs ). Content current as of 03/16/2018.
Wei, Jingwei et al. 2018. Cattle with a precise, zygote mediated deletion safely eliminate the major milk allergen betalactoglobuline. Science Reports 8:7661 DOI:10.1038/s41598-018-25654-8)
Young, Amy E. et al 2019. Genomic and phenotypic analyses of six offspring of a genome-edited hornless bull Nature Biotechnology https://doi.org/10.1038/s41587-019-0266-0
RE QUESTION 5
• Principles of risk management currently used in a diverse range of management systems should be used to enhance the principles basis for risk-proportionate gene-technology regulation.
• Process oriented rather than final product-oriented hazard analysis of new breeding technologies is illustrated in recent research publications.
• The potential of new breeding technologies to give greater precision in genetic modification requires the concurrent implementation of effective quality assurance systems throughout the new product development chain.
Principles of risk management currently used in a diverse range of management systems should be used to enhance the principles basis for risk-proportionate gene-technology regulation.
The issues paper Part 2.2 lists Objectives of risk-proportionate regulation and identifies objectives as follows.
It is important that work to progress a risk-proportionate approach is guided by agreed objectives,
including that it should:
• efficiently respond to changes in scientific understandings of GMOs and the risks they may pose…
I propose an expanded revision of the objectives for risk proportionate regulation as follows:
It is important that work to progress a risk-proportionate approach is guided by agreed objectives, including that it should:
• efficiently respond to changes in scientific understandings of GMOs and the risks they may pose.
• draw on accepted principles of risk assessment and management, is structured, systematic and timely, with assurance of safety being built into each GMO by risk prevention at all stages of the development process
• respond to changes in scientific understanding of the processes in which gene technologies are used,
• …
Explicit mention of process-related risks and objectives and accumulated knowledge on management systems would assist the formulation of principles-based regulations, as these concepts have a rich history. Risk management systems are applied in many fields of engineering, technology and project management, and highly relevant general principles have emerged from this experience.
A key tool that has emerged is failure mode and effects analysis (FMEA; Montgomery 2009, Adams and Moss 2008, Luning and Marcelis 2009), which involves proactive identification of hazards, uncertainties, potential failures and errors, and systematically prioritising them according to likelihood and potential impact – the essence of risk-proportionate regulation.
This project management tool is widely used in the food industry for quality and safety assurance, primarily as the starting point of Hazard Analysis and Critical Control Points (HACCP) safety assurance systems. It has led to identification of seven essential principles of HACCP (Adams and Moss 2008, CAC 1997) that could form the backbone of a modernised principle-based approach to risk-proportionate regulation.
Key principles of HACCP used in the food industry (Adams and Moss 2008, CAC 1997) are
1) Conduct a hazard analysis.
2) Determine the Critical Control Points (CCPs).
3) Establish critical limits.
4) Establish a system to monitor control of the CCP
5) establish corrective action to be taken when monitoring indicate that a particular CCP is not under control.
6) Establish procedures to verify that the HACCP system is working effectively.
7) Establish documentation concerning all procedures and records appropriate to these principles and their application.
Standards for food safety programs (food safety management systems) that incorporates HACCP principles include the International Standards Organisation (ISO) 22000 series standards (e.g most recently ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain, but generally the ISO systems discussed in Chapter 7, 7.6 Quality assurance from a chain perspective, by Luning and Marcelis 2009).
Key elements to ensure safety.
In discussing ISO 22000 Luning and Marcellis (2009) nominate the following key elements to ensure food safety along the food supply chain as follows:
1) Prerequisite programs such as codes of good manufacturing practice and good hygienic practices.
2) Hazard analysis and critical control point principles (as listed above).
3) The monitoring procedures used in process control.
4) System management which is documented in a written manual and which includes documentation associated with food safety programs (food safety management systems).
5) Interactive communication.
Clear recognition of suitably adapted versions of these key elements as discussed below could enhance systematic assurance of the safety of new gene-technologies and lessen the chances of bias and gaps in risk management. The key elements are part of frameworks that are best practice in a variety of fields, from food manufacturing to new drug discovery; from business management practice to best government legislative practice.
Although this body of knowledge is quite extensive (See note 1), the main points can be captured succinctly and effectively. The Therapeutic Goods Administration does this well in their webpage overview of how these system management ideas are used in medical Good Manufacturing Practice ( TGA 2017 ). David Hoyle (2009) does this concisely in an introductory chapter on best management practices for business operations. Excellence Through Stewardship (2016) show how this applies to laboratory operations that use gene-technology (ETS 2016).
What could emerge from the Phase I Issues paper consultation is explicit roadmaps that take full advantage of this history of good system management practice.
Process oriented rather than final product-oriented hazard analysis of new breeding technologies is illustrated in recent research publications.
In the literature just mentioned, general principles for hazard analysis of manufacturing operations, engineering design projects, and microbial contamination of food are well described, but hazard analysis of gene-technology is less extensive.
Recent scientific publications illustrate how hazard and failure mode and effects analysis might be applied to the biological and intracellular processes that are the first stage of new gene technology deployment. These publications illustrate that the potential of new breeding technologies to give greater precision in genetic modification will require the concurrent implementation of best practices in quality assurance throughout the chain of new product development.
Young et al. 2019 illustrate how genetic process-related risk can emerge and provide context for interpreting it. Young et al. show DNA template used for homologous recombination directed repair of targeted single standard breaks can lead to unintended (foreign) inserts at the target site. Extensive use of genomic sequencing technologies and bioinformatics was needed to detect unexpected events, and third-party auditing of findings was useful.
These workers demonstrate how such risks can be mitigated (and cite Wei et al. 2018 on this). They mention mitigation by selective genetic screening of candidate progeny, and by choosing single-stranded oligodeoynucleotide repair templates in gene editing procedures. Young et al. 2019 also argue that with gene editing risks of off target changes may be small compared with (i) background mutation events (normal level of DNA replication errors) appearing in progeny each generation of natural mating, and (ii) the large numbers of single nucleotide polymorphism differences among breeds of cattle. The historical background of genetic and phenotypic variability from conventional breeding provides evidence about the boundaries of generally safe genetic variation. These are considerations which are relevant to evaluation of proportionate risk.
General principles highlighted by these reports are that (i) deployment of best laboratory management practices can mitigate risks from gene technologies, and (ii) proportionate genetic risk of new breeding technology should be judged against the unavoidable background level of risks from conventional breeding.
Note 1.
Food safely management systems are elaborated by Codex Alimentarius Commission (1997), and in several resources published by Food Standards Australia New Zealand. Australian Standard/New Zealand standard ISO 31000:2009 and Department of Health and Aging 2013 provides systematic risk management principles, and the latter document at page 18, under Guiding principles of risk analysis, elaborates many of these management principles in a gene technology context.
Excellence Through Stewardship (ETS) publications such as Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products (2016) available at https://www.excellencethroughstewardship.org/ show how these management principles relate to crop GMO development for use in agricultural applications. Module 1: Research in the Laboratory in this ETS document explains how these management principles apply to laboratory work with GMOs. The Therapeutic Goods Administration provides and overview of how these system management ideas fit into medical Good Manufacturing Practice ( https://www.tga.gov.au/good-manufacturing-practice-overview Good manufacturing practice - an overview 29 September 2017; https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products Manufacturing principles for medicinal products 2 January 2018). The book Golden Rice: The Imperiled Birth of a GMO Superfood (Regis 2019) provides an extensive narrative on the problems of misdirected regulatory objectives, highlighting the value of a systems management approach.
Bibliography
Australian Standard/New Zealand standard ISO 31000:2009. Risk Management--Principles and guidelines.
Adams M R and M O Moss 2008. Chapter 11. Controlling the microbiological quality of foods. In Food Microbiology 3rd Ed. RCH Publishing.
Codex Alimentarius Commission (CAC) 1997. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application: Annex to CAC/RCP 1-1969, Rev.3 (1997). Codex Alimentarius Commission (CACV), Geneva. http://www.fao.org/docrep/004/y1579e/y1579e03.htm
Department of Health and Aging 2013. Risk Analysis Framework Version 4 ISBN 978-1-74241-953943-5
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
Excellence Through Stewardship (ETS) 2016. Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products available at https://www.excellencethroughstewardship.org/
Food Standards Australia New Zealand (FSANZ) 2015. Food Standard Code 3.2.1 . Food Safety Programs. https://www.foodstandards.gov.au/industry/safetystandards/programs/Pages/default.aspx Webpage August 2015.
Food Standards Australia New Zealand (FSANZ) 2007. Food Safety Programs. A guide to Standard 3.2.1 Food Safety Programs.
Hoyle, David 2009. Chapter 1 Putting ISO 9000 in Context pages 1-20 in ISO 9000 Quality Systems Handbook.
International Standards Organisation (ISO) 2008. Quality management systems – Requirements. (ISO 9001:2008). International Organization for Standardization (ISO), Geneva. http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm;
ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain https://www.standards.org.au/standards-catalogue/international/iso-slash-tc--34-slash-sc--17/iso--22000-colon-2018
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019. https://www.ich.org/page/safety-guidelines accessed 26 November 2019.
Luning, P. A. and Willem J Marcelis 2009. Food Quality Management: Technological and Managerial Principle and Practices. Wageningen Academic Publishers.
Montgomery D C 2009. Chapter 2. The DMAIC problem solving process. In Statistical Quality Control: A Modern Introduction 6th Ed. John Wiley.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) 2017. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13, 01 January 2017
Regis, Ed 2019. The Imperiled Birth of a GMO Superfood, Johns Hopkins University Press.
Therapeutic Goods Administration 2017. Good manufacturing practice - an overview 29 September 2017 https://www.tga.gov.au/good-manufacturing-practice-overview
Therapeutic Goods Administration 2018 Manufacturing principles for medicinal products 2 January 2018 https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products
US Food and Drug Administration (FDA) 2018. (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs ). Content current as of 03/16/2018.
Wei, Jingwei et al. 2018. Cattle with a precise, zygote mediated deletion safely eliminate the major milk allergen betalactoglobuline. Science Reports 8:7661 DOI:10.1038/s41598-018-25654-8)
Young, Amy E. et al 2019. Genomic and phenotypic analyses of six offspring of a genome-edited hornless bull Nature Biotechnology https://doi.org/10.1038/s41587-019-0266-0
Q6: What additonal risk tiers could be considered and what criteria could be applied to determining what falls in or out of any required tiers?
Response
Not addressed
Q7: Is the introduction of additional risk tiers the only way to ensure regulation is proportionate to the level of risk?
Response
Key Points
RE QUESTION 7
• Guidelines for sponsoring institutions requiring documented and audited “gene technology safety programs” (analogous to the current FSANZ standard for “food safety programs”) would enhance the effectiveness of genetic risk management.
• A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Section 3 Enhancing risk-proportionate regulation
Is risk tiering the only way to ensure regulation is risk-proportionate?
QUESTION 7: Is the introduction of additional risk tiers the only way to ensure regulation is proportionate to the level of risk?
Guidelines for sponsoring institutions requiring documented and audited “gene technology safety programs” (analogous to current FSANZ standard for “food safety programs”) would enhance the effectiveness of genetic risk management.
The current Australia and New Zealand Food standards code 3.2.1 uses food safety programs to allow inherent risks in food products to be flexibly managed by organisations involved in food operations that are exposed to hazards (FSANZ 2015; FSANZ 2007).
A food safety program is a documented management system put in place by an operating organisation such as a food company to demonstrate that it will control food safety hazards that are associated with the activities of the organisation.
An analogous document -- a “genetic technology safety program” -- could be required of organisations involved in developing products using new gene technologies. It could be implemented by flexible guidelines, and by regular auditing by government agencies or suitably qualified third parties.
Such business management system documentation is a standard feature of management systems (for example ISO 22000 systems previously mentioned in responding to QUESTON 5)
Published guidelines are commonly used as a flexible regulatory tool for managing risk. Guidelines are issued by Codex Alimentarius as a tool for managing food risks. Similarly, guidelines are suggested by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019, and by guidance documents issued by the US FDA (2018). Flexibility can be accomplished by allowing organisations to depart from guidelines if a revision can be justified to the regulatory agency.
A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Other regulatory arrangements to complement the use of risk tiers could include consultations between the sponsor and the regulatory agency prior to initiating major projects. Such early dialog illustrates the key risk management element of interactive communication.
Such regulatory consultations could enable recording of a register of gene technology activities without a burden of expensive regulatory compliance, and provide assurance to the company of a free path to the marketplace after supplying some project details. Eriksson et al. (2019) provide a discussion of the arrangements now used in Argentina for management of new crop breeding technologies that illustrate this option. The key features highlighted by their report is (1) proposals are handled on a case-by-case basis; (2) the decision on whether to regulate or deregulate a proposed product is not restricted to a predefined list of new breeding technologies; (3) a developer can pose questions about a hypothetical product (from a new gene technology for instance), and (4) a decision that a product is not regulated as a GMO is possible within 60 days.
Published general frameworks for risk management and the principles associated with them are widely useful for all aspects of ensuring regulation that is proportionate to the level of risk. One such framework is already used by the OGTR (Department of Health 2013; Australian Standard/New Zealand standard ISO 31000:2009) and provides a model (with appropriate transparent principles and guidelines) to allow more efficient and flexible regulation of new technologies.
Bibliography
Australian Standard/New Zealand standard ISO 31000:2009. Risk Management--Principles and guidelines.
Adams M R and M O Moss 2008. Chapter 11. Controlling the microbiological quality of foods. In Food Microbiology 3rd Ed. RCH Publishing.
Codex Alimentarius Commission (CAC) 1997. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application: Annex to CAC/RCP 1-1969, Rev.3 (1997). Codex Alimentarius Commission (CACV), Geneva. http://www.fao.org/docrep/004/y1579e/y1579e03.htm
Department of Health and Aging 2013. Risk Analysis Framework Version 4 ISBN 978-1-74241-953943-5
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
Excellence Through Stewardship (ETS) 2016. Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products available at https://www.excellencethroughstewardship.org/
Food Standards Australia New Zealand (FSANZ) 2015. Food Standard Code 3.2.1 . Food Safety Programs. https://www.foodstandards.gov.au/industry/safetystandards/programs/Pages/default.aspx Webpage August 2015.
Food Standards Australia New Zealand (FSANZ) 2007. Food Safety Programs. A guide to Standard 3.2.1 Food Safety Programs.
Hoyle, David 2009. Chapter 1 Putting ISO 9000 in Context pages 1-20 in ISO 9000 Quality Systems Handbook.
International Standards Organisation (ISO) 2008. Quality management systems – Requirements. (ISO 9001:2008). International Organization for Standardization (ISO), Geneva. http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm;
ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain https://www.standards.org.au/standards-catalogue/international/iso-slash-tc--34-slash-sc--17/iso--22000-colon-2018
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019. https://www.ich.org/page/safety-guidelines accessed 26 November 2019.
Luning, P. A. and Willem J Marcelis 2009. Food Quality Management: Technological and Managerial Principle and Practices. Wageningen Academic Publishers.
Montgomery D C 2009. Chapter 2. The DMAIC problem solving process. In Statistical Quality Control: A Modern Introduction 6th Ed. John Wiley.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) 2017. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13, 01 January 2017
Regis, Ed 2019. The Imperiled Birth of a GMO Superfood, Johns Hopkins University Press.
Therapeutic Goods Administration 2017. Good manufacturing practice - an overview 29 September 2017 https://www.tga.gov.au/good-manufacturing-practice-overview
Therapeutic Goods Administration 2018 Manufacturing principles for medicinal products 2 January 2018 https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products
US Food and Drug Administration (FDA) 2018. (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs ). Content current as of 03/16/2018.
Wei, Jingwei et al. 2018. Cattle with a precise, zygote mediated deletion safely eliminate the major milk allergen betalactoglobuline. Science Reports 8:7661 DOI:10.1038/s41598-018-25654-8)
Young, Amy E. et al 2019. Genomic and phenotypic analyses of six offspring of a genome-edited hornless bull Nature Biotechnology https://doi.org/10.1038/s41587-019-0266-0
RE QUESTION 7
• Guidelines for sponsoring institutions requiring documented and audited “gene technology safety programs” (analogous to the current FSANZ standard for “food safety programs”) would enhance the effectiveness of genetic risk management.
• A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Section 3 Enhancing risk-proportionate regulation
Is risk tiering the only way to ensure regulation is risk-proportionate?
QUESTION 7: Is the introduction of additional risk tiers the only way to ensure regulation is proportionate to the level of risk?
Guidelines for sponsoring institutions requiring documented and audited “gene technology safety programs” (analogous to current FSANZ standard for “food safety programs”) would enhance the effectiveness of genetic risk management.
The current Australia and New Zealand Food standards code 3.2.1 uses food safety programs to allow inherent risks in food products to be flexibly managed by organisations involved in food operations that are exposed to hazards (FSANZ 2015; FSANZ 2007).
A food safety program is a documented management system put in place by an operating organisation such as a food company to demonstrate that it will control food safety hazards that are associated with the activities of the organisation.
An analogous document -- a “genetic technology safety program” -- could be required of organisations involved in developing products using new gene technologies. It could be implemented by flexible guidelines, and by regular auditing by government agencies or suitably qualified third parties.
Such business management system documentation is a standard feature of management systems (for example ISO 22000 systems previously mentioned in responding to QUESTON 5)
Published guidelines are commonly used as a flexible regulatory tool for managing risk. Guidelines are issued by Codex Alimentarius as a tool for managing food risks. Similarly, guidelines are suggested by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019, and by guidance documents issued by the US FDA (2018). Flexibility can be accomplished by allowing organisations to depart from guidelines if a revision can be justified to the regulatory agency.
A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Other regulatory arrangements to complement the use of risk tiers could include consultations between the sponsor and the regulatory agency prior to initiating major projects. Such early dialog illustrates the key risk management element of interactive communication.
Such regulatory consultations could enable recording of a register of gene technology activities without a burden of expensive regulatory compliance, and provide assurance to the company of a free path to the marketplace after supplying some project details. Eriksson et al. (2019) provide a discussion of the arrangements now used in Argentina for management of new crop breeding technologies that illustrate this option. The key features highlighted by their report is (1) proposals are handled on a case-by-case basis; (2) the decision on whether to regulate or deregulate a proposed product is not restricted to a predefined list of new breeding technologies; (3) a developer can pose questions about a hypothetical product (from a new gene technology for instance), and (4) a decision that a product is not regulated as a GMO is possible within 60 days.
Published general frameworks for risk management and the principles associated with them are widely useful for all aspects of ensuring regulation that is proportionate to the level of risk. One such framework is already used by the OGTR (Department of Health 2013; Australian Standard/New Zealand standard ISO 31000:2009) and provides a model (with appropriate transparent principles and guidelines) to allow more efficient and flexible regulation of new technologies.
Bibliography
Australian Standard/New Zealand standard ISO 31000:2009. Risk Management--Principles and guidelines.
Adams M R and M O Moss 2008. Chapter 11. Controlling the microbiological quality of foods. In Food Microbiology 3rd Ed. RCH Publishing.
Codex Alimentarius Commission (CAC) 1997. Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application: Annex to CAC/RCP 1-1969, Rev.3 (1997). Codex Alimentarius Commission (CACV), Geneva. http://www.fao.org/docrep/004/y1579e/y1579e03.htm
Department of Health and Aging 2013. Risk Analysis Framework Version 4 ISBN 978-1-74241-953943-5
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
Excellence Through Stewardship (ETS) 2016. Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products available at https://www.excellencethroughstewardship.org/
Food Standards Australia New Zealand (FSANZ) 2015. Food Standard Code 3.2.1 . Food Safety Programs. https://www.foodstandards.gov.au/industry/safetystandards/programs/Pages/default.aspx Webpage August 2015.
Food Standards Australia New Zealand (FSANZ) 2007. Food Safety Programs. A guide to Standard 3.2.1 Food Safety Programs.
Hoyle, David 2009. Chapter 1 Putting ISO 9000 in Context pages 1-20 in ISO 9000 Quality Systems Handbook.
International Standards Organisation (ISO) 2008. Quality management systems – Requirements. (ISO 9001:2008). International Organization for Standardization (ISO), Geneva. http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm;
ISO 2200:2018 Food safety management systems — Requirements for any organization in the food chain https://www.standards.org.au/standards-catalogue/international/iso-slash-tc--34-slash-sc--17/iso--22000-colon-2018
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for Biotechnological Products (ICH) 2019. https://www.ich.org/page/safety-guidelines accessed 26 November 2019.
Luning, P. A. and Willem J Marcelis 2009. Food Quality Management: Technological and Managerial Principle and Practices. Wageningen Academic Publishers.
Montgomery D C 2009. Chapter 2. The DMAIC problem solving process. In Statistical Quality Control: A Modern Introduction 6th Ed. John Wiley.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) 2017. PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13, 01 January 2017
Regis, Ed 2019. The Imperiled Birth of a GMO Superfood, Johns Hopkins University Press.
Therapeutic Goods Administration 2017. Good manufacturing practice - an overview 29 September 2017 https://www.tga.gov.au/good-manufacturing-practice-overview
Therapeutic Goods Administration 2018 Manufacturing principles for medicinal products 2 January 2018 https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products
US Food and Drug Administration (FDA) 2018. (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs ). Content current as of 03/16/2018.
Wei, Jingwei et al. 2018. Cattle with a precise, zygote mediated deletion safely eliminate the major milk allergen betalactoglobuline. Science Reports 8:7661 DOI:10.1038/s41598-018-25654-8)
Young, Amy E. et al 2019. Genomic and phenotypic analyses of six offspring of a genome-edited hornless bull Nature Biotechnology https://doi.org/10.1038/s41587-019-0266-0
Q8: What principles or criteria should be applied in moving an organism/technique across risk-tiers?
Response
No response
Q9: Are there any elements of the Scheme that would NOT benefit from a principles/outcome-based approach?
Response
No response
Part 3 - Streamlining Regulatory Requirements and Processes to Reduce Regulatory Burden
Q10: What other objectives might guide streamlining of regulatory requirements?
Response
No response
Q11: Are there any particular issues to be considered when streamlining any of these regulatory requirements?
Response
No response
Q12: What mechanisms or tools would reduce the regulatory burden and administrative burden on the end user interacting with the regulator/regulatory system?
Response
See Q 5, also added here
A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Other regulatory arrangements to complement the use of risk tiers could include consultations between the sponsor and the regulatory agency prior to initiating major projects. Such early dialog illustrates the key risk management element of interactive communication.
Such regulatory consultations could enable recording of a register of gene technology activities without a burden of expensive regulatory compliance, and provide assurance to the company of a free path to the marketplace after supplying some project details. Eriksson et al. (2019) provide a discussion of the arrangements now used in Argentina for management of new crop breeding technologies that illustrate this option. The key features highlighted by their report is (1) proposals are handled on a case-by-case basis; (2) the decision on whether to regulate or deregulate a proposed product is not restricted to a predefined list of new breeding technologies; (3) a developer can pose questions about a hypothetical product (from a new gene technology for instance), and (4) a decision that a product is not regulated as a GMO is possible within 60 days.
Published general frameworks for risk management and the principles associated with them are widely useful for all aspects of ensuring regulation that is proportionate to the level of risk. One such framework is already used by the OGTR (Department of Health 2013; Australian Standard/New Zealand standard ISO 31000:2009) and provides a model (with appropriate transparent principles and guidelines) to allow more efficient and flexible regulation of new technologies.
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
A consultative arrangement for technology proposals prior to project commencement, as used in Argentina, could improve regulatory efficiency, and provide clarity to project sponsors about the scope and cost of regulatory requirements.
Other regulatory arrangements to complement the use of risk tiers could include consultations between the sponsor and the regulatory agency prior to initiating major projects. Such early dialog illustrates the key risk management element of interactive communication.
Such regulatory consultations could enable recording of a register of gene technology activities without a burden of expensive regulatory compliance, and provide assurance to the company of a free path to the marketplace after supplying some project details. Eriksson et al. (2019) provide a discussion of the arrangements now used in Argentina for management of new crop breeding technologies that illustrate this option. The key features highlighted by their report is (1) proposals are handled on a case-by-case basis; (2) the decision on whether to regulate or deregulate a proposed product is not restricted to a predefined list of new breeding technologies; (3) a developer can pose questions about a hypothetical product (from a new gene technology for instance), and (4) a decision that a product is not regulated as a GMO is possible within 60 days.
Published general frameworks for risk management and the principles associated with them are widely useful for all aspects of ensuring regulation that is proportionate to the level of risk. One such framework is already used by the OGTR (Department of Health 2013; Australian Standard/New Zealand standard ISO 31000:2009) and provides a model (with appropriate transparent principles and guidelines) to allow more efficient and flexible regulation of new technologies.
Eriksson, Dennis, Drew Kershen, Alexandre Nepomuceno, Barry J. Pogson, Humberto Prieto, Kai Purnhagen, Stuart Smyth, Justus Wesseler and Agustina Whelan 2019. A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward. New Phytologist. https://nph.onlinelibrary.wiley.com/doi/10.1111/nph.15627
Q13: Are there any particular issues to be considered when streamlining any of these regulatory processes?
Response
No response
Q14: Are there any other key processes that might be streamlined without impacting the safety of people or the environment?
Response
No response
Q15: What specific areas are suitable for harmonisation between regulators? Are there any overlaps that could be removed?
Response
No response
Q16: What are some of the ways in which the role of IBCs could be strengthened to achieve efficiencies in a co-regulatory model?
Response
No response
Q17: What could be some avenues that would empower the Regulator to make decisions about changes to regulatory requirements and processes deemed low-risk?
Response
No response