ANTHROPOGENIC EMISSIONS: NOVEL ENTITIES

Short- and long-term risk arising from daily exposures to novel entities, are disregarded and downplayed in Aotearoa New Zealand[i] [ii] [iii]. Media and governance institutions do not sufficiently communicate nor reflect the complexity and degree of risk, that is represented in the scientific literature.

The failure to steward - and resource science relating to - chemicals and pollution is a global phenomenon. Only a small fraction of chemicals are stewarded, there is an absence of horizon scanning to identify risk, there is an absence of feedback loops into the policy and regulatory communities, and there is a failure to provide resourcing and latitude for expert interdisciplinary communities that can traverse the issues at hand.

Scientific research required to identify and assess risk to novel entities is markedly under-resourced. Scientists who maintain staff and expensive research facilities cannot easily access funding to explore human and environmental health risk from synthetic chemical, heavy metal and biotechnological emissions.[iv]

NOVEL ENTITIES

Many Anthropogenic emissions can be classified as novel entities. In 2015, Will Steffan et al. recognised novel entities as:

“new substances, new forms of existing substances and modified life forms that have the potential for unwanted geophysical and/or biological effects… These potentially include chemicals and other new types of engineered materials or organisms not previously known to the Earth system as well as naturally occurring elements (for example, heavy metals) mobilized by anthropogenic activities”.[vii]

Everyday commercial industries; factories; transport; agriculture; service industries and the functions of household and community life, result in emissions of chemicals and the biotechnologies into to air, water, soil and into human, animal and other forms of life. Anthropogenic deployment of novel entities into the environment are of concern at the global level when these entities exhibit (i) persistence, (ii) mobility across scales with consequent widespread distributions, and (iii) potential impacts on vital Earth System processes or sub-systems. [xvii] Risk increases from chemical mixtures which can produce additive and/or synergistic effects.

The year 1950 is recognised as the start of the Anthropocene[viii], when the great expansion in industries and human activity surged post World War II. Since the 1950’s expansion of these industries has been multiscalar, without concomitant resourcing to identify risk both at scale, and to reflect the complex use patterns of these products.

Only a small proportion of chemicals undergo risk assessment,[ix] and frequently risk assessment uses outdated methodologies, or patterns of assessment that result in industry data being kept secret, and the profile of the drug as it is marketed, being thoroughly assessed.[x] [xi] [xii] [xiii]

Most media and governance focus revolve around carbon emissions and the control of carbon emissions by the alteration of agriculture and daily activities. Chemical and biotechnology emissions and risks from manmade technologies remain fundamentally disregarded.

Stewardship[xiv], including monitoring and research, risk assessments and national emissions standards have not kept space with the speed of introduction and deployment into the environment. Scientists consider that human activity has modified and potentially disrupts many critical earth system processes. In order to protect these processes, scientists urge that governing bodies steward a safe operating space where earth systems do not decline into irreversible tipping points.

Recently, the lag in stewardship has resulted in Stockholm Institute scientists proposing that the safe operating space of the planetary boundary for novel entities is exceeded when annual production and releases increase at a pace that outstrips the global capacity for assessment and monitoring.[xv]

Meaningful regulation remains set aside as regulators turn to industry for evidence of harm. For example, the co-operative relationships between pharmaceutical drug producers and governments does not extend to the development of public policy treaties, protocols and agreements that include demands to reduce the presence of pharmaceutical products in water.[xvi] Pesticides regulation continues to be shaped by industry influence, biotech industries and patent holders pressure for biotechnology regulation and meaningful regulation fails to be implemented to steward and protect all vertebrates from endocrine disruptors in diets and in the environment.

STEWARDSHIP OF MANMADE TECHNOLOGIES DENIED & DISCOUNTED?

The term ‘science denial’ reflects

‘an activity aimed at renouncing some well-justified assertion or theory in mainstream science’ , irrespective of whether this activity targets research or policy-making.

'Chemicals denial' has been identified as a phenomenon that consists of repeated patterns to deny and dismiss the degree to which chemicals and waste represent a risk to biological function. Such activities occur in New Zealand. In the PSGR & the Soil and Health Association released a 2019 paper that documented the patterns of chemical denial that has distorted New Zealand policy on freshwater for at least ten years, steering government consideration away from industrial chemicals, and directing consultation and policy exclusively towards 'pathogens, nutrients and sediment.'

Fail to resource and under-resourcing of monitoring capacity and scientific research not only applies to research exploring effects in the natural environment.[v] For medical doctors attempting to identify the drivers of chronic disease in patients, there are systemic barriers to conducting serum and tissue analysis to identify relationships and identify potential disease drivers, using advanced technologies, including biomarker assisted technologies. Associations from exposures can include inflammation, neurotoxicity, endocrine disruption and oxidative stress.

As we have noted:

‘Omics technologies (adductomics, epigenomics, proteomics, metabolomics and transcriptomics) traverse a broader biological space, and can complement the traditional biomarker endpoints and play an important role in understanding mixture effects, and the early molecular events in the pathways leading to disease which to date has been largely excluded from regulatory considerations.’[vi]

Such technologies are available and widely incorporated in drug development, as well as in environmental research to understand system stressors of vertebrates.

CONSOLIDATION OF INDUSTRY POWER

Novel entities can be broadly grouped into synthetic chemicals, products of biotechnology and include heavy metals. Industry sectors are powerful, and work closely with governments and their regulators to advance policy and shape (and resist changes to) guidelines.

The chemical industry is the second largest manufacturing industry globally. Industry restructuring and consolidation has dominated the past decade, accompanied by vertical integration, increasing control along the chain of production. Between 2010 and 2050, production is projected to triple. There are an estimated 350 000 chemicals (or mixtures of chemicals) on the global market, with 6,000 of these chemicals accounting for more than 99 per cent of the total volume. Material extraction as feed stocks for novel entities was approximately 92 billion tonnes globally in 2017, and is projected to reach 190 billion tonnes by 2060.[xviii]

Patterns of concentration in major industries that are emitters of novel have occurred across the global food system[xix], the pesticides and crop protection sector[xx] and the pharmaceutical industry[xxi]. Unimpeded corporate concentration has expanded the market power of investment management institutions and dominant industries, distorting prices[xxii] and leading the IMF to question whether extreme market power suppresses innovation.[xxiii]

The power of these large institutions and related investment management institutions are woven into government policies through processes of international trade agreements, industry meetings to develop regulatory guidelines and via global treaties. Public organisations are often excluded from these processes, and there are barriers to participation. Media rarely cover these events, and advertising incentives reduce the likelihood that a critical perspective will be adopted.

The global crop protection chemicals market was projected to grow from $59.41 billion in 2021 to $81.74 billion in 2028.[xxiv] From 1990-2009 annual imports of pesticides into New Zealand increased by 70%.[xxv] In 2009 recording-keeping ceased.

The global biotechnology market is expected to expand from US$ 852.88 billion in 2020, and to be worth around US$ 3.44 trillion by 2030. A CAGR of 17.83% during forecast period 2021 to 2030. Market growth has been driven by SARS-CoV- which is ‘driving the market’, through supportive government initiatives and advances in nanobiotechnologies, using nanotechnologies for drug delivery. [xxvi]

In 2020 global pharmaceutical revenues were valued at USD1.42 trillion.[xxvii]

The scientists, pivoted to recognise that substantial growth in volumes of these technologies, effectively means that novel entities are ungoverned:

‘increasing trends of production and emissions of diverse novel entities that outstrip our efforts at safety assessment and monitoring are a transgression of the planetary boundary and that immediate actions are needed to return us to the safe operating space’.

The acknowledged the problem of lock-in where companies shift sideways to produce replacement compounds (which have potential to be regrettable substitutes). The scientists recommended a preventative and precautionary hazard-based approach to steward these technologies, and concluded

‘that increases in production and releases of novel entities are not consistent with keeping humanity within the safe operating space, in the light of the global capacity for management.’ [xxviii]

For 20 years, PSGR NZ have released reports and made submissions to government consultations. Reports focussing on novel entities include:

BIOTECHNOLOGY & GENE EDITING TECHNOLOGIES

Report: Transgenic cotton, a toxic business (2017)

Report: Genetic Engineering FAQs (2010)

DEPLETED URANIUM.

Report: Why depleted uranium should be banned from New Zealand (2012)

FLUORIDE TOXICITY

Submission on endocrine (thyroid hormone) - related risk, Fluoridation of Drinking water Amendment Bill (2021)

Report: The Fluoride Debate (2014)

MERCURY TOXICITY

Report: Dental amalgam & mercury poisoning (2015)

NANOTECHNOLOGY

Report: Nanotechnology. A New Zealand Perspective (2014).

PESTICIDES

Submission: NZEPA Glyphosate Call for Information (2021)

Article: Glyphosate. Twenty years of highlighting cancer risk.

SYNTHETIC BIOLOGY.

Report: Synthetic biology (2017)

REFERENCES

[i] PSGR (2021 Aug), Inquiry on the Natural and Built Environments Bill: Parliamentary Paper Environment Committee. https://psgr.org.nz/component/jdownloads/send/1-root/72-21nba

[ii] PSGR (2022, March 16) Submission Te Ara Paerangi - Future Pathways Green Paper. Submitted to the: Future Pathways Policy Team Ministry of Business, Innovation & Employment. https://psgr.org.nz/component/jdownloads/send/1-root/88-nzscience

[iii] PSGR (2021, Oct 3). Submission Hazardous Substances and New Organisms (Hazardous Substances Assessments) Amendment Bill. https://www.parliament.nz/resource/en-NZ/53SCEN_EVI_112194_EN7820/81f0cd1bb6c6cd56e4630e975b9f0e6dcb0d888c

[iv] Bruning, J. (2021). Master’s thesis (research). Innovation and Ignorance: How Innovation Funding Cultures Disincentivise

Endocrine Disruption Research. Department of Sociology. University of Auckland.

[v] Parliamentary Commissioner for the Environment (2022, March) Knowing what’s out there: Regulating the environmental fate of chemicals

[vi] PSGR (2022, Aug, 7) Submission Public consultations on the Food Regulatory System Strategic Plan 2023-2026. Ref: ANON-NESK-81CH-5

[vii] Steffen, Wet al. (2015). Planetary Boundaries: Guiding Human Development on a Changing Planet. Science 2015, 347 (6223), 1259855−1259855.

[viii] Crutzen et al. (2002), Geology of mankind. Nature 415, 23 (2002). 10.1038/415023a doi:10.1038/415023a

[ix] UN Environment. Global Chemicals Outlook II - From Legacies to Innovative Solutions: Implementing the 2030 Agenda for Sustainable Development; 978-92-807-3745-5, 2019.

[x] Demeneix, B., & Slama, R. (2019). Endocrine Disruptors: from Scientific Evidence to Human Health Protection. requested by the European Parliament's Committee on Petitions. PE 608.866 - March 2019. Brussels: Policy Department for Citizens' Rights and Constitutional Affairs.

[xi] Benbrook et al 2021. Commentary: Novel strategies and new tools to curtail the health effects of pesticides. Environmental Health volume 20: 87 2021

[xii] Robinson et al 2020. Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions. European Journal of Risk Regulation. DOI:10.1017/err.2020.18

[xiii] Kassotis et al 2020. Endocrine-disrupting chemicals: economic, regulatory, and policy implications. The Lancet 8:719-730

[xiv] Boston et al. (2019) Foresight, insight and oversight: Enhancing long-term governance through better parliamentary scrutiny. Institute for Governance and Policy Studies, Victoria University of Wellington. ISBN 978-0-473-48292-3

[xv] Persson L et al. (2022) Outside the Safe Operating Space of the Planetary Boundary for Novel Entities. Environmental Science & Technology 56 (3), 1510-1521 DOI: 10.1021/acs.est.1c04158

[xvi] González Peña, O. I., López Zavala, M. Á., & Cabral Ruelas, H. (2021). Pharmaceuticals Market, Consumption Trends and Disease Incidence Are Not Driving the Pharmaceutical Research on Water and Wastewater. International journal of environmental research and public health, 18(5), 2532. https://doi.org/10.3390/ijerph18052532

[xvii] Persson L et al. (2022) Outside the Safe Operating Space of the Planetary Boundary for Novel Entities. Environmental Science & Technology 56 (3), 1510-1521 DOI: 10.1021/acs.est.1c04158

[xviii] UN Environment. Global Chemicals Outlook II - From Legacies to Innovative Solutions: Implementing the 2030 Agenda for Sustainable Development; 978-92-807-3745-5, 2019.

[xix] Clapp, J. (2021). The problem with growing corporate concentration and power in the global food system. Nature Food. 2, 404–408 (2021). https://doi.org/10.1038/s43016-021-00297-7

[xx] Watson D. (2018) Pesticides and Agriculture Profit, Politics and Policy. Burleigh Dodds Science Publishing Limited

[xxi] Shepherd J. (2018). Consolidation and Innovation in the Pharmaceutical Industry: The Role of Mergers and Acquisitions in the Current Innovation Ecosystem, 21 J. Health Care L. & Pol'y 1 (2018). https://digitalcommons.law.umaryland.edu/jhclp/vol21/iss1/2

[xxii] Clapp J. & Isakson SR. (2018). Speculative Harvests Financialization, Food, and Agriculture. Practical Action Publishing.

[xxiii] Diez et al (2018). Global Market Power and its Macroeconomic Implications. International Monetary Fund, 15/06/2018

[xxiv] Fortune business insights

[xxv] MfE & StatsNZ 2020 MfE’s Our Freshwater paper, Ministry for the Environment and Stats NZ Publication number: ME 1490 https://environment.govt.nz/assets/Publications/Files/our-freshwater-2020.pdf

[xxvi] BioSpace (2022, April 25) Biotechnology Market Size to Worth Around US$ 3.44 Trillion by 2030 https://www.biospace.com/article/biotechnology-market-size-to-worth-around-us-3-44-trillion-by-2030/

[xxvii] Statista (2022, August 23) Revenue of the worldwide pharmaceutical market from 2001-2021 https://www.statista.com/statistics/263102/pharmaceutical-market-worldwide-revenue-since-2001/

[xxviii] Persson L et al. (2022) Outside the Safe Operating Space of the Planetary Boundary for Novel Entities. Environmental Science & Technology 56 (3), 1510-1521 DOI: 10.1021/acs.est.1c04158