Nicosia, March 17th 2022

Ms. Irene Charalambidou,
President of the Committee on Human Rights
and on Equal Opportunities for Men and Women

ΜΕΜΟ

Integration of the principles and provisions of the EU Communication (COM[2000]) on the “Precautionary Principle” in the legislative and regulatory framework, for effective Prevention and Protection of Health, especially Children’s Health, against toxic factors

Dr. Stella Canna Michaelidou

President of the Cyprus Committee on Environment and Children’s Health

The purpose of the present MEMO is documenting the need and advocating a first approach for the integration of the principles and provisions of the EU Communication (COM[2000]) on the “Precautionary Principle” in the legislative and regulatory framework, for the effective Prevention and Protection of Health, especially Children’s health, against toxic factors. This is the contribution of the National Committee on Environment and Children’s Heath (NCECH) to the Parliamentary Committee on Human Rights and on Equal Opportunities for Men and Women during the session of January 31^st, 2022 on: “The human right to live in a healthy environment.”

A. The impact of Environment on Children’s Health

According to the World Health Organization (WHO), the 80% of the morbidity effects is primarily attributed or/and related to the Environment (Prüss-Üstün & Corvalán, 2006). Polluted air accounts for the 26% of premature death of children aged 0-5 years. In the USA, the annual cost of child morbidity due to environmental reasons, for 2017, amounted to $76.6 billion (ΕΡΑ 2017).

As 5-15% of cancer incidents are linked to hereditary/genetic factors, while 75-95% are of undetermined etiology and/or related to a combined effect of carcinogenic & genetic factors and/or to multifactorial synergy, the role of environment is pointed out. According to the WHO (2010), “approximately, 1/3 of cancers can be avoided if we prevent our children’s exposure to carcinogenic factors.”

In recent years, there has been an upward trend in diseases affecting children, especially in developed countries, which are primarily, and/or due to synergy, attributed to toxic agents in the child’s environment. Such examples are asthma and other respiratory diseases, obesity, diabetes, cardiovascular diseases, abnormalities of the reproductive organs, and some types of childhood cancer. Lastly, the silent pandemic of the children’s brain damage is extremely alarming and increasing, and generates cognitive weaknesses, autism, attention deficit with or without hyperactivity etc. This silent pandemic affects millions of children; 1 out of 6 children aged 2-8 years present some kind of mental, development or behavior disorder. The underlying reasons for this global pandemic are only partially comprehensible. (Ref. Νeurobehavioural effects of developmental toxicity Review» Philippe Grandjean Philip J Landrigan, Lancet Neurol 2014; 13: 330–38).

The determinants are: a) the genetic factors to which the 30-40% is attributed, b) medical reasons, injuries etc., c) infections, d) exposure to neurotoxic factors such as lead, mercury, some pesticides, the non-ionizing radiation of wireless communication and lastly, e) the combined impact of factors (IARC, 2013; Neira. M. et al, 2008; Neira M., 2019; Pronczuk et al., 2011; Prüss-Üstün & Corvalán, 2006; Trasande & Landrigan, 2004; WHO, 2010).

B. Loopholes in the system and in the practices for the evaluation and management of toxic agent risks

But why are we still experiencing an increase in diseases due to environment reasons or/and associated with the environment and our lifestyle, at the dawn of the twenty-first century? In the E.U. there has been a significant progress in toxic chemicals management, thanks to REACH Regulation. However, the Regulation’s fundamental principle “No data, no market”, obliging the industry to prove the safe use of a specific product in advance, does not apply to technological innovations, such as wireless communication, nanotechnology etc. Moreover, the risk evaluation and management system as a whole has inherent weaknesses and gaps (Landrigan & Trasande, 2004):

1. The risk assessment is based on one and only toxic agent, while the effects are multifactorial. The cocktail of exposure types (within and beyond the limits) and their synergy, as well as the interaction between toxic and genetic factors constitute a “black box” and are not taken into consideration when it comes to the establishing of limits. Until now, the synergy of low “safe” exposure limits have been little evaluated.

2. There are scientific uncertainties/gabs, incomplete data and disputes which in the end lead to assessments such as: “potentially dangerous”, “possibly carcinogenic”, “inconclusive information”, “further research is needed”. Such standpoints, although NOT proving safety, lead to postponing and lack of action, prevent legislative measures and regulations or/and give rise to the perception that “there is no problem.”

3. There is a delay in properly specifying and evaluating the long-term effects, so that they be qualified for precautionary approach.

4. There is a huge lack of research focused on children. We are compelled to end up to conclusions and evaluations and we determine safety indexes without efficiently taking into consideration neither the highest and multiple exposure of a child per unit of weight (2-5 times higher compared to that of an adult), nor the increased sensitivity and vulnerability of children. As developing organisms, children are particularly vulnerable and have the so called “windows of vulnerability” (WHO 2014), their brain being particularly vulnerable (ANSES 2016, American Cancer Society 2018). Furthermore, children mostly have incomplete or weaker defense and detoxification mechanisms.

5. Legislation has in many cases failed to cover emerging risks, and while awaiting their full confirmation, comes after many years having been wasted. Striking examples are asbestos, lead, mercury and the cigarette smoke, the harmfulness of which took 100 years to be legislatively covered.

C. The need for implementing Prevention and Precaution

In view of the data and the aforementioned findings, it is imperative that we change from a “reaction” strategy to a holistic “precaution” strategy. Although prevention and precaution have been always at the heart of Public Health practices, in the past, the Public Health measures taken were mainly focused on the elimination of the risks that had already been identified and “proven”. Over time, this approach has proven to be inadequate and to have serious consequences for children, as well as for other people. That’s why, it is absolutely essential that science keep politicians informed towards a direction of supporting a holistic “precaution” strategy. In other words, scientific analysis and risk assessment should include, apart from fully documented effects, reference to the gaps, the uncertainties, the potential risks/hazards, the cost of inaction, and the possibility of alternative solutions. Such a process, in order to be effective, should be subject to rules and principles, that will help avoid arbitrariness.

A milestone of this effort is the Precautionary Principle, which was established in 2000 by the EU with COM(2000). It’s a text which describes the need, the framework, the principles and the conditions governing the implementation of the Precautionary Principle. The main points are the following:

1. Recourse to the Precautionary Principle: According to the European Commission, the Precautionary Principle may be invoked when a phenomenon, product or process may have a dangerous effect, identified by a scientific and objective evaluation, if this evaluation does not allow the risk to be determined with sufficient certainty.

Recourse to the Precautionary Principle belongs in the general framework of risk analysis (which, besides risk evaluation, includes risk management and risk communication), and more particularly in the context of risk management which corresponds to the decision-making phase.

2. The precautionary principle may only be invoked when the three preliminary conditions are met:

• identification of potentially adverse effects;

• evaluation of the scientific data available;

• the extent of scientific uncertainty.

3. Precautionary Principle shall be informed by three specific principles:

• the fullest possible scientific evaluation, the determination, as far as possible, of the degree of scientific uncertainty;

• a risk evaluation and an evaluation of the potential consequences of inaction;

• the participation of all interested parties in the study of precautionary measures, once the results of the scientific evaluation and/or the risk evaluation are available.

In addition, the general principles of risk management remain applicable when the Precautionary Principle is invoked. These are the following five principles:

• proportionality between the measures taken and the chosen level of protection;

• non-discrimination in application of the measures;

• consistency of the measures with similar measures already taken in similar situations or using similar approaches;

• examination of the benefits and costs of action or lack of action;

• review of the measures in the light of scientific developments.

4. The burden of proof

In the case of an action being taken under the Precautionary Principle, the producer, manufacturer or importer may be required to prove the absence of danger. This possibility shall be examined on a case-by-case basis. It cannot be extended generally to all products and procedures placed on the market.

In the light of the above, it is self-evident that the implementation of the Precautionary Principle is neither contrary to sound science’s dogmas nor incompatible with the rules of “justified” decision making. There is no conflict between pursuing scientific progress and taking precautionary actions. On the contrary, its implementation requires:

• Holistic scientific approach, so that complex risks can be determined, knowledge gaps can be clarified and early warnings, as well as unintended action effects, can be identified.

• Harnessing science, not only to diagnose environmental risks, but also to identify, develop and evaluate safer alternatives to potentially harmful activities.

• Pointing out the need for scientific research, which is necessary for filling knowledge gaps.

COM(2000), pending conclusive scientific evidence on risks that have been well documented, specifies and imposes the need for preventive actions based on a holistic approach and the best available evidence on the risks, recognizing at the same time the uncertainties and gaps, as well as the possible consequences.

It is true that, in any case, what is considered as “justified risk” or what can be considered as efficiently justified does not depend only on the risk and evidence level and on the uncertainty. It is also based on the possibility of the risk reversibility, precaution and elimination, if sensitive groups – especially children – are affected, and on the advantages/disadvantages/availability of alternative solutions. Lastly, it is subject to the culture and values of a society. This indicates the need for a certain degree of flexibility, whilst the consistency of the Principle’s implementation will be based on the use of the same principles and conditions framework in every case, as well as on the use of the same evaluation process as the one provided by COM(2000).

Prevention is absolutely required and also possible at an individual, family and state level. It presupposes awareness and knowledge, which provides the possibility of the least harmful solution. A well-informed public can contribute to the implementation of Prevention and Precaution and to push for the improvement of the relevant legislations. At this point, the need for timely and reliable information and education by the state arises, so that “the right to know” be guaranteed.

RECOMMENDATIONS 

1. Incorporation of the provisions of COM(2000) in legislations related to the assessment of the impact on Environment on Health, especially on children’s Health. This will ensure a holistic assessment, precautionary measures and, where necessary, shift the obligation to prove the safety of a development to the proposer. In Environmental Impact Assessment Studies, the assessment of the impact on human health should be comprehensive, meeting the provisions of COM(2000).

2. At the stage of adoption of EU directives, concerning the quality and safety of the environment, “legislative windows” must be included, for the cases/developments that are not covered or when potential risks of toxic factors are not explicitly mentioned in the Directive. It is presupposed that these factors are obvious, can clearly affect health, especially children’s health, and are seriously documented. There are indications but not yet fully proven/substantiated. Thus, the Legislation, and without the need for continuous reviewing, will be able to address emerging problems, in a constantly changing world, in a timely manner, enabling the state to manage risks proactively by taking preventive measures, limiting exposure, informing, investigating and promoting less harmful options.

3. The right to “know” should be ensured for all citizens, as well as the access to timely and sound information, regarding the effects on their health. Provision should be made for the obligation of the state to ensure, in cooperation with several bodies, the necessary education and awareness.

The Cyprus National Committee on “Environment and Children’s Health” has multifaceted expertise and may contribute, within the framework of its terms of reference, at advisory level but also in essence, to the different stages of risk assessment, as well as to the incorporation of COM(2000) on the Precautionary Principle in legislation. The Committee may also contribute to the Principle’s implementation, through educating and raising awareness among all stakeholders and to the promotion of recommendations addressed to the state, based on science (science based policies).

Nicosia, March 17th 2022

For further information, please contact:

Dr. Stella Canna Michaelidou

President of the Cyprus Committee on Environment and Children’s Health

E-mail: stellacm@spidernet.com.cy

Tel.: 99431695, 22809410

ANNEX Ι – Bibliographical references:

Αρχή της Προφύλαξης COM(2000): Επιτροπή των Ευρωπαϊκών Κοινοτήτων. (2000). Ανακοίνωση της Επιτροπής για την Αρχή της Προφύλαξης, Βρυξέλλες. 2.2.2000 COM(2000). (Available at: https://eur-lex.europa.eu/legal-content/EL/TXT/PDF/?uri=CELEX:52000DC0001&from=EL).

Centers for Disease Control and Prevention (CDC). (2022). Data and statistics on children’s mental health. (Available at: https://www.cdc.gov/childrensmentalhealth/data.html) [Accessed March 3, 2022].

EPA 2017: U.S. Environmental Protection Agency (EPA). (2017). NIEHS/EPA Children’s Environmental Health and Disease Prevention Research Centers Impact Report: Protecting children’s health where they live, learn, and play. EPA Publication No. EPA/600/R-17/407. (Available at: https://www.epa.gov/sites/default/files/2017-10/documents/niehs_epa_childrens_centers_impact_report_2017_0.pdf).

Grandjean, P., & Landrigan, P. J. (2014). Neurobehavioural effects of developmental toxicity. The Lancet Neurology, 13(3), 330–338. https://doi.org/10.1016/S1474-4422(13)70278-3

IΑRC Working Group on the Evaluation of Carcinogenic Risks to Humans. (2013). Non-ionizing radiation, Part 2: Radiofrequency electromagnetic fields. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, 102(Pt. 2), 1–460.

Landrigan, P.J., & Trasande, L. (2004). Applying the precautionary principle in environmental risk assessment to children, in M. Martuzzi & J. A. Tickner (Eds.), The precautionary principle: Protecting public health, the environment and the future of our children (pp. 121–144).

Martuzzi, M. & Tickner, J.A. (Eds.). (2004). The precautionary principle: protecting public health, the environment and the future of our children. WHO. (Available at: https://www.euro.who.int/__data/assets/pdf_file/0003/91173/E83079.pdf)

Neira, M. P. (2019). Air Pollution and Human Health: A Comment from the World Health Organization. Annals of Global Health. 85(1), 141. https://doi.org/10.5334/aogh.2712

Neira, M., Gore, F., Brune, M.-N., Hudson, T., & de Garbino, P. (2008). Environmental threats to children’s health – a global problem. International Journal of Environment and Health, 2(3-4), pp. 276-292.

Pronczuk, J., Bruné, M.-N., & Gore, F. (2011). Children’s Environmental Health in Developing Countries. In Encyclopedia of Environmental Health (pp. 601–610). Elsevier. https://doi.org/10.1016/B978-0-444-52272-6.00008-8

Prüss-Üstün, A., & Corvalán, C. (2006). Preventing disease through healthy environment: Towards an estimate of the environmental burden of disease. WHO. (Available at: https://apps.who.int/iris/handle/10665/43457) [Accessed March 3, 2022].

Trasande L., & Landrigan, P.J. (2004). The National Children’s Study: A critical national investment. Environmental Health Perspective, 112(14), A789–A790. https://doi.org/10.1289/ehp.112-1247577

WHO. (2010). Fifth Ministerial Conference on Environment and Health: Protecting children’s health in a changing environment. Parma, Italy, 10-12 March 2010. (Available at: https://www.euro.who.int/__data/assets/pdf_file/0011/78608/E93618.pdf).