OAG Health Canada’s adherence to the precautionary principle
Health Canada’s adherence to the precautionary principle
Issue(s): Governance, human health/environmental health, and toxic substances
Petitioner(s): Frank Woodcock
Date Received: 23 July 2009
Summary: The petitioner alleges that Health Canada is not adhering to the precautionary principle. Claiming that Health Canada does not ban toxins and carcinogens until the United States or the European Union take action, the petitioner cites the recent ban on phthalates as an example. The petitioner also asks that Health Canada ban triclosan.
Federal Departments Responsible for Reply: Health Canada
35 Tyrell St.
July 20, 2009
The Auditor General of Canada
Commissioner of the Environment and Sustainable Development
240 Sparks St.
Please accept the following petition under the Auditor General Act.
The health of Canadians is not the number one priority of Health Canada. Until the “Precautionary Principle” becomes the guiding principle of Health Canada this will continue. Until the “Precautionary Principle” is embraced by Health Canada there will be harmful toxins and carcinogens in the Canadian environment, toxins and carcinogens familiar to Health Canada. Their existence in Canadian consumer products is well known and yet Health Canada does nothing about them until the USA, the EU or public outrage forces them to act. In my opinion this is corruption; it is interdepartmental and therefore systemic.
On Friday, June 19, 2009 the CBC reported that the Minister of Health Canada banned six types of phthalates used in children’s plastic products. These phthalates are DEHP (di-2-ethylhexyl phthalate), DINP (diisononyl phthalate), DBP (dibutyl phthalate), BBP (benzyl butyl phthalate), DNOP (di-n-octyl phthalate) and DIDP (diisodecyl phthalate). Phthalates are chemicals used to make plastic flexible. Studies have shown this chemical can have feminizing effects on male fetuses and cause kidney or liver failure in youngsters. This follows, but not closely, bans in the EU and USA. http://www.cbc.ca/health/story/2009/06/19/phthalate-ban-aglukkaq268.html
It is clear from the article mentioned above that phthalates are considered dangerous by the EU and more notably by the United States since 2008. For the United States to ban a chemical is very noteworthy. They do not ban a chemical lightly and pay only lip service to the “Precautionary Principle”. It seems to be a policy of Health Canada to follow bans initiated by the United States but to ignore bans by the EU. One only has to look into the history of GM foods, “Genetic Roulette – The documented health risks of genetically engineered foods” by Jeffrey M. Smith to understand.1
Health Canada’s move to ban phthalates might have been prompted by the release of “Slow Death by Rubber Duck – How the toxic chemistry of everyday life affects our health.” by Rick Smith and Bruce Lourie.2 The book had national media coverage several days prior to Health Canada’s phthalates ban. For once Health Canada acted before public outrage but still after the USA and EU.
On a government of Canada WEB site it asks:
“What is the precautionary approach?” and it goes on to offer platitudes to the “Precautionary Principle”
Wikipedia defines the “Precautionary Principle” as: “The precautionary principle is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public or to the environment, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action. The principle implies that there is a responsibility to intervene and protect the public from exposure to harm where scientific investigation discovers a plausible risk in the course of having screened for other suspected causes. The protections that mitigate suspected risks can be relaxed only if further scientific findings emerge that more robustly support an alternative explanation. In some legal systems, as in the law of the European Union, the precautionary principle is also a general and compulsory principle of law. http://en.wikipedia.org/wiki/Precautionary_principle
On the Health Canada WEB site http://www.hc-sc.gc.ca/sr-sr/advice-avis/decision/index-eng.php the “Precautionary Principle” is endorsed.
If the “Precautionary Principle” is so important to the decision making process of Health Canada why did it take so long to ban phthalates, Vioxx, Trasyol, Climacteron, Tequin, Prexige, Permax, Zelnorm, Mellatil, Bextra, Nefazodone and Atomoxetine (Strattera), bovine growth hormone, trans fats, methyl tertiary-butyl ether (MTBE), etc., etc? The “Precautionary Principle” is a low priority principle in the decision making of Health Canada. Health Canada’s use of the term is a sham. Health Canada should purge the corruption within its ranks, reinstate the “Precautionary Principle” and give Canadians the health protection they deserve.
Question 1: How could the “Precautionary Principle” possibly be adhered to by Health Canada when both the USA and the EU had already banned Phthalates? There were many scientific warnings prior to the EU and USA bans but Health Canada ignored them. How could this conundrum possibly exist considering the earnestness of the government of Canada’s professions for the “Precautionary Principle”?
Question 2: This is not the first case of Health Canada’s failure to follow the “Precautionary Principle” in the areas of: Prevention; Pesticides; Carcinogens; Health Crises; Air; Product Safety; Drugs; Food; Industrial Chemicals; Water and EMR (electromagnetic radiation and electromagnetic sensitivity) which demonstrate that not only does Health Canada ignore the “Precautionary Principle’, much worse, it is throughout departments which makes it systemic and worse still, they defend the position of industry over the safety of Canadians. Surely Health Canada remembers Dr. Chopra’s “Corrupt to the Core” published this year?3 Why does Health Canada repeatedly ignore the “Precautionary Principle”?
Question 3: After reading “Slow Death by Rubber Duck – How the toxic chemistry of everyday life affects our health.” by Rick Smith and Bruce Lourie, will Health Canada ban triclosan (IUPAC name: 5-chloro-2-(2,4-dichlorophenoxy)phenol) for the sake of Canadians?
[Original signed by Frank Woodcock]
1 “Genetic Roulette – The documented health risks of genetically engineered foods” by Jeffrey M. Smith published by Chelsea Green Publishing, 2007, ISBN-13: 9780972966528.
2 “Slow Death by Rubber Duck – How the toxic chemistry of everyday life affects our health.” by Rick Smith and Bruce Louire published by Knopf Canada, 2009 ISBN: 978-0-307-39712-6
3 Corrupt to the Core – Memoirs of a Health Canada Whistleblower by Dr. Shiv Chopra published by KOS Publishing, 2008, ISBN 0-9731945-5-3?6.
Minister's Response: Health Canada
2 December 2009
Mr. Frank Woodcock
35 Tyrell Street
Simcoe, Ontario N3Y 2H2
Dear Mr. Woodcock:
This is in response to your environmental petition No. 289 of July 20, 2009, addressed to the Commissioner of the Environment and Sustainable Development (CESD).
In your petition you raised concerns regarding the ban of phthalates and triclosan and the application of the precautionary principle.
I am pleased to provide you with the enclosed Health Canada response to your petition.
I appreciate your interest in this important matter, and I hope that you will find this information useful.
[Original signed by Leona Aglukkaq, Minister of Health Canada]
c.c. Mr. Scott Vaughan, CESD
Health Canada Response to
Environmental Petition No. 289 filed by Mr. Frank Woodcock
under Section 22 of the Auditor General Act
Received August, 2009
Ban of Phthalates and Triclosan
December 4, 2009
Minister of Health
Q1: How could the “Precautionary Principle” possibly be adhered to by Health Canada when both the USA and the EU had already banned Phthalates? There were many scientific warnings prior to the EU and USA bans but Health Canada ignored them. How could this conundrum possibly exist considering the earnestness of the government of Canada’s professions for the “Precautionary Principle”?
The restrictions on six phthalates (DEHP, DBP, BBP, DINP, DIDP and DNOP) in soft vinyl children’s toys and child care articles under the proposed Phthalates Regulations will strengthen the November 1998 voluntary action by Canadian industry, carried out at the request of Health Canada, to stop marketing soft vinyl buccal products (those designed and intended to be mouthed by young children, such as pacifiers, teethers and rattles) that contain the phthalates DEHP and DINP. This voluntary action did not involve other phthalates because no other phthalates were being used in these products marketed in Canada at the time and no data was available showing a risk to children’s health. This voluntary action also did not apply to all soft vinyl children’s products because a potential health risk was identified only with soft vinyl buccal products.
In December 1998, the United States Consumer Product Safety Commission (CPSC) asked their industry to take similar action on phthalates in soft vinyl buccal products (see .
The voluntary action by the Canadian industry also coincided with a temporary ban put in place late in 1999 by the European Union on the use of six phthalates in soft vinyl buccal products (see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:1999:0577:FIN:EN:PDF).
The current action proposed for Canada under the Phthalates Regulations aligns with regulatory actions since taken in the United States under the Consumer Product Safety Improvement Act (CPSIA) of 2008 (www.cpsc.gov/cpsia.pdf) and in the European Union in accordance with Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005 (eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:344:0040:0043:EN:PDF), thereby ensuring that Canadian children receive the same level of protection from phthalate exposure as children in these other jurisdictions. Effective no later than January 16, 2007 in the European Union and in effect on February 10, 2009 in the United States, DEHP, BBP and DBP are prohibited from being used in all soft vinyl toys and child care articles at concentrations of more than 1 000 mg/kg on the basis of potential harm to reproduction. Despite uncertainty regarding the associated health risks, DINP, DIDP and DNOP are also prohibited at concentrations of more than 1 000 mg/kg in soft vinyl toys and child care articles that can be placed in a child’s mouth; note that this prohibition is temporary in the United States pending a full scientific assessment.
Detailed information on the proposed Phthalates Regulations, including (i) the use of precaution in the absence of scientific certainty and (ii) the history of actions taken on phthalates in soft vinyl children’s products by Canada, the United States and the European Union, is found in the accompanying Regulatory Impact Analysis Statement published with the proposed Regulations in Part I of the Canada Gazette on June 20, 2009 (attached; see also .
Q2: This is not the first case of Health Canada’s failure to follow the “Precautionary Principle” in the areas of: Prevention, Pesticides; Carcinogens; Health Crises; Air; Product Safety; Drugs; Food; Industrial Chemicals; Water and EMR (electromagnetic radiation and electromagnetic sensitivity) which demonstrates that not only does Health Canada ignore the “Precautionary Principle” , much worse, it is throughout departments which makes it systemic and worse still, they defend the position of industry over the safety of Canadians. Surely Health Canada remembers Dr. Chopra’s “Corrupt to the Core” published this year? Why does Health Canada repeatedly ignore the “Precautionary Principle”?
Health Canada’s mission is to help the people of Canada maintain and improve their health. Prudence and careful decision making are critical to the Department’s ability to achieve its objectives, and therefore, Health Canada has adopted a precautionary approach in its regulatory functions.
The Government of Canada endorses the application of a precautionary approach, which is described in “A Framework for the Application of Precaution in Science-Based Decision Making About Risk, 2003.1” This framework provides guiding principles for the application of precaution to science-based decision making regarding federal regulatory activity designed to protect health, safety, and the environment and the conservation of natural resources.
This document acknowledges that governments can rarely act on the basis of full scientific certainty and they cannot guarantee zero risk. Therefore, governments need to address new and emerging risks and manage issues where there is significant scientific uncertainty.
The framework outlines five general principles of application, as follows:
- The application of precaution is a legitimate and distinctive decision-making approach within risk management;
- It is legitimate that decisions be guided by society’s chosen level of protection against risk;
- Sound scientific information and its evaluation must be the basis for applying precaution; the scientific information base and responsibility for producing it may shift as knowledge evolves;
- Mechanisms should exist for re-evaluating the basis for decisions and for providing a transparent process for further consideration; and
- A high degree of transparency, clear accountability and meaningful public involvement are appropriate.
This framework also contains five principles for precautionary measures, which are as follows:
- Precautionary measures should be subject to reconsideration, on the basis of the evolution of science, technology and society’s chosen level of protection;
- Precautionary measures should be proportional to the potential severity of the risk being addressed and to society’s chosen level of protection;
- Precautionary measures should be non-discriminatory and consistent with measures taken in similar circumstances;
- Precautionary measures should be cost-effective, with the goal of generating (i) an overall net benefit for society at least cost, and (ii) efficiency in the choice of measures; and
- Where more than one option reasonably meets the above characteristics, then the least trade-restrictive measure should be applied.
This Government of Canada document is intended to assist in achieving coherent and cohesive application of precaution to risk decision making where there is a lack of scientific certainty. Departmental and agency officials consider this framework and its guiding principles in decision making and to develop guidance for the application of precaution in their particular area. Health Canada has done this in part through the development of the “Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks.2” This document recognizes that decisions are often made in the presence of considerable scientific uncertainty. A precautionary approach to decision making emphasizes the need to take timely and appropriately preventative action, even in the absence of a full scientific demonstration of cause and effect. A lack of full scientific certainty should not be used as a reason not to take preventive measures when reasonable evidence indicates that a situation could cause a significant adverse health effect.
A precautionary approach is incorporated in Health Canada’s more recent legislation, such as the Pest Control Products Act, which states in Section 20 that:
“Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent adverse health impact or environmental degradation 3”
In the Canadian Environmental Protection Act 1999 (CEPA) the following statement in the preamble gives guidance on the use of precaution:
“Whereas the Government of Canada is committed to implementing the precautionary principle that, where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.4”
In addition, Part 1 of CEPA requires that the National Advisory Committee use a precautionary approach in its advice and recommendations, as is evidenced below:
“(1) For the purpose of enabling national action to be carried out and taking cooperative action in matters affecting the environment and for the purpose of avoiding duplication in regulatory activity among governments, the Minister shall establish a National Advisory Committee.
(1.1) In giving its advice and recommendations, the Committee shall use the precautionary principle.[emphasis added]
(2) The Committee shall consist of the following members:
(a) one representative for each of the Ministers;
(b) one representative of the government of each of the provinces; and
(c) subject to subsection (3), not more than six representatives of aboriginal governments, to be selected on the following regional basis…”
More importantly, in section 76.1, the Act requires that when the Ministers (Environment and Health) are conducting and interpreting the results of
a) a screening assessment;
b) a review of a decision of another jurisdiction; or
c) an assessment of a substance on the Priority Substance List they shall apply the precautionary principle.
Bill C-65 (Canada Consumer Product Safety Act) which has passed in the House of Commons and is currently in front of the Senate, contains the following statement in the preamble: “Whereas the Parliament of Canada recognizes that a lack of full scientific certainty is not to be used as a reason for postponing measures that prevent adverse effects on human health if those effects could be serious or irreversible”
Health Canada has demonstrated that it uses a precautionary approach in risk-based decision making. For example, Canada was the first country in the world to propose a prohibition on the import and sale of polycarbonate baby bottles containing Bisphenol A (BPA). Health Canada applied a precautionary approach in announcing its intention to regulate some products that contain BPA so that newborns and infants are not exposed to chemicals that could affect their early development, although the scientific evidence is not yet conclusive.
The Cabinet Directive on Streamlining Regulation also includes a precautionary approach. It applies to all departments and agencies involved in the federal regulatory process, and government officials are responsible for following this directive in all stages of the regulatory lifecycle. The Directive commits the federal government to:
- protect and advance the public interest in health, safety and security, the quality of the environment, and the social and economic well-being of Canadians, as expressed by Parliament in legislation; and
- make decisions based on evidence and the best available knowledge and science in Canada and worldwide, while recognizing that the application of precaution may be necessary when there is an absence of full scientific certainty and a risk of serious or irreversible harm.
This Directive also elucidates a precautionary approach as it states that “When there is a risk of serious or irreversible harm, the government recognizes that the absence of full scientific certainty shall not be used as a reason for postponing decisions to protect the health and safety of Canadians, the environment, or the conservation of natural resources.6”
Q3: After reading “Slow Death by Rubber Duck – How the toxic chemistry of everyday life affects our health” by Rick Smith and Bruce Lourie, will Health Canada ban triclosan (IUPAC name: (5-chloro-2-(2,4-dichlorophenoxy)phenol) for the sake of Canadians?
Triclosan (5-chloro-2-(2,4-dichlorophenoxy)phenol) is an antimicrobial active ingredient that has been used in consumer products for over 35 years. In Canada, triclosan is used as a material preservative in textiles, leather, paper, plastic and rubber materials, institutional fabric softeners and toilet bowl deodorizers which are regulated under the Pest Control Product Act (PCPA). Use of triclosan in cosmetic and personal care products, such as antibacterial soaps and moisturizers, are regulated under the Food and Drugs Act (FDA). It is Health Canada’s view that cosmetic products sold in Canada should not exceed 0.3% triclosan and drug products should not exceed 1% triclosan as an active ingredient.
Health Canada initiated the re-evaluation of pesticidal uses of triclosan in 2008. Health Canada and Environment Canada also considered triclosan to be a priority for assessment of potential risk to human health and the environment under the Chemicals Management Plan. Consequently, Health Canada and Environment Canada are currently completing a scientific review of available information relevant to the evaluation of all triclosan uses in Canada based on a precautionary approach. As with all such assessments the precautionary principle will be incorporated into the decision-making process.
The Canadian review of triclosan considers the recent scientific assessments from the United States Environmental Protection Agency (USEPA). In addition, other information from the European Union Scientific Committee on Consumer Products, the Norwegian Scientific Committee for Food Safety (VKM) and the Australian Department of Health and Aging, as well as relevant scientific literature available in the public domain are being considered in this review. Assessments will be available for public comment once completed.
3 Pest Control Products Act, 2002, c.28, s.20.
4 Canadian Environmental Protection Act 1999, c.33.
OAG Health Canada’s adherence to the precautionary principle.