Health Canada’s adherence to the precautionary principle

Petition: 289

Issue(s): Governance, human health/environmental health, and toxic substances

Petitioner(s): Frank Woodcock

Date Received: 23 July 2009

Status: Completed

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

Petition
Frank Woodcock
35 Tyrell St.
Simcoe, ON
N3Y 2H2
July 20, 2009
519-428-4031
f_woodcock@hotmail.com

The Auditor General of Canada

Commissioner of the Environment and Sustainable Development
240 Sparks St.
Ottawa, ON
K1A 0G6

Attn. Petitions:

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 http://www.ec.gc.ca/econom/pamphlet_e.htm 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]

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 [top of page]

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.

Yours sincerely,

[Original signed by Leona Aglukkaq, Minister of Health Canada]

Leona Aglukkaq

Enclosure

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 http://www.cpsc.gov/CPSCPUB/PREREL/PRHTML99/99031.html).

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 http://www.hc-sc.gc.ca/cps-spc/legislation/consultation
/phthalates-phtalates-eng.php).

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.

1
http://www.pco-bcp.gc.ca/docs/information/publications/precaution/Precaution-eng.pdf

2
http://www.hc-sc.gc.ca/ahc-asc/alt_formats/hpfb-dgpsa/pdf/pubs/risk-risques-eng.pdf

3
Pest Control Products Act, 2002, c.28, s.20.

4
Canadian Environmental Protection Act 1999, c.33.

5
http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docid=3986468&file=4

6
http://www.tbs-sct.gc.ca/ri-qr/directive/directivepr-eng.asp?format=print

Date Issued: 2010-03-01