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Strengthening and
Modernizing Canada鈥檚 Safety
System for Food, Health and
Consumer Products

A DISCUSSION PAPER ON
CANADA鈥橲 FOOD AND CONSUMER
SAFETY ACTION PLAN
TABLE OF CONTENTS

INTRODUCTION 3

1. OveRvIew 5
1.1 Defining the Problem 5
1.2 Toward a Modernized Safety Regime 5
1.3 Common Issues 7

2. FOOD PRODUCTs 9
2.1 Address Safety along the Food Continuum 10
2.2 Enhance the Safety of Food Imports 10
2.3 Modernize Inspector Powers 11
2.4 Strengthen Standard Setting 12

3. HealTH PRODUCTs 13
3.1 Take A Life-cycle Approach through Progressive Licensing 14
3.2 Reporting 15
3.3 Improve Compliance and Enforcement Powers 16
3.4 More Effective Fines and Penalties 16
3.5 Improve Import Safety 16
3.6 Improve Information for Consumers and Decision-makers 17

4. CONsUmeR PRODUCTs 18
4.1 Expand the Post-market Safety Regime (General Prohibition) 19
4.2 Report Serious Product Safety Incidents and Record Keeping 19
4.3 Strengthen Consumer Product Recall and Other Corrective Measures 20
4.4 Improve Import Safety 20
4.5 More Effective Fines and Penalties 21
4.6 Improve Information for Consumers and Decision-makers 21
INTRODUCTION

The Government of Canada is committed to promoting the health and safety of Canadians by ensuring safe food,
health and consumer products in the Canadian marketplace. This is a key federal role. That鈥檚 why the 2007 Speech
from the Throne committed to 鈥渋ntroducing measures on food and product safety to ensure that families have
confidence in the quality and safety of what they buy.鈥?

On December 17, 2007, Prime Minister Stephen Harper announced Canada鈥檚 Food and Consumer Safety Action
Plan. The Action Plan proposes a series of initiatives to modernize and strengthen Canada鈥檚 safety system for food,
health and consumer products and to better support the collective responsibilities that government, industry and
consumers have for product safety. These initiatives focus on:


鈥? Preventing problems in the first place 鈥? Government would provide better product information to
consumers and guidance to industries on building safety throughout their supply chains. This would
encourage a renewed focus on prevention.

鈥? Targeting the highest or unknown risks 鈥? Government would be able to require companies that pro-
duce and/or supply consumer and health products to conduct safety tests and provide the results. That
information would allow a closer watch on products where the risks are not yet fully understood or that
pose the greatest potential hazard to the public.

鈥? Rapid Response 鈥? New legislation would allow the Government to take faster action than ever before to
protect the public when a problem occurs. This includes the power to pull unsafe consumer and health
products from store shelves and enhanced capacity to oversee food product recalls.




The key departments that currently administer and enforce the Acts that govern food, health and consumer
product safety are: Health Canada, Canada Border Services Agency and the Canadian Food Inspection Agency.




3
The Action Plan recognizes that the vast majority of today鈥檚 manufacturers, processors, distributors and import-
ers provide Canadians with safe food, health and consumer products. At the same time, it reflects the need to
modernize and sharpen the focus of Government action to protect Canadians. The Action Plan responds to the
new technological and economic realities of the 21st century, such as globalization and the introduction of more
complex products.

Ensuring the safety of food, health and consumer products is a shared responsibility. The federal, provincial and
territorial governments, industry, consumers and trading partners each have roles to play.




Health products include human and veterinary drugs, vaccines, blood and blood products, natural health
products, biologics and genetic therapies, medical devices and other therapeutic products.




Consumer products are those products that adults and children commonly use for personal, family, house-
hold or garden use or in recreation or sports.




Food means anything that people eat or drink, and includes chewing gum, bottled water and ingredients to
be used in food, such as the flour that will be used to make bread.
1. OveRvIew


1.1 Defining the Problem
In the recent past, Canadians have read or heard about incidents of unsafe food, health and consumer products,
including: the global withdrawal of some non-steroidal anti-inflammatories (cox-2s); high levels of lead found
in imported children鈥檚 toys; and food recalls that crossed national boundaries. These events, changing consumer
demands, new technologies and the increasing complexity of global supply chains are the major drivers behind the
need to modernize regulatory tools.

Canada鈥檚 current safety regime is solidly based on the best scientific evidence to determine the risks and benefits of
products, and has served Canadians well for many years. It is now outdated however, and reflects an era in which
the system operated differently. On the supply side, for example: products were predominantly manufactured and
produced in a local plant from limited sources; product development was slow. On the demand side, consumers
had fewer choices; and the volume and scientific or technical complexity of available products was considerably
less than today.

Today, industry needs to innovate quickly to compete globally. Globalization has expanded supply chains, often
across multiple borders. As a result, many products manufactured in one country are made from parts and ingredi-
ents that have been produced elsewhere, and many products used by Canadians are imported. Overall, the global
trade environment is very complex and the number of products and producers is vast and growing. Consumers
want more choice and more involvement with health professionals in managing their health, but making informed
decisions about the vast array of health, consumer and food products is increasingly difficult 鈥? and the challenge is
further complicated by the fact that accurate and reliable safety information is not always readily available.



1.2 Toward a Modernized Safety Regime
This Action Plan is based on three fundamental principles:

1. industry has a responsibility for the safety of products it brings onto the market;

2. consumers and health professionals need access to accurate information to make informed decisions;
and

3. Government must have the clear authority it requires to address health and safety risks.

The Action Plan proposes to enhance Canada鈥檚 health and safety protection system by: supporting collaboration;
strengthening safety programs; and replacing outdated statutes with new regimes. Fundamental to the Action
Plan is a focus on active prevention, targeted oversight and rapid response.




5
Active Prevention

To encourage a renewed focus on prevention, emphasis would be placed on building-in safety considerations in
the development or use of products, to prevent as many incidents as possible. Government would provide infor-
mation to consumers and work closely with industry to promote awareness, provide regulatory guidance, help
identify and systematically assess safety risks at early and ongoing stages, and develop standards and share best
practices.

Targeted Oversight

The proposed approach recognizes the need to detect safety problems as early as possible and verify the benefits
and risks at all stages in a product鈥檚 lifecycle. Government would have improved authorities to ensure that the
necessary actions are being taken to both determine the safety profile of products and to verify that preventative
measures are being implemented effectively. Additionally, the Government would have clear authority to promptly
intervene if necessary when risks are identified.

Rapid Response

The Government would have authority in areas where none currently exists, to compel appropriate responses to
identified risks. For example, the Government would be equipped to respond rapidly to remove unsafe consumer
and health products from shelves, preventing them from reaching consumers, and by having the authority to
require that industry issue public advisories about product risks.




6
Framework for Canada鈥檚 Food and Consumer Safety Action Plan




Objective Protecting the health and safety of Canadians



Strategy Oversight where risks are greatest over the life cycle of a product




Principles 1. Corporate Responsibility
2. Empowered consumers
3. Enabling government




Action Plan Active Prevention Targeted Oversight Rapid Response




Inter-Agency co-operation




1.3 Common Issues
In implementing a modernized safety regime, it is important to note that food, health and consumer product
safety regimes are not all regulated in the same way. However, a number of gaps or pressures are common across
all regulatory systems and are being addressed through integrated and complementary measures.

Improved Oversight of Imported Product Safety: The volume of imports has increased substantially in the last
ten years, with products coming from a wide variety of countries, not all of which have similar safety standards.
At the same time, in today鈥檚 environment of global supply chains, it is often difficult to differentiate between
imported and domestic products. Further, products should be safe wherever they are produced or made, meaning
new safety rules should not discriminate unfairly against imported products over domestic ones. The Action Plan
proposes to enhance Canada鈥檚 safety system overall, regardless of product origin, and to ensure that new rules are
applied fairly and consistently, regardless of whether a product is imported or produced domestically.




7
Improved Authorities to Take Compliance, Enforcement and Other Corrective Measures: Authorities govern-
ing food, health and consumer products in Canada come from legislation developed in the 1950鈥檚 and 60鈥檚; and as
a result, they are out of step with modern realities and needs. For example, fines and penalties are low compared
with those of our international trading partners and other Canadian legislation. To form an effective deterrent,
fines and penalties must reflect the impact violations can have on health and safety. Under the Action Plan, fines
and penalties would be updated so that they act as effective deterrents and reflect current economic realities.

As well, The Government of Canada currently lacks sufficient authority to issue mandatory recalls of a health or
consumer product if it poses a serious or imminent risk to health and safety or to compel manufacturers to take
steps to reduce the risk associated with a product, such as issuing a public advisory or changing a label. Enhancing
the Government鈥檚 authorities in these areas would ensure that action can be taken more quickly to address risks to
Canadians and that Canada鈥檚 product safety regimes are comparable to those of other countries.

Improved Information for Consumers and Decision-makers: Currently, for consumers, governments and
industry; food, health and consumer product information is often hard to access, use or share, due to its complex-
ity, incompleteness or the fact that the confidentiality of some information must be protected. Action Plan measures
across all types of products will support the distribution of greater and more accessible, consumer-friendly and
credible product information.
2. FOOD PRODUCTs

Canada has one of the safest food supplies in the world. However, the globalization of the food supply chain, new
production practices and technologies, and changing consumer demands have created new risks and challenges for
traditional food inspection and oversight mechanisms.

Modernizing our food safety system demands an integrated, proactive approach. It should provide new and better
information on food risks in the Canadian marketplace and involve industry and Canadians to address those risks.

All food sold in Canada is subject to the Food and Drugs Act. The Government also uses legislative authorities that
currently exist under the Canada Agricultural Products Act, Meat Inspection Act, Fish Inspection Act and CFIA Act to
Act Act
implement food safety programs for many food categories. The Action Plan includes both legislative amendments
to the Food and Drugs Act and expanded program measures to enhance Canada鈥檚 food safety system. The proposed
amendments to the Food and Drugs Act would help streamline and provide more consistent regulatory tools across
all food sectors and better position the Government of Canada to achieve its food safety mandate.

Many of Canada鈥檚 major trading partners have already reviewed and modernized their food safety systems. At the
same time, they are increasingly demanding evidence of the effectiveness of Canada鈥檚 system as a prerequisite for
access to their markets. Implementing the proposed measures would better position Canada to meet current and
future challenges, to protect consumers and support Canada鈥檚 food sector competitiveness.



ThE ACTIOn PlAn fOR fOOd wIll:



Prevent problems by:

鈥? broadening the coverage of potentially unsafe food imports;
鈥? enhancing authority to require industry to implement food safety controls to prevent problems; and
鈥? creating a specific prohibition against tampering with food

Enhance targeted oversight by:

鈥? strengthening the Government鈥檚 authority to verify the safety of food at all points in the food
continuum, including prior to importation into Canada;

Support rapid response by:

鈥? providing new authority to require adequate records be kept by those who handle food;
鈥? strengthening access to the information that is needed in order to effectively respond to identified
problems; and
鈥? modernizing and streamlining inspection systems.




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2.1 Address Safety Along the Food Continuum
To better enable Government to verify the safety of food at all points along the food continuum, from production
to consumption, a number of new authorities are proposed that will:

Broaden Coverage of Potentially Unsafe Food: The Food and Drugs Act would be amended to improve its
coverage of potentially unsafe food. It is proposed that the Act be broadened to cover food at all points along the
food continuum including at time of importation, rather than just at point of sale. In addition, the Act would be
amended to more clearly describe food not permitted for importation into or sale in Canada.

Prevent Problems With High Risk Foods: The Government is proposing a new enabling authority to require
that high-risk foods be prepared, packed and stored using a system of preventative food safety controls. These
requirements would need to be created in regulations, which would be developed in consultation with stakeholders.
Such authority would strengthen the Government鈥檚 ability to require the implementation of risk-based food safety
control systems, such as Hazard Analysis and Critical Control Point (HACCP) or equivalent processes, to reduce
food-borne illnesses from high-risk foods. Use of such systems would also provide much-needed information to
identify and assess risk along the food continuum and enhance government capacity to identify high risk products.

Find the Source of Problems When They Do Occur: Amendments are proposed to allow the Government to
require that certain records be kept by those involved in importing, processing or otherwise preparing or selling
food. If a food safety issue was identified, this information would help the industry and Government to track and
trace problem food products and respond more quickly.

Prohibit Tampering With Food: The Government is proposing to strengthen its legislative authorities to effec-
tively deal with persons who tamper with or threaten to tamper with food, its packaging or labels or falsely claim
that any of these things has been tampered with.



2.2 Enhance the Safety of Food Imports
The Government proposes some specific authorities to enhance its ability to prevent the importation of unsafe
foods and better manage food safety issues. The proposed authorities would allow the Government to place
conditions on the importation of food, refuse to allow importation of foods identified as potentially harmful
and respond more rapidly when problems occur.
Work with Exporting Countries to Better Address Risks at Source: Imported products pose particular challenges
as often it is difficult to determine, by simply looking at a product, whether it is safe for Canadians. The systems
used to produce imported food and the oversight exercised by the regulatory authorities in the country of origin
are important considerations in determining if an imported product meets Canadian requirements. Therefore,
the Government is proposing an authority that would allow for the recognition of comparable foreign inspection
systems and results.

This approach would share the responsibility for food safety with the exporting country while facilitating the
movement of food into Canada.

Registration or Licensing: The Government is proposing to add provisions to the Food and Drugs Act to allow
for the registration or licensing of products, persons or establishments. Registration or licensing authority would
permit the Government to proactively identify food importers and the foods that they bring into Canada. This
direction is consistent with the provisions contained in other federal food-related Acts and would allow for the
more uniform application of regulatory tools for all food in Canada. It would also be consistent with the approaches
implemented by a number of Canada鈥檚 international trading partners.

If problems associated with specific foods or sectors are identified, this authority would also allow for additional
measures to ensure food safety, regardless of whether the problem is foreign or domestic. Implementation of any
registration or licensing regime would require the creation of regulations, which would be developed in consulta-
tion with stakeholders.



2.3 Modernize Inspector Powers
A number of new authorities are proposed to better enable Canada鈥檚 food inspectors to appropriately monitor food
and take action when warranted.

Hold and Test: An inspector would be able to hold, prohibit or restrict movement of food for purposes of deter-
mining if it is in compliance with the Food and Drugs Act without having to seize or detain the food. This addition
would provide consistent authority for all food, including imports.

Obtaining Information: Food inspectors would gain authority to access the documents they need in order to do
their jobs. This includes redefining what is meant by a record and providing authority for an inspector to use, or
to ask regulated parties to use equipment such as photocopiers and computers to create documents or copies of
documents.

Telewarrants: The provision would permit an inspector or peace officer to provide information and obtain a war-
rant by telephone or other means of telecommunication (e.g., a fax machine) 鈥? which would prove useful in cases
where an inspector is located in a remote area, where it would be impractical to quickly appear before a provincial
court judge or a justice of the peace.




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2.4 Strengthen Standard Setting
Under the Food and Drugs Act, the Government establishes regulations, policies and standards for the safety and
nutritional quality of all food sold in Canada. However, standards, policies and the related pre-market approval
processes (e.g., for food additives, infant formula and novel foods) have not been able to keep pace with the
changing food safety environment. As a result, the Government is considering new initiatives to enhance poli-
cies, standards and processes to strengthen the prevention of food safety issues. Examples of emerging areas for
standard and policy development include allergens, chemical contaminants, emerging food-borne pathogens and
bioactives in foods.

Building on the work of recognized international standard setting bodies is important to help establish global
standards that are comparable and compatible with those in Canada and reflect, as much as possible, the food
safety expectations of Canadians.

Providing Better Information to Consumers: Product of Canada Labelling
To protect consumers and provide them with information, the Government requires that products be labelled and
advertised accurately and truthfully. Canadians have asked for better information to assist in making more
informed decisions and choices. Government will undertake a review of current policies for voluntary 鈥淧roduct of
Canada鈥? and 鈥淢ade in Canada鈥? claims on product labels.




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3. HealTH PRODUCTs

Over the last two years, the Government has held national consultations with over 150 stakeholders on updating
the regulation of health products in Canada. The consultations confirmed a number of problems, including:

鈥? few legislative tools to support the ongoing assessment of risks and benefits once a product is on the
market;

鈥? an inadequate range of tools to support post-market actions by Government when necessary and
post-market reporting of safety data across the health system; and

鈥? lack of a legislative authority that would allow the Government to order recalls of unsafe health products.




ThE ACTIOn PlAn fOR hEAlTh PROduCTS wIll:



Prevent problems by:

鈥? giving consumers and health professionals more and better information to make informed decisions
about the safety and safe use of products; and
鈥? enabling safety planning at an early stage.

Enhance targeted oversight by:

鈥? supporting the ongoing assessment of the risks and benefits of a product over its lifecycle through a
progressive licensing system; and
鈥? providing modern inspection authorities and undertaking new strategies to oversee the safety of
imported products.

Support rapid response by:

鈥? enabling the recall of unsafe products; and
鈥? compelling the communication of safety risks to the public.
3.1 Take a Life-cycle Approach Through Progressive Licensing
Under the current regulatory system, manufacturers must obtain a license or 鈥渕arket authorization鈥? to market a
product in Canada. However, once a product reaches the market and new safety information becomes available
about its use in the broader population, there are currently few obligations on the manufacturer to continue to
produce or share this information with the Government, and other than a requirement to report adverse drug
reactions, the Government cannot compel a manufacturer to carry out post-market activities, including long-
term post-market safety studies.

The Government believes that a modern regulatory system requires a progressive licensing framework. This would
shift the focus from pre-market review to one that continuously assesses a product鈥檚 risks and benefits, both before
and after it reaches the market.

Progressive licensing would apply to all health products. However, focus would first be on pharmaceuticals and
biologics.The regulatory frameworks for medical devices and natural health products are more up to date and the
Natural Health Product Regulations are currently under review.

Ongoing Safety Oversight: Under the Action Plan, the Food and Drugs Act would be amended to support a
lifecycle approach to product assessment, from clinical trials through to post-market monitoring of health prod-
ucts. This new approach would still require manufacturers to demonstrate that their products鈥? potential benefits
outweigh any potential risks to the public before they could be authorized for sale.

Additionally, manufacturers would be required to show the benefit-risk profile continues to be positive in order to
maintain their authorization to sell a product. The obligations given to a manufacturer as a condition of the license
to sell could be amended, suspended or cancelled as necessary as more is learned about the product in the market.
The types of obligations that a manufacturer might be required to meet in order to sell a product in Canada would
be identified in legislation, and could include:

鈥? active post-market surveillance, and reporting;

鈥? regular submission of periodic safety update reports;

鈥? issuing risk information to the public when required (e.g., letters to health professionals and public
advisories); and

鈥? re-evaluation of a product when necessary, based upon its risk profile or nature.

The details of these authorities would be set out in regulations, which would be the subject of further consultations.
The Government鈥檚 objective is to create a broad and flexible set of requirements that would enable the ongoing
assessment of a product, based on its level of risk, that are consistent to the extent possible with those already in
place internationally.




14
Enhanced Safety Planning: The Government meets with manufacturers early in the product development process
to identify potential safety concerns and to discuss scientific issues associated with the product. Based on interna-
tional best practices, the proposed legislative amendments would permit the Government to make the scientific
and regulatory advice it provides at these meetings binding, subject to any subsequent, substantial changes in the
science underpinning the advice.

The proposed legislation would also set out requirements for the development and submission of risk management
plans, in which a manufacturer would be required to set out the actions it would take to monitor and mitigate
the risks of a product over its lifecycle. These would be considered when the manufacturer submits a product for
market authorization.

More and Better Safety Information: Those who regulate, prescribe or use health products would have access to
ongoing, updated information about health products, resulting in more informed decisions about when and how
to use them. Greater partnerships with key players in the health care system, such as provincial and territorial
governments, prescribers, and other health professionals, can assist in identifying and managing risks of a product
throughout its lifecycle and in better linking regulatory decision-making and health care outcomes.

The Government would also seek opportunities to work with international and domestic partners to improve the
generation and dissemination of evidence on the safety and effectiveness of drugs based on their real world use
after they have been approved for market. This new evidence would support improved decision-making by govern-
ments related to access as well as safe and optimal use of drug products.



3.2 Reporting
In addition to the new requirements for industry to share information with the regulator as part of a progressive
licensing framework, the Action Plan also includes other proposed pre- and post-market reporting initiatives such
as the requirement to publicly register any clinical trials relied upon in drug submissions.

In addition, the Government continues to explore ways that could further improve post-market reporting of
safety data. For example, a requirement for health care institutions to report serious adverse reactions would be
a practical option to address this situation. The Government intends to work with the provinces and territories,
and to build on existing systems (such as those for critical incident reporting) to establish such a requirement. The
proposed legislation would set out an enabling authority for such a system.

The details of these requirements would be the subject of further consultations as they are developed with key
stakeholders.




15
3.3 Improve Compliance and Enforcement Powers
Under the Action Plan, the Government would have enhanced authorities to address risks to the health and safety
of Canadians when they occur. These would include the power to issue a mandatory recall of a health product if
it poses a serious or imminent health and safety risk. Currently, the Government can only recommend, but not
compel a recall. Recalls are currently done by industry on a voluntary basis in Canada, while all other major inter-
national health regulators have the authority to issue them.

New powers would also include the authority to order a company to take steps to reduce risks, such as stopping
activities in a part of or an entire manufacturing facility, or requiring changes to product labels. Inspectors would
also have the authority to require manufacturers, distributors or importers to provide any necessary safety informa-
tion about a product. Proposed amendments to the Food and Drugs Act to modernize food inspector powers in
such areas as hold and test, obtaining information, and telewarrants, as described in section 2.3, would also apply
to health products.



3.4 More Effective Fines and Penalties
The current maximum fine for a serious offence under the Food and Drugs Act is $5,000 for health products and
$250,000 for food. Meanwhile, Australia and the United States have fines of up to $1 million. In the European
Union, the maximum fine is five percent of an offending company鈥檚 annual revenue. The Action Plan proposes in-
creasing the maximum fine under the Food and Drugs Act to an uncapped amount to be determined by the courts,
based on the nature of the offence. This would allow for a fines and penalty framework that maintains relevancy
over time, and does not quickly become outdated.



3.5 Improve Import Safety
The Action Plan recognizes the need to reduce the amount of prohibited and unapproved health products entering
Canada. Government licensing information indicates that 80% of drugs and medical devices are imported from
foreign sources.

The plan proposes measures that would provide the Government with 鈥渞eal time鈥? information on health product
importation, allowing closer monitoring of what is coming into Canada from foreign sources and faster responses
to safety issues when they arise. As well, an increasing amount of the active pharmaceutical ingredients used in the
manufacturing of drugs also originate outside of Canada. The Action Plan would require industry to demonstrate
that these ingredients meet international standards for good manufacturing practices.




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3.6 Improve Information for Consumers and Decision-makers
In addition to the proposals to improve information available to consumers, patients, and health professionals that
are previously described in the overview, the Action Plan also includes proposals to:

鈥? step-up publication of drug product monographs, which provide comprehensive information on a drug
for health professionals and consumers, and of health product Summary Basis of Decision documents,
which provide information on how the Government has made a decision about a health product; and

鈥? amend the regulations to require manufacturers to list all non-medicinal ingredients (NMIs) on non-
prescription drug labels, so that consumers can make informed product choices (some exceptions
would apply).

Unlike in other countries, the current Food and Drugs Act and Hazardous Products Act do not contain explicit pro-
visions for managing information, including confidential business information, to support open and transparent
regulatory decision-making and information-sharing in Canada. As a result, the Action Plan includes legislative
proposals on how product review information will be managed. The Government will ensure that safeguards are in
place to protect trade secrets and personal information.




17
4. CONsUmeR PRODUCTs

The Action Plan proposes legislative and regulatory initiatives as well as program measures to enhance the Government鈥檚
ability to help protect Canadians from unsafe consumer products. The Action Plan proposes the introduction of a
new Canadian Consumer Product Safety Act that would modernize the consumer product safety regime in Canada,
and generate needed amendments to the Food and Drugs Act (for cosmetics) and the Radiation Emitting Devices
Act (for products such as microwave ovens and tanning beds). Other products such as consumer pesticides regu-
lated under the recently revised Pest Control Products Act, while not requiring new authorities would be addressed
Act
under the Action Plan through program measures.

Currently, the Government鈥檚 key legislation governing consumer product safety is the Hazardous Products Act. Part
I of the Act lists consumer products, which are either restricted through regulation or outright prohibited from be-
ing advertised, sold or imported into Canada. There are approximately 30 products and product categories that are
regulated (e.g. toys, consumer chemicals), and some 25 others that are prohibited (e.g. baby walkers, lawn darts,
and products containing toxic substances). The manufacture, import and sale of products may be regulated or
controlled under other acts.

In the event that a product that is not regulated or prohibited poses a health or safety risk, it is up to industry to
voluntarily issue and manage a recall. The Government鈥檚 authority is limited to issuing a public warning and, as
necessary, undertaking the process of regulating or prohibiting the product under the Hazardous Products Act.



ThE ACTIOn PlAn fOR COnSumER PROduCTS wIll:



Prevent Problems by:

鈥? creating a new general prohibition that would allow Health Canada to address any consumer product
in Canada that poses a danger to the health or safety of the public; and
鈥? providing expanded information, guidance and tools to industry to reinforce awareness of, and
commitment to consumer product safety.

Enhance Targeted Oversight by:

鈥? creating new authorities requiring suppliers to report health- and safety-related product defects and
adverse incidents; and
鈥? expanding compliance promotion and enforcement activities by facilitating more cost-effective
risk-based inspections.

Support Rapid Response by:

鈥? creating new authorities to order recalls or other corrective measures when products pose a danger
to health or safety of the public; and
鈥? communicating safety risks to the public: including annual compliance reports, and reports on injuries
and illness.

4.1 Expand the Post-market Safety Regime (General Prohibition)
Consumer products covered under the Hazardous Products Act are generally safe and are less likely to carry health
or safety risks, when designed, manufactured and used appropriately. As such, they do not warrant a pre-market
approval process as is the case for health products. Furthermore, the large range and number of consumer products
in the marketplace would make such a process cumbersome and place unnecessary burden on industry.

Nevertheless, given that all Canadians interact with consumer products on a daily basis, a baseline level of consumer
protection is required, particularly where specific product regulations or standards do not exist and unforeseen
hazards arise. The proposed legislation would introduce a general prohibition against the manufacture, importation,
advertisement and sale of consumer products that are, or are likely to be, a danger to the health or safety of the public
regardless of whether they are subject to product-specific regulations. This approach would address general types
of hazards such as flammability, chemical, physical, electrical, biological and mechanical/design hazards that could
reasonably be expected to cause illness, injury or death. It would also be consistent with regimes used by international
partners.

The new Act would also provide the authority to order corrective measures when product safety concerns are
identified (e.g., product recall, stop sale, labelling, product re-design). It would be up to the company to carry out
the corrective measures and to demonstrate that the safety concerns have been addressed. Failure to comply with
the corrective measures could result in significant monetary penalties or criminal charges (see section 4.5 More
Effective Fines and Penalties).



4.2 Report of Serious Product Safety Incidents and Record Keeping
The new Act would require industry to report health and safety issues concerning their products. For example:

鈥? reports of serious injuries, near-miss incidents and deaths arising from use of a product; and

鈥? test results or quality control information revealing that a product is defective, noncompliant or
otherwise unsafe.

The new Act would ensure that this information could be shared as appropriate, balancing privacy and confidentiality
concerns with the public鈥檚 information requirements for protecting health and safety.
Since more products are sourced abroad, it is increasingly important that appropriate records, including informa-
tion about the foreign manufacturer, be maintained by the Canadian supplier, so that effective follow up action
can be taken with them. Under the new Act, Canadian companies would be required to keep records related to the
traceability of their product and be able to make them available to inspectors upon request.



4.3 Strengthen Consumer Product Recall and Other Corrective Measures
The new Act would provide enhanced authorities to address consumer products that pose a danger to the health
and safety of Canadians when they occur, including the power to require that corrective measures be implement-
ed. The ability to order recalls of consumer products would improve the Government鈥檚 ability to respond effec-
tively to health or safety risks and bring Canada鈥檚 approach in line with those of major trading partners such as the
United States and the European Union.

Other corrective measures would include the authority to order a company to take steps to reduce risks, such as
issuing public advisories; stop manufacturing, importing and advertising; product labelling or other corrective
measures deemed necessary to deal with the risk to health or safety.



4.4 Improve Import Safety
International Partnerships: China is an important partner for Canada in the trade of consumer products. For
example, some 80% of toys imported into Canada are from Chinese origin. Recent concerns about imports of
China have emphasized the need for our two countries to work together to resolve issues of common concern.
Accordingly, a Memorandum of Understanding (MOU) was signed in November 2007, that will see the establish-
ment of technical working groups on consumer product safety issues of interest, and other mechanisms to facili-
tate information exchange, including conducting urgent consultations on significant consumer product
safety concerns.

Border Surveillance: In support of the new Act, collaboration among affected Government of Canada Departments
and Agencies will be undertaken to identify consumer products of concern at point of entry into Canada and to
reduce the level of prohibited and non-compliant consumer products from gaining access to market. As imports of
consumer products into the Canadian market continue to increase emphasis on border issues, including information-
sharing would provide access to 鈥渞eal time鈥? information on importation, thereby allowing closer monitoring of
what is coming into Canada from foreign sources and faster responses to health or safety issues. This collaboration
would also extend to products covered by the Pest Control Products Act.
4.5 More Effective Fines and Penalties
The Action Plan proposes new approaches to fines and penalties that would be used when industry does not
comply with safety requirements. For example, the new Act would raise penalties for criminal offences related to
consumer products, in order to provide a stronger deterrent for significant violations of the Act or regulations that
jeopardize the health or safety of the public. These penalties would be consistent with other modern federal health
protection legislation such as the Pest Control Products Act and the proposed new fines and penalties under the
Food and Drugs Act.

Currently, under the Hazardous Products Act, offenders can face criminal charges. However, experience shows that
criminal charges may not always be appropriate. They are cumbersome and time-consuming in cases where the
offence is less serious or administrative in nature.

Alternatively, a new Administrative Monetary Penalties Scheme (AMPS) would be created as a means to encour-
age compliance with the new Act. The AMPS would not replace criminal offences under the new Act. Significant
violations of the Act or regulations would continue to be offences and could be prosecuted through the courts, as
under the previous Hazardous Products Act.

The rationale for proposing an AMPS scheme in the new Act is the need for a timely and effective mechanism to
promote compliance with the legislation. For consumer products, the AMPS would be an effective post-market
tool for addressing situations that cannot be resolved voluntarily, and for which criminal prosecution is not
appropriate.

Many of the specifics for the AMPS, in particular, classes of violations, the level and range of penalties and the
review process will be set out in regulations that will support the new legislation. The Government will be seeking
feedback on how best to establish and administer the AMPS.



4.6 Improve Information for Consumers and Decision-makers
Consumers want to be equipped with complete and reliable information to ensure that they are acquiring safe
consumer products and using them safely. A consumer information initiative would make greater, more accurate,
relevant and credible information available to and accessible by consumers to help make product choices accord-
ing to health and safety risks, and use them safely. Elements of this initiative would include producing educational
materials related to the safe selection of toys and the safe use of chemicals, as well as posting summary information
on injuries and incidents, compliance reports and consultations.




21

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