Notice

Vol. 142, No. 38 — September 20, 2008 

Order Adding Toxic Substances

to Schedule 1 to the Canadian

Environmental Protection Act,

1999

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT 

ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issue and objectives

The purpose of the Order Adding Toxic Substances to Schedule 1 to

the Canadian Environmental Protection Act, 1999 (hereinafter

referred to as the proposed Order) made pursuant to subsection 90(1)

of the Canadian Environmental Protection Act, 1999 (CEPA 1999) is

to propose the addition of chlorinated paraffins to the List of Toxic

Substances in Schedule 1 of the Act. These substances were found to

be toxic as set out in section 64 of CEPA 1999.

Description and rationale

Background

Chlorinated paraffins refer to three classes of substances: short chain

chlorinated paraffins (i.e. chlorinated paraffins with 102013;13

carbon atoms), medium chain chlorinated paraffins (i.e. chlorinated

paraffins with 142013;17 carbon atoms) and long chain chlorinated

paraffins (i.e. chlorinated paraffins with 18 or more carbon atoms). In

Canada, these substances are mainly used in metalworking, in

plastics/rubber and as lubricating additives.

Chlorinated paraffins were initially assessed under the first Priority
Substances List program. The assessment report concluded that short

chain chlorinated paraffins constitute or may constitute a danger to

human health or life as set out in CEPA 1999 (s ee footnote 1) ;

however, data identified at that time were considered insufficient to

conclude whether short, medium or long chain chlorinated paraffins

were harmful to the environment or whether medium or long chain

chlorinated paraffins were considered a danger to human health.

Discussions aimed at managing the risks posed by short chain

chlorinated paraffins were engaged with stakeholders under the

framework of the Toxic Substances Management Policy. However,

risk management discussions were suspended, pending the generation

and review of new information concerning the risk of chlorinated

paraffins to human health and the environment.

Final follow-up assessment report on chlorinated paraffins

Environment Canada and Health Canada conducted the follow-up

assessment report on chlorinated paraffins pursuant to section 68 of

CEPA 1999.

The final assessment concludes that

• all chlorinated paraffins meet the criteria under

paragraph 64(c) of CEPA 1999; and 

• chlorinated paraffins containing up to 20 carbon atoms (shortand medium-chain chlorinated paraffins, as well as liquid long

chain paraffins) meet the criteria under paragraph 64(a) of

CEPA 1999. 

Based on conclusions of the assessment, it is therefore recommended

that all chlorinated paraffins be added to the Schedule 1 of CEPA

1999. 

Furthermore, chlorinated paraffins containing up to 20 carbon atoms

are predominantly anthropogenic and the available data regarding

their persistence and bioaccumulation potential indicates that they

satisfy the criteria outlined in the Persistence and Bioaccumulation

Regulations, made under CEPA 1999. Chlorinated paraffins

containing up to 20 carbon atoms thus meet the criteria for virtual

elimination (s ee footnote 2) of releases to the environment as set out

in the Toxic Substances Management Policy.

The full assessment report may be obtained from the Chemical

Substances Web site at www.chemicalsubstances.gc.ca, from the

Existing Substances Division, Environment Canada, Gatineau,

Quebec K1A 0H3, 819-953-4936 (fax), or by email at

Existing.Substances.Existantes@ec.gc.ca.

Authority

Under subsection 90(1) of CEPA 1999, the Governor in Council may,

if satisfied that a substance is toxic, make an order adding the

substance to the List of Toxic Substances in Schedule 1 of the Act.

The Adding Order is made on the recommendation of the Minister of

the Environment and the Minister of Health.
Alternative

One of the following measures can be applied after an assessment is

conducted under CEPA 1999: taking no further action in respect of

the substance; unless the substance is already on the Priority

Substances List, adding the substance to the Priority Substances List;

or recommending that the substance be added to the List of Toxic

Substances in Schedule 1, and when applicable, the implementation

of virtual elimination.

The follow-up assessment report on chlorinated paraffins concludes

that these substances are entering, or likely to enter, the environment

in a quantity or concentration or under conditions that constitute or

may constitute a danger to the human health or life and that

chlorinated paraffins containing up to 20 carbon atoms have or may

have an immediate or long-term harmful effect on the environment or

its biological diversity. Additionally, chlorinated paraffins containing

up to 20 carbon atoms are persistent, bioaccumulative, inherently

toxic and present in the environment primarily as a result of human

activity. 

Given that these substances meet the criteria for 201C;toxic201D;

under section 64 of CEPA 1999, adding them to Schedule 1 is the

only option considered. 

In addition and as previously mentioned, chlorinated paraffins

containing up to 20 carbon atoms are predominantly anthropogenic

and the available data regarding their persistence and

bioaccumulation potential indicates that they satisfy the criteria

outlined in the Persistence and Bioaccumulation Regulations, made

under CEPA 1999. Chlorinated paraffins containing up to 20 carbon

atoms thus meet the criteria for virtual elimination of releases to the

environment as set out in the Toxic Substances Management Policy.

Benefits and costs

The addition of chlorinated paraffins to Schedule 1 of CEPA 1999

would enable preventive or control actions on these substances to be

taken to ensure the protection of human health and the environment.

The decision to add toxic substances to Schedule 1 of CEPA 1999 is

based primarily on a scientific assessment. Adding a substance to

Schedule 1 of CEPA 1999 allows the Government of Canada to

access the regulatory tools provided for under the Act. The

Government will undertake appropriate socioeconomic assessment of

the potential impacts of a range of possible instruments during the

risk management phase.

Consultation

On June 11, 2005, the Ministers of the Environment and of Health

published in the Canada Gazette, Part I, for a 60-day public comment

period, the summary of the scientific results of the follow-up

assessment on chlorinated paraffins and a statement indicating the

measures they propose to take on the basis of scientific

considerations. Prior to this publication, the CEPA National Advisory
Committee was informed about the release of the follow-up

assessment on chlorinated paraffins and the public comment period

mentioned above.

During the 60-day public comment period, submissions were received

from industry and industry associations on the scientific assessment.

No comments were received from non-governmental organizations,

members of the public or academia. Technical comments on the

assessment report submitted by stakeholders were carefully reviewed

by Environment Canada and Health Canada. The assessment report

was revised based on these comments. Responses to the comments

are summarized below. The full responses to the comments are

available on the Chemical Substances Web site at

www.chemicalsubstances.gc.ca.

Industry stakeholders acknowledged that the toxicity of short chain

chlorinated paraffins is well documented, but they were concerned

about the paucity of information and the uncertainty in the assessment

with regards to medium- and long-chain chlorinated paraffins.

Considering the state of science and current international work on

these substances, they believe that the conclusion on whether

medium- and long-chain chlorinated paraffins meet the criteria set out

in paragraph 64(a) of CEPA 1999 is premature. They also sought

clarification or provided suggestions on what the appropriate risk

management of chlorinated paraffins should be.

In addition, industry stakeholders provided various technical

comments on the assessment. They criticized the use of nonCanadian, outdated or conservative data and assumptions for

estimating effects and exposure. They also questioned the validity of

some calculation methods and modeling used to determine the

persistence and bioaccumulation. Finally, they proposed that the

modes of action by which some tumours are induced in animals

exposed to short-chain chlorinated paraffins are not relevant to human

health. 

Environment Canada indicated that data used in the assessment are

selected on the basis of their relevance to Canadian conditions. The

data used and assumptions made about the exposure, persistence and

bioaccumulation potential were updated to reflect current

international practices used in risk assessment. In addition, the

department modified the approach for the assessment of long-chain

chlorinated paraffins by subdividing them further into three groups

and recognizing their different physical and chemical properties. New

information in support of the bioaccumulation conclusion on all

chlorinated paraffins was also added. 

With respect to the comment pertaining to human health, Health

Canada indicated that there is insufficient information to rule out

concerns of tumour induction for humans similar to those stated for

animals and that, in addition, short-chain chlorinated paraffins already

meet the criterion under paragraph 64(a). Therefore, the department

considered that further research is not a priority.

As a result of a thorough scientific review of experimental and

modeled data, Environment Canada and Health Canada believe there
is now sufficient information to conclude that short- and mediumchain chlorinated paraffins, as well as liquid long-chain paraffins

containing up to 20 carbon atoms, meet the criteria set out in

paragraphs 64(a) and (c) of CEPA 1999. However, based on the

limited information available, the assessment conclusions for longchain paraffins containing over 20 carbon atoms have been revised so

that these substances meet the criterion set out in paragraph 64(c) of

CEPA 1999, but do not meet the criterion set out in paragraph 64(a)

of the Act. A risk management approach for chlorinated paraffins is

being prepared and consultations will be held with affected

stakeholders following publication of the final assessment report in

2008.

Implementation, enforcement and service standards

As the proposed Order would add the substances to Schedule 1 of

CEPA 1999, developing an implementation plan, compliance strategy

or establishing a service standard are not necessary. In addition, there

is no compliance or enforcement requirement associated with

Schedule 1 of CEPA 1999, itself.

Contacts

Danie Dub00E9;

Existing Substances Division

Environment Canada

Gatineau, Quebec

K1A 0H3

Telephone: 819-956-9313

Fax: 819-953-4936

Email: Existing.substances.existantes@ec.gc.ca

Markes Cormier

Regulatory Analysis and Instrument Choice Division

Environment Canada

Gatineau, Quebec

K1A 0H3

Telephone: 819-953-5236

Fax: 819-997-2769

Email: Markes.cormier@ec.gc.ca

Arthur Sheffield

Risk Management Bureau

Health Canada

Ottawa, Ontario

K1A 0K9

Telephone: 613-957-8166

Fax: 613-952-8857

Email: Arthur_Sheffield@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) (see footnote a)

of the Canadian Environmental Protection Act, 1999 (see footnote b),

that the Governor in Council proposes, on the recommendation of the

Minister of the Environment and the Minister of Health, pursuant to
subsection 90(1) of that Act, to make the annexed Order Adding

Toxic Substances to Schedule 1 to the Canadian Environmental

Protection Act, 1999.

Any person may, within 60 days after the date of publication of this

notice, file with the Minister of the Environment comments with

respect to the proposed Order or a notice of objection requesting that

a board of review be established under section 333 of that Act and

stating the reasons for the objection. All comments and notices must

cite the Canada Gazette, Part I, and the date of publication of this

notice, and be sent to the Executive Director, Existing Substances

Division, Environment Canada, Gatineau, Quebec K1A 0H3 by mail,

by fax at 1-800-410-4314 or 819-953-4936, or by email to

Existing.Substances.Existantes@ec. gc.ca.

A person who provides information to the Minister of the

Environment may submit with the information a request for

confidentiality under section 313 of that Act.

Ottawa, September 4, 2008

MARY PICHETTE

Assistant Clerk of the Privy Council

ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1

TO THE CANADIAN ENVIRONMENTAL PROTECTION

ACT, 1999

AMENDMENT

1. Schedule 1 to the Canadian Environmental Protection Act, 1999

(see footnote 3) is amended by adding the following:

Chlorinated paraffins that have the molecular formula

CnHxCl(2n+22013;x) in which 10 2264; n 2264; 38

COMING INTO FORCE

2. This Order comes into force on the day on which it is

registered.

[38-1-o]

Footnote 1

The Canadian Environmental Protection Act is now repealed and

replaced by the Canadian Environmental Protection Act, 1999. 

Footnote 2

The federal government's Toxic Substances Management Policy

further require virtual elimination from the environment of toxic

substances that are persistent and bioaccumulative and are present in

the environment primarily due to human activity (Track 1), and of

their precursors. 

Footnote a
S.C. 2004, c. 15, s. 31

Footnote b

S.C. 1999, c. 33

Footnote 3

S.C. 1999, c. 33