Canada Gazette, Part I, Volume 151, Number 45: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999

November 11, 2017

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Government of Canada (the Government) has conducted a screening assessment (see footnote 1) on mitotane (see footnote 2) to determine whether the activities associated with the substance could constitute a danger to human health or the environment. The screening assessment has concluded that mitotane meets the environmental criterion for a toxic substance, as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA or the Act). In addition, because mitotane meets the criteria set out in the Persistence and Bioaccumulation Regulations (see footnote 3) and is found in the environment predominantly as a result of human activity, it meets the criteria for virtual elimination as set out under subsection 77(4) of CEPA. It is therefore mandatory that the Minister of the Environment and the Minister of Health recommend that mitotane be added to the List of Toxic Substances in Schedule 1 of CEPA as set out in subsection 77(3) of the Act.

Virtual elimination aims to reduce to minimal levels the concentrations of persistent and toxic substances as well as the risks associated with these substances. However, in determining the preventative or control actions to take in relation to a substance, the Minister of the Environment and the Minister of Health (the ministers) must take into consideration any factor or information that, in the opinion of the ministers, is relevant, including, but not limited to, any other relevant social, economic or technical matters. Considering the essential use of mitotane as a therapeutic cancer drug in Canada, none of the measures currently being proposed would limit the use of mitotane in treating cancer.

Background

On December 8, 2006, the Chemicals Management Plan (CMP) (see footnote 4) was launched by the Government to assess and manage chemical substances that may be harmful to human health or the environment. A key element of the CMP is the Challenge initiative, which assessed approximately 200 high-priority chemical substances, including mitotane, to identify those posing a risk to the environment or human health.

Based on available information, mitotane was identified as a high priority for screening assessment because it was found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms (e.g. plants and animals). In addition, the screening assessment determined that mitotane is highly persistent and bioaccumulative and has the potential to cause harm to non-human organisms at low concentrations.

In 2009, stakeholders submitted information on activities and uses associated with mitotane in response to mandatory surveys issued under section 71 of CEPA. (see footnote 5) There were no reports for the use of mitotane in consumer products in Canada. The only reported use for mitotane was as a therapeutic product for the treatment of cancer of the adrenal gland. Direct exposure from the use of mitotane as a therapeutic product is addressed under the Food and Drug Regulations. There are no additional risk management measures currently being proposed or considered by the Government to control the essential use of mitotane as a therapeutic cancer drug in Canada.

Substance description, use and sources of release

Mitotane does not occur naturally in the environment but has been measured, in Canada, in air, soil, surface water, precipitation and sediment. Its presence in the environment is likely as a result of past applications of the insecticides (see footnote 6) dichlorodiphenyltrichloroethane (DDT) and dicofol. (see footnote 7) Through its current use as a therapeutic cancer drug, continued release to the environment is possible. Mitotane has low solubility in water, has minimal volatility and has a tendency to partition to the particles and lipids of organisms.

According to information received under section 71 of CEPA, mitotane is not manufactured in Canada, but it is imported into Canada for use as a therapeutic cancer drug. An estimated 93 kg, 100 kg and 60 kg of mitotane were used in pharmaceuticals in 2007, 2011 and 2012, respectively.

In Canada, mitotane is registered in Health Canada's Drug Product Database as an ingredient in a licensed pharmaceutical drug. This prescription drug is an oral chemotherapeutic agent used in the treatment of cancer of the adrenal gland. Specifically, mitotane is used in the treatment of inoperable, metastatic and recurrent adrenocortical cancers and is considered by many clinicians as the drug of choice for the treatment of adrenocortical cancers. As the drug is only prescribed to a limited number of users in Canada, mitotane is expected to be released to only a few sites at any point in time; specifically, mitotane may be released in wastewater and may be found in biosolids from wastewater treatment systems as well as in water and sediments in proximity to the source of release.

Summary of the screening assessment

A screening assessment was conducted for mitotane to determine whether it meets one or more of the criteria for a toxic substance, as set out in section 64 of CEPA. Specifically, the assessment involves determining whether mitotane is entering or may enter the environment in a quantity or concentration or under conditions that

Human health assessment

In Canada, the only known use of mitotane is as a therapeutic cancer drug for the treatment of adrenal cancer. The potential for direct exposure to the general population from this use is already addressed under the Food and Drug Regulations; exposure is not a source of concern regarding human health. (see footnote 8) Under section 71 of CEPA, there were no reported uses of mitotane in consumer products; therefore, exposure to the general population from consumer products containing mitotane is not expected. Given the current control measures and uses of mitotane in Canada, the screening assessment determined that mitotane did not meet the human health criterion under paragraph 64(c) of CEPA. (see footnote 9)

Ecological assessment

The ecological assessment found that mitotane has the potential to be highly hazardous to aquatic organisms because this substance is expected to cause acute and chronic harm to several species of aquatic organisms at low concentrations. (see footnote 10) In addition, the assessment concluded that mitotane is expected to be highly persistent in air, water, soil and sediment, that it has the potential to bioaccumulate in aquatic organisms and that it may biomagnify in aquatic food chains.

While limited quantities of mitotane are used as a pharmaceutical in Canada, a relatively large proportion of this amount may be released to municipal wastewater systems through excretion. These releases may be concentrated at a small number of sites. The ecological assessment compared estimated levels of mitotane near points of release in lakes and rivers receiving wastewater system effluent with levels expected to cause harm to aquatic organisms and found that there is a potential for ecological harm. Furthermore, there are long-term risks associated with persistent and bioaccumulative substances due to the compounding effects over long periods of time. Thus, although only small amounts of mitotane may be released based on its use as a therapeutic cancer drug, these releases remain a source of concern for the environment in Canada. These releases add to the total quantity of mitotane currently present in the environment as a result of the historical use of DDT and dicofol. The final screening assessment has concluded that mitotane meets the criterion set out in paragraph 64(a) of CEPA.

In addition, because mitotane meets the criteria set out in the Persistence and Bioaccumulation Regulations and is found in the environment predominantly as a result of human activity, it meets the criteria for virtual elimination as set out under subsection 77(4) of CEPA. It is therefore mandatory that mitotane be recommended for addition to the List of Toxic Substances in Schedule 1 of CEPA as set out in subsection 77(3) of CEPA.

Objectives

The objective of the proposed Order Adding a Toxic Substance to Schedule 1 of the Canadian Environmental Protection Act, 1999 (the proposed Order) is to enable the Minister of the Environment (the Minister) to propose future risk management measures under CEPA, should such measures be deemed necessary to manage environmental risks associated with potential future uses of mitotane. None of the measures currently being proposed would limit the use of mitotane in treating cancer.

Description

The proposed Order would add mitotane to Schedule 1 of CEPA.

“One-for-One” Rule

The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business.

Small business lens

The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business.

Consultation

The draft screening assessment was peer-reviewed, and additional advice was sought through the Challenge Advisory Panel. (see footnote 11) On July 6, 2013, the ministers published a summary of the draft screening assessment for mitotane in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 12) During the 60-day public comment period, no comment was received on the draft screening assessment report.

Prior to this publication, the Government informed the governments of the provinces and territories through the CEPA National Advisory Committee (see footnote 13) (NAC) of the release of this report and of the related public comment period. No comments were received from CEPA NAC.

On October 28, 2017, the final screening assessment report for mitotane was published on the Government's Chemical Substances website. (see footnote 14)

Rationale

Mitotane is present in the environment as a result of past DDT use. Mitotane continues to be released to the environment from its current use as a therapeutic cancer drug to treat adrenal cancer and possibly from degradation from any remaining DDT concentrations. The substance is expected to be highly persistent in air, water, soil and sediment, has the potential to bioaccumulate in aquatic organisms and may biomagnify in aquatic food chains. Mitotane is expected to cause acute and chronic harm to several species of aquatic organisms, at low concentrations, near sources of release. Thus, the screening assessment has concluded that mitotane meets the environmental criterion as defined under paragraph 64(a) of CEPA.

In addition, because the assessment found that mitotane meets the criteria set out in the Persistence and Bioaccumulation Regulations, and because the presence of mitotane in the environment is a direct result of human activity, mitotane meets the criteria in section 77 of CEPA for virtual elimination. The Act, therefore, makes it mandatory that the ministers recommend the addition of mitotane to Schedule 1 of CEPA.

The proposed addition of mitotane to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance requirements on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the proposed Order would enable the Minister to propose future risk management measures under CEPA, should such measures be deemed necessary to manage potential environmental risks associated with potential future uses of mitotane. None of the measures currently being proposed would limit the use of mitotane in treating cancer.

If the Minister determines that future uses of mitotane require further risk management, the Minister would assess the costs, risks and benefits and consult with the public and other stakeholders during the development of any risk management measure to address potential environmental concerns associated with future uses of mitotane in Canada.

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. (see footnote 15)

Implementation, enforcement and service standards

The proposed Order would add mitotane to Schedule 1 of CEPA, thereby enabling the Minister to propose future risk management measures under CEPA, should such measures be deemed necessary to manage environmental risks associated with potential future uses of mitotane. As developing an implementation plan, an enforcement strategy, or establishing service standards are only considered necessary when there is a specific risk management proposal, these particular actions are not considered necessary for this proposed Order.

Contacts

Julie Thompson
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Fax: 819-938-5212
Email: eccc.substances.eccc@canada.ca

Michael Donohue
Risk Management Bureau
Department of Health
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue2@canada.ca

PROPOSED REGULATORY TEXT

Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance 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, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819-938-5212; email: ec.substances.ec@canada.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, November 2, 2017

Jurica Čapkun
Assistant Clerk of the Privy Council

Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999

Amendment

1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 16) is amended by adding the following:

Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl]-, which has the molecular formula C14H10Cl4

Coming into Force

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

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