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The Challenge Frequently Asked Questions

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

• Overarching Program Questions
  • What were the criteria for determining the substances that are in the Challenge? Why were they different criteria for EC and HC?
  • What are the timelines and deadlines associated with the Challenge?
  • Why are there both mandatory (CEPA 1999 section 71 Notice) and non-mandatory (Questionnaire) components of the Challenge?
  • Is addition of a substance to Schedule 1 of CEPA 1999 the only option for substances in the Challenge?
  • What is meant when the Government says that it is "predisposed to treat the Challenge substances as CEPA-toxic"?
  • Will the Government of Canada impose Virtual Elimination and/or prohibitions on all PBiT substances? If so, what is the incentive for industry to respond to the Challenge Questionnaire?
  
  
• Section 71 Notice (Survey)
  • I'm seeking assistance on responding to a section 71 Notice that has been published in the Canada Gazette for a substance in one of the Challenge batches.
  • Are companies obliged to respond to a section 71 Notice if they didn't receive a survey package or letter?
  • My company uses, imports, exports and/or manufactures substances in several batches of the Challenge. Can I submit information for all these substances now?
  • What is the difference between the 2006 section 71 Notice on PBiT substances and the survey(s) we are being asked to complete for substances on the Challenge? Why are we being asked to submit information on these substances twice?
  • What kind of information will qualify as "new and valid information"?
  • Please provide examples of "information you may reasonably be expected to have access to".
  • How committed/stringent are the deadlines for the section 71 survey? Would you ever modify the timelines if important new information is discovered or submitted?
  • Will the information on a substance collected under the Challenge be publicly available? Under what circumstances will the information be kept confidential?
  
  
• Questionnaire
  • For Challenge substances that are manufactured or imported in small quantities, is it necessary to complete the entire non-mandatory Challenge Questionnaire?
  • For companies that are not subject to the section 71 Notice, what incentives are there to fill out the Challenge Questionnaire and/or to participate in the process?
  • The questions in the Questionnaire are focussed on industry. If I am part of another stakeholder group (e.g. NGO, aboriginal group or citizen group) that wants equal input into management of these substances, what opportunities will there be?
  • How will information submitted in the Questionnaire influence the management of a substance?
  
  
• Other Questions
  • Aside from responding to the section 71 Notice and the Challenge Questionnaire, what other opportunities will there be to provide information and for interaction and input on the Challenge process?
  • I wish to submit information to the Government and/or I have other questions about the Challenge. Who should I contact?

Overarching Program Questions

Q: What were the criteria for determining the substances that are in the Challenge? Why were they different criteria for EC and HC?

The Challenge to industry and other stakeholders is to provide new information about how industry is managing approximately 200 chemical substances. These are substances that have been identified by the Government, during Categorization, as high priorities for further action due to their potential hazard to the environment or human health. The hazard potential was determined based on the following  Categorization criteria:

• The substances were found to meet all of the ecological categorization criteria, including persistence, potential for bioaccumulation, and inherent toxicity to aquatic organisms (PBiT), and are believed to be in commerce in Canada, and/or
• The substances were found either to meet the categorization criteria for greatest potential for exposure (GPE) or intermediate potential for exposure (IPE) as well as being identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity.

Health Canada identified substances that have the greatest or intermediate potential for human exposure and pose a high hazard to human health and Environment Canada identified substances that are persistent and/or bioaccumulative, and inherently toxic to aquatic organisms.

Q: What are the timelines and deadlines associated with the Challenge?

Under the Challenge, the approximately 200 substances of highest priority have been divided up into a number of smaller groups ("batches") of substances, which are being addressed sequentially. These batches comprising all of the substances will be launched within a three-year timeframe.

Timelines for the activities on each of these batches are being posted on the Chemical Substances Website, as each new batch is launched. Refer to the appropriate link for each batch under the Challenge.

Information on the deadlines for submitting comments on substance profiles, and for responding to section 71 Notices and Questionnaires for substances in each batch can also be found on the Chemical Substances Website, at the following location:

• Deadlines associated with the Challenge

Q: Why are there both mandatory (CEPA 1999 section 71 Notice) and non-mandatory (Questionnaire) components of the Challenge?

The Government is using the mandatory information gathering provisions of section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to gather information deemed required for improved decision-making with regard to screening assessment and risk management. Information required may include, for example:

• the total quantity of a substance (whether alone, in a mixture, in a product or in a manufactured item) that was manufactured, imported, released, used or sold for use in Canada;
• the concentration (or range of concentrations) of the substance in a mixture, product or manufactured item; and
• use pattern codes and NAICS (North American Industry Classification System) codes that apply to the use of a substance.

The non-mandatory component is an invitation to interested stakeholders to submit additional information relating to the extent and nature of management/stewardship of substances listed under the Challenge. Additional information that it would be beneficial to provide includes information in the following areas:

• import, manufacture, and use quantities;
• substance and product use details;
• releases to the environment and spill management;
• current and potential risk management and product stewardship actions;
• existing legislative or regulatory programs controlling/managing the substance; and
• information to support the development of a regulatory impact assessment.

Providing this type of information as part of the Challenge will ensure that all relevant business activity in Canada is considered and will help the Government of Canada design appropriate risk management approaches and tools for the Challenge substances.

Q: Is addition of a substance to Schedule 1 of CEPA 1999 the only option for substances in the Challenge?

Based upon screening assessment conclusions, the Ministers of Environment and Health may propose one of the following measures for a substance in the Challenge:

• taking no further action at this time under CEPA 1999;
• adding the substance to the Priority Substances List (PSL) for further assessment; or
• recommending addition of the substance to Schedule 1 of CEPA 1999, and development of risk management instruments and, where appropriate, implementation of virtual elimination.

Q: What is meant when the Government says that it is "predisposed to treat the Challenge substances as CEPA-toxic"?

The Government is currently predisposed to conclude that the substances included in the Challenge meet the definition of toxic under section 64 of CEPA 1999 due to their potential high hazards to organisms in the environment and/or human health as identified during the Categorization process, and because they are believed to be in commerce in Canada, and/or have been identified as having a high potential for human exposure.

The Government, however, wants to provide stakeholders with the opportunity to provide new, relevant information to gain a better understanding of the use and hazard associated with these substances. Should no new information be provided during the 6-month call for information, it is expected that the assessment conclusion for these substances will be that they meet the definition of toxic under section 64 of CEPA 1999, and the Ministers will recommend that the substances be added to Schedule 1 of CEPA 1999.

Q: Will the Government of Canada impose Virtual Elimination and/or prohibitions on all PBiT substances? If so, what is the incentive for industry to respond to the Challenge Questionnaire?

Under CEPA 1999, when a screening assessment of a substance determines that a substance is toxic under the Act, and the substance is persistent and bioaccumulative in accordance with the  Persistence and Bioaccumulation Regulations, predominantly anthropogenic, and is not a naturally occurring radionuclide or naturally occurring inorganic substance, the Ministers of the Environment and Health shall recommend the substance for addition to the List of Toxic Substances in Schedule 1 of CEPA 1999 and propose the implementation of Virtual Elimination under the Act. Under CEPA 1999, Virtual Elimination is the reduction of a toxic substance released to the environment to a quantity or concentration below that which can be accurately measured.

Responses from industry to the Challenge Questionnaire will inform the Government of business activities involving substances on the Challenge and of management practices that industry may currently have in place with regard to these substances. This information will be taken into account when the Government develops risk management instruments or combinations of instruments for these substances. Examples of relevant information to provide on the Questionnaire would include best management practices and/or any preventive or control actions with respect to substance use and release that are currently employed by industry.

Section 71 Notice (Survey)

Q: I'm seeking assistance on responding to a section 71 Notice that has been published in the Canada Gazette for a substance in one of the Challenge batches.

You are required to respond to a section 71 Notice published in the Canada Gazette if you meet the reporting requirements.

If you have questions when responding to a section 71 Notice, after reading both the section 71 Notice and the guidance document for completing the Notice (which can be found on the Chemical Substances Website - refer to the appropriate link for each batch of substances under the Challenge), you may contact the DSL Surveys Coordinator for assistance.

Q: Are companies obliged to respond to a section 71 Notice if they didn't receive a survey package or letter?

Any Canadian company that meets the requirements of a section 71 Notice published in the Canada Gazette is legally obliged to respond to the survey, regardless of whether or not they received a letter or survey package.

Q: My company uses, imports, exports and/or manufactures substances in several batches of the Challenge. Can I submit information for all these substances now?

The Challenge documents (section 71 Notices and guidance documents) are targeted to the substances contained in each individual batch of the Challenge. The Government will be releasing information and section 71 Notices on the batches in sequence, at approximately three-month intervals, and stakeholders will be required to provide information regarding a substance, as specified in each section 71 Notice. However, the Government will be accepting all information voluntarily submitted ahead of a deadline. When a formal section 71 Notice is issued, stakeholders will be able to refer back to information that was already submitted, when they respond to the Notice.

Q: What is the difference between the 2006 section 71 Notice on PBiT substances and the survey(s) we are being asked to complete for substances on the Challenge? Why are we being asked to submit information on these substances twice?

The section 71 Notice published on March 4th, 2006 entitled  Notice with respect to selected substances identified as priority for action surveyed a total of 496 substances. This Notice applied to any person who, during the 2005 calendar year, manufactured or imported a total quantity greater than 100 kilograms of the substance, whether alone, in a mixture, in a product or in a manufactured item. The 2006 section 71 Notice requested only quantity ranges and NAICS (North American Industry Classification System) codes for the substances. The primary intent of this survey was to determine which substances were still in commerce in Canada in 2005.

The current surveys for "batches" of substances in the Challenge are requesting additional industrial data on some of these same substances, as well as for some other substances (i.e., some human health priority substances that have not been surveyed under previous section 71 Notices). Detailed information is now being requested for these substances in the Challenge, including: quantities manufactured, imported, used and released during the 2006 calendar year (rounded to the nearest 100 kg), concentrations, product names or manufactured item types, suppliers, customers, use codes and NAICS codes. However, a few substances in some Challenge batches may not be included in the current section 71 Notices, if they were already surveyed under a previous section 71 Notice in 2001, Notice with Respect to Certain Substances on the Domestic Substances List, which has already collected detailed information on these substances, and if the information gathered was deemed sufficient not to warrant inclusion in the current section 71 Notices.

Q: What kind of information will qualify as "new and valid information"?

New and valid information is information not currently included in the substances profiles, or in the open literature, and which could inform the risk assessment or risk management conclusions. The type of information that the Government is requesting for risk management purposes is outlined in the Challenge Questionnaire and the section 71 Notice for each batch of substances in the Challenge. You are not required to conduct tests to comply with a section 71 Notice.

Q: Please provide examples of "information you may reasonably be expected to have access to".

You are requested to provide information that your organization possesses or to which you may reasonably be expected to have access. For example, when importing a substance, mixture or product, you may reasonably be expected to have access to the relevant Material Safety Data Sheet (MSDS). An MSDS is an important source of information on the composition of a purchased product. Also, a facility may reasonably be expected to have access to its parent organization's information regarding substances, mixtures or products.

Q: How committed/stringent are the deadlines for the section 71 survey? Would you ever modify the timelines if important new information is discovered or submitted?

Under the Act (CEPA 1999), companies are obligated to respond to a section 71 Notice by the deadline specified in the Notice. Penalties are detailed in the "Explanatory Notes" section of the Notices. Extensions can be requested prior to the deadline. Requests for extension must be submitted in writing and should include the CAS numbers of substances for which information will be provided and a rationale for the extension request. The extension request should also include the name of the company, contact person, address, phone number and fax number.

No extension will be granted after the deadline has expired. It is recommended that a request for extension be submitted at least five business days before the deadline, so that the request can be processed by the Government of Canada before the deadline. You may send your request by mail, by fax, or by email.

Q: Will the information on a substance collected under the Challenge be publicly available? Under what circumstances will the information be kept confidential?

The Government is committed to the values of openness and transparency, and to providing opportunities for public participation. The Government will therefore make publicly available summaries of the information received on each substance. In accordance with section 313 of CEPA 1999, these summaries will not include confidential business information (trade secrets). Section 313 states that a person submitting information may request that it be kept confidential. A request for confidentiality should specify which item of information is to be treated as confidential, and should include a justification, examples of which may include:

• that the information has always been kept confidential by a company;
• that the disclosure of the information may reasonably be expected to cause substantial harm to a company's competitiveness.

Confidential information will not be disclosed by the Government except in situations outlined in sections 315, 316, or 317 of CEPA 1999, such as if disclosure is in the interest of public health, public safety or the protection of the environment, and the public interest outweighs any harm to competitiveness or damage to privacy.

For more detailed information on confidentiality requests, please consult  CEPA 1999 sections 313-317.

Questionnaire

Q: For Challenge substances that are manufactured or imported in small quantities, is it necessary to complete the entire non-mandatory Challenge Questionnaire?

The non-mandatory Challenge Questionnaire is only a template and does not need to be filled out completely. Only pertinent information that will help the Government of Canada understand the use of the substance should be provided. If the information to be provided does not fit into the format of the non-mandatory Challenge Questionnaire, the Government of Canada will accept and consider new and relevant information in other formats.

Information on completing the Challenge Questionnaire can be found in the Guidance Document for Completing the Challenge Questionnaire that accompanies the Questionnaire for each Batch of substances in the Challenge.

Q: For companies that are not subject to the section 71 Notice, what incentives are there to fill out the Challenge Questionnaire and/or to participate in the process?

It may be important that stakeholders not subject to the section 71 Notice ensure that the Government of Canada is aware of all relevant activities related to the substance by responding to the Challenge Questionnaire. This information will be considered in the development of the risk management approach, including instrument selection and design. Participation in the questionnaire will also ensure that the Government of Canada will be aware of stakeholders that should be consulted throughout the implementation of the Challenge.

Q: The questions in the Questionnaire are focussed on industry. If I am part of another stakeholder group (e.g. NGO, aboriginal group or citizen group) that wants equal input into management of these substances, what opportunities will there be?

The non-mandatory Questionnaire can be used by all stakeholders to provide input. The Questionnaire is intended as a guidance template to indicate the type of information the Ministers are interested in receiving from any stakeholder. However, it is recognized that not all questions in the Questionnaire may be relevant to a particular substance, use, industrial sector or stakeholder. We encourage you to make use of the template; however, if your information is outside of the scope of the Questionnaire, it is possible to submit it in a format which is convenient to you. If the nature of the information is complex, then please submit a summary of the information to the DSL Surveys Coordinator.

Q: How will information submitted in the Questionnaire influence the management of a substance?

After a screening level assessment has been conducted, and in the absence of further information on existing management practices for a substance, subsequent risk management activities will be proposed by the Government based on the application of the precautionary principle under CEPA 1999.

Information collected through the Questionnaire will be used to inform risk management decisions for a particular substance by helping the Government of Canada to:

• determine potential exposure pathways to humans and the environment so that risk management can be properly targeted;
• acquire information that will inform the risk management approach and, where appropriate, instrument selection;
• identify any existing programs that collect information that may facilitate benchmarking of the substance's use and release;
• estimate costs to industry as a result of risk management action; and
• consider the substitutes that could be potentially used to replace the substance.

Other Questions

Q: Aside from responding to the section 71 Notice and the Challenge Questionnaire, what other opportunities will there be to provide information and for interaction and input on the Challenge process?

In addition to responding to the section 71 Notices and the Challenge Questionnaires, stakeholders have the opportunity to provide comments on the substance profiles that are made public when each batch of substances on the Challenge is released. These substance profiles are available through the Chemical Substances Website; refer to the appropriate link for each batch under the Challenge.

Following the subsection 77(1) publication of the draft risk assessment for each substance, there will be a 60-day public comment period. There will also be other opportunities for interested parties to submit comments, during the standard comment periods that follow regular risk assessment and management activities under CEPA 1999. There will also be formal stakeholder engagement for risk management in the form of consultations, meetings, etc.

Online submissions of persistence, bioaccumulation, and inherent toxicity data can be entered into the online web forum at  https://www.ec.gc.ca/substances/ese/datasubmission/index_en.cfm. Other information or comments can be sent via email, fax or mail to the DSL Surveys Coordinator.

Q: I wish to submit information to the Government and/or I have other questions about the Challenge. Who should I contact?

If you wish to submit information on a substance on the Challenge, or if you cannot find the information you are looking for on the Chemical Substances Website for the Challenge, please contact the DSL Surveys Coordinator at:

DSL Surveys Coordinator
Existing Substances Program
Gatineau (QC) K1A 0H3

Telephone: 1-888-228-0530 (in Canada) or 819-956-9313
Fax: 1-800-410-4314 (in Canada) or 819-953-4936
E-mail: DSL.surveyco@ec.gc.ca