Vol. 150, No. 25 — December 14, 2016

Registration

SOR/2016-308 December 2, 2016

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

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

P.C. 2016-1083 December 2, 2016

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on October 15, 2011, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

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 1) is amended by adding the following in numerical order:

Coming into Force

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Government of Canada (the Government) has carried out screening assessments for three chemical substances to determine whether they may constitute a danger to human health or the environment. The substances are

The screening assessments determined that these substances may have harmful effects on the environment or human health as defined in paragraphs 64(a) and (c) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government is adding the three substances to the List of Toxic Substances in Schedule 1 of CEPA.

Background

On December 8, 2006, the Government launched the Chemicals Management Plan (CMP) to assess and manage chemical substances that may have detrimental effects on human health or the environment. A key element of the CMP was the Challenge initiative, which included approximately 200 high priority chemical substances. These substances were divided into 12 batches of 10 to 20 chemicals each. DEHA and PREPOD belong to batch 11 while Solvent Red 23 belongs to batch 6 of the Challenge initiative.

Under the Challenge initiative, via mandatory surveys issued under section 71 of CEPA, affected industry stakeholders were required to submit information on the approximately 200 substances such as quantities imported, manufactured or used in Canada.

Based on the information received through the Challenge initiative and other available information, screening assessments for DEHA, PREPOD and Solvent Red 23 were conducted to assess whether the substances meet the criteria of section 64 of CEPA. Under section 64 of CEPA, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

The draft screening assessments were peer-reviewed and additional advice was sought through the Challenge Advisory Panel. (see footnote 2) It was concluded that the three substances meet the criterion set out for a toxic substance under section 64 of CEPA. The draft screening assessments were published on the Chemical Substances website along with a notice published in the Canada Gazette, Part I, on October 2, 2010.

After considering public comments and available information, the final screening assessments were published on the Chemical Substances website along with a notice that was published in the Canada Gazette, Part I, on September 10, 2011. Risk management approach documents, which include information on existing risk management actions associated with the substances in Canada, including an indication of where the Government will focus its risk management activities, were also released in conjunction with these publications. (see footnote 3) A proposed Order adding the three substances to Schedule 1 of CEPA was published in the Canada Gazette, Part I, on October 15, 2011. (see footnote 4)

In addition, documents providing an update on the risk management activities for PREPOD, DEHA and Solvent Red 23 were published by the Department of the Environment in September 2013. (see footnote 5)

All the publications mentioned above may be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, 819-938-5212 (fax), or by email at eccc.substances.eccc@canada.ca.

Substance descriptions, screening assessment summaries and conclusions
DEHA

The substance DEHA is not produced naturally in the environment. It is primarily used as a plasticizer in the flexible vinyl industry and is widely used in flexible polyvinylchloride (PVC) such as cling wraps for food packaging. Also, it is used in rubber, urethane, adhesives, sealants, hydraulic fluids, lubricants, auto protectants and heavy-duty hand cleansers, as well as in certain personal care products. (see footnote 6)

According to submissions in response to a survey made under section 71 of CEPA, between 1 000 000 and 10 000 000 kg of DEHA were manufactured in Canada and approximately 250 000 kg were imported into Canada in 2006. The substance may be released to the environment during its manufacture, distribution, industrial use and the use and disposal of finished products by consumers.

According to the available information at the time, the screening assessment concluded that DEHA can be released into the Canadian environment in quantities that have the potential to cause harm to aquatic organisms. Based on its detrimental ecological properties and its estimated releases into the environment, it was concluded that DEHA met the criterion set out in paragraph 64(a) of CEPA. However, after the finalization of the screening assessment, the Government acquired new environmental monitoring and industrial practices information from industrial facilities manufacturing or using DEHA in Canada, and measured concentrations associated with industrial and municipal wastewater treatment plants. This information called into question the validity of the published monitoring data that were an important line of evidence in the screening assessment. The new data were documented and analysed in the Ecological State of the Science Report. (see footnote 7) The new ecological exposure data indicate that concentrations of DEHA in the aquatic environment are likely below the level causing environmental harm, and the substance is not expected to cause harm to aquatic organisms. Therefore, according to the Ecological State of the Science Report, DEHA does not meet the criterion set out in paragraph 64(a) of CEPA.

Canadians are currently exposed to DEHA, particularly through the use of certain personal care products. Based on identified health effects related to DEHA (developmental effects), and current exposure levels of the general population, it is estimated that Canadians are exposed to DEHA at levels that may constitute a danger to human health. As a result, it was concluded that DEHA meets the criterion set out in paragraph 64(c) of CEPA.

Since the new data had no bearing on human health risks, the Ecological State of the Science Report did not reassess human health risks. Therefore, the original conclusion that DEHA meets the criterion set out in paragraph 64(c) of CEPA has not changed.

In April 2014, DEHA was added to Health Canada’s list of prohibited and restricted cosmetic ingredients (the Cosmetic Ingredient Hotlist) as a restricted substance, to address the potential harm from DEHA to human health. The wording outlined in the Natural Health Products Ingredients Database with regards to the permitted use of DEHA in natural health products was also revised for consistency with the Cosmetic Ingredient Hotlist. Targeted surveys of DEHA in foods and food packaging materials were performed and DEHA was added to the Canadian Total Diet Study (TDS) to better define Canadian exposure to DEHA through dietary intake. Results of the targeted survey and TDS samples have been published. (see footnote 8), (see footnote 9)

Internationally, the Organisation for Economic Co-operation and Development (OECD) developed a Screening Information Data Set Initial Assessment Report (SIAR) for DEHA that identified its potential chronic aquatic hazards. In May 2012, the United States Environmental Protection Agency (US EPA) announced that it will reassess DEHA under the Integrated Risk Information System. In the European Union (EU), DEHA is listed for future assessment under the European Chemical Agency’s Community Rolling Action Plan, as it is on the list of carcinogenic, mutagenic and toxic to reproduction (CMR) substances.

PREPOD

The substance PREPOD is not naturally produced in the environment. It is an organic substance used mainly as an antioxidant in rubber products to prevent the loss of strength and flexibility of the rubber. It is used in tires, as well as in other automotive parts. PREPOD consists of numerous chemical components, not all of which may have been identified, and the concentrations of the individual components in the mixture can vary. (see footnote 10) As a result, PREPOD is classified as being of “Unknown or Variable Composition, a Complex Reaction Product or Biological Material,” or UVCB for short.

According to information submitted in response to a survey under section 71 of CEPA, between 100 000 and 1 000 000 kg of PREPOD were manufactured in Canada in 2006. During the same year, between 100 and 1000 kg of PREPOD were imported into Canada as a component of vehicle parts. The quantity of PREPOD manufactured and used in Canada indicates significant potential for release of this substance into the Canadian environment.

Based on their physical and chemical properties, many components of PREPOD are expected to persist in water, soil and sediment, but not in air. Moreover, one component, diisopropyldimethylacridan (DIPDMA), has been identified as having the potential to accumulate in organisms and may increase in concentration within food chains. Both DIPDMA and one other component, 4-(1-methyl-1-phenylethyl)-N-(4-(1-methyl-1-phenylethyl)phenyl)aniline (DCDPA) are potentially harmful to aquatic organisms. The screening assessment concluded that PREPOD meets the criterion as set out in paragraph 64(a) of CEPA.

With respect to human health, the screening assessment determined that, at current exposure levels, PREPOD does not pose a danger to human health in Canada.

Based on the available evidence, PREPOD meets the criteria set out in the Persistence and Bioaccumulation Regulations, made under CEPA. Because of this, and because it is not a naturally occurring substance, PREPOD meets the criteria for virtual elimination set out under subsection 77(4) of CEPA.

In the United States, this substance (CAS RN 68412-48-6) is listed as a high priority for future ambient monitoring in sediment under the U.S. National Water-Quality Assessment Program.

Solvent Red 23

Solvent Red 23 is not naturally produced in the environment. It is an organic substance that is used as a colourant in oils, fats and waxes, in alcohol-based ester and hydrocarbon solvents and in polystyrene. In Canada, it is used in cosmetics, and is also identified as being used in natural health products where it is permitted for external use only. Although it is permitted in Canada to be used as a colourant in externally applied non-prescription drugs, no pharmaceutical or veterinary products have been identified. The substance is also used as a colourant in some pesticides (for commercial pesticides only).

According to information submitted in response to section 71 surveys, Solvent Red 23 was not manufactured in Canada in 2005 and 2006. However, between 100 and 1 000 kg of the substance were imported in 2005. Importation of the substance was reported to be in some retail personal care products.

Solvent Red 23 is a member of a class of substances characterized by the presence of one or more azo groups containing bonds which, when broken, may result in the release of 4-aminoazobenzene. 4-Aminoazobenzene has been classified as a carcinogen by the International Agency for Research on Cancer (IARC) and the European Commission on the basis of its genotoxicity and carcinogenicity. Also, Solvent Red 23 is structurally similar to Sudan I, which has been classified as a mutagen and carcinogen by the European Commission. Therefore, it is determined that genotoxicity and carcinogenicity are the effects considered critical to assessing the risks to human health.

Based on potential exposure of the general population to Solvent Red 23 from use of certain personal care products (i.e. oral exposure from use of lip gloss/lip balm), and the evidence of genotoxicity and carcinogenicity, the screening assessment concluded that Solvent Red 23 has the potential to be harmful to human health. As a result, this substance was concluded to meet the criterion as set out in paragraph 64(c) of CEPA.

The quantity of Solvent Red 23 that may be released to the environment is below the level expected to cause harm to organisms. Therefore, it was concluded that Solvent Red 23 is not likely to be harmful to the environment and does not meet the criterion as set out in paragraph 64(a) of CEPA.

In April 2014, Solvent Red 23 was added to the Health Canada’s Cosmetic Ingredient Hotlist as a restricted substance to address the potential harm from Solvent Red 23 to human health. As a result, Solvent Red 23 is not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth and hair dye products containing Solvent Red 23 must contain warnings. The wording outlined in the Natural Health Products Ingredients Database with regards to the permitted use of Solvent Red 23 in natural health products was also revised for consistency with the Cosmetic Ingredient Hotlist.

Internationally, the health effects of Solvent Red 23 have been previously evaluated by IARC, the European Commission Scientific Committee on Consumer Products (SCCP), and the European Food Safety Authority (EFSA). The IARC and SCCP indicated there was insufficient information for a clear conclusion on the carcinogenicity of Solvent Red 23; however, in the absence of sufficient data, EFSA considered it prudent to assume Solvent Red 23 to be “potentially genotoxic and possibly carcinogenic.” (see footnote 11)

Objectives

The objective of the Order Adding Toxic Substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 is to enable the Government to implement regulatory instruments under the statutory authority of CEPA if such actions are deemed necessary.

Description

The Order adds DEHA, PREPOD and Solvent Red 23 to Schedule 1 of CEPA (the List of Toxic Substances).

The proposed Order, which was published on October 15, 2011, proposed the addition of “Reaction products of 2-propanone with diphenylamine, containing diisopropyldimethylacridan that has the molecular formula C21H27N” (i.e. PREPOD containing DIPDMA) to Schedule 1 of CEPA. Given that DIPDMA cannot be intentionally removed from PREPOD, the Order now only lists “PREPOD,” without specifying the component DIPDMA.

“One-for-One” Rule

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

Small business lens

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

Consultation

On October 2, 2010, the Minister of the Environment and the Minister of Health (the Ministers) published summaries of the draft screening assessments in the Canada Gazette, Part I, and made available the full screening assessments on the Chemical Substances website for a 60-day public comment period. Risk management scope documents were also released on the same date, outlining the preliminary options being examined for the management of the substances meeting the criteria under section 64 of CEPA.

Prior to this publication, the Department of the Environment and the Department of Health (the Departments) informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessments on the substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.

During the 60-day public comment period, no comments were received on the draft screening assessment for Solvent Red 23. A total of seven submissions on the screening assessments for DEHA and PREPOD were received from three industry stakeholders, one researcher, two industry associations, and two non-governmental organizations (NGOs). (see footnote 12) All comments were considered in developing the final screening assessments for the three substances.

Below is a summary of some key comments and responses:
Summary of comments and responses related to DEHA:
Summary of comments and responses related to PREPOD:
Comments received following publication of the proposed Order in the Canada Gazette, Part I

On October 15, 2011, the Ministers published a proposed Order to add substances including DEHA, PREPOD containing DIPDMA, and Solvent Red 23 to Schedule 1 of CEPA in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 14)

During the 60-day public comment period, a Notice of Objection was filed by one industry association, under subsection 332(2) of CEPA, regarding the proposed addition of DEHA to Schedule 1 of CEPA, requesting the establishment of a Board of Review pursuant to section 333 of CEPA.

The information provided in the Notice of Objection was reviewed by the Departments. It was determined that none of the information provided supports a change in the conclusions of the screening assessment that DEHA is harmful to the environment and human health. After considering whether an inquiry into the nature and extent of the danger posed by that substance was necessary, the Ministers decided not to establish a Board of Review. (see footnote 15)

In addition to the Notice of Objection regarding DEHA, two submissions related to the overall proposed Order were received from four citizens. These submissions supported the addition of the substances to Schedule 1 of CEPA. One of these two submissions also provided comments on Solvent Red 23.

Summary of comments and responses from the Notice of Objection on DEHA
Summary of comment and response related to Solvent Red 23
Summary of stakeholder engagement following publication of the proposed Order in the Canada Gazette, Part I

The Government has had regular discussions with stakeholders since the proposed Order to add DEHA, PREPOD and Solvent Red 23 to Schedule 1 of CEPA was published in 2011. In the Risk Management Update (see footnote 17) published in September 2013, stakeholders were advised that the Government had added PREPOD to the CMP Monitoring and Surveillance Program and that an analytical method was being developed. In early 2014, multiple stakeholders using the substance were contacted to confirm if they were still using PREPOD and also to invite them to participate in a sampling campaign to measure releases of the substance into the environment.

In addition, the Department of Health has had opportunities to engage with stakeholders who use DEHA and Solvent Red 23. In April and October 2013, the Department was invited to speak at industry meetings where various stakeholders were informed of potential additions to the Cosmetic Ingredient Hotlist, including DEHA and Solvent Red 23. In April 2014, DEHA and Solvent Red 23 were added to the Cosmetic Ingredient Hotlist. Prior to being formally added, proposed changes to the Cosmetic Ingredient Hotlist were posted for consultation on Health Canada’s website for a 60-day comment period. Three comments were provided with respect to the addition of DEHA and four comments were received with respect to the addition of Solvent Red 23 to the Cosmetic Ingredient Hotlist. None of the comments received impacted the course of action.

Rationale

Developmental toxicity is the critical health effect from exposure to DEHA. As the margin between estimated exposures to DEHA and the level at which DEHA is harmful to human health is inadequate, it is concluded that DEHA is harmful to human health and meets the criterion set out in paragraph 64(c) of CEPA.

Based on their physical and chemical properties, all components of PREPOD evaluated are expected to persist in water, soil and sediment, but not in air. Moreover, one component, DIPDMA has been identified as having the potential to accumulate in organisms and may increase in concentration within food chains. In addition, it is found that at least two components of PREPOD are potentially harmful and present a risk to aquatic organisms. Given these concerns, it is concluded that PREPOD meets the criterion set out in paragraph 64(a) of CEPA.

Exposure of the general population to Solvent Red 23 can occur through the use of certain personal care products. The potential breakdown product of Solvent Red 23 has been classified as a carcinogen by the IARC and the analogue, Sudan I, has also been classified as a mutagen and carcinogen by the European Commission. Given these concerns, it is concluded that Solvent Red 23 is harmful to human health and meets the criterion set out in paragraph 64(c) of CEPA.

One of the following three measures can be taken after a screening assessment is conducted under CEPA:

Given the concerns identified above and the screening assessment conclusions, the addition of DEHA, PREPOD, and Solvent Red 23 to Schedule 1 of CEPA is therefore the preferred option among the three alternatives.

The addition of the three substances to Schedule 1 of CEPA does not impose any incremental impacts (benefits or costs) on the public or on industry, since there are no compliance requirements. Accordingly, there is no compliance or administrative burden on small businesses or businesses in general.

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. See http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php.

Implementation, enforcement and service standards

The Order adds DEHA, PREPOD, and Solvent Red 23 to Schedule 1 of CEPA, thereby allowing for developing and publishing regulations or instruments under CEPA if such actions are deemed necessary. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary for this Order.

Contacts

Greg Carreau
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