by Tammy J. Murphy
Canadian law requires scientific information on new chemical substances to be submitted for assessment before using the substances in Canada. However, many substances were in existence and in use prior to the enactment of these laws. To address these “existing” substances, the Canadian Environmental Protection Act, 1999 (CEPA, 1999), mandated that all substances on the Domestic Substances List (DSL) be categorized to determine which of these substances presented the greatest potential for exposure or were persistent, bioaccumulative and inherently toxic. These substances required additional assessments/research/control measures. This led to the formation of the Chemicals Management Plan (CMP) under which chemicals are assessed and managed using multiple tools. While the first phase of the CMP, the “Challenge to Industry,” continues, the next phase of the CMP was announced in October 2011 and also continues with substance evaluations/assessments, product safety improvements, research of substances that affect human hormone function and/or the environment, etc. Although there is a focus on those substances identified as part of the “Challenge” or as part of the second phase of the CMP, chemical management for Canada extends beyond just those substances.
Update on “Challenge” Substances:
Batch 7 consisted of 14 substances, including Methanone, bis[4-(dimethylamino)phenyl]- (also known as Michler’s ketone) and n-Butyl glycidyl ether. In March 2010, the summary of the screening assessments for these 2 substances was published with the conclusion that they “constitute or may constitute a danger….to human life or health” and that they met the CEPA, Section 64 criteria for toxic. In December 2011 these substances were added to CEPA, Schedule 1, List of Toxic Substances. Addition to Schedule 1, List of Toxic Substances, allows the Minister of the Environment and the Minister of Health “to develop proposed risk management instruments” in order to manage human health and environmental risks posed by these substances. These tools can be implemented for any part of a substance’s life cycle and can range from regulations to guidelines to codes of practice. And, in the August 28, 2013 edition of the Canada Gazette, Part II, an Order applying Significant New Activity (SNAc) provisions to these substances was published.
Batch 12 consisted of 16 substances and in January 2011, final screening assessment reports for 12 of those substances were published in the Canada Gazette, Part I. And, in June 2013, the final decisions after the screening assessment were published for 9 substances. Based on the information from the screening assessments, the Government of Canada has proposed to “take no further action” on 6 of the substances. However, the final screening assessment report for 3 substances showed that although the substances did not meet the CEPA, Section 64 criteria for toxic, they were “persistent, bio-accumulative, and inherently toxic to non-human organisms and have the potential to cause adverse impacts on the environment.” As such, the Minister of the Environment applied SNAc provisions and/or notification requirements for 3 substances. The Order applying SNAcs to the following 3 substances was published in the July 3, 2013 edition of the Canada Gazette, Part II.
- 1H-Indene, 2,3-dihydro-1,1,3,3,5-pentamethyl-4,6-dinitro-
- Ethanamine, N-ethyl-N-hydroxy-, reaction products with hexamethylcyclotrisiloxane, silica and 1,1,1-trimethyl-N-(trimethylsilyl)silanamine
- Pyridine, 2-[3-(3-chlorophenyl)propyl]-
And, the recommendations after the screening assessments, for an additional 4 Batch 12 substances were published in the July 6, 2013 edition of the Canada Gazette, Part I. These include proposals to recommend adding 2 of the substances [Benzene, 1-chloro-2-[2,2-dichloro-1-(4-chlorophenyl)ethyl] (also known as “Mitotane”) and 2,4,11,13-Tetraazatetradecanediimidamide, N,N’’-bis(4-chlorophenyl)-3,12-diimino-, diacetate (also known as “Chlorhexidine acetate)] to CEPA, Schedule 1. And, the proposals for the other 2 substances [1-Naphthalenepropanol, .alpha.-ethenyldecahydro-2-hydroxy-.alpha.,2,5,5,8a-pentamethyl-,[1R-[1.alpha.(R*),2.beta.,4a.beta.,8a.alpha.]- (also known as “Sclereol”) and Benzenamine, 4,4’-[(1-methylethylidine)bis(4,1-phenyleneoxy)]bis-,] are to apply SNAcs to them. There is a 60-day, from date of publication, comment period for these proposed recommendations.
Update on “Petroleum Stream” Sector Approach:
Another part of the Chemicals Management Plan also includes a sector specific “Challenge” for the petroleum industry. It is very similar to the “Challenge” but focuses on those substances used predominantly in the petroleum sector. Like the “Challenge,” high priority substances were identified, calls for information have been issued and screening assessments and recommendations are issued. Similar to the “Challenge,” this is an ongoing process. In the July 27, 2013 edition of the Canada Gazette, Part I, “publication of final decision after screening assessment” for 10 “industry-restricted” substances was published. It was concluded that they do not meet the CEPA, Section 64 criteria for toxic and that, currently, the proposal is to take no further action on these 10 substances:
- Distillates (petroleum), light catalytic cracked
- Distillates (petroleum), light thermal cracked
- Residues (petroleum), hydrocracked
- Gas oils (petroleum), heavy atmospheric
- Distillates (petroleum), intermediate vacuum
- Distillates (petroleum), light vacuum
- Distillates (petroleum), vacuum
- Naphtha (petroleum), full-range straight-run
- Naphtha (petroleum), light hydrocracked
- Naphtha (petroleum), heavy hydrocracked
Update on “Substances Groupings Initiative:”
Part of the 2nd phase of the CMP consists of the assessment and potential management of 9 groups of substances. The 9 groups include:
- Aromatic azo- and benzidine-based substance group;
- Boron-containing substances;
- Selected substances with potential for human exposure that have been internationally classified;
- Selected organic flame retardants;
- Cobalt-containing substances;
- Methylenediphenyl diisocyanates and diamines;
- Selenium-containing substances;
- Substituted diphenylamines
“Section 71 Notices” have previously been published for multiple groupings. These notices fall under Section 71 of CEPA, 1999 and are mandatory surveys for those who meet the requirements. The purpose of these surveys is to gather information and assess whether the substances listed in the appropriate Schedule of the Notice are toxic or are capable of becoming toxic. It also provides information that will help determine whether risk management controls need to be imposed for these substances. Persons described in the Notices are required to submit the required information as stipulated by a certain date. Substances may be included in the Notice that were not originally included in the ‘groupings.’ On July 13, 2013, a Section 71 Notice was issued for 14 substances in the Phthalates group. The Section 71 Notice requires “any person described in Schedule 2 to this notice who possesses or who may reasonably be expected to have access to the information required in Schedule 3 to this notice, to provide that information no later than November 13, 2013, 5 p.m. Eastern Daylight Saving Time.” Please see the notice for a complete list of substances and requirements.
Full text of all notices can be found in the appropriate edition of the Canada Gazette: