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Canada: building on progress with the CMP

Canada: building on progress with the CMP

Global Business Briefing, October 2014 / Canada

The Chemicals Management Plan (CMP) was launched the same month – December 2006 – as the REACH Regulation was adopted in the EU, but the two are very different. Key examples are that the CMP conducted its prioritisation process right at the beginning of the programme and did not require companies to register all their substances or submit scientific studies for all the substances they provide, whereas REACH requires both registration and the submission of scientific studies for all substances and only brings prioritisation processes into play at a later stage.
With discussions continuing in Washington DC on how the US Toxic Substances Control Act (TSCA) might be revised, and several Asian countries recently passing chemicals management laws, the pros and cons of the Canadian and European regimes are being brought to light.

Amardeep Khosla, executive director of the Cepa Industry coordinating Group (ICG), an umbrella group of trade associations and companies, describes the CMP as “widely seen as credible and results oriented”. Speaking at the ICG’s recent conference in Mississauga, near Toronto, he said that back in the 1990s when Cepa 1999 was being drafted, there was a “very polarised, fractious environment” but “it’s the CMP’s track record that changed this”.
Virginia Poter, director general of Environment Canada’s chemicals sector directorate, told the conference that the CMP “is about how to achieve risk management objectives without undue burdening of the economy. The CMP’s prioritisation process is world leading.” Since the CMP began, said Ms Poter, it has issued information requests (under Cepa Section 71) for 671 substances, and has learned that targeted approaches and early stakeholder engagement are important for the development of information gathering approaches and strategies. Some 60 risk management instruments have been drawn up for the 96 substances deemed to be toxic.

John Graham, dean of Indiana University’s school of public and environmental affairs, told delegates that the categorisation of the DSL (see box) demonstrates that prioritisation is feasible based on limited data. Presenting the findings of a study his school has conducted, with funding from the American Chemistry Council (ACC), on lessons the US could learn from the CMP and REACH, he said the former’s use of screening level risk assessments shows that full risk assessments “are not necessary for government to make regulatory decisions”, while adding that REACH registration dossiers also do not include full risk assessments and often use modelling and read-across data.
In a panel discussion on the CMP’s place in the world, the ACC’s Mike Walls said Canada has had a significant influence on the discussions in the US on reforming TSCA, and “that’s appropriate – our industries are closely connected. When Canada introduced the CMP, it had very similar policy objectives to those the US has today.”

Bob Diderich of the OECD, said the CMP “was the first programme to get prioritisation right and is the only one still. The reason there’s no prioritisation process in REACH is that under the previous regime, prioritisation was a disaster.”

Speaking later in the conference, ICG chair and Arkema regulatory affairs manager Robert Roth, said international recognition for the CMP is increasing , but “REACH is still predominant. If international recognition continues to build, hopefully we can get CMP on top. There is a need to promote the ‘CMP concept’ internationally to counter REACH.”
Responding to the suggestion from one of the industry speakers that the CMP Stakeholder Advisory Council could commission or draft a report “on why the CMP is a good alternative”, AJ Preece, director general of Health Canada’s safe environments directorate, said it was “a great idea”.

New substances
There has been a “tremendous amount” of work on Snacs (see box below) to improve timeliness, minimise administrative delays (rather than those caused by data inadequacies) and exclude R&D activities, said Gord Cluett, head of regulatory affairs and product stewardship at DuPont Canada, and of the ICG’s new substances subcommittee. “We want Snacs to be as simple and understandable as possible – and as targeted as possible, impacting only the uses of concern.” But ICG members still have some concerns about operational matters, such as the timeliness and effectiveness of the pre-notification consultation (PNC) process. This has to be quicker than submitting a new substance notification application and getting it back, he said, otherwise a company might as well do the latter. Also, the requirements of the New Substance Notification Regulations (NSNR) for organisms, as opposed to those for chemicals or polymers, can be complex, and the data packages for organism notifications are typically very large. As a result, there is often a significant delay before the applicant hears back on any deficiencies in the package, and there can be a lot of revision requested before a package is considered complete and ready for assessment. But the government has established operational service standards and convened a new working group to keep it informed on industry’s concerns and to propose improvements.
An advisory note on Snacs will be published next spring, says Environment Canada, with a draft version sent to the ICG new substances subcommittee sometime before then. The note will clarify the government’s approach on the so-called “instant non-compliance” issue for new substance Snacs. Another advisory note, on so-called “masked names”, will be published “shortly”, and clarify that masking the identity of a substance should be based on the explicit chemical name (that is, any Cas approved name) of the notified substance. A draft advisory note on substances released from imported manufactured items, will also be sent to the new substances subcommittee. The note will provide a list of products and clarify which substances would be notifiable under the NSNR.

Under phase two of the Canada/US Regulatory Cooperation Council, the two countries are exploring areas of commonality between Snacs and the US Significant New Use Rules (Snurs). Termed a North American Notification Consultation (Nan-C), the process would allow companies planning to introduce a new substance in both countries to approach the two governments simultaneously (CW 9 October 2014). The final work plan for taking this project forward is due to be developed by December.
Canada also plans to review all Snacs currently in force to see whether updates are needed.

Nanomaterials
A nano-scale material that is not explicitly on the DSL (see box on page 2) is considered to be a new substance. A draft advisory note sent to the ICG provides guidance on what types of substances can expect to be scrutinised as potential nanomaterials, Linda Santry of Nova Chemicals told the conference, and these include carbon nanotubes; inorganic carvon; metal oxides and metalloid oxides; metals, metal salts and metalloids; and semi-conductor quantum dots. During the new substance notification review for these classes of substance there may be additional information requested to assess their nano status, even for bulk materials, she said. Companies should also expect fairly comprehensive nano-specific information in Snac notices, and this is “an excellent example”, she said, of where a Pre-notification Consultation would be a good idea.
Brad Fisher, manager of Environment Canada’s nanomaterials section, said the government recently published an advisory note on which classes of substances are likely to behave differently than their nanoscale forms, and that a consultation document will be published later this year on a proposed approach for addressing nanomaterials on the DSL. Initial thoughts include identifying those nanomaterials on the list with Cas numbers; prioritising these; and examining some nanomaterials for their potential environmental and health impacts.

Cosmetic and food ingredients
Since 2001, substances in products regulated under Canada’s Food and Drugs Act (F&DA), such as cosmetics, pharmaceuticals and food additives, have been regulated under Cepa 1999 and are subject to the New Substances Notification Regulations for uses beyond the scope of the F&DA. But currently, the government is not asking for notifications for substances on the list provided they are manufactured or imported solely for use in products regulated under the F&DA. To date, the government has assessed more than 800 notifications for such substances. Those which were not on the DSL were added to a second inventory, known as the In-Commerce List. This is being revised, and the most recent updated version was current as of 31 March 2014. The list currently contains around 3,400 substances, but further updates will published periodically. The government is working to prioritise the substances on the list by 2016, using both hazard and exposure, and identify which warrant further consideration, said Shaunalea Savard, of Health Canada’s F&DA substances assessment division. So far around 250 substances have fallen into this category, and include certain azo dyes, some for which high toxicity or ecotoxicity has been identified, and substances containing metals such as lead, mercury and cadmium. Assessment of substances warranting further consideration will be conducted during the CMP’s next phase (CMP3) in 2016-2020, and the government may issue a Section 71 information request to address data gaps on areas of the greatest uncertainty for substances of highest concern.
CMP3

To finish the assessment of substances under CMP2 and complete the assessment of the remaining 1,700 or so during CMP3, the government will need to assess some 350 substances each year, which is an “ambitious task”, said Health Canada’s AJ Preece. The government will discuss with industry how it plans to group the substances. Its approach, she said, may be based on functional use in some cases, as well as chemical structure, and combinations of both are being explored. The most frequently reported uses during the last update of the DSL were paints and coatings; personal care products; cleaning and furnishing care products; and lubricants and greases.
ICG chair Robert Roth pointed out that the CMP3 substances include polymers and substances of unknown or variable composition (UVCBs), some are data poor, and it will be difficult to fit them into a manageable number of groupings. “Chemical groupings may not work. When we looked at it, we came up with 109, which is unmanageable.”

Another challenge in CMP3, said Mr Roth, will be confidential business information (CBI). “Government needs the ability to include details in risk assessments and risk management decisions for broader transparency for stakeholders and more flexibility in communicating the rationale for decisions…I’m pleading with you in industry: don’t claim everything as CBI – because it’s not. Allow the government to publish some information.”
The current expected schedule for the publication of the remaining draft assessments under CMP2 is this autumn for cobalt-containing substances, and “winter 2015” for substituted diphenylamines, selenium-containing substances, certain organic flame retardants and boron-containing substances. A “state of the science report” on phthalates will be published next spring (CW 18 August 2014).

Mr Roth went on to warn the audience that “we aren’t going to be ‘done’ in 2020” as there will be a need to assess new substances. He also forecast that Canada’s plans to implement the UN Globally Harmonized System (GHS) of classification “will be the most labour intensive programme of the last 25 years”. Regulations to implement the GHS in the workplace, and bring them in line with those being introduced in the US, are expected to come into force in Canada by 1 June 2015.

Next DSL update
The first two inventory updates of the DSL were focused on the 4,300 categorised substances, and there remains a need to improve information about the commercial status of chemicals in Canada. This is illustrated, said Daren Kelland, Environment Canada information collection manager, by the fact “more than 75% of the substances already surveyed reported uses that were completely different from the ones we had”. But he added that the government has not yet decided on the scope of future inventory updates.
Criteria to prioritise the scope of future inventory updates will need to be established in consultations with stakeholders, says Environment Canada. For example, instead of asking for information on particular substances, said Mr Kelland, “we are considering setting reporting conditions based on criteria such as international programmes for high production volume chemicals, or requiring information for all substances that meet them – with exceptions, for example, for pesticides.” Reporting thresholds, set as tonnages, could be based across several years to take account of fluctuations, and the survey model could include industry identifying which substances on the current DSL are used in “higher quantities”. Other criteria to establish the scope could include high hazard substances, substances with potential high exposure use patterns and substances addressed in other jurisdictions.

ICG chair Robert Roth told the conference it was in industry’s best interest to provide accurate information to government in a timely manner. “No information can lead to controls”, he warned. He also urged companies to submit information on a voluntary basis, where relevant. “Voluntary submissions by industry are critical. For example, for the boron series, you didn’t see a survey request because the government was able to get the information it needed without one.” If the government does issue more survey notices, he said, it needs to include a de minimis reporting threshold.
The government also plans to further develop its chemicals assessment approaches, said Christine Norman, director of Health Canada’s existing substances risk assessment bureau. Until now, most assessments have been chosen through the categorisation and new substance notification routes, but other “feeders”, such as industry information, emerging science and international activity, are becoming increasingly relevant. An approach document describing principles and considerations in greater detail will be published on the chemical substances website this autumn. Health Canada is also exploring in partnership with the US EPA how high throughput screening data from the US ToxCast and Tox21 programmes could be used to identify chemical hazards and thus support health risk assessments. The use of rapid screening, and a willingness to work with a certain level of uncertainty, are essential, said ICG speakers, if countries are going to meet the UN’s goal, as set out in Saicm (Strategic Approach to International Chemicals Management) programme, of achieving sound chemicals management across the globe by 2020.

BOX: Key elements of the CMP

Canada has assessed new chemicals since 1994. The Canadian Environmental Protection Act (Cepa) 1999 required the government to prioritise, through categorisation, the 23,000 “legacy chemicals” introduced to the market before this time. These substances comprise the Domestic Substances List (DSL).
Because the DSL does not reflect the current commercial status of substances in Canada, it requires updating. The first update (DSL IU1) was launched in 2009 and covered some 550 substances; DSL IU2 followed in 2012-13 and included 2,700 chemical substances and polymers. Today, the number of substances on the DSL has grown to more than 27,000.

Launched in 2006, the CMP is overseen jointly by the environment and health ministries, Environment Canada and Health Canada, and is the government’s plan to address, by 2020, the 4,300 substances that categorisation selected as needing further attention. These substances were chosen either because they are persistent and/or bioaccumulative and inherently toxic, or because they “may present to individuals in Canada the greatest potential for exposure”. A three-phase screening assessment programme was established to determine which of these 4,300 substances are “toxic” or capable of becoming “toxic”, as defined in Cepa 1999. Importantly, Cepa 1999’s definition of “toxic” is different from the usual meaning of the term, and takes account of releases into the environment and resulting concentrations in environmental media, as well as inherent toxicity. Under CMP1 (2006-11), 1,064 substances were assessed; under CMP2 (2011-16), another 1,500 are being assessed; and the final phase will assess around 1,700.
If, following the screening assessment, a more comprehensive assessment is needed for a substance, it may be added to the Priority Substances List (PSL). These must be done within five years of the substance being added to the PSL.

Once the government has conducted a screening assessment, a risk assessment of a PSL substance or a review of a prohibited or severely restricted decision for a substance by another OECD jurisdiction, it must decide whether to add it to the PSL; recommend that it is added to Schedule 1 of the List of Toxic Substances (which requires the government to proceed with risk management measures such as regulations, pollution prevention plans or environmental emergency plans); or propose that no further action is taken. If a substance is added to the List of Toxic Substances, a proposed regulation or other instrument for managing the risks must be developed within 24 months.

Cepa 1999 also allows the government to require companies to submit information on substances before they are used for a significant new activity (Snac). They can apply to existing or new substances, toxic or non-toxic, and more than 400 have been issued.
Substances not on the DSL and therefore considered to be new, must be notified. Some 525 pre-market assessments of new substances are conducted each year. Substances not on the DSL but in commercial use internationally, are listed in the Non-Domestic Substances List.

http://chemicalwatch.com/21653/canada-building-on-progress-with-the-cmp