Approach for the prioritization of substances on the Revised In Commerce List
The revised In Commerce List (ICL) is a list of substances in Canadian commerce used in products regulated by the Food and Drugs Act between January 1987 and September 2001. This was a transition period preceding the date on which new substances used in these products became subject to the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Substances on the revised ICL include substances in pharmaceuticals, veterinary drugs, cosmetics, biologics, food products, natural health products, and medical devices. As part of the Chemicals Management Plan (CMP), Health Canada is prioritizing substances on the revised ICL to identify those substances that are not expected to pose a risk to human health or the environment, and thus need not be considered further in the context of the revised ICL. Substances identified for further evaluation to determine whether they may pose a significant risk will be subject to a more rigorous assessment, which may involve further information gathering following the completion of this prioritization exercise.
The following Approach has been developed by Health Canada for the prioritization of substances on the revised ICL. The list can be found posted on Health Canada’s Web site and is periodically updated. This prioritization Approach is intended to be protective and risk-based, as well as expedient and pragmatic. The process is risk-based in that readily available information on hazard and exposure will be considered together when possible in much the same manner that a risk assessment is conducted. However, the process is also pragmatic in that hazard or exposure information may be used independently in order to facilitate an expedited process of prioritization. Files identified for further consideration using these flags for hazard or exposure will be further refined using a risk-based Approach. The Approach draws upon recommendations received during multi-stakeholder consultations that took place between 2007 and 2011, experience gained during the categorization of the Domestic Substances List (DSL) and subsequent evaluation of priorities, and experience from assessments conducted on new substances notified under the NSNR of CEPA 1999.
1. Substances Previously Reviewed
The first step of the prioritization process is to identify those substances on the revised ICL that are also on the DSL, and have either undergone categorization as part of the CMP, or else were added to the DSL following notification and assessment under the NSNR as part of the New Substances Program, which is jointly administered by Health Canada and Environment and Climate Change Canada. Since these substances have already undergone a review for their potential impact on the environment and human health, they are not considered further in the revised ICL prioritization process.
Substances on the revised ICL that have been notified under the NSNR but not yet added to the DSL may also be prioritized for no further consideration in the context of the revised ICL when the toxicological characteristics, quantities and uses in products regulated under the Food and Drugs Act are thought to be comparable to those identified during the assessment under NSNR and no concerns were identified. Alternatively, the assessment under NSNR may identify toxicological or ecotoxicological concerns that support a decision for further consideration.
2. Substances with Certain High Health or Environmental Hazard Considerations
The second step of the prioritization process is to identify substances having certain high health or environmental hazard considerations. Classifications by national or international agencies or information in pharmaceutical product monographs that identify substances considered to be carcinogenic, genotoxic, or toxic to reproduction will be used as hazard flags for substances requiring further consideration. Endocrine disrupters will also be considered. Additionally, those substances internationally recognized as Persistent Organic Pollutants (POP) will be identified. Substances associated with these hazard flags will generally require further evaluation to determine whether they pose a significant risk to human health or the environment when their use patterns and environmental exposure are taken into consideration. If reliable information on current and anticipated use pattern and quantities mitigates these hazard concerns such that the substance is unlikely to pose a significant risk to human health or the environment, then a decision of no further consideration is warranted.
3. Substances from Natural Sources
This next step involves a qualitative review of substances considered to be from natural sources. Types of substances in this group include natural biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes, and carbohydrates. Also included are certain derivatives of these substances (for example, hydrolysates). Examples of products utilizing these substances range from food products, to cosmetics, to natural health products. Expert judgement in chemistry, toxicology and ecotoxicology is applied to identify substances that are considered unlikely to be persistent or bioaccumulative, or to have significant health or environmental impacts resulting from its use as a product regulated under the Food and Drugs Act. These substances will not be considered further in the revised ICL prioritization process.
4. Potential Exposure and Use Patterns
Exposure is a key factor determining the potential of a substance to harm the environment or human health and, as such, can also be used as a rapid screening flag to identify substances that warrant further consideration, or no further consideration. Health Canada will use available information on the quantities and use patterns of a substance to characterize potential exposure of the general population and release to the environment. During this analysis, consideration will also be given to whether the quantities and use pattern are likely to change in the future. If potential exposure is considered to be negligible and the substance is unlikely to cause harm to human health or the environment, then no further consideration is warranted. For instance, substances no longer in commerce, or known to be in commerce only in limited quantities, and/or with limited defined use patterns, may not warrant further consideration in the revised ICL prioritization process.
If the potential for environmental release or exposure of the general population is considered to be high, then further consideration, particularly regarding potential toxicological hazards, environmental fate, and use pattern, would be required to more fully assess the impact of the substance on human health and the environment. Substances in commerce at high quantities, or whose use pattern is likely to result in significant releases to the environment will generally require further consideration.
5. Substance Groupings
In order to be both comprehensive and expedient, prioritization will involve identifying groups of substances that can be reviewed together. Substances will be grouped based on similar chemical structure, or in the case of micro-organisms, their taxonomical classification, and/or use pattern. Examples of groupings based on chemical structure include quaternary ammonium compounds, alcohol ethoxylates, and substances with certain metal moieties. Examples of groupings based on use pattern include pharmaceuticals with similar mechanism of action, or substances used as fragrances. Grouping substances together will enable more efficient information gathering, and a consistent handling of substances within a group.
6. Remaining Substances
For substances that do not obviously fit within any grouping, substance-specific information regarding the properties, toxicity, ecotoxicity, use pattern, quantities, and releases will be gathered, and/or modelled and used to inform a prioritization decision. Search criteria for information gathering on these substances will be standardized to ensure that there is a systematic Approach to research and reasonable effort is applied. This information will be used in a weight of evidence and precautionary manner to determine whether the substance requires further consideration to determine whether it is likely to pose a significant risk to the environment or human health.
Enquires related to the Approach to prioritization of the revised ICL may be directed to the following address:
Environmental Assessment Unit 2
99 Metcalfe Street, 11th Floor, PL 4111A,
Ottawa, Ontario K1A 0K9
By e-mail to: RICL-LRSC@hc-sc.gc.ca
Please include your full contact information: name, address, phone number and email address.
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