Response to comments on proposed Prohibition of Certain Toxic Substances Regulations: chapter 5
|Accredited Laboratories||Several stakeholders stated that it is unclear whether the government or the regulatees are required to verify compliance with the Regulations using an accredited laboratory and what should be the frequency. Regulatees should not be limited only to having to use accredited laboratories.||
The Regulations allow for either the use of an accredited laboratory or one that meets an equivalent standard.
Any quantities and concentrations that are required to be reported to Environment Canada under the Regulations must be obtained through accredited laboratories under the standard ISO/IEC 17025:2005 or from a laboratory that meets an equivalent standard, and in accordance with generally accepted standards of scientific practice.
As for the frequency in which a manufacturer/seller/importer/user would conduct testing as part of an internal evaluation to verify their compliance with the Regulations there is no specific requirement in the Regulations. Nonetheless, the Regulations do prescribe the testing frequency for information that needs to be reported to Environment Canada. Environment Canada also promotes environmental audits, as set out in the Compliance and Enforcement Policy for CEPA (1999)- March 2001.
For the purpose of verifying and securing compliance with the Regulations, the Government of Canada will use an accredited laboratory, as prescribed in the Regulations.
|CAS Registry Numbers||Several industry stakeholders and an industry association recommended that the CAS Registry Numbers be included in Regulations so that specific substances and groups of substances can be clearly identified.||It may not be possible to list the CAS Registry Numbers in the Regulations for the following reasons: not all substances have a CAS number, it can be difficult to identify an exhaustive list of CAS numbers, and CAS numbers may change over time. However, a non-exhaustive list of known CAS Registry Numbers is provided as part of the guidance materials on the Regulations.|
|Incidental Presence||An industry association noted that the text in the Regulations regarding the prohibition of HCB “unless incidentally present” is supported, however the text in the RIAS could be interpreted otherwise.||The description of the Regulations under section 5 of the Regulatory Analysis Impact Statement has been updated to better capture that the exemption for incidental presence applies to HCB.|
|Reporting||A non-governmental organization proposed that the reporting of all substances listed on the Regulations should be required regardless of threshold and also to include information on alternatives.||The Regulations prohibit the manufacture, import, use, sale and offer for sale of toxic substances or products containing them with certain exceptions. The reporting requirements focus on those areas where there may be on-going use as per one of the exemptions.|
|An industry stakeholder suggested that the exemption for incidental presence should be universal, applying to all situations, including reporting for substances listed in Schedule 2, Part 4.||There are only 2 substances listed in Schedule 2, Part 4 for which reporting could be required. These reporting requirements are limited in scope and are intended to gather information that can be used to assess whether additional control measures should be considered for these substances.|
|Record Keeping||An industry stakeholder noticed that in Section 12 of the Regulations there is no reference to confidential business information, which may be found in submitted reports or permits. Provisions should be included in the Regulations to ensure that confidential business information will be protected.||Under Section 313 of CEPA, 1999 any person submitting information under the Act may request that it be treated as confidential.|
|Laboratory Use||An industry stakeholder suggested that the Regulations clarify the restrictions on the distribution of substances in research labs, schools and industrial labs.||There is an exemption for Research and Development use in the lab for analysis, scientific research or as an analytical standard. This exemption applies to manufacture, use, sale, offer for sale and import of substances intended for this purpose.|
|Transition||An industry stakeholder asked if section 13 in the Proposed Regulations (now section 16) transitional provisions are redundant.||The Prohibition of Certain Toxic Substances Regulations, 2005 have been repealed, thus it is necessary to include this provision to ensure that a permit cannot be obtained for an activity that had been previously prohibited.|
|Permits||An industry stakeholder wanted to clarify whether permit requirements were applicable for the incidental presence of HCB in products.||The Regulations prohibit the manufacture, import, use, sale and offer for sale of HCB or products containing it unless incidentally present. Since incidental presence is exempt from the Regulations no permits would be required in these circumstances.|
|An industry stakeholder raised a question regarding the meaning of the term “interested person” within section 14 of the Regulations.||The term “interested person” refers to a person who is required to submit a report as per subsections 3(2), 3(3) or 3(4) or section 12 of the Regulations or a person who submits a permit application as per section 9 of the Regulations.|
|An industry stakeholder stated that the use of the term “insufficient” in paragraph 10(2)(b) is too subjective and should be deleted.||Paragraph 10(2)(b) describes the conditions under which the Minister must refuse to issue a permit. This provision states that the Minister must refuse to issue a permit if the information required under subsection 9(4) has not been provided or is insufficient to enable the Minister to process the application. “Insufficient” therefore includes where an incomplete permit application is submitted, or if there is not enough information provided to demonstrate that the conditions of issuance identified under subsection 10(1) are satisfied.|
|An industry stakeholder stated that the phrase in paragraph 10(1)(a) “…other than a substance regulated under these Regulations…” is not clear.||Paragraph 10(1)(a) outlines one of the conditions under which the Minister must issue a permit. This condition is that there is no technically or economically feasible alternative available or substitute available. Within this context, “…other than a substance regulated under these Regulations…” excludes other substances listed in the Regulations from consideration as technically or economically feasible alternatives or substitutes.|
|An industry stakeholder noted that they were supportive of the proposed permit provisions in general. However they asked whether an activity prohibited under the Regulations could be allowed to continue while a permit application is being processed.||The Regulations do not enter into force until three months after they are registered. This three month period allows time for an activity to continue while potential permit applications are being evaluated against the conditions of issuance outlined in Section 10 of the Regulations.|
|An industry stakeholder suggested that the intent of the requirement in Section 4, paragraph 2(c) be clarified.||This provision of the Regulations is to gather information on either the estimated quantity manufactured or imported. This has been clarified in the Regulations.|
|An industry stakeholder asked whether sellers at a retail level would be required to obtain a permit.||
The Regulations streamline the permit provisions by specifying that only persons who are manufacturing or importing a toxic substance subject to the Regulations or a product containing it, on the day on which the Regulations come into force may continue that activity if they have been issued a permit under section 10 of the Regulations.
Furthermore, the prohibition on use, sale or offer for sale of a toxic substance or a product containing it, does not apply if they were manufactured or imported by a person to whom a permit has been issued.
|An Aboriginal organization reinforced that if a permit could potentially impact Aboriginal rights, the Government of Canada must first consult First Nations.||Consultations with First Nations will be undertaken as per existing policies relating to Aboriginal consultations, such as the Updated Guidelines for Federal Officials to Fulfill the Duty to Consult.|
|Cost-Benefit||An industry stakeholder noted that the RIAS did not provide a total cost estimate of benefit expected by the prohibition of BNST. This raises concern because it is not certain that the Regulations would be guaranteed to result in positive results.||BNST was assessed to be persistent, bioaccumulative, and inherently toxic to the environment. It has potential to harm aquatic organisms and may biomagnify in food chains. Prohibiting BNST is expected to result in net benefits.|
|An industry stakeholder commented that the RIAS discussion of 0.5 cents per litre being negligible should be worded differently as different markets react to costs differently.||The wording in the RIAS has been reviewed and the incremental costs to consumers are now described as minimal; however, as described in the cost benefit analysis, this price increase is not expected to place a significant burden on consumers because the magnitude should be small relative to the overall price of the product.|
|An industry stakeholder mentioned that monitoring costs will be more than the estimated $13,000.|
|An industry stakeholder stated that since new reporting systems will be created for the substances added to the Regulations, there will be additional costs and compliance risks. Both of these factors should be recognized in the RIAS.||It is expected that new reporting requirements would not result in significant additional costs since many organizations, such as laboratories are already submitting reports for substances that were included in the former Regulations. In addition, the costs associated with new reporting requirements for short-chain chlorinated alkanes are expected to be limited.|
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