Regulatory
REGULATORY NEWS FOR WEEK OF DECEMBER 10, 2020
Canadian Federal News
The final screening assessment for the Phthalates Substance Grouping has been published. It is concluded that fourteen substances do not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA).
Fourteen additional phthalates substances were also assessed within the scope of the assessment to determine the cumulative risk from combined exposure to phthalates. It is concluded that DEHP may be posing harm to the environment and meets the criteria under section 64(a) of CEPA. A risk management approach has been published concurrently to outline the proposed risk management actions.
While exposure of the general population and the environment to 20 of the 28 substances is not of concern at current levels, these substances are associated with human health and/or ecological effects of concern. Therefore, there may be concern if exposure levels were to increase. Follow-up activities may involve including the substances in future information gathering initiatives, such as a mandatory survey under section 71 of CEPA.
To achieve the proposed risk management objective and to work towards achieving the proposed environmental objective, the proposed action for DEHP is to develop regulations amending the Prohibition of Certain Toxic Substances Regulations, 2012 to include the substance DEHP and all products containing DEHP.
The IRAP approach is a systematic compilation and review of information on substances from a large number of information sources. It enables the Government of Canada to communicate how emerging issues are tracked, and to identify and prioritize substances requiring further work.
The results of the 2019 IRAP review have been published and include recommendations for further scoping/problem formulation (85 substances), for additional data gathering (443 substances), and for monitoring of ongoing international activity (101 substances).
Notice is hereby given that the Minister of the Environment, pursuant to subsection 105 of the Canadian Environmental Protection Act, 1999,footnotea intends to delete 22 living organisms referred to in the annexed proposed Order from the Domestic Substances as these living organisms do not meet the criteria prescribed in subsection 105(1) of the Act.
The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to siloxanes and silicones, di-Me, alkene Me, [(alkenedimethylsilyl)oxy]-terminated, polymers with hydrogen-terminated di-Me siloxanes, Confidential Substance Identity Number 19494-2, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.
Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, updates the fees that are payable for the provision of Drug Master Files and Certificate of Pharmaceutical Product services by 2%.
Notice is hereby given, under subsection 30.61(1) of the Food and Drugs Act, that in keeping with section 4.1 of the 2020 Fees in Respect of Drugs and Medical Devices Order, every fee outlined in the Order is to be adjusted annually by the Consumer Price Index (CPI). The fees for a Drug Establishment License to import active pharmaceutical ingredients increases on April 1, 2021 to $28,975.
The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made on November 27, 2020 and is effective immediately. This interim order (IO) introduces new measures to help ensure that bulk importation programs of other countries do not cause or exacerbate a drug shortage in Canada.
Under the IO, certain drugs intended for the Canadian market are prohibited from being sold for consumption outside of Canada if that sale could cause or exacerbate a drug shortage. The IO also authorizes the Minister to require specific information from a manufacturer or drug establishment licence (DEL) holder to help Health Canada take steps to prevent or alleviate an existing or anticipated drug shortage.
As of January 1, 2021, CETA will no longer cover the UK; therefore, an interim Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) will govern the terms of trade between Canada and the UK until a comprehensive free trade agreement is established. Canadian and UK Negotiators continue to finalize the agreement in preparation for signature and subsequent domestic approvals. Once in force, the Canada-UK TCA will provide continued access to the benefits of CETA, on a bilateral basis, and Canadian firms will see little to no change in the terms of trade with the UK, post January 1st.
The purpose of this notice is to inform Canadians and interested stakeholders that Health Canada has published additional historical items on the list of non-novel determinations for foods and ingredients that are not considered to fall within the definition of “novel food”.
Starting on December 16th 2020, the following chapters of the Terrestrial animal products and by-products: Import policy framework will be implemented and become active:
- 8. General import requirements: Introduction, Zoosanitary certificate, and Importer’s declaration
- 10.2 Integumentary tissues and animal-origin display items
- 10.3 Contaminated things
- 10.9 Pet chews
- 15.2 Annex 2: Acceptable treatments for feathers
- 15.4 Annex 4: Bacterial culture testing requirements for pet chews
The implementation of these chapters will not have an impact on existing import conditions or international trade.
The following policies will simultaneously be removed from the CFIA website as they will be replaced by the new chapters above:
- Importation of Integumentary Tissue
- Import of Used Equipment and Things from Non-designated Countries
This message is to inform Canadian Food Inspection Agency (CFIA) clients who declare imports using the Request for Documentation Review (5272) form of an important change to enhance the section for payment processing.
While CFIA clients have been previously advised to refrain from providing credit card information on the form, specific instructions have now been included to explain how to make payment using a credit card, as well how to sign up for a CFIA account. If you require assistance or have any questions, please contact the National Import Service Centre (NISC) at 1-800-835-4486.
The purpose of this notice is to inform you that in the week of December 14, 2020, the organic import and admissibility requirements for processed products of chapter 20 will be incorporated into AIRS, in accordance with clause 357(3) of Part 13 of the Safe Food for Canadians Regulations.
The importer/broker must confirm the possession of the certificate at the time of import in the Integrated Import Declaration (IID)
Starting 2022, importers of organic commodities for which the import requirements are included in AIRS will be required to submit a digital copy of the organic product certificate when declaring organic products online using the IID.
If passed by Parliament, Bill C-15 would require the Government of Canada, in consultation and cooperation with Indigenous peoples, to take all measures necessary to ensure that the laws of Canada are consistent with the rights of Indigenous peoples set out in the Declaration, as well as to develop an action plan to achieve its objectives.
Canadian Provincial News
At its November 2020 meeting, WorkSafeBC’s Board of Directors approved the adoption of the 2016, 2017, and 2018 new and revised American Conference of Governmental Industrial Hygienists Threshold Limit Values for selected chemical substances.
The lower limit is $27,321 and the highest limit is $83,500 under the Workers Compensation Act.
This booklet is designed to offer the guidance that New Brunswick workplaces need to help get business back up and running safely considering the pandemic.
Effective December 1, 2020, masks are required to be worn by all Yukon residents, five years and older in most indoor public spaces.
US News
The U.S. Environmental Protection Agency (EPA) is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SERs) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) panels. There will be one panel for carbon tetrachloride and one panel for trichloroethylene (TCE). Each will focus on the agency’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.
721.11453 Phosphonium, trihexyltetradecyl-, salt with 1,1,1-trifluoro-N [(trifluoromethyl)sulfonyl]methanesulfonamide (1:1).
721.11454 Calcium manganese titanium oxide.
721.11455 Rare earth oxide (generic).
721.11456 Acid-modified polyether (generic).
721.11457 Alkenoic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3- alkyldiol, 1,1′-methylenebis(4-isocyantocarbomonocycle) and 3- methyl-1,5-alkyldiol (generic).
721.11458 Bis-alkoxy substituted alkane, polymer with aminoalkanol (generic).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT) is requesting comment on the development of a framework for Automated Driving System (ADS) safety. The framework would objectively define, assess, and manage the safety of ADS performance while ensuring the needed flexibility to enable further innovation. The Agency is seeking to draw upon existing Federal and non-Federal foundational efforts and tools in structuring the framework as ADS continue to develop. NHTSA seeks specific feedback on key components that can meet the need for motor vehicle safety while enabling innovative designs, in a manner consistent with agency authorities.DATES: Written comments are due no later than February 1, 2021.
International News
The National Fire Protection Association (NFPA) has announced the addition of the 2021 edition of NFPA 101®, Life Safety Code®, to NFPA LiNK™, the Association’s new information delivery platform that will include all NFPA codes and standards, supplementary content, and visual aids for building, electrical, and life safety professionals and practitioners.
On 3 December 2020, amendments adopted at COP9 enter into force for most Parties, adding Dicofol and PFOA, its salts & PFOA-related compounds to Annex A, and amending the exemptions for PFOS, its salts and PFOSF in Annex B.
Other Relevant Information
Safety Share
The Canadian Centre for Occupational Health and Safety (CCOHS) invites youth aged 13 to 19 across Canada to share their perspective about what working safely means to them.
Together with our partners, the Standards Council of Canada is working to improve road safety by reducing commercial driver fatigue. Starting in June 2021, federally regulated commercial truck and bus operators will be required to use third party certified electronic logging devices (ELDs). These devices will replace paper-based daily logbooks. Mandatory ELDs were recommended in the coroner’s report into the Humboldt Broncos bus crash.
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