Regulatory
REGULATORY NEWS FOR WEEK OF APRIL 6, 2020
Canadian Federal News
Health Canada has done a good job of keeping their COVID-19 portal updated to help business regarding the supply of these critical products. RDC is waiting for more information on fast track approvals for use against SARS-CoV-2. As soon as we have information, we will update everyone.
Starting today, April 1, 2020, the Commercial Vehicle Safety Alliance’s (CVSA) 2020 North American Standard Out-of-Service Criteria is now in effect. The 2020 out-of-service criteria replaces and supersedes all previous versions.
The North American Standard Out-of-Service Criteria (OOSC) is the pass-fail criteria for roadside safety inspections. The purpose of the criteria is to identify critical safety violations. Those violations render the driver, vehicle and/or motor carrier out of service until the condition(s) or violation(s) are corrected or repaired.
Health Canada has published 10 Bulletins regarding interim measures for annual and establishment and drug licensing in response to COVID-19. Here is the summary of the Bulletins:
- Bulletin 71 – reminder of obligations to report and expedited review of DEL license applications.
- Bulletin 74 – expedited imports for use in Canada authorized for use in the USA or MRA country; products with English only labelling
- Bulletin 75 – Annual Drug Establishment Licence review extended until July 1, 2020
- Bulletin 76 – Expand use of unique identifiers, allowance for shipping product from fabricator to Canada in quarantine and defer confirmatory testing when required
- Bulletin 77 – Relaxing of confirmatory testing for low risk non-prescription drugs
- Bulletin 79 – Extension of deadlines for risk assessments and subsequent actions
- Bulletin 80 – Revised Drug Establishment Licences guides and forms
- Bulletin 81 – Pilot to launch electronic issuance of Drug Establishment Licences
- Health Canada Application and Notification Form for Exceptional Release of Disinfectant and Sanitizing Products Version 2-2
- Health Canada Form for Submitting a Proposal for Inclusion of a Non-Compliant Drug under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 on the List of Drugs for Exceptional Importation and Sale Version 3
Health Canada (HC) recognizes that the COVID-19 pandemic has had a significant impact on business operations, within both the pharmaceutical industry as well as governments.
To help ensure critical business lines such as drug establishment licensing can continue with minimal delays to regulated parties, effective today Thursday, April 2nd, 2020, HC is launching a pilot to implement the electronic issuance of DELs via email with electronic signatures and will no longer be sending paper copies of DELs by mail.
The temporary certificate for hand sanitizers has not yet been added to the Transport Canada website. Click on the title to download a copy.
Following the declaration of a pandemic outbreak of COVID-19 (coronavirus) by the World Health Organization on March 11, 2020, and with the adoption of temporary measures put in place by provincial authorities, Transport Canada is issuing temporary certificates pursuant to subsection 31(2.1) of the Transportation of Dangerous Goods Act, 1992.
This message is for all importers and customs brokers who do business with the Canadian Food Inspection Agency (CFIA) National Import Service Centre (NISC).
Please be advised during the upcoming statutory holidays (April 9th to 14th, 2020), the NISC’s service hours will remain from 7am to 3am (Eastern Standard time) but its telephone lines (1-800-835-4486 and 1-877-493-0468) will not be monitored from 6:00PM on April 9th to 7:00AM on April 14th EST. If you require assistance from NISC during this period, please email [email protected]. For more information about the NISC, visit the Agency’s website.
Given the ongoing COVID-19 pandemic and the impact it may be having on your ability to work towards the implementation of the Transportation of Dangerous Goods by Rail Security Regulations (Regulations), an additional extension is being granted to allow you more time to meet the regulatory requirements applicable to your operations. For all railway loaders, an extension to all regulatory requirements applicable to your operations has been granted to August 3, 2020. For railway loaders required to implement a security plan under section 10 of the Regulations, we will be providing information on how to submit your security plan electronically through a Transport Canada secure portal in the coming months.
The New Substances Program has updated the New Substances Fees Payment Form to reflect adjusted fees that will be in effect between April 1, 2020 and March 31, 2021.
A notice announcing the extension of the public comment period will be published in the Canada Gazette, Part I the soonest possible. Any person may submit comments on the Draft Science Assessment of Plastic Pollution to the Minister of the Environment until May 1, 2020.
Obligate all travellers and conveyance operators to notify Canadian authorities of either suspected or confirmed presence or exposure to the illness in accordance with subsections 15(2) and paragraph 34 (2)(a) of the Quarantine Act through addition of COVID-19 coronavirus disease to the Schedule of reportable communicable diseases. The addition is intended to further protect the health of travellers as well as the health and safety of the general public from COVID-19 coronavirus disease.
Quarantine Act
- Minimizing the Risk of Exposure to COVID-19 in Canada Order (Mandatory Isolation)
- Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any country other than the United States)
- Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from any Country other than the United States)
- Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States)
- Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States)
Health Canada’s Food Directorate completed a review of the scientific and taxonomic data that was available and determined that an update to the source organism name, based on re-identification of the source organism, did not require a pre-market safety assessment. Furthermore there was no need to re-evaluate the safety of the already-permitted source organism. Therefore, the Department has enabled the use of invertase from A. fijiensis, by adding the source organism name A. fijiensis, alongside A. japonicus, in the permitted source field in the Listing for Invertase (item number I.1) on the List of Permitted Food Enzymes, effective March 30, 2020.
This is your chance to help shape the future of open government in Canada! From March 2 to May 1, 2020, we’ll be connecting with Canadians online and across the country. Our goal is to hear what Canadians coast to coast to coast want to see in our next plan. Tell us your ideas, experiences, insights and stories on what open government means to you; what could be improved and what direction you think open government needs to go.
Canadian Provincial News
The Saskatchewan Workers’ Compensation Board (WCB) is introducing additional relief measures for employers who are unable to pay their WCB premium payments.
To stop the spread of COVID-19 and keep people safe, the Ontario government is launching a new $50 million Ontario Together Fund to help businesses provide innovative solutions or retool their operations in order to manufacture essential medical supplies and equipment, including gowns, coveralls, masks, face shields, testing equipment and ventilators.
The extension will apply to workers who successfully completed their working-at-heights training between February 28 and August 31, 2017. The validity period, normally three years, would have ended this year. It will now end in 2021.
We expect businesses who rely on truck drivers to provide necessary facilities for these heroes. We need everyone to do their part to make sure drivers can keep doing their jobs safely. As a government we are working closely with truck drivers and associations to respond to the issues they face on the road.
Regulation to amend the Regulation respecting halocarbons and the Regulation respecting hazardous materials.
WCB Nova Scotia wants to help employers and workers keep working safely during the Coronavirus pandemic. From now until the public health risk ends, we’ll be sending you special, regular editions of our Safe and Secure e-newsletter, to provide all the latest safety and prevention news and resources you need.
US News
The U.S. Environmental Protection Agency (EPA) is announcing its plan to consider a proposed rule that would look at potential exemptions to the TSCA Fees Rule in response to stakeholder concerns about implementation challenges. By considering a proposal to narrow the broad scope of the current requirements, the agency could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments to the Toxic Substances Control Act (TSCA) to protect human health and the environment.
To help the public better understand List N: Disinfectants for use against SARS-CoV-2 , EPA has updated the content on List N and the Frequently Asked Questions about disinfectants related to coronavirus. The FAQ update provides new information on pesticide safety, enforcement, and pesticide devices. It also includes enhanced explanations of why List N products are qualified for use against SARS-CoV-2 and how these products can be used most effectively.
The U.S. Environmental Protection Agency (EPA) took steps to provide additional flexibilities to manufacturers of disinfectants and other pesticides. EPA intends for these flexibilities to increase the availability of products for Americans to use against the novel coronavirus. After meeting with stakeholders last week and discussing supply chain challenges posed by the pandemic, EPA is allowing manufacturers to obtain certain inert ingredients—or inactive ingredients like sodium chloride or glucose—from different suppliers without checking with the agency for approval.
EPA is proposing to amend the significant new use rules (SNURs) for chemical substances, which were the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN).
EPA is proposing to revoke the significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as alpha 1,3-polysaccharide, which was the subject of premanufacture notice (PMN) identified as P-16-581.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Significant New Alternatives Policy (SNAP) Program (EPA ICR Number 1596.10, OMB Control Number 2060-0226) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act . This is a proposed extension of the ICR, which is currently approved through May 31, 2020.
The Formaldehyde TSCA Risk Evaluation Consortium represents a variety of stakeholders including manufacturers, importers, and suppliers of formaldehyde and formaldehyde products throughout the value chain.
International News
According to the BPR, a biocidal product cannot be made available on the market unless the substance supplier or product supplier is included in the Article 95 list of suppliers for the relevant product types. However, some national authorities, which are responsible for enforcing this obligation, have stated that disinfectant products do not have to fulfil this obligation for the time being.
That said, we are speeding up the evaluation of Article 95 applications for disinfectants and will start the evaluations before the fees are paid. Final decisions will, however, only be issued after the payment of fees.
To assist us in maintaining efficient services during the COVID-19 pandemic, we now prefer that you submit new chemicals applications electronically where possible.
Other Relevant Information
Safety Share
Referenced in the field, in training, and in court, NFPA 921 sets the bar for scientific-based investigation and analysis of fire and explosion incidents and is trusted as the foremost guide for rendering accurate opinions as to incident origin, cause, responsibility, and prevention
Article by: Glen Rudner, Norfolk Southern Corporation
Emergency responders are dispatched to incidents on, near or across the railroad right of way on a regular basis and these responses require extra caution every time. The life of the crew, the community and your own depends on it.
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