Regulatory
REGULATORY NEWS FOR WEEK OF MAY 28, 2020
Canadian Federal News
Last month, the Health Product Inspection and Licensing Division held a meeting with interested stakeholders to gain further insights into the challenges faced with drug establishment licensing and inspections in the context of the pandemic.
In response to the feedback received at that meeting, and our ongoing monitoring of the landscape, Health Canada has issued the attached DEL Bulletin ( # 86). This DEL Bulletin provides guidance on the following three items:
- Transportation and Storage Considerations
- Deferral of Low Risk Investigations
- Document Approvals when Working Remotely
Please contact the following e-mail address if you require any clarification: [email protected]
Effective immediately domestic manufacturers, and importers, of these products must also meet the following labelling requirements:
- Packaging of imported product may be in French-only or English-only, or English or French and another language; however, importers will be required to post the bilingual label text on their website. This website should not contain any additional advertising or claims outside what is authorized, for these products, in the antiseptic skin cleanser or hard surface disinfectant monographs.
- Importers must provide sellers with a means to inform consumers, at time of sale, of where they can access bilingual information on the product. This could be made available through a sticker applied directly to the products, posters, or signage with take-away pamphlets at the point of sale.
- Domestic manufacturers of these products must use bilingual labelling on the product.
Effective immediately, products previously accepted with unilingual labelling under the interim measure will be required to meet the above labelling requirements by June 8, 2020.
Due to the challenges posed by COVID-19, the timeline for the consultation on Annex 4 to the Good manufacturing practices guide – Veterinary drugs (GUI-0012) has been extended until July 19, 2020. Please refer to the updated dates for the DEL Bulletin LEPPP No. 70 Notice of Consultation.
Canadian Provincial News
Alberta’s Relaunch Strategy puts safety first while gradually reopening businesses, resuming activities and getting people back to work.
We know that every workplace is unique. That makes it so important that every workplace assess functions carried out by their workforce to ensure they take action to protect against the hazards presented by COVID-19.
WorkSafeNB is committed to keeping New Brunswickers safe at work. Here are some of the questions you’ve had for us since the province declared a state of emergency on March 19, 2020.
US News
This Notice applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-21 or products that serve as the source of active ingredient for disinfectants on EPA’s List N.
This Notice also applies to food contact surface sanitizer products containing the active ingredient isopropyl alcohol that are used in the essential role of food manufacture and preparation.
As directed by President Trump’s Executive Order to promote transparency through improved agency guidance, the U.S. Environmental Protection Agency (EPA) is announcing its first-ever proposed rule to establish consistent requirements and procedures for the issuance of guidance documents.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT) is issuing this final rule to amend the Hazardous Materials Regulations (HMR) to maintain alignment with international regulations and standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods–Model Regulations. Additionally, PHMSA is adopting several amendments to the HMR that would allow for increased alignment with the Transport Canada, Transportation of Dangerous Goods Regulations.
DATES: Effective date: This rule is effective May 11, 2020, except for instruction 17, which is effective January 2, 2023.
The Occupational Safety and Health Administration (OSHA) is increasing in-person inspections at all types of workplaces. The new enforcement guidance reflects changing circumstances in which many non-critical businesses have begun to reopen in areas of lower community spread. The risk of transmission is lower in specific categories of workplaces, and personal protective equipment potentially needed for inspections is more widely available. OSHA staff will continue to prioritize COVID-19 inspections, and will utilize all enforcement tools as OSHA has historically done.
International News
Companies can now upload and submit notifications in the test environment as if they were in the official ECHA Submission portal. The full user experience allows different submission scenarios to be tested and full validation checks to be done for dossiers. Now with the test environment, companies can check how the portal works without appointed bodies and poison centres receiving misleading data.
The Secretariat of the Basel Convention has created a frequently asked questions and answers regarding amendments to plastic waste.
Other Relevant Information
Safety Share
Canadians value accurate and timely information when hurricanes threaten our lands and waters. Environment and Climate Change Canada’s meteorologists and scientists work around the clock, even during the COVID-19 pandemic, to provide accurate forecasts that help people and weather-sensitive businesses and industry be prepared when a tropical storm is on its way.
The U.S. Environmental Protection Agency (EPA), joined by the National Council on Skin Cancer Prevention and the Centers for Disease Control and Prevention, is recognizing the Friday before Memorial Day as “Don’t Fry Day” to encourage Americans to take a few simple steps to protect their skin and eye health from overexposure to the sun. One of these steps is to download and use EPA’s free Ultraviolet (UV) Index app on a mobile device.
Canadian Centre for Occupational Health and Safety – Ladders are common to almost every home and workplace, giving the impression that ladder work requires no special knowledge or skills. But anyone who uses a ladder should have hands-on safety training to learn about the various risks involved and the precautions necessary to prevent falling. Every year, a significant number of injuries occur when people use ladders at work or at home.
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