Regulatory
REGULATORY NEWS FOR WEEK OF SEPTEMBER 1, 2020
Canadian Federal News
Health Canada’s Food Directorate completed a premarket safety assessment of a food additive submission seeking approval for the use of protease (serine protease) from Trichoderma reesei RF8963 in hydrolyzed animal, milk and vegetable protein.
These guidelines apply to all persons (individuals and companies) involved in the storage and transportation of drugs, including importers. It will help those who store and/or transport drugs to comply with Canada’s Food and Drugs Act (the Act) in accordance with C.02.015 of the Food and Drug Regulations (the Regulations). It is the responsibility of each person to ensure that the required storage and transportation conditions are met throughout the supply chain.
Replaces: Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines – Selected Category IV Monograph Drugs (GUI-0066) June 10 2011. This annex applies to the non-sterile, selected non-prescription drugs that are subject to Part C, Division 2 of the Food and Drug Regulations and have a Drug Identification Number (DIN).
The NDSL is amended by deleting CASRN 6591-53-3.
The objective of this code of practice (herein referred to as the “Code”) is to minimize the potential for respiratory sensitization of the general population from exposure to certain methylenediphenyl diisocyanates (MDIs). The Code will help to achieve this objective by promoting consistent health and safety practices and facilitating access to this information in order to help reduce exposure of the general population to MDIs resulting from the use of low-pressure two-component spray polyurethane foam (SPF) products containing MDIs that are available to users. The Code concerns the MDIs identified in the Substance Groupings Initiative of the second phase of the Chemicals Management Plan (see Table 1).
The Canadian Centre for Occupational Health and Safety (CCOHS) has released the e-course Pandemic Planning: Reopening for Business, to help organizations across Canada safely return to work during the COVID-19 pandemic.
The course will guide employers, supervisors, managers and workers on how to prepare for a safe return to work, and what controls are needed to be put in place to protect everyone and minimize the impact of the pandemic.
The Chemicals Management Plan (CMP) Science Committee (the committee) met face-to-face on June 12 and 13, 2019. This meeting focused on new approaches for integrating chemical fate, spatial, and temporal scale in exposure assessment in chemical assessment in Canada. The committee was asked a number of charge questions, including when is it appropriate to predict environmental concentrations beyond the local scale, how can the Government of Canada better integrate chemical fate at relevant spatial and temporal scales to reduce key uncertainties in predicted environmental concentrations for both prioritization and risk assessment activities, and what are the primary advantages/disadvantages and key uncertainties the Government of Canada might expect from implementing dynamic and more spatially resolved exposure assessment approaches for CMP chemical evaluation. The meeting included presentations from core and ad hoc members identifying considerations, models, and fundamental elements to better integrate multimedia chemical fate modelling in current exposure practices.
Exposure and hazard are the main components of risk assessment. Through the Chemicals Management Plan (CMP), Environment and Climate Change Canada (ECCC), and Health Canada (HC), collectively referred to hereafter as the Government of Canada (GoC), are seeking ways to improve the consideration of exposure using modelling. Under consideration are ecological risk assessment and “far-field” human health risk assessment. “Far-field” human exposures are from inhalation of outdoor air and ingestion of drinking water and foods that contain chemicals that have entered the contact media through fate and transport processes in the natural environment (Arnot et al., 2010; Isaacs et al., 2014; National Academies of Sciences, 2017).
Pursuant to subsection 31(1) of the Special Import Measures Act, the Canada Border Services Agency initiated an investigation on August 14, 2020, respecting the alleged injurious dumping of certain wheat gluten originating in or exported from Australia, Austria, Belgium, France, Germany and Lithuania.
Canadian Provincial News
his new made-in-Ontario mobile privacy-first app, a joint initiative of the Governments of Ontario and Canada, lets you know quickly if you may have been exposed to COVID-19. You can then get tested, sooner, to help protect yourself and those around you. By alerting more Ontarians faster of potential exposure to COVID-19 and providing direct access to public health resources, COVID Alert can help keep us safe and help reduce community spread.
The regulation affects how the termination, severance and constructive dismissal rules under the ESA apply during the COVID-19 period (March 1, 2020 to September 4, 2020).
Know anyone in the province who went above and beyond? Nominations are now being accepted for the province’s highest honour, the Saskatchewan Order of Merit. The deadline to nominate an individual is November 1, 2020.
Although wearing a mask is not mandatory in New Brunswick, use of community masks is encouraged by public health. WorkSafeNB has created posters employers can download, print, and post in their workplaces. These posters thank customers for choosing to wear a mask.
US News
New approach methodologies (NAMs), such as quantitative structure activity relationship (QSAR) models based on chemical structure information, are commonly used to predict hazard in the absence of experimental data. QSAR models are developed and validated using experimental (i.e., in vitro or in vivo) toxicity data. However, variability in experimental toxicity data introduces limitations in the development, evaluation, validation, reliability and regulatory acceptance of computational models. Experimental variability can arise from biological (e.g., test species, environmental conditions) and/or technical (e.g., measurement errors, different experimental protocols) sources. Characterization of various sources of data variability, adequate incorporation of variability in computational model development, and quantification of data-driven uncertainty in model predictivity are critically needed to improve the reliability and acceptance of computational models. This talk will present these ideas using repeat dose toxicity studies and also illustrate the use of variability to quantify uncertainty in developing QSAR models for points of departure and neurotoxicity equivalency values for polychlorinated biphenyls. Register for the August 27, 2020 webinar.
This legislation will commence on January 1, 2025 and will prohibit cosmetics products that contain any of the listed ingredients, unless they are unintentionally present as an impurity.
International News
The EU is the 1st to address ALL intentionally added microplastics in products – cosmetics, medicines, etc. Our restriction proposal aims at cutting down emissions by 500,000 tonnes over 20 years.
Notifications from EU companies to export certain hazardous chemicals outside the Union have continued to steadily rise over the last three years. More than 10 000 notifications were processed in 2019 – an increase of around 35 % compared to 2016. With the increased workload, adequate resourcing is a necessity for future PIC work.
Other Relevant Information
Safety Share
Transport Canada has collaborated with the Public Health Agency of Canada (PHAC) to develop guidance to help protect drivers and employees working in commercial vehicle operations. Employment and Social Development Canada (ESDC – Labour Program) has reviewed this guidance document to ensure that it does not contravene Part II of the Canada Labour Code. Building on guidance developed by the Government of Canada and other recognized public health authorities and organizations, this document has been prepared to summarize recommendations made to date to limit the spread of COVID-19 in the context of commercial vehicle operations. It is intended for use by fleet managers and commercial vehicle drivers undertaking local, inter-provincial or inter-territorial, and international activity.
If you are caring for a person who has been diagnosed with COVID-19, follow this advice to protect yourself and others in the home, as well as those in your community.
(August 25, 2020 – Workplace Safety & Prevention Service) The term “vulnerable workers” has commonly referred to new and young workers, temporary workers, older workers, pregnant workers, and people for whom English is a second language. These workers are considered vulnerable because their age, literacy level, job experience, and/or physical and mental condition could put them at a greater risk of injury and illness. But since the advent of COVID-19, our understanding of what may make a worker vulnerable has expanded.
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