REGULATORY NEWS FOR THE WEEK OF NOVEMBER 7, 2022

• This week is drowsy driving prevention week

The National Sleep Foundation’s Drowsy Driving Prevention Week® encourages everyone to prioritize sleep and drive when they are alert and refreshed. Now in the 15th year of our annual campaign, our goal is to help people get the sleep they need and reduce the number of drivers who choose to drive while sleep deprived.

• Consultation: Release of Draft (Step 2) ICH guideline Q5A(R2)

The Q5A(R2) EWG is working on the revision of the of the Q5A(R1) Guideline, providing additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products: selecting and testing cell lines and other raw materials; assessing the capacity of the production process to clear infectious viruses; testing the product at appropriate steps of production.

• Canada’s Drug Precursor Controls Directorate has internal policy to not address queries from 3^rd parties

The Chemicals Precursor Section of Health Canada’s Office of Controlled Substances has informed us that they have an approved internal policy and standard procedures to communicate only directly with regulated parties or prospectors without intermediates. For questions and information requests please send your queries to the generic email account: [email protected].

• Alberta publishes Mental Health in the Workplace documents

Information on psychosocial hazards – what they are and how to prevent harm.

• Alberta Occupational Health and Safety moves to ministry

This change in ministries does not affect Alberta’s OHS legislation. Contact information for Alberta OHS (including the OHS Contact Centre and online links to ask an OHS expert, report an OHS concern, report serious injuries, illnesses or incidents, etc.) remains the same.

• British Columbia Workers Compensation changes

Amendments to the Workers Compensation Act will better support workers in British Columbia. These changes will restore fairness for workers injured on the job and their families, and bring British Columbia in line with other provinces in providing benefits for injured workers.

• Saskatchewan introduces new legislation to make workplaces safer

The Government of Saskatchewan introduced amendments to The Saskatchewan Employment Act that will help improve health and safety and better meet the needs of modern workplaces in the province.

• FDA, NIH, and EMA Launch Global Substance Registration System

To address the public health impacts of these global shifts, the FDA has been working closely with the National Institutes of Health (NIH) and the European Medicines Agency (EMA) on recent, large-scale international efforts to promote knowledge-sharing.

• Manufactured Food Regulatory Program Standards 2022 Updates

The U.S. Food and Drug Administration (FDA) has issued revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods.

• Changes to Reporting Injuries and Illnesses

Employers must connect their Injury Tracking Account to a Login.gov account to submit their 2022 workplace injury and illness data.

• EPA ramps up monitoring of air pollution

(The Hill) The Environmental Protection Agency will fund 132 air pollution monitoring projects in 37 states, including in Detroit, tribal lands and Louisiana, as part of the “largest investment in air pollution monitoring in EPA’s history,” said EPA Administrator Michael Regan. The monitoring will look at particle pollution, smog, ethylene oxide and other substances.

• California: Safe Harbor Warning Regulation for Exposures to Acrylamide from Food

On October 26, 2022, the Office of Administrative Law approved the Office of Environmental Health Hazard Assessment’s proposal to amend Title 27, California Code of Regulations by adding new subsection 25607.2(b) to Section 25607.2. This new subsection addresses warning content for exposures to acrylamide in food by providing an additional non-mandatory, safe harbor warning option for businesses that cause significant exposures to acrylamide in foods. The regulation will be effective on January 1, 2023.

• Europe calls for evidence: Investigation report on polyvinyl chloride and its additives

The European Chemicals Agency (ECHA) is looking for information on polyvinyl chloride (PVC) and its additives related to:

• uses;
• EU volumes per use sector and end-use;
• end-of-life information per use; and
• experimental/measured release and exposure information.

This call for evidence consultation is open until 6 January 2023 (23:59 Helsinki time).

• European Commission publishes guidance for safe and sustainable chemicals and materials

The European Commission’s Strategic Research and Innovation Plan (SRIP) accelerates the shift to safe and sustainable chemicals and materials. The aim of this guidance is to boost the protection of people and the planet against hazardous substances.

Safety Share

• November is Fall Prevention Month

You don’t have to fall far to be seriously hurt or killed. Learn how you can avoid falls.

• Information on psychosocial hazards – what they are and how to prevent harm

Designed to broaden your understanding of workplace violence and harassment, these sessions will provide strategies to keep workers safe both in the workplace and when dealing with customers.

• Global Forum on Environment: Working towards elimination of mercury – November 7-8, 2022 Paris

The Global Forum on Environment on Mercury will bring together leading actors in the field of chemicals and waste management of mercury to promote effective engagement, collaboration and action on eliminating or reducing mercury from the supply chain.

• SQF Unites November 7-9, 2022 Orlando, Florida

SQF Unites offers a unique combination of educational formats and engagement activities that you can tailor to meet your company and personal goals.

• Machine Safeguarding – New CSA Z432 Standard Highlights – November 16, 2022 10:30-12:00 ET

Reserve for this complimentary session where we will discuss some of the updates expected in the soon to be released new CSA Z432 Safeguarding of Machinery standard.