Regulatory
REGULATORY NEWS FOR WEEK OF DECEMBER 13, 2021
Canada’s Chemicals Management Plan (CMP) program is sharing the following Risk Assessment Publications Plan to inform stakeholders of publications from January to March 2022. Please note that the targeted publication dates are subject to change. The program anticipates sharing the Risk Assessment Publications Plan for April-June 2022 by spring 2022. Publications targeted for January to March 1-nitropropane FSAR b Alcohols DSAR a Alkyl Halides DSAR a Assessment of Select Hydrocarbon-based Substances DSAR a Benzoxazole, 2,2’-(1,4-naphthalenediyl)bis- FSAR b Esters DSAR a Framework for the Risk Assessment of Manufactured Nanomaterials under the Canadian Environmental Protection Act, 1999 c Heptamethylnonane FSAR b Substances Identified as Being of Low Concern Using the Ecological Risk Classification of Inorganic Substances and Biomonitoring or Rapid Screening Science Approaches a Version 2.0 of the Ecological Risk Classification Approach for Prioritizing Organic Substances on the Canadian Domestic Substances List DSL that Did Not Meet Categorization Criteria (ERC2) c a) Draft Screening Assessment Reports (DSAR) presenting information on health and ecological considerations and, where criteria under s. 64 are proposed to be met, Risk Management Scope documents. b) Final Screening Assessment Reports (FSAR) presenting information on health and ecological considerations and, where criteria under s. 64 are met, Risk Management Approach documents. c )Science-based approach document. Note: Group names are not final and may change This is the final week of Parliamentary business before the Christmas break. ENVI will elect it’s chair tomorrow on December 14th which will enable ENVI to begin work in earnest when Parliament resumes January 31st, 2022. The U.S. Food and Drug Administration released the Foodborne Outbreak Response Improvement Plan to enhance the speed, effectiveness, coordination, and communication of investigations into outbreaks of foodborne illness. The plan was informed by an independent review of the FDA’s structural and functional capacity to support, participate in, or lead multistate foodborne illness outbreak investigation activities. Ensuring that essential goods reach middle class Canadian households as quickly as possible, and that food, medicine and other critical supplies are accessible to all who need them, is a top priority for the Government of Canada. Yet, Canada’s transportation supply chains have been significantly impacted by the global COVID-19 pandemic and recent extreme weather events. Federal The proposed amendments to the TDGR would remove the term “adequately trained”; incorporate by reference a new training standard developed under the Canadian General Standards Board (CGSB); and specify that to be considered competent to handle, offer for transport or transport dangerous goods, a person must receive both general awareness and function-specific training and assessment. The Canadian Food Inspection Agency is working to update its systems to reflect the soon to be updated Harmonized System (HS) code structure coming into effect January 1st, 2022 as a result of recent changes announced by the World Customs Organization. These codes are used at the CFIA as part of the Automated Import Reference System (AIRS) and are updated every five years. HS codes are used worldwide for the uniform classification of goods traded internationally. This is a reminder of the requirements when bringing gift baskets into Canada. All foods within a gift basket need to comply with the Canadian Food Inspection Agency’s (CFIA) import conditions. In December 2021, a Consultation Document on Proposed Regulations for Coal Tar-based Sealant Products was published for a 60-day consultation period. The purpose of this consultation is to inform stakeholders and solicit feedback on the key elements of proposed regulations for coal tar-based sealant products. Coal tars and their distillates are proposed to be added to Schedule 1. The Government of Canada will propose regulations under Part II of the Canada Labour Code to make vaccination mandatory in federally regulated workplaces. These regulations would complement existing occupational health and safety measures, such as masking, handwashing, and physical distancing, and provide further protection against the risk of COVID-19 transmission in the workplace.
Essential travel restrictions on Highway 7 between Mission and Hope have been lifted, helping restore regular travel activities between the communities. Highway 11 between Hazelwood Avenue and Clayburn Road has reopened to passenger and emergency vehicles, restoring the highway connection between Abbotsford and Mission. The Policy, Regulation and Research Department has prepared draft 2022–2024 Policy Workplans for stakeholder review and comment. These workplans encompass policy priorities relating to compensation, occupational disease, assessments, and occupational health and safety. Stakeholders are invited to review the discussion paper and proposed workplans, and to provide feedback by January 14, 2022. The Ontario government is extending its Worker Income Protection Benefit program, which provides paid sick days, until July 31, 2022 to continue keeping workers safe and ensure they do not lose pay if they need to miss work for reasons related to COVID-19. Employees can continue to access this paid leave to get tested, vaccinated, self-isolate, or care for a family member. Should the Canada Recovery Sickness Benefit be extended, workers in Ontario have access to the most generous paid sick days program in Canada. The entire province has returned to Level 1 with many restrictions now in force. [/vc_column_text] EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs). The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.” This draft guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs, as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances. The U.S. Food and Drug Administration issued a draft guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. The U.S. Food and Drug Administration has completed the review of a notification regarding specific health claims related to the introduction of certain foods to infants and the reduction in the risk of developing food allergies. The FDA is asking establishments currently exporting certain food products to China to voluntarily submit information. We are making this request in response to new facility registration requirements from China. While China has not confirmed that collecting this information is a prerequisite for U.S. establishments to export to China, the FDA is making this request as a precaution against potential trade disruption. In April 2021, China’s General Administration of Customs (GACC) announced new registration requirements that affect all overseas food manufacturers, processors, and storage facilities of food products exported to China. These requirements are described in China’s Decree 248 and will be in effect on January 1, 2022. In the latest project of ECHA’s Enforcement Forum, enforcement authorities found that most inspected products sold online were non-compliant with at least one requirement under relevant EU chemicals legislation being checked. The European Chemicals Agency has launched a call for evidence to collect further information on a possible restriction dossier for 10 ortho-phthalates from the Authorisation List. For these phthalates, a screening report under Article 69(2) has been drafted to investigate if their use in articles is adequately controlled. In addition, we are also collecting information on other ortho-phthalates where regulatory needs are being assessed. We are requesting interested parties to provide relevant information during the call for evidence, which will be open until 26 January 2022. ISO 31000:2018 – Risk management – A practical guide was developed in collaboration with UNIDO (United Nations Industrial Development Organization). It is available from your national ISO member or the ISO Store. Safety Share With the holiday season and winter weather upon us, the Office of the Fire Marshal (OFM) is reminding everyone about the importance of fire safety as Ontarians get together with friends and family to celebrate. Some people are taking the drug ivermectin, in some cases the version intended foranimals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use and it may be unsafe to use the drug for this purpose. December 8, 2021 – Hamilton, ON – Canadian Centre for Occupational Health and Safety (CCOHS) – The Canadian Centre for Occupational Health and Safety (CCOHS) has released a free online course to help workplaces understand and respond to the impact of stigma towards people who use substances.
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