Regulatory
REGULATORY NEWS FOR THE WEEK OF DECEMBER 5, 2022
The FDA is issuing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), released in 2006. Edition 5 (Final Guidance) contains the questions and answers from Edition 4 (Final Guidance) that remain unchanged, with the exception of minor or editorial changes. The agenda for the new upcoming informational webinar on the recently released Food Traceability final rule issued under the FDA Food Safety Modernization Act (FSMA) is now available. The webinar will be held on Wednesday, December 7, 2022, from 1:00 pm – 4:00 pm (ET). The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy’ ” that appeared in the Federal Register of September 29, 2022. We are taking this action in response to a request from stakeholders to extend the comment period to allow interested persons additional time to submit comments. Written comments must be submitted on the proposed rule by February 16, 2023.
Winter weight season will begin in all regions of Saskatchewan on Friday, December 2, 2022. Winter weights allow shippers to increase the weight of their loads on secondary highways to primary weight. This supports our export-based economy by maximizing the efficiency of each truckload and reducing costs for shippers. WorkSafeNB wants to improve safety for the farmers, their workers who are responsible for much of the food we eat. We remind anyone who works in the agriculture industry to pay special attention to silo safety, machine safeguarding and monthly inspections. (Lambros Kromidas, MS PhD and Carl D. Ruiz11.29.22) The US FDA, EPA and NGOs continue to raise questions about formulas’ impact on human health and the environment. The Climate Pledge Friendly program on Amazon now includes antimicrobial products like disinfectants and sanitizers certified by the U.S. Environmental Protection Agency’s (EPA) Design for the Environment (DfE) program. DfE joins EPA’s Safer Choice and 46 other sustainability certifications in Climate Pledge Friendly, which helps customers shop for over 300,000 more sustainable products in the company’s online store. U.S. Customs and Border Protection (CBP), will collaborate with 13 partner government agencies to deploy a Global Business Identifier (GBI) pilot program that will test the concept of a single business identifier solution to improve the US Government’s ability to efficiently identify high-risk shipments and facilitate legitimate trade. The Environmental Protection Agency (EPA) is proposing to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). Comments must be received on or before February 3, 2023. The Environmental Protection Agency (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) and a Microbial Commercial Activity Notice (MCAN). 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. This rule is effective on January 31, 2023. The Environmental Protection Agency (EPA) is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Comments must be received on or before January 3, 2023. The U.S. Environmental Protection Agency (EPA) finalized a rule that adds 12 chemicals to the list of chemicals subject to Toxics Release Inventory (TRI) reporting requirements. The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list 1-bromo-3-chloropropane (CAS RN 109-70-6), 1-butyl glycidyl ether (CAS RN 2426-08-6), and glycidyl methacrylate (CAS RN 106-91-2) as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. The Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022 took effect on 25 November 2022. The amended rules, made by the Assistant Minister for Health and Aged Care, follow on from our public consultation. The Practical Guide on ‘How to act in substance evaluation’ has been updated with clarifications to information concerning dossier updates during the decision-making process. The guide is now also aligned with the Practical Guide for dossier evaluation. The European Chemicals Agency (ECHA) has launched 18 new consultations on testing proposals. The deadline for comments is 12 January 2022. There are currently 51 open consultations on testing proposals. Chemsec just released its annual ranking of the world’s largest chemical companies and their work to reduce their chemical footprint. And there are a lot of interesting things to find out. Safety Share Don’t sacrifice safety during the holiday shopping season – prioritize worker protections in retail sales, delivery services and order fulfillment centers. The Government of Canada provides consular assistance to Canadians abroad should they need it. The number of Canadians requiring urgent consular assistance is usually highest during the winter months. Regulatory Toxicology has reached a tipping point – animal tests are increasingly outmoded by New Approach Methodologies (NAMs) that offer the potential to improve human health and environmental protection. The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm – 5:00 pm (ET) on the recently released Food Traceability final rule issued under the FDA Food Safety Modernization Act (FSMA). Are you prepared for emergencies? Join WSPS for a discussion about emergency preparedness and how you can ensure you are ready.
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