REGULATORY NEWS FOR THE WEEK OF DECEMBER 5, 2022

• Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)

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.

• Agenda Now Available for the Webinar on the Food Traceability Final Rule

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).

• FDA extends comment period for food labelling definition of “healthy”

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.

• Saskatchewan winter weights for commercial vehicles has begun

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 and their workers

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.

• Sunscreens in the US Are Under Attack on Two Fronts

(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.

• EPA’s Design for the Environment Program Highlighted in Amazon’s Climate Pledge Friendly Program

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.

• CBP Launches Global Business Identifier Pilot to Increase Supply Chain Visibility

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.

• Proposed Changes to Reporting Requirements for PFAS

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.

• Final Significant New Use Rules for 14 substances published

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.

• Proposed Significant New Use Rule for 24 substances published

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.

• EPA Adds 12 Chemicals to Toxics Release Inventory

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.

• Notice to List Chemicals: 1-Bromo-3-Chloropropane, 1-Butyl Glycidyl Ether, and Glycidyl Methacrylate

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.

• Australia changes to the general rules introductions of 10 kg or less

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.

• Europe’s practical guide on substance evaluation revised

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.

• Europe has launched 18 new consultations on testing proposal

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.

• CHEMSCORE 2022 is now out

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

• Holiday Workplace Safety

Don’t sacrifice safety during the holiday shopping season – prioritize worker protections in retail sales, delivery services and order fulfillment centers.

• Advice for travel outside Canada this winter

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.

• Register for Webinar on Reducing Vertebrate Animal Testing – December 7, 2022 – 10:00-11:00 am EDT

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.

• FDA to Hold Webinar on the Food Traceability Final Rule – December 7, 2022 – 1-5pm ET

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).

• Emergency Response/Emergency Preparedness – January 23, 2023 10:30-12:00 pm ET

Are you prepared for emergencies? Join WSPS for a discussion about emergency preparedness and how you can ensure you are ready.