REGULATORY NEWS FOR THE WEEK OF AUGUST 14, 2023

• Final message from Get Updates on COVID-19 subscription service

After three years and over 10 million email notifications sent since the beginning of the COVID-19 pandemic, Health Canada is stopping the Get Updates on COVID-19 subscription service.

• Updates to T-4-130 Labeling requirements for fertilizers and supplements

Please be advised that on July 20, 2023, updates were made to Sections 3.2 to 3.5 of trade memoranda T-4-130: Labeling requirements for fertilizers and supplements.

These updates clarify labelling requirements in the Guaranteed Analysis section including: an updated description of the “minimum” or “actual” guarantee options for supplements; the corresponding requirements for titling the guarantee section as “guaranteed minimum analysis” or “guaranteed analysis”; and clarification on the requirement to carry forward guarantees on active ingredients from “upstream products” for labels of mixed products.

The Directions for use section (3.3), has been expanded to provide more clarity, and a new section (3.4) has been created to expand on the requirements for substantiation of product claims related to environmental safety.

Finally, labelling directions for products intended for tank mixing have been updated to reflect recent changes implemented by the Pest Management Regulatory Agency, and Table 2 has been updated for precautionary statements required when products contain or may contain allergens or prohibited material. This document is available on the Fertilizer web page, Trade Memoranda.

• Alberta drivers must slow down and move over for roadside worker vehicles

Starting Sept 1, drivers must move over or slow down when passing a roadside worker vehicle with its lights flashing. Failure to comply with these rules can result in a fine and three demerit points.

• FDA revokes uses of partially hydrogenated oil in foods

The Food and Drug Administration (FDA or we) is amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS). This rule is effective December 22, 2023. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by October 23, 2023.

• FDA seeks input on food labelling requirements

The Food and Drug Administration (FDA) is announcing that a proposed collection of information supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. Sections 4, 5, and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e), establish provisions under which a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. Submit written comments (including recommendations) on the collection of information by September 11, 2023.

• FDA seeks input on Voluntary Qualified Importer Program.

This information collection supports implementation of FDA’s Voluntary Qualified Importer Program (VQIP), a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States. Program participants may import products to the United States with greater speed and predictability, avoiding unexpected delays at the point of import entry. Importers interested in applying can start their application (Form FDA 4041) by submitting a notice of intent to participate after setting up an account through the FDA Industry Systems (FIS) website at https://www.access.fda.gov, which includes a VQIP Portal User Guide. To participate, importers must meet eligibility criteria and pay a user fee that covers costs associated with FDA’s administration of the program. Consistent with section 743(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-31(b)(1)), FDA annually publishes a schedule of fees applicable to VQIP in the Federal Register.

• Recordkeeping Requirements for Human Food and Cosmetics Manufactured From Material From Cattle

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. Information must be submitted by October 10, 2023.

• Classification Categories for Certain Supplements Under the  Biosimilar User Fee Amendments available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Classification Categories for Certain Supplements Under BsUFA III.” This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

• Consultation extended for cumulative risk assessment guideline and problem formulation

The U.S. Environmental Protection Agency (EPA) is announcing an extension of the public comment period by 15 days for the draft Cumulative Risk Assessment Guidelines for Planning and Problem Formulation. The original Federal Register document announcing the public comment period was published on June 16, 2023. The EPA must receive comments on or before August 30, 2023, to be considered.

• EPA issues proposed regulation for used drum management and reconditioning

The U.S. Environmental Protection Agency (the EPA) is soliciting information and requesting comments to assist in the potential development of non-regulatory and regulatory options that would ensure the proper management of used industrial containers that held hazardous chemicals or hazardous waste, up to and including the drum reconditioning process. Options could include revising the Resource Conservation and Recovery Act (RCRA) regulations or other, non-regulatory options. This Advance Notice of Proposed Rulemaking (ANPRM) does not propose any regulatory requirements or change any existing regulatory requirements. Comments must be received on or before September 25, 2023.

• EPA Temporarily Waives Some Requirements under New CBI Procedures Rule

The final rule includes a provision at 40 CFR 703.5(f), requiring that all TSCA submissions bearing Confidential Business Information (CBI) claims (with limited exceptions) be submitted via EPA’s electronic submission portal, CDX. Many TSCA submissions are already filed using previously developed CDX submission tools, including some tools required under existing TSCA regulations.

• Anthracene, 2-Bromopropane, and Dimethyl Hydrogen Phosphite added to Proposition 65

Effective August 11, 2023, the Office of Environmental Health Hazard Assessment (OEHHA) is adding anthracene (CAS RN 120-12-7), 2-bromopropane (CAS RN 75-26-3), and dimethyl hydrogen phosphite (CAS RN 868-85-9) to the list of chemicals known to the State of California to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986, sections 25249.5 et seq. of the Health and Safety Code (HSC), otherwise known as Proposition 65.

• Roadside Emissions Monitoring Devices (REMD) are being used throughout California

Please note that, as of January 2023, Roadside Emissions Monitoring Devices (REMD) are being used throughout California to screen for potential high emitting vehicles. Owners of vehicles identified as potential high emitters will be issued a Notice to Submit to Testing (NST) letter and have 30 days to submit a passing emissions test to CARB. Failure to submit a passing test may result in an enforcement violation. If you receive an NST, please visit the If You Receive a Notice to Submit to Testing (NST) Letter webpage for details.

• Europe updates guidance on Environmental Exposure Assessment

This document provides guidance on how to carry out environmental exposure assessment in 4 the context of REACH. REACH requires, according to Article 14(4), exposure assessment and 5 subsequent risk characterisation to be carried out for substances subject to registration, which 6 are manufactured or imported in quantities equal to or greater than 10 tonnes/year, and 7 where the substance meets any of the criteria to be classified as hazardous.

Safety Share

• Health and Safety Innovations Help Address the Changing World of Work at National Forum

The Canadian Centre for Occupational Health and Safety (CCOHS) will highlight a diverse lineup of health and safety innovations and tools at Forum 2023: The Changing World of Work, September 26-27, 2023, in Halifax, Nova Scotia.

Have an event you would like to share? Please send details to [email protected].

• ChemEdge 2023 – August 16-18, 2023 – The Woodlands, Texas

ChemEdge 2023 is bringing supply chain professionals all along the chemical distribution industry together to share best practices and business solutions.

• EPA Announces New Webinar Series on the Use of NAMs to Reduce Animal Testing

The first webinar in the series will take place on August 23, 2023, from 11 a.m.-12 p.m. EDT.

• Asian Chemicals Forum – September 5-6, 2023 – New Delhi, India

Asian Chemicals Forum (ACF) will cover a wide range of topics related to safe chemical management.

• European Association Chemical Distributors Annual Congress – September 11-13, 2023 – Barcelona, Spain

“Diving into the future“ is the future-oriented motto of this year’s Annual Congress of Fecc (= the European Association of Chemical Distributors), which will return to beautiful Sitges/Barcelone from Monday, 11 September 2023 afternoon to Wednesday, 13 September afternoon.

• The CCOHS Forum is Back -September 26-27, 2023 – Halifax, NS

There is no other health and safety event like this in Canada. Make a plan to join us for this two-day national event that will bring together leaders, change makers, and subject experts representing government, labour, and workplaces, to share their knowledge and experience around current and emerging health and safety issues.

• World Food Forum – October 16 – 20, 2023 – Rome, Italy

The World Food Forum officially unveiled its theme for 2023: “Agrifood systems transformation accelerates climate action” and launched its activities for the year culminating in a series of global events, competitions  and actions taking place from 16-20 October at the Rome headquarters of the Food and Agriculture Organization of the United Nations (FAO).

• International Baking Association –  October 22-26, 2023 – Munich, Germany

The International Baking Association (IBA) trade fair, a leading trade fair for the baking and confectionery industry set for Oct. 22-26 in Munich, will feature an area focused on innovative start-up businesses.

• ECHA Conference 2024 – February 28, 2024 – Helsinki, Finland

The next European Chemicals Agency (ECHA) Conference will take place on 28 February 2024 in Helsinki. As we are preparing the programme, we want to hear what would be the most important topics for you. So, fill in our short survey and help us shape a relevant and inspiring stakeholder event.