Regulatory
REGULATORY NEWS FOR THE WEEK OF NOVEMBER 20, 2023
(Jurist November 16, 2023) The Federal Court of Canada delivered a decision on Thursday November 16, 2023 overturning the federal government’s order to list plastic-manufactured items (PMIs) under Schedule 1 of the Canadian Environmental Protection Act 1999 (CEPA). The court’s decision may affect the government’s ban on single-use plastics, which was made possible by the order. The National Products Canada Cluster is a national program with access to matching funding for growing businesses who make ingredients or products that originate in nature, including food, animal feed, and crop-related products. This group helps businesses gain access to financing, help with hiring the right talent, and reach commercialization milestones through their Proof-of-Concept Program. Their main focus is to provide strategic guidance to start-ups and SMEs and to create connections through their innovation hub. NPC also has an investment fund that may help certain select opportunities meet growth objectives as well as connect investors with interests in supporting Canadian natural product innovations. As the hub of the cluster, NPC also helps to tackle issues that impact this sector. For more information on this group, please reach out to their program coordinator, Kim Johnstone, PhD at [email protected]. Membership to this program starts at just $150 per year and is based on the size of your business. Food Preventive Control Services Canada Inc. has joined. For businesses in the business of developing new products, consider this important federal tax incentive. While many smaller businesses may think that they do not qualify for this program, consider the foundational principles; the Government of Canada supports innovation no matter the size of your business, and participating in SR&ED (fondly referred to as SHRED) isn’t complicated, but it does require careful expense tracking and you must be able to show that through a series of experiments that you have increased your know-how about your products and processes. The idea is that you can show learning, especially in light of failure, that results in an increase in understanding. Experiments don’t have to be original research to the world, but the work must show how you have improved your understanding of your own products and processes. A quick example would include scaling a product up from a bench sample to commercial production where adjustments had to be made to the process that are new to your business. This isn’t about taking an existing product and swapping in a new colour with prior knowledge that this is a slam-dunk for success, but rather about projects where there is uncertainty for success. From the Canada Revenue Agency’s (CRA) website: If your business is engaged in scientific research and experimental development (SR&ED), you may be able to earn tax incentives that reduce your income tax payable. Corporations, individuals, trusts, and partnerships that conduct SR&ED work in Canada may be able to: For your work to be eligible for SR&ED tax incentives, it must be conducted in Canada and meet both of the following requirements: The CRA has many helpful tools to help you understand if you qualify for this incentive, including FAQs and videos. For more information, please check out CRA’s SR&ED site. In many cases fees for our services that are directly related to your R&D efforts may be eligible for inclusion in your annual claims. The Government of Canada published the Notice with respect to certain substances under the Chemicals Management Plan ─ 2023 on June 24, 2023, in the Canada Gazette, Part I, pursuant to Section 71 of the Canadian Environmental Protection Act, 1999. You are invited to attend the following information session in English. Please note that this session is non-interactive (view only). Section 71 CMP notice English information session on November 29, 2023, at 1:30 PM ET. Chemical Compliance CA Inc. will attend and report on the session. Antimicrobial resistance (AMR) poses a threat to humans, animals, plants, and the environment, and it affects everyone. The theme for WAAW 2023, maintained from 2022 is: “Preventing antimicrobial resistance together”. The theme emphasizes the need for a One Health approach involving multiple sectors to preserve the efficacy of antimicrobials. Agriculture and Agri-Food Canada (AAFC), the Canadian Food Inspection Agency (CFIA), Fisheries and Oceans Canada (DFO), Health Canada (HC), and the Public Health Agency of Canada (PHAC) have made a number of advancements in implementing the Agri-food and Aquaculture Roadmap. The directive came into effect on November 6, 2023. To coincide with the coming into effect date, the CFIA has revised the directive in order to provide clarity on ship reporting, contact points, and to provide tools for industry. The requirements specified in the shipment dunnage program remain the same, however, certain sections of the directive have been clarified. The use of phytosanitary certificates (section 5) and the scope of the program in relation to marine containers (section 5.2) have been clarified. In addition, the notification process for ships entering Canadian waters with the intent to discharge dunnage has been improved by providing the coordinates of CFIA local offices and a ship notification template (section 5.2.1 and appendix 3). A flow chart summarizing how shipborne dunnage is managed in Canada has also been added (Appendix 9). For more information regarding the application of this directive, please consult a local CFIA office. The Canadian Food Inspection Agency (CFIA) has launched a public consultation seeking feedback on proposed revisions to the directive D-99-06: Policy on the Issuance of Phytosanitary Certificates for Export and for Re-export. Proposed revisions include procedural changes for the application and issuance of phytosanitary certificates using the My CFIA online service portal, to clarify the issuance date on the phytosanitary certificate, and general administrative updates where appropriate. The main objective of the proposed Certain Products Containing Toxic Substances Regulations (the proposed Regulations) is to prohibit the manufacture, import and sale of certain coal tar-based sealant products and certain sealant products containing PAH levels above 1 000 ppm in order to prevent harmful ecological impacts and to help reduce the risk of adverse health impacts resulting from exposure to these toxic substances in Canada. The 2-Butoxyethanol Regulations would be repealed and amalgamated under the proposed Regulations as part of a generic regulation strategy. No substantive changes to the 2-BE Regulations would be made, but some text would be modified to be consistent with the legislative drafting of more recent regulations. Meanwhile, regulatory requirements for permitting and record keeping would remain the same. The Treasury Board of Canada Secretariat (TBS) is currently coordinating a third round of Regulatory Reviews, which includes a Supply Chain Regulatory Review, announced in the 2022 Fall Economic Statement. This Supply Chain Regulatory Review will examine federal regulations and regulatory practices, with a view to better support the movement of commodities and goods in Canada and across the border. This note is to remind you of the coming into effect of the regulatory limits for Volatile Organic Compounds (VOCs) for the manufacture and import of products in Canada listed in schedules 1 and 2 of the Volatile Organic Compound Concentration Limits for Certain Products Regulations (the Regulations). The regulatory limits will come into effect on January 1, 2024, for all product categories, except disinfectants, whose limits come into effect on January 1, 2025. The purpose of the Regulations is to prohibit the import and manufacture of products in Canada that exceed prescribed VOC concentration limits for approximately 130 product categories and subcategories. Products include: The Guidelines for Canadian Recreational Water Quality comprise multiple guideline technical documents that consider the various factors that could interfere with the safety of recreational waters from a human health perspective. This includes technical documents on understanding and managing risks in recreational waters, fecal indicator organisms, microbiological methods for monitoring fecal contamination, cyanobacteria and their toxins, physical, aesthetic, and chemical characteristics, and microbiological pathogens and other biological hazards. These documents provide guideline values for specific parameters used to monitor water quality hazards and recommend science-based monitoring and risk management strategies. Health Canada would also like to inform you that Health Canada tabled the 2022-2023 Report on Fees in Parliament on November 8th, 2023. Health Canada will be discussing the content of this report during its December 7th event. The Agricultural Methane Reduction Challenge builds on the successes of existing industry commitments on the environment. Livestock producers and industry groups are setting voluntary targets and goals to reduce emissions and these commitments are already seeing results. For example, the Canadian Beef Advisors has a 2030 goal of reducing emission intensity from primary beef production by 33 per cent, while the Dairy Farmers of Canada have set a goal to reach net-zero by 2050. This Challenge has been designed in collaboration with the sector to accelerate these successes, spur innovation and reduce emissions. Transport Canada will be seeking feedback on proposed regulatory amendments to update and clarify the ship-source oil spill preparedness and response requirements for response organizations and oil handling facility operators. The consultation opened on November 13, 2023 and closes on January 16, 2024. The Health Canada Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation in Canada. The public registry is where you can learn more about all pest control products registered for use in Canada.
An article entitled “Changes coming to Alberta’s Certificate of Recognition (COR) program” was published earlier this month in the November edition of OHS eNews. Officials learned that the article was misleading to some who read it, and would like to formally apologize for that. The Ontario government is introducing new legislation to continue leading the country in ground-breaking protections for workers. These proposed changes expand on the historic measures in the Working for Workers Acts, 2021, 2022 and 2023. To be ready for unpredictable winter weather, vehicles should have winter tires, cold temperature antifreeze and an emergency kit. This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document discusses FDA’s compliance policy for these requirements. FDA intends to delay enforcement of these requirements for six months to help ensure that industry has sufficient time to submit facility registration and product listing information. The U.S. Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetics product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA also intends to make the Cosmetics Direct electronic submission portal available in the future at https://direct.fda.gov/. Cosmetics Direct will be an FDA provided SPL authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the ESG. The Environmental Protection Agency (EPA) released the meeting minutes and final report from the September 12-14, 2023, Science Advisory Committee on Chemicals (SACC) virtual public meeting regarding the Draft Supplement to the Risk Evaluation for 1,4-Dioxane. Join the U.S. Environmental Protection Agency (EPA), PETA Science Consortium International, Institute for In Vitro Sciences and California Department of Pesticide Regulation on Wednesday, November 29 at 11 a.m. EST for the second webinar in the EPIC series on the use of new approach methodologies in risk assessment. Effective January 16, 2024 the Federal Motor Carrier Safety Administration (FMCSA) amends the regulations pertaining to financial responsibility requirements for brokers of property and freight forwarders in five separate areas: assets “readily available”; immediate suspension of broker/freight forwarder operating authority; surety or trust responsibilities in cases of broker/freight forwarder financial failure or insolvency; enforcement authority; and entities eligible to provide trust funds for brokers and freight forwarders, which are filed using Form BMC-85, Broker’s or Freight Forwarder’s Trust Fund Agreement under 49 U.S.C. 13906 or Notice of Cancellation of the Agreement. The Environmental Protection Agency (EPA) is announcing a 60-day public comment period on the draft revision of the Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (EJ Technical Guidance). The EJ Technical Guidance was first published in 2016. The EPA is updating it to reflect the state of the science; new peer-reviewed agency guidance; and new terminology, priorities, and direction, including Executive Order 14096. The purpose of this guidance is to outline analytic expectations and discuss technical approaches and methods that can be used by agency analysts to evaluate EJ concerns for regulatory actions. This technical guidance builds on the EPA’s experience in evaluating environmental justice concerns within the rulemaking analytic process and underscores the EPA’s ongoing commitment to ensuring the just treatment and meaningful involvement of all people with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. Comments must be received on or before January 15, 2024. The U.S. Environmental Protection Agency (EPA) announced proposed updates to the Safer Choice Standard, which identifies the requirements that products and their ingredients must meet to earn EPA’s Safer Choice label or Design for the Environment (DfE) logo. The Agency is requesting public comments on the proposed updates by Jan. 16, 2024, and will hold a webinar on Dec. 19, 2023, to provide information on proposed updates to the Standard. The Executive Order 14081 on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy,” (E.O. 14081) recognizes the importance of a regulatory process that supports safe innovation. Section 8 of E.O. 14081 calls out the need for clarity and efficiency in the regulatory process and requires, as a first step, that the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, and the Commissioner of the Food and Drug Administration identify areas of uncertainty in the regulatory framework that remain after the 2017 update to the Coordinated Framework for the Regulation of Biotechnology. The three agencies, in consultation with the Office of Science and Technology Policy (OSTP), elected to begin the process with a Request for Information (RFI) to the public, open from December 15, 2022, through February 3, 2023. The Federal Motor Carrier Safety Administration (FMCSA) amends its regulations by making technical corrections throughout the Federal Motor Carrier Safety Regulations (FMCSRs). The Agency makes minor changes to correct inadvertent errors and omissions, remove or update obsolete references, and improve the clarity and consistency of certain regulatory provisions. The Agency also makes a change to its rules of organization, procedures, and practice. Effective November 17, 2023, the Office of Environmental Health Hazard Assessment (OEHHA) is adding coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers 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, otherwise known as Proposition 65. The European Food Safety Authority (EFSA) has assessed the safety of eight[1] smoke flavourings on the EU market, the authorisation of which was due for renewal, according to the applicable legislation. The eight products just assessed have been on the EU market for the past 10 years and the applicants have requested the European Commission to extend their authorisations for an additional 10. France has launched a call for evidence to support the preparation of a REACH restriction proposal concerning octocrilene. The European Chemicals Agency (ECHA) has published a new report on ‘Key areas of regulatory challenge 2023’ that identifies areas where research is needed to protect people and the environment from hazardous chemicals. It also highlights where new methods, that support the shift away from animal testing, are needed. In case C-559/21 P, the European Court of Justice has dismissed the appeal brought by Global Silicones and others against the judgment of the General Court which confirmed ECHA’s decision to identify the substances D4, D5 and D6 as substances of very high concern (persistent, bioaccumulative, toxic or very persistent, very bioaccumulative). This judgment is final and no further appeal is available. Safety Share The Commercial Vehicle Safety Alliance (CVSA) has set the dates for next year’s Human Trafficking Awareness Initiative (HTAI) for each of its three member countries. In the U.S., the initiative is scheduled for Jan. 8-12, 2024. Canada’s HTAI dates are Feb. 19-23, 2024. And in Mexico, HTAI is set for March 11-15, 2024. Have an event you would like to share? Please send details to [email protected]. IHSA welcomes you to join us via Zoom for the second annual NCSO®/NHSA™ Educational Conference on Thursday, Nov. 23rd at 8:00 a.m. This half-day event will provide NCSO/NHSAs with an opportunity to increase their knowledge of relevant health and safety topics and learn more about some of the key areas important to maintaining their NCSO®/NHSA™ status. As Agriculture and Agri-Food Canada begins to organize logistics around the Wrap-up Conference, we ask that parties interested in attending please reply to this message by September 8, 2023 email to: [email protected] The Forum is an annual event and brings together scientists and public and private stakeholders with expertise on endocrine disruptors to exchange information and best practices, identify challenges and build synergies. This year the Forum will include sessions on regulatory updates by the European Commission and Agencies; global developments; research; national, regional and local initiatives; and a specific focus on PFAS. 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. The 2024 SOT Annual Meeting and ToxExpo will take place March 10–14, 2024, in Salt Lake City, Utah. Visit the 2024 website to view upcoming deadlines. The Baking Association of Canada’s national baking industry event will feature a bustling trade show and conference, inspirational speakers, education sessions, competitions and demonstrations and countless opportunities to network and benefit your business.Advocacy
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