Biotech Firms Secure Living Organisms Waivers

Environment Canada grants CEPA exemptions from key environmental and antibiotic data requirements for multiple living organisms in the March 28, 2026 Canada Gazette.

Mar 30, 2026

On a quiet Saturday in late March 2026, the latest edition of the Canada Gazette Part I, Vol. 160, No. 13, appeared online and in official print distribution. Inside its pages, the Department of the Environment quietly recorded a series of living organisms waivers approved under subsection 106(9) of the Canadian Environmental Protection Act, 1999. These decisions allow selected companies to move forward with importing or manufacturing new living organisms without submitting full packages of test data on potential effects to aquatic and terrestrial species or on antibiotic susceptibility.

The waivers form part of the New Substances program, which requires anyone proposing to import or manufacture a living organism not on the Domestic Substances List to provide information under subsection 106(1) of the Act. A person may request a waiver of specific requirements under subsection 106(8), and the Minister of the Environment may grant it after consultation with the Minister of Health. The Gazette notice lists the recipients and the exact information exempted, ensuring transparency while facilitating timely regulatory decisions.

CEPA Living Organisms Waivers: Exemptions for Aquatic, Terrestrial and Antibiotic Data

The annex to the notice details the living organisms waivers granted to 15 companies. Most exemptions cover data from tests to determine the effects of the living organism on aquatic plant, invertebrate and vertebrate species likely to be exposed, data from tests to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed, and data from tests of antibiotic susceptibility. Some companies received multiple identical waivers, indicated by numbers in brackets.

Allogene Therapeutics obtained waivers for both aquatic and terrestrial species effects data plus antibiotic susceptibility testing. Almac Clinical Services Group received parallel exemptions covering the same categories twice. AstraZeneca Canada Inc. secured waivers for aquatic and terrestrial impacts together with antibiotic susceptibility data. BlueRock Therapeutics Canada ULC gained identical relief for aquatic and terrestrial species effects along with antibiotic susceptibility.

Capsida Biotherapeutics, Inc. received exemptions for aquatic and terrestrial species data and antibiotic susceptibility. Cytophage Technologies Inc. obtained waivers for aquatic and terrestrial effects on plants, invertebrates and vertebrates, as well as antibiotic susceptibility. Gilead Sciences Canada Inc. secured similar coverage for aquatic and terrestrial species plus antibiotic susceptibility testing. Immatics US, Inc. received exemptions across aquatic, terrestrial and antibiotic categories.

MavriX Bio, LLC gained waivers for aquatic and terrestrial species effects and antibiotic susceptibility. Novozymes Canada Limited received targeted waivers focused on aquatic vertebrate species effects and antibiotic susceptibility. Qeen Biotechnologies obtained multiple exemptions, including aquatic and terrestrial species effects data (multiple times), antibiotic susceptibility, and data from tests of pathogenicity valid for related living organisms that are pathogenic to humans. Sanofi Pasteur Limited received a waiver for antibiotic susceptibility data only.

Sensorion secured aquatic and terrestrial species effects data and antibiotic susceptibility. Theolytics Limited obtained the same trio of exemptions. Yourway Transport Inc. received waivers for aquatic and terrestrial effects together with antibiotic susceptibility testing.

These living organisms waivers illustrate the case-by-case approach embedded in the Act. Companies still must meet all other obligations, and the Minister retains authority to require additional information if new concerns arise.

Parallel Chemical Substance Waivers Under the Same Regulatory Framework

Immediately following the living organisms section, the Gazette publishes a companion notice under subsection 81(9) of the Canadian Environmental Protection Act, 1999. The Minister waived specific information requirements for chemical substances not on the Domestic Substances List. Recipients include Advancion Corporation (hydrolysis rate as a function of pH and acute mammalian toxicity data), Allnex Canada Inc. (hydrolysis rate and octanol/water partition coefficient), and Amfine Chemical Corporation (in vivo mammalian mutagenicity test for chromosomal aberrations or gene mutations).

Axalta Coating Systems Canada Company received a waiver for water extractability data. Chevron Oronite Company LLC obtained exemptions for repeated-dose mammalian toxicity testing of at least 28 days and in vitro and in vivo mutagenicity tests. Cytec Canada Inc. secured a waiver for octanol/water partition coefficient data. Dow Chemical Canada ULC received relief for both hydrolysis rate and octanol/water partition coefficient. Ecolab Co. gained waivers for melting point, boiling point and vapour pressure data.

FilmTec Water Canada Company obtained exemptions for number average molecular weight and maximum concentrations of residual constituents below specified molecular weights. Richard Gouin received waivers for vapour pressure, hydrolysis rate and in vivo mutagenicity testing. Toyota Tsusho Canada Inc. secured relief for vapour pressure, octanol/water partition coefficient and ready biodegradation testing. William Blythe Limited obtained a waiver for ready biodegradation data.

The explanatory note accompanying both waiver notices states that the decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, approximately 300 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999. Around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Act. Further details are available on the New Substances program website.

Additional Regulatory Actions Published in the Same Canada Gazette

The March 28, 2026 edition also records several other government notices. Under the Canadian Environmental Protection Act, 1999, Order 2026-87-03-02 amends the Non-domestic Substances List by deleting two specific chemical identifiers in Part I and one entry in Part II. The order comes into force on the same day as the companion Domestic Substances List amendment.

The Department of Transport sets two levies effective for the fiscal year beginning April 1, 2026. Pursuant to the Canada Transportation Act, the levy on shipments of crude oil by rail is $2.16 per tonne for payments into the Fund for Railway Accidents Involving Designated Goods. Under the Marine Liability Act, the levy in respect of payments into the Ship-source Oil Pollution Fund would be 64.63 cents per relevant unit if imposed.

Innovation, Science and Economic Development Canada released Notice No. SMSE-003-26 proposing revisions to the Canadian Table of Frequency Allocations 2026 Edition to reflect outcomes of the 2023 World Radiocommunication Conference and recent domestic policy decisions. Comments are due by May 4, 2026.

Under the Bank Act, the Office of the Superintendent of Financial Institutions issued letters patent continuing ABCU Credit Union Ltd. as a bank effective April 1, 2026, and letters patent amalgamating Innovation Federal Credit Union and ABCU Credit Union Ltd. into one bank under the name Innovation Federal Credit Union, also effective April 1, 2026. An order authorizing the amalgamated entity to commence and carry on business was issued on the same date.

The Privy Council Office lists current Governor in Council appointment opportunities, including positions at the Office of the Commissioner of Competition and the Office of the Commissioner of Indigenous Languages. The House of Commons records standing order notices for private bills and the deregistration of the Fleetwood—Port Kells Green Party Association effective April 15, 2026. Royal assent was signified by written declaration on March 12, 2026, for a bill not identified by short title in the notice.

These entries appear alongside the living organisms waivers in the same official publication, underscoring the breadth of federal regulatory activity captured each Saturday in Part I of the Canada Gazette.

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