Conditional permit for avermectin B1
Canada Gazette, Part I, Volume 159, Number 31: GOVERNMENT NOTICES
Ministerial Condition No. 22083 allows the notifier to manufacture or import avermectin B1 (CAS RN 123997-26-2) only to produce a drug for export or an approved veterinary drug for sale in Canada, subject to strict conditions. The conditions prohibit releases to the environment, require incineration or disposal in engineered hazardous waste landfills, immediate notification of any releases, and specific record-keeping; they came into force on 2025-07-21.
Summary
Summary#
This notice sets out Ministerial Condition No. 22083 under the Canadian Environmental Protection Act, 1999. It allows the manufacture or import of avermectin B1, 4″-(acetylamino)-4″-deoxy-, (4″R)-, (CAS RN 123997-26-2) but only under strict conditions intended to limit releases to the environment. The conditions came into force on July 21, 2025.
What it does#
- Allows the person who notified the government (the notifier) to manufacture or import the named substance, subject to the listed conditions.
- Limits permitted uses to:
- making a drug for export outside Canada, or
- making or distributing for sale a drug approved for treating domestic animals and livestock in Canada.
- Prohibits releasing the substance or waste containing it into the environment.
- Requires waste containing the substance to be either:
- incinerated in accordance with local laws, or
- disposed of in an engineered hazardous waste landfill facility under local laws.
- Requires immediate action and notification if any release occurs (stop further release, limit spread, and notify authorities or the provincial 24-hour emergency contact).
- Before transferring possession, the notifier must:
- give the transferee written notice of these conditions, and
- get written confirmation that the transferee agrees to follow the rules.
- Record-keeping rules require the notifier to keep records showing:
- how the substance is used;
- quantities manufactured, imported, exported, purchased, distributed, sold and used;
- names and addresses of anyone the notifier gives the substance or its waste to; and
- the written confirmations from transferees.
- Timing and storage of records:
- create or update certain records within 30 days when information becomes available or when addresses change;
- keep records at the notifier’s principal place of business in Canada for at least five years;
- records may be electronic but must be readable.
Who's affected#
- Primarily the notifier (the person who provided information about the substance on March 26, 2025) — the notice names this role but does not give a public company name.
- Companies that manufacture or import the substance under the allowed uses, including drug makers focused on export and veterinary drug suppliers.
- Waste handlers and disposal sites, such as incinerators and engineered hazardous waste landfill facilities, which may be asked to accept and manage this material.
- Regulators and emergency response authorities who would be notified of any accidental release.
- If it’s unclear who exactly the notifier is from the public notice, other parties in the supply chain may need to check whether they are the notifier or are receiving material from the notifier.
Why it matters#
- The government flagged this chemical as potentially toxic, but has set conditions to allow limited use while controlling risks. That matters to communities near manufacturing sites, transport routes, and disposal facilities because the rules aim to prevent environmental releases.
- For businesses, the conditions make clear what uses are allowed and add paperwork, handling, and disposal obligations. This affects drug manufacturers (especially veterinary drugs) and waste management contractors.
- The rules create traceability (who had the substance, how much, where it went) and require quick action and reporting if anything leaks. That improves the chance of limiting harm if an accident happens.
Key topics
Source: Canada Gazette