Part IPublic NoticeVolume 159, Number 31Published: August 2, 2025

Avermectin B1 import and manufacture conditions

Canada Gazette, Part I, Volume 159, Number 31: GOVERNMENT NOTICES

Ministerial Condition No. 22083 allows a notifier to manufacture or import avermectin B1 (CAS 123997-26-2) only to make drugs for export or approved veterinary drugs, subject to strict handling, disposal, notification and record-keeping rules. The conditions, effective July 21, 2025, ban environmental release, require incineration or engineered hazardous-waste landfill disposal of waste, and mandate written notices and five-year record retention.

Published
August 2, 2025
Department
Unavailable
Section
DEPARTMENT OF THE ENVIRONMENT
Comment deadline
Unavailable
Effective date
July 21, 2025
Publication part
Part I

Summary

Summary#

This notice, Ministerial Condition No. 22083, issued under the Canadian Environmental Protection Act, 1999, lets a specific company (the “notifier”) manufacture or import a chemical called avermectin B1, 4″-(acetylamino)-4″-deoxy-, (4″R) (CAS 123997-26-2) but only under strict conditions because the government suspects it may be toxic. The conditions took effect on July 21, 2025.

What it does#

  • Allows the notifier to manufacture or import the substance only for:
    • making a drug that will be exported outside Canada, or
    • making or selling a drug approved under the Food and Drugs Act for treating domestic animals and livestock.
  • Prohibits releasing the substance or any waste that contains it into the environment.
  • Requires the notifier to collect any waste containing the substance and either:
    • incinerate it under the laws where the incinerator is located, or
    • dispose of it in an engineered hazardous waste landfill facility under applicable laws.
  • If any release occurs, the notifier must immediately stop further release, limit spread, and notify an enforcement officer or the provincial 24-hour emergency contact.
  • Before giving the substance or its waste to anyone else, the notifier must:
    • inform that person in writing about these conditions, and
    • obtain written confirmation that the person was informed and will follow the rules.
  • Record-keeping requirements:
    • keep records of how the substance is used and of the quantities manufactured, imported, exported, purchased, distributed, sold and used;
    • record the names and addresses of anyone who receives the substance or waste, and keep the written confirmations described above;
    • create records no later than 30 days after the information becomes available and update recipient addresses within 30 days of learning of a change;
    • keep records in English or French at the notifier’s principal place of business in Canada for at least five years; electronic records must be readable.

Who's affected#

  • The primary party affected is the notifier (the company or person who supplied information about the chemical on March 26, 2025).
  • Companies that make drugs for export and companies that make or sell approved veterinary drugs could be affected if they work with this notifier or use the substance.
  • Waste handlers, incinerators, and hazardous-waste landfill operators who accept this material must meet the disposal rules and applicable laws.
  • Anyone who receives the substance or its waste must get written notice of the conditions and agree in writing to follow them.
  • Provincial enforcement officers and emergency contact services may be involved if a release happens.

Why it matters#

  • The government is allowing limited use of a chemical it believes could be harmful, but only under tight controls to reduce the risk of environmental release and human or animal exposure.
  • The rules let certain drug-related work continue (exports and approved veterinary drugs) while forcing strict disposal, tracking, and notification steps that improve oversight and traceability.
  • For nearby communities and the environment, the notice aims to lower the chance of accidental contamination and ensure faster response if a release happens.

Key topics

Canadian Environmental Protection Act, 1999CEPAMinisterial Condition No. 22083avermectin B1, 4″-(acetylamino)-4″-deoxy-, (4″R)123997-26-2Food and Drugs ActEnvironment and Climate Change CanadaHealth Canadaengineered hazardous waste landfill facilityincinerationenvironmental release notificationrecord-keeping requirementsveterinary drugsdrug export

Source: Canada Gazette

Official source