CEPA Risk Group 2 Pathogens on the DSL
How the Human Pathogens and Toxins Act Impacts Risk Group 2 Organisms Evaluated Through ECCC and Health Canada Screening Assessments
16 December 2021
Did You Know?
Environment and Climate Change Canada (ECCC) has undertaken an effort to assess the risk of many microorganisms that are on the Domestic Substance List (DSL). This has resulted in the publication of Final Screening Assessment Reports (fSARs). Depending on the outcome of the risk assessment contained in an fSAR, ECCC can take the following actions:
- If the organism is determined to be toxic under the Canadian Environmental Protection Act, 1999 (CEPA), then ECCC may take risk management actions, including removal of the organism from the DSL.
- If some foreseeable use causes the organism to become CEPA toxic, then ECCC may apply Significant New Activity (SNAc) provisions to limit the uses of the organism, pending additional information supplied in a significant new activity notification (SNAN).
- If no foreseeable use will cause the organism to become CEPA toxic, then no further action is required by ECCC.
What Does This Mean?
ECCC has completed fSARs on Pseudomonas aeruginosa (strains: ATCC 31480, ATCC 700370, and ATCC 700371), Enterobacter aerogenes ATCC 13048, Bacillus cereus ATCC 14579, and Bacillus subtilis 11685-3. A common theme arose in all the fSARs: The hazard level was deemed medium, but the exposure level was deemed low. Therefore, a SNAc was imposed on each organism to limit their future use to keep the exposure low. This same exercise has occurred before, with organisms assessed as Risk Group 1 (RG1) under the Human Pathogens and Toxins Act (HPTA). However, these latest organisms are Risk Group 2 (RG2) pathogens under the HPTA.
Are There Any Handling Policies for These Organisms?
Health Canada requires facility licenses for handling RG2 organisms. Under the HPTA, RG2 organisms must be handled in a facility following containment level 2 (CL2) procedures and building design. To reduce regulatory overlap, RG2 organisms on the DSL will be no longer be subject to SNAc provisions, because the users of the organism must adhere to licensing and containment requirements under the HPTA to prevent exposure to the organisms. For this reason, the SNAc on each of these organisms is likely to be rescinded.
This likely means that, going forward, any RG2 organisms notified under the new substances program will not be authorized for use. Their only acceptable use will be within CL2 facilities that are regulated under the HPTA. RG1 organisms not on the DSL must still be notified under the new substances program, except in the cases where they are regulated by certain other legislation.
It is important to understand how this impacts your company and what information is required, including how to handle these microorganisms prior to being manufactured, imported, sold, or distributed in Canada. Do you have questions about this topic or a related topic? Do you need assistance preparing a dossier? Contact our experts at Intertek Assuris. We're here to help!
To learn more about how we can support your business, visit: https://www.intertek.com/green/chemicals/.
HPTA (2009) Human Pathogens and Toxins Act (justice.gc.ca)
Potential removal of SNAc Canada Gazette, Part 1, Volume 155, Number 25:
fSAR Bacillus cereus and Bacillus subtilis Final Screening Assessment of Bacillus cereus and Bacillus subtilis - Canada.ca