Section 71 Surveys – Upcoming Release

Posted Date: 13-June-2023

DEL Bulletin No. 189 – Notice of Publication Annex 13 to the GMP Guide for Drugs used in Clinical Trials

Good Day CA Canada Members

 

We, through our engagement with the CEPA Industry Coordinating Group (CEPA-ICG), are aware that a couple of large Section 71 Surveys that have been under development for the past couple of years are likely to be released by Environment and Climate Change Canada (ECCC) and Health Canada (HC) this summer/early fall.

 

Survey 1:

Will focus on information collection in relation to Per- and Poly-Fluorinated Alkyl Substances (PFAS). Given the recent release of the PFAS State of the Science Reports and corresponding Risk Management Scoping Document, this survey is intended to provide key information that will direct ECCC/HC’s risk management approach, and influence the scope and target of any such measures, moving forward. We understand that this is likely to be the first of a number of PFAS surveys that may be issued over the next few years. This one is likely to focus on an initial subset of PFAS presently listed on the Canadian Domestic Substance List (DSL) and potentially in significant volumes of use and/or of highest potential risk (based on preliminary hazard/exposure profiles) as outlined in the State of Science Reports. Based on discussions with officials, this survey is likely to involve around 100 – 200 substances (which represents a relative narrow scope, given that PFASs as a class, could represent 1,000’s of substances).

 

Survey 2:

By far the larger potential burden of the two, is intended to be the next iteration of survey instruments in line with previous ‘Inventory Update’ surveys [now under the banner of ‘Standard Notice’]. It is possible that this survey will become an annual survey (although this has yet to be confirmed). This (and potentially annually reoccurring) survey(s) will inform next phases of work under the Canadian Chemicals Management Plan (CMP) and will provide base ‘volume’/’use’ type information that will support prioritization, risk assessment and risk management activities under the CMP, moving forward. The original proposed survey was very large, involving 2,000+ substances. Through technical stakeholder sessions with Trade Associations, including CA Canada, this list has been narrowed to likely just under 1,000 substances. Although this is a very large number of substances, this is a generic survey across industry/user communities, as such, only a fraction of these may be significant/relevant from a personal care perspective.   Regardless, it is highly like that a significant number of substances that will need to be screened and managed.

 

On this basis – CA members need to get ready, as these surveys will mark the beginnings of a significant ‘information gathering’ season under the CMP.  Although these surveys are likely to feature reporting deadlines with 3 – 6 month windows, past experience with these types of surveys suggest that even these relatively long reporting windows can prove to be way too narrow and short (although extensions are likely to be possible). So time to get ready!

 

WHAT IS A SECTION 71 SURVEY?

A Section 71 Survey is a mandatory information gathering instrument that ECCC/HC can issue to compel information from stakeholders, in this case, to help inform priority setting and/or decision-making. First the good news: for both surveys, they should not obligate information requiring de novo testing, and therefore, should only extend to information/calculations ‘readily in your possession’. However, because these are mandatory surveys, if you meet the activities (manufacture/import/use) covered in the survey, any of the substances identified in the survey, you will need to respond/engage with the survey. Information gathered through these surveys will inform prioritization, risk assessment and/or risk management efforts under the CMP. More information on these instruments can be found here.

 

HELPING YOU GET READY!

Although these surveys have not yet been officially published, we have worked with officials to secure an unofficial, preliminary list of substances that are likely to be covered in the survey. As these are preliminary lists, it is important to note that they are still subject to possible refinement/change; however, they should allow members to get a ‘heads start’ to get a preliminary sense of the possible scope of work (i.e., identify the rough number of substances that may be in your product portfolios that may be implicated).  We strongly recommend that members take the opportunity to review these lists and initiate a ‘cross-referencing’ exercise across your product portfolios to assist with internal resource planning to facilitate engagement with both surveys. This way, when the official surveys are ultimately published, you are in the best position to make the most of the response window. This advanced notice could also allow you to initiate outreach, as necessary, to your supply chain, giving your more time for follow-up and planning to support your mandatory engagement.

 

PFAS Survey (preliminary substance list)

Annual Standard Notice 2023 (preliminary substance list)

 

IMPORTANT NOTE: These preliminary substances lists are shared for information purposes only (to facilitate work planning).  These represent draft courtesy working documents as shared by ECCC/HC. On this basis, they are shared in confidence, and we ask that they not be broadly shared (externally with non-members) without prior consent from CA Canada. Thank you in advance for your understanding.

 

WHAT YOU WILL NEED TO DO:

Once the surveys are published, you will need to:

  1. Understand the reportable activities (and reporting triggers).
  2. Review the schedule of substances covered by the survey.
  3. Initiate a plan to collect/calculate the mandatory information requirements (including determining what information would be ‘readily accessible for reporting’.
  4. Submit your responses, as appropriate.

 

On publication of these surveys, ECCC/HC will be hosting an ‘information session’ (in both official languages) and making guidance documents available to facilitate your data gathering.

 

These surveys can be quite onerous – so get engaged early to maximize the time you can spend with these surveys!

 

Questions / Thoughts / Concerns?

Reach out to your CA Canada Regulatory Team (regulatory@cosmeticsalliance.ca)