| Recommendations |
Management Response:
- Accept
- Accept with conditions
- Reject
|
Planned Management Actions |
Deliverables |
Expected Completion Date |
Accountability |
Recommendation 1:
It is recommended that the Assistant Deputy Minister of Healthy Environments and Consumer Safety Branch (HECSB) formalize and document a framework for prioritizing new substance assessments. |
Accept |
- In cooperation with other government department partner, formalized criteria for prioritization based on risk and legislative timelines will be developed and implemented, including a mechanism to document decisions on level of priority
|
In cooperation with our partner, development of a:
- Screening Sheet for incoming notifications of micro-organisms, similar to that which exists in the NSACB for chemicals and polymers
- Criteria as required in each department or jointly for prioritization and decision tree that will trigger red/orange/green levels response timeframes based on risk and legislative timelines
- Form to capture decisions
- Implementation plan, including mechanism to review effectiveness of process and adjustments as required
|
December 2009 |
Director NSACB |
Recommendation 2:
It is recommended that the Assistant Deputy Minister of Healthy Environments and Consumer Safety Branch develop measures to address issues involving legislative and regulatory needs, including those related to volume splitting. |
Accept |
- Revision of notification regulations for living organisms: Develop and implement amendments for "higher organisms" portion of the regulations with partner.
|
|
December 2009 |
Director NSACB |
- Develop drafting instructions for amended regulations
|
December 2010 |
- Regulatory framework for environmental assessment of new substances in products subject to the Food and Drugs Act: Preparation of drafting instructions for notification regulations that deal with all 9 commodity groups
|
- Drafting instructions developed in collaboration with partners, including Health Products and Food Branch (HPFB)
|
September 2011 |
- Volume Splitting: Monitor each notification and advise partner department of any potential volume splitting and continue to work with partner department on compliance and promotion activities including informing and educating new and existing notifiers on the subject.
|
- Plan for promotion of the new advisory note published on the New Substances website in December 2008
|
On-going |
- Communications to enforcement officials of potential volume splitting cases.
|
On-going |
- Drafting instructions for legislative amendments regarding aggregate quantities as longer term solution
|
Completed |
- Regulatory framework for manufactured nanomaterials: Work in collaboration with other department partner and other parts of HC (HPFB, PSP, SPB and PMRA) on definition, stakeholder consultations and development of regulatory framework, based on legislative authority in a two phased approach
|
Based on current legislative authority:
- Participation in development of interim definition
|
On-going |
- Development and consultation on a regulatory framework with partner
|
March 2011 |
- Drafting instructions for legislative amendments to enhance authority to regulate nanomaterials
|
Completed |
Recommendation 3:
It is recommended that the Assistant Deputy Minister of Healthy Environments and Consumer Safety Branch ensure that the new Directorate has a process in place for the identification and communication of risks associated with new substances that cross both organizational and departmental boundaries. |
Accept |
Recognizing the inevitable need for further integration of the work on new and existing substances and the need to reach out to new partners including those in the occupational health area, work to ensure that information obtained through new substance assessments is available to other program partners.
In cooperation with legal services and directorates within HECS, HPFB and PMRA, implement new mechanisms on information sharing: |
- In cooperation with HC and other partners, develop a needs assessment and policy paper for consideration as part of the renewal of the Chemicals Management Plan
|
March 2010 |
Director NSCAB in consultation with HC and other partners |
- Development and implementation of an action plan based on existing resources
|
March 2010 |
Director NSCAB |
- Negotiate with other CEPA programs and provide access to databases that contain Confidential Business Information by other risk assessment groups in SED
|
- Agreements on roles and responsibilities for the maintenance and use of databases and authorization for access
|
December 2009 |
Director, NSACB and Directors for commodity group and
Legal Services in HECSB, HPFB and PMRA, and our CEPA partner |
- Develop an Alert System for unanticipated hazards
|
- Alert System developed and implemented
|
February 2010
|
- Identify legal barriers that may exist with respect to the sharing of scientific information collected under different Health Canada Acts (e.g. CEPA, F&DA, PCPA). If legal barriers exist, identify methods and procedures to overcome these barriers, to the extent possible. Negotiate roles and responsibilities for the handling of Confidential Business Information and implement sharing agreements
|
- Identification of any legal barriers in collaboration with Legal Services in HECSB, HPFB and PMRA, and our CEPA partner
|
January 2010 |
- Agreements on roles and responsibilities for Information Sharing
|
June 2010 |
- Implement sharing agreements
|
July 2010
and on-going |
Recommendation 4:
It is recommended that the Assistant Deputy Minister of Healthy Environments and Consumer Safety Branch, in the interim, enhance their Spreadsheet to automate query routines for monitoring and measuring performance. |
Accept |
- Enhance the current Excel spreadsheet to automate query routines for monitoring and measuring performance
|
- Enhanced spreadsheet in use
|
May 2010 |
Director
NSACB |
- Continue to work with partner department and HC IMSD to find a longer term solution to link to partner department's One Window solution for new and existing substances
|
- One Window solution and input into HC IT priorities process (dependent upon partners)
|
tbd |
- Establish baselines for performance based on risk, define service standards and review performance on a regular basis
|
- In collaboration with partner department, performance standards for receiving notifications
|
September 2009 |
- Performance standards for each Schedule type based on level of potential risk
|
March 2010 |
- Production and review of reports on performance on a regular basis
|
March 2010 and on-going |