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Management Response and Action Plan (MRAP) Audit of New Substances Assessment and Control Bureau (NSACB)

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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. 
  • Stakeholder consultation
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