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4704e

Technical Update

Risk Assessment: Transition Process from the “Guideline for
Use at Contaminated Sites in Ontario” to the “Record of Site
Condition Regulation”

1. General Information

· The purpose of this update is to provide general information regarding the transition from the Site Specific Risk Assessment (SSRA) acknowledgement under the Guideline for Use at Contaminates Sites in Ontario (the Guideline) to the acceptance of risk assessments under the Record of Site Condition Regulation (Regulation) under the Environmental Protection Act (EPA). The Regulation itself should be consulted for the requirements to be met when it comes into force.

• The Regulation and related legislation will come into force on October 1, 2004.
• The Regulation encompasses the requirements of the Guideline and builds upon them to provide a clearer more transparent process.
• Under the Guideline, the date of submission of a risk assessment refers to the date of the most recent submission or re-submission in response to MOE review comments. A risk assessment is considered under review by MOE from the most recent date of submission until the date MOE provides a response.

2. Transition of SSRAs under review by MOE Prior to June 17, 2004

• A SSRA that was under review prior to June 17, 2004, will be assessed by the MOE according to the Guideline process before October 1, 2004.
• A SSRA which MOE acknowledges as satisfactory under the Guideline process before October 1, 2004 is deemed to be a Risk Assessment that has been accepted under the Regulation for the purpose of filing a Record of Site Condition.
• A SSRA which has been or will be returned to the proponent with MOE comments that the risk assessment is, in the opinion of the Ministry, unsatisfactory under the Guideline process before October 1, 2004 must meet the requirements of the new Regulation when it is re-submitted.

3. Transition of SSRAs Submitted Between June 17 and July 9, 2004

• For all SSRA submissions received prior to July 9, 2004, the MOE will make every effort to complete a review under the Guideline process prior to October 1, 2004.
• Depending upon the complexity of the submission, and the number of other SSRAs to be reviewed that preceded the submission, SSRAs submitted between June 17, 2004 and July 9, 2004 may not receive comment or acknowledgement from the MOE by October 1, 2004.
• For this reason, it is strongly recommended that any SSRA submitted after June 17, 2004 but before July 9, 2004 meet the requirements of Section 4 of Schedule C of the Regulation. These risk assessments do not have to satisfy the other requirements of Schedule C such as the requirements for pre-submission form (PSF) in Section 3 of Schedule C or certification statements set out in Section 5.
• A SSRA which MOE acknowledges as satisfactory under the Guideline process before October 1, 2004 is deemed to be a Risk Assessment that has been accepted under the Regulation for the purpose of filing a Record of Site Condition.
• A SSRA which has been or will be returned to the proponent before October 1, 2004 with an indication that in the opinion of the Ministry the risk assessment is unsatisfactory under the Guideline process must meet the requirements of the new Regulation when it is re-submitted.

4. Transition of SSRAs Submitted Between July 9 and October 1, 2004

· As it is unlikely that MOE will be able to review this SSRA before October 1, 2004, a SSRA submitted between July 9, 2004, and October 1, 2004 should meet the requirements of Section 4 of Schedule C of the Regulation. Part B of this update explains the steps necessary to meet the requirements of Section 4 of Schedule C of the Regulation.

• Risk Assessments do not have to include requirements of other sections of Schedule C such as the PSF or certification statements, if they are submitted prior to October 1, 2004.

5. Transition of Risk Assessments Commenced before October 1, 2004, but Submitted After October 1, 2004

• Special provisions are in place for Risk Assessments which are commenced before October 1, 2004 but are not completed and submitted until after October 1 (including the date of the most recent resubmission of previously reviewed SSRA or Risk Assessments).
• A Risk Assessment that was commenced before October 1, 2004, but that was not submitted by October 1, 2004 must meet the requirements of Section 44 of the Regulation. Section 44 states that:
  1. work completed before October 1, 2004 must be reviewed by a qualified person and that person must certify in writing (in the form of an appendix) that the components of the SSRA meet the requirements of the new Regulation, except that they were not completed by a qualified person; and,
  2. any components that are required under Schedule C of the new Regulation that were not completed when this Regulation came into force, must be completed by a qualified person and submitted in accordance with the new Regulation.
• All risk assessments submitted after October 1, 2004 must include a PSF and all other requirements of the Regulation. MOE will make the appropriate forms available in July 2004 and the MOE will begin to review PSF’s no later than October 1, 2004.

6. Risk Assessments Commenced After October 1, 2004

• As of October 1, 2004, under the Regulation, the date of submission of a risk assessment will be the date at which the timeline starts accordingto the provisions of the Regulation.
• Risk Assessments commenced and submitted after October 1, 2004 are expected to meet all requirements of the Regulation.

7. Transition for Re-submissions

• After July 9, 2004 all re-submissions including responses to reviewer comments should be in accordance with Section 4 of Schedule C of the Regulation to be eligible for the provisions of the Regulation if approved by MOE after October 1, 2004.
• After October 1, 2004 all re-submissions must be in accordance with the new Regulation to be eligible for the provisions of the Regulation.

Part B – Meeting Section 4 of Schedule C of the Regulation

Section 4 of Schedule C requires risk assessments to meet the minimum requirements in Table 1 of Schedule C. This includes laying out both the human health and ecological risk assessment reports under one cover with sections and sub-headings as prescribed in Table 1 of Schedule C. The majority of the information to be provided will be the same as required in the Guideline process. The purpose of prescribing a consistent format for all risk assessments is to streamline the risk assessment review process in order to meet regulatory timelines for review, beginning October 1, 2004.

Schedule C also covers estimation of local background concentrations, which comes under the heading ‘alternative risk assessment procedures’, so that it may provide an alternative to the prescribed site condition standards as it did under the Guideline process. Estimation of local background concentrations is predominantly a sampling procedure, however, and is exempted from the human health and ecological risk assessment reporting requirements of Table 1 of Schedule C.

Information required under the Regulation which was not specifically required under the Guideline process includes:

• The proposal of a standard (a numeric concentration of a contaminant) specified in the risk assessment as a property-specific standard for each contaminant identified by the Qualified Person who did the environmental site assessment(s) as a contaminant of concern.
• A pre-submission form (PSF) submitted under Section 3 (for risk assessments submitted after October 1 2004) describing the conceptual site model, self-declaration of the qualifications of the Qualified Person for risk assessment and the type of risk assessment being submitted to which Section 46 of the Regulation applies.
• The inclusion in the exposure assessment calculations of all potential exposure pathways, with and without risk management assumptions.
• A description of the expertise required to undertake the risk assessment, the qualifications, including the resumes, for the qualified person and technical leads and their role in preparing the risk assessment report, and justification for the omission of expertise normally associated with risk assessment.
• A summary of the phase one and two sampling programs, specifically considering data quality, uncertainty and suitability of the data for use in the risk assessment.
• Details of any additional sampling undertaken to support the risk assessment.
• If the risk assessment will assume the ground water under the RA property does not or will not serve as a raw water supply for a drinking-water system, as defined in the Safe Drinking Water Act, 2002, provide a copy of the notification to local government, and the response provided from the local government.
• Additional specific and enforceable detail in the description of risk management performance objectives and proposed risk management measures, including requirements for monitoring, maintenance, replacement and contingency planning.
• Detailed plans and specifications of any proposed engineering or hydrogeological controls, duly stamped by an appropriate person.

Changes from the Guideline process:

• Schedule C is more explicit in the assessment of off-site risk than was the case under the Guideline process. Schedule C requires an assessment of whether the property specific standard being proposed in the risk assessment is likely to result in a concentration greater than the applicable full depth site condition standard at the nearest receptor located off-site. Where the applicable full depth site condition standard is expected to be exceeded at a point of offsite impact, the location and type of receptor which may be impacted must be specified.
• If the property-specific standard proposed by the risk assessment for groundwater is greater than 50% solubility, the requirement for risk management measures (Level 2 risk management under the Guideline) will not automatically be assumed but will be property-specific based on a demonstration of the risk of free product formation and the need for mitigation.
• Public communication is required where the risk assessment has been identified by the Ministry as being located in an area where multiple sites are affected by contaminant plumes including one or more sites of origin (Wider Area of Abatement) (for risk assessments submitted after October 1, 2004).

Contacts:
Mark Turner
Coordinator –Risk Assessment
Standards Development Branch
Tel: (416) 327-6949

Tim Krsul
Program Coordinator
Central Region ADO
Tel: (416) 326-4840

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