Table Of Content

Brownfields Risk Assessment FAQs February 1, 2008 It is important to note that this document does not deal with site specific conditions and should not be used as a substitute for the exercise of professional judgment. It should also be noted that the description of the legislative and regulatory requirements given in this document are for convenience only. The relevant legislation and regulations, available at www.e-laws.gov.on.ca, should be reviewed to determine the exact requirements. Table of Contents Subject Area No. of Q&A’s Date of Last Update A Qualified Persons 1 February 1, 2008 B Pre-Submission Forms (PSF) 4 February 1, 2008 C Risk Assessment Process 7 February 1, 2008 D C onducting Risk Assessments 6 February 1, 2008 Contaminants of Concern E 16 February 1, 2008 (COCs), Standards F Sensitive Sites 6 February 1, 2008 Wider Area of Abatement G 1 February 1, 2008 Classification H Use of Models 2 February 1, 2008 I Risk Management 4 February 1, 2008 Certificate of Property Use J 4 February 1, 2008 (CPU) K General/Other 1 February 1, 2008 This Q&A is updated from time to time. It is recommended that the latest version be downloaded from the Record of Site Condition web site found at http://www.ene.gov.on.ca/envision/land/decomm/condition.htm Date of Last Update of this document: February 1, 2008 1 Main Body of FAQ Date of Last Q# A. Qualified Persons Update What are the regulatory requirements to be a Qualified February 1, Q1 Person for Risk Assessment (QP )? 2008 RA This Q&A is updated from time to time. It is recommended that the latest version be downloaded from the Record of Site Condition web site found at http://www.ene.gov.on.ca/envision/land/decomm/condition.htm <return to FAQ Table of Contents> Q1: What are the regulatory requirements to be a Qualified Person for Risk Assessment (QP )? RA A1: Qualified persons for the purpose of preparing a risk assessment are defined based on education and years of related experience. Part II (6) of O.Reg. 153/04 details the regulatory requirements and is recreated below. Qualified persons, risk assessment (taken from O.Reg. 153/04) 6. (1) A person meets the qualifications to be a qualified person for the purposes of Section 168.1 of the Act in relation to the preparation or supervision of a risk assessment if, (a) the person holds a bachelor’s degree in science, engineering or applied technology from a post-secondary institution; (b) the person has experience in the conduct or supervision of environmental site assessments, or in the conduct, supervision or review of assessment of risk described in clause (c), or in any combination of both, as follows: (i) if the person holds a doctoral degree in science or engineering from a university, five years’ experience, (ii) if the person holds a master’s degree in science or engineering from a university, seven years’ experience, (iii) in any other case, eight years’ experience; and (c) within the period of experience required by clause (b), the person has two years’ experience, 2 (i) in the conduct or supervision of an assessment of risk, or (ii) in the technical or scientific review of an assessment of risk on behalf of a public authority. 3 Date of Last Q# B. PRE-SUBMISSION FORMS (PSF) Update February 1, Q1 What is the purpose of the pre-submission form (PSF)? 2008 What is the ministry turn-around time for the review of pre- February 1, Q2 submission forms? 2008 What must be included in the “Contaminant Inventory” February 1, Q3 Section of the PSF? 2008 How should I present my Conceptual Site Model (CSM) to February 1, Q4 the ministry when risk management controls will block 2008 some of the exposure pathways? This Q&A is updated from time to time. It is recommended that the latest version be downloaded from the Record of Site Condition web site found at http://www.ene.gov.on.ca/envision/land/decomm/condition.htm <return to FAQ Table of Contents> Guidance on the PSF is provided in the MOE Technical Update “Preparation and Submission of a Pre-Submission Form for a risk assessment to be submitted under the new Record of Site Condition Regulation (O.Reg. 153/04)” and is available at: (http://www.ene.gov.on.ca/envision/gp/4725e.pdf. Q1: What is the purpose of the pre-submission form (PSF)? A1: The PSF was developed in response to stakeholder requests for a feedback mechanism early in the risk assessment process. The PSF allows for early feedback from the MOE on the proposed risk assessment approach. By providing an overview of the problem formulation and conceptual site model, MOE reviewers are able to provide advice to proponents on the requirements of O.Reg. 153/04. This should occur early enough in the process to allow proponents to modify their approach based on MOE comments and thus increase the likelihood that the risk assessment will satisfy the requirements of O.Reg. 153/04. The ministry will also provide as part of the comments, the anticipated regulatory review timeline for the proposed approach (8, 16, or 22 weeks). The PSF supports the declaration of the QP to the Ministry, allowing for RA the submission of a risk assessment report. The PSF also authorises the QP to act on behalf of the property owner for the purpose of supervising RA the risk assessment work and preparing the risk assessment report. 4 Q2: What is the ministry turn-around time for the review of pre- submission forms? A2. There is no regulated turn around time on PSF’s. The ministry attempts to turn around comments on the PSF as quickly as possible. Typical turn- around times range from 5 to 7 weeks. Q3: What must be included in the “Contaminant Inventory” Section of the PSF? A3: The QP is required to determine which of the contaminants identified in the Phase 1 and Phase 2 Environmental Site Assessments (ESA) are of potential concern and which should be included in the risk assessment (RA). The Inventory lists all contaminants considered, based on the Phase 1 and 2 ESAs and identifies those that are COCs (Contaminants of Concern), as defined by O.Reg. 153/04. The QP has some discretion in determining if a contaminant is of potential concern by considering the following: • If a Site Condition Standard (SCS) is exceeded, the contaminant MUST be considered as a COC; • If a SCS is met but the Conceptual Site Model (CSM) is not adequately represented by the generic assumptions used by the MOE to develop the Site Condition Standards, the QP MAY wish to INCLUDE this contaminant as a COC; • If there is no SCS and the contaminant is of toxicological concern or present at a potentially significant concentration, the QP MAY wish to INCLUDE this contaminant as a COC. • If there is no site condition standard and it is likely the chemical is of natural origin, (i.e. not related to site activities identified in the Phase 1 ESA) the QP MAY wish to EXCLUDE the chemical from further consideration. The rationale for QP discretion should be provided in text accompanying the PSF. If a contaminant is not listed in the Inventory, the QP is considered to have not assessed the property for that contaminant and determined that it is not considered relevant to the site history or potential risk. Q4: How should I present my Conceptual Site Model (CSM) to the ministry when risk management controls will block some of the exposure pathways? A4: A CSM should indicate all pathways which are present or potentially present and which of those pathways are blocked by RMM. The ministry encourages the presentation of multiple CSMs when appropriate. i.e. CSM with risk management and CSM without. O.Reg 153/04 requires that, 5 where RMM are proposed, a separate CSM be provided that identifies the RMM. Separate CSMs should be presented for Site Characterization, Human Health risk assessment and Ecological risk assessment. Refer to the relevant clauses in Section 3 of Schedule C. 6 Date of Last Q# C. RISK ASSESSMENT PROCESS Update February 1, Q1 What is the review timeline for risk assessments? 2008 Are there any fees for the ministry review of risk February 1, Q2 assessments? 2008 What information is required when filing an RSC on a RA February 1, Q3 accepted prior to October 1, 2004? 2008 How can I view or obtain a copy of a risk assessment February 1, Q4 report? 2008 What information is required if a change in QP or February 1, RA Q5 property owner occurs AFTER a pre-submission form is 2008 submitted? Under O.Reg. 153/04, what can be done on a property February 1, Q6 currently undergoing a risk assessment, but before the 2008 RSC has been issued? What is the best way to communicate with MOE during the February 1, Q7 review process? 2008 This Q&A is updated from time to time. It is recommended that the latest version be downloaded from the Record of Site Condition web site found at http://www.ene.gov.on.ca/envision/land/decomm/condition.htm <return to FAQ Table of Contents> Guidance on the general risk assessment process is provided in the MOE publication “Procedures for the Use of Risk Assessment under Part XV.1 of the Environmental Protection Act” and is available at: http://www.ene.gov.on.ca/envision/gp/5404e.pdf Q1: What is the review timeline for risk assessments? A1: Under O.Reg. 153/04, the risk assessment review timeline will be 16 weeks unless: 1. You are submitting a limited scope risk assessment or an estimation of natural local background risk assessment: the review timeline is 8 weeks; 7 2. You are submitting a new science risk assessment or a wider area of abatement risk assessment: the review timeline is 22 weeks. Q2: Are there any fees for the ministry review of risk assessments? A2: There are no fees for the review of risk assessments or pre-submission forms. Q3: What information is required when filing an RSC on a RA accepted prior to October 1, 2004? A3: The following items are required by the MOE: 1. Copy of Regional Director’s Letter of Acceptance of the SSRA; 2. All the information from the first page of the PSF (property location information); 3. Information from the last two pages of the PSF (QP and property owner RA information); 4. State the applicable Site Condition Standards as assumed in the RA (i.e. the applicable table of Site Condition Standards); 5. Copy of the table of property specific standards as proposed in the SSRA and indication of where in the SSRA report this information can be found; 6. Proposed property use; and 7. Copy of Order or CPU that was issued by the District (if one was issued) Q4: How can I view or obtain a copy of a risk assessment report? A4: The following options exist: 1. Solicit a copy of the RA report from the property owner; 2. If a request to view a risk assessment report is made, MOE will contact the property owner to see if he/she agrees that it can be released. If the property owner agrees in writing, then the requestor can be allowed to view the risk assessment during business hours either in the MOE District Office or at Standards Development Branch; and, 3. Request a copy of the report through the FOI process. Q5: What information is required if a change in QP or property owner RA occurs AFTER a pre-submission form is submitted? A5: O.Reg. 153/04 states: Part 1 – Section 13 of Schedule C of the O.Reg. 153/04: If, at any time, after submitting the pre-submission form, a) the qualified person who is identified in the pre-submission form as being responsible for preparation of the risk assessment changes, or b) the owner mentioned who is identified in the pre-submission form changes; the 8 property owner shall give notice to the Director of the change in circumstance. The Director must be notified of any change in QP via submission of an RA appropriate letter from the property owner to the Director. In addition, Sections 1 and 8 through 11 of the PSF form must be completed (signed) and attached. The cover letter should include the appropriate MOE Reference Number (SDB file number and/or IDS reference number), or if not known, then it should include a completed Section 1 of the PSF form. All documents should be sent to the: The Director, Environmental Assessment and Approvals Branch, 2 St Clair Avenue West Toronto, ON M4V 1L5 Q6: Under O.Reg. 153/04, what can be done on a property currently undergoing a risk assessment, but before the RSC has been filed? A6: On-site work may include excavation and shoring in relation to development, the construction of retaining walls and remedial activities (for soil and groundwater). Where an RSC is required under the EPA, the building of structures may not begin before the RSC is filed for the property as a building permit is required and cannot be issued before the RSC is filed. Q7: What is the best way to communicate with MOE during the review process? A7: The best option is via email to the Risk Assessment Review Coordinator: [email protected] You can also submit questions in writing to: Risk Assessment Coordinator (Mark Turner) Standards Development Branch 40 St Clair Ave W, 7th floor Toronto, ON M4V 1M5 (416) 327-6949 9 Date of Last Q# D. CONDUCTING RISK ASSESSMENTS Update Is there written guidance available for conducting RAs February 1, Q1 under O.Reg. 153/04? 2008 How does one determine the human health effects of a February 1, Q2 chemical recognised as having both carcinogenic and non- 2008 carcinogenic systemic effects? Does MOE review radioactive chemicals during the RA February 1, Q3 process? 2008 When is a qualitative risk assessment February 1, Q4 appropriate/acceptable? 2008 Why does the ministry require the calculation of risk both February 1, Q5 without risk management measures and with risk 2008 management measures if these are proposed? Can alternative property specific standards be developed February 1, for the top 20 cm of the surface soil, given that most 2008 Q6 ecological VECs are only exposed to the top 10-20 cm of soil? This Q&A is updated from time to time. It is recommended that the latest version be downloaded from the Record of Site Condition web site found at http://www.ene.gov.on.ca/envision/land/decomm/condition.htm <return to FAQ Table of Contents> ________________________________________________________________ Q1: Is there written guidance available for conducting RAs under O.Reg. 153/04? A1: Yes. The ministry has published a document titled, “Procedures for the Use of Risk Assessment under Part XV.1 of the Environmental Protection Act”. It is available at: http://www.ene.gov.on.ca/envision/land/decomm/condition.htm Q2: If a chemical can elicit both non-threshold carcinogenic and non- carcinogenic toxic effects, and these effects are predicted to occur at approximately the same concentrations, how should the chemical be evaluated in the HHRA? A2: Risks should be characterized for both the cancer and non-cancer critical effects. If health-based concentrations are subsequently back-calculated 10