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4725eThe 1996 Ministry of the Environment (Ministry) “Guideline for Use at Contaminated Sites in Ontario” (as revised February 1997), (Guideline) and associated technical support documents, were created to provide property owners and their consultants with options and guidance for site restoration. One option provided was to conduct site-specific risk assessments (SSRA). SSRAs prepared in accordance with the Guideline underwent external peer review and were submitted to the Ministry for review. SSRAs, which were determined to have been conducted in accordance with the Guideline, were considered complete by the Ministry and the owners received acknowledgement from the Ministry.
Under the new Record of Site Condition Regulation (O. Reg. 153/04) (RSC Regulation), there are several clarifications and changes to the risk assessment process as originally described in the Guideline, including the requirements that site specific risk assessments (now simply called risk assessment or RAs) include the preparation and submission of a Pre-Submission Form (PSF) under the supervision of a qualified person (QP). This requirement will come into effect on October 1, 2004. Qualifications for the QP and the key people involved in conducting the risk assessment (referred to as the RA team) are set out in the RSC Regulation.
The RSC Regulation specifies the form and content of a RA for the development of site-specific standards to support the filing of a record of site condition (RSC). Other types of RAs (contaminated land or otherwise) are not bound by the RSC Regulation, unless it is specified in a legal instrument that they must meet the RA provisions of the RSC Regulation. If a RSC is required, the rules in the Regulation must be followed. Examples of those RAs that are not explicitly bound by the RSC Regulation (but may incorporate many of the requirements described in the RSC Regulation) include:
a) RAs which result from Ministry orders or other responses or directives by the Ministry to manage community or area-wide contamination issues,
b) RAs associated with the Nutrient Management Act or other Ministry or external processes identified as risk assessments.
Requirements for submission of a Pre-Submission form (PSF) are specified in the RSC Regulation in Section 3 of Schedule C. A form containing much of the information required by the RSC Regulation has been approved by the Director and is available on the Ministry Brownfields website (www.ene.gov.on.ca/envision/land/decomm/brownfields.htm). The PSF must be accompanied by a site plan and conceptual site model diagrams as described in the RSC regulation. Guidance for completion of the form is provided in the table below.
Once complete the PSF form and supporting attachments are to be submitted to the Environmental Assessment and Approvals Branch at the address at the top of the application form. Submissions to other Ministry offices will be returned to the QP with a request to submit to the proper office.
RAs will NOT be accepted for review before the PSF submission/comment process has been completed (i.e. RAs will not be accepted as complete by the Ministry until a PSF has been submitted, reviewed, and a Ministry response sent to the proponent). The Ministry response and how Ministry concerns, if any, were addressed must be attached to the RA submission in order for it to be considered complete as stated in Schedule C, Part 1, Section 4, Subsection 6 of the RSC Regulation.
A PSF is required as part of any RA submitted after October 1, 2004 that supports filing of a RSC. Submission of a PSF is not required if a RA is not being conducted to support the filing of an RSC. Transition-related provisions are specified in sections 44 and 45 of the RSC Regulation. Additional guidance related to transitioning to the new RA requirements can be found in the Ministry Technical Update entitled: Risk Assessment: Transition Process from the “Guideline for Use at Contaminated Sites in Ontario” to the “Record of Site Condition Regulation”.
A PSF should be prepared following a review of site history and environmental site assessment information, interpretation of soil and hydrogeological information and formulation of the conceptual site model. The PSF indicates the scope of the risk assessment, which the QP intends to undertake. Also included is the scope of the data to be relied upon, a description of transport and exposure pathways which may be relevant to the site, the potential receptors to be included in the assessment, and types of toxicological information that is being considered.
The PSF also establishes for the Ministry the site location and contact information for the property owner with whom the Ministry will correspond and the Qualified Person who has been authorized by the property owner to conduct or supervise the risk assessment. The PSF provides the opportunity for the Qualified Person to self-declare to the Ministry that they meet the qualifications under the RSC regulation and to provide evidence to support their declaration.
The Ministry will review the PSF and may provide views to the property owner regarding;
As a result of the Ministry review, the property owner may choose to revise the planned risk assessment approach. The views provided by the Ministry are not binding on either party, as the understanding of site conditions may develop and change during the course of the risk assessment. Any changes to the risk assessment approach are to be recorded by the proponent at the time of submitting the risk assessment report.
The PSF is comprised of a completed form and attached drawings. Drawings that support and elaborate on the content of the form are to include a scale site plan, one or more cross-sections of the property and other line drawings, including pictures, line art, flow diagrams, text and tabulated data at the discretion of the proponent and QP.
The goal of the drawings is to provide a three dimensional illustration of the subsurface hydrogeological conditions, contaminant sources, extent of contamination, transport pathways, receptors and routes of exposure which, together, comprise a preliminary conceptual site model. The soil layers and groundwater units identified on the PSF should be clearly identified in the drawing(s). Combined with the information provided in the form, the drawings are intended to convey to the Ministry the risk assessment team’s current understanding of the types and location of hazards, potential exposure pathways and barriers within pathways, and the type and location of potential receptors consistent with the proposed land use. Sufficient site information data should be provided to determine if there is adequate knowledge of the site on which to base a risk assessment consistent with the illustrated conceptual site model and the planned risk assessment approach.
While not legally required, it is suggested that a location map showing the property in context to the local neighbourhood and adjacent land uses be included.
The proponent should include with the PSF any additional supporting information, which may not be site-specific and, which they believe provides additional information to support the proposed risk assessment as well as any plans for the collection of additional information. This may include a discussion of the issues outlined below.
In developing and illustrating a conceptual site model, the qualified person should consider;
If a risk assessment is to be submitted to support a naturally elevated background concentration as a property specific standard, the requirements of a PSF relating to human and ecological receptors and exposure pathways do not apply. In these cases, the site plan and cross sections of the property are intended to convey the rationale for attributing elevated concentrations to natural geological features and to support and describe the planned sampling program to meet Schedule C subsections 8(4) to (9)
The proponent may also include in the PSF any toxicological information relating to potential adverse human health effects and surrogate ecological test species, if these have been considered at the time of submitting the PSF, on which the proponent wishes to seek Ministry comment.
The proponent may attach other documents which they believe support the risk assessment approach. This would include any documentation which supports deviation from best practice or regulatory requirements, if any are contemplated at the time of PSF submission, for consideration by the Director. They would also include plans for additional data collection, if any are contemplated at the time of PSF submission.
If a public communication plan has been developed at the time of the PSF submission, this may be attached for the Ministry comment.
If the QP (for risk assessment) has not previously self declared their qualifications to the Ministry, the PSF will have attached the resume, work references and post-secondary transcripts that support the QP declaration. If a QP has previously self declared, they are not required to attach supporting documentation to subsequent PSFs.
The PSF can be obtained from the Ministry Brownfields website. (http://www.ene.gov.on.ca/envision/land/decomm/brownfields.htm) To facilitate completion of the PSF, guidance relating to each section is provided below, together with an explanation of the goal the information in each section is intended to achieve.
The RSC Regulation should be consulted for all specific requirements that must be met.
| Component | Summary of Requirements | Goal/Rationale |
|---|---|---|
General Information and Instructions |
Answer “yes”, a previous PSF has been filed for the property, if the most recent risk assessment previously submitted for this property was not accepted by the Director (through a notice under EPA 168.5 (1) (b)). Identify the previous PSF/RA reference number. Answer “no” if
Answer “yes”, it is intended to file a Record of Site Condition
for this property, if comment is to be provided by Ministry
based on the requirements of the RSC Regulation. |
Provide for |
Section 1: Property Information |
The field titled, Ministry District Office Name, requires the name of the Ministry District office (e.g. Toronto District) which is responsible for the district in which the site is located. To identify the appropriate Ministry District Office go to: http://www.ene.gov.on.ca/envision/org/op.htm#Reg/Dist For properties which do not have a street address, the Alternate Site Identifier/Locators field is provided. This field provides the opportunity to provide additional information (e.g. Legal Description of Property) to help identify the site location. The Geo reference field requires data suitable for locating
a property in a GIS system in a manner consistent with the ESR
for RSC filing. All Geo Reference data collected and presented
in the PSF should correspond to the centroid of the site. |
To identify the location and local Ministry District Office responsible for the site to which the RA and PSF corresponds. The Ministry District Office will be the contact for determining
whether the site falls within an Area of Wider Abatement and
for any third party consultation. |
Section 2: Planned Risk Assessment Approach |
The Planned Risk Assessment Approach indicates the type of RA approach which corresponds to the appropriate risk assessment review timeline according to O. Reg 153/04 Schedule C. One of the five approach boxes must be checked in order for the PSF to be considered complete. For the Limited Scope or the Use of Toxicity Data or Models approach, ensure that the underlying approach which is the reason for this type of approach is also indicated by checking the adjacent yes/no boxes. If using a proprietary model, the name of the model should be provided in the available field. If more than one of the alternative approaches, including underlying approaches, listed in the Planned Risk Assessment Approach section are to be used, the Additional Risk Assessment Approaches portion of Section 2 provides the ability to identify all approach(s) used, including the one which will determine the review timeline. The risk assessment approach which is associated with the longest review timeline will be the approach which determines the timeline for the review. If computer models will be used in the conduct of the risk assessment, a list should be provided. The Comment on method field allows for open comments / explanation
which the proponent may want to provide on the planned approach.
|
To identify and justify the planned RA approach and associated timelines for review. To allow the Ministry to identify if any proprietary models
will require detailed documentation and review. |
Section 3: Site Information |
Site Land Use Information requires information about the historical, present and proposed land use for the property. Land use types are listed which are described in O. Reg 153/04 and refer to actual human activities on the property, rather than zoning. Please indicate all types (e.g. agricultural) of land use known to be associated with the historical use of the property. If the present and/or proposed land use includes several types of land use activity, indicate all that apply. If the land use is unknown, please check the Not Determined box. If the proposed land use is not known or specified, a Residential land use should be used in the risk assessment. The Adjacent Land Use Information requires one to indicate the types of land uses for properties which are hydraulically downgradient / upgradient of surface water runoff/ground water flow. The All Other Adjacent Properties column corresponds to properties which are not directly up-gradient or down-gradient (i.e. may be cross gradient) of either groundwater or surface water flow through the site property. Comment fields are to be used to provide more specific information
relevant to sources of contamination, such as types of industrial
processes, chemicals stored or used, wastes produced, presence
of contaminant plumes, other contaminant distribution processes
such as air dispersion. |
To identify past and present land uses which are indicative of the type and extent of contaminating activities at the site. These in turn support the sampling effort, subsequent contaminant inventories and conceptual site model. To identify proposed future land uses which are indicative
of the type of receptors which may come in contact with contaminants
and must be included in the risk assessment conceptual site
model. |
Section 3: Site Information |
The Additional Project Information requires general characterization data for the property relating to water supply, ecological sensitivity, contaminant sources and remediation activities and the extent to which the Phase 1 and Phase 2 Environmental Site Assessments support the data requirements of the risk assessment. Some or all of the required information may be available at the time of PSF submission. Where the information is not available or not applicable it should be identified as such on the form. Consideration should be given by the QP as to whether additional information is required prior to finalizing the Conceptual Site Model for the risk assessment. Soil layers and groundwater units identified in the PSF should be clearly identified on the drawings. The Sampling Summary requires a summary of which media has
been sampled during Phase 2 ESA activities. The opportunity
is provided to record sampling of media which are not specific
requirements of a Phase 2 ESA (e.g. soil vapour) but which may
support the assumptions of a risk assessment. The year of the
most recent sample collection must also be stated. Note: Data
older than 2 years should be confirmed with more recent sampling
to support the assumptions of a risk assessment. |
To give an indication of the vulnerability of water supply in the area and its suitability for non-potable assumptions. To give an indication of the vulnerability of surface water and sensitive ecosystems in the area. To identify the assessment and remediation status of the property
at the time of risk assessment problem formulation. |
Section 3: Site Information |
The Contaminant Inventories require more detailed information on the sampling data collected at the time of the PSF submission. Information is requested for all media identified in the Sampling Summary, including as appropriate: the Surficial Soil Layer, Soil Layers Below the Surface, Groundwater, Sediment, Soil Vapour, Indoor Air, Outdoor Air, Surface Water and any Other media sampled The Surficial Soil Layer and Soil Layers Below the Surface may be defined by the QP at depths relevant to the Conceptual Site Model for the property. The QP is not constrained by the Ministry generic model (1.5m surface soil). The Surficial Soil Layer typically refers to the soil layer corresponding to direct contact with relevant human and ecological receptors. Soil Layers Below the Surface may relate to indirect exposure pathways or soil horizons or a combination of these, as required, to describe the Conceptual Site Model. If more than one Soil Layer Below the Surface is to be described, page 5 is to be copied and identified as pages 5a, 5b etc… as required for the number of soil strata. Also indicate the physical / chemical characteristics of each layer (i.e.: soil texture, pH). Similar options are provided to describe one or more water bearing units in the Ground Water / Aquifer Information. Also indicate what is known of the physical description of each water bearing unit. The depth of concern at a site typically extends to the (full delineation) depth of contamination. The QP is required to determine which of the contaminants identified in the Phase 1 and Phase 2 ESAs are of potential concern and which should be included in the risk assessment. The QP has discretion in determining if a contaminant is of potential concern by considering:
For the Surficial Soil Layer, Soil Layers Below the Surface, and Groundwater, Sediment Soil Vapour, Indoor Air, Outdoor Air, Surface Water and any Other media the Contaminant Inventory is to include:
And for each COC
For the Surficial Soil Layer, Soil Layers Below the Surface, Groundwater and Sediment, please also indicate whether a Ministry standard currently exists for the COC in that media and which, if any, standard in the appropriate background, full depth potable or full depth non-potable standards table was met by the maximum concentration. For the Soil Vapour, Indoor Air, Outdoor Air, Surface Water
and any Other media sampled, please indicate the Sampling Method
and Analytical Method used, the Minimum Detection Limit and
its Unit of Measure. |
To identify the Contaminants of potential Concern in specific media, assess evidence of transport within and between media and evidence of contamination within exposure pathways, contributing to development of a Conceptual Site Model. Meeting or exceeding Ministry Site Condition Standards in a specific media may indicate if that media is contaminated and may support certain risk assessment and/or site remediation approaches. Media for which there are no published standards or analytical
methods may be described according to the procedures used and
method detection limits obtained. These will indicate the usability
of the results in an assessment of risk. |
Section 3: Site Information |
The Laboratory Information requires the Laboratory Name, Laboratory Address, and Laboratory Contact Information. Please attach additional pages if more than one laboratory was used and number as 10a, 10b etc. Please indicate the media tested by each laboratory used. Laboratories should have accreditation in accordance with O. Reg. 153/04 for the contaminant and media which they analyse. Analyses should be done according to the methods documented in “Protocol for Analytical Methods Used in the Assessment of Properties under Part XV.1 of the Environmental Protection Act”. |
Identify a contact for any queries which may be made regarding analytical methods or data quality and confirmation of accreditation. |
Section 4: Human Health Conceptual Site Model – Exposure Pathways |
Section 4 requires an indication of which receptors are applicable based on the proposed land use, including a choice of;
For each land use which may involve residential use of the site, a distinction is to be made between Adult and Child (less than 18 years) receptors. For each land use which may involve occupational use of the site, receptors are to be distinguished according to the type of activities they would engage in. Construction/Remediation Workers would be engaged in media- intrusive activities resulting in potentially high levels of exposure with limited duration. Repetitive Short-term Workers would be engaged in short duration exposures but repeated over a working lifetime. Long-term Workers would be exposed in a typical occupational setting (for example an 8-12 hour day) over working lifetime Receptors which may visit a property periodically as site visitors are to be distinguished according to the level of knowledge and control of the visit available to the site owner. Recreational Visitors are those for which access to the site is planned and accounted for in site design. Trespassers are those who may access the site without permission or knowledge of the site owner. Other receptors may include those with unusual exposure conditions, for example inhabitants or visitors using the site for subsistence agriculture, hunting or fishing. For each applicable receptor, identify all potential on-site and off-site exposure pathways (e.g. soil ingestion) based on the characteristics and anticipated activities of that receptor and the expected mobility of the potential COCs under the geological conditions present at the site. For each receptor and exposure pathway, please indicate further if a man-made barrier or measure to interrupt this pathway is present or anticipated. Any exposure pathways which can be anticipated based on chemical
properties and site geology should be included in the risk assessment.
Elimination of these pathways from assessment will require justification
in the form of pathway-specific site assessment evidence. Pathways
which can be anticipated but which will be mitigated by a barrier
or other measure should be included as risk management measures
in the development of property-specific criteria. |
To identify the relevant potential human receptors at the site for the land use proposed in Section 2. To identify potential exposure pathways for those receptors based on physical/chemical characteristics of the COCs and geological characteristics of the site as identified in Section 3. To clearly distinguish between pathways which are naturally
incomplete and those which may be rendered incomplete through
risk management measures. |
Section 4: Human Health Site Model – Toxicological Information |
For each of the COCs identified in Section 3, list the toxicological information that is being considered to evaluate potential human health effects including information on toxicological end points (i.e. developmental/ reproductive) and time scale of effects (i.e. acute/ chronic) , which are considered relevant for the pathways and receptors identified in the tables above. Relevant supporting information may be provided in a free form list or grouped in a table. |
Indicate the planned approach and the types of toxicological data being considered for the human health toxicological assessment |
Section 5: Ecological Conceptual Site Model – Valued Ecosystem Components |
Section 5 requires an identification of which ecological receptors are applicable based on local habitat types, including terrestrial and/or aquatic habitats (e.g. Deciduous Forest, Wetlands) present on-site and off-site. List any endangered or threatened species on-site or off-site (including common and species name). The area (distance) characterized by ‘off-site’ should be based on the species range area. Considering the habitats present and based on observations both on and off site, identify species representing Valued Ecological Components (VECS) including the terrestrial and aquatic species to be studied and list them in the appropriate classification field (for example, Terrestrial VECS - Mammals). On and off-site VEC species are to be listed together. Off-site VECS are to be considered if their range area is within an area of potential contaminant impact. If a classification field is not applicable both on and off-site, based on the habitats present, indicate this with N/A. If surrogate species are to be used in the study of the VECS, these may be listed together with the VEC species they are to represent for Ministry comment. It should be clearly stated which species are surrogates and which ones are VECS |
Broadly describe the local environment, including any vulnerable species and species selected for study as representing specific values to be protected. |
Section 5: Ecological Conceptual Site Model – Exposure
Pathways |
In the Terrestrial Ecological Pathways and Aquatic Ecological Pathways identify the potential on-site and off-site exposure pathways for both animals and vegetation (e.g. dermal contact, root uptake of soil), if present, based on the characteristics and anticipated activities of those receptors and the expected mobility of the potential COCs under the geological conditions present at the site. Pathways should be identified which cover potential exposure for all identified VECS combined within the categories, for example the exposure pathways of all terrestrial animals would be identified together. On site exposure is specified separately from off site exposure, however. For each receptor and exposure pathway, please indicate if a man made barrier or other measure(s) to interrupt this pathway is present or anticipated. Any exposure pathways which can be anticipated based on chemical
properties and site geology should be included in the risk assessment.
Elimination of these pathways from assessment will require justification
in the form of pathway-specific site assessment evidence. Pathways
which can be anticipated but which will be mitigated by a barrier
or other measure should be included as risk management measures
in the development of property-specific criteria. |
To identify the potential exposure pathways for on site and off site ecological receptors based on physical/chemical characteristics of the COCs identified in Section 3 and geological characteristics of the site identified in Section 3. To clearly distinguish between pathways which are naturally
incomplete and those which may be rendered incomplete through
risk management measures. |
Section 6: Risk Assessment Team |
Section 6 requires a listing and business contact information for the risk assessment team leads covering the four key risk assessment disciplines and other disciplines at the discretion of the QP. An individual may be team lead for more than one discipline. Team leads may be affiliated with the same firm as the QP or with other firms. |
To demonstrate that all risk assessment disciplines have been considered and that a multi-disciplinary team has been identified with clear responsibility assigned for each discipline area. Identify contacts for any queries which may be made regarding
specific risk assessment disciplines. |
Section 6: |
Provide a listing of any additional documents provided in support of the PSF. These documents could include, but are not limited to the following:
Please provide a brief description of the document including the name, number of copies to be provided (Note: any additional documents which are provided should come with a total of six copies), the delivery method, whether an electronic version is attached and provided and if so the directory/file name for the document.
|
To provide a check list of additional supporting documentation supplied with the PSF. To confirm that the complete submission of the PSF has been
received by the Ministry. |
Section 7: Public Communication |
Section 7 requires an indication of whether there will be public communication and if the Ministry District office has been notified. Note: If the risk assessment is within a Wider Area of Abatement
public communication is required. If the groundwater is considered
to be non-potable, the municipality must be notified. |
To confirm that the public, District and municipality is involved appropriately. |
Section 8: Business Contact Information – Qualified Person |
Section 8 requires the QP (for Risk Assessment) to complete his/her contact and employer information. |
For follow-up communication if necessary. |
Section 9: Statement of Qualified Person |
Section 9 requires the QP to make a statement regarding the authenticity of the information provided within the PSF and to self declare that they meet the qualifications of a Qualified Person as set out in O. Reg. 153/04 for the purpose of preparing a PSF and undertaking the supervision of a RA. The QP must indicate via the boxes that all required documents have been attached and submitted. The attachment documents are not required if they were previously submitted to the Ministry. This is indicated by ticking the appropriate box. The QP is also required to declare that they have no financial interest in the outcome of the risk assessment or the redevelopment of the property. Please ensure this section is signed and dated. |
To declare Qualified Person status and affirm the integrity of the information provided. To provide a check list of documentation supplied with the PSF to support the QP declaration. To confirm that the complete submission of the PSF has been
received by the Ministry |
Section 10: Property Owner Information |
Section 10 requires the Property Owner to complete his/her business and contact information. |
For follow-up communication if necessary. |
Section 11: Statement of Property Owner |
Section 11 requires the property owner to make a statement that the information submitted in the PSF is complete and accurate and that the Qualified Person identified in Section 8 is authorized to act on the property owner’s behalf for the purpose of preparing the PSF and supervising the RA. Please ensure this section is signed and dated. |
To affirm the authorization of the QP to act on the owner’s behalf and to affirm the integrity of the information provided. |
If there are questions or need for further clarification, please
make your enquiries to:
Mark Turner
Ontario Ministry of the Environment,
Standards Development Branch,
40 St. Clair Ave West, 2nd floor
Toronto, Ontario M4V 1M2
Tele: 416-327-6949 Main Fax: 416-327-2936
If you are having difficulty accessing a document, please contact the Ministry of the Environment at picemail@ene.gov.on.ca or phone the ministry's Public Information Centre at 1- 800-565-4923, in Toronto 416-325-4000 or by mail to the Ministry of the Environment, Public Information Centre, 135 St. Clair Ave. West, 1st Floor, Toronto, ON. M4V 1P5.
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