Syntro Health Richmond - Amenity Assessment Swan Street Syntro Pty Ltd 23 July 2021 - Yarra City Council
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Syntro Health Richmond Amenity Assessment Swan Street Syntro Pty Ltd 23 July 2021 The Power of Commitment
GHD Pty Ltd | ABN 39 008 488 373 180 Lonsdale Street, Level 9 Melbourne, Victoria 3000, Australia T +61 3 8687 8000 | F +61 3 8732 7046 | E melmail@ghd.com | ghd.com Printed date 23/07/2021 12:24:00 PM Last saved date 23 July 2021 File name https://projectsportal.ghd.com/sites/pp17_05/syntrohealthamenitya/ProjectDocs/12553343- REP_Syntro Health Amenity Assessment Report.docx Author Sophie Materia Project manager Sophie Materia Client name Swan Street Syntro Pty Ltd Project name Syntro Health Amenity Assessment Richmond Document title Syntro Health Richmond | Amenity Assessment Revision version 0 Project number 12553343 Document status Status Revision Author Reviewer Approved for issue Code Name Signature Name Signature Date S3 Draft A 20/07/2021 S4 0 Sophie Materia M Asimakis E Smith 23/07/2021 © GHD 2021 This document is and shall remain the property of GHD. The document may only be used for the purpose for which it was commissioned and in accordance with the Terms of Engagement for the commission. Unauthorised use of this document in any form whatsoever is prohibited. The Power of Commitment
Executive summary GHD Pty Ltd (GHD) has been engaged by Swan Street Syntro Pty Ltd (Swan Street Syntro) care of Ratio Consultants to undertake an Odour and Dust Amenity Assessment for 558-562 Swan Street, Richmond (herein after ‘the subject site’). The Amenity Assessment will form part of a Planning Permit Application for the proposed pharmaceutical manufacturing use of the subject site. The assessment has been conducted in accordance with Clause 53.10, EPA Publication 1518 and EPA Publication 1961 (Level 1 assessment). The assessment concludes that: – There is no threshold or separation distance applicable to the subject site outlined in Clause 53.10 or EPA Publication 1518. – The emission rates are so low they can be considered negligible. – The air quality risk associated with the subject site and receiving environment is also considered to be negligible and managed in accordance with the GED. It follows that the nature of the activities proposed, materials used, and site context are such that the proposal is unlikely to have any unacceptable impacts on the amenity of the area. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond i
Contents Executive summary i 1. Introduction 1 1.1 Overview 1 1.2 Purpose of this report 1 1.3 Scope and limitations 1 1.4 Scope of works 2 1.5 Assumptions 2 2. Site overview 3 2.1 Site location and land use 3 2.2 Sensitive receptors 3 2.3 Site operations 6 2.4 Proposed layout 6 2.5 Potential sources of odour and dust 6 3. Relevant guidelines 7 3.1 Threshold / separation distances 7 3.1.1 Clause 53.10 7 3.1.2 EPA Victoria Publication 1518 Recommended Separation Distances for Industrial Residual Air Emissions (2013) 7 3.2 EPA Victoria Publication 1961 Guideline for assessing and minimising air pollution in Victoria (2021) 8 4. Threshold / separation distance assessment 9 4.1 Clause 53.10 9 4.2 EPA Publication 1518 9 4.3 Application to the site 9 5. EPA Publication 1961 10 5.1 Description of emission sources 10 5.2 Receiving environment 10 5.2.1 Size and vulnerability of nearby population 10 5.2.2 Meteorology 11 5.2.3 Background air quality 12 5.2.4 Topography 12 5.3 Proposed risk controls and checks 12 5.3.1 Risk controls 12 5.3.2 Checks 13 5.4 Rationale 13 6. Conclusions 14 Table index Table 1 List of chemicals to be used the subject site 6 Table 2 Frequency of wind directions 12 GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond ii
Figure index Figure 1 Site location 4 Figure 2 Identified sensitive receptors 5 Figure 3 Melbourne (Olympic Park) 2019 annual wind rose 11 GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond iii
1. Introduction 1.1 Overview GHD Pty Ltd (GHD) has been engaged by Swan Street Syntro Pty Ltd (Swan Street Syntro) care of Ratio Consultants to undertake an Odour and Dust Amenity Assessment for 558-562 Swan Street, Richmond (herein after ‘the subject site’). The Amenity Assessment will form part of a Planning Permit Application for the proposed pharmaceutical manufacturing use of the subject site. This Odour and Dust Amenity assessment investigates if a separation distance is applicable to the subject site and provides a qualitative odour and dust risk assessment, taking into consideration the proposed operations, control measures and locations of sensitive receptors respective to the subject site. 1.2 Purpose of this report The purpose of this report is to assess potential odour and dust impacts from the proposed pharmaceutical manufacturing activities, through an odour and dust amenity assessment, to form part of the Planning Permit Application. The findings, conclusions and recommendations of this assessment should be read in conjunction with the limitations presented in section 1.3. 1.3 Scope and limitations This report: has been prepared by GHD for Swan Street Syntro Pty Ltd and may only be used and relied on by Swan Street Syntro Pty Ltd for the purpose agreed between GHD and Swan Street Syntro Pty Ltd as set out in section 1.2 of this report. GHD otherwise disclaims responsibility to any person other than Swan Street Syntro Pty Ltd arising in connection with this report. GHD also excludes implied warranties and conditions, to the extent legally permissible. The services undertaken by GHD in connection with preparing this report were limited to those specifically detailed in the report and are subject to the scope limitations set out in the report. The opinions, conclusions and any recommendations in this report are based on conditions encountered and information reviewed at the date of preparation of the report. GHD has no responsibility or obligation to update this report to account for events or changes occurring subsequent to the date that the report was prepared. The opinions, conclusions and any recommendations in this report are based on assumptions made by GHD described in this report (refer section 1.5 of this report). GHD disclaims liability arising from any of the assumptions being incorrect. GHD has prepared this report on the basis of information provided by Swan Street Syntro Pty Ltd and others who provided information to GHD (including Government authorities), which GHD has not independently verified or checked beyond the agreed scope of work. GHD does not accept liability in connection with such unverified information, including errors and omissions in the report which were caused by errors or omissions in that information. If the GHD document containing the disclaimer is to be included in another document, the entirety of GHD’s report must be used (including the disclaimers contained herein), as opposed to reproductions or inclusions solely of sections of GHD’s report. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 1
1.4 Scope of works The scope of works for this assessment included the following: – Request and review of information – Separation distance assessment – Qualitative odour and dust risk assessment – Reporting 1.5 Assumptions The following assumptions were used in this report: – All information provided is correct and representative of proposed operations at the subject site – The local meteorological data from BoM Melbourne (Olympic Park) AWS is representative of the subject site GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 2
2. Site overview 2.1 Site location and land use The subject site is located at 558-562 Swan Street, Richmond, Victoria. An aerial image of the subject site is shown in Figure 1. The subject site and surrounding area are currently zoned Commercial 2. To the south of the site is the Burnley railway corridor (zoned Public Use Zone 4) and to the north of the land is Swan Street which is Road Zone 1. 2.2 Sensitive receptors The definition of a sensitive receptor or sensitive land use is defined by the EPA1 (2013, p. 17) as: ‘any land uses which require a particular focus on protecting the beneficial uses of the air environment relating to human health and well-being, local amenity and aesthetic enjoyment, for example residential premises, child care centres, pre-schools, primary schools, education centres or informal outdoor recreation sites’. It is further defined in EPA Publication 1961 (2021, p. 8) as: 2 “A land use where is it plausible for humans to be exposed over durations greater than 24 hours, such as residential premises, education and childcare facilities, nursing homes, retirement villages, hospitals.” A number of sensitive land uses were identified surrounding the subject site, as follows: – West of the subject site (directly adjacent to subject site): Green Leaves Early Learning Centre – North, northwest and northeast of the subject site (approximately 20 m from subject site): Residential housing along Swan Street – South of the subject site (approximately 70 m from subject site): Residential housing along Madden Grove (located south of the Burnley railway corridor) The identified sensitive uses are shown in Figure 2. 1 EPAV 2013 “Recommended separation distances for industrial residual air emissions” Publication. 1518, March 2013 2 The definition provided in the Consultation Draft version of EPA Publication 1961 may change in the final revision of the guideline, however any changes are not expected to affect the outcomes of this assessment. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 3
Document Path: \\ghdnet\ghd\AU\Melbourne\Projects\31\12553343\GIS\Maps\Working\12553343-QGIS-Working.qgz Data Source: Google Earth Imagery 2021. Print Date: 19/07/2021 Created By: smateria ©2021. While GHD has taken care to ensure the accuracy of this product, GHD and DATA CUSTODIAN(S), make no representations or warranties about its accuracy, completeness or suitability for any particular purpose. GHD and DATA CUSTODIAN(S) cannot accept liability of any kind (whether in contract, tort or otherwise) for any expenses, losses, damages and/or costs (including indirect or consequential damage) which are or may be incurred as a result of the product being inaccurate, incomplete or unsuitable in any way and for any reason.
Document Path: \\ghdnet\ghd\AU\Melbourne\Projects\31\12553343\GIS\Maps\Working\12553343-QGIS-Working.qgz Data Source: Google Earth Imagery 2021. Print Date: 19/07/2021 Created By: smateria ©2021. While GHD has taken care to ensure the accuracy of this product, GHD and DATA CUSTODIAN(S), make no representations or warranties about its accuracy, completeness or suitability for any particular purpose. GHD and DATA CUSTODIAN(S) cannot accept liability of any kind (whether in contract, tort or otherwise) for any expenses, losses, damages and/or costs (including indirect or consequential damage) which are or may be incurred as a result of the product being inaccurate, incomplete or unsuitable in any way and for any reason.
2.3 Site operations Syntro Health is proposing to manufacture small scale batches of pharmaceutical products (for clinical trials approved by the Therapeutic Goods Administration) at the subject site, namely: – Placebo tablets (which contain no active ingredient), only excipients (e.g. microcrystalline cellulose) (approximately 50,000 tablets per day (approximately 50 kg), occurring once per week) – Small solutions for oral and topical use (not sterile) (maximum batch size 50L) – Over encapsulation of commercial tablets and capsules in order to blind for clinical trials The products will include prescription drugs but no high potent products (such as cytotoxics, steroids). Operations will involve the pressing of tablets from a commercial granulated blend (Prosolv Easytab), the packaging of tablets into bottles/blister packs, and the labelling of cartons/bottles. There will be no chemical production occurring at the subject site. Most equipment will be small-scale (benchtop) and will include an overhead stirrer for up to 50 L of solution, a homogenizer (15 kg batch), water baths, induction sealers, tablet counters, analytical scales, and a fumehood for manufacture of pH adjusting solutions (100 mL). The largest piece of equipment will be a 10 station tablet press, which will be used to punch placebo tablets, likely operating one day per week. This will be located in the IS08 room, which will be under negative pressure to the outside rooms. This room will be serviced with inbound HEPA filters and outbound F5 filters to remove particulates. The subject site will operate between 9:00 am to 5:00 pm, Monday to Friday, with daily pickups and deliveries of product occurring during these hours. Waste pharmaceutical materials will be bagged and collected weekly by an EPA certified waste disposal company (similar to a compounding pharmacy waste collection). Approximately 10 L of rise water will be discharged weekly. The proposed operations are comparable to that of a community pharmacy or GP clinic. 2.4 Proposed layout The proposed operations will be contained within a pre-existing commercial building and will include a manufacturing area, compounding pharmacy, wash, packing, and storage rooms. The tablet press is proposed to be located in the IS08 room, adjacent to two packaging rooms. 2.5 Potential sources of odour and dust The subject site has the potential to emit odour and dust emissions from the following sources: – Dust: • Tablet press – a pre-granulated mix is used (Prosolv Easytab). The mix is pre-granulated and has a high particle weight (i.e. not powder) and therefore not subject to aerosolization. – Odour: • The use of chemicals in the preparation of pharmaceuticals. This includes hydrochloric acid, sodium hydroxide for pH adjustment, water for injection, mixing and cleaning. A summary of the raw chemicals proposed to be used at the subject site and their associated odour detection thresholds3 are provided in Table 1. From Table 1 it can be seen that all of the chemicals are considered odourless, according to the Material Safety Data Sheets for each product. Table 1 List of chemicals to be used the subject site Product name Compounds Odour description Odour threshold (ppm) ProSolv SMCC 50/90 Silicified Microcrystalline Odourless N/A Cellulose (C6H10O5) 1N Hydrochloric Acid Hydrochloric Acid (HCl) Odourless N/A 1N Sodium Hydroxide Sodium Hydroxide (NaOH) Odourless N/A 3 The odour detection threshold is the lowest concentration of a certain odour compound that is perceivable by the human sense of smell. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 6
3. Relevant guidelines 3.1 Threshold / separation distances Two classes of threshold/separation distance guidelines are relevant in the context of planning in Victoria, as follows: – Clause 53.10: Where there is an industrial use proposed on a land parcel, then the particular provisions of Clause 53.10 apply for specified uses with adverse amenity potential. If the threshold distance is not to be met or no threshold distance is specified for a use in the table then the proposed industry must be referred to the Environment Protection Authority under Section 55 of the Act. – EPA Victoria’s Recommended Separation Distances for Industrial Residual Guidelines (Publication 1518, 2013): Referred to for existing industries and when the above outlined condition is met. 3.1.1 Clause 53.10 The Planning Policy framework seeks to ensure that planning resolves and does not create land use conflicts. This is typically acheived by providing separation distances between potentially conflicting land use zones that may result in incompatable uses. Clause 53.10 of the Victorian Planning Provisions (VPPs) seeks to define those types of industries and warehouses, which if not appropriately designed and located, may cause offence or unacceptable risk to the neighbourhood. The clause sets out the threshold distance that is the minimum distance from any part of the land of the proposed use of or buildings and works for specified uses that have adverse amenity potential. The table to the Clause 53.10 includes three columns that refer to the type of production or use or storage (purpose), which may result in adverse amenity potential and includes the threshold distance in metres and notes: – Note 1 is where the threshold distance is variable, dependent on the process to be used and the materials to be processed or stored. – Note 2 is where an assessment of risk to the safety of people located off the land may be required. Clause 53.10 does not itself trigger the need to obtain a permit, however Clause 66.02 – 7 (use and development referrals) requires that an application is referred to the EPA as the determining referral authority, if the proposal is to use land for an industry or warehouse for a purpose listed in the table to Clause 53.10 shown with a Note 1, or if the threshold distance is not met. 3.1.2 EPA Victoria Publication 1518 Recommended Separation Distances for Industrial Residual Air Emissions (2013) In the case of an existing industrial use, the EPA recommends buffer distances should be considered when preparing a planning scheme, planning scheme amendment or planning permit application. A buffer distance is a planning instrument used to provide separation of sensitive land uses (i.e. residential, schools, hospitals) from existing premises with the potential for off-site emissions (odour or dust) that can cause disamenity in the event of an upset or malfunction. Under routine operations, any adverse impact is to be confined on-site so that an external buffer should not be required. The purpose of EPA Publication 1518 (the EPA buffer guideline) is to provide recommended minimum separation distances between odour or dust emitting industrial land uses and sensitive land uses. Accordingly, the relevant sections of the guideline for this assessment are to: – Provide clear direction on which land uses require separation – Inform and support strategic land use planning decisions – Prevent new sensitive land uses from impacting on existing industrial uses – Prevent new or expanded industrial land uses from impacting on existing sensitive land uses – Identify compatible land uses that can be established within a separation distance area GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 7
In the case of the subject site, the EPA buffer guideline will apply if the threshold distance is not to be met or no threshold distance is specified. 3.2 EPA Victoria Publication 1961 Guideline for assessing and minimising air pollution in Victoria (2021) As part of the new Victorian Environment Protection Act 2018 (EP Act), EPA Victoria has produced a new air quality guideline namely; Guideline for assessing and minimising air pollution in Victoria (EPA Publication 1961), which is currently in Consultation Draft form. The guideline is to be finalised by the end of 2021 and would likely be applicable when the facility is operational. This guideline forms part of Victoria’s environmental protection framework that establishes the state of knowledge to protect the environmental values of the ambient air environment. The guideline describes the General Environmental Duty (GED) which requires anyone engaging in any activity that may give rise to risks of harm to human health or the environment from pollution or waste to minimise those risks, so far as reasonably practicable. As such, emitters of pollution to air have a responsibility to put in proportionate controls to eliminate or minimise risks to human health or the environment. Being proportionate and preventative requires duty holders to: – Understand their risks – Actively seek out ways to eliminate or minimise these risks, so far as reasonably practicable – Ensure any risks remaining after the implementation of all controls are within acceptable limits The purpose of the guideline is to provide a framework to assess and control risks associated with air pollution. The guideline outlines a risk management approach that involves a repeating cycle of four steps, namely: 1. Identifying hazards This involves identifying, and if necessary, quantifying emission sources. This also involves characterising the receiving environment including local topography, meteorology, background air quality and nearby sensitive land uses. 2. Assessing risks A three-tiered approach to the assessment of risks from air pollution is outlined, namely: – Level 1 assessment: qualitative or semiquantitative assessment, used to assess risks from activities that either have intrinsically low risks, or have common, well-understood risks that can be controlled without extensive assessment. – Level 2 assessment: involve the use of dispersion modelling or monitoring with predicted concentrations benchmarked against air quality assessment criteria (AQAC). – Level 3 assessment: detailed risk assessment, used when a simple comparison of a pollutants concentration to an AQAC cannot adequately assess risks. 3. Implementing controls Emitters should demonstrate how existing or proposed risk controls minimise risks so far as reasonably practicable. 4. Checking controls To evaluate performance, emitters should have clearly documented environmental performance objectives that can be monitored and reported on. GHD has used the risk assessment approach outlined in EPA Publication 1961 to inform the air quality assessment. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 8
4. Threshold / separation distance assessment 4.1 Clause 53.10 The closest category applicable to the subject site outlined in Clause 53.10 is “pharmaceutical and veterinary chemical production” which requires a threshold distance of 1,000 m. GHD notes that the proposed operations at the site will be similar to a community pharmacy (i.e. producing pharmaceutical products from pre-made materials). The category in Clause 53.10 likely refers to large-scale industrial pharmaceutical production which would consist of milling, granulation and hot melt extrusion. It also is likely to refer to facilities that manufacture the chemicals used in pharmaceutical product production. As none of these activities will be occurring at the subject site, this threshold distance is not considered applicable. 4.2 EPA Publication 1518 Similar to Clause 53.10, the closest category in EPA Publication 1518 is “pharmaceutical and veterinary product production” which requires a separation distance of 500 m for throughputs greater than 2,000 tonnes per year. Similar to the category outlined in Clause 53.10, this category likely refers to large-scale industrial pharmaceutical production, whereas the proposed operations at the site will be similar to a community pharmacy. Further, the throughput at the subject site will not exceed 2,000 tonnes per year (50 kg of Prosolv Easytab per week is equivalent to 2.6 tonnes per year) and therefore even if this category were applicable to the subject site, no separation distance would be required. 4.3 Application to the site Based on the above findings, there is no threshold or separation distance applicable to the subject site. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 9
5. EPA Publication 1961 Section 5 of EPA Publication 1961 Guideline for assessing and minimising air pollution in Victoria states that when determining the level of assessment required for an assessment, the first step involves identifying if the emissions meet the guiding principles outlined in Section 5.2 of the guideline. The guiding principles include: 1. Routine activities that have controls that are known to be effective (such as concrete batching plants). 2. Mass emission rates that are so low they can be considered negligible. As a general rule, emission sources that are not required to report to the NPI can often be considered to pose a negligible inherent risk. 3. Fugitive emissions that are difficult to assess accurately, including earth-moving activities and construction activities. If it is determined that a Level 1 assessment is sufficient to inform the implementation of appropriate risk controls, then the following must be provided: – A description of the emission sources in line with identifying hazards in Publication 1961 (provided in section 5.1) – A description of the receiving environment in line with identifying hazards in Publication 1961 (provided in section 5.2) – All the proposed risk controls and checks in line with implementing controls and checking controls in Publication 1961 (provided in section 5.3) – A concise rationale justifying proposed approach against the three principles listed above (provided in section 5.4) 5.1 Description of emission sources As discussed in section 2.5, the potential sources of odour and dust at the subject site include: – Dust: • Tablet press – a pre-granulated mix is used (Prosolv Easytab). The mix is pre-granulated and has a high particle weight (i.e. not powder) and therefore not subject to aerosolization – Odour: • The use of chemicals in the preparation of pharmaceuticals. This includes hydrochloric acid, sodium hydroxide for pH adjustment, water for injection, mixing and cleaning. From the Material Safety Data Sheets for each product (refer to Table 1) it can be seen that all chemicals proposed to be used at the subject site are classified as odourless. As such the risk of off-site odour emanating from the subject site is considered negligible. Therefore, only dust has been considered further in this assessment. The dust sources are classified under the second guiding principle, namely: mass emission rates that are so low they can be considered negligible - when a source of emissions is very minor, it may be acceptable to assume these emissions are close to zero. Therefore, a Level 1 assessment has been undertaken. 5.2 Receiving environment 5.2.1 Size and vulnerability of nearby population An overview of the land uses and sensitive receptors surrounding the subject site is provided section 2. EPA Publication 1961 states that in addition to the identification of sensitive land uses, it is useful to consider additional descriptive data to characterise the potentially exposed population, such as the size and vulnerability of the exposed population. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 10
The population density of an area is reported by the Australian Bureau of Statistics (ABS) by Mesh Blocks. The relevant sensitive receptors surrounding the subject site (Richmond) have a population density of 5,287 persons per km² as reported in the 2016 Census. This is slightly more than surrounding areas Hawthorn and Toorak which have population densities of 4,354 and 3,255 persons per km², respectively. However, the population density in Richmond is much less than surrounding area South Yarra – East which has a population density of 9,009 persons per km². Overall, the population density surrounding the subject site is considered high. The vulnerability of a community is classified through the Socio-Economic Indexes for Areas (SEIFA) by the ABS, which ranks areas according to their relative socio-economic advantages and disadvantages. Of particular interest is the index of relative socio-economic disadvantage (IRSD) for the statistical area level 1 (SA1). EPA Publication 1961 states that if the IRSD score is in quintile one (most disadvantaged), then the population is likely to be particularly vulnerable to pollution. The SEIFA index for the area surrounding the subject site has a quintile rating of five (i.e. least disadvantaged) and therefore the population surrounding the subject site is not expected to be particularly vulnerable to pollution. 5.2.2 Meteorology An analysis of the wind climate at representative locations near the subject site gives some indication of the potential for off-site exposure to emissions. In particular, the typical distribution of wind speed and wind direction can highlight key issues with regards to dispersion from source to receptor impacts. The BoM operated automatic weather station (AWS) at Melbourne (Olympic Park) (2.5 km west of the subject site) is considered representative of the area due to the weather station’s similar exposure to prevailing winds. The 2019 annual wind rose for Melbourne (Olympic Park) is shown in Figure 3. The average wind speed was 2.9 m/s. The overall predominant wind direction is from the north (occurs for 17% of the year), which consists of the highest frequency of winds between 2 – 4 m/s. Winds from the south-southwest are the second most common (occurs for 14% of the year) which also consists of the highest frequency of winds between 2 – 4 m/s. Figure 3 Melbourne (Olympic Park) 2019 annual wind rose GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 11
5.2.2.1 Application to the site GHD has analysed the percentage of time (frequency) the identified receptors (refer to section 2.2) would be located downwind of the subject site, based on the local meteorology, discussed above, throughout the year. The frequency of each direction resulting in a sensitive receptor being downwind of the subject site is provided in Table 2. The frequencies presented in Table 2 can be used to infer the likelihood of these receptors being downwind of the subject site in the unlikely event that off-site dust emissions were to occur. From Table 2, it can be seen that the highest percentage of winds of interest occurs from the north, placing the residential housing along Madden Grove downwind of the subject site for 17% of the year. It is noted that these receptors are located south of the Burnley railway corridor, which would likely obstruct/minimise dust from dispersing to these houses. The residential housing along Swan Street has the next highest percentage of winds of interest occurring for 14% from the south-southwest and 10% from the south. All remaining receptors are downwind of the subject site less than 5% of the time. GHD considers there to be a very low likelihood that the identified receptors would be downwind of the subject site in the unlikely event that off-site dust emissions were to occur. Table 2 Frequency of wind directions Receptor Direction(s) downwind of the Frequency of winds from that subject site direction throughout the year (%) Green Leaves Early Learning Centre E 0.3% Residential housing along Swan Street SW 5% SSW 14% S 10% SSE 5% SE 1% Residential housing along Madden N 17% Grove 5.2.3 Background air quality A review of industries surrounding the project site with an EPA Victoria licence and of the National Pollutant Inventory (NPI) was undertaken. It was found that no industries that have an EPA Victoria licence or that report to the NPI were identified within 1 km of the subject site. Therefore, background sources of dust in the area are expected to be minor. 5.2.4 Topography The topography of the area surrounding the subject site is largely flat and would likely not be conducive to trapping ground-based emissions due to terrain heights. 5.3 Proposed risk controls and checks 5.3.1 Risk controls Under the GED, Syntro Health have a responsibility to prioritise the elimination of risks from air emissions. When this is not possible, emitters must implement appropriate controls to minimise or mitigate risks to human health or the environment. When risk cannot be eliminated, risk control options should be prioritised, based on the risk and waste management hierarchies. Risk minimisation under the GED involves following the risk management hierarchy, which in order of effectiveness is as follows: 1. Eliminate the hazard 2. Substitute the hazard / engineering controls 3. Administrative controls GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 12
This hierarchy has been applied to the facility as follows: Eliminate the hazard Elimination of the hazard (dust generated as a result of operations) is not feasible, so the application of engineering controls will be the most practical way to minimise risk. Substitute the hazard / engineering controls – The facility will be commissioned to achieve certain room particle counts, air change rates in order to minimise microbiological and particulate contamination. – The IS08 room, which will house the tablet press, will be under negative pressure to the outside rooms. The room will be serviced with inbound HEPA filters and outbound F5 filters to minimise any potential dust. This is considered best practice and Syntro Health will apply for a Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) certification. Administrative controls – Rooms will be cleaned before and after each operation. – For liquid spills, standard spill kits will be used, as rooms don’t have drains. The solution will be contained, collected and placed into container for destruction. – An offsite destruction company will be used to collect all waste in yellow biohazard bins. 5.3.2 Checks EPA Publication 1961 states that the development of risk controls is not intended to be the end of the risk management process. Ongoing performance evaluation through monitoring and continual improvement is required under the GED to ensure ongoing compliance. One of the most useful ways to evaluate ongoing performance with respect to risk management of air quality is through monitoring. It is recommended that Syntro Health keep an environmental register (to log any spills, incidents, complaints, should they occur) and do regular perimeter inspections surrounding the site to assess for any off-site dust impacts. Further, Syntro Health have stated that the following checks in relation to dust will be implemented: – HVAC preventative maintenance will occur every three months – Filter integrity testing will occur annually and replaced as required 5.4 Rationale Based on the above, it was determined that: – The emissions associated with operation of the facility are classified under the second guiding principle, namely: mass emission rates that are so low they can be considered negligible – The receiving environment has: • The SEIFA index has a quintile rating of five (i.e. least vulnerable) and therefore the population surrounding the subject site is not expected to be particularly vulnerable to pollution. • A very low likelihood that the identified receptors would be downwind of the subject site in the unlikely event that off-site dust emissions were to occur. • No industries that have an EPA Victoria licence or that report to the NPI within 1 km of the subject site. • Topography that is largely flat and would likely not be conducive to trapping ground-based emissions due to terrain heights. – Engineering and administrative controls will be implemented by Syntro Health – Checks to enable continual improvement will be conducted by Syntro Health Therefore, the air quality risk associated with the subject site and receiving environment is considered to be negligible and managed in accordance with the GED. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 13
6. Conclusions GHD has been engaged by Swan Street Syntro care of Ratio Consultants to undertake an Odour and Dust Amenity Assessment for 558-562 Swan Street, Richmond. The assessment has been conducted in accordance with Clause 53.10, EPA Publication 1518 and EPA Publication 1961. The following conclusions can be made: – Syntro Health are proposing to manufacture pharmaceutical products at the subject site. Operations will involve the pressing of tablets from a commercial granulated blend (Prosolv Easytab), the packaging of tablets into bottles/blister packs, and the labelling of cartons/bottles. There will be no chemical production occurring at the subject site. – There is no threshold or separation distance applicable to the subject site outlined in Clause 53.10 or EPA Publication 1518. – GHD used the assessment methodology outlined in EPA Publication 1961 to assess the risk of odour and dust emissions from the subject site. – The emissions associated with operation of the facility were identified as: • Dust from a tablet press – a pre-granulated mix is used (Prosolv Easytab). The mix is pre-granulated and has a high particle weight (i.e. not powder) and therefore not subject to aerosolization. • Odour from the use of chemicals in the preparation of pharmaceuticals. This includes hydrochloric acid, sodium hydroxide for pH adjustment, water for injection, mixing and cleaning (determined to be negligible and therefore not assessed further). – The emission sources were classified under the second guiding principle in EPA Publication 1961 (section 5.2), namely: mass emission rates that are so low they can be considered negligible. – It was determined that a Level 1 assessment in accordance with EPA Publication 1961 was sufficient to inform the implementation of appropriate risk controls. The following was therefore provided: • A description of the emission sources in line with identifying hazards in Publication 1961 (provided in section 5.1) • A description of the receiving environment in line with identifying hazards in Publication 1961 (provided in section 5.2) • All the proposed risk controls and checks in line with implementing controls and checking controls in Publication 1961 (provided in section 5.3) • A concise rationale justifying proposed approach against the three principles listed above (provided in section 5.4) – Based on the Level 1 assessment outcomes, the air quality risk associated with the subject site and receiving environment is considered to be negligible and managed in accordance with the GED. GHD | Swan Street Syntro Pty Ltd | 12553343 | Syntro Health Richmond 14
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