1 / 45

Bringing Clarity to your Environment

Air Acts and Regulations Review for the Health Care/Pharmaceutical Sector EnviroPharm 2009 October 1, 2009 Greg Brown, P.Eng, M.A.Sc., MBA, C.E.A.S President, Pollutech Environmental Limited. Bringing Clarity to your Environment. Presentation Overview. Federal NPRI

egan
Download Presentation

Bringing Clarity to your Environment

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Air Acts and Regulations Review for the Health Care/Pharmaceutical Sector EnviroPharm 2009 October 1, 2009 Greg Brown, P.Eng, M.A.Sc., MBA, C.E.A.S President, Pollutech Environmental Limited Bringing Clarity to your Environment

  2. Presentation Overview • Federal NPRI • Ontario Regulation 127/01 • Ontario Toxics Reduction Act, 2009 • Ontario Environmental Protection Act • Ontario Certificate of Approval (Air) • Ontario Regulation 419/05 “Air Pollution ­ Local Air Quality” & Proposed Amendments • USEPA AERMOD Dispersion Modelling • Sound Level Limits • Acoustic Assessments/Audits • Future Regulatory Initiatives?

  3. Presentation Overview • Provides summary overview of regulatory requirements in Ontario • Applicable legislation should be referenced to confirm applicability to specific situations

  4. Federal: National Pollutant Release Inventory (NPRI) • Under authority of Canadian Environmental Protection Act (CEPA) • General reporting requirements are: • > 20,000 hours per year (approx. 10 full time employees) • MPO > mass threshold of NPRI listed substance • MPO > 1% concentration by weight • Includes Criteria Air Contaminants (Part 4 - CO, NOx, SO2, PM, VOCs, PM10, PM2.5 • Annual Reporting due by June 1st

  5. Federal: National Pollutant Release Inventory (NPRI) • Example MPO Thresholds • Part 1A Core Substances (231 substances) with 10 tonnes per year MPO threshold • Part 1B (mercury & cadmium) with 5 kg per year MPO threshold • Part 1B (arsenic, hexavalent chromium, lead, tetraethyl lead) with 50 kg per year MPO thershold • Part 2 (20 PAHs) with threshold based on special criteria of 50 kg total

  6. Federal: National Pollutant Release Inventory (NPRI) • Example MPO Thresholds • Part 3 (dioxins/furans and hexchlorobenzene) with no threshold and obligatory reporting • Part 4 (Criteria Air Contaminants) with threshold based on quantity released to air (ranging from 0.3 tonnes per year [PM2.5] to 20 tonnes per year [CO, NOx, SO2, PM]) • Part 5 (75 Speciated VOCs) with additional reporting requirements if > 1 tonne air release

  7. Federal: National Pollutant Release Inventory (NPRI) • If exceed MPO Thresholds • Calculate and report NPRI substance releases to • Air • Water • Soil • Waste • Recycle

  8. Federal: National Pollutant Release Inventory (NPRI) • Exemptions • Research and testing activities – only Part 4 (Criteria Air Contaminant) emissions from stationary combustion equipment are considered if nameplate capacity > 10 million BTU/hour • For biomedical or hospital waste incineration of 26 tonnes or more of waste per year – for all activities consider all releases to air, however, for waste incineration - Part 4 (Criteria Air Contaminants) emissions are considered from stationary combustion equipment

  9. Provincial: Regulation 127/01 • Airborne Contaminant Discharge Monitoring and Reporting Regulation • Revised in December 2007 to reflect changes to Ontario's air monitoring and reporting program • Streamlined the reporting requirements in order to harmonize with the federal National Pollutants Release Inventory (NPRI) program • Applicability by NAISC • 325410 Pharmaceutical and Medicine Manufacturing • 541380 Testing Laboratories • 62211 General (except Pediatric) Hospitals [for hospitals with incinerators only] • Annual Reporting due by June 1st

  10. Provincial: Regulation 127/01 • Contaminants with MOE Graded MPO Thresholds Listed in Table 2B • > 20,000 hours per year (approx. 10 full time employees) • MPO in an amount > threshold amount • No Table 2A Contaminants • One (1) Table 2B Contaminant • Acetone with 3,000 kg/year MPO threshold

  11. Ontario Toxics Reduction Act, 2009 • Draft Regulation posted September 18, 2009 • Regulation intended to encourage regulated facilities (about 2,000) to find greener alternatives to toxic substances and new technologies that are less dependant on toxics • Act requires regulated facilities to track and quantify toxics they use and create, to develop plans to reduce their toxics, and make summaries of plans available to the public

  12. Ontario Toxics Reduction Act, 2009 • Accounting, planning and reporting for prescribed toxic substances is mandatory • Implementation is voluntary • First Phase Applies To Priority Toxics • List of 47 substances and substance groups in the list of priority toxics (Table A) • List developed by Toxics Reduction Scientific Expert Panel which ranked substances on the NPRI based on emissions and hazard

  13. Ontario Toxics Reduction Act, 2009 • Draft regulation would apply to facilities at which manufacturing and mineral processing activities (except physical extraction, crushing and grinding) take place that meet prescribed toxic substance and employee thresholds • First reports on toxic substance reduction plans from regulated facilities would be due by June 1, 2011 • Once the first reports are prepared, facilities would complete their toxics reduction plans by December 31, 2011 and submit a summary of their plan to the ministry and make it available to the public.

  14. Ontario Toxics Reduction Act, 2009 • Second Phase Applies To All NPRI Substances • Facilities that use or create a substance listed in the NPRI, but which is not listed in Table A, would provide their first report to the ministry by June 1, 2013, covering the calendar year 2012. • Facilities would complete a plan and provide a summary of their plan to the public and the ministry by December 31, 2013.

  15. Provincial: Environmental Protection Act • 9. (1) No person shall, except under and in accordance with a certificate of approval issued by the Director, • (a) construct, alter, extend or replace any plant, structure, equipment, apparatus, mechanism or thing that may discharge or from which may be discharged a contaminant into any part of the natural environment other than water; or • (b) alter a process or rate of production with the result that a contaminant may be discharged into any part of the natural environment other than water or the rate or manner of discharge of a contaminant into any part of the natural environment other than water may be altered.

  16. Provincial: Environmental Protection Act • 13. (1) Every person, • (a) who discharges into the natural environment; or • (b) who is the person responsible for a source of contaminant that discharges into the natural environment, • any contaminant in an amount, concentration or level in excess of that prescribed by the regulations shall forthwith notify the Ministry of the discharge.

  17. Provincial: Environmental Protection Act • 14. (1) Despite any other provision of this Act or the regulations, no person shall discharge a contaminant or cause or permit the discharge of a contaminant into the natural environment that causes or is likely to cause an adverse effect.

  18. Provincial: Environmental Protection Act • 1. (1) In this Act, • "adverse effect" means one or more of, • (a) impairment of the quality of the natural environment for any use that can be made of it, • (b) injury or damage to property or to plant or animal life, • (c) harm or material discomfort to any person, • (d) an adverse effect on the health of any person, • (e) impairment of the safety of any person, • (f) rendering any property or plant or animal life unfit for human use, • (g) loss of enjoyment of normal use of property, and • (h) interference with the normal conduct of business

  19. Certificate of Approval (Air) • Two types of Certificate of Approval (Air): • Traditional or Consolidated Approval • Prepare ESDM Report & submit Application • C of A (Air) issued • Timeline??? 3 months - > 2 years • Basic Comprehensive Approval (5 yr term) • Prepare ESDM Report & submit Application • C of A (Air) issued • Can make approved modifications • Modification Log, update ESDM Report and Annual Written Summary to MOE • Toxicological Assessments (costly at $5,000 per contaminant without POI Standard)

  20. Certificate of Approval (Air) • As of October 1st, 1998 all applications under Section 9 of approvals must include information that demonstrates that the entire facility complies with Regulation 419/05 POI Standards • Must include ALL sources of emission • Based on absolute worst case emissions estimates • Noise Screening Process and/or Acoustic Assessment or Acoustic Audit

  21. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • revoked and replaces Regulation 346 "General ­ Air Pollution" on November 30, 2005. • Regulation 419/05 is the primary regulatory tool for creating standards for contaminants that are protective of local air quality and which emitters in Ontario must meet.

  22. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • SUMMARY of O. REG. 419/05 STANDARDS and POINT of IMPINGEMENT GUIDELINES & AMBIENT AIR QUALITY CRITERIA (AAQCs) – December 2005, Standards Development Branch, MOE • Applicants for approval under Section 9 of the EPA will be required to demonstrate compliance with the appropriate POI guideline and/or AAQC for the contaminants that are the subject of the application

  23. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • Some contaminants are not listed in Schedules 1, 2 and 3 of the Regulation, but are instead listed as a half-hour POI guideline or an AAQC • The Regulation allows a Director to issue certain Notices and impose certain notification requirements on emitters if a discharge from a facility may cause an adverse effect. • Exceedence of a POI guideline or of an AAQC may cause adverse effects and as such could trigger the issuance of a Director's Notice. • Odour not listed in Regulation: MOE typically applies Guideline of 1 OU for residential receptor and 5 OU for industrial receptor

  24. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • There are differences between the current and previously released listings of standards, guidelines and AAQCs. This is primarily due to the fact that Regulation 419/05: • introduces several new standards, phases in the requirement to meet effects-based standards (Schedule 1, 2 and 3 of the Regulation) • phases in the requirement to use U.S. Environmental Protection Agency air dispersion models (i.e. `approved dispersion models‘)

  25. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • Phase-in based on NAISC Code • 325410 = Pharmaceutical and Medicine Manufacturing • Listed in Schedule 4 of the Regulation as Target Sector [352 Chemical Manufacturing] for 2013

  26. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality"

  27. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • Alteration of Phase 3 Standards • A person may make a request for approval of an alteration to a standard set out for a contaminant in Schedule 3 if : • The person discharges or causes or permits the discharge of the contaminant from a facility to which, according to an approved dispersion model, discharges of the contaminant from the facility would result in the concentration of the contaminant at a point of impingement exceeding the standard set out in Schedule 3 that is the subject of the request.

  28. Ontario Regulation 419/05 "Air Pollution ­ Local Air Quality" • Alteration of Phase 3 Standards • Request must be made before February 1, 2010 or after October 31, 2011.  • The request must include” • detailed technical and financial assessment • number of days modelling indicates non-compliance • publish notice in newspaper, advise neighboring properties with 500 m, notify Medical Officer of Health, notify Municipality • many other requirements – looks like an onerous undertaking!

  29. Ontario Regulation 419/05Proposed Amendments – June 2009 • Allow the Minister to have the authority to establish sector-specific Technical Standards • Proposed sector-based approach is intended to identify practical solutions to manage better and reduce exposures to air toxics by applying consistent rules across a sector rather than seeking reductions and timelines for each facility • Forest Products and the Foundry sector have been identified as sectors that would likely benefit from this proposed new Minister’s authority

  30. Ontario Regulation 419/05Proposed Amendments – June 2009 • This approach could be considered in situations where MOE is dealing with multiple facilities in a sector where technical solutions for the sector to reduce air pollution are practical, easy to identify and easy to implement • MOE proposes that facilities in these sectors have the option of either • complying with the air standard(s) by the phase-in date; • submitting a request for a site-specific alteration of a standard; or • adding a new option to comply with the proposed sector-based technical standard which would be established by the Minister with public consultation

  31. Ontario Regulation 419/05Proposed Amendments – June 2009 • A sector-based approach would require implementation of the best available technology to reduce the contaminant concentrations as much as possible over time • Economic issues can also be considered

  32. Ontario Regulation 419/05Other Proposed Amendments – June 2009 • MOE proposes to phase-out the use of ISCPRIME as an approved dispersion model by February 1, 2012 • Operating conditions must include start up, shut down and process malfunctions (upsets), if these conditions results in the highest concentration of a contaminant at a POI. • Any ESDM report prepared by a facility that is affected by a new or updated air standard or a new model that is completed one year before a new requirement is phased in, must prepare that ESDM report as if the new requirements were in place. • It is proposed to have these draft amendments take effect on February 1, 2010.

  33. Ontario Regulation 419/05Proposed Updated Point of Impingement Standards

  34. Ontario Regulation 419/05Proposed Updated Point of Impingement Standards

  35. USEPA AERMOD Modelling

  36. USEPA AERMOD Modelling

  37. Sound Level Limits • Noise is deemed a contaminant emission • Class 1 Area • acoustical environment typical of major population centre, background noise dominated by urban hum • Class 2 Area • acoustical environment that has qualities of Class 1 and Class 2 Areas, absence of urban hum between 19:00 and 23:00 hours • Class 3 Area • Rural area, acoustical environment dominated by natural sounds, little or no road traffic, small community with less than 1,000 population

  38. Sound Level Limits • Sound Level Limit • Equivalent to Minimum Value of One Hour Equivalent Sound Level (Leq) caused by road traffic • Exclusionary Sound Level Limits

  39. Assessing Compliance with Sound Level Limits • Noise Screening Process • Determination of minimum separation distance to sensitive receptors based on NAISC code of facility operations and/or type and number of noise sources at facility • Acoustic Assessment • Noise measurements at noise sources and/or manufacturer’s data and prediction of sound level at points of reception • Acoustic Audit • Noise measurements at point of reception with and without noise sources in operation

  40. Acoustic Assessment Modelling

  41. Acoustic Assessment Modelling

  42. Acoustic Assessment Modelling

  43. Acoustic Assessment Modelling

  44. Future Regulatory Initiatives? “EPA Tightens Air Emissions for Hospital, Medical, and Infectious Waste Incinerators” WASHINGTON – EPA is setting new limits that will affect most existing hospital, medical, and infectious waste incinerators. This final action will reduce about 390,000 pounds of several pollutants each year including acid gases, nitrogen oxides, and metals such as lead, cadmium, and mercury. 

  45. For additional information feel free to contact: Greg Brown @ 905 847- 0065 gbrown@pollutechgroup.com Visit the Pollutech Group of Companies at: www.pollutechgroup.com Bringing Clarity to your Environment

More Related