Medical waste streams: Legal Requirements

1. Medical waste streams: Legal Requirements Enviropharm November 17 2011 Jackie Campbell, B.Sc.(Pharm.), LLB

2. Outline • Types of waste • Why do we care? • Regulation of waste • Case study: mercury Jackie Campbell

3. Types of waste • Specific chemicals/elements • Mercury (e.g., amalgam, others) • Mixtures of chemicals • Pharmacy wastes • Lab chemicals/wastes • Biomedical waste • Sharps Jackie Campbell

4. Types of waste • Mercury waste - Amalgam • Dense, accumulates in plumbing; may then slowly vapourize or methylate • Accumulates in sewage treatment sludge, which is incinerated or spread on farmland • How much is there? • In 2000, 6% of Canada’s atmospheric mercury emissions came from municipal waste/sewage incineration, and 12% from hazardous/biomedical waste incineration • Dental practices contributed to 8-14% of mercury discharged to sewage systems • How does it get into the environment? • What does it do? Jackie Campbell

5. Types of waste • Pharmacy waste • How much is there? Nobody knows • Ontario’s MHSW Program Plan said approx 10% of pharmaceuticals not consumed; Estimate 659 tonnes avail for collection • How does it get into the environment? • Through use/excretion • Inappropriate disposal • Appropriate disposal - Incineration • What does it do? Jackie Campbell

6. Types of waste • Biomedical waste • How much is there? • <10% of waste generated in health care • Must be segregated, managed • How does it get into the environment? • What does it do? Jackie Campbell

7. Why do we care? • Contaminants reach our water, air, soil • Effects • Human health • Sensitive habitats • Wildlife • Emerging scientific knowledge • Confirms/refutes concerns..or..adds to confusion? • Balance against efficient, cost-effective business operations • Can we reduce emission? By how much? What’s cost? Jackie Campbell

8. How are wastes regulated? • All levels of government have laws that regulate impact of business activities on the environment • Federal • Canadian Environmental Protection Act, 1999 (CEPA), Fisheries Act, • Provincial (e.g., Ontario) • Environmental Protection Act, Ontario Water Resources Act, Toxics Reduction Act, 2009 • May set discharge limits for various parameters • Some discharge permitted - e.g., under Certificate of Approval • Control collection, handling, transportation, storage of parameter • Again, via CofA - waste management • Reporting requirements • Waste Diversion Act, 2002 • Stewardship recycling programs Jackie Campbell

9. How are wastes regulated? • Municipalities - by-laws • Control discharges • May have reporting requirements • Say what goes in waste streams - garbage, recycling…collection programs ….On the other hand: • Voluntary initiatives • Dental associations - mercury amalgam • Pharmacist groups - pharma waste Jackie Campbell

10. What if you don’t comply? • Offences - under laws, regulations, by-laws • Penalties can be substantial • Fines and/or imprisonment • Sometimes mandatory minimum fines • Liability imposed on directors, officers, employees, agents of corporate offender - if they authorized, permitted or acquiesced in commission of an offence - even if company not prosecuted • Adverse publicity Jackie Campbell

11. Case study - Mercury • In 2001, CCME endorsed Canada-Wide Standard - 95% reduction in releases from amalgam by 2005 (base year - 2000) • Voluntary initiative • through MOU between Environment Canada & Cdn Dental Association • Environment Canada provided info and tech support • Included • improved waste management practices • use of amalgam separators by dentists Jackie Campbell

12. Case study - Mercury • B.C. worked with GVRD, Capital Regional District to develop source-control by-laws to restrict mercury from amalgams • Alberta Dental Assoc & College developed a BMP guide on how to handle and dispose of amalgam; Alberta Environment met with major municipalities • Manitoba worked with Manitoba Dental Association, which agreed to voluntarily implement CWS • N.B. Dept of the Environment and Local Government and the N.B. Dental Society signed a letter of understanding to promote better management of amalgam waste Jackie Campbell

13. Case study - Mercury • Ontario added amalgam waste disposal to the General Regulation (O.Reg. 205/94) under the Dentistry Act • Adopted a new standard of practice to reduce the amount of amalgam that directly/indirectly enters the sewage system via wastewater from dentists’ offices • Dentists must adhere to standards of practice, or face sanctions from their regulatory body Jackie Campbell

14. Case study - Mercury • Some municipalities enacted by-laws to address mercury releases from dental clinics - e.g., North Bay, Ottawa, Toronto • Toronto requires pollution prevention plan (PPP) • Discharge limit of mercury into sewer is 0.01 mg/L, and City also limits concentration of mercury in drains that leave the clinics and enter sewers • The separator required by the Ontario regulation may not be capable of meeting Toronto’s more stringent standard • Compliance audits/enforcement measures taken Jackie Campbell

15. Case study- Mercury • Report card • 95% reduction in releases from by 2005 not achieved • From 2007 survey of Canadian dentists • 70% use ISO certified amalgam separator (up from 27%) • 71.2% had hired a licensed waste carrier to remove amalgam waste • Gap of 1.2% of dentist who don’t use separator but have waste removed appropriately • CCME recommended further action… Jackie Campbell

16. Case study - Mercury • May 2010 - Environment Canada published a notice under Part 4 of CEPA • Triggers requirement to prepare & implement a PPP for a substance/group of substances specified on the List of Toxic Substances (Sched 1 CEPA) • Sets out requirements to prepare and implement PPP for mercury releases from dental amalgam waste • Notice applies to dentists and/or owner of building where a dental facility is located and dental amalgams are used • Targets dental facilities that have not implemented BMP under MOU Jackie Campbell

17. Case study - Mercury • Proposed regulations under Canadian Environmental Protection Act, 1999 - published by Environment Canada - February 2011 • Emissions already reduced by 90% since 1970s - via curbing industrial emissions • 27% of Canada’s atmospheric emissions from use and end-of-life disposal of mercury containing products • Would prohibit manufacture, import and sale of mercury-containing products • Some exemptions - e.g., research applications, dental amalgam • Anticipated decrease of 90,000 kg of mercury emissions by 2032 • Part of a global strategy to reduce damage from methyl mercury Jackie Campbell

18. Case study - Mercury • Most end-of-life mercury-containing products are considered as hazardous waste - e.g., Ontario Regulation 347 (General - Waste Management) under the EPA, hazardous wastes must be • Segregated • Removed from the general waste stream • Collected in dedicated containers • Collected and transported by approved waste management companies • Under Regulation 347, Ontario required hospital incinerators to close by the end of 2003 -- a few years ago there were over 70 such incinerators, and the hospitals sector was the 4th largest mercury emitter in the province • Lakeview generating station stopped burning coal by April 2005 - reducing annual mercury emissions by 45-75 kg • Falls under the Occupational Health & Safety Act Designated Substances Regulation (does not apply to dental offices) • Reg sets out the amount of mercury workers may be exposed to in a given time period and methods to control/measure workplace mercury • Applies to elemental, inorganic and organic mercury Jackie Campbell

19. Case study - Mercury • Toronto’s Environmental Reporting & Disclosure By-law requires businesses and facilities to report on 25 substances of priority health concern • That they manufacture, use or release to the environment, if these amounts are at or above reporting limits • Hospitals may use and release other chemicals of concern that are not subject to the by-law • By-law excludes medical, dental offices • Mercury: concentration threshold for reporting - 0% w/w Jackie Campbell

20. Case study - Mercury From Toronto’s Resource for Greening General Medical and Surgical Hospitals Pollution Prevention Information - Dec 2010 Jackie Campbell

21. Conclusion • Know your processes • Who uses chemicals, produces waste? • What are the wastes produced? • How much? • Where do they go - air, water, sewer, soil? Jackie Campbell

22. Conclusion • Green procurement policy • Use less hazardous chemicals • Minimize release of chemicals/by-products • Purchasing products & services • What are handling, storage, disposal costs? • Do products/packaging contain hazardous materials? • Anything facility won’t buy? - “unless required” - anything that contains mercury, asbestos, alkyl phenol ethoxylates, methylene chloride • Give preference to products that don’t contain certain chemicals Jackie Campbell

23. Conclusion • Know the laws • Federal, provincial, municipal? • Reporting requirements • Usually for emissions of more toxic substances • Toxics laws, by-laws Does anything else apply? • Professional standards of practice? Jackie Campbell

24. Thanks! SAXE LAW OFFICE email: jackie@envirolaw.com Blog: envirolaw.com Jackie Campbell