2016-127 Audit Scope and Objectives

Home-Generated Pharmaceutical Waste Disposal

The audit by the California State Auditor will provide independently developed and verified information related to the California Department of Public Health (CDPH), the California Department of Resources Recycling and Recovery (CalRecycle), and a selection of countiesí waste disposal standards for home-generated sharps and pharmaceutical waste, and will include, but not be limited to, the following:

  1. Review and evaluate the laws, rules, and regulations significant to the audit objectives.
  2. To the extent that home-generated medical waste information is available, do the following:
    1. Determine, to the extent possible, the volume of home-generated sharps waste and pharmaceutical waste that was disposed of statewide using approved household disposal methods over the past three years.
    2. Estimate, to the extent possible, the volume of home-generated sharps waste and pharmaceutical waste that may have been improperly disposed of statewide over the past three years.
    3. Assess, to the extent possible, differences in home-generated sharps waste and pharmaceutical waste in areas with needle exchange programs versus areas without such programs.
  3. Identify the methods that exist currently for free home-generated sharps and pharmaceutical waste disposal within California.
  4. To the extent that information is available, determine the collection rate for voluntary take-back programs manufacturers funded in the past three years for home-generated sharps and pharmaceutical waste.
  5. Determine which medical waste collection models generate the best waste collection results for both home-generated sharps and pharmaceutical waste. Consider county-based collection models, including needle exchange programs, as well as those adopted in Canada and other countries.
  6. Identify any existing regulatory limitations on establishing home-generated sharps or pharmaceutical waste collection sites or on methods for collecting that waste. Assess the reasonableness of any barriers that exist.
  7. To the extent that information related to waste processing capacity is available, do the following:
    1. Determine the statewide capacity for processing home-generated sharps and pharmaceutical waste in each of the last three years.
    2. Determine the existing waste processing capacity in California that could accommodate growth in proper home-generated sharps and, if applicable, pharmaceutical waste disposal.
  8. Determine where home-generated sharps and pharmaceutical waste is processed and the methods used to process the waste.
  9. To the extent possible, compare processing rates for home-generated sharps waste and, if applicable, home-generated pharmaceutical waste, in a selection of jurisdictions the CDPH oversees to a comparable selection of jurisdictions with local oversight. Determine what differences exist among the jurisdictions that may affect Californiaís processing rates.
  10. Identify the recommendations CalRecycle and CDPH have made regarding home-generated sharps and pharmaceutical waste collection and disposal. Assess whether the recommendations reflect best practices.
  11. Review and assess any other issues that are significant to the audit.

California State Auditorís Office
5/19/2016


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