Response to the Audit
April 27, 2017
Doug Cordiner, CGFM
Chief Deputy State Auditor
621 Capitol Mall, Suite 1200
Sacramento, California. 95814
Dear Mr. Cordiner:
Thank you for the opportunity to review and comment on the April 11, 2017 draft report, titled “Home Generated Sharps and Pharmaceutical Waste: By Designating a Lead Agency, the State Could Increase Proper Disposal.”
CalRecycle appreciates this opportunity to provide feedback on the information contained in the report. In general, and as noted in previous discussions with audit staff, CalRecycle does deal with end of life management for a number of products. However, pharmaceuticals and sharps are particularly complicated products to manage, and their management and handling intersects multiple state and federal agencies. CalRecycle is concerned that the department does not have the resources, expertise and enforcement authority to oversee the disposal of home generated sharps and pharmaceuticals as recommended and described in this report.
CalRecycle continues to have concerns with being designated the most appropriate state agency to oversee the management of home-generate sharps and pharmaceuticals and looks forward to further conversation on how the department can be helpful in ensuring these materials are safely and effectively managed state-wide.
Please find attached the department’s comments to the draft audit report.
Chief Deputy Director
cc: Mr. John Baier, Audit Principal, State Auditor’s Office
Mr. Joshua Hooper, State Auditor’s Office
Ms. Christine Hironaka, Deputy Director for Legislation, California Environmental Protection Agency
Ms. Mindy McIntyre, Legislative Director, Department of Resources Recycling and Recovery
Ms. Josephine Urban, Branch Chief, Audits Office, Department of Resources Recycling and Recovery
CalRecycle Response to Draft Report: Home Generated Sharps and Pharmaceutical Waste: By Designating a Lead Agency, the State Could Increase Proper Disposal.
Overall Management System and Authority – The proper management for the disposal of these materials includes collection, consolidation, storage, transport, and treatment. During these stages, these materials would be considered medical and/or hazardous waste and would therefore fall under the authority of the California Department of Public Health (CDPH), Board of Pharmacy (BOP), and the Department of Toxic Substances Control (DTSC). With the exception of collection and consolidation of household hazardous waste by local government programs (which sometimes includes home-generated sharps and pharmaceuticals), CalRecycle is not involved with the overall management system of these materials. Furthermore, the household hazardous waste local government programs are not the entire universe of the existing overall management system nor are they necessarily convenient. As the report notes, treated sharps are currently landfilled and there is plenty of capacity for disposal of sharps. Pharmaceuticals are predominantly incinerated at out-of-state incinerators.
Appropriate Collection Sites – The Board of Pharmacy (BOP) regulates reverse distributors and also regulates how pharmacists properly manage pharmaceuticals. Pharmacies can lose their license for failure to adhere. CalRecycle has no such enforcement authority and no expertise in the collection of controlled substances. As noted in the report, “…the only entities allowed to collect controlled substances for disposal are law enforcement or DEA registered collectors such as retail pharmacies.” Thus, curbside collection of home-generated pharmaceutical waste is not appropriate for these materials. CalRecycle suggests that backhauling through pharmacies’ reverse distribution system would be a more appropriate process to manage materials that will be considered pharmaceutical waste and potentially subject to federal and state controlled substances restrictions.
Even if existing state statutes are revised for disposal of home-generated sharps and pharmaceutical waste as the report suggests, there are still medical and/or hazardous waste requirements for the collection, consolidation, storage, transport, and treatment steps. Further, and notwithstanding changes to state law, federal requirements remain that specify medical and/or hazardous waste requirements.
Beyond this, CalRecycle has the following comments and questions on the information contained in the draft audit report:
· Page 4 re: CalRecycle oversight for “all state-managed waste-handling programs”
o This statement is incorrect. CalRecycle is responsible for solid waste management and, to some extent, has a limited role in household hazardous waste oversight. However, the department is not responsible for medical waste or hazardous waste management, such authority appropriately rests with other agencies.
· Page 4, paragraph 2 regarding list of collection sites
o CDPH is required by statute to maintain a list of sharps collection locations; there are no statutory requirements for any agency to maintain a list of pharmaceutical collection locations.
· Page 4, paragraph 2 regarding subsidizing use of mail-back containers
o While the audit report discusses subsidizing this use, it does not provide recommendations on how such a program would be financed.
Page 5, paragraph 1 regarding incinerators operating within the state that could dispose of pharmaceutical waste
o This would necessitate considerable permit processes across various federal, state and local agencies, including local governments, counties, air districts, CDPH, DTSC, CalRecycle, and the DEA. Additionally, this could require environmental impact review and public comment. Current solid waste facilities are not permitted to handle disposal of pharmaceutical waste except by special arrangement with law enforcement agencies that are disposing of materials that could include pharmaceuticals, e.g., contraband drugs.
· Page 6 lists 3 of the key recommendations
o While the audit report makes recommendations regarding a public education campaign and maintaining a database, it makes no specific recommendations regarding funding sources for these activities or for authority (including enforcement) to require that information be submitted.
· Page 9 regarding waste haulers
o Special licensing would be required for a solid waste hauler to transport household-generated pharmaceuticals and sharps. This licensing authority rests with CDPH and DTSC.
· Page 11 regarding model guidelines
o The model guidelines expired in 2013.
· Page 14 regarding “oversight for it [sharps waste] transfers to CalRecycle”
o Sharps are considered solid waste only after they are treated. Once treated, sharps may be disposed in a solid waste landfill, which is under the purview of CalRecycle.
· Page 16: The report indicates state and federal agencies send mixed messages for the disposal of home-generated sharps waste. The FDA’s website is consistent with state agency messages encouraging consumers to check local requirements and does not recommend putting those bottles in the trash.
· Page 16 regarding unified educational campaign
o The audit report does not make recommendations about how such an activity would be funded.
· Page 16, last paragraph regarding CalRecycle’s role
o The statement that CalRecycle has “oversight of landfills, incinerators, and processing stations” is true for solid waste facilities (landfills, transfer stations, compost facilities, transformation). The department does not have oversight of incinerators that process hazardous materials or medical wastes.
· Page 17 top, “CalRecycle already has oversight of treated sharps”
o As a point of clarification, sharps are regulated by CDPH; CalRecycle has oversight of landfills where treated sharps are disposed.
· Page 17 regarding “medical expertise required to operate a collection program”
o A medical and pharmaceutical collection program is not simply a disposal program. CalRecycle regulates solid waste disposal while BOP, CDPH, DTSC, and Department of
Transportation regulate the collection, consolidation, treatment and transportation of pharmaceuticals and sharps.
Pages 21-22 regarding lists of collection sites and FacIT
o CDPH is required to provide the public with an accurate list of sharps collection sites throughout the state. CalRecycle provides a voluntary, detailed user-friendly database to the public mapping all solid waste facilities through FacIT. However, we also have a secondary site, http://www.calrecycle.ca.gov/Recycle/Maps/ that provides additional locational information on collection and recycling facilities including facilities that collect medications and sharps.
· Page 24 regarding the statement of requiring that locals include sharps and pharmaceutical services when they contract out for waste services.
o In addition to the required statutory changes, haulers would be required to become a DEA registrant for controlled substances. This requirement may invite legal challenges by haulers.
This is why San Luis Obispo County’s mandatory retail pharmaceutical takeback ordinance has faced retailer challenges and DEA scrutiny and all other extended producer responsibility ordinances in the state only have voluntary retail participation.
· Page 25 regarding Form 303 data
o Home-generated sharps and pharmaceutical collection data is limited because of:
§ Inconsistent reporting. In many cases, contractors report collection data on behalf of the local government organization. Unfortunately, some local governments have limited resources to verify whether the data is complete and correct.
§ Incomplete reporting. Home-generated sharps are collected in airports, restaurants, large special events and are not statutorily required to be reported.
· Pages 29-30: the report states CalRecycle’s model guidelines “require” collectors manage consolidated HGPW as hazardous or medical waste. While following the guidelines would ensure a program complied with state law (until 2013), the recommended guidelines were only voluntary.
· Page 32: The report states, California law does not exclude HGPW from the definition of hazardous waste for solid waste incinerators. However, it’s worth noting that the federal Resource Conservation and Recovery Act already does that.
· Page 38 regarding “without creating additional costs for consumers”
o It is not clear what the funding source would be for implementing an advanced disposal fee program (i.e., Option #2).
· Page 39: The report discounts pursuing EPR legislation because “…manufacturers are likely to pass on those costs to consumers, either directly or indirectly…” However, EPR program fees would be more transparent and consistent with “beneficiary pays” principles.
· Page 41: As noted, CalRecycle may not be the appropriate agency for ensuring the proper disposal of sharps and pharmaceutical waste given associated medical and/or hazardous waste requirements.
· Page 42 regarding the second bullet point
o Absent mandatory reporting authority from all sharps and pharmaceutical collection sites, CalRecycle could not maintain an accurate list nor could it track amounts collected for further analysis.
· Page 42 regarding the third bullet point
- As noted, solid waste haulers would require special medical and/or hazardous waste permits and licensing.
CALIFORNIA STATE AUDITOR’S COMMENTS ON THE RESPONSE FROM CALRECYCLE
To provide clarity and perspective, we are commenting on the response to our audit report from CalRecycle. Although we did not direct any recommendations to CalRecycle, we provided it an opportunity to review the draft report because we are recommending that the Legislature entrust it with statutory oversight responsibility for home-generated sharps and pharmaceutical waste disposal. The numbers below correspond to the numbers we have placed in the margin of the CalRecycle’s response.
We are disappointed with CalRecycle’s reluctance to assume leadership responsibility for the proper disposal of home-generated sharps and pharmaceutical waste, especially given that CalRecycle itself in its recommendations report recognized that there was a pressing need for a single state agency to lead these efforts, as we discuss in the Audit Results. Throughout its response, CalRecycle correctly describes some of the difficulties facing the State with these efforts because of the involvement of various government agencies and the complexities of the existing legal and regulatory structure. These difficulties are, in part, due to the absence of a lead state department to coordinate with local, state, and federal agencies to find solutions, and to propose legal and regulatory changes to streamline the disposal process. Therefore, we stand by our conclusion that CalRecycle is best positioned to take leadership responsibility over the proper disposal of home-generated sharps and pharmaceutical waste.
We clearly recognize that CalRecycle lacks the authority and possibly the funding to assume the lead role for the proper disposal of home-generated sharps and pharmaceutical waste. Therefore, as we recommend in the Audit Results, if the Legislature entrusts CalRecycle with this leadership role, it should provide CalRecycle statutory oversight responsibility, which would include enforcement power, as well as additional resources to the extent that CalRecycle can demonstrate the need.
Our report does not suggest the use of curbside service as a collection method for disposal of pharmaceutical waste that contains controlled-substances. Rather, as indicated in the Audit Results, the State could recommend local entities include collection of home-generated sharps and pharmaceutical waste; other than controlled substances, as part of local waste contracts. We also find it perplexing that CalRecycle would criticize curbside service as an option when data we obtained from its website shows that five local entities reported to CalRecycle that their household hazardous waste sites operated either a curbside or door-to-door program during fiscal year 2015-16 to collect pharmaceutical waste. Similarly, this data also indicated that 23 local entities also reported to CalRecycle that their household hazardous waste sites operated either a curbside or door-to-door program for home-generated sharps collection.
While preparing our draft report for publication, some page numbers shifted. Therefore, the page numbers CalRecycle cites in its response do not correspond to the page numbers in our final report.
This is an issue that we would have expected CalRecycle to discuss with us during its review of the draft report. Yet, despite numerous attempts to contact CalRecycle, it declined to discuss these concerns during its review of the draft report. Nevertheless, we have made a minor change to the report text to address CalRecycle’s concern.
Senate Bill 1305 (Chapter 1305, Statutes of 2006) encouraged the predecessors of both CalRecycle and Public Health, among other entities, to identify on their web sites locations that accept home‑generated sharps. As we note in the Audit Results, Public Health has chosen to make this list available as a public service, but indicated to us that it does not ensure that the list is accurate or complete. In fact, our analysis found that the list contained errors. That is why, in recommending that the Legislature provide CalRecycle with oversight authority for the proper disposal of home-generated sharps and pharmaceutical waste, we also recommended in the Audit Results that one of its responsibilities should be to maintain an up-to-date, well-publicized, and accessible statewide list of collection sites.
Contrary to CalRecycle’s assertion, all three California waste-to energy incinerators have either processed home-generated pharmaceutical waste in the past or their operations documents explicitly allow them to accept pharmaceutical waste under certain circumstances, as we note in the Audit Results. However, as we also state in the Audit Results on that same page, these incinerators may put their permits at risk if they accept pharmaceutical waste that is hazardous under state law. Therefore, to reduce the cost of processing home‑generated pharmaceutical waste, we recommended in the Audit Results that the Legislature expressly authorize solid waste incinerators to burn limited quantities of this waste. If the Legislature adopts our recommendation, this will facilitate or eliminate many of CalRecycle’s concerns.
CalRecycle’s statement implies that the expiration of SB 966, which required CalRecycle to develop the model guidelines, diminishes their relevance. Yet, CalRecycle’s website currently includes discussion of the model guidelines as well as links to them, which would indicate that CalRecycle continues to believe that the model guidelines have applicability. Moreover, because the model guidelines are the State’s most recent efforts to better manage the proper disposal of home-generated pharmaceutical waste, we believe that a discussion of these guidelines is relevant and valid in the context of our audit scope.
We agree that CalRecycle does not oversee commercial hazardous waste or medical waste incinerators, because, as we indicate in the Audit Results, there are none of these types of incinerators operating in California. However, CalRecycle does oversee the State’s three waste-to-energy incinerators for solid waste which can incinerate pharmaceutical waste as we note in the Audit Results.
CalRecycle overstates the usefulness of its FacIT database. As we note in the Audit Results, the FacIT database contains inaccuracies, in part because it is based on Public Health’s inaccurate database, and also because, as CalRecycle acknowledges in the Audit Results on the same page, it did not design FacIT to track sharps and pharmaceutical collection sites. Regarding CalRecycle’s claim that the FacIT database is “user-friendly,” we note in the Audit Results that, users must navigate a detailed set of drop‑down menus and choose among many potentially confusing options and that the database is not configured for use on mobile devices—both of which create difficulties for potential users. Further, the accuracy of CalRecycle’s secondary site, http://www.calrecycle.ca.gov/Recycle/Maps/, is also dubious because it is based on the inaccurate data from FacIT. While we appreciate that CalRecycle has voluntarily made these lists available, until CalRecycle can improve their accuracy and accessibility, their usefulness is limited.
CalRecycle mischaracterizes our recommendation. Contrary to CalRecycle’s statement, our recommendation in the Audit Results is, among CalRecycle’s responsibilities, that it encourage municipalities to include sharps and pharmaceutical collection as part of local waste contracts, not that it impose such a requirement on them. We are also fully aware that there are legal requirements that CalRecycle and municipalities will need to consider. But by taking on the oversight responsibility that we recommend, CalRecycle will be positioned to help municipalities navigate those legal requirements.
CalRecycle is correct that federal law exempts home-generated pharmaceutical waste from the definition of hazardous waste. However, California’s definition is more broad and creates ambiguity over whether the State’s waste-to-energy incinerators may accept home-generated pharmaceutical waste from sources other than law enforcement. Because of this ambiguity, our recommendation in the Audit Results is that the Legislature should expressly authorize these solid waste incinerators to burn limited quantities of home-generated pharmaceutical waste.
We are puzzled as to why CalRecycle questions the funding source for the advanced disposal fee program, the fourth option in its recommendations report. As we state in the Audit Results, this option would require consumers to pay a fee at the time of purchase to finance the waste collection program. However, this option is inconsistent with one of the criteria the Legislature established for model programs, which was that there should be no additional cost to consumers.
CalRecycle’s statement that our report “discounts pursuing EPR legislation” is incorrect. To the contrary, we recommend in the Audit Results that the Legislature adopt standard requirements for counties to follow when implementing EPR programs, which would help ensure consistency and limit additional costs imposed on consumers.