21 June 2001 Mr. Grant McPhee Zone F/15 Ashdown House 123 Victoria Street London SW1E 6DE Dear Mr. McPhee Thankyou for the opportunity to respond to the Review of Special Waste Regulations (March 2001). Our comments are enclosed below, but please note that papers were originally sent to our old address. Our new address is detailed above and we would be grateful if you would update your records for the future: Comments on recommendations by Enviros Aspinwal relating to the Review of Special Waste Regulations General The Sanitary Medical Disposal Services Association is a Trade Association representing the views and interests of a majority of contractors operating in the clinical and sanitary waste sectors. With relevance to this review our comments relate mostly to Pharmaceuticals and, in particular Prescription only Medicines (POMs) and some Low Level Radioactive wastes (which are made Special by virtue of the presence of solvents with a flash point <55C). We have included comments also that reflect our members‟ views in the general case. Our members operate a number of high temperature incinerators with a varied range of authorisations and permits for both Hazardous and non-hazardous clinical wastes (many in each category also holding RSA3 permits for disposal of LLRA waste), and in addition, the majority of clinical waste transfer stations in the UK many of which are also licensed to receive Special wastes (essentially POMs). Our members‟ customers include the large-scale producers within the NHS, and range down through other Healthcare waste producers to (at the small scale end of Special waste producers) high street chemists who may produce only a single small package once or twice per year. The latter are normally collected by our members on a Carriers‟ Round with a large number of small collections being delivered initially to a transfer station before re-consigning a larger shipment to an incinerator. These consignments include movements throughout the UK and between Scotland/England and England/N. Ireland. The SMDSA thus represents interests across the full spectrum of this industry. Department’s Proposals - Para 1.9: Although it is stated that the review will resolve inconsistencies between the Hazardous Waste List and the Special Waste Regulations, in adopting a more stringent approach domestically we still have hazardous waste as defined in the UK, and Directive Hazardous waste. This will continue to cause problems and we would query if it is necessary to adopt a more stringent approach than the Directive. If other Countries do not do so then for example statistics on hazardous waste between Member States will not be comparable, and implications of the Landfill and Waste incineration Directives will vary from state to state. In the wider sense this may have both cost and competition implication to industry. The wider definition of hazardous waste proposed (whereby thresholds are not applied to listed wastes, and non listed wastes would be hazardous if falling within any hazard criteria, rather than the more limited list as before) will mean that the amounts of waste classed as hazardous will in the medium term increase. We would agree that an audit trail that confirms disposal to the producer rather than The Agencies is preferable.
We do not agree that this reduces the administrative burden on the industry. It will actually increase it. Whilst the burden of responsibility may be shifted to the producer, the administrative burden will not, since, experience of previous changes shows that producers will expect carriers and disposers to produce documentation on their behalf. This has been particularly evident within the NHS. Changes to special waste definition Paras 2.3 – 2.5 See comments above. Removal of thresholds for Listed Wastes and extension of all hazard criteria to any unlisted waste considerably widens the scope of the Regulations and is an increased legislative and financial burden on industry. As stated, our members own and operate a range of incinerators. The largest plants are Part A processes which have IPC authorisations including variations issued in 2000 permitting the disposal of hazardous wastes, as defined by the Hazardous Waste Incineration Directive, a definition substantially different to the definition of Special Waste. All the other plants are Part B processes having Waste Management Licences as well as authorisations. None of these plants are authorised to incinerate hazardous waste, although most are permitted to incinerate Special Waste. The vast majority of the Special Waste incinerated is in the form of outdated Prescription Only Medicines (POMs) with smaller quantities of cytotoxic drugs and waste chemicals from hospital pharmacies. Many of the latter group also have authorisations issued under the Radioactive Substances Act 1993 to incinerate low level radioactive waste, most of which arises from the diagnosis and treatment of cancer patients. A particular type of radioactive waste – organic liquid scintillants – creates a specific problem, as the waste is Special as well as radioactive, and also meets the criteria for hazardous waste (flash point < 55C). Hence these plants are not authorised under the HWID to incinerate hazardous waste, but are under RSA 1993 to incinerate a waste type that meets one of the hazardous waste criteria. The problem has been overcome by agreement with the Environment Agency to apply RSA 93 alone, but needs to be enshrined in legislation. Para 2.8 If the rest of Europe does not classify prescription only medicines (POMs) as hazardous waste, we fail to see why they should be in the UK. Although this has historically been the case since the 1980 Regulations, it simply adds to the cost and administrative burden of disposal of very small amounts of such wastes. It is difficult to see how adding selected medicines to the EWC would work, as presumably the list could be vast, and would need constant updating. If it is intended that all POMs are hazardous waste (and therefore subject to the full range of controls) then it needs to be made clear to The Agencies that this is the case and fully enforced. If, on the other hand, it is permissible for the Agencies to rewrite “deminimus” clauses to effectively exclude part of a waste stream then this should be written into the legislation. We refer to the practice by The Agencies of not acting over failure to consign „fully discharged‟ sharps that contain small amounts of POMs. Para 2.9: Issues in relation to submitting evidence to the regulators regarding what is hazardous or nonhazardous will result in disagreements and test cases (like whether flower pots are waste, bringing ridicule on the whole industry). A better system of appeal should be implemented, independent from The Agencies Para 2.12: As indicated above the definition of hazardous waste proposed would not be based solely on the Directive and the revised EWC Approved Supply List/CHIP - Para 2.13: Once newer versions of CHIP (or any documents of this type) are produced, older ones are no longer available. Reference to older versions of CHIP therefore could mean that they cannot be obtained. The Department needs to take steps to prevent this happening. New requirements for Agencies - Para 3.3:
The outcome of this is that the Agencies will inspect those who consign special waste and register as producers to see if they are doing it properly. However those who never consign and never register will not be inspected. The result will be that those who attempt to comply will be targeted and those who don‟t will avoid inspection and hence enforcement. This has been a common complaint of many recent legislative introductions. What is particularly important is to ensure that any changes made by The Agency eg devoting less resources to special waste and more to inspection, are reflected in their charges for hazardous waste and other activities in an equitable manner. Producer registration system - Para 3.4: We welcome the proposal to introduce Producer Registration as a means of increasing producer awareness and best practice, but consideration should be given to allowing contractors to register small scale and especially one off small scale producers, with charges paid by contractors and passed on to producers. Many of our customers are pharmacists and similar premises. We can see no reason why registration should be annual. Small and infrequent producers, would thus have to reregister for every few loads. Registration could be indefinite, and The Agencies required to send out an annual bill to all those registered, based on the amounts of waste they produced in the previous year, rather than producers having to pro-actively register. Producers could then de-register by not paying. That would also mean that The Agency would have an indication of who may be hazardous waste producers from previous years registration, otherwise, a producer may continue to produce the waste, even if not re -registering. There will be a requirement to produce some form of registration certificate. Para 3.5: Adjusting fees payable in following years would have to reflect both the need for increases or decreases. It would be unacceptable for Agencies to be able to require any increases within the year, but only give refunds by decreasing the following years fee. Para 3.4/3.8: Although reference is made to producers retaining responsibility, and identifying the amounts/types etc to be produced, if contractors are able to register for small scale producers this would need to reflect that the contractor can provide that information. Also that one off producers need not contact The Agency, but can be registered by their contractor as part of a Carriers‟ Round, as it would be illogical for regular producers to be registered by contractors, but not one off collections. Para 3.7: If the intention is to free Agency resources for advice to industry the Department will need to ensure that such advice is actually available and given. Currently, obtaining advice or definite opinions from The Agency is impossible, and such Guidance as is available is frequently in the form of a very expensive documents. Removal of pre-notification - Para 3.9/3.10: Further justification for removing the need for 72 hour pre-notification is that there are already many provisions for eliminating pre-notification by successions, used for many wastes, and that The Agencies frequently do not react within the 72 hours in any case. However the suggestion that prenotification gives Agencies scope to prevent inappropriate disposal is largely incorrect. The very greatest number of pre-notifications are for proper disposal, and if a contractor or producer were going to carry out inappropriate it is unlikely that they would notify the Agency to that effect. By not consigning the waste at all, they would be far less likely to be detected. That presents a further justification, in that pre-notification does not even fulfill the purpose for which it was intended.
Most clinical waste incinerators and treatment plants are only permitted to store waste for 48 hours. In the event of breakdown, it is impossible to pre-notify waste for onward movement without breaching the storage restrictions. Whilst the Agency is considerate on this point, it provides a further justification to remove pre-notification. Producer Quarterly Returns -Para 3.11: If contractors (as carriers or consignees) are allowed to register and provide the details of likely consignments as suggested, it would be logical for them to be able to provide The Agencies with the producers quarterly summaries. As above it is inevitable that contractors will be required to do so anyway. Again, in the case of small producers, the Agency would end up with vast quantities of summaries whereas the contractor could provide these in more concise format. The reference to the overall burden being less, in view of producers not being required to pre-notify overlooks the fact that they do not currently pre-notify in many cases anyway, and this again is usually done by the contractor Given the very small amounts concerned with pharmacists for example, the need for quarterly returns is disproportionate, and annual returns should be allowed below certain producer based limits Consignee Quarterly Returns - Para 3.12: As operators with large numbers of small producers as customers, the provision of combined producer/consignee summaries would be very much more efficient and would provide The Agencies with all the detail required in a much more effective manner. Notification producers of receipt - Para 3.13/3.14/3.15: We strongly disagree with the statement that that this will not significantly increase workload on the industry. Currently, our members‟ sites will send all the yellow copies in a single envelope to their Agency. The proposal suggests that each one will have to be returned each to its individual producer. We would acknowledge that in many cases copies of consignment notes are sent with invoices, frequently invoices are not received or handled by the person who would require to receive the yellow copy and often they are not even on the same site. We can envisage that substantial duplication will occur with greatly increased cost and workload. It is also proposed that the consignor may not be the waste producer, when later the proposal is that only producers can consign. With collection rounds there is only one producer copy of the consignment note, and therefore each producer would be sent a photocopy. Whilst this may be adequate for invoicing, it is open to abuse and alterations could not be detected on a photocopy, whilst this is not the case with an NCR copy. The receipt sent to the producer in the case of multiple copies for carriers rounds will not therefore replace the receipt copy currently sent to the Agency, and one piece of paper is being replaced by potentially up to 30 or 40, all requiring post. This is neither cost effective or environmentally sound. In the case of waste going via transfer stations, it would need to be made clear in regulations that the producer receipt confirms receipt at that site, not the final disposal site. For disposal sites to send confirmation of receipt to producers when the waste has come via transfer stations would be unrealistic and unworkable. It would mean that a carrier/contractor would have to be prepared to give a disposal site full customer details, and this may compromise commercial sensitivity. Multiple carriers on conisgnment notes - Paras 3.16/3.17: It is presumed that this transfer between carriers excludes hand over at transfer stations, and envisages changeover at ports. However the problems with shipments from Northern Ireland/Great Britain is not the use of different carriers at each end, but that different notes are required by different legislations in NI and Great Britain for each end of the journey, whether one carrier or multiple carriers. What is required therefore is not just a single consignment note when multiple carriers are involved, but also when one carrier moves waste between NI and Great Britain. We would however welcome the proposal in respect of changing vehicles and/or driver.
Producer/holder as consignor - Paras 3.18/3.19/3.20: See comments above re reviews suggestion in Para 3.14 that consignor may not be waste producer, which contradicts this proposal (other than when transfer stations re-consigns waste as a new producer). It is very common in this industry sector for the carrier etc to be the consignor to ensure that correct information is given and forms correctly completed. This is particularly the case for small producers and frequently for the even the NHS. In the latter case, collections from the NHS are frequently made out of normal hours due to heavy site congestion, and competent persons are often not available to sign paperwork out of hours. To force daytime collections will greatly increase costs to our members. The 1980 Special Waste Regulations required producers only to consign, and this was changed in 1996. We doubt there is any evidence that indicates that others consigning is a problem. Whilst producer consigning is consistent with the Duty of Care, the 1996 Regulations expanded consigning to others at the same time as DOC was being heavily promoted. In the case of carriers rounds, it is impossible for each producer to consign, which appears to have been overlooked. The text refers to producers only consigning, but the heading refers to producer/holder. Given this, and the earlier comments this section reflects confusion over what is proposed. Amendments to carriers round notes - Para 3.21: Enviros Aspinwall have misinformed the Department on this issue, as there is clearly already a requirement for totalling of carriers rounds under the existing system, at the time Section E is filled in, to record the amount of waste accepted from the carrier. That must therefore be done by the carrier or the consignee already. If The Agencies are reporting receipt of notes without amounts totalled, they should have been contacting consignees as regards incomplete filling of Section E. There is therefore no burden on regulators to total waste, and no amendment required. We have contacted Enviros Aspinwall regarding this error, but they have not responded. Charges – Paras 3.22 – 3.27 The main waste we collect, POMs and possibly sharps special by virtue of POMs has very little scope for re-cycling or re-use (other than energy from waste when incinerated) and there would be unlikely for any incentive to do so. Any charges should specifically reflect wastes of this type, and in fact they should attract a lower fee as any charges largely impact upon the health services, both private and NHS. In the same way that a lower charge was allowed for lead-acid batteries to accommodate the scrap industry, a special case should be made for POM related wastes. As clinical waste facilities tend to be less in number any charge based on proximity would not be workable. Where contractors register on behalf of producers, a system will be needed to reflect that these change throughout the year, and that new ones can be added, and older ones removed. An overall system of fee paying based on the total number of consignments/amount/types of waste moved by the contractor will be required, rather than being based on each small scale producer. Separation of special waste – Para 4.1/4.2: The inclusion of “where technically and economically feasible” is unlikely to be enforceable. It is for example both technically and economically feasible to separate sharps from other wastes, but the health services, both private and NHS, persist in failing to do so.
General Comments: Infectious: A clear definition is required for the word “infectious” with respect to hazardous waste. Current policies of The Environment Agencies result in yellow sacks of waste being labelled as infectious (if Group 2 or 3 pathogens) under Carriage of Dangerous Goods legislation, but not being infectious for special waste purposes. The two need harmonising, and we would suggest if such waste is not hazardous then it should not be classified as Dangerous Goods for Transport, unless the high levels of infection (Group 4 pathogens) are being reached. Alternatively if it is Dangerous Goods, then it should be consigned as hazardous waste. These mismatches between carriage and waste legislation result in considerable misunderstandings and incorrect application Prescription only medicines: As indicated earlier, if the Department are minded to continue to include POMs, then a threshold should be included to cover small amounts, or The Agencies should be made quite clear that they cannot introduce the non-consignment of special waste by the back door. This should be in guidance accompanying new Regulations that clarifies that there is, or is not a threshold. These policies have also resulted in The Agencies allowing sites which are not licenced to receive Special wastes, handling large quantities of Sharps which are likely to be Special by strict definition. If apragmatic approach is to be taken then this should be formalised in legislation. European Waste Catalogue: In any DETR Guidance accompanying new Regulations, the intent behind the changes to the EWC should be explained Eg: 18 01 03 – „removal of the word „other‟ Special Waste Explanatory Notes Since 1996, a significant number of Special Waste Explanatory Notes ( SWENs ) have been published to clarify various issues, but these are not generally available and many customers are unaware of their existence and contents. It would be beneficial to see the SWENs included in the review, or alternatively, published as a complete document that is more generally available.
Yours sincerely
Martin Foulser Secretary