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Imposing EPR for End-of-Life Medicines and Batteries
By Keith R | May 31, 2007
Topics: Corporate Social Responsibility, Environmental Protection, Hazardous Substances, Pharmaceutical Issues, Waste & Recycling | No Comments »
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Loading...Back in April, Colombian Environment Minister Juan Lozano promised proposals for mandatory extended producer responsibility (EPR) regimes for expired medicines and end-of-life (EOL) lead-acid batteries. Earlier this month he made good on that promise: the Environment Ministry (Ministerio de Ambiente, Vivienda y Desarrollo Territorial –MAVDT) has published for public comment two draft decrees, one on medicines, the other on lead-acid batteries and accumulators.
Common Elements
The two proposals share many elements in common, namely:
Primary responsibility for ensuring compliance with the new rules will be on all persons, natural and judicial (i.e., companies) that manufacture or import the product. These parties can chose to work jointly or even contract third parties to implement key provisions, but it still will be the producers/importers held responsible if compliance falls short.- Broadest product coverage — all types, sizes, brands and end uses [for example, the medicines decree will even cover veterinary drugs and the batteries decree sealed lead-acid batteries and lead-acid batteries used for inverters, back-up power arrays and uninterruptible power supplies (UPS)] throughout the country.
- Producers/importers must submit to MAVDT, implement and update annually very detailed Management Plans for Post-Consumer Product Return covering everything about how the EOL products will be returned, collected, stored, transported, treated and recycled or adequately disposed of, including timetables, quantitative goals and designation of operational responsibilities. There is a key difference between the two products though: medicine producers/ importers only have a year to submit their Plans, while lead-acid battery producers/importers have 18 months.
- Tough recovery targets are set for each product, and these must be reflected in the Management Plans submitted and companies must report on their progress toward meeting them. The goals for each product differ, though (see below).
- Manufacturers/importers must report annually extremely detailed data to MAVDT, including the number of the products placed on the Colombian market by type, brand and useful life. Manufacturers cannot withhold most of this data by citing trade secrets protection. MAVDT will publish aggregated data on its website.
- Distributors and points of sale (which in the case of medicines would include all pharmacies and most supermarkets) must participate in the execution of the Management Plans, primarily as collection and transfer points. These parties are also primarily responsible for instructing end-consumers on safe return procedures and the health and environment risks of the EOL products involved.
- Both type of EOL products will be banned from sanitary landfills and so-called “security cells” within such fills, from being treated or recycled by unlicensed operations, from being abandoned in open-air dumps or being burned.
Important Diffetrences
There are key differences, however. One involves scope: the draft medicines decree would also make producers/importers responsible for medicine packaging and labels by defining them as “an integral part of the product.”
Another involves the recovery targets. The regime for lead-acid batteries and accumulators is relatively simple: by 2010 90% by weight must be recovered in all of Colombia, rising to 95% by 2012. The expired medicines targets are more complex:
- in the first year, the program must cover all of the metropolitan areas with population of two million or more (i.e., Bogota, Cali and Medellin);
- second year, all those with one million or more (i.e., adding Barranquilla);
- in the third, all with over 300,000 (i.e., adding another 11, including Cartagena);
- fourth year, 50% of the national territory;
- fifth year, 80% of the national territory.
A third major difference is the emphasis on recycling: it is not really an option for medicines, but for the lead-acid batteries and accumulators, MAVDT wants recycling of all their components to be top priority.
A fourth difference involves waste prevention, reduction and minimization: only the decree on batteries calls for producers/imports to propose strategies to minimize/reduce the wastes caused by their EOL products, and to “rationalize their design” and the selection of materials and packaging in order to minimize waste generation.
Input Wanted
If you wish to submit comments on either proposal, you have until 15 June to email them to jarodriguez@minambiente.gov.co for the medicines proposal, or alopez@minambiente.gov.co for the battery proposal, or mail a print version of your comments to
Dr. César Augusto Buitrago
Director, Dirección de Desarrollo Sectorial Sostenible
Ministerio de Ambiente, Vivienda y Desarrollo Territorial
Calle 37 No. 8-40
Edificio Anexo segundo piso
Bogotá
MAVDT asks that your coimments follow the format found in this document.
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