The New Test of Environmental Protection for Six Kinds of Pharmaceutical Enterprises
The Chinese Ministry of Environmental Protection has recently issued “Regulations on Permits for Pollutant Discharge (Trial)” (hereinafter referred to as “the regulations”) and six kinds of pharmaceutical enterprises will face a new test of environmental protection.
The regulations stipulate the different responsibilities of enterprises with different environmental hazards. According to the list of classified management of pollutant discharge permits for fixed pollution sources issued by the Ministry of Environmental Protection in July, 2017, the key management objects for pollutant discharge in pharmaceutical industry are units with large quantities of pollutants, large discharges and high environmental risks, including four categories: manufacturing enterprises which further process raw materials needed for the preparation of chemical drugs and are pharmaceutical intermediates mainly used in drug production, outsourcing enterprises of the manufacture, research and development of chemical drugs, outsourcing enterprises of the manufacture, research and development of veterinary medicine, and outsourcing enterprises of the production of biochemical drugs, genetic engineering drugs and the research and development of biological drugs by biological technology. There are two kinds of pharmaceutical enterprises of implementation of simplified management: Chinese patent medicine production enterprises with refining technology, and manufacturing enterprises of hygienic materials, surgical dressings, drug packaging materials, auxiliary materials and other internal and surgical medical products. All the above units shall apply for the pollutant discharge permit according to the prescribed time limit, and discharge pollutants according to the provisions of the pollutant discharge license. The pollutant discharge unit that should have the pollutant discharge license but has not obtained it shall not discharge pollutants.
The regulations clarify the procedures for issuing permits and the permits for discharge of pollutants. Besides, the regulations set penalties for five cases of undocumented sewage, illegal sewage, material fraud, illegal monitoring, and unlawful disclosure of environmental information. Among them, the serious case will not only face a fine of 1 million yuan, but also will be ordered to shut down.
The Ministry of Environmental Protection requires that the licensed pollutant discharge units must discharge the pollutants within the allowable emission concentration and the range of allowable emissions of the pollutant discharge license. In addition, they should carry out their own monitoring, set up records and write implementation reports to ensure the strict implementation of related requirements of the pollutant discharge license. The Ministry of Environmental Protection will carry out unified coding and management of pollutant discharge units and their production facilities, pollution prevention facilities and discharge ports.
Eddited by KOSBEST