【Haichuan Environmental News 2】The Strictest “Technical Thresholds” in the Country – Zhejiang’s Emission Standards for Air Pollutants from Chemical Synthesis-Based Pharmaceutical Production

Taking action against the \"hidden killers\": In recent days, the severe air pollution in the Beijing-Tianjin-Hebei region has not subsided, and similar severe pollution has returned to the Northeastern region; PM2.5 levels in many cities across the country have reached dangerous levels. Amidst the gray haze, air pollution has once again become a hot topic. “Pollution by volatile organic compounds, represented by the ozone index (referred to as VOCs in this text), has not decreased but rather increased in certain areas and during certain periods in Zhejiang, creating a serious situation that demands urgent measures for prevention and control. ”Lu Chunzhong, deputy director of the Provincial Department of Environmental Protection, said in a media interview that since Zhejiang’s pharmaceutical industry is primarily focused on the production of chemical drug raw materials, there are significant environmental pollution and risks associated with production, storage, and transportation processes, resulting in considerable pressure to control VOCs. There is a famous curve in economics known as the Kuznets curve. This inverted “U” shape illustrates the dilemma that all developed countries have encountered in the process of modernization: the more economically developed a country becomes, the more severe its environmental pollution becomes. Today, Zhejiang seems to be struggling to climb up the steep upward section of this curve. According to the latest estimates, Zhejiang’s annual VOC emissions from the manufacturing of chemical drug raw materials amount to 38,680 tons, ranking it seventh among the industrial pollution sources in the province, accounting for 4.6% of the total emissions. Since the chemical pharmaceutical industry involves numerous raw materials and ingredients, if not handled properly, it can easily cause problems such as water and air pollution; in particular, there are issues related to unpleasant odors and high ozone concentrations caused by VOC emissions. According to the monitoring and analysis of urban air quality conducted by the Provincial Environmental Monitoring Center from January to September this year, the maximum 8-hour average concentration of ozone in cities at the county level and above increased by 1 microgram per cubic meter compared to 2015. In 50 county-level cities, there were days when the ozone levels exceeded the permissible limits, with an average excess rate of 10.4% in cities with district status. With the further advancement in air pollution control, the prevention and control of VOCs has gradually become a top priority. The newly enacted **Air Pollution Act** stipulates that pharmaceutical companies must implement stricter management practices, adopt measures such as centralized collection and treatment, in order to strictly control the emission of dust and gaseous pollutants. The 12th Five-Year Plan for Air Pollution Prevention and Control in Key Areas designates the manufacture of chemical drug APIs as a key industry. “The standards introduced by Zhejiang this time focus on addressing VOCs, the main source of ozone pollution, and will have a positive impact on improving the environmental air quality in areas where pharmaceutical companies are concentrated in Zhejiang, as well as on reducing the odor problems caused by these companies and the amount of pollutants emitted. ”Zhang Fujian, head of the Department of Science, Technology and Cooperation at the Provincial Environmental Protection Agency and a senior engineer, aptly compared the \"Standards\" to \"technical red lines,\" using a professional perspective to set red limits for pollutant emissions and providing protection for the public, ensuring that they share the same breath and fate.

The strictest “technical red lines” in the country: Looking at the newly introduced Standards, differentiated treatment based on quality and category, along with phased implementation, constitute a key feature. In accordance with the Standards, VOCs are classified into three categories – A, B, and C – based on criteria such as \"severe impact on human health,\" \"impact on human health or high potential for ozone formation,\" and \"evidence of photochemical effects on the environment.\" There are 16 substances in Category A and 33 in Category B, covering the typical VOC pollutants found in chemical active ingredients. “As early as 2015, the Provincial Department of Environmental Protection and the Provincial Academy of Environmental Sciences began conducting a survey of enterprises in the province that were subject to severe VOCs-related pollution. Using more than 170 key chemical drug raw material manufacturers in Zhejiang as a basis for the investigation, they identified over 300 different VOCs substances. ”According to Dr. Xu Zhirong from the Policy and Standards Research Institute of the Provincial Academy of Environmental Sciences, which was involved in the development of these standards, aside from the dioxin levels which are on par with **the standard**, all other parameters are stricter than **that standard**. For example, the emission limit for benzene is 1 microgram per cubic meter, which is much stricter than the standard of **12 micrograms per cubic meter. It is worth noting that in addition to setting general emission limits for air pollutants, the Standards also establish higher and stricter special emission limits for air pollutants. Under the general emission limits for air pollutants, the emission limits for particulate matter and hydrogen chloride are 15 and 10 micrograms per cubic meter respectively. Under the special emission limits, these values are set at 10 and 5 micrograms per cubic meter respectively, which is only two-thirds and half of the normal emission limits. “Special emission limits are set to facilitate local **adjustments to industrial planning. ”Xu Zhirong explained that the decision on whether to implement special emission limits lies with the local authorities. Keeping up with the times is also a key feature of standard-setting. In the past, the main control techniques for VOCs in Zhejiang’s pharmaceutical industry have been methods such as spraying, adsorption, and low-temperature plasma oxidation; however, these approaches yielded unsatisfactory results and were prone to causing secondary pollution. Combustion treatment methods such as incineration are currently the most effective ways to remove VOCs; they are suitable for dealing with waste gases that are highly concentrated and have no value for recovery, with a removal efficiency of over 95% in most cases. This method is being gradually adopted in Zhejiang. In light of the increasing adoption of combustion treatment technologies such as incineration, the Standards also specify requirements for a baseline oxygen content, thereby filling a regulatory gap and ensuring thorough combustion of VOCs to prevent diluted emissions.

This forces a reshuffle in the pharmaceutical industry. Addressing air pollution cannot be achieved in one go; it must go hand in hand with the optimization of the industrial structure. The pharmaceutical industry has always been a key sector for regulation in Zhejiang. As early as the Zhejiang Province Clean Air Action Plan, it was required that the pharmaceutical industry take measures to address organic waste gases, ensuring that both the emission concentrations from exhaust stacks and those at the factory boundaries met the specified standards. In the successively issued \"Implementation Plan for the Prevention and Control of Air Pollution from Multiple Pollutants in Zhejiang Province\" and \"Plan for the Control of Volatile Organic Pollutants in Zhejiang Province\", the pharmaceutical industry has also been identified as a key sector for VOCs control in Zhejiang, with requirements to carry out relevant remediation actions. In accordance with the requirements of the Standards, new projects have been required to comply with them as of October 1 this year, while existing enterprises must do so by October 1, 2018. Enterprises that fail to meet the standards will face strict restrictions on production or even suspension of operations until they can meet the emission requirements. “By setting a two-year buffer period, it gives enterprises an opportunity to conduct self-assessments and make adjustments, while also leaving the decision of whether to implement things ahead of schedule in the hands of local authorities, who can make judgments based on the actual circumstances. ”Zhang Fujian believes that the implementation of standards is equivalent to introducing a pair of \"tangible hands\" to intervene; it relates not only to environmental protection but also to economic conditions and industrial structure adjustments, and can trigger a series of \"butterfly effects.\" Therefore, it is necessary to give enterprises some time to catch their breath. In fact, during the formulation of the Standards, not only the environmental protection bureaus of various counties (cities, districts) contributed their opinions, but also the departments in charge of development and reform, economy and industry, quality supervision, and environmental protection at the provincial, municipal, and county levels, as well as various chemical synthesis-based pharmaceutical companies, all had the opportunity to express their views. “During the formulation process, the most common feedback was that the standards set were too high and difficult to meet, but in fact, some companies have already satisfied the requirements. ”Zhang Fujian said that the \"Standards\" essentially serve as a measure for the pharmaceutical industry; they create pressure to phase out outdated production methods and highly polluting enterprises. This forces synthetic pharmaceutical companies to increase their investments, innovate their production processes, improve pollution control measures, and undergo transformation and upgrading. “Of course, we also oppose companies making blind investments and undergoing renovations merely out of fashion. For companies with outdated equipment and obsolete technology, or those whose products lose their competitiveness in the market even after barely meeting the standards, this is also an opportunity to shift to other industries or business areas at an appropriate time. ”Zhang Fujian believes that the implementation of these \"Standards\" will lead to a reshuffle in the development of the chemical synthesis-based pharmaceutical industry, and it is an inevitable trend for backward enterprises to be eliminated. (Reporter Jiang Fan)

Zhejiang’s “Emission Standards for Air Pollutants from Chemical Synthesis-based Pharmaceutical Manufacturing” have been issued and put into effect by the provincial authorities