On January 3, 2017, Zhejiang Huabang Pharmaceutical and Chemical Co., Ltd. located in Linhai, Zhejiang, experienced a detonation accident that resulted in three deaths due to design defects and human errors. The main cause of the accident was due to the failure to conduct reaction risk research during the research and development process, and the lack of data on the decomposition temperature of the product whey acid. The design adopted a steam heating method that is prone to overheating. On January 5th, the State Administration of Work Safety issued the "Guiding Opinions on Strengthening the Safety Risk Assessment of Fine Chemical Reactions" (General Administration of Work Safety [2017] No. 1, hereinafter referred to as the "Guiding Opinions"), which clarifies the scope and content of fine chemical reaction safety risk assessment, and reflects the application of risk assessment results to strengthen the safety production management of fine chemical enterprises, improve the level of intrinsic safety, and enhance the ability of enterprise safety production guarantee. Based on the current situation of pharmaceutical and chemical enterprises in Taizhou City and the requirements of the higher-level safety supervision department, and after conducting medical and chemical investigations and research within the jurisdiction, the following thoughts have been made on carrying out safety risk assessments for fine chemical reactions:

1、 The necessity of conducting safety risk assessment for fine chemical reactions

1. The needs of the enterprise itself. The Huabang accident fully demonstrates the importance and necessity of conducting risk safety risk assessments. If Huabang Company conducted risk research before the project was put into operation and learned that during the preparation of whey acid, there would be an instantaneous pressure increase at a temperature of 105 ℃, and steam heating was not chosen, accidents could be avoided. Conducting a reaction safety risk assessment provides a basis for enterprise product development, enabling early awareness of the hazards of materials and processes involved in the product. Especially during the research and development stage, a batch of products with high process hazards and difficult safety control can be eliminated. At the same time, a risk safety assessment of existing product reactions was conducted, and a comprehensive physical examination of the production process was carried out to promptly identify safety hazards in the existing chemical processes, ensuring a clear understanding and preventing potential problems before they occur.

2. The need for government regulation. The safety supervision department has a long history of risk management for hazardous chemicals. For example, the A-level elements in the acceptance evaluation of hazardous chemical safety standards clearly require enterprises to carry out risk management. At the same time, the 12 related elements in the "Guidelines for the Implementation of Process Safety Management in Chemical Enterprises" (AQ/T3034-2010) include process hazard analysis elements. The Guiding Opinions have further clarified the study of reaction risk, requiring enterprises to select automation control systems based on the assessment level of reaction process hazard, and have clear requirements for the installation of automation levels, which are more detailed and operational. Conduct a reaction safety risk assessment, reproduce the accident process through experiments, and facilitate the investigation and analysis of the cause of the accident. Facilitate project source management, conduct in-depth analysis of project processes before implementation, eliminate outdated hazardous materials and projects in advance, reflect safety risk assessment conclusions, and provide a basis for government decision-making.

3. The need to enhance the medical and chemical industry. At present, Taizhou City is preparing to establish the Zhejiang "Thousand Talents Plan" Taizhou Biomedical Industry Research Institute. In order to ensure the development of Taizhou's medical and chemical industry towards a safer path, the construction of the Reaction Safety Evaluation Center has been listed as a priority development project, indicating that the government recognizes the importance of reaction safety risk research and evaluation for the improvement of the medical and chemical industry. The development of products is based on safety, and R&D personnel conduct reaction risk assessments to predict the safety of the developed product processes, prioritizing the elimination of a batch of processes with high risk levels that are difficult to control in terms of safety; The selection of products is based on safety, with priority given to products with low safety risks. For projects with high risks that require industrialization, priority should be given to process optimization or changing process methods to reduce risks.

2、 Difficulties encountered in conducting safety risk assessment for fine chemical reactions

1. Currently, there are relatively few units in the country that can conduct evaluations. According to the recommendations of the provincial bureau, only Tianjin University, Nanjing University of Science and Technology, and Shenyang Kechuang Chemical Co., Ltd., a subsidiary of Sinochem Group, are capable of conducting fine chemical reaction assessments. Only some of the projects of these units have the qualification of China National Accreditation Service for Conformity Assessment (CNAS) accredited laboratories. Due to the small number of testing units, limited testing instruments, and the need for a certain period of time for testing, efforts have been made throughout the country to promote this work, resulting in long queues for enterprises to complete testing and evaluation. This has caused some enterprises that need to launch new projects to be unable to enter project approval due to waiting for testing and evaluation reports, delaying the industrialization process of the projects.

2. It takes some time for enterprises to incubate independently. After preliminary investigation, currently only Haizheng Pharmaceutical and Lianhua Technology are able to carry out reaction safety risk detection and assessment work normally in Taizhou city; Although Huahai Pharmaceutical, Yongtai Technology, and Langhua Pharmaceutical have purchased relevant testing equipment, due to the fact that the equipment is imported from foreign countries, they require technical personnel with a certain foundation in chemical testing. The relevant personnel need some time to train and take up their posts. Currently, this work is in the exploratory stage and cannot produce a complete evaluation report. The Taizhou Reaction Safety Evaluation Center, based on Taizhou University, and related equipment from Aoxiang Pharmaceutical are currently being ordered and purchased. At the same time, the complete configuration of relevant testing equipment requires an investment of over 10 million yuan and the deployment of relevant testing personnel, which is not practical for small and medium-sized medical and chemical enterprises with few projects and research and development to establish independent laboratories.

3. The safety risk assessment report lacks a unified standard. Obtaining an effective response safety risk assessment report requires companies to provide authentic process parameters, which involve commercial secrets for the survival of the enterprise. Some companies may retain these parameters and provide incomplete data, resulting in inaccurate testing data. At the same time, according to normal assessment, if the process hazard level exceeds level 3, the investment in automation control is huge and it is not easy to pass the review. Some companies will resort to fraud and deliberately lower the assessment level in order to pass the review. Although the "Guidelines for Safety Risk Assessment of Fine Chemical Reactions (Trial)" have been formulated in the "Guiding Opinions", there are no specific requirements for the standardized preparation of safety reaction risk assessment reports. The quality of the reports varies greatly, and there are some reports with various names and incomplete signatures, which makes it difficult to take responsibility for the authenticity of the test data and the reliability of the evaluation, resulting in difficulties in accountability.

3、 Related countermeasures

1. Increase supply. Actively encourage strong enterprises to configure testing instruments and professional technical personnel according to requirements, establish process safety laboratories, and conduct comprehensive safety risk assessments for all their products. At the same time, relying on colleges and universities, we actively encourage qualified scientific research service institutions to establish reaction risk assessment laboratories to meet the needs of testing and evaluation for small and medium-sized fine chemical enterprises in Taizhou.

2. Ensure quality. We should encourage existing laboratories to improve their quality by issuing the "Guidelines for the Preparation of Reaction Safety Risk Assessment Reports for Fine Chemical Enterprises" to unify the standards for report preparation and achieve standardization of reports. Actively promote the safety laboratory to obtain SNAS certification and gradually transition to all testing reports being issued by certification units.

3. Implement responsibilities. According to the accountability system of "who tests, who is responsible, and who prepares, who is responsible", experts and third-party testing institutions are invited to conduct regular quality and normative sampling of evaluation and testing reports; Through the investigation of the accident enterprise, the authenticity of the testing data will be verified, and companies that engage in fraud will be severely punished.