HJ 611-2011Technical guidelines for environmental impact assessment. Pharmaceutical constructional project (English PDF)
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Issued by
Ministry of Ecology and Environment
Level / Type
National · Mandatory
Issue date
February 11, 2011
Implementation date
June 1, 2011
Scope
HJ 611-2011 (Technical guidelines for environmental impact assessment. Pharmaceutical constructional project) is available as an English-translated PDF.
HJ 611-2011 — This standard specifies the general principles, contents, methods and technical requirements for environmental impact assessment of pharmaceutical construction projects.
This standard is applicable to the environmental impact assessment of pharmaceutical construction projects for new construction, reconstruction, expansion and enterprise relocation.
The environmental impact assessment of construction projects for the production of veterinary drugs and pharmaceutical intermediates can be carried out in accordance with this standard.
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Document preview — HJ 611-2011
National Standard of the People's Republic of China
- ICS
- 13.020
- Classification
- Z 00
Issued by: Ministry of Ecology and Environment
Contents
- Foreword
- 1 Scope of application
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 4.1 Environmental Impact Assessment Work Classification
- 4.2 Environmental Impact Assessment Work Procedures
- 4.3 Environmental Impact Factors and Evaluation Factors
- 4.4 Environmental function zoning and evaluation criteria
- 4.5 Evaluation work level
- 4.6 Evaluation scope and environmentally sensitive targets
- 4.7 Thematic settings
- 5 Environmental Quality Status Survey and Evaluation**
- 5.1 Survey and evaluation of current environmental air quality**
- 5.2 Survey and evaluation of current status of surface water environment**
- 5.3 Survey on the status of groundwater environmental quality*
- 5.4 Investigation and evaluation of the current status of acoustic environment **
- 5.5 Survey of soil environment status*
- 6 Environmental Impact Prediction and Evaluation**
- 6.1 Atmospheric Environmental Impact Prediction and Evaluation*
- 6.2 Prediction and evaluation of surface water environmental impact*
- 6.3 Acoustic environmental impact prediction and evaluation*
- 7 Environmental Risk Assessment*
- 8 Environmental Protection Measures and Technical and Economic Feasibility Analysis**
- 9 Total pollutant control analysis**
- 10 Environmental Management and Environmental Monitoring**
- 11 Environmental Impact Economic Profit and Loss Analysis**
- 12 Public participation**
- 13 Policy, Planning Compliance and Site Selection Rationality Analysis and Argumentation**
Foreword
To implement the Environmental Protection Law of the People's Republic of China, the Environmental Impact Assessment Law of the People's Republic of China and the Environmental Protection of Construction Projects the Regulations governing and guiding the environmental impact assessment of pharmaceutical construction projects shall be formulated.
This standard specifies the general principles, contents, methods and technical requirements for environmental impact assessment of pharmaceutical construction projects.
This standard is the first release.
Appendix A of this standard is a normative appendix, and Appendix B and Appendix C are informative appendices.
This standard was formulated by the Science and Technology Standards Department of the Ministry of Environmental Protection.
This standard is mainly drafted by. Jilin Province Environmental Engineering Evaluation Center and PetroChina Northeast Refining & Chemical Engineering Co., Ltd.
This standard was approved by the Ministry of Environmental Protection on February 11, 2011.
This standard was implemented on June 1, 2011.
This standard is explained by the Ministry of Environmental Protection.
Technical Guidelines for Environmental Impact Assessment Pharmaceutical Construction Project
1 Scope of application
This standard specifies the general principles, contents, methods and technical requirements for environmental impact assessment of pharmaceutical construction projects.
This standard is applicable to the environmental impact assessment of pharmaceutical construction projects for new construction, reconstruction, expansion and enterprise relocation.
The environmental impact assessment of construction projects for the production of veterinary drugs and pharmaceutical intermediates can be carried out in accordance with this standard.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. Valid versions of undated references Applicable to this standard.
GB 5085 Hazardous Waste Identification Standard GB 18218 Identification of major hazard sources of hazardous chemicals GB 18484 Hazardous Waste Incineration Pollution Control Standard GB 18597 Hazardous Waste Storage Pollution Control Standard GB/T 14848 Groundwater Quality Standard GB/T 15190 Urban area environmental noise applicable area division technical specification HJ/T 2.1 Technical Guidelines for Environmental Impact Assessment HJ 2.2 Technical Guidelines for Environmental Impact Assessment Atmospheric Environment HJ/T 2.3 Technical Guidelines for Environmental Impact Assessment Surface Water Environment HJ 2.4 Environmental Impact Assessment Technical Guidelines Acoustic Environment HJ/T 14 Environmental Air Quality Functional Area Division Principles and Technical Methods HJ/T 25 Industrial Enterprise Soil Environmental Quality Risk Assessment Benchmark HJ/T 164 Groundwater Monitoring Technical Specification HJ/T 166 Technical Specifications for Soil Environmental Monitoring HJ/T 169 Technical Guidelines for Environmental Risk Assessment of Construction Projects HJ/T 176 Technical Specifications for Construction of Hazardous Waste Centralized Incineration Disposal Project HJ/T 338 Technical specification for division of drinking water source protection zones National Directory of Hazardous Wastes (Order No. 1 of the Ministry of Environmental Protection) "Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects" (Order No. 2 of the Ministry of Environmental Protection) Interim Measures for Public Participation in Environmental Impact Assessment (Huanfa [2006] No. 28)
3 Terms and definitions
The following terms and definitions apply to this standard.
Drugs pharmaceuticals Refers to the production approved by the drug regulatory authority of the State Council for the prevention, diagnosis and treatment of human diseases, and the purposeful regulation of human physiology Functional and prescribed substances with adaptive or functional indications, usage and dosage.
Pharmaceutical intermediate Refers to chemical raw materials or chemical products used in the process of drug synthesis.
Veterinary drug
Refers to substances used to prevent, treat, diagnose, or purposefully regulate the physiology of animals.
Active pharmaceutical ingredient, API Refers to the production of the active ingredients and active ingredients approved by the drug regulatory department of the State Council, which constitutes a part of the raw materials of the drug.
Chemical synthesis
The production process of chemical or chemical raw materials by chemical reaction of organic or inorganic substances.
Biochemical products manufacturing biological pharmacy the use of organisms and biological life activities to manufacture pharmaceutical products, including fermenting pharmaceuticals, extracting pharmaceuticals, and biotechnology pharmaceuticals.
Fermentation pharmacy refers to the production of medicines through the process of fermentation, filtration and purification of organic raw materials through the life activities of microorganisms.
Cheng.
Extraction of pharmaceuticals refers to the use of physical, chemical, and biochemical methods to extract active substances that play an important physiological role in living organisms.
Separation, purification and other means to produce a pharmaceutical production process.
Biotechnology pharmacy refers to the use of microorganisms, parasites, animal toxins, biological tissues, etc., using modern biotechnology (mainly genes) Engineering technology, etc.) The production process of peptides and protein drugs, vaccines, etc.
Simple drug dispensing and compounding pharmaceuticals subpackage and compounding by mixing, processing and formulating, the pharmaceutically active ingredients and excipients are made into a process for the production of a dosage form.
Chinese medicine decoction pieces processing and Chinese patent medicine manufacturing pharmacy of traditional Chinese medicine decoction pieces and Traditional Chinese patent medicine Taking medicinal plants and medicinal animals as the main raw materials, according to the Chinese Pharmacopoeia, the pharmaceutical process of Chinese herbal medicine pieces and Chinese patent medicines is produced.
Pharmaceutical construction project Refers to the manufacture of chemical drugs, the manufacture of biochemical products, the dispensing and compounding of simple drugs, the processing of Chinese herbal medicines and the manufacture and matching of proprietary Chinese medicines.
Set of construction projects.
3.10
Pharmacy manufacturing enterprise Pharmaceutical and API manufacturing companies.
3.11
Production workshop
A unit of a pharmaceutical production enterprise that produces medicines and APIs consisting of production equipment.
3.12
Production plant
A combination of one or more interrelated production process units.
3.13
Process unit
Within the production unit, a combination of equipment, piping and instrumentation for a relatively independent production or operation process can be completed according to the process flow.
3.14
Auxiliary facility
Water, electricity, steam and other facilities, storage and transportation facilities in the pharmaceutical company, independent of the environmental protection facilities and office facilities of the production workshop Wait.
3.15
Heat processing with supplementary materials Refers to the preparation of medicinal materials through net processing, cutting, and cannon processing to produce a certain size of decoction pieces to meet the medical requirements and the needs of blending and preparation.
Ensure that medications are safe and effective. Commonly used methods of cannoning are. frying, hot, calcining, carbon, steaming, boiling, stewing, single, wine, vinegar, salt, Ginger juice, candied fruit, oil sputum, frosting (de-oiling into frost), water flying, sputum.
3.16
Environmental factor Various natural and artificially modified natural factors, including. atmosphere, water, land, mineral deposits, forests, grasslands, wild animals Things, natural monuments, cultural relics, nature reserves, scenic spots, cities and villages.
3.17
Environmental sensitive area Refers to the protection of all levels and types of nature and culture established in accordance with the law as stipulated in the Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects.
And areas that are particularly sensitive to certain types of pollution factors or ecological impact factors in pharmaceutical construction projects.
4 General
4.1 Environmental Impact Assessment Work Classification
4.1.1 According to the provisions and requirements in the "Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects".
Environmental impact report for chemical manufacturing and bio-chemical product manufacturing construction projects, and preparation of Chinese patent medicine manufacturing construction projects with refining process book;
The environmental impact report form for the preparation of traditional Chinese medicine decoction pieces, the manufacture of proprietary Chinese medicines without refining process, and the preparation of simple drug packaging and compounding projects.
4.1.2 The regional environmental impact assessment or related planning environmental impact assessment work has been carried out in the area where the pharmaceutical construction project is located, including Specific pharmaceutical construction projects, under the premise that the regional environmental quality status has not changed significantly and the regional pollution sources have not increased significantly, the environment the topics such as environmental quality survey and evaluation and environmental impact prediction in impact assessment work can be appropriately simplified. Evaluation focuses on pharmaceutical construction projects Engineering analysis, environmental protection measures, clean production analysis and environmental impact assessment of characteristic pollutants, etc.
The conformity of price or planning environmental impact assessment requirements and the compatibility of regional environmental resource carrying capacity.
4.2 Environmental Impact Assessment Work Procedures
The environmental impact assessment work procedures for pharmaceutical construction projects shall be carried out in accordance with the provisions of HJ/T 2.1, HJ 2.2, HJ/T 2.3, and HJ 2.4.
4.3 Environmental Impact Factors and Evaluation Factors
4.3.1 Environmental impact factors. The factors affecting the environment during the construction and operation of pharmaceutical construction projects mainly include. land occupation, discharged wastewater, Exhaust gas, noise, solid waste, etc.
4.3.2 Evaluation factor. Pharmaceutical construction project evaluation factors except conventional indicators of wastewater and exhaust pollutants [such as chemical oxygen demand (COD), ammonia nitrogen, in addition to total phosphorus, non-methane total hydrocarbons (NMHC), malodorous gases, etc., it should also identify its characteristic pollution factors according to the characteristics of the production process of pharmaceutical construction projects.
Son to determine the evaluation factor. One of the following basic principles should be used as an evaluation factor.
a) Limit emissions in national or local regulations and standards;
b) control of total national or local pollutant emissions;
c) including the Convention on Persistent Organic Pollutants (POPs);
d) having "three-way" toxicological properties;
e) having a characteristic of a bad odor;
f) Project environmental impact characteristic pollutants.
4.4 Environmental function zoning and evaluation criteria
4.4.1 Environmental function zoning. The list of the drawings shows the environmental function zoning and protection zone planning requirements of the town where the pharmaceutical construction project is located.
4.4.2 Evaluation criteria. It mainly includes national or local environmental quality standards, national or local pollutant discharge standards and other relevant standards;
The principle of the evaluation criteria is that the local standards are preferred, followed by the national standards, and again the reference standards.
a) According to the requirements of the urban environmental function zoning of the pharmaceutical construction project, implement the corresponding environmental quality standards and pollutant discharge standards.
b) The environmental function zone has not been demarcated, and the environmental function zone standard is determined according to the requirements of HJ/T 14, GB/T 15190 and HJ/T 338.
c) When there are no national or local environmental protection standards for pollutants in pharmaceutical construction projects, refer to the importing country of pharmaceutical construction projects or Introduce relevant standards of the region; if there is no reference value, it can be estimated according to the multi-medium environmental target value (MEG) according to the toxicological index.
The law (see Appendix C) calculates and proposes environmental management recommended control limits.
d) The evaluation criteria shall be confirmed in writing by the relevant environmental protection administrative department.
4.5 Evaluation work level
4.5.1 Atmospheric, surface water, acoustic environmental assessment level. Performed in accordance with the provisions of HJ 2.2, HJ/T 2.3 and HJ 2.4 respectively.
4.5.2 Groundwater and soil environmental assessment grades. Survey or monitor the status of groundwater and soil that may be affected by pharmaceutical construction projects only, and develop environmental protection measures and follow-up monitoring plans.
4.5.3 Environmental risk assessment level. Perform as specified in HJ/T 169.
4.6 Evaluation scope and environmentally sensitive targets
4.6.1 Evaluation scope
4.6.1.1 Scope of assessment of atmospheric, surface water and acoustic environment. Performed in accordance with the provisions of HJ 2.2, HJ/T 2.3 and HJ 2.4 respectively.
4.6.1.2 Scope of investigation of groundwater and soil environment. The hydrogeological conditions of the proposed site, the permeability coefficient of the soil, and the site should be considered comprehensively.
Near the groundwater environment sensitive target distribution, etc., the scope of investigation of groundwater status is reasonably determined. The scope of the survey is determined as the perimeter of the plant Within the scope of the groundwater, the groundwater range that may be affected by the pharmaceutical construction project may be appropriately adjusted.
The scope of the soil current survey is determined by the scope of the plant and the extent to which it may be affected outside the plant.
4.6.1.3 Scope of environmental risk assessment. Perform as specified in HJ/T 169.
4.6.2 Environmentally sensitive targets
The attached table describes the environmental function categories or levels of various environmental factors within the scope of evaluation, the sensitive protection objectives and functions of each environmental factor and their systems the relative position and distance of the drug construction project.
4.6.3 Drawing requirements
A color map of the evaluation range of the wind rose diagram and the environmentally sensitive target is attached, and the scale is indicated.
a) The atmospheric environmental impact assessment scope map shall indicate the ambient air monitoring point;
b) The surface water environmental impact assessment scope map shall indicate the monitoring section, water flow direction, surface runoff inlet and sewage discharge port;
c) The groundwater environmental impact assessment scope map shall indicate the monitoring point and groundwater flow direction;
d) The soil environmental impact assessment scope map should indicate the soil monitoring point;
e) The environmental risk assessment scope map should indicate the environmentally sensitive area;
f) The general layout plan of the plant area shall indicate the noise monitoring point.
4.7 Thematic settings
4.7.1 For pharmaceutical construction projects that require an environmental impact report, the environmental impact assessment work should generally set the evaluation topics listed in Table 1.
a) If the construction unit of the new project is newly established within the scope of evaluation, there may be no survey on the status quo of the enterprise;
b) Survey of groundwater environmental quality status and survey of soil environment status can be based on project pollution and emission characteristics, site selection and environmental sensitivity the degree of sensation is determined whether it is set;
c) The sewage generated by the pharmaceutical construction project is discharged into the sewage treatment plant in use and its treatment process and processing capacity can meet the pharmaceutical construction project.
The topic of surface water environmental impact prediction and evaluation can be simplified when needed;
d) Biotechnology pharmaceutical projects can visualize the pollution and emission characteristics of the project, and the environmental sensitivity of the site selection does not have atmospheric and acoustic environmental impacts.
Forecast and evaluation, environmental risk assessment topics.
Table 1 List of the special settings for environmental impact assessment of pharmaceutical construction projects
Serial number topic name setting requirements
1 Status of regional natural and social environment**
2 Enterprise Status Survey*
3 Engineering Analysis**
4 Cleaner Production and Circular Economy Analysis**
5 Environmental Quality Status Survey and Evaluation**
5.1 Survey and evaluation of current environmental air quality**
5.2 Survey and evaluation of current status of surface water environment**
5.3 Survey on the status of groundwater environmental quality*
5.4 Investigation and evaluation of the current status of acoustic environment **
5.5 Survey of soil environment status*
6 Environmental Impact Prediction and Evaluation**
6.1 Atmospheric Environmental Impact Prediction and Evaluation*
6.2 Prediction and evaluation of surface water environmental impact*
6.3 Acoustic environmental impact prediction and evaluation*
7 Environmental Risk Assessment*
8 Environmental Protection Measures and Technical and Economic Feasibility Analysis**
9 Total pollutant control analysis**
10 Environmental Management and Environmental Monitoring**
11 Environmental Impact Economic Profit and Loss Analysis**
12 Public participation**
13 Policy, Planning Compliance and Site Selection Rationality Analysis and Argumentation**
Note. ** must be set;
* According to the contents of the pharmaceutical construction project and the environmental characteristics of the development area, select the settings according to the provisions of a) to d).
4.7.2 The pharmaceutical construction projects that prepare the environmental impact report form can be set up according to the specific conditions, such as engineering analysis and environmental protection measures.
Line evaluation.
5 Survey of regional natural and social environment
5.1 Survey content
Focus on the following to understand.
a) Overview of the natural environment. Including geology, geomorphology, meteorology, climate, hydrology, hydrogeology, surrounding natural remains and nature reserves Distribution of the situation, etc.
b) Overview of the social environment. Including the economic development of the region, the number of residential areas and population, the scale of enterprises and institutions, and the relative the orientation and distance of pharmaceutical construction projects, and the distribution of related cultural relics protection sites.
c) Regional pollution sources. The survey was conducted in accordance with HJ 2.2 and HJ/T 2.3.
d) Environmental function zoning and ecological function zoning.
5.2 Survey method
On-site inspections, visits by relevant departments, collection of existing data and maps (such as water system maps, land use maps, environmental function maps, etc.).
5.3 Drawing requirements Attached to the geographical location map of the pharmaceutical construction project, the regional location map of the pharmaceutical construction project, the distribution map of the environmentally sensitive area, etc., can use the 4.6.3 rules the drawings are given.
6 Enterprise Status Survey
6.1 Survey scope
The scope of the investigation includes the production equipment and auxiliary facilities belonging to the construction unit and located in the same area as the pharmaceutical construction project.
It shall include the total amount of pollutants discharged by the construction unit covered by the environmental protection administrative department.
6.2 Survey content
6.2.1 Basic overview of the company Including the production workshop (or installation) of the enterprise, the auxiliary facilities; the product types and production methods of each production workshop (or installation), Production scale; product type and output during the evaluation period, types of raw materials and auxiliary materials used and their consumption; production workshops during the evaluation period (or Equipment, and auxiliary facilities, water, electricity, steam and other public works.
6.2.2 Utilization of water resources Including the water supply and drainage conditions, water supply and drainage balance map or table in the production workshop (or installation) and auxiliary facilities during the evaluation period.
Calculate the water reuse rate of the enterprise and explain its water use level.
6.2.3 Analysis of pollution sources
6.2.3.1 Exhaust gas emissions. Investigate the exhaust emissions (m3/h) of each exhaust pipe or chimney, and the mass concentration of major pollutants.
(mg/m3) and rat...
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 18218Identification of major hazard installations for hazardous chemicals
- GB 18484Standard for pollution control on hazardous waste incineration
- GB 18597Standard for pollution control on hazardous waste storage
- GB/T 14848Standard for groundwater quality
- GB/T 15190Technical specifications for regionalizing environmental noise function
GB 5085
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Related Standards
GB 18218-2018 — Identification of major hazard installations for hazardous chemicals
GB 18484-2020 — Standard for pollution control on hazardous waste incineration
GB 18597-2023 — Standard for pollution control on hazardous waste storage
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