No.2568 Announcement of the Ministry of Agriculture of People's Republic of China

The Detailed Rules on Pesticide Production Permit Evaluation prepared by the Ministry in accordance with the Regulations on Management of Pesticides and the Measures on Management of Pesticide Production Permit is hereby promulgated and shall come into force as of October 10, 2017.

                                                                                           Ministry of Agriculture
                                                                                           September 3, 2017

  

Detailed Rules on Pesticide Production Permit Evaluation

Chapter I. General Provisionszz

Article 1. These Rules are prepared in accordance with the Regulations on Management of Pesticides, and the Measures on Management of Pesticide Production Permits, to regulate evaluation practices in relation to pesticide production permits.
Article 2. The pesticide production permit evaluation shall be conducted in a lawful, scientific and impartial manner.
Article 3.  The pesticide production permit evaluation shall be conducted based on the applicants’ scope of production applied for, and a conclusion shall be drawn for each item evaluated. 

Chapter II. Requirements on Application Materials

Article 4. The application may be submitted for production of a technical material (concentrate) or of a preparation.
The application for production of a technical material (concentrate) shall be made based on the type of the technical material (concentrate). The application for production of a preparation shall be made based on the dosage form of the preparation, and the application materials provided shall serve the purpose of application for production of the same pesticide.
Article 5. In case of applying for a pesticide production permit for the first time, or for expanding the scope of production described in the permit or changing the production address, applicants shall submit materials specified in Article 9 of the Measures on Management of Pesticide Production Permits and bound in a volume in sequence, and at the same time, submit the electronic copy of such materials.
In case of applying for production of more than two technical materials or preparations simultaneously, applicants shall bind the documents required under clauses 6, 7 and 9, paragraph 1 of Article 9 of the Measures on Management of Pesticide Production Permits in a separate volume based on the type or dosage form of the pesticides applied for.
Article 6. In case of applying for change of the name, legal representative (responsible person) or address of the pesticide producer during the validity period of the pesticide production permit, a copy of the updated business license shall be provided; in case of applying for change of the legal representative (responsible person), a copy of the ID card of the legal representative (responsible person) shall also be provided;
Article 7. In case of applying for extension of a pesticide production permit, a summary report on production conditions, including any change in key technicians, equipment/facilities, process technology, quality assurance systems, and the production and sale of the pesticides involved shall be provided;

Chapter III. Evaluation Process

Article 8. Agricultural authorities at the provincial level shall organize the pesticide production permit evaluation.
Agricultural authorities at the provincial level may, where necessary, set up an evaluation team composed of experts in pesticide management, production process and quality control, to conduct technical evaluation or on-site inspection.
The evaluation team is composed of more than 3 persons, including one leader who assumes the overall responsibility for the whole team. The technical evaluation and on-site inspection may be conducted by different evaluation teams.
Article 9. Experts involved in pesticide production permit evaluation shall meet the following conditions:
(1) Be familiar with laws and policies concerning pesticide production management;
(2)  Holding a bachelor's degree or above, or a senior professional title in pesticide, chemistry or chemical engineering or any relevant field, be familiar with the pesticide production process, product quality standards or pesticide management, and having at least five-year experience in pesticide research, production, testing or management;
(3) Healthy and competent;
(4) Other conditions prescribed by the agricultural authorities at the provincial level.
Article 10. Members of the evaluation team shall practice a system of withdrawal. Members who have direct interest in the pesticide production permit application shall actively withdraw from the evaluation process.
Article 11. Agricultural authorities at the provincial level shall, upon receipt of application materials, timely organize paper examination and technical evaluation, and shall develop a report following the completion of the technical evaluation. The technical evaluation report shall include the following:
(1) Conclusion drawn from the technical evaluation;
(2) Major problems discovered;
(3) The Pesticide Production Permit Evaluation Form (to be filled out based on the pesticide production scope, refer to Appendix 1 and Appendix 2).
(4) Other matters to be described;
Article 20. Agricultural authorities at the provincial level shall timely organize an on-site inspection under any of the following circumstances:
(1) Producers apply for a pesticide production permit for the first time;
(2) Non-chemical pesticide producers apply for adding pesticides into their scope of production;
(3) Producers apply for change of their production address or expand their scope of production;
(4) This is so suggested by the paper examination or technical evaluation.
Article 13.Where it is necessary to conduct an on-site inspection, agricultural authorities at the provincial level shall send 2 days’ prior written notice to the applicant concerned and to their local counterpart in the place where the applicant is located. The local agricultural authority may send observers to participate in the on-site inspection.
Any objection of the applicant to any evaluator upon receipt of the on-site inspection notice shall be made in writing and submitted to the agricultural authorities at the provincial level in a timely manner.
Article 14. The on-site inspection by the evaluation team shall follow the following procedures:
(1) Informs the applicant concerned of members of the evaluation team, the contents and procedures of inspection, announces the disciplines and gains knowledge about the producer concerned;
(2) Consults materials, inspects the site and conducts interviews, while focusing on the main problems discovered during the technical evaluation;
(3) Conducts internal exchange of views, to form a preliminary conclusion;
(4) Communicates the main problems discovered during the on-site inspection to the applicant for comments.
Article 15. The evaluation team shall timely prepare, following the completion of the on-site inspection and submit a report to the agricultural authority at the provincial level. The on-site inspection report shall include the following:
(1) Basic information about the applicant concerned;
(2) Conclusion drawn from the on-site inspection;
(3) Main problems to be communicated to the applicant;
(4) Main items, the conclusions for which are inconsistent with that drawn from the technical evolution, and descriptions;
(6) The Pesticide Production Permit Evaluation Form (to be filled out based on the pesticide production scope);
(5) Other problems discovered during the on-site inspection;

Chapter IV. Contents of Evaluation

Article 16. The contents to be evaluated include but are not limited to, the basic information about the applicant concerned, information about his personnel, site layout, production process technology, production equipment, workshops, quality assurance systems, management systems and compliance with industrial policies.
Article 17. The basic information about the applicant shall be examined to identify the consistency between the name, the legal representative (responsible person) and the address of the applicant with whose in the business license, and consistency between the declared production address and the actual production address.
Article 18. The selection of the production address shall be in compliance with relevant provisions of the Measures on Management of Pesticide Production Permits.
Applicants shall have obtained the land use right certificate or lease contract for the production site. The lease contract shall be valid for at least 5 years from the application date.
Article 19. Personnel of applicants include managers, technical personnel, operators and quality inspector, etc. Relevant training and appraisal records of such personnel shall be available; for posts having special technical requirements, corresponding qualification certificates shall be available.
(1) Managers Managers of pesticide producers shall be familiar with the pesticide management laws, regulations and policies.
(2) Technical personnel Technical personnel shall have a bachelor’s degree or above or at least an intermediate professional title in chemistry, chemical engineering, pharmacology, plant protection or a relevant field and more than 2 years of work experience. Producers of chemical pesticide technical materials shall have at least five technicians competent for production of the pesticides applied for; and other pesticide producers shall have at least two technicians of such kind.
(3) Operators Operators shall be provided with pre-job training. Operators involved in high-risk processes shall acquire relevant certificates before taking the post.
(4) Quality inspectors Pesticide producers shall have at least two quality inspectors with an associate’s degree or above in relevant fields or having accepted and passed the professional training.
(5) Personnel engaged in special operations Personnel engaged in operations of pressure vessels, electric equipment, welding, crane, elevator, forklift truck and transportation of hazardous substances shall be properly trained and certified by the competent authority in accordance with law.
Applicants shall not employ any person described in paragraph 1, Article 63 of the Regulations on Management of Pesticides.
Article 20. Workshops, facilities and equipment include building facilities, production units and equipment, fire safety facilities and “three wastes” disposal facilities, etc.
Article 21. The overall layout of the pesticide workshops shall be arranged in a scientific and rational manner.
The construction of workshops and auxiliary facilities shall be in line with the general layout plan, and meet the requirements of the production process, to ensure all links are well connected, materials appropriately and orderly delivered.
Applicants shall provide a list of main workshops, equipment, facilities and auxiliary facilities ensuring normal operations (refer to Appendix 3 for requirements on main production equipment for different scopes of production) based on the process flow diagram, the layout plan of production units, the production process flow diagram and process descriptions, and provide names, quantities and photos of facilities for tracing the pesticide products.
Article 22. The pesticide production workshops and facilities shall be arranged in a scientific and appropriate manner and meet the following requirements:
(1) The main production equipment and facilities shall meet the requirements for production of relevant pesticides and may be automatically operated (excluding some links or products that are not appropriate for automatic production for the time being).
(2) Products showing an obvious difference in dosage forms shall be produced with independent production units;
(3) Workshops producing herbicides, plant growth regulators and raticides shall be separated from workshops producing other pesticides to avoid cross-contamination;
(4) Raw materials, finished products and packaging materials shall be stored in separate areas.
Article 23. The quality inspection sites shall be arranged to meet the requirements for pesticide quality control, and the inspection equipment shall be relatively centralized, as opposed to the instrumental analysis room, the chemical analysis room, the balance room, the sample room and the heating room, which shall be separately located.
Article 24. With respect to product quality assurance systems, attention shall be paid to following aspects:
(1) The quality inspection unit shall be independently arranged;
(2) The quality testing instruments and equipment shall meet the requirements for ensuring products’ compliance with the quality standards, and for in-process control and testing of raw materials; the legal dosing controls shall be subject to periodical inspection;
(3) Quality inspection and control systems, product quality standards, complete and effective operation procedures, ex-factory inspection and procedures for disposing substandard products.
Article 25. Management systems include systems concerning raw material procurement and control, production process control, equipment management, product storage and transportation, product sale management, traceability management, product recall, safe production, occupational health, environmental protection, waste recycling and disposal, personnel training, documentation and recording, etc.
Article 26. Original records of pilot production of three batches of pesticides include: inspection records of incoming raw materials, inspection or checking records of raw materials, intermediate/semi-finished and finished products, main production records and finished product warehouse entry records, etc.
Evaluators shall conduct a comprehensive evaluation of the completeness, scientific base, validity and effectiveness of corresponding documents concerning quality assurance systems and management systems by taking into account the original records of pilot production of three batches of pesticides applied for.

Chapter V. Conclusion from the Evaluation

Article 27. Conclusion drawn from a technical evaluation or an on-site inspection may be a conclusion for a single item or a comprehensive conclusion.
Article 28. The conclusion for a single item may be “qualified”, “suggested for improvement”, “unqualified” or “N/A”.
“Qualified” means relevant regulations are met. “Suggested for improvement” means there is an accidental and isolated problem of general nature that can be further improved. “Unqualified” means there is at least one regional or systematic problem; “N/A” means the contents inspected have nothing to do with the scope of the production applied for and there is no need to evaluate them.
Any conclusion for a single item of “unqualified” or “N/A” shall be accompanied by a statement of reasons.
Article 29. A comprehensive conclusion may be “qualified” or “unqualified”.
The comprehensive conclusion shall be “qualified” if the following conditions are met:
(1) No conclusion of “unqualified” is drawn for any item inspected;
(2) The total number of items deemed “suggested for improvement” is less than 5.
Article 30. Where the conclusion drawn from the on-site inspection is different from that drawn from the technical evaluation, the former shall govern.
Article 31. When applicants apply for production of more than two technical materials or preparations simultaneously, but the conditions are not fully met as discovered in inspections, agricultural authorities at the provincial level shall issue the permit for the part that meets the conditions, and inform the applicants of the part that fails to meet the conditions in writing, with reasons clearly stated.

Chapter VI. Supplementary Provisions

Article 32. Applicants that have obtained the pesticide registration certificate permit prior to the effective date of the Measures on Management of Pesticide Production Permits, but have not obtained the pesticide production certificate or the pesticide production permit, shall be evaluated as new pesticide producers when applying for a pesticide production permit.
Article 33. When applicants apply for production of a technical concentrate or a new pesticide technical material, the registration of the pesticide shall be checked.
Article 34. When applicants apply for direct production of preparations due to difficulties in producing technical materials (technical concentrates) caused by technology, safety or other reasons, the registration of the pesticide, as well as the conditions for production of technical materials (technical concentrates) and preparations shall be checked, and the scope of production shall be expressed as the name of the pesticide, plus the dosage form.
Article 35. These Rules shall come into force as of October 10, 2017.

Appendixes:
      1. Pesticide Production Permit Evaluation Form (applicable to technical materials or concentrates)
      2. Pesticide Production Permit Evaluation Form (applicable to preparations)
      3. Requirements on Pesticide Production Equipment

 

Annex 1

 

 Annex 2

Appendix 3