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Title: Environmental Agent Factory Establishment Standards Ch
Date: 2006.07.10
Legislative: 12 articles jointly promulgated by
Environmental Protection Administration,
Ministry of Economic Affairs and
Taiwan Provincial Government orders on August 12, 1998

12 articles revised and promulgated by
Environmental Protection Administration and
Ministry of Economic Affairs orders on October 24,2001

Article 1 revised and promulgated by
Environmental Protection Administration and Ministry of Economic Affairs
orders on July 10, 2006
Content:

Article 1

     These Standards are determined pursuant to Article 13 of the Environmental Agents Control Act

(herein referred to as “this Act”).

Article 2

The establishment of an environmental agent factory must comply with the following regulations.

I. Those environmental agent factories manufacturing internal pressure aerosols shall have a surrounding

    wall or natural barrier, and may not obstruct environmental sanitation and safety.

II. The manufacturing and storage areas of those factories engaged in the synthesis of highly flammable,

     highly explosive, or highly toxic technical grade environmental agents shall be a distance of at least 8

     meters from the factory's outer wall. Necessary facilities shall be employed to separate manufacturing

     and storage areas from each other and from other working areas.

III. Plant and warehouse structures shall be sturdy and clean. Walls and floors shall be made of concrete,

      terrazzo, or other easily washable materials.

IV. Operating areas shall possess good ventilation and may not generate dust. Dustproof equipment shall

      be required in operating areas containing dust agents.

V. The floors of those factories engaged in the synthesis of technical grade environmental agents and of

     operating areas where emulsions, liquid, suspensions, oils, and ultra-low capacity agents are

     manufactured (or processed) shall be made of impermeable material, may not allow puddling to occur,

     and shall be equipped with channels and pipes specifically for collecting wastewater and conveying it

     to a wastewater treatment facility.

VI. Manufacturing and administrative areas within a factory shall be clearly delineated. All operating areas

      shall be clearly distinguished, and separation facilities shall be employed to prevent mutual

      contamination.

VII. Environmental agent storage areas shall be clearly marked. Those factories storing technical grade

      environmental agents shall establish special storage areas subject to locking control and separated from

      other materials. Those environmental agent finished products and semi-finished products in storage

      must be clearly segregated from other materials.

Article 3

     Those factories manufacturing microbial preparations used as environmental agents shall possess the

following equipment.

I. Microbial fermentation, culture, or preparation equipment

II. Packaging equipment

III. Storage equipment

IV. Sterilization and disinfection equipment

     Structural equipment in operating areas containing microbial preparations used as environmental

agents, including indoor ceilings, walls, doors and windows, and floors, etc., shall be convenient to wash and

disinfect; areas where such agents are manufactured or processed shall be equipped with independent air

conditioning systems.

Article 4

    Areas where emulsions, liquid, suspensions, oils, and ultra-low capacity environmental sanitation

agents are manufactured or processed shall posses the following equipment.

I. Blending containers

II. Mixing machines

III. Storage tanks

IV. Filling equipment

V. Packaging equipment

     Those factories manufacturing internal pressure aerosols shall possess pressurized filling equipment and

leak testing and inspection equipment.

Article 5

     Those factories manufacturing and processing dust environmental sanitation agents shall possess the

following equipment.

I. Grinding machines or sifting equipment

II. Mixing or smelting equipment

III. Packaging equipment

Article 6

     Those factories manufacturing and processing environmental sanitation agents in the form of granules,

tablets, chunks, flakes, or gels shall possess the following equipment.

I. Mixing or smelting equipment

II. Molding, shaping, or filling equipment

III. Packaging equipment

Article 7

     Equipment used for the production of rodenticide environmental agents may not be used

interchangeably with equipment used to produce other environmental sanitation agents.

Article 8

    Except in the case of rodenticides and microbial preparations, the manufacturing, processing, and

packaging equipment of those environmental sanitation agent manufacturing enterprises that concurrently

produce pesticides must be used exclusively for specific purposes.

Article 9

     Environmental agent factories shall possess testing equipment or testing laboratories to test the quality

of environmental agent finished products. However, if the environmental agent finished products at a

factory are entirely identical with technical grade environmental agents in composition and contents, that

factory shall not be subject to this restriction.

Article 10

          Those environmental agent manufacturing enterprises that wish to apply for an environmental agent

manufacturing permit shall first obtain a factory registration certificate in accordance with the law.

    When an environmental agent factory wishes to apply for an environmental agent manufacturing

permit, the dosage form equipment of the agent in question shall comply with these Standards.

Article 11

          (deleted)

Article 12

          These Standards shall take effect on the date of promulgation.

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