The possession, use, import and export, storage or disposal of BSAT shall be governed by the provisions of this chapter; for specific select toxins announced by the central competent authority, of which the aggregate amount does not exceed the announced control limit, the rules governing pathogens in Risk Group 3 shall apply.

Before a laboratory or storage facility possesses, uses, stores or disposes of BSAT the first time, the entity shall draft biosafety, biosecurity and emergency response plans and submit them to its IBC for approval.
The entity shall submit the approved plan mentioned in the preceding paragraph and the proposed appointment of a designated Responsible Official and an alternate Responsible Official to the competent authority for approval before starting to possess, use, import and export, store or dispose of BSAT.
The Responsible Official must be an executive level officer who may not be the BSO.
An entity shall report changes to the matters listed below to the central competent authority for approval before the changes take effect; when there are changes to other matters, the entity shall report them to the central competent authority for record keeping within one month after the changes take place:
1. The entity’s Responsible Official and an alternate Responsible Official.
2. Addition of BSAT at the BSAT laboratory or storage facility.
3. Location or address of BSAT laboratory or storage facility.

An entity shall appoint the Responsible Official as a member of its IBC within one month after approval of the central competent authority pursuant to Paragraph 2 of the preceding article.
The Responsible Official and an alternate Responsible Official shall attend at least 12 hours of continuing education courses every year, and have their professional competence re-approved once every three years.
The continuing education courses prescribed by the preceding paragraph shall contain the following:
1. At least four hours of courses on BSAT every year.
2. At least eight hours of other biosafety courses every year in addition to the courses mentioned in the preceding subparagraph.

An entity’s Responsible Official shall oversee the management of BSAT laboratory or storage facility; the Responsible Official’s duties include those of the BSO mentioned in Article 12 in addition to the following:
1. Review biosafety, biosecurity and emergency response plans of BSAT laboratories and storage facilities every year.
2. Review the validation of the deactivation process of BSAT laboratories.
3. Designate personnel to undertake the tasks of possessing, using or storing BSAT, or terminate such designations.
4. Supervise the performance evaluation of personnel and the operation of biorisk management system of BSAT laboratories or storage facilities.
5. Supervise the pre-employment and ongoing suitability assessment of personnel with access to highly dangerous BSAT.
6. Act as the contact person of the entity for external communication of BSAT matters.
7. Provide an anonymous reporting channel for BSAT laboratories and storage facilities.

The term of the designated personnel prescribed by Subparagraph 3 of the preceding article shall not be longer than three years; new personnel shall be designated to undertake the tasks when the term of the existing personnel expires or when there is a change to the designated personnel.
When a designated person is in serious violation of laboratory biosafety and biosecurity management rules or is suspected of participating in a domestic or foreign bioterrorism activity, the Responsible Official shall immediately suspend such personnel’s authority to possess, use or store such BSAT, and report it to the central competent authority for record keeping.

Newly established laboratories or storage facilities that possess, store or use BSAT may be inaugurated only after passing the review of the entity’s Responsible Official and obtaining the approval of its IBC as well as that of the central competent authority.

The provisions of Article 15 herein apply or apply mutatis mutandis to BSAT possessed, used, stored or disposed of by laboratories or storage facilities that work with BSAT after the review of entity’s Responsible Official and the approval of its IBC.
For the transfer of BSAT under the preceding paragraph, the sender may proceed with the transfer only after the recipient has obtained approval from the central competent authority. The recipient shall, within two working days after receiving the BSAT, report the receipt to the central competent authority for record keeping.
When a BSAT laboratory or storage facility removes an infectious biological material from its inventory, the entity shall report it to the central competent authority for record keeping within 30 days following the removal.

For the import and export of BSAT, an entity shall follow the provisions of Paragraph 1, Article 16 herein and submit documents evidencing the consent of its IBC.
The consent documents prescribed in the preceding paragraph shall be signed by the entity’s Responsible Official.

A BSAT laboratory or storage facility shall establish a biorisk management system.
A BSAT laboratory or storage facility shall submit its biosafety, biosecurity and emergency response plans to the Responsible Official for review every year.
A BSAT laboratory or storage facility shall conduct an emergency response drill according to the established plan every year and a field drill once every three years.

An entity whose BSAT laboratory detects BSAT while performing clinical or diagnostic examination or participating in proficiency testing shall report the detection to the central competent authority within seven days and complete destruction or storage of detected BSAT or transfer them to another BSAT laboratory or storage facility approved by the central competent authority within the following time period:
1. Clinical or diagnostic examination: 30 days.
2. Proficiency testing: 90 days.

The foundation courses or continuing education received by personnel in BSAT laboratories or storage facilities pursuant to Paragraphs 1 and 2 of Article 21 herein shall include BSAT related courses.
Personnel in highly dangerous BSAT laboratories or storage facilities shall receive safety awareness education once a year.

BSAT laboratories and storage facilities shall safekeep the records on the inventory of BSAT, personnel training and other relevant activities for at least three years and safekeep records on disposal and anomalous events for at least ten years.

Competent authorities to which Paragraphs 1 to 3 of Article 28 herein shall be applicable or applicable mutatis mutandis should conduct inspections of BSAT laboratories and storage facilities, order them to take corrective actions within a given time period or impose other disciplinary actions.
Entities shall not evade, interfere with or refuse the supervision or inspections by the competent authorities.