This Act is formulated to prevent toxic chemical substances from polluting the environment and endangering human health.
Competent authority
as referred to in this Act means the Environmental Protection Administration, Executive Yuan, at the central government level, the municipal government in special municipalities and the county or city government in counties or cities.
Terms used in this Act are defined as follows.
Toxic chemcial substancesrefers to those chemical substances that are intentionally produced by human activity or unintentionally derived from production processes and that have been officially announced by the central competent authority as having toxicity subject to the following classification regulations. Toxic chemical substances shall be classified as follows.
Handlingrefers to such activities as the manufacture, import, export, sale, transport, use, storage or discarding of chemical substances.
Pollution of the environmentrefers to an alteration of the quality of air, water or soil due to the handling of chemical substances such that it causes an impact on the normal use of the air, water or soil, destruction of the natural ecology or damage to property.
Release quantityrefers to the total quantity of a chemical substance that is dispersed into the air, water or soil due to handling.
The matters designated as the responsibility of the central competent authority:
The responsibilities of special municipality, county and city competent authorities are as follows:
The competent authority may appoint a subordinate agency or commission another agency or group to perform research, personnel training, risk assessment, and prevention work in connection with toxic chemical substance management.
The central competent authority shall officially announce toxic chemical substances as Class 1, Class 2, Class 3 or Class 4 when the toxicological characteristics of chemical substances conform to the toxic chemical substance classification definitions prescribed in Article 3 of this Act.
The central competent authority may restrict or prohibit the handing of Class 1, Class 2 and Class 3 toxic chemical substances.
Handlers may apply for the removal of the restrictions or prohibitions prescribed in the foregoing paragraph when they can prove that prevention and control methods employed in the toxic chemical substance use process can prevent or avoid pollution of the environment or the endangerment of human health. The applicant may submit an appeal when an application is rejected, but only one appeal may be made. The central competent authority shall determine regulations governing documents to be attached to the appeal application, rejection, the deadline for submission of an appeal, and other binding matters.
With the exception of requirements for the reporting of toxicological information concerning the toxic chemical substances at issue and the regulations of Article 8, Article 11, Article 12, Article 15, Paragraph 2, articles 24 through 38, Article 41, and Article 42, the handling of Class 4 toxic chemical substances shall not be subject to the restrictions of other regulations of this Act.
The handler shall produce and regularly report records concerning the handling of toxic chemical substances and their release quantities; such records shall be preserved properly for future reference.
The central competent authority shall determine regulations governing the production, format, and preservation of the records in the foregoing paragraph, the content, frequency, and method of reports, and other binding matters.
The central competent authority may control the handling of Class 1 and Class 2 toxic chemical substances by means of total release quantity control methods.
The handlers of Class 1, 2, and 3 toxic chemical substances shall submit risk prevention and response plans concerning the toxic chemical substances at issue to the special municipal, county, or city competent authority to be filed for future reference, and shall implement measures in accordance with the content of the risk prevention and response plans.
The competent authority shall provide Class 3 toxic chemical substance risk prevention and response plans in the foregoing paragraph to the public for reference.
The central competent authority shall determine regulations governing risk prevention and response plan production, content, reporting, implementation, disclosure for public reference, and other binding matters with regard to the toxic chemical substance risk prevention and response plans in the foregoing two paragraphs.
Unless other regulations apply, the handling of toxic chemical substances shall be conducted in accordance with methods officially announced or approved by the central competent authority.
The central competent authority may, based on management requirements, officially announce control concentration standards and large-scale handling standards for toxic chemical substances.
When it is verified through scientific techniques or field testing and research of a toxic chemical substance that original officially announced management items fail to meet requirements, the central competent authority shall promptly issue an official announcement of modification or cancellation.
A manufacturer, importer or seller of Class 1, 2 or 3 toxic chemical substances shall apply to the competent authority for a permit, and shall operate in accordance with the content of the permit.
An enterprise using or storing Class 1, 2 or 3 toxic chemical substances shall apply to the special municipal, county, or city competent authority for registration, and shall operate in accordance with the content of the registration document.
An enterprise disposing of or exporting Class 1, 2 or 3 toxic chemical substances shall apply by the batch or shipment to the special municipality, county or city competent authority for registration, and may only begin handling after doing so.
With regard to the handling of Class 1, 2 or 3 toxic chemical substances mentioned in Paragraphs 1 or 2, when the total quantity handled is lower than the large-scale handling standard officially announced pursuant to Article 11, Paragraph 2, the handler shall, after receiving the approval of the special municipality, county or city competent authority and obtaining an approval document, not be subject to the restrictions of Paragraph 1, Paragraph 2, Article 10, Article 18, and Article 19.
The central competent authority shall determine regulations governing permit, registration, and approval application, review procedures, issuance (replacement or renewal), change, extension, revocation, cancellation, and other binding matters in the foregoing four paragraphs.
The permit mentioned in Paragraph 1, the registration document mentioned in Paragraph 2, and the approval document mentioned in Paragraph 4 of the foregoing article shall have a validity period of five years. Those who must continue handling the toxic chemical substances after permit/document expiration shall apply for an extension within the period between three and six months prior to the expiration of the permit/document; each extension may not exceed 5 years.
The competent authority may modify or cancel the permit, registration document or approval document in the foregoing paragraph when necessary to prevent Class 1, Class 2, and Class 3 toxic chemical substances from polluting the environment and endangering human health.
Those handlers of a toxic chemical substance whose permit, registration, or approval has been revoked or cancelled, or that have been ordered to terminate business, pursuant to the regulations of this Act may not apply for a permit, registration or approval for the handling of the toxic chemical substance at issue within two years.
Those handlers that have partially or completely suspended work or business pursuant to the regulations of this Act shall submit explanations and verification documents concerning the completion of improvements before the resumption of work or business, and may resume work or business only after verification and approval by the competent authority. This also applies to those that have been ordered by the competent authority to make improvements within a limited period and that voluntarily report the suspension of work or business.
Handlers of Class 1, Class 2, and Class 3 toxic chemical substances shall adopt measures necessary to protect third parties, and shall, pursuant to regulations, purchase liability insurance to cover handling risks.
The central competent authority shall determine regulations governing the handlers required to purchase liability insurance and insurance targets, insurance contract items, minimum insurance amount, insurance content, and document preservation and relevant document content in the foregoing paragraph.
Handlers of Class 1, Class 2, or Class 3 toxic chemical substances shall actively prevent the occurrence of accidents, and shall bear responsibility for adopting necessary protective, response, and disposal measures when an accident occurs.
An enterprise manufacturing, using, storing or transporting Class 1, Class 2, or Class 3 toxic chemical substances shall establish a nationwide toxic chemical substance joint prevention organization, which shall assist protective, response, and disposal measures adopted in the event of an accident in the foregoing paragraph.
The handler shall, pursuant to regulations, mark matters related to toxicity and pollution control on Class 1, Class 2, and Class 3 toxic chemical substance containers, packaging, handling sites, and facilities, and shall keep materials safety data sheets for the corresponding toxic chemical substances.
The central competent authority shall determine regulations governing the marking of containers, packaging, handling sites, and facilities, the production, classification, illustration, content, format, and establishment of materials safety data sheets, and other binding matters in the foregoing paragraph.
An enterprise manufacturing, using, storing or transporting Class 1, Class 2, and Class 3 toxic chemical substances shall employ professional technical management personnel pursuant to regulations for the performance of toxic chemical substance pollution control and risk prevention and response work.
The central competent authority shall, with regard to the professional technical management personnel in the foregoing paragraph, determine regulations governing qualifications and training; issuance, revocation or cancellation of qualification certificates; employment grade; number of personnel; work responsibilities; deputies; changes; and other binding matters.
The normal operation of discharge and leakage prevention facilities shall be maintained and response equipment shall be kept available while toxic chemical substances are in the process of being handled.
The central competent authority shall determine regulations governing installation, construction, operation, inspection, maintenance, service, calibration, record-keeping, record preservation, and other binding matters with regard to the response equipment and detection and alarm equipment in the foregoing paragraph.
For those circumstances in which the handling of Class 1, Class 2, or Class 3 toxic chemical substances is to be suspended for a period that exceeds one month, the statutory responsible person shall, within thirty days from the day handling is suspended, submit a list of the remaining toxic chemical substances to the competent authority for approval and handle the remaining toxic chemical substances in accordance with the following methods.
The following circumstances in which Class 1, Class 2, and Class 3 toxic chemical substances are handled shall be deemed as the suspension of handling:
Owners of Class 1, Class 2, and Class 3 toxic chemical substances shall, prior to transport, submit a transport manifest to the special municipality, county or city competent authority at the place of dispatch, and shall send a copy of the authorized transport manifest to the special municipality, county or city competent authority at the destination.
Vehicles transporting Class 1, Class 2, and Class 3 toxic chemical substances shall, pursuant to regulations, be installed with real-time tracking systems, which shall be kept in normal operation.
The central competent authority in conjunction with the Ministry of Transportation and Communications shall determine regulations governing transport manifest reporting and preservation, real-time tracking system installation, transport markings, documents to be carried, safety equipment, accident handling, and other binding matters in the foregoing paragraph.
Handlers of Class 1, Class 2, and Class 3 toxic chemical substances may not sell or transfer the toxic chemical substances at issue to those that have not obtained a permit, registration or approval pursuant to Article 13, Paragraphs 1 through 4. However, those that receive prior approval from the competent authority shall not be subject to this restriction.
For those toxic chemical substances for which one of the following circumstances applies, the handler shall promptly adopt emergency control measures and, within no more than one hour, notify the local competent authority.
For the circumstances in the subparagraphs of the foregoing paragraph, the special municipality, county or city competent authority, in addition to ordering the adoption of necessary measures, may also order the partial or complete suspension of handling related to the accident at issue.
If an unexpected accident occurs during transport in Paragraph 1, Subparagraph 2, the handler or owner shall, within no more than two hours, send professional response personnel to the site of the accident in order to bear responsibility for accident response and clean-up matters.
The handler in Paragraph 1 shall, in addition to being required to bear responsibility for clearance and disposal pursuant to relevant regulations after the occurrence of an accident, also submit a report to the special municipality, county, or city competent authority for reference. The central competent authority shall determine standards governing the format, content, items to be recorded, and other binding matters of said report.
The competent authority may send personnel bearing documents verifying their duties or markings providing sufficient identification to enter public or private premises and to check the handling of toxic chemical substances and related articles and sites and order the provision of relevant information; when necessary, the personnel may collect samples of toxic chemical substances or related articles, for which receipts shall be issued, and perform testing, and may provisionally seal the premises, which shall be put under the safekeeping of the statutory responsible person.
Samples collected pursuant to the foregoing paragraph shall be tested as quickly as possible, and an analysis laboratory that has been issued a permit by the central competent authority may be commissioned to perform testing; the period for testing may not exceed one month.However, those that receive the approval of the competent authority shall not be subject to this restriction.
The environmental analysis and testing organization in the foregoing paragraph shall perform work consistent with the testing and analysis categories on its permit. The central competent authority shall determine regulations governing the required conditions and facilities; the qualifications and in-service training of analysis personnel; permit application, review procedures, period of validity, issuance, replacement, revocation, and cancellation; suspension and resumption of business; checking and evaluation procedures; information reporting; and other binding matters in connection with the organizations.
The central competent authority shall officially announce the methods and quality control items for the testing of toxic chemical substances.
Toxic chemical substances or related articles checked pursuant to Paragraph 1 of the foregoing article shall be handled as follows depending on the outcome of checking:
Each industry competent authority shall provide guidance for pollution abatement work for toxic chemical substances.
The handling of toxic chemical substances by government agencies and academic organizations may be managed in accordance with the following regulations:
The perpetrator shall be punished by life imprisonment or a minimum of seven years imprisonment, and may be fined a maximum of NT$15 million, when any of the following circumstances occur and cause human death:
Those in one of the following circumstances shall be punished by a maximum of three years imprisonment, detention and/or a fine of a maximum of NT$5 million.
For those circumstances in which a statutory responsible person of a juridical person, or an agent, employee or other working personnel of a juridical person or natural person, violates, due to the performance of business activities, Article 29 or the previous article, in addition to the perpetrator being punished, said juridical person or natural person shall also be fined pursuant to the regulations of each article violated.
Those in one of the following circumstances shall be fined NT$1,000,000 to NT$5,000,000 and shall be ordered to make improvements within a limited time period; those that have failed to make improvements by the deadline may be ordered to suspend work or suspend business; when necessary, the competent authority may issue orders for the termination of business, the revocation or cancellation of registration or the revocation or cancellation of permits.
Those that evade, obstruct or refuse checking, orders, the collection of samples and testing, or sealing and safekeeping work performed by the competent authority pursuant to Article 25, Paragraph 1 shall be fined NT$1.5 million and may be fined per violation.
Those in one of the following circumstances shall be fined NT$100,000 to NT$500,000 and shall be ordered to make improvements within a limited time period; those that have failed to make improvements by the deadline may be ordered to suspend work or suspend business; when necessary, the competent authority may issue orders for the termination of business, the revocation or cancellation of registration or the revocation or cancellation of permits.
Those in one of the following circumstances shall be fined NT$60,000 to NT$300,000 and shall be ordered to make improvements within a limited time period; those that have failed to make improvements by the deadline may be ordered to suspend work or suspend business; when necessary, the competent authority may issue orders for the termination of business, the revocation or cancellation of registration or the revocation or cancellation of permits.
Toxic chemical substances or related articles checked pursuant to Article 25 shall be handled as follows depending on the outcome of checking:
The period for making improvements, reporting or performing conversion for those notified pursuant to this Act to make improvements, report or perform conversion within a limited period may not exceed thirty days unless there are actual needs and the central competent authority grants approval.
After the official announcement by the central competent authority of those toxic chemical substances that are already being handled prior to official announcement, the handler shall, within the officially announced period, complete improvement with regard to matters that must be declared, reported or implemented in accordance with regulations, and shall obtain a permit, complete registration or obtain approval pursuant to this Act, and may only continue handling after doing so.
Those enterprises that have obtained a registration document or approval document in accordance with law prior to the implementation of revisions to this Act shall apply to the special municipality, county or city competent authority for an extension within five years of the implementation of revisions to this Act; the registration or approval document shall lose its validity if no application has been made by the deadline or no extension has been obtained.
The central competent authority shall determine the standards of fees collected by competent authorities at all levels pursuant to this Act.
Confidentiality shall be maintained concerning reviews, checking, and the collection of samples and testing performed pursuant to this Act that involve national defense, industrial or commercial secrets.However, relevant physical, chemical, toxicity and safety information related to chemical substances shall not be subject to this regulation.
The competent authority may grant incentives to enterprises that comply with one of following conditions:
The competent authority shall determine regulations governing applicable targets, selection, incentive methods, and other binding matters with regard to the incentives in the foregoing paragraph.
The central competent authority shall determine the enforcement rules of this Act.
This Act shall take effect on the date of promulgation.