Toxic Substances Control Act
The Toxic Substances Control Act 1976 (TSCA, pronounced: "Toska"), also known as the "Hazardous Substances Control Act ", is an important standard of the US chemical regulation . The Environmental Protection Agency (EPA) is responsible for its implementation .
In 1976 this law was passed by the United States Congress . The TSCA is intended to enable the EPA to use the least expensive method to reduce the chemical risk to a reasonable level while taking into account the advantages of the chemical product or process ("TSCA directs EPA to use the least burdensome method to reduce chemical risk to reasonable levels while taking into consideration the benefits provided by the chemical product or process ").
The TSCA Chemical Substance Inventory is comparable to the EINECS , ELINCS and NLP directories of the EU . Substances not included are "new" substances and must be registered. Only substances that are listed in the TSCA directory may be imported into the USA.
There is no separate TSCA number for the substances; CAS numbers are used .
On June 22, 2016, US President Obama passed a US chemicals law, named after Senator Frank Lautenberg , Frank R. Lautenberg Chemical Safety for the 21st Century Act , which replaces the Toxic Substances Control Act. The House of Representatives accepted the proposal on May 24, and the Senate also approved it on June 7. The revision of the Toxic Substances Control Act is one of the most extensive interventions in US environmental law since the 1990s. The draft amendment came about after years of negotiations between Democrats and Republicans. The law aims to close numerous weaknesses and loopholes in the current legislation on chemical safety. In the future, this should be based on scientific data and provide state authorities with more competencies. For example, after the change in the law, chemicals can only receive marketing authorization if they have been classified as safe by the EPA. Furthermore, the change in the law provides for greater regulation of animal experiments and for research into so-called "cancer clusters" to be included in the legislation. The latter allows government agencies to investigate possible environmental impacts when abnormally high numbers of cancer cases are determined in a region.
Examples of different chemical inventories
- REACH - EU
- AICS - Australian Inventory of Chemical Substances
- DSL - Canadian Domestic Substances List
- NDSL - Canadian Non-Domestic Substances List
- KECL - Korean Existing Chemicals List
- ENCS (MITI inventory) - Japanese Existing and New Chemical Substances (see Chemicals Law (Japan) )
- PICCS - Philippine Inventory of Chemicals and Chemical Substances
- IECSC - Inventory of Existing Chemical Substances Produced or Imported in China
- NECI - National Existing Chemical Inventory in Taiwan
- NZIoC - New Zealand Inventory of Chemicals
- Poison List - Swiss Poison Lists 1-3 (until 2005)
The TSCA is considered one of the first major environmental laws in the United States. In terms of legal policy, the TSCA has recently been repeatedly criticized as ineffective and in need of reform. The last attempt at reform is the draft Safe Chemicals Act 2011 by Frank Lautenberg .
The TSCA does not provide for the approval of chemical substances, but the state has the right to intervene: This is based on the assumption that the majority of chemical substances do not develop any excessively risky effects. The presumption of harmlessness applies until the EPA proves to the contrary. The distinction between existing and new substances is fundamental. The Chemical Substance Inventory therefore contains all substances that were commercially available before 1979; these are considered existing substances. The inventory is updated roughly every six months; the downloadable list contains more than 68,000 substances in October 2019.
A registration procedure must be carried out for new substances, i.e. those that are not listed as existing substances in the inventory: A premanufacture notice (PMN) must be submitted to the EPA 90 days before the start of production . It is sufficient if the producer intends to manufacture the substance; placing on the market is not necessary. For the PMN, the manufacturer only has to pass on information that they already have themselves; However, you do not have to produce any safety or health-related data yourself and submit it to the EPA.
The EPA then has 90 days to check whether the substance to be produced could pose an unreasonable risk . After the 90 days have expired, it will be included in the inventory and a notice of commencement will be sent to the first applicant within 30 days . Within the 90-day period, the EPA has several options to react: If it remains inactive, the producer can conclude that there is no unreasonable risk and that after the period has expired, he may manufacture, import or market the substance without any conditions. This is also the rule. In 86% of all registrations, the decision is made very early not to undertake any further examination. If the EPA needs further information about the substance, it can temporarily restrict or prohibit production, processing, marketing and disposal through so-called proposed orders . If the EPA cannot rule out an unreasonable risk , according to s. 4 (a) TSCA that the notifier of the chemical substance or process must perform further tests. The EPA itself lacks any legal basis for its own tests. The justification of a test rule must on the one hand refer to the incompleteness of the data, on the other hand also to a possible qualitative (A-finding) or quantitative risk (B-finding).
In the case of existing substances, it is assumed that they are not dangerous; a PMN is not required. However, as an exception, after s. 8 TSCA from the manufacturer of the PMN, similar information can be requested from the manufacturer. A notification of an existing substance is only necessary if a new use of the substance is intended (significant new use notive).
The linchpin of risk assessment is the question of whether there is an unreasonable risk . The term is not legally defined , so that there is much controversy about its interpretation. The leading decision here is Corrosion Proof Fittins v. EPA 947 F.2d 1201 ( 5th Cir. 1991). The court relied largely on the interpretation of John S. Applegate in its interpretation.
If the EPA has test results that suggest an unreasonable risk , it must either determine within 180 days that there is no unreasonable risk or take safety measures according to the SS. 5, 6, and 7 TSCA to take.
The TSCA imposes lower requirements for substances that are only used in small quantities in research and development. In addition, the TSCA is not responsible for
- Food, pharmaceuticals, cosmetics and medical devices (the "Food, Drug, and Cosmetic Act" is responsible)
- Pesticides ("Insecticide, Fungicide, and Rodenticide Act")
- Tobacco and tobacco products (requirements of the "Bureau of Alcohol, Tobacco, Firearms and Explosives")
- radioactive materials and waste (requirements of the "Nuclear Regulatory Commission")
Many US states have further, usually stricter, regulations for substances that are subject to the TSCA.
- Notes on the Toxic Substances Control Act ( Memento of July 2, 2012 in the Internet Archive )
- Notes on the TSCA Chemical Substance Inventory at EPA (United States Environmental Protection Agency)
- Andrea Kuhn: REACH - the new European regulatory system for chemicals . Lexxion Verlag , Berlin 2010, ISBN 978-3-86965-131-6 , Chapter I BI - Chemicals Regulation in the United States (Berliner Stoffrechtliche Schriften Vol. 9).
- congress.gov: S. Rept. 114-67 - FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT | Congress.gov | Library of Congress (PDF, 570 kB), accessed November 2, 2019
- eenews.net: CHEMICALS: Obama signs TSCA reform into law - Wednesday, June 22, 2016 , accessed July 25, 2016
- epa.gov: Frank R. Lautenberg Chemical Safety for the 21st Century Act , accessed July 25, 2016
- kooperation-international.de: Cooperation International: USA: Amendment to the Chemical Safety Act , accessed on July 25, 2016
- Andrea Kuhn: REACH - the new European regulatory system for chemicals . Lexxion Verlag, Berlin 2010, Chapter I BI - Chemical Regulation in the United States.
- epa.gov, How to Access the TSCA Inventory , accessed October 23, 2019 .
- John S. Applegate: The perils of unreasonable risk: information, regulatory policy, and toxic substances control . In: CLR . 1991, p. 261-333 (271 sqq.) .