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TSCA 2013 Reform Bill

TSCA is a federal policy that is still in legislation process for reformation. It is heard on May 23, 2013 by senators Frank Lautenberg Democrat from New York and David Vitter Republican from Louisiana introducing with strong bipartisan support and the hearing was held at United States House Energy Subcommittee on Environment and Economy Chemical Safety Improvement Act is TSCA’s subsection S.1009 that is taken in to consideration of reforming which will, if passed, give the Environmental Protection Agency critical tools to significantly strengthen health protections to the public as well as improving the initial TSCA of 1976. The bill's key revision includes: • “mandating safety evaluations for all chemicals in active commerce, • requiring new chemicals to be deemed likely safe before entering the market, • fixing the key flaws in TSCA’s safety standard that led to EPA’s inability even to ban the deadly carcinogen asbestos, • allowing EPA to issue orders to require testing without the Catch-22 of first having to show potential risk, and making more information about chemicals available to states, health professionals and the public by limiting current trade secret allowances”

Most recently in Feb 4, 2014, the senate committee on Environment and Public Works Subcommittee on Water and Wildlife held hearings on Chemicals Safety Improvement Act This hearing was mostly focusing on the non-disclosure of chemical substances in manufacturing and it the revamp of the bill has potentials of hurting the businesses.

Reference:

1. "Subcommittee Continues Review of TSCA with Look at Testing and Reporting Requirements." Energy & Commerce Committee. 04 Feb. 2014. 26 Feb. 2014 <https://energycommerce.house.gov/press-release/subcommittee-continues-review-tsca-look-testing-and-reporting-requirements>

2. "Chemicals Policy Reform." Environmental Defense Fund. N.p., n.d. Web. 09 Mar. 2014. Plagakis, Sofia. "We Need a Chemical Safety Bill Worthy of Sen. Lautenberg's Legacy | Center for Effective Government." We Need a Chemical Safety Bill Worthy of Sen. Lautenberg's Legacy | Center for Effective Government. N.p., 06 Mar. 2013. Web. 09 Mar. 2014

3. "Bill Summary & Status 113th Congress (2013 - 2014) S.1009All Information." Bill Summary & Status. N.p., n.d. Web. 09 Mar. 2014

TSCA vs. REACH

Like the TSCA in the U.S., the European Union (EU) has enabled laws called Registration, Evaluation and Authorization of Chemicals (REACH ) on June 1st 2007 to improve the former chemicals regulations in the European Union (EU). In order to review the approaches of both TSCA and REACH on requiring chemical companies to develop information on chemicals’ effects, controlling risk from chemicals, and making information on chemicals available to the public, the U.S. Government Accountability Office analyzed and compared the applicable regulations, interviewed the officials, industry representatives, and environmental advocacy organizations in both legislations.

REACH vs. TSCA requirements for chemical companies on developing more Information on chemical effect on human health and the environment

TSCA requires chemical companies to submit to EPA any available human health and environmental data on their existing chemicals Those companies do not have to develop additional information on their new chemicals as well as existing companies unless EPA requires additional test data through a test rule . Under REACH and European Chemicals Agency’s regulations, chemical companies are required to provide quantity of chemicals and further develop the date on human health and environment .

For new chemicals, companies have to file pre-manufacture notification (PMN) and that enables EPA to examine existing data on newly created chemicals or the new uses and purposes of existing chemicals. After examing if . TSCA also requires chemical companies to submit data and other information on the physical and chemical properties, fate, or health and environmental effects of a chemical (hazard information), that the companies possesses or is reasonably ascertainable by them because TSCA does not require hazard information before submitting a premanufacture notice .

REACH created a single system for the regulation of new and existing chemicals. For chemicals produced or imported at 1 ton or more per year, chemical companies are required to register and submit information for their chemicals including information on chemical production process, purpose of usage, safety guidance, exposure information, and summaries of physical and chemical properties and their effects on human health or the environment . REACH requires different chemical information depending on their amount produced or imported, 1 ton or more, 10 tons or more, 100 tons or more, and 1,000. For example at the one or more tonnage band, REACH requires information on environmental effects that include short-term toxicity on invertebrates, toxicity to algae, and ready biodegrability . At the 10 or more tonnage band, chemical safety assessment, a physiochemical hazard, an environmental hazard, and chemical’s persistence, bioaccumulative, and toxic pollutant assessments are required .

TSCA vs. REACH regulations on potential chemical risks

Under TSCA, EPA must collect data needed to assess the potential risks of chemicals and required to develop substantial evidence in the in order to withstand judicial review and policy making.. Due to the section 6 of TSCA, EPA has had difficulty proving that chemicals pose unreasonable risks because in order to regulate an existing chemical, EPA must find a reasonable basis to conclude that the chemical presents unreasonable risk of injury to health or the environment. However the section is taken into consideration to modification in the 2013 reform . The Section 6 also limits or restricts the production of polychlorinated biphenyls, fully halogenated chlorofluoroalkanes, dioxin, asbestos, and hexavalent chromium . In addition for 160 existing chemicals, under Section 5(a)(2), TSCA issued required chemical companies to submit notices to EPA prior to manufacturing, importing, or processing of the substance for new use .

REACH requires chemical manufactures, importers, and downstream users ensure that the chemicals do not negatively affect human health or the environment and they should request authorization to produce or import hazardous chemicals and should look for the companies to search for safer alternatives for the harmful chemicals . The authorization procedures involves first European Chemicals Agency to publish a candidate list of chemicals, secondly, the European Commission to determine authorizations or exempts from candidate lists, and finally if a chemical is deemed to require authorization, a chemical company will have to apply to the European Commission for an authorization for each use of the chemical . However, even these chemicals may receive authorization if a chemical company can demonstrate that social and economic benefits outweigh the risks. Likewise TSCA, REACH restricts chemicals that pose an unacceptable risk to health or the environment and the proposal must demonstrate that there is a risk to human health or the environment that needs to be addressed at the community wide level and to identify the most appropriate set of risk reduction measures .

TSCA vs. REACH Disclosing Chemical information to Public

TSCA and REACH both require public disclosure of information on chemicals produced or imported. . However there are certain extents to which the chemical information can be claimed as business confidential and protected as an business information under TSCA and REACH. TSCA has provisions to protect information claimed by chemical companies as confidential or sensitive business information, such as information on chemical production volumes and trade secret formulas . Health and safety studies, however, generally cannot be considered confidential business information, and TSCA has provisions for making such studies available to the public . Additionally, EPA can disclose confidential business information when it determines such disclosure is necessary to protect human health or the environment from an unreasonable risk. EPA interprets the term health and safety study broadly and, as such, it may include but is not limited to epidemiological, occupational exposure, toxicological, and ecological studies .

However, TSCA allows chemical companies to claim any information provided to EPA as business confidential other than the chemicals for health and safety studies . In this extent of TSCA restricts EPA’ s ability to share information including its identity, the chemical’s identity, site of operation, with the state officials or with officials of foreign governments. State and local environmental agencies, environmental advocates and other public interested groups are important in obtaining those chemical information in order to use towards environmental activities, such as developing contingency plans to develop effective emergency response in the presence of highly toxic substances. Likewise, the general public may find information collected under TSCA useful to engage in dialogues with chemical companies about reducing chemical risks and limiting chemical exposures at nearby facilities that produce or use toxic chemicals.

Similar to TSCA, REACH has provisions to protect information claimed by chemical companies as business confidential or sensitive, including trade secret formulas and production volumes. Without the chemical company’s claim, REACH considers the details of the full composition of the chemicals and the preparation, the precise use, function, or application of the chemical, the precise tonnage or volume of the chemical manufactured or placed on the market and relationships between manufacturers/importers and downstream users as confidential for an industry’s economic purpose . REACH authorizes the European Chemicals Agency to publicly disclose the confidential information if there are immediate threat to human health and safety or to the environment. REACH also requires that safety data sheets for Bioaccumulative and Toxic Substances and Very Persistent , Very Bioaccumulative and Toxic Substances and other chemicals classified as dangerous be provided to ensure that downstream users and distributors of a chemical, as well as chemical manufacturers and importers, have the information they need to safely use chemicals . Similar to TSCA, REACH requires public disclosure of health and safety information allows public to have access to basic chemical information, including brief profiles of hazardous properties, labeling requirements, authorized uses, and risk management measures. Unlike TSCA, REACH has provisions under which confidential information can generally be shared with government authorities of other countries or international organizations under an agreement between the parties provided.

Comparison of TSCA and REACH’s selected provisions

Definition of new and existing chemicals

REACH has a single system for both new and existing chemicals. TSCA: New chemicals are not listed on the TSCA inventory. Existing chemicals are listed in the TSCA Inventory .

Number of chemicals covered in the inventory

REACH: After enacting REACH in European Union, the officials estimated approximately 30,000 cases that have produced or imported at a level of at least 1 metric ton chemicals .

TSCA: Currently more than 82,000 chemicals are in the TSCA inventory and 20,000 of them were added after 1979 into the inventory after the EPA program started reviewing the existing chemicals .

Complete risk assessment requirements

REACH requires chemical companies that produce at level of 1 metric tons per year to conduct risk assessment along with European Chemical Agency’s review and for the companies that produce more than 10 tons or more per years need to conduct chemical safety assessment for all the chemicals produced .

TSCA does not require chemical companies to perform risk assessments on new chemicals. However, it allows companies to perform voluntary risk assessments on their new chemicals. For existing chemicals, companies are required to notify EPA immediately of new unpublished information on chemicals that potentially risky but are not required conduct risk assessments .

Production quantity disclosure

REACH requires chemical companies to submit their registration yearly with the information on the overall quantity of production or importing of a chemical in metric tons per year in a technical dossier and immediately report if any significant changes occur in the quantity . TSCA: Chemical companies must provide EPA a reasonable third year estimate for their new chemicals in total production volume at the time a Premanufacture Notices is submitted. For every 5 years, the existing chemicals on the TSCA inventory and produced at quantities of 25,000 pounds or more must be reported .