Chemicals & Materials Now!
From basic to specialty, and everything in between
TOSCA is an Opera, TSCA can be a Drama
Posted on January 12th, 2016 by Dr. Sina Ebnesajjad in Chemical Manufacturing Excellence
When Puccini composed his magnificent opera Tosca he never imagined an environmental law’s acronym would be pronounced Tosca! While Tosca has not changed over time, TSCA is undergoing significant changes with looming impact on industries producing or consuming chemicals.
What is TSCA?
The Toxic Substances Control Act (TSCA) was promulgated in 1976 in response to the escalating concerns about the effects toxic chemicals pose to humans and the environment. The legislation intended to give the Environmental Protection Agency (EPA) broad oversight over all aspects of chemical substance management, including manufacturing, importation, processing, distribution, use and disposal. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.
TSCA gives the EPA three major responsibilities: 1) to gather information on new and existing chemicals being manufactured in the US; 2) to collect and produce data for use in the risk assessment of chemicals; and 3) to properly control chemicals that are deemed as presenting—in the words of the act—an “unreasonable risk of injury to health or the environment” through rule making, including restrictions, labeling and bans. The legislation provides EPA with the authority to require reporting, record keeping and testing, and restrictions.
The term “chemical substance” is defined by TSCA as “any organic or inorganic substance of a particular molecular identity, including: (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical.” The EPA states: “TSCA defines ‘chemical substance’ broadly and in terms which cover microorganisms as well as traditional chemicals.”
TSCA established a framework, guidance and authority for chemical risk management. It also allowed 62,000 chemicals to be “grandfathered” into the system, making them immune to the scrutiny to which new chemicals or existing chemicals with new uses are subject. The number of chemicals in use today is around 83,000.
When a new chemical is produced: The PMN process
PMN stands for pre-manufacture notice. Chemical substances manufactured in or imported into the US that are not listed on the TSCA Inventory, and not otherwise exempt from the listing, are considered “new” and subject to TSCA Section 5 PMN requirements. Companies must ensure that the PMN provides a notice of commencement (NOC) for manufacturing a new chemical at least 90 days before initiating the activity. Exempt from the PMN requirement are substances that are either (1) excluded from TSCA reporting or (2) exempt from all/part of PMN reporting because EPA has determined that they do not warrant review or require only a short review.
The PMN form seeks information on the submitter’s identity, the chemical substance’s identity, production volume, uses, exposures and environmental fate. While TSCA does not require a submitter to test new chemical substances before submitting a PMN, any health and safety data relating to a new chemical substance’s health or environmental effects that are in a submitter’s possession or control must be submitted with the PMN.
The EPA has developed the PMN review process to estimate the risk attributable to a new chemical substance and to determine whether an unreasonable risk of injury to health or the environment may occur if the chemical substance is distributed in commerce. It involves extensive amounts of work, thus requiring dedicated personnel.
The EPA’s authority under TSCA
TSCA grants the EPA the authority to conduct inspections to enforce the Act. This includes inspecting any establishment, facility or other premises in which chemical substances or mixtures are manufactured, processed, stored or held before or after their distribution in commerce, and any conveyance being used to transport chemical substances in connection with their distribution in commerce. Failure or refusal to permit entry or inspection as required under Section 11 constitutes an unlawful act under TSCA Section 15, giving rise to civil penalties.
TSCA authorizes EPA to seek criminal penalties against any person who “knowingly or willfully” violates any provisions of TSCA. EPA can seek criminal fines of up to $32,500 for each day the violation continues and/or imprisonment for up to one year. EPA can seek criminal penalties in lieu of, or in addition to, civil penalties.
What has TSCA accomplished?
While TSCA has been viewed as the regulation that allowed the EPA to promulgate regulations for the management, storage, use and disposal of Polychlorinated Biphenyls (PCB), it was never limited to asbestos, lead and PCB’s. TSCA was intended to protect both public health and the environment more comprehensively from unreasonable risks of a variety of hazardous materials and wastes, including biological and chemical substances, mixtures and even the byproducts of those materials.
TSCA has proven to be a complex and unwieldy law since it has been on the books. To date, TSCA has contributed to the elimination of some chemicals but not achieved the broader chemical risk management originally sought. With no safety testing required by TSCA for existing chemicals, the EPA has been responsible for obtaining data in order to assess their risks. According to Washington Post, TSCA has succeeded to regulate a tiny percentage of chemicals, eliminated less than a half dozen and studied around two hundred substances.
In addition, the EPA has had the authority to control/restrict chemicals that posed an “unreasonable risk of injury to health or the environment.” However, the EPA’s ability to obtain safety information and set regulatory standards as outlined under the TSCA has fallen far short of expectations. “Unreasonable risk” is subjective and has been a source of difficulty in the enforcement of TSCA. To work around obstacles, the EPA has increasingly relied on voluntary programs and procedures designed to encourage chemical producers to provide the agency with data.
TSCA is being reformed right now
There has been an emerging scientific consensus that environmental presence of industrial chemicals especially at “high” concentrations may present risks for chronic disease. Often “high” has been defined as concentrations detectable in the ambient environment or the human body. Since 2009 various stakeholders— including the chemical industry, environmental and public health advocates, and the EPA—have called for reform of the TSCA act.
Some specific reasons for the inability of the TSCA Act to function as originally envisioned include:
- Complexity of the Act;
- Data trap – TSCA poses the proverbial catch 22! The EPA is responsible for obtaining data in order to assess their risks. Before testing a chemical for risk, the EPA must demonstrate that the product poses “unreasonable risk.” In addition, the legislation’s requirement that the EPA show that its proposed rule to restrict the use of a chemical is the “least burdensome” alternative for controlling the public’s exposure to the chemical often consumes significant time and resources.
- Failure in regulating asbestos, in spite of its known hazards, was a de facto surrender of its authority to develop rules that would place even limited restrictions on chemicals.
- Few politicians have shown interest in championing chemicals policy while the powerful opponents of the rule consistently supported the status quo.
Pressure from Europe to reform TSCA has been felt after the passing of REACH law by the European Union. The law requires data from chemical manufacturers applying a principle of “no data, no market.” Another factor has been legislative activity at the state level because of public demand. The move has created tens of new rules and requirements in different states adding to the difficulty of conducting for companies.
At this time, the U.S. House of Representative has passed a reform of TSCA. The U.S. Senate has been contemplating its own bill. Consequently, the reform awaits legislative action and final approval. Here are the highlights of the House bill:
- The standard for EPA to act on a chemical will be “health only” as opposed to a “cost benefit” standard, which means that the consideration of costs when determining chemical safety is essentially prohibited.
- EPA will be required to ensure that vulnerable populations, like pregnant women and children or heavily exposed communities, are protected when acting on a chemical.
- The current law’s requirement to prove banning a chemical is the “least burdensome” alternative—one key factor for TSCA’s failure—will be removed.
- EPA will be able to require toxicity testing on any chemical by a much simpler process of an “order” versus the currently complex process of a formal rulemaking.
- EPA will be required to screen existing chemicals for the combined properties of persistence, bioaccumulation and toxicity; publish a list of those; and fast-track them for regulation.
- States will be able act to protect their citizens at any point until the EPA has either exonerated a chemical or taken action to restrict it. Even then, previous state actions are preserved and several categories of state regulations are exempted.
- Rules for Confidential Business Information (CBI) will be tightened in the future, allowing the information to be shared with states, first responders and health care providers.
With its shifting course towards requiring evidence of a chemical’s safety in order to enter or remain in the market, the effects of TSCA on the chemicals industry will indeed be something to watch.
 S. A. Vogel and J. A. Roberts, Health Affairs, vol. 30 no. 5 pp898-905, May 2011 doi: 10.1377/hlthaff.2011.0211
 BR. A. Mears, Director of Enviro. Health and Safety, Amherst College, Toxic Substance Control Act, Environmental Law, November 18, 2002.
R&D Solutions for Chemicals & MaterialsWe're happy to discuss your needs and show you how Elsevier's Solution can help.
Dr. Sina Ebnesajjad
President at FluoroConsultants Group, LLC
- Equal access to data can streamline the entire R&D phase
- The New Knovel is Live!
- In Pursuit of Safer Chemical Substitutions
- Make America Make Again
- One Company, Multiple Information Solutions