The Toxic Substances Control Act (TSCA) Public Law 94-469, was first signed into Law on October 11, 1976 due to the use of a large number of chemicals in the United States (US) and exposure to human health or the environment. This act was recently updated under 'The Frank R. Lautenberg Chemical Safety for the 21st Century Act', Public Law 114-182, and was signed into Law on June 22, 2016 by US President Obama. The scope of the reform does not include; pesticides, tobacco, nuclear materials, food, drugs or cosmetics. TSCA allows the Environmental Protection Agency (EPA) to assess chemical risks to human health and the environment and to take action to control these risks. In summary, TSCA authorizes the EPA to keep an 'inventory' of all existing chemicals. Currently the inventory comprises approximately 83,000 chemicals that are being manufactured or imported into the US. Chemicals on the inventory can be manufactured or imported into the US, chemicals that are not on the inventory cannot be manufactured or imported into the US.

1. Introduction
The Toxic Substances Control Act (TSCA) Public Law 94-469, was first signed into Law on October 11,
1976 due to the use of a large number of chemicals in the United States (US) and exposure to human
health or the environment. This act was recently updated under ‘The Frank R. Lautenberg Chemical Safety
for the 21st Century Act’, Public Law 114-182, and was signed into Law on June 22, 2016 by US President
Obama. The scope of the reform does not include; pesticides, tobacco, nuclear materials, food, drugs or
cosmetics. TSCA allows the Environmental Protection Agency (EPA) to assess chemical risks to human
health and the environment and to take action to control these risks.
In summary, TSCA authorizes the EPA to keep an ‘inventory’ of all existing chemicals. Currently the
inventory comprises approximately 83,000 chemicals that are being manufactured or imported into the
US. Chemicals on the inventory can be manufactured or imported into the US, chemicals that are not
on the inventory cannot be manufactured or imported into the US.
TSCA authorizes the EPA to regulate existing and new chemicals. EPA reviews all new chemicals
prior to being placed on the market. EPA can authorize testing and can ban manufacture or import
of chemicals posing an unreasonable risk prior to that chemical being allowed on the market.
EPA does this through the pre-manufacturing (PMN) notification process. If the EPA concludes that
certain uses of a chemical present an unreasonable risk, it can issue restrictions. The EPA can request
manufacturers and processors produce additional data if required for the risk determination.
Under the previous act, TSCA ‘grandfathered’ in 62,000 existing chemicals that were in current use, and
were generally considered to be safe. Since then only 200 chemicals have been tested to date, and only
five chemicals have been restricted. In addition, TSCA lacked mandatory safety requirements i.e., new
chemicals could be placed on the market without basic toxicity data.
TSCA Inventory
After all active substances have been identified as being high priority or low priority, the EPA will conduct
risk evaluation of all high priority chemicals and for those chemicals requested by industry. This will
involve a safety determination of whether the chemical poses unreasonable risks of harm to human health
or the environment. Low priority chemicals do not require further action, but can be elevated to high
priority based on new information.
US TOXIC SUBSTANCES
CONTROL ACT (TSCA)
REFORM

2. Risk Evaluation/Safety Assessment Process
Safety assessment evaluates risk, while safety determination evaluates whether a chemical meets the safety
standard. Both of these processes are risk based. Risk is based on hazard and exposure. EPA will evaluate
both the hazard of the chemical and the extent to which humans or the environment are exposed to the
chemicals. This assessment will be science based and if insufficient information is available, the EPA can
request manufacturers and processors to provide more data or testing if necessary using a tiered-testing
approach. In summary, TSCA authorizes the EPA to keep an ‘inventory’ of all existing chemicals.
TSCA Workplan-Prioritized Chemicals
Under the revised act, the EPA required risk evaluations for ten of the chemicals on the 2014 TSCA
workplan. The list of prioritized chemicals is shown in Table 1. EPA must expedite review of those
chemicals, so within three years EPA must propose a rule to manage the risk of these chemicals,
for e.g., persistent, bioaccumulation or toxic (PBT) chemicals. Therefore, thousands of chemicals
previously unregulated will now be regulated under the TSCA reform.
Table 1. Chemicals Prioritized Under Revised TSCA Reform
Prioritized Chemicals
▶ 1,4 dioxane
▶ 1-Bromopropane (1-BP)
▶ Asbestos
▶ Carbon tetrachloride
▶ Cyclic aliphatic bromide cluster (HBCD)
▶ Methylene chloride
▶ n-methylpyrrolidone (NMP)
▶ Pigment violet 29
▶ Tetrachloroethylene (perc)
▶ Trichloroethylene (TCE)

3. New Chemicals/Significant User Notifications (Snuns)
Manufacturers and processors cannot produce a new chemical until the EPA approves it following
a PMN, and EPA has 90 days to do this. EPA must provide affirmative decisions on new chemical or
significant new use notifications (SNUNs) of existing chemicals before the chemical can enter the
market, see Table 2. Depending upon the outcome, the EPA may take a range of actions, including
placing a ban on the chemical or request additional data or testing of the chemical.
Table 2. EPA Evaluation Process for Chemicals
‘Presents’ unreasonable risk of
injury to health or environment
‘May present’ unreasonable risk
of injury to health or environment
‘Not likely to present’ unreasonable
risk of injury to health or environment
▶ EPA rules restricting substance ▶ EPA order restricting substance
(pending further information)
▶ Manufacture or use may commence
Confidential Business Information (CBI)
Under the revised act, industry will be required to provide comprehensive information to the EPA
in order to substantiate CBI claims. This will require companies to justify why they are entitled
to confidentiality, the steps taken to keep the information secret and how disclosure would cause
competitive harm. This can include information regarding chemical manufacture, process or
distribution, marketing/sales, chemical identity i.e., chemical name and CAS number. CBI cannot
include health and safety information including safety assessments and determination, and results
of any testing requested by the EPA, as all health and safety data will remain public. All CBI claims
will automatically expire after ten years unless these are renewed.
Fees
Under the revised act, the EPA will be able to collect fees for information gathering and testing.
EPA may now levy up to $25 million in annual user fees from regulated entities. The EPA has
the authority to collect fees from manufacturers and processors who:
▶ Are required to submit test data
▶ Submit notice of an intent to manufacture a new chemical or new use of a chemical
▶ Manufacture or process a chemical that is subject to risk evaluation
▶ Request EPA to conduct a risk evaluation on an existing chemical

4. TSCA Timelines for Implementation of New Guidelines
Table 3. EPAs Timelines for Implementation
Year 1
▶ Publish final rule for TSCA inventory
▶ Issue guidance to industry for risk evaluation
▶ Establish science advisory committee on chemicals
▶ Establish scope of initial ten assessments
▶ Issue rule to designate chemicals as either ‘high’ priority or ‘low’ priority
Year 2
▶ Must develop a strategic plan to promote development and implementation of alternative testing methods
and to reduce animal testing
Year 3
▶ Publish final rule for TSCA inventory
▶ Within three and a half years, EPA must have identified 20 ‘high’ priority and 20 ‘low’ priority chemicals -
i.e. continuous cycle
Longer Term
▶ Approximately four to five years - completion of first risk evaluations
▶ Every five years - report to Congress on capacity and resource requirements to conduct risk evaluations
▶ Every ten years- Re-evaluate CBI requests
Implications for Industry
As a first step, industry will need to review the TSCA work plan list and submit to the EPA
information on chemicals that are active i.e., chemicals being manufactured or imported into
the US, for these to be included onto the ‘active’ list. In addition, PMN and SNUN submissions
will need to be submitted immediately. Industry should consider actions and decisions made under
EU REACH Regulation/ECHA and Canadian authorities, and be proactive in providing information
to the EPA and to defend their chemicals, and comment early on the scope of the assessments.
Industry should also review the EPA databases, to understand whether the data is sufficient and
identify any data gaps/studies that may be required to assess specific uses and exposure. The TSCA
Reform implements a new requirement on the use of animal alternatives and read across approaches
i.e., quantitative structure activity relationships (QSAR’s). Companies wishing to submit CBI claims
will need to be prepared to provide detailed information to justify the need for confidentiality,
and monitor EPA’s requirements for the new certification statement.

5. Key Differences Between EU Reach and US TSCA Reform
▶ REACH applies to all chemicals used ≥ one ton/year in Europe, whereas TSCA only applies
to those ‘active’ chemicals on the TSCA inventory, and all new chemicals being manufactured
or imported in the US
▶ REACH comprised three registration deadlines based on tonnage, i.e., 2010, 2013 and 2018
for substances manufactured or imported into EU at ≥1000 tons/year, 100-1000 tons/year
and 1-100 tons/year respectively. TSCA will be developing a substance evaluation process
to ensure 20 substances are being evaluated on a continuous basis
▶ REACH requires specific data requirements for the different tonnage bands i.e. the higher the
tonnage of a substance, the more data required, whereas TSCA has no specific data requirements,
unless the EPA issues an order for further data depending on the outcome of the risk evaluation
▶ Under REACH, highly hazardous substances are identified as substances of very high
concern (SVHCs), with the potential for authorizations/restriction, this is in contrast
to TSCA, where substances are identified as ‘may present a risk’ to ‘presents a risk’,
with a wide range of available solutions
Conclusions
Chemical organizations could be forgiven for thinking that their requirements under TSCA are
far less onerous than those which were seen under REACH. Although there will be less demand
for safety testing due to the increased drive for data sharing across global systems, there will still
be an acute need to carefully analyze and interpret the vast amounts of data available to ensure
compliance and consumer and environmental safety.
In these circumstances it’s important for organizations to partner with a regulatory consultancy
that really understands the context of the data against the relevant regulations and can help
identify any potential gaps to minimize the risk of rejection or the request of new data by EPA.
A supplier who has the capability and expertise in alternative methodologies to testing and
providing data e.g., QSARs would also be advantageous as this will be a key strategic area
the EPA will be developing from 2018 onwards.
References
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-
safety-21st-century-act
https://www.natlawreview.com/article/epa-publishes-tsca-framework-final-rule-tsca-inventory-
notification-active-inactive
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