Every government is keen to ensure that the chemicals produced, manufactured and used within their countries are safe for consumers and used appropriately. Globally, since 2007, the European Union's Registration, Evaluation, Authorization and Restriction of Chemical (REACH) regulation has brought effective management of chemicals in to sharp focus.

1. 1
TOXIC SUBSTANCES CONTROL ACT (TSCA)
SAFETY FIRST:
YOUR GUIDE TO THE
TOXIC SUBSTANCES
CONTROL ACT (TSCA)
Discover the latest developments
and what they mean for your business

2. 2
TOXIC SUBSTANCES CONTROL ACT (TSCA)
Introduction 3
Old TSCA vs. New TSCA 4
TSCA Scope: What Does it Cover? 5
Process Overview 6
Process for New Chemicals 7
Process for Existing Chemicals 9
Work Plan List 11
Animal Alternatives 13
Data Considerations 13
Other Considerations 14
Implications for the Chemical Industry 15
CONTENTS

3. 3
TOXIC SUBSTANCES CONTROL ACT (TSCA)
WHAT IS TOXIC SUBSTANCES
CONTROL ACT (TSCA) AND
WHAT’S CHANGED?
The ‘Frank R. Lautenberg Chemical
Safety for the 21st Century Act’
was signed by President Obama
on June 22, 2016. It is in effect
now for new and existing chemicals
and is the United States’ main
chemical management law.
Obama’s signature updated the
previous TSCA of 1976 which
provided the Environmental
Protection Agency (EPA) with
the authority to require reporting,
recordkeeping and testing
requirements, and restrictions
relating to chemical substances
and/or mixtures.
Every government
is keen to ensure that
the chemicals produced,
manufactured and used
within their countries
are safe for consumers
and used appropriately.
Globally, since 2007,
the European Union’s
Registration, Evaluation,
Authorization and
Restriction of Chemical
(REACH) regulation
has brought effective
management of
chemicals in to
sharp focus.
WHY HAS IT
BEEN UPDATED?
As the title suggests, the new act
has been enhanced for the modern
world including improvements
in the following areas:
▶▶ Mandatory requirement for EPA
to evaluate existing chemicals with
clear and enforceable deadlines
▶▶ New risk-based safety standard
▶▶ Increased public transparency
for chemical information
▶▶ Consistent source of funding for
EPA to carry out the responsibilities
under the new law
An overview of some of the new
additions to TSCA is given on the
next page but broadly speaking the
new measures have received approval
from the chemical industry, suppliers,
consumers and other stakeholders.
INTRODUCTION

4. 4
TOXIC SUBSTANCES CONTROL ACT (TSCA)
OLD TSCA VS. NEW TSCA
LAUTENBERG ACT
KEY UPDATES
CRITICISM OF
PREVIOUS TSCA
SOLUTION UNDER
NEW TSCA
Safety standard and vulnerable populations
Chemicals judged solely on health risk,
including too vulnerable populations.
▶▶ Paralyzing regulatory hurdle
▶▶ No requirement to protect most
vulnerable
▶▶ Health-only safety standard
▶▶ Explicit protections for vulnerable
Chemical reviews
New law requires safety review of all
existing and new chemicals.
▶▶ Existing chemicals were presumed safe
▶▶ New chemicals lacked adequate
safety data
▶▶ Mandate to review chemicals
▶▶ Safety finding for all new chemicals
Testing authority
Increased authority to require industry
to test its chemicals.
▶▶ Weak testing power ▶▶ New stronger testing authority
Confidential Business Information (CBI)
Ability to keep chemical information
secret is dramatically reduced.
▶▶ Excessive CBI claims
▶▶ CBI kept indefinitely
▶▶ Greater transparency
▶▶ Time limits on CBI claims
Funding
Substantially more funding for EPA,
partially from industry.
▶▶ Insufficient funding ▶▶ Broad dedicated fees to
future-proof agency

5. 5
TOXIC SUBSTANCES CONTROL ACT (TSCA)
NEW CHEMICALS
Before a chemical can enter the
market, the EPA must make an
affirmative determination that
the chemical:
▶▶ Presents an unreasonable risk
▶▶ May present an unreasonable risk
▶▶ Information is insufficient to permit
a reasoned evaluation of risk
EXISTING CHEMICALS
Substances that are currently being
manufactured and utilized can
continue to do so but the EPA must
again review them depending upon
their respective risk profile:
▶▶ High priority – the chemical
may present unreasonable risk
▶▶ Low priority – does not meet
the standard for high priority
There are three key
areas the new act
encompasses. They
are new chemicals
which are due to enter
the market, existing
chemicals currently
in production and
high priority or risk
substances which
the EPA feel warrant
extra measures.
INITIAL 10 SUBSTANCES OR
‘WORK PLAN LIST’
The EPA has already identified
10 key substances they feel are high
risk which require extra measures.
Also known as the work plan list the
scope of these first ten assessments
were released in 2017.
TSCA SCOPE: WHAT DOES IT COVER?

6. 6
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PROCESS OVERVIEW
Chemical presents
an unreasonable risk
Restrict
More data
required
Continue
to use
Insufficient information or may present
unreasonable risk or is produced in large amounts
and significant release or exposure
Chemical is not likely to
present an unreasonable risk
SUBMISSION REVIEW DETERMINATION RESULT
New chemicals and significant
new uses of existing chemicals
EPA reviews and
decides on three
courses of action
Existing chemicals
Work plan list

7. 7
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PROCESS FOR NEW CHEMICALS
There are approx. 1,000 new chemical notices received each year.
Manufacturer/
importer submits PMN
1 PMN
EPA review of notice and risk determination
90 days
> 90 days refund fee
< 90 not likely to present unreasonable risk
2 EPA
review
Chemical presents
an unreasonable risk
Chemical is not likely to
present an unreasonable risk
Insufficient information or may present
unreasonable risk or is produced in large
amounts and significant release or exposure
EPA can issue an order to require
testing to get the additional data
SUBMISSION
ANDREVIEW
DETERMINATION
EPA must, by rule or order, prohibit
or impose restrictions necessary
to protect against the risk
EPA must, by rule or order, prohibit
or impose restrictions necessary to protect
against any risk, including pending receipt
of additional information
Chemical may commence manufacture
and EPA must publish finding

8. 8
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PROCESS FOR NEW CHEMICALS – TIMINGS
There are approx. 1,000 new chemical notices received each year.
DETERMINATION
The ‘determination’ evaluation must occur before a new chemical can enter the market
Chemical is not likely to
present an unreasonable risk
Insufficient information or may present
unreasonable risk or is produced in large
amounts and significant release or exposure
EPA can issue an order to require
testing to get the additional data
EPA must, by rule or order, prohibit
or impose restrictions necessary to protect
against any risk, including pending receipt
of additional information
Chemical may commence manufacture
and EPA must publish finding
Chemical presents
an unreasonable risk
EPA must, by rule or order, prohibit
or impose restrictions necessary
to protect against the risk

9. 9
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PROCESS FOR EXISTING CHEMICALS
There are 85,000 chemicals on the TSCA inventory
Determination Risk
management
EPA must issue a
regulation banning
or restricting
the chemical
EvaluationPrioritization
Inactive
Reset of TSCA Inventory
(85,000)
Need to establish whether
substance is active or inactive
(used in the last 10 years).
6 month reporting period
when rule in place
High priority
Low priority
Assess and
classify chemicals
Does the chemical present an
unreasonable level of risk?
Active substances are
categorised as high
or low priority
Risk evaluation Risk determination No
3 years
At this stage, if
information is insufficient
or more is needed, EPA
can issue an order to
require testing to get the
additional data
Safety standard:
“No unreasonable risk to human
health or the environment”
Based solely on risks
to health/environment
EPA cannot consider costs
Eliminates ‘least burdensome’
requirement
Determine whether
substance presents an
unreasonable risk
Restrictions
Identify chemicals
in commerce
Yes
Active
01 02 03 04 05

10. 10
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PROCESS FOR EXISTING CHEMICALS – TIMINGS
There are 85,000 chemicals on the TSCA inventory
Risk
management
Restrictions
05
DeterminationEvaluationPrioritisation
Inactive
Reset of TSCA Inventory
(85,000)
Need to establish whether
substance is active or inactive
(used in the last 10 years).
6 month reporting period
when rule in place
High priority
Low priority
Assess and
classify chemicals
Does the chemical present an
unreasonable level of risk?
Active substances are
categorised as high
or low priority
Risk evaluation Risk determination No
3 years
At this stage, if
information is insufficient
or more is needed, EPA
can issue an order to
require testing to get the
additional data
Safety standard:
“No unreasonable risk to human
health or the environment”
Based solely on risks
to health/environment
EPA cannot consider costs
Eliminates ‘least burdensome’
requirement
Determine whether
substance presents an
unreasonable risk
Identify chemicals
in commerce
Yes
Active
01 02 03 04
Risk
management
Restrictions
05
DeterminationEvaluationPrioritisation
Inactive
Reset of TSCA Inventory
(85,000)
Need to establish whether
substance is active or inactive
(used in the last 10 years).
6 month reporting period
when rule in place
High priority
Low priority
Assess and
classify chemicals
Does the chemical present an
unreasonable level of risk?
Active substances are
categorised as high
or low priority
Risk evaluation Risk determination No
3 years
At this stage, if
information is insufficient
or more is needed, EPA
can issue an order to
require testing to get the
additional data
Safety standard:
“No unreasonable risk to human
health or the environment”
Based solely on risks
to health/environment
EPA cannot consider costs
Eliminates ‘least burdensome’
requirement
Determine whether
substance presents an
unreasonable risk
Identify chemicals
in commerce
Yes
Active
01 02 03 04
Retrospective reporting
periods ran from;
Manufacturers
August 2017
to February 2018
Processors
August 2017
to October 2017
High priority designation
triggers risk evaluation to
be completed in 3 years
For each risk evaluation completed,
EPA must designate a new
high priority chemical
Within 3 years, EPA must have 20
on-going chemical risk evaluations
EPA must take
risk management
action in 2 years
to address
unreasonable
risks

11. 11
TOXIC SUBSTANCES CONTROL ACT (TSCA)
WORK PLAN LIST
‘First ten’ high priority chemicals identified
Chemical is not likely to
present an unreasonable risk
Insufficient information or may present
unreasonable risk or is produced in large
amounts and significant release or exposure
EPA can issue an order to require
testing to get the additional data
DETERMINATION
EPA must, by rule or order, prohibit
or impose restrictions necessary to protect
against any risk, including pending receipt
of additional information
Chemical may commence manufacture
and EPA must publish finding
FIRST 10
SUBSTANCES
ALL THESE
SUBSTANCES
ARE REGISTERED
UNDER REACH
1. 1,4 dioxane
2. 1-bromopropane (1-BP)
3. Asbestos
4. Carbon tetrachloride
5. Cyclic aliphatic bromide cluster (HBCD)
6. Methylene chloride
7. n-methylpyrrolidone (NMP)
8. Pigment violet 29
9. Tetrachloroethylene (perc)
10. Trichloroethylene (TCE)
Chemical presents
an unreasonable risk
EPA must, by rule or order, prohibit
or impose restrictions necessary
to protect against the risk

12. 12
TOXIC SUBSTANCES CONTROL ACT (TSCA)
WORK PLAN LIST
‘First ten’ high priority chemicals identified
Chemical presents an unreasonable risk Chemical is not likely to
present an unreasonable risk
Insufficient information or may present
unreasonable risk or is produced in large
amounts and significant release or exposure
EPA can issue an order to require
testing to get the additional data
DETERMINATION
EPA must, by rule or order, prohibit
or impose restrictions necessary
to protect against the risk EPA must, by rule or order, prohibit
or impose restrictions necessary to protect
against any risk, including pending receipt
of additional information
Chemical may commence manufacture
and EPA must publish finding
FIRST 10
SUBSTANCES
ALL THESE
SUBSTANCES
ARE REGISTERED
UNDER REACH
1. 1,4 dioxane
2. 1-bromopropane (1-BP)
3. Asbestos
4. Carbon tetrachloride
5. Cyclic aliphatic bromide cluster (HBCD)
6. Methylene chloride
7. n-methylpyrrolidone (NMP)
8. Pigment violet 29
9. Tetrachloroethylene (perc)
10. Trichloroethylene (TCE)
Chemical presents an un hemical is not likely to
ent an unreasonable risk
EPA can issue an order to require
testing to get the additional data
DETERMINATION
EPA must, by rule or o
or impose restriction
to protect against
may commence manufacture
EPA must publish finding
FIRST 10
SUBSTANCES
ALL THESE
SUBSTANCES
ARE REGISTERED
UNDER REACH
1. 1,4 dioxane
2. 1-bromopropane (1-BP)
6. Methylene chloride
7. n-methylpyrrolidone (NMP)
nreasonable risk Ch
prese
Insufficient information or may present
unreasonable risk or is produced in large
amounts and significant release or exposureorder, prohibit
ns necessary
t the risk EPA must, by rule or order, prohibit
or impose restrictions necessary to protect
against any risk, including pending receipt
of additional information
Chemical
and E
3. Asbestos
4. Carbon tetrachloride
5. Cyclic aliphatic bromide cluster (HBCD)
8. Pigment violet 29
9. Tetrachloroethylene (perc)
10. Trichloroethylene (TCE)
THE SCOPE FOR EACH OF THE
‘FIRST TEN’ ASSESSMENTS WERE
RELEASED IN MID-JUNE 2017

13. 13
TOXIC SUBSTANCES CONTROL ACT (TSCA)
The EPA has already made strides in the proposed use
of non-animal technologies including QSARS, read
across, ToxCast, Tox21, EDSP21, AOPs, IVIVE and OPP.
The updated guidance gives clear direction on the
objectives of the EPA in this arena including the
development of a strategic plan by June 2018 to
promote the development and implementation
of alternative test methods and strategies.
With many other global authorities
setting the agenda with their
chemical safety regimes,
manufacturers and importers can
benefit from data sharing under
TSCA. This includes REACH and
K-REACH and has been designed to
avoid un-necessary new data studies
resulting in reduced costs, time and
the use of animals.
However, the process could prove
complex and there are many variables
still to be ironed out. Who funds this
data sharing exercise for instance?
And how do organizations centrally
locate this data?
In line with other leading chemical
regimes one of the main aims of
TSCA is a reduction in the use of
animals in research by validating
and promoting alternatives.
Unlike EU REACH, TSCA
does not have set data
requirements. The EPA
now has testing order
authority to determine
chemical risk and
information requirements
are now more targeted
than a catch-all blanket
approach.
ANIMAL ALTERNATIVES
DATA CONSIDERATIONS
TSCA
K REACH EU REACH

14. 14
TOXIC SUBSTANCES CONTROL ACT (TSCA)
FEES
Chemical organizations are likely to
see the fees they are expected to pay
to rise. However, these will go directly
to the EPA to continue to fund the
program in the future.
PBT AND WORK PLAN LIST
There is likely to be a fast track set-up
for PBT persistent, bioaccumulative
or toxic chemicals substances on the
TSCA work plan list but these details
are yet to be released. The EPA will
now be able to restrict certain uses
of these types of chemicals or put
limitations on uses. Manufacturers
of these types of substances are
advised to keep a close eye
on developments.
NEW CHEMICALS
The 90-day period is still in force
under the updated TSCA, but if
extra time is needed to determine
risk an extension may be required.
Around 300-500 new applications
are currently under review since new
law established and are very close to
making assessment. Manufacturers
are reminded that they need to wait
for the EPA for a decision before their
products are available on the market.
UNCERTAINTY
There remains a large amount of
ambiguity and uncertainty around
the new requirements with finer
details still to be decided. Industry
leaders will be keeping a keen
eye on developments over the
coming months.
OTHER CONSIDERATIONS
CONFIDENTIALITY
BUSINESS CLAIMS (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, 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 10 years
unless these are renewed.

15. 15
TOXIC SUBSTANCES CONTROL ACT (TSCA)
There are considerable benefits to the updated TSCA
including a clear focus on the reduction in the use of
animals in safety testing and long overdue data sharing
across borders.
However, a large amount of the details still need to
be defined and organizations affected by the updated
guidance are advised to work with a regulatory
consultancy to ensure a close dialogue on key
developments and their interpretation.
The benefits of partnering with
a global, full-service regulatory
consultant and safety testing
partner include:
▶▶ A team of experts who will bring their knowledge
and experience of other global registration programs
(e.g. REACH) to TSCA and who can capitalize
on their regulatory body relationships
▶▶ Single point of contact for both regulatory
interpretation and contextualized risk assessment
and safety testing programs
▶▶ Expertise in:
▶▶ Animal alternative models e.g., QSAR’s
▶▶ SVHC’s - CMR and PBT
▶▶ Adherence to and understanding of
compliance standards
▶▶ Quality of data i.e., Good Laboratory Practice (GLP)
and reporting
WHAT DOES IT MEAN FOR YOU?

16. 16
TOXIC SUBSTANCES CONTROL ACT (TSCA)
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