TOXIC SUBSTANCE CONTROL ACT
Richard A. Mears
Environmental Law
November 18, 2002
The Toxic Substances Control Act, here-after referred to as TSCA was enacted by
Congress in 1976 to fill the voids that were not adequately covered by other laws and regulations
such as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), The Occupational
Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA).
In several publications, TSCA was highlighted as the regulation that allowed the federal
Environmental Protection Agency (EPA) to promulgate regulations for the management, storage,
use and disposal of Polychlorinated Biphenyl (PCB), but the scope of the regulation was always
much more significant than people realized. TSCA was intended to more comprehensively
protect both public health and the environment from unreasonable risks to a variety of hazardous
materials and wastes, including biological and chemical substances, mixtures and even the
byproducts of those materials. It was never limited to asbestos, lead and PCB’s
This Act, because of its complexity is very confusing and difficult to follow. There are
twenty-eight different, parts which include: general practices, chemical imports and exports,
records and reports, pre-manufacture notifications, reporting requirements, asbestos, lead, PCB’s
and identification of specific chemical substances and mixture testing requirements. It also has
five very detailed sections that include test results (section 4), pre-manufacturer notifications
(PMN) (section 5), reporting rules (section 8), exports (section 12), and imports (section 13), which will
be detailed later in this report.
TSCA requirements have been problematic for businesses, including Colleges and
Universities because each believed they were exempt from the requirements, based on the fact
that they were teaching or research and development facilities, not chemical manufacturers.
1
If a company, college or university does not formulate or manufacture biohazardous materials,
chemicals, or generate the byproducts, then why does TSCA apply?

 The actual definition for manufacturers in the TSCA regulation, 15 U.S.C. Sec 2602
is “produce, manufacture, import and extract.” chemicals, which helps to clarify some
of the confusion with respect to who needs to comply.
Importers in the United States who receive chemicals from companies in other countries are just
as responsible for complying with TSCA as are the manufacturers who formulate and market
chemical substances inside our borders, or wish to ship abroad.
Not every chemical is listed on the TSCA Inventory of 63,000, there are exceptions.
Some chemical substances and mixtures are not required to be listed because they meet criteria,
specified by EPA that makes the listing unnecessary. The quantity may be below the threshold of
reporting, or it may be for scientific (non-commercial) purposes. The only way to determine
whether or not the chemical you plan to manufacture, import, export or process is listed is to
consult the “TSCA Inventory List.” If found on the list, the chemical can now be imported or
manufactured. If the material is not excluded or exempted from the TSCA list, the manufacturer
and/or importer will have to comply with the paperwork requirements, such as the PMN found in
the Act. Unfortunately, the business (manufacturer, college) or importer is required to go through
the motions of obtaining paperwork, filling out the required forms, testing and then documenting
the information on the pre-manufacturing notice (PMN), before producing or importing a new
chemical substance, which could later be deemed exempt.
Another TSCA requirement is the “Significant New Use Rules (SNUR). SNUR is to be
incorporated into the reporting process to help reduce the risk of exposure to humans and/or the
environment. This portion of the Act applies when the EPA, under TSCA discovers that a
2
chemical substance or mixture can be used for other reasons, or has other applications that could,
if not proven otherwise have adverse effects on the health and well-being of people and/or the
environment.
The EPA, through the above referenced Act can require the testing of both old and new
chemicals, which include manufactured and synthetic chemicals, as determined by the
Administrator of the EPA or their designee. Unlike any other federal requirement, the TSCA
Act, which is enforced by EPA only, mandates’ testing and reporting of chemicals with
dangerous characteristics or unknown toxic properties before it reaches the consumer. There is
no state agency delegated to handle requirements for new, manufactured or imported chemicals.
Ideally, the federal EPA, through TSCA would like to regulate the manufacture, imports,
exports, distribution, process, use and disposal of all listed chemicals in commerce.
“The new chemicals program functions as the gatekeeper, which can identify conditions, up to and including a ban on production,
to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture or import a new
chemical substance for a non-exempt commercial purpose is required under Section 5 of TSCA to provide EPA with notice
before initiating the activity.” 1
Under TSCA, the EPA has strictly regulated and monitored many of the chemical substances and
mixtures known to be high risk, imminent hazards, such as asbestos, dioxin’s, hydrofluorocarbons, polychlorinated biphenyls and radon contamination. These materials, which have been
linked to cancer for many years, have a substantial amount of documentation to support the tight
control and restriction. For reasons such as this, the EPA has the authority to mandate testing,
medical monitoring, report and inventory controls and the pre-manufacturing notifications forms
to protect human health and the environment from manufacturing mistakes like asbestos,
dioxin’s and PCB’s. Even in recent years, after we believed we had identified and properly
3
regulated material such as asbestos, we find asbestos in children’s crayons, and in potting soil
(vermiculite), or hydrofluorocarbons in “new fire suppression agents”, like Halon.

 Would earlier testing have prevented this from reaching the consumer?
In addition to all of the exceptions referenced above, there are materials that are exempt from the
requirements of TSCA, because they are regulated in detail by other federal requirements such as
pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), tobacco
products, food, drugs and cosmetics under the (FDA), Radioactive Materials through the Nuclear
Regulatory Commission (NRC) and firearms and ammunition which does not meet the definition
of chemical substance, under TSCA.
Unfortunately, one of the reasons why the TSCA regulations are confusing is that the exemptions
do not stop there. The Act exempts other chemicals and substances for different reasons in other
parts of this regulation, “subject to EPA approval”.
For example, under 40 CFR part 723, chemicals and substances are excluded from premanufacturing notifications (PMN) requirements if they fall under one of the following
categories:
1. Test Market Exemption (TME)

Chemical substances in this category are exempt if they are for test marketing purposes and proposed testmarketing activity, and will not pose an unreasonable harm to the environment or human health.
2. Low Volume Exemption (LVE)

After a 30 days the EPA will exempt from PMN requirements certain new chemicals manufactured in low volumes
3. Lo-Rex Exemption (low release and exposure)

In conjunction with the LVE, the EPA will exempt chemical substances that are released at low levels and will not
place persons at risk during production regardless of type of manufacture or volume, provided that the
manufacturer or importer meets all stringent exposure and release criteria.
4
4. Research and Development Exemption (R&D)

EPA exempts chemical substances from the PMN and SNUR if they are used for Research and development, in
small quantities, under the direction of a qualified person.
5. Polymer Exemption

New chemical polymers, which are not otherwise excluded and that meet specific exemption requirements,
provided that an annual report is submitted to the EPA, with certain records being maintained.
6. Bulk Chemicals

Provided that they are imported for the manufacture of food or drug products, so long as the importer certifies that
the shipment is not regulated under TSCA.
Not all chemical substances are regulated under TSCA, but those that are, require a certification
before manufacture in the United States or prior to importation. In order to find out what
chemical substances are listed under TSCA, the TSCA Inventory can be obtained from the
United States Government Printing Office (USGPO) or the National Technical Information
Center (NTIC) in Springfield, Virginia at order@ntis.fedworld.gov, or by phone at
703.487.4028 or 800.553.NTIS.
The TSCA Inventory is a list of not only the chemical substances already recorded, but the
associated health and environmental risks that have already undergone a permitting process that
provides for accountability for distribution in commerce.
There are numerous sections in the TSCA Act that deal with chemical substance control, five of
which will be covered in greater detail than the rest. Those sections of specific interest were
referenced on page one, and they appear to be the most important parts of the ACT covered by
the EPA both in writing and at a majority of the training sessions held in Region 1.
5
I. Notification and Reporting Requirements
When required by the Act, businesses (including companies, colleges, universities, research and
development facilities, individuals etc.) must provide the EPA with information to assist with
regulatory requirements, record keeping activity, inventory control, health and safety data, health
and environmental effects, chemical fate, general practices and procedures, pre-manufacturing
information as well as imports and exports when dealing with chemical substances that are, or
have the potential to be regulated under TSCA.
These reporting requirements must include;
1. Pre-manufacturing Notification (PMN), 40 CFR 720

In order to manufacture or import a chemical substance, including those that are
naturally occurring, which is not listed on the TSCA Inventory, you must file a PMN
with the EPA, 90 days prior to manufacture or importation of that chemical
substance. The PMN will require the following information;


Physical properties of the chemical or substance

Quantity to be manufactured

How the chemical o substance will be used

How it will be distributed

How it will be processed

Anticipated environmental and health related risks, and

Appropriate test data
The PMN also asks for information on how you plan to reduce or minimize risks
associated with manufacturing, processing, use and disposal of the chemical
substance, although under the TSCA Act, use and disposal are not defined
o Under subpart 716.50 of the Act, studies of physical and chemical properties
must be performed and reported for the purposes of determining the
6
environmental or biological fate of the chemical substance, mixture and the
by-products. Some of the properties that need to be evaluated are:
1.
Water solubility
2.
Absorption on particulate surfaces, such as soil
3.
Vapor pressure
4.
Water partition coefficient
5.
Vapor Density
6.
Specific Gravity
7.
pH
8.
Particle size distribution for insoluble solids
9.
Dissociation constant
10. Degradation

If the EPA fails to respond to your PMN or other regulatory requirements within the
identified 90 period, it is acceptable to initiate manufacture, but you must submit the
Notice of Commencement (NOC) to the EPA, which EPA will add to the inventory as
a new chemical.

The new chemicals program, which is part of EPA’s Office of Pollution Prevention
and Toxics must review PMN submissions and identify new chemicals and
substances that require action, under the Act.
2. Significant New Use Reporting (SNUR), 40 CFR 721

Once a chemical substance has already been placed on the TSCA Inventory, a new or
additional use for that material may be identified that come affect the environment
and/or human health in a way that was not previously anticipated. If the EPA believes
that this material, which was already listed in the inventory, would create a
“significant new use,” which may increase possible human or environmental
7
exposure, then the EPA may issue a SNUR. This specific report mandates that the
manufacturer of the chemical substance give the EPA 90 day prior notice, before
manufacture or importation is initiated. The SNUR must include;


Possible production volume

Increased potential, quantity or duration of environmental or human exposure.

Distribution or manufacturing hazards
This report, which is referred to as the Significant New Use Notification (SNUN) is
completed and sent back to the EPA on the PMN form. This process of sending in the
SNUR changes the existing chemical substance into a new material, under TSCA.
3. Preliminary Assessment Information Rule (PAIR), 40 CFR 712

Any company or individual that manufactures or imports must file a PAIR report
form with the EPA for each plant site involved in the manufacturing or importing an
Interagency Testing Committee (ITC)-listed chemical substance. This committee
identifies those chemical substances that are suspected of causing or contributing to a
form of cancer, gene mutation, or birth defects, and recommends testing
considerations to the EPA. The PAIR is completed to;

Provide preliminary exposure information to the EPA, so that
they are better able to determine testing priorities.


List production and exposure data
The report must be submitted within 60 days of the chemical or substance listing
o
Again, depending on circumstances, not listed here in, certain small research and development
manufacturers are exempt from having to complete the PAIR
8
4. Comprehensive Assessment Information Rule (CAIR), 40 CFR 712

.
In 1988, the EPA provided an additional reporting form for specific substances. It
was referred to as the CAIR list and only 19 substances were initially included on that
list. However, in 1995 the CAIR initiative was challenged by the manufacturing
industry, so the EPA repealed it, and deemed the rule(s) no longer in effect.
5. Records of Significant Adverse Reactions, 40 CFR 717

This rule, under the Act requires manufacturers and some processors who are
engaged in oil refining and chemical processing to keep records of significant
adverse effects on health and the environment as reported to them by their
employees, customers and others, which have been caused by a chemical substance or
mixture that the company manufactures, processes or imports.

This significant chemical reaction must reflect substantial damage to, or impairment
of normal activities, or long lasting, irreversible damage to the environment and or
public health.

Recordkeeping requirement only!
o
Should not be sent to the EPA, unless specifically requested
6. Health and Safety Studies, 40 CFR 716

TSCA requirements also mandate manufacturers, distributors, processors and
importers to submit unpublished health and safety studies on specific chemical
substances, mixtures and even byproducts, which are listed in 40 CFR 716.120. This
means that the manufacturer or other above referenced entity shall include any health
and safety related study of a chemical substance on the environment, public health or
both.
9

This shall mean that any inspection, monitoring or testing, regardless of how
insignificant it may seem may be considered a health and safety study by the EPA.

Under section 2603, Testing of Chemical Substances and Mixtures, the Administrator
of the EPA can require testing of the chemical substance for health and environmental
effects. Of particular interest would be the development of a database for test data
that may be used for the identification of carcinogen, mutagen, teratogen, behavioral
disorders, such as those that were attributed to lead based paint

Cumulative or synergistic effects and any other effect, which may present an
unreasonable risk of injury to health or the environment

The administrator would be checking for those chemical substances or mixtures for
which standards may be prescribed including acute toxicity, subacute toxicity ,
chronic toxicity and any other characteristic that may present a health risk
o After all documentation has been received and reviewed, the Administrator
shall give the interested persons an opportunity for a presentation of date, their
particular views and arguments, in addition to making written submissions
o To assist the Administrator, Congress established the Interagency Testing
Committee (ITC) to make recommendations about the chemicals and the
testing procedures. The committee must consider all key factors, such as…

Quantities being manufactured

How the material will enter the environment

The number of people that may be exposed to the material

Duration of exposure

How closely the material resembles or reacts to a known material

The amount and type of testing that will be required
10
7. Substantial Risk Information

The Act also requires, manufacturers, distributors, processors and importers of
chemical substances to report any information to EPA that “reasonably supports the
conclusion that there is a substantial risk of personal injury to the health and wellbeing of a person, or the environment, which is or can be linked to the chemical
substance that is being manufactured, processed, distributed or imported.

It is possible, under this act, that company officials and their employees can be held
liable, unless specific complex procedures are followed and enforced.

Proposed Chemical Reporting Rule - Recently the EPA drafted a new rule, under
TSCA that would require manufacturers and importers to file information on
chemical use and employee exposure. This report will have to be performed every
four years, in order to better monitor worker exposure.


A reporting threshold of 10,000 lbs per facility has been suggested
Should the Administrator, through the committee identify a chemical substance or
mixture that will present an unreasonable risk of injury to health or the environment, the
Administrator shall apply one of the following requirements:
a. prohibit the manufacture, process or importation of the chemical substance or
mixture, or
b. limit the amount of the material that can be manufactured,
processed or distributed in commerce
 If limitation of the material is to be controlled, the Administrator shall have
the authority to…
11

give public notice about the material being manufactured, processed or
imported to processors, distributors and the general public, as
necessary.

Monitor quality control

Reduce the risk of injury to health and the environment as is prudent
and reasonable.
8. Inventory Update Report (IUR), 40 CFR 710

Manufacturers and importers of chemical substances that are in excess of 10,000 lbs
at any time during the most recently completed corporate fiscal year shall have to
report criteria on the plant site, production volume and site limited status.
9. Microbial Commercial Activity Notice (MCAN), 40 CFR 725.155 and (TERA), 40
CFR 725.255 for Experimental Releases.

This section is part of TSCA’s biotechnology regulation. It was specifically required
for microorganism reporting.

MCAN’s must be submitted to the EPA 90 days before new microorganisms are used

TERA’s should be submitted to the EPA 60 days before initiating field trials of new
microbes
10. Import and Export Notification, 40 CFR 707

Manufacturers, processors, distributors and importers/exporters of chemical
substances are required to follow several TSCA requirements as referenced in the
Act.
12
o Exception – under part 712.28 persons who qualify as a small manufacturer or
importer with respect to a specific chemical substance or mixture listed in
712.30 are exempt from reporting requirements. However, this exception does
not apply with respect to a chemical substance or mixture that is found in
712.30, which is designated by an asterik.
Import Certification
o Any manufacturer, processor, distributor or importer of chemical substances
referenced in the Act shall follow the stipulations identified in TSCA.
o Although EPA is responsible for the implementation of most of the TSCA
regulations, the Act specifically identifies the United States Customs Service
as the agency responsible for the importation and control of chemical
substances entering the country.

Any importer is required to provide the USCSB with written
documentation that the chemical substances in transit do not violate
TSCA rules, specifically 19 CFR 12.121(a).

Before any new chemical substance is imported, the importer must
have already complied with the requirements of TSCA’s PMN.
Exception – the EPA, and not the United States Customs Service
Bureau regulate hydrofluorocarbons that are imported, unlike other
chemical substances, which are controlled by the USCSB.
13

Importers of certain HCFC’s are required to provide the EPA
with hydrofluorocarbon information as it pertains to health and
safety. This requirement includes the 90-day prior notice that
all importers of HCFC 133a and HCFC-132b submit all
appropriate paperwork before receiving either of these
chemicals.
Export Information

The Act requires anyone who exports chemical substances to follow
TSCA requirements.

If any business plans to export a chemical substance or mixture
regulated under TSCA, it must notify EPA within 7 days of
exportation, or “forming the intent to export the chemical” (whichever
comes first), if this is the first time that the material is being exported
in a calendar year, to the same country
Exception – the EPA, not the USCSB receives exporters notification
Additional exceptions
1.
Notification is not required if the material being exported
is an article, unless that article contains PCB’s
2.
If a manufacturer or processor was prohibited from
exporting chemical substance under section 5 or 6, they
could notify the EPA under section 12(b), and then
export.
14
II. Inspection, Enforcement and Penalties
1. Inspections

Under the provisions of the Act, EPA agents can inspect manufacturers,
processors, distributors and importers premises, vehicles, records and
paperwork for compliance with TSCA. The agency could
obtain, if necessary an administrative search warrant
when access to the facility or piece there-of has been denied.
The EPA agent can…
a.
Subpoena witnesses
b.
Confiscate documents and records
c.
Seize immediately hazardous materials, and
d. Halt the production of processes
2. Non-Compliance, Civil and Criminal Penalties

Any company, business, distributor, manufacturer, processor and/or importer that
fails or refuses to comply with any EPA order, including TSCA can receive both
criminal sanctions with imprisonment of up to one year and monetary fines in the
amount of $25,000.00 per day. The infractions could be for improper
recordkeeping, failure to file reports, notices and other pertinent information.
Citations could also be levied for failing to provide an inspector access to records,
or to use for commercial purposes a chemical substance or mixture that was know
to be manufactured, processed or imported in violation of TSCA, section 5 or 6.
15

Should the Administrator identify, or otherwise be notified of an imminently
hazardous chemical substance or mixture, he or she may commence a civil action
in U.S. District Court for seizure of the material and/or any other appropriate
relief, including temporary or permanent injunctions, mandatory injunction,
recall, and repurchase of the substance by the manufacturer, processor or
distributor.
III. Laboratory Requirements as they pertain to the Act, known as TSCA
 Laboratories, including those that are engaged in research and development must be
familiar with the requirements of TSCA.
o The EPA shall require that we protect human health and the environment from the
negative effects of chemical substances and mixtures. The responsibility to
properly address the manufacture, production and transport of these chemicals
shall fall on the manufacturers, processors and importers, with EPA oversight, as
required or as is necessary.
o Chemicals that are regulated under TSCA shall include:

“Any organic or inorganic substance of a particular molecular identity
including any combination of such substances occurring, in whole or in
part, as a result of a chemical reaction or occurring in nature and any
element or uncombined radical.”2
16
o Research and Development

Exemption: Chemical substances are exempt from many of the
requirements of TSCA, when…
a. the chemical is imported, manufactured or used in small
quantities, and
b. it will strictly be used for non-commercial scientific
experimentation, analysis or research, and used under the
direct supervision of a technically qualified individual.
o In order to maintain a TSCA approved Research and Development
Laboratory, in exempt status, the facility must…
a. Certify the TSCA status of all imports for the R&D facility,
in writing
b. Notify all receiving companies of exports within 7 days, in
writing
c. Label all containers, the shipping containers they are
packaged in, and attach the shipping papers for any
substance shipped for R&D purposes, in the United States.
i. Communicate all risks (known or potential) using labels,
Material Safety Data Sheets and Shipping Papers
d. Create and maintain all records for future information. It is
especially important to identify effects to human health and
the environment which may be caused by the substances
found in the R&D laboratory
17
e. Document and support any significant risk to health and the
environment, as it may be associated with the R&D facility.
f. Grants used for funding must specify that the money has
been made available for research activities, and not for
commercial purposes.
o To ensure proper compliance with the Act, TSCA requires laboratory
groups or types of operation to complete the following steps:
1. Determine whether or not TSCA applies to your laboratory facility
2. Identify a TSCA coordinator for the laboratory
3. Establish a TSCA compliance file for administrative and
recordkeeping purposes. The file must contain the following:
a. TSCA applicability form
b. Import Certifications
c. Import and Export Notifications
d. Inter-facility shipping records
e. Significant adverse health and environmental effect log
f. Substantial risk reports
4. Develop a process for review of TSCA applicability & compliance.
o Recordkeeping is especially important for R&D facilities, if they
would like to maintain the TSCA exceptions. Unfortunately, this
process is labor intensive and can be very overwhelming for the
designated TSCA compliance person. As stipulated under section 8 of
the Act, the designated person(s) must keep detailed records of all
18
correspondences, applications, forms and exceptions for each chemical
substance or mixture, as well as the adverse health risks, potential
injury to the environment, and any complaints received by an
aggrieved party. These records must be maintained for a period of not
less than five (5) years, if prepared by someone outside the business,
or for not less than 30 years, if performed in house.
TSCA regulations and requirements are not only overwhelming in terms of work, but
extremely confusing as well. The exceptions, counter-exceptions and poorly defined
definitions, and terminology make it a very difficult “Act to follow.” It is very easy to
understand why laboratories felt that they were exempt from the requirements identified
here-in. If you were unfamiliar with the actual definition of manufacturer, you would
have no way of knowing that you or your facility is out of compliance.
“If EPA’s regulations implementing the various subsections of TSCA applied to everyone who fell within the literal
language of these broad definitions, TSCA requirements would be imposed on thousands of businesses that Congress
never intended the law to touch”3
Another key issue is the need to have a copy of the actual TSCA Inventory. Without this
piece of information (63,000 chemicals) the manufacturer, processor and/or importer
would not know if the chemical substance or mixture was “listed”, as required. If you
opted to export, seek commercial benefit or otherwise modify a chemical or substance,
without proper EPA awareness, under TSCA, then serious penalties, both criminal and
financial could befall upon the facility, laboratory, manufacturer, processor, importer or
distributor. Consequences could include inability to continue research, loss of product,
reduction of resources, confiscation of property, loss of grants and future work etc.
Awareness of TSCA rules and regulations under the Act is painful, but necessary.
19
1.
The New Chemicals Program functions as the “gatekeeper….”
New Chemicals Program, U.S. Environmental Protection Agency
www.epe.gov/opptinr/newchems/index.htm
2.
Chemical Substances regulated by TSCA include:
Toxic Substances Control Act (TSCA) Fact Sheet, EH&S TSCA website (no other information available)
3.
Environmental Law Handbook, 16th edition, Page 526
Additional Resources

Environmental Management, 2nd Edition, National Safety Council – Copyright 2000

Code of Federal Regulations, 40 CFR – Chapter I, Part 700-799

US Code Collection, Title 15, Chapter 53 – Toxic Substances Control Act, Legal Information
Institute, www4.law.cornell.edu/uscode/15/ch53.html

Toxic Substances Control Act (TSCA), Statute 15 U.S.C. sec 2601-2692,
www.ntc.blm.gov/learningplace/res_TSCA.html

Prudent Practices in the Laboratory, Second Printing, National Academy Press, - Copyright
1999., Pages 200, 210-212.

Toxic Substances Control Act – Related Internet Sites
New Chemicals Program, U.S. Environmental Protection Agency
www.epe.gov/opptinr/newchems/tscasite.htm

Core TSCA Region 1: New England
U.S. Environmental Protection Agency
www.epa.gov/region01/compliance/enftsca.html

Risk Assessment in the Workplace, Section 2

Worker Education and Training, Section 4
The Occupational Environment – Its Evaluation and Control, A publication of the American
Industrial Hygiene Association – Copyright 1997

US Code Collection, Title 15, Chapter 53, Subsection I – Control of Toxic Substances, Legal
Information Institute,
20
www4.law.cornell.edu/uscode/15/ch53schI.html

Subchapter R – Toxic Substances Control Act, Laws and Regulations, U.S. Environmental
Protection Agency
www.epa.gov/docs/epacfr40/chapt-I.info/subch-R.htm
21