United States Office of EPA 560/1-91-005
Environmental Toxic Substances November 1991
Protection Agency
New Chemicals
Program
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What is the
New Chemicals
Program?
Anyone who plans to manufacture or import a new
chemical substance is required to provide the Envi-
ronmental Protection Agency (EPA) with a pre-
manufacture notice (PMN) at least 90 days prior to
the activity. EPA's New Chemicals Program,
which is part of the Office of Toxic Substances
(OTS), is responsible for reviewing PMN submis-
sions and identifying new substances that require
regulatory action.
The PMN program is mandated by section 5 of the
Toxic Substances Control Act (TSCA). The law,
enacted by Congress in 1976, gives EPA broad
authority to identify and control substances that
pose a threat to human health or the environment.
3000-
g 2000-
o
1000-
Total Notices Received*
2993
2738
1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991
Fiscal Year
Total includes PMNs, low-volume exemptions, test-market exemptions, and polymer exemptions.
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What chemical
substances
are "new"
chemicals?
How can the
TSCA Inventory
be consulted?
EPA classifies chemical substances as either "exist-
ing" chemicals or "new" chemicals. The only way
to determine if the substance you are working with
is a new chemical is by consulting EPA's Inventory
of Chemical Substances, which is commonly re-
ferred to as the TSCA Inventory. Any substance
that is not on the TSCA Inventory is classified as a
new chemical.
Note to importers: Many chemical substances that
are manufactured in other countries are not on the
TSCA Inventory. If you intend to import any of
these chemical substances into the United States,
you must follow all U.S. laws and regulations
pertaining to new chemicals.
The TSCA Inventory is available in report form or
on computer tape. The TSCA Inventory in report
form was updated in 1990 and does not reflect
additions to the inventory since then. The com-
puter tape is updated every six months. EPA does
not provide searches of the TSCA Inventory, but
there are a number of ways you can research
whether a chemical is listed on the TSCA
Inventory:
• Many public libraries and company libraries
have copies of the TSCA Inventory. In addition,
the inventory is available at federal depository
libraries. To find the closest federal depository
library, call your local library or look in the
Directory of U.S. Government Depository Libraries.
• Assistance in determining whether a chemical
substance is on the TSCA Inventory is available
from two companies: CAS Online and Dialog.
To request assistance, phone CAS Online at
(800) 848-6533 or Dialog at (800) 334-2564.
Other companies may offer similar services in the
future; contact the TSCA Assistance Information
Service for an up-to-date list.
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How can it be
determined
whether a
substance is a
new chemical if
its identity is a
trade secret?
• Online access to the TSCA Inventory is available
through Dialog. To open an account, call
(800) 334-2564.
• A copy of the TSCA Inventory can be purchased
from the Government Printing Office (GPO) or
the National Technical Information Service
(NTIS).
GPO: (202) 783-3238
1985 TSCA Inventory (report form)
Order* 055-000-00254-1
Price $161
1990 Supplement (report form)
Order* 055-000-00361-1
Price $15
NTIS: (703)487-4650
TSCA Inventory (computer tape)
Order* PB90504226
Price $450 or $560 (depending on type of tape)
The identity of an existing chemical that has been
claimed as confidential business information will
not be listed on the public portion of the TSCA
Inventory. In these cases, EPA will search the
confidential portion of the TSCA Inventory for you
if a bona fide intent to manufacture or import a
chemical substance is demonstrated.
For more information about submitting a bona
fide inquiry, see 40 CFR 720.25 or contact the
TSCA Assistance Information Service.
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Are any new
substances
exempt from
PMN reporting?
Some new chemical substances are not subject to
PMN reporting. These substances are either ex-
empt from TSCA, or EPA has determined that
they do not warrant review or require only a short
review.
EPA does not review new substances in the follow-
ing product categories, which are exempt from
TSCA authority: tobacco, nuclear materials, mu-
nitions, food additives, drugs, cosmetics, and sub-
stances used solely as pesticides. These new sub-
stances fall under the jurisdiction of other federal
laws and are reviewed by other federal programs.
In addition, the following are excluded from PMN
reporting under certain conditions: products of
incidental reactions, products of end-use reactions,
mixtures, byproducts, substances manufactured
solely for export, nonisolated intermediates, and
substances formed during the manufacture of an
article. See 40 CFR 72030(a)-(h) for more infor-
mation about exclusions from PMN reporting.
EPA has limited the reporting requirements for
new chemical substances in the following cases:
• the substance is manufactured in small quanti-
ties for research and development, and special
procedural and recordkeeping requirements are
met;
• less than 1,000 kilograms of the substance will
be manufactured or imported each year;
• the substance is being manufactured or imported
for test marketing; or
• the substance is a polymer that meets certain
specified criteria.
For information about PMN exemptions, contact
the prenotice coordinator at (202) 260-1745 or
(202) 260-3937.
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What
information
must be
submitted about
new chemical
substances?
How does
EPA handle
proprietary
information
submitted in a
PMN?
PMN submissions must be made on a specific
form which requires all available data on chemical
identity, production volume, byproducts, use, envi-
ronmental release, disposal practices, and human
exposure. EPA also requires that the following
information be submitted with the PMN: all exist-
ing health and environmental data in the possession
of the submitter, parent company, or affiliates, and
a description of any existing data known to or rea-
sonably ascertainable by the submitter.
The PMN instruction manual explains all reporting
requirements. When you request a PMN form, an
instruction manual is included. Both are available
from the TSCA Assistance Information Service.
Under section 14 of TSCA, EPA is required to
protect from disclosure confidential business
information (CBI) that is explicitly claimed by
a submitter. Substantiation of CBI claims for
chemical identity is required when a Notice of
Commencement of Manufacture or Import is
submitted. OTS reviews CBI claims to determine
whether they meet the legal definition of CBI. If
the answer to any of the following questions is
"no," a submission probably will not meet the
legal definition of CBI when reviewed by OTS.
• Is the information that is claimed as confidential
known only to the company that is making the
CBI claim?
• Has the company made reasonable efforts to
ensure that the information is and will remain
confidential?
• Is the information obtainable only from the
submitter?
• Is disclosure of the information likely to cause
substantial harm to the company's competitive
position?
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How are you
notified of the
outcome of the
PMN review?
What is the fee
for submitting a
PMN?
When is a new
chemical
substance added
to the TSCA
Inventory?
When EPA receives your PMN form, you will
be sent a letter that includes the PMN number
assigned to your submission and the expiration
date of the PMN review period. If the agency has
any concerns about the substance, you will be
notified by the end of the review period. Other-
wise, you will receive no subsequent notification,
and you are free to manufacture or import the
substance the day after the review period ends.
The fee for most PMN submissions is $2,500.
The fee is reduced under certain conditions: (1) if
your company qualifies as a small business, the fee
is $100; (2) if a PMN for an intermediate sub-
stance is submitted with a final product PMN, the
fee for the intermediate substance is $1,000; and
(3) if a PMN is filed for multiple chemicals that
are related, the total fee is $2,500.
For information about filing a notice for multiple
chemicals, contact the prenotice coordinator at
(202) 260-1745 or (202) 260-3937.
For information about PMN fees, contact the
TSCA Assistance Information Service.
A new chemical is eligible for addition to the
TSCA Inventory after the PMN review has been
completed. To add a substance to the TSCA
Inventory, the company that submitted the PMN
must provide a Notice of Commencement of
Manufacture or Import to EPA within 30 days
of the date the substance is manufactured or
imported for nonexempt commercial purposes.
Once a substance is listed on the TSCA Inventory,
it is considered an existing chemical.
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How does EPA
assess potential
risk?
What are the
possible
outcomes of
PMN review?
EPA toxicologists, chemists, biochemists, engi-
neers, and scientists in other disciplines work to-
gether to predict the potential risks to humans or
the environment from each new substance. In
doing so, they draw on data submitted with the
PMN form, other information available to the
agency, and exposure and release modeling.
TSCA does not require prior testing of new chemi-
cals. Consequently, more than half of the PMN
forms submitted do not include toxicological data.
In these cases, OTS scientists assess the chemical's
structural similarity to known toxic chemicals—
called a structure-activity relationship—to predict
toxicity.
Almost 90 percent of the PMNs submitted to the
program complete the review process without
being restricted or regulated in any way. If the
agency determines that a new chemical substance
may pose a risk to health or the environment, how-
ever, section 5(e) of TSCA allows EPA to (1) enter
into a consent order permitting the PMN
submitter to manufacture or import the new sub-
stance under specified conditions or (2) allow the
PMN submitter to suspend the review period
while developing additional test data. In cases
where the agency determines that a new substance
will present an unreasonable risk, section 5(0 of
TSCA allows EPA to issue an injunction to pro-
hibit the manufacture, processing, or distribution
in commerce of the substance.
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What is a
significant new
use rule?
How is the
New Chemicals
Program related
to EPA's pollution
prevention
efforts?
A frequent outcome of PMN review is the negotia-
tion of a section 5(e) consent order to allow the
PMN submitter to manufacture or import the new
substance under specified conditions. A section
5(e) consent order, however, is not binding on
other companies that may manufacture or import
the substance. Consequently, EPA generally fol-
lows the signing of a section 5(e) consent order
with a significant new use rule (SNUR).
SNURs require that manufacturers, processors,
and importers notify EPA 90 days before begin-
ning any activities that are defined as new uses.
These typically are those activities not permitted
by the section 5(e) consent order. EPA also uses
SNURs when use of a new substance may present
risks to health or the environment if exposures or
releases are significantly different from those de-
scribed in the PMN. The advance notification
required by SNURs allows EPA to prevent poten-
tially adverse exposure to or effects from the new
use of the substance.
By assessing new chemical substances before they
are manufactured or imported, the New Chemicals
Program is actively carrying out EPA's strategy to
prevent pollution before it can occur. The pro-
gram also supports development of safer chemical
substances by minimizing regulatory burdens on
new chemicals if they will replace riskier sub-
stances already in the marketplace.
The New Chemicals Program strongly encourages
industry efforts to prevent pollution. One of the
ways this is accomplished is through the PMN
form, which requests industry to voluntarily pro-
vide information about steps taken to reduce expo-
sures to or releases of chemical substances. During
the PMN review, EPA carefully considers this
information in evaluating potential risks.
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Summary of
accomplishments
Since 1979, EPA's New Chemicals Program has
reviewed almost 20,000 new chemical substances.
This figure includes nearly 16,000 PMNs that
have undergone full review and approximately
4,000 low-volume, test-market, and polymer ex-
emptions. In that time, the agency has taken ac-
tion to prevent potential risks to people and the
environment from nearly 1,700 new substances.
New Chemicals
Program
Activities
Through
September
30,1991
TYPE OF SUBMISSION NO. SUBMITTED TIME PERIOD
Premanufacture notices 15,901 7/1/79-9/30/91
Test marketing
exemption applications
547 7/1/79-9/30/91
Low-volume exemptions 1,941 ...6/10/85-9/30/91
Polymer exemptions 1,547 1/4/85-9/30/91
Total 19,936
REGULATORY ACTION
NO. ISSUED
Section 5(e) orders ........................................ 504
Section 5(f) actions ........................................... 4
PMNs withdrawn in face of action ................ 779
Voluntary testing actions ............................. 401
Total cases regulated ................................. 1,688
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The TSCA Assistance Information Service (TSCA
For RIOTS hotline) is available to answer general questions
information about the PMN process or filing a PMN form. The
TSCA hotline operates Monday through Friday,
from 8:30 a.m. to 5:00 p.m. Eastern time. Call
(202) 554-1404. FAX requests for documents are
received every day, at all times, on (202) 554-5603.
To request assistance by mail, write
Environmental Assistance Division (TS-799)
Office of Toxic Substances
U.S. EPA
401 M Street, S.W.
Washington, D.C, 20460
For answers to questions about procedural, techni-
cal, or regulatory requirements prior to submitting
a PMN, call the PMN prenotice coordinator at
(202) 260-1745 or (202) 260-3937,
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