vvEPA
United States Office of EEPA-743-F-95-001
Environmental Pollution Prevention May 1995
Protection Agency and Toxics
New Chemicals
Program
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What is the
New Chemicals
Program?
Anyone who plans to manufacture or import a new
chemical substance for a non-exempt commercial pur-
pose is required to provide the Environmental
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 Pollution Prevention and Toxics (OPPT), is
responsible for reviewing PMN submissions and iden-
tifying 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 may
pose a threat to human health or the environment.
This document incorporates changes made1, to the PMN
program by the 1995 rule amendments (60 FR 16298).
3000 r-
2000
z 1000
Total Notices Received*
2720
1979 1980 1981, 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994
Fiscal Year
"Total includes PMNs, low-volume exemptions, tesl-market exemptions, and polymer exemptions.
U.S. ENVIRONMENTAL PROTECTION AGENCY
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What chemical
substances
are "new"
chemicals?
How can the
TSCA Inventory
be consulted?
EPA classifies chemical substances as either "existing"
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 Toxic Substances
Control Act Chemical Substance Inventory which is
commonly referred 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 hi 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 computer 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 at
(202) 554-1404 for an up-to-date list.
NEW CHEMICALS PROGRAM
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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)512-1800
1985 TSCA Inventory (report form)
Order #055-000-00254-1
Price $161
1990 Supplement (report form)
Order #055-000-00361-1
Price $24
NTIS: (703)487-4650
TSCA Inventory
9-track magnetic computer tape
Order #PB95503108
Price $360 (January 1995)
CD ROM
Order #PB94502168
Price $250 (May 1994)
The identity of an existing chemical mat 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.1
U.S. ENVIRONMENTAL PROTECTION AOENCY
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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 exempt
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 following
product categories, which are excluded from TSCA
authority: tobacco, nuclear materials, munitions, food
additives, drugs, cosmetics, and substances used solely
as pesticides. These new substances 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 condi-
tions: products of incidental reactions, products of
end-use reactions, mixtures, byproducts, substances
manufactured solely for export, nonisolated intermedi-
ates, and substances formed during the manufacture of
an article. See 40 CFR 720.30(a)-(h) for more
information about exclusions from PMN reporting.
EPA has limited reporting requirements for new
chemical substances in the following cases:
• the substance is manufactured in small quantities for
research and development, and special procedural
and recordkeeping requirements are met
(40 CFR 720.36 and .78);
• 10,000 kilograms or less of the substance will be
manufactured or imported each year
(40 CFR 723.50);
• the substance is expected .to have low releases and
low exposures (40 CFR 723.50);
• the substance is being manufactured or imported for
test marketing (40 CFR 720.38); or
• the substance is a polymer that meets certain
specified criteria where the substance is not
considered chemically active or bioavailable
(40 CFR 723.250).
NEW CHEMICALS PROGRAM
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When Are You Required to Submit a PMN?
Does the chemical substance fall into one of the
following categories: drugs, tobacco, nuclear
materials, munitions, food additives, cosmetics, or
substances used solely as pesticides?
1/lto
Is the substance formed during the manufacture of
an article, manufactured solely for export, or formed
by an incidental reaction, or end-use reaction,
2T. is the substance a mixture, byproduct, or a'non-
isolated intermediate?
No
Is the chemical substance on the TSCA Inventory?
iNo
Will the substance be manufactured or imported in
small quantities solely for research or development?
See 40 CFR 720.36 and 720 78
i
No
Will 10,000 kilograms or less of the substance be
manufactured or imported each year?
See 40 CFR 723.50.
No
Will the substance have low environmental releases
and low human exposure (LoREX) during its manu-
facture, distribution, processing, use, and disposal?
See 40 CFR 723.50.
No
Will the substance be manufactured or imported
solely for test marketing? See 40 CFR 720.38.
I No
\s the substance a polymer? See 40 CFR 723.250.
I No
PMN submission is required at least 90 days prior to
manufacturing or importing the chemical substance.
Yes
No PMN submission is required. Substance
is not regulated by TSCA.
yes
Substance may be excluded from PMN
reporting. See 40 CFR 720.30(a)-(h).
Is the substance subject to regulation by a
Significant New Use Rule?
No PMN submission is required
Consult CFR text or EPA's prenolice
coordinator® for more informaton on
abbreviated exemption reporting require-
ments: (202) 260-1745, (202) 250-3937
or (202) 260-8994.
Yes
Will the substance be used fora
"significant new use"?
Yes
No
No PMN submission is required.
U.S. ENVIRONMENTAL PROTECTION AGENCY
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What
information
must be
submitted about
new chemical
substances?
How does
EPA handle
proprietary
information
submitted in
aPMN?
PMN submissions must be made on EPA form
7710-25 which requires all available data on chemical
identify, production volume, byproducts, use, environ-
mental release, disposal practices, and human
exposure. EPA also requires that the following
information be submitted with the PMN: all existing
health and environmental data in the possession of the
submitter, parent company, or affiliates, and a descrip-
tion of any existing data known to or reasonably
ascertainable by the submitter.
The Instruction Manual for Premanufacture Notifica-
tion of New Chemical Substances explains all report-
ing 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, EPAis 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 Manu-
facture or Import is submitted. OPPT reviews CBI
claims to determine whether they meet the legal defin-
ition 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 OPPT.
• 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 sub-
stantial harm to the company's competitive position?
NEW CHEMICALS PROGRAM
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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 sub-
stance added to
theTSCA
Inventory?
When EPA receives your PMN form, you will be sent
an acknowledgement letter that includes the PMN
number assigned to your submission and the date the
PMN review began. If the agency has any concerns
about the substances, you will be notified before the
end of the review period. Otherwise, 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 (sales are less
than $40 million/year), the fee is $100; (2) if a PMN
for an intermediate substance is submitted with a final
product PMN, the fee for the intermediate substance is
$1,000; and (3) if a consolidated PMN, as approved by
a prenotice coordinator, 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(s) at
(202) 260-1745, (202) 260-3937 or (202) 260-8994.
For information about PMN fees see 40 CFR 700, or
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
(EPA Form 7710-56) 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.
U.S. ENVIRONMENTAL PROTECTION AGENCY
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How does EPA
assess potential
risk?
Hazard x Exposure = Risk
What are the
possible
outcomes of
PMN review?
EPA lexicologists, chemists, biochemists, engineers,
and experts in other disciplines work together to
predict the potential risks to humans or the environ-
ment from each new substance. In doing so, they draw
on data submitted with the PMN form, other informa-
tion available to the agency, and exposure and release
modeling.
TSCA does not require prior testing of new chemicals.
Consequently, less than half of the PMN forms submit-
ted include toxicological data. In these cases, OPPT
scientists assess the chemical's structural similarity to
chemicals for which data are available—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 hi any way. If the agency deter-
mines that a new chemical substance may pose a risk
to health or the environment and lacks sufficient toxi-
cological information; however, section 5(e) of TSCA
allows EPA to (1) enter into a consent order permitting
the PMN submitter to manufacture or import the new
substance under specified conditions (risk-based
consent order) or (2) permit the PMN submitter to sus-
pend the review period while developing additional
test data. In the absence of a risk finding and suffi-
cient toxicological data and faced with the potential
for substantial human or environmental exposure—
section 5(e) of TSCA allows EPA to enter into a con-
sent order to collect data that will better characterize
the substance's toxicity and risk (exposure-based con-
sent order). In cases where the agency determines that
a new substance will present an unreasonable risk, sec-
tion 5(f) of TSCA allows EPA to issue an injunction to
prohibit the manufacture, processing, or distribution hi
commerce of the substance.
NEW CHEMICALS PROGRAM
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Premanufacture Notification (PMN) 90 day review process
PMN or Exemption
Receipt
Early Review Drops—
Chemical Review Meeting
Profiles of Exposure
and Releases
Search of the
TSCA Inventory
No
Structure Activity Meeting
l_
Drop/Letterof Concern
Drop/Non5(e)SNUR
Exposure or Risk
Based 5(e) Categories
Less than 5% of
cases continue on (mm
Focus through Standard'
Review process.
Focus Meeting
Found on
Inventor/
Yes
Company Notified that They
are Free to Manufacture
Standard Review
— Focus Drops
- Exemptions (Grant or Deny).
• Test Market Exemptions (45-day review)
•Low Volume Exemptions (30-day review)
•Low Release/Low Exposure Exemptions
(30-day review)
Workplan Meeting with
Multi-Disciplinary Team
Hazardous/Exposure/
Risk Assessment
Drop or
Drop/Letter of Concern
U.S. ENVIRONMENTAL PROTECTON AGENCY
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What are
consent orders
and significant
new use rules?
An occasional outcome of the PMN review is the
negotiation of a section 5(e) consent order, which
allows the PMN submitter to manufacture or import
the new substance under specified conditions (e.g., use
of worker protective equipment or release controls).
EPA may develop a consent order based on a finding
of potential unreasonable risk or substantial exposure.
A section 5(e) consent order is not binding, however,
on other companies that may manufacture or import
the substance. Consequently, after signing a section
5(e) consent order, EPA generally promulgates a
significant new use rule (SNUR).
SNURs require that manufacturers, importers and
processors of certain substances notify EPA at least 90
days before beginning any activity that EPA has
designated as a "significant new use." These new use
designations typically correspond with activities
prohibited by the section 5(e) consent order and are
generally promulgated on an expedited (i.e., "direct
final," see 54 FR 31299) basis. The advance notifica-
tion required by SNURs allows EPA to prevent or limit
potentially adverse exposure to, or effects from, the
new use of the substance.
In cases where EPA does not issue a section 5(e)
consent order, the Agency may promulgate an expedit-
ed SNUR when potential new uses—not identified in
the PMN—could result in increased exposures to or
releases of the substance, and in turn an unreasonable
risk to health or the environment. The 1995 TSCA
PMN rule amendments expanded the types of signifi-
cant new use designations that EPA may promulgate in
expedited SNURs. This change is intended to improve
the efficiency of the SNUR procedure for both EPA
and the chemical industry.
NEW CHEMICALS PROGRAM
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How is the
New Chemicals
Program related
to EPA's
pollution
prevention
efforts?
Summary of
accomplishments
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 program also
supports development of safer chemical substances by
minimizing or eliminating regulatory burdens on new
chemicals if they will replace riskier substances
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 provide information
about steps taken to reduce exposures to or releases of
chemical substances. During the PMN review, EPA
carefully considers this information in evaluating
potential risks. A guidance document on how to report
pollution prevention activities is included as an
attachment to the PMN Instruction Manual.
As with all the exemptions to full PMN reporting,
the low release and low exposure (LoREX) chemicals
exemption was especially designed with EPA's overall
pollution prevention strategy. This exemption
encourages companies to develop manufacturing,
processing, use, and disposal techniques which
minimize exposures to workers, consumers, the
general public, and the environment.
Since 1979, EPA's New Chemicals Program has
reviewed almost 30,000 new chemical substances.
This figure includes nearly 22,000 PMNs that have
undergone full review and approximately 5,500
low-volume, test-market and polymer exemptions.
In that time, the agency has taken action to prevention
potential risks to people and the environment from
nearly 2,700 new substances.
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U.S. ENVIRONMENTAL PROTECTION AGENCY
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New Chemicals
Program
Activities
Through
December
31,1994
IJffffiOFgMisiiH'
Premanufacture notices ...... 21,599 ....... 7/1/79-12/31/94
Test Marketing
Exemption Applications .......... 604 ....... 7/1/79-12/31/94
Low-volume exemptions ...... 2,868 ..... 6/10/85-12/31/94
Polymer exemptions* ........... 2,054 ....... 1/4/85-12/31/94
Total .................................... 27,125
^,,..,_:: ..... , ..... ,a,,;M_JjrJiMJ
Section 5(e) orders ............................................... 677
SNURs [[[ 417
Section 5(f) actions .................................................. 4
PMNs withdrawn in face of action ................... 1,093
Voluntary testing actions ...................................... 871
Total cases regulated** ..................................... 2,645
* As of 5/30/95 reporting for exempt polymers will no
longer be required.
** Total does not include order-related SNURs, as these are
already counted under Section 5(e) orders.
New Chemicals
and Existing
Chemicals
Why does EPA regulate a new chemical and not a
similar chemical already on the market? This issue is
sometimes referred to as a "new chemical bias."
Before 1976, there was no comprehensive chemical
law like TSCA to require the review of new chemicals.
Under TSCA, industrial chemicals in commerce in
1975-1977 were "grandfathered" into the Inventory
without considering if the chemicals were hazardous.
Once on the Inventory, a substance is considered an
"existing" chemical and for EPA to control its use, a
legal finding has to be made that the chemical will
NEW CHEMICALS PROGRAM
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New Chemicals
and Existing
Chemicals
(Continued)
present an unreasonable risk to human health or the
environment. This is a standard which requires EPA to
have conclusive data on that particular chemical. By
comparison, newly introduced chemicals can be regu-
lated under TSCA based on whether they may present
an unreasonable risk and this finding of risk can be
based on data for structurally similar chemicals.
Existing chemicals are oftentimes of similar toxicity
to new chemicals being controlled by EPA under the
PMN program. Lack of controls on the older chemi-
cals may cause a misunderstanding that since there are
less (or no) requirements that they are considered safer
than new, regulated chemicals. In fact, the same pro-
tective measures would probably be imposed on the
older chemicals if they were submitted as "new"
chemicals to EPA today.
EPA continues to work to lessen the apparent inequity
between it regulation of new and existing chemicals.
EPA screens and selects from among the 15,000 chem-
icals in commerce (of the total of 70,000 chemicals on
the Inventory) that appear to be of greatest concern to
human health and the environment. The Agency then
uses a variety of approaches to reduce risks from
chemicals that appear to pose problems. These
approaches include voluntary agreements, alone or in
combination with regulatory approaches; regional, fed-
eral, state and local partnerships; dissemination of risk
management information to assist the selection of safer
substitutes; emphasis on pollution prevention and
innovative control technology to reduce exposure and
environmental release; use of chemical emission data
from the Toxics Release Inventory (TRI) to help
address site-specific chemical concerns; refined risk
assessment and cost/benefit analysis; and the challenge
to industry to meet its Product Stewardship and
Responsible Care principles.
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U.S. ENVIRONMENTAL PROTECTION AGENCY
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For more
information
The TSCA Assistance Information Service (TSCA
hotline) is available to answer general questions 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 (7408)
Office of Pollution Prevention and Toxics
U.S. EPA
401M Street, S.W.
Washington, D.C. 20460
For answers to questions about procedural, technical,
or regulatory requirements prior to submitting a PMN,
call a PMN prenotice coordinator at (202) 260-1745,
(202) 260-3937, or (202) 260-8994.
NEW CHEMICALS PROGRAM
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