United States  Office of     EEPA-743-F-95-001
Environmental  Pollution Prevention May 1995
Protection Agency and Toxics

New Chemicals



What is the
New Chemicals
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-
z  1000
           Total Notices Received*
       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

What chemical
are "new"
 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.

How can it be
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)
 • 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

Are any new
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).

              —n	——""""""-^—^—iiBMIIiniBHgBMMI^BI
 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?
   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?
   Is the chemical substance on the TSCA Inventory?
  Will the substance be manufactured or imported in
  small quantities solely for research or development?
  See 40 CFR 720.36 and 720 78
  Will 10,000 kilograms or less of the substance be
  manufactured or imported each year?
  See 40 CFR 723.50.
 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.
 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.
                                  No PMN submission is required. Substance
                                  is not regulated by TSCA.
                                 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.
                              Will the substance be used fora
                              "significant new use"?
                                                      No PMN submission is required.
                                                     U.S. ENVIRONMENTAL PROTECTION AGENCY

must be
submitted about
new chemical
  How does
  EPA handle
  submitted in
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
  • Has the company made reasonable efforts to ensure
     that the information is and will remain confidential?
   • Is the information obtainable only from the
   •  Is disclosure of the information likely to cause sub-
      stantial harm to the company's competitive position?

How are you
notified of the
outcome of the
PMN review?
What is the fee
for submitting a
When is a new
chemical sub-
stance added to
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

 How does EPA
 assess potential
  Hazard x Exposure = Risk
What are the
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

 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.

Premanufacture Notification (PMN) 90 day review  process
                              PMN or Exemption
         Early Review Drops—
Chemical Review Meeting
     Profiles of Exposure
        and Releases
                                                                Search of the
                                                               TSCA Inventory
Structure Activity Meeting
       Drop/Letterof Concern
           Exposure or Risk	
       Based 5(e) Categories

               Less than 5% of
          cases continue on (mm
         Focus through Standard'
               Review process.
     Focus Meeting
                                                                  Found on
                               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
                                    Risk Assessment
        Drop or
  Drop/Letter of Concern
                                                 U.S. ENVIRONMENTAL PROTECTON AGENCY

 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.

How is the
New Chemicals
Program related
to EPA's
 Summary of
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.
                                         U.S. ENVIRONMENTAL PROTECTION AGENCY

 New Chemicals

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
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
and Existing
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.
                                          U.S. ENVIRONMENTAL PROTECTION AGENCY

 For more
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
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.