Attachment H

Instruction Manual 2015

INSTRUCTION MANUAL FOR REPORTING UNDER THE
TSCA §5 NEW CHEMICALS PROGRAM

Instruction Manual 2015

Contents
A.

1.

GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TSCA §5 NEW
CHEMICALS PROGRAM................................................................................................. 5
Substances which must Be Reported ("New" Chemicals) .................................................. 5
a. General .......................................................................................................................... 5
b. Bona fide request for a TSCA Inventory search ........................................................... 5

2.

Who Must Submit A PMN ................................................................................................. 6

3.

Substances Excluded from Notification.............................................................................. 7
a. Statutorily Excluded Categories ................................................................................... 7
b. Research and Development (R&D) Exemption ............................................................ 8
c. Test-marketing Exemption Applications (TMEA) ....................................................... 8
d. TSCA Section 5(h)(4) Exemptions ............................................................................... 9
i. Low Volume Exemption (LVE) ............................................................................. 9
ii. Polymer Exemption .............................................................................................. 10
iii. Low Release and Exposure (LoREX) Exemption ................................................ 10

4.

When to Submit a Notice .................................................................................................. 11

5.

Filling Out and Submitting the Form ................................................................................ 11
a. e-PMN software .......................................................................................................... 11
b. General Information .................................................................................................... 13
c. TSCA User Fee ........................................................................................................... 14
i. What is the fee for submitting? ........................................................................ 14
ii. How do you submit PMN fees? ....................................................................... 15
d. Incomplete Notices ..................................................................................................... 16

6.

Binding Boxes ................................................................................................................... 16

7.

Test Data and Other Data .................................................................................................. 17

8.

Confidentiality .................................................................................................................. 18
a. Asserting claims .......................................................................................................... 18
b. Substantiating claims .................................................................................................. 19

9.

Consolidated Notices; One-Pot Mixtures ......................................................................... 20

10. Submission of Information by Others ............................................................................... 21
a. Submission by an agent .............................................................................................. 21
b. Letter of support/ Joint submissions ........................................................................... 21
11. Consultation with EPA Concerning the Premanufacture Notice ...................................... 22
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a. Before notice submission ............................................................................................ 22
i. General inquiries ................................................................................................... 22
ii. Specific inquiries .................................................................................................. 22
b. During notice review................................................................................................... 22
12. Notice of Commencement (NOC) of Manufacture (or Import)........................................ 23
13. Recordkeeping .................................................................................................................. 25
a. PMN or SNUN............................................................................................................ 26
40 CFR 720.78(a) requires that you retain documentation of information for a
PMN or SNUN for five years from the date of commencement of manufacture.
You are not required to develop information solely for recordkeeping purposes,
but only to retain information you have obtained or developed in the course of
completing your submission. ....................................................................................... 26
b. Research and Development......................................................................................... 26
c. Test-Marketing Exemption ......................................................................................... 26
d. LVE or LoREX ........................................................................................................... 26
e. Polymer Exemption .................................................................................................... 26
14. Recognition of Pollution Prevention and Recycling Benefits .......................................... 27
B.

PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5 NEW
CHEMICALS PROGRAM PREMANUFACTURE NOTICE (PMN) FORM 7710-25 . 30
1.

Administrative Information .............................................................................................. 30
a. Identify Type of Notice, Your Submission (PMN Page 1) ......................................... 30
b. Certification (PMN Page 2) ........................................................................................ 32

2.

GENERAL INFORMATION-- (Part I) ............................................................................ 32
a. Submitter Identification (Section A, PMN Page 3) .................................................... 32
b. Chemical Identity Information (Section B, PMN Pages 4-6) ..................................... 34
i. Class 1 or Class 2 chemical substances (PMN Page 4) ........................................ 36
ii. Polymers (PMN Page 5) ....................................................................................... 38
iii. Impurities (PMN Page 6) ...................................................................................... 41
iv. Synonyms (PMN Page 6)...................................................................................... 42
v. Trade Identification (PMN Page 6)....................................................................... 42
vi. Generic chemical name (PMN Page 6) ................................................................. 42
vii. Byproducts (PMN Page 6) .................................................................................... 43
c. Production, Import, & Use Information (Section C, PMN Page 7) ............................ 43
i. Production volume ................................................................................................ 43
ii. Use information .................................................................................................... 44
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iii. Hazard information ............................................................................................... 47
3.

HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Part II, PMN Pages 8-10)
........................................................................................................................................... 47
a. Industrial Sites Controlled by the Submitter (Section A, PMN Pages 8-9) ................ 48
b. Industrial Sites Controlled by Others (Section B, PMN Page 10) .............................. 55

4.

(OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION
(PMN Page 11) ................................................................................................................. 57
a. Product Information .................................................................................................... 58
b. Toxicity Information ................................................................................................... 58
c. Technical Information ................................................................................................. 58
i. Process Chemistry................................................................................................. 58
ii. Product Substitution/ Source Reduction ............................................................... 59
iii. Process Modifications ........................................................................................... 60
iv. Operating Practices ............................................................................................... 61
v. Alternative Waste Disposal Methods.................................................................... 63

5.

LIST OF ATTACHMENTS (Part III, PMN Page 12)...................................................... 63

6.

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET (Optional).................... 63

Appendix A -- EXAMPLES OF TEST DATA ............................................................................ 64
Appendix B -- CONTACT LIST: 2015 ........................................................................................ 66

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A.

GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TSCA §5
NEW CHEMICALS PROGRAM

1. Substances which must Be Reported ("New" Chemicals)
a. General
You are responsible for determining whether a substance you intend to manufacture is
a "new" chemical substance as defined by the Toxic Substances Control Act (TSCA, the
Act) and 40 Code of Federal Regulations (CFR) §720.3. You must submit a notice under
§5 of TSCA (i.e., a premanufacture notice (PMN), Low Volume Exemption (LVE), Low
Release, Low Exposure Exemption (LoREX), Test Marketing Exemption Application
(TMEA) or Significant New Use Notice (SNUN)) if you intend to manufacture (import
is considered manufacture) any new chemical substance which is not on the TSCA
Inventory or otherwise excluded from notification, as discussed below. Section B of this
report is a guide to filling out and submitting this electronic form, EPA form 7710-25.
b. Bona fide request for a TSCA Inventory search
The specific identities of some chemical substances on the Inventory are confidential
and therefore do not appear on the Inventory available to the public. Such substances
are described by generic names in the Appendix to the Inventory. If a substance you
intend to manufacture is not on the published Inventory but you think it may be in
commerce based on a confidential Inventory listing, you may request that EPA search
the Inventory's confidential file. EPA will search the confidential file only if you can
demonstrate a bona fide intent to manufacture the substance. This policy is to ensure
that this search procedure cannot be used for, essentially, industrial espionage.
The procedure for demonstrating such a bona fide intent is codified at 40 CFR 720.25 for
PMNs and at 40 CFR 725.15 for MCANs. Certain information must be submitted with a
bona fide request: an infrared spectrum must be supplied unless this analysis is not
suitable for the particular substance, in which case a spectrum or instrument readout
from a more appropriate method must be submitted; a currently correct Chemical
Abstracts (CA) Index name or CA preferred name, whichever is appropriate; a
currently correct Chemical Abstracts Service (CAS) register number (CASRN) (if the
substance already has a CASRN assigned to it); molecular formula and a complete or
partial chemical structure diagram if known or reasonably ascertainable; a description
of R&D activities that have already been conducted (include, for example, years
research conducted, end use application, toxicity data, etc.); the most probable
manufacturing site; "major intended application or use" of the substance; and the
approximate date when the submitter would be likely to submit a §5 notice for the
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substance if it is not found in the Inventory. If the substance is being imported, a
statement should include: a) how long the substance has been used outside of the U.S.,
b) name of the country(ies) in which the substance is being used, and c) whether the
substance has been used outside the U.S. for the same use as that intended after
proposed importation. No specific form is required to be used. Please refer to 40 CFR
720.25 and 40 CFR 721 for instructions on how to submit the statement of bona fide
intent.
After conducting its search, EPA will tell you if the substance is included on the
Inventory and therefore not subject to premanufacture notification or if you must
submit a PMN or an exemption application. If the chemical substance is on the
Inventory, EPA will also tell you if there are restrictions on the material; for example, if
there is a Significant New Use Rule (SNUR) in effect for the substance, you may need to
submit a SNUN.
2. Who Must Submit A PMN
If you intend to manufacture a new chemical substance for a commercial purpose, you
must submit a PMN or an exemption application to EPA. You must submit a notice if
you intend to import a new substance in bulk form or as part of a mixture, but not if
you intend to import the substance only as part of an article. The use of the term
"manufacture" in this manual includes both manufacture and import. Importers must
fully comply with the information requirements outlined at 40 CFR 720. However,
importers are not required, under 40 CFR 720.50(d)(3), to submit any data which relates
solely to exposure to humans or the environment outside the United States. Importers
must submit non-exposure data such as data on health effects (including
epidemiological studies), ecological effects, physical and chemical properties, or
environmental fate characteristics and (on sites under their control within the United
States) exposure information.
"Article" is defined at 40 CFR 720.3 as a manufactured item which: (1) is formed to a
specific shape or design during manufacture; (2) has an end use function(s) dependent
in whole or in part upon its shape or design during end use; and (3) either has no
change of chemical composition during its end-use or only those changes in
composition which have no commercial purpose separate from the article of which it is
a part and that may occur as described in 40 CFR 710.4(d)(5) and 40 CFR 720.30(h)(5).
Articles are excluded from PMN requirements. Fluids and particles do not meet the
definition of an article and are therefore not excluded from inventory reporting
requirements. Therefore, all particles or fluids must be reported for the purposes of
TSCA unless they can be considered mixtures. Also, OPPT will consider items being
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imported to be "articles" only if they are manufactured in a specific shape or design for
a particular end use application, and this design is maintained as an essential feature in
the finished product.
PMNs for imported new chemical substances should be submitted by the principal
importer. "Principal importer" is defined at 40 CFR 720.3(z). It is not necessarily the
same as "Importer of Record" under customs regulations.
Generally, when you contract with another person to manufacture a new chemical
substance, that person must submit the notice. However, if you request another person
to manufacture a new chemical substance, and if you specify the identity and total
amount of the substance to be manufactured and the basic technology and controls
under which the substance will be produced, and if that person manufactures the
substance exclusively for you, that person is considered a "toll manufacturer", and you
must submit the notice. Information regarding human exposure and environmental
release should be submitted on EPA form 7710.25 in Part II, Section A, Industrial Sites
Controlled by the Submitter. EPA recognizes that in this and similar instances, the other
manufacturer may have information useful to the Agency's review of the new chemical.
Therefore, EPA strongly encourages a letter of support, or a joint submission in these
situations.
This manual does not discuss biotechnology submission information requirements for
new intergeneric microorganisms subject to section 5 of TSCA. For specific information
on submitting notices for biotechnology products please see 40 CFR 725 and EPA’s web
site at: http://www.epa.gov/oppt/biotech.
For additional information on who must submit a notice, see 40 CFR 720.22 or consult a
Prenotice Coordinator. Prenotice Coordinators (see Contact List, Appendix B) are staff
in the New Chemicals Program who specialize in assisting with status questions and
questions on how to properly complete the notifications.
3. Substances Excluded from Notification
a. Statutorily Excluded Categories
Section 3(b) of TSCA excludes certain substances from premanufacture notification.
These include mixtures (individual substances comprising the mixtures are NOT
exempted), substances manufactured solely for use as pesticides, food, food additives,
drugs, or cosmetics; tobacco and tobacco products; nuclear source materials; firearms
and ammunition; impurities; byproducts which have no commercial use; non-isolated
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intermediates; and new chemical substances manufactured solely for export. Statutory
exclusions are covered also at 40 CFR 720.3(e) and (u) and through criteria at 40 CFR
720.30(h)(3)-(h)(7).
b. Research and Development (R&D) Exemption
R&D includes synthesis of new chemical substances for analysis, experimentation, or
research on new or existing chemical substances, including product development
activities. R&D may include tests of the physical, chemical, production, and
performance characteristics of a substance.
You do not have to submit a notice for a new substance manufactured in small
quantities solely for research and development as specified in 40 CFR 720.36. "Small
quantities" are those not greater than reasonably necessary for research and
development purposes. The quantity which is reasonable may vary depending on the
nature of the research and development activities. It is your responsibility to determine
what is reasonable in your situation. You do not have to apply for this exemption.
However, you must submit a PMN 90 days before you intend to manufacture the
substance for a purpose other than research and development undertaken in
compliance with 720.36. For additional information on R&D requirements see The New
Chemical Information Bulletin: Exemptions for Research and Development and Test
Marketing available at http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf
or contact the TSCA Assistance Information Service (TAIS, TSCA Hotline) (see Contact
List, Appendix B).
c. Test-marketing Exemption Applications (TMEA)
You may apply for an exemption from premanufacture notification if you plan to
manufacture a new chemical substance for test-marketing. Test-marketing involves the
distribution of a predetermined limited amount of a chemical substance, or of a mixture
or article containing the chemical substance, to specified number of customers to
explore market acceptability before general distribution. The submitter needs to show
that the intended activity is not commercial production and is not appropriately
considered to be research and development.
To approve a test-marketing exemption application, the Agency must make an
affirmative finding that the new chemical substance will not present an unreasonable
risk to health or the environment during the test-marketing activities. 40 CFR 720.38
identifies the type of information you should submit with a test-marketing exemption
application. EPA must approve or deny the application within 45 days. If you do not
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provide sufficient information for EPA to make its determination, the Agency will deny
the request. For additional information on test-marketing requirements, see The New
Chemical Information Bulletin: Exemptions for Research and Development and Test
Marketing available at http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf
or contact the TSCA Assistance Information Service (TAIS, TSCA Hotline) (see Contact
List, Appendix B).
d. TSCA Section 5(h)(4) Exemptions
Under section 5(h)(4) of TSCA, you may apply to EPA for an exemption from some or
all premanufacture notification requirements. EPA may grant an exemption if it makes
an affirmative finding that the manufacture, processing, distribution in commerce, use,
or disposal of the new substance will not present an unreasonable risk to health or the
environment. Unlike other exemptions, such as test marketing, EPA may only grant a
section 5(h)(4) exemption by rule. In the rulemaking proceeding, the applicant should
provide information sufficient to show that the chemical substance will not present an
unreasonable risk to health or the environment. The following exemptions have been
promulgated under section 5(h)(4):
i. Low Volume Exemption (LVE)
Requirements for a LVE application are found at 40 CFR 723.50. This exemption is
available for substances manufactured in quantities of 10,000 kg or less per year.
Multiple LVEs can be issued if there are several manufacturers of a single substance;
however, second and subsequent applications will be evaluated in the context of
existing permitted exposures. Low volume substances are not added to the TSCA
Inventory. The notice must include the site of manufacture and proposed use of the new
chemical substance; these are legally binding upon the company. The manufacturer
may also provide information on exposure controls. If provided, any controls specified
in the notice are binding throughout the period of the exemption. EPA will grant the
LVE if it determines that the substance will not present an unreasonable risk of injury.
The review period for an LVE is 30 days, which can be extended if more information is
required.
Companies must notify the Agency within 30 days of a change of the site of
manufacture or application. Manufacturers must notify processors and industrial users
that the substance can be used only for the uses specified in the exemption notice.
Manufacturers must also notify processors and users of any exposure controls. An LVE
submitter is required (per 40 CFR 723.50(k)) to notify its processors and industrial users
of the limits on use and required controls for the LVE material, and the Agency can
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require a letter exchange between the manufacturer and its customers demonstrating
that customers have agreed to these terms. When exposures/risks of potential concern
are associated with second-level customers, however, Agency policy encourages
submission of a PMN in lieu of an LVE. PMN submission allows control through
Significant New Use Rules (SNURs) and consent orders rather than by letter exchange.
Submitters whose materials have characteristics which may lead to Agency concerns,
and which are expected to go to a second-level customer before being reacted or
consumed, should contact a Prenotice Coordinator to discuss whether a LVE or PMN
submission is more appropriate.
Recordkeeping requirements are discussed at Section A.13, Recordkeeping.
ii. Polymer Exemption
Requirements for a Polymer Exemption can be found at 40 CFR 723.250. The exemption
was first published at 49 Federal Register (FR) 46066. It was subsequently amended on
March 29, 1995 (60 FR 16316) and again on January 27, 2010 (75 FR 4295) and there are
useful discussions in the Preamble to those publications. This exemption is available for
certain classes of polymers which are not chemically active or bioavailable. The
manufacturers are not required to submit a polymer exemption notice to EPA prior to
manufacture, but must notify the Agency by 31 January of each year for new materials
first manufactured in the preceding calendar year. Recordkeeping requirements are
discussed at Section A.13, Recordkeeping.
iii. Low Release and Exposure (LoREX) Exemption
Eligibility for this exemption category is independent of production volume.
Performance standards for this exemption are set out in 40 CFR 723.50 (c) and include
both absolute criteria (e.g., an upper limit on surface water releases) and goals (e.g., no
worker exposure). The notice must include the site of manufacture and proposed use of
the new chemical substance which are legally binding on the company. The applicant's
exemption notice must describe how exposures and releases of the new chemical
substance compare to the criteria of 40 CFR 723.50(c). If the exemption is granted the
applicant is responsible for complying with the standards and with any controls or
limitations specified in this exemption notice. These requirements must be followed
throughout the period of exemption. LoREX exemption notices are subject to 30-day
review periods by the Agency. Recordkeeping requirements are discussed at Section
A.13, Recordkeeping.

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4. When to Submit a Notice
You must submit a PMN or SNUN at least 90 days before you begin to manufacture a
new chemical substance for a commercial purpose. You are required to submit a notice
for LVE or LoREX exemptions 30 days before you begin to manufacture a new chemical
substance, and 45 days before manufacture under a TME. If information additional to
that provided with the application is needed, these periods can be extended through
suspension requests. If your application is not denied, you will be able to initiate
manufacture at the end of these review periods. It is prudent for submitters who think
their substances may be required to submit additional testing during PMN review to
confer with the Agency before submitting and to submit further in advance of their
hoped-for start dates than the minimum number of days for review, as additional
testing will extend the Agency review period for the PMN. To initiate this process
contact a Prenotice Coordinator (see Appendix B).
5. Filling Out and Submitting the Form
a. e-PMN software
The Agency has established TSCA section 5 electronic reporting regulations at 40 CFR
Parts 700, 720, 721, 723 and 725. These electronic reporting regulations established
standards and requirements for use of EPA’s Central Data Exchange (CDX) to
electronically submit premanufacture notices (PMNs and exemption applications),
other TSCA section 5 notices such as Notices of Commencement (NOCs), Bona Fide
Notices of Intent to Manufacture and support documents to the Agency. The
documents which are not to be submitted electronically to EPA include section 5(e)
Consent Orders, Polymer Exemptions, and Prenotice Communications.
The e-PMN software provides an efficient way to complete and submit TSCA section 5
notification forms and associated data. The e-PMN software is a module within the
Chemical Information Submission System (CISS). The CISS was developed by EPA as a
web-based reporting tool for use in submitting data for all sections of TSCA
electronically to the Agency.
CDX is EPA’s electronic system for environmental data exchange to the Agency. The
electronic reporting regulations require all persons who will be working online on a
submission to register with EPA’s CDX and to use the e-PMN module within the CISS
to prepare data for submission. CDX registration enables CDX to authenticate the
identity of submitters. To submit Section 5 submissions electronically to EPA via CDX,
individuals must first register with that system through EPA’s web page at
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https://cdx.epa.gov/. Limited access of encrypted documents has made it more
challenging for companies submitting notices to make changes when employees leave
and are replaced. This has been particularly difficult for a few companies whose
registered employees have died or been terminated, and whose document passphrases
are then not available. We advise companies to think about their succession plans for
the individuals who fill these roles.
Since the e-PMN software now exists in the cloud (Thin Client), the role of the
Authorized Official (AO) has been expanded. Not only does the AO of the submitting
company certify initial notices and submit all types of section 5 documents to EPA via
CDX, the role has been broadened to allow non-certifying AOs who work in the
submitting company to conduct all section 5 business on behalf of certifying AO; they
can do everything except for certifying and submitting initial notices including joint
submissions and letters of support. A new role has also been created for Agents and
Consultants to conduct all section 5 business on behalf of the submitting company
except for certifying and submitting initial notices including joint submissions and
letters of support. Support persons have the ability only to edit information in forms to
which they have been granted access by the AO.
All persons preparing a section 5 submission are required to use the e-PMN software.
The software guides users through a “hands-on” process of creating an electronic
submission. Once a user completes the relevant data fields, attaches appropriate PDF
files or other allowable file types, the web-based tool validates the submission by
performing a basic error check and makes sure all the required fields and attachments
are provided and complete. The e-PMN software creates a sanitized version of the data
in the EPA Form 7710-25; however, submitters must sanitize their attachments before
attaching them to the sanitized e-PMN form.
Further instructions on submitting TSCA section 5 notifications, support documents,
and for uploading PDF attachments or other file types are available through EPA’s web
page at http://www.epa.gov/oppt/newchems/epmn/epmn-index.htm
To submit an amendment to a “valid” notice, the notifier needs to revise the necessary
information in the initial notice or a previously modified version of the initial notice and
the entire updated notice can then be resubmitted to EPA at this point or saved and
resubmitted later. This provides EPA with a complete updated version of the entire
submission in one document. The resubmission process will request identification of
the changes incorporated into the revised notice in a text field established for this
purpose. The notifier must treat “incomplete” or “invalid” notices differently; they
cannot be amended as mentioned above. In this instance, the notifier must recreate a
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new original notice that includes the corrected information before submitting to the
Agency; the submission will receive a new case number and a new day 1.
For Section 5 notices and support documents, there are role designations referred to in
registration as “primary” and “secondary” (for both AOs and support persons).
“Primary” is the role designation for persons responsible for the original notice
submission that is awaiting to be completed by the Secondary joint submitter.
“Secondary” is the role designation for persons who will create and submit joint
submissions and letters of support.
Submitters should refer to the Users’ Guide for instructions in determining their roles.
The Users’ Guide is available through EPA’s web page at
http://www.epa.gov/oppt/newchems/epmn/epmn-index.htm

b. General Information
All information provided in a notification must be in English, with the exception that
open-literature reports can be submitted in their original languages. If data appears in
the open scientific literature, the submitter need only provide a standard literature
citation. A standard literature citation includes author, title, periodical name, date of
publication, volume and page numbers. We invite submitters to assist the Agency by
providing a photocopy of the article as an electronic attachment to the notice. This is the
only exception to the requirement that all information must be submitted in English.
Provide all information requested on the notice form to the extent that you know or can
reasonably ascertain it. If you do not know or cannot reasonably ascertain the
information, enter "NK" ("not known"). Many submitters want to know what is meant
by "reasonably ascertainable". In general, the Agency views information in the current
literature, held by the submitter or a parent or subsidiary company, or held by a
supplier to be reasonably ascertainable.
Some staff members in large corporations have expressed concern for their personal
liability on information submission - that there can be information held by their
organization which a reasonable search will not uncover. As an example, a branch office
of a parent company may have called for a study of a substance and not have retained
its results in the ordinary or expected record locations, or a study of a family of
substances undertaken for commercialization of one of them may not be found when
commercialization of another of those substances is later undertaken. If you think you
are in some danger that you might not find all of your company's information about a
substance on which you are preparing notification, you should document that you
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made a serious search for information, which should have yielded all reasonably
ascertainable information, and keep a record of your search with your records of the
submission. You should be able to make available to an EPA inspector records showing:
that you identified where in your corporate organization (or your suppliers) the
information might be, that you sent requests for information to each site where you
think the information might be kept, and that you followed up with any nonresponding site until you got a response. You should review all applicable information
on the substance, such as the Safety Data Sheet (SDS) or Material Safety Data Sheet
(MSDS) for the existence of testing on the new chemical substance. It is helpful if there
is a corporate information policy to ensure that this sort of information is available to a
responsible PMN submitter.
Form 7710-25 is used for several different types of submissions (i.e., PMNs, LVEs,
LoREXes, SNUNs, modifications to LVEs and LoREXes, and TMEAs). Notices of
Commencement (NOCs) must be submitted electronically, as well, on Form 7710-56.
c.

TSCA User Fee

A user fee must be remtted for PMN, MCAN and SNUN Section 5 notices in accordance
with 40 CFR 700.45. You must create a unique alpha-numeric identification number
(“TS-number”) to identify and link your notice with the remittance fee. This six digit
number must be placed on the first page of the form in the boxes that have been
provided. This number must also be placed on your fee remittance. EPA uses a private
bank in St. Louis to receive checks, money orders and bank drafts; they should be made
payable either to ‘USEPA’ or ‘US Treasury’. After the bank has processed the payment,
the TS Number is sent to EPA Headquarters with certification that payment has been
made. EPA Headquarters then verifies that the appropriate remittance with a TS
identification number corresponds to a user fee identification number on a PMN and
further processing of the notice commences. However, if a problem arises in the
payment procedure, (i.e., insufficient funds, improper usage of the TS-number), the
notice will be given incomplete notice status in accordance with 40 CFR 720.65(c). The
EPA will inform the submitter in writing if this action is taken.
i. What is the fee for submitting?
The fee for most PMN submissions is $2,500.00. The fee is reduced under certain
conditions: (1) if your company qualifies as a small business (sales, including those of
subsidiary/parent companies, are less than $40 million/year), the fee is $100.00; (2) if a
PMN for an intermediate substance is submitted with a final product PMN, the fee for
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the intermediate substance is $1,000.00; and (3) if a consolidated PMN, as approved by
a Prenotice, is filed for multiple chemicals (no more than six) that are related, the total
fee is $2,500, except that for a small business it is $100.00.
When several product PMNs have been consolidated, the Agency will consider
consolidation for intermediates used in their syntheses where those intermediates are
used at parallel stages in their syntheses.
For information about PMN fees see 40 CFR Section 700, or contact the TSCA (Toxic
Substances Control Act) Assistance Information Service ([email protected]).
ii. How do you submit PMN fees?

Fees can be submitted by check or paid by credit card.

To send checks:
The bank that for a number of years provided "lock box" services accepting TSCA
section 5 Premanufacture Notice user fees (Mellon Bank, Pittsburgh, PA) has been
changed; we are now using US Bank in St Louis Missouri. User fees sent to the
Pittsburgh post office box address formerly listed for PMN payments are no longer
being forwarded to the St. Louis lock box service at the address below. Please use the
address below for user fee payments.
US Mail:
U.S. Environmental Protection Agency
Washington Finance Center
Toxic Substances Control Act User Fees
P.O. Box 979073
St. Louis, MO 63197-9000
Courier services:
U.S. Environmental Protection Agency
Washington Finance Center
Toxic Substances Control Act User Fees
Lockbox 979073 - US Bank
1005 Convention Plaza
St Louis, MO 63101
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The telephone number for US Bank staff, which the courier service can use, is: 314-4181618
To pay by credit card, using the US Treasury Pay.gov program:
The New Chemicals program can accept payments made through the Pay.gov program
of the US Treasury. Pay.gov can be a mechanism for paying using a credit card. Pay.gov
has generated a form for paying TSCA fees. The form can be found on the Agency List
at the Pay.gov homepage, as well.
d. Incomplete Notices
40 CFR 720.65 specifies administrative procedures applicable to incomplete notices in
general. The most frequent reason for a submission to be incomplete is a name which is
not in conformance with the current CA Index of Chemical Abstracts nomenclature
rules and conventions (this definitive guide to CA nomenclature has been used since
1972.) If the notice is declared incomplete, the submission becomes invalid. The review
period begins again when a complete notice is refiled. Also, if one chemical in a
consolidated set is declared incomplete due to chemical identity, the entire set is
declared incomplete. If the notice is declared incomplete, the review period has not begun
no matter when in the initial review period the notice is declared incomplete. Therefore, the
default review period begins again at day one when a complete notice is received. EPA
can, however, choose to restart the clock on the day the notice was declared incomplete
if it determines that its review can be completed within the remaining period. This
decision is made case-by-case. [See 40 CFR 720.65(c)]
6. Binding Boxes
Control measures instituted by the submitter to reduce exposures and/or releases of the
substance may have a direct bearing on the Agency's conclusions regarding risk.
Therefore, you may wish to indicate your willingness to be bound to certain submitted
information on the form which is related to the issue of potential risk such as use,
production volume, protective equipment, engineering controls, and/or process
description. In order to make your willingness known to EPA, mark in the "Binding
Option" box on EPA Form 7710-25 located to the right of the appropriate information.
In the case of PMNs, if Agency reviewers think binding control measures for your PMN
can enable us to approve your application, a Program Manager will contact you.
Indicating a willingness to be bound by the terms of your PMN notice does not by itself
prohibit the submitter from deviating after the end of the review from the information
(except chemical identity) which had been reported in EPA Form 7710-25 (unless the
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submitter and the Agency enter into a binding TSCA section 5(e) Consent Order), but it
does provide a starting point for discussions between EPA and the submitter.
A checked box can help EPA and the PMN submitter negotiate efficiently in the
development of 5(e) consent orders and help the Agency promulgate Significant New
Use Rules (SNURs) for those new chemical substances that the Agency determines may
present an unreasonable risk if certain control actions are not implemented. The
purpose of the binding box is to reduce delays that can slow the development of
consent orders absent such prior agreement.
In the case of exemption applications (i.e., TMEs, LVEs and LoREXes), however, use,
protective equipment, engineering controls, and process description are binding on the
submitter when the Agency approves the exemption applications whether or not the
binding boxes are checked. Production volume can be binding when so identified by
the Agency during review, and in no case can go over 10,000 kg/yr in the case of a LVE
application.
7. Test Data and Other Data
You are required to provide any test data on the health and environmental effects of the
new chemical substance, including data on physical/chemical properties, in your
possession or control, and a description of any other health and environmental effects
data on the substance known to or reasonably ascertainable by you. Data in the
possession or control of either a parent company or an affiliated subsidiary located
outside the U.S. are considered by the Agency to be data that should be known to or
reasonably ascertainable by a submitter (see section A.5.b, above).
Data must be submitted in English. Standard literature citations may be submitted for
data in the open scientific literature. Complete test data (not summaries) must be
submitted if they do not appear in the open literature. Incomplete reports (e.g., from
ongoing studies) are exempt from full reporting. However, you must describe the
nature and objective of any incomplete study, report, or test, the name and address of
any laboratory developing the data; progress to date; type of data collected; significant
preliminary results; and an anticipated completion date. If significant preliminary
results or final results are obtained prior to the completion of the notice review period
or any other additional information significant to the review of the notice becomes
available to you, you must submit this information within 10 days of receipt, but no
later than 5 days before the end of the review period. If information becomes available
during the last 5 days of the review period, you must immediately inform EPA by
telephone.
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Examples of the types of test data you must submit are provided in Appendix A of this
manual. In addition, a Physical and Chemical Properties Worksheet appears on the last
page of EPA Form 7710-25. For additional information on health and safety studies and
on submitting test data, see 40 CFR 720.3 and 40 CFR 720.50. Attach test data to EPA
Form 7710-25 and it will be referenced in Part III, List of Attachments.
You are not required to submit any data previously submitted to EPA with no claims of
confidentiality if you identify in your submission the office or person to whom you
submitted the data, the date it was submitted, and, if appropriate, a standard literature
citation. If, however, you submitted data with claims of confidentiality, you must
resubmit the data with the notice and any claim of confidentiality under 40 CFR 720.80.
You also are not required to submit data related solely to product efficacy. This
exception does not apply to information required in the notice, test data, or other data.
8. Confidentiality
a.

Asserting claims

You may assert a claim of confidentiality for any information submitted to EPA. To
assert confidentiality for specific information on the form (e.g., submitter identity,
chemical identity, or use information), mark in the "Confidential" or Confidential
Business Information (CBI) box on EPA Form 7710-25 located to the right of the
information. As well, the box at the bottom of PMN Page 1 of the form is checked if any
information in the notice was claimed as confidential in the form.
To assert confidentiality claims for information in attachments to the form, provide a
complete copy of the attachment that clearly indicates (e.g., by circling, bracketing or
boxing) the information you wish to claim as confidential. Bracket only the specific
information you claim as confidential. For example, if you submit a study which
contains a physical or chemical property and it is only that property which you wish to
claim as confidential, bracket only that property. You must also provide a redacted
version for the public file. As well, you must also clearly and specifically identify any
confidentiality claims you wish to make for information or correspondence
subsequently submitted to EPA about your notification, and it is prudent to provide a
redacted version for the public file.
If you claim the identity of the new chemical substance or its category of use as
confidential, you must provide a generic description of this information, as indicated in
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the appropriate sections of the form. Guidance on developing generic names is given in
Section B.2.b of this instruction manual.
This version ("sanitized", "redacted") will be placed in the public file. It must contain all
non-confidential information, including health and safety studies. A health and safety
study means any study of any effect of a chemical substance or mixture on health or the
environment or on both, including underlying data and epidemiological studies,
studies of occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological, or other studies of a chemical substance or mixture, and any test
performed under TSCA. If you later provide amendments/additional information, you
must also provide a redacted version for the public file.
Information from health and safety studies which can be claimed confidential is quite
limited - this is discussed at 40 CFR 720.90. Chemical identity is assumed to be part of a
health and safety study. 40 CFR 720.90(b)(2) discusses the claims which must be made
and substantiated for chemical identity in a health study to be confidential: that
disclosure would reveal manufacturing or processing information, that it would
disclose the fraction of a mixture which the substance comprises, that the study could
be interpreted without knowing the identity of the substance, and that disclosure would
have harmful competitive effects on the submitter.
Not only is information which arises as a result of a formal, disciplined study included,
but other information relating to the effects of a chemical substance or mixture on
health or the environment is also included. In sum, any data that bear on the effects of a
chemical substance on health or the environment would be included.
b. Substantiating claims
You are not required to provide substantiation of any confidentiality claim when you
submit your notice. However, you must substantiate your claim of confidentiality for
chemical identity at the time you submit a Notice of Commencement of Manufacture
(NOC), if you want EPA to maintain your confidentiality claim after you begin
manufacture. (NOC requirements are described in 40 CFR 720.102 and in Section A.12
of this manual.) To substantiate that claim, you must provide EPA with detailed
answers to questions which appear in 40 CFR 720.85(b)(3)(iv).
This substantiation must accompany your NOC. You may be required to substantiate
other confidentiality claims if EPA receives a Freedom of Information Act (FOIA)
request on that information.
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9. Consolidated Notices; One-Pot Mixtures
If you are manufacturing two or more, but no more than six, structurally similar new
substances, you may contact a Prenotice Coordinator (see Appendix B) to obtain
approval to submit a single consolidated PMN notice. A consolidated notice is suitable
for chemical substances of similar structure with the same or similar uses and which
share similar test data and other information. A consolidated notice must identify each
new substance individually; you may not submit a consolidated notice for an openended category. A separate chemical identity page must be provided for each
substance. A distinct Agency "PMN" number is assigned to each chemical. It will be
unusual if the Agency approves a request to consolidate a series of intermediates and a
final product as they generally will not share common uses, test data, and other
information. Consolidations are not given for LVEs, LoREXs and TMEA applications.
EPA encourages you to submit consolidated notices when appropriate. You may submit
a consolidated notice only after you have received prior approval from a Prenotice
Coordinator. This request should concisely describe the chemical identity of each
substance to be included in your consolidated notice (note: you need not use names
from the Inventory Expert Service of the CAS to request approval for a consolidation).
You need only to describe the chemical substances well enough that EPA personnel can
determine whether they are similar enough for combined review. You must, however,
use separately obtained Method I names for each substance in a consolidation when
PMN is submitted. Many requestors provide this information using the chemical
identity pages of the form or in a one page table format. Remember to enter your
prenotice communications number given to you by the Prenotice Coordinator in Part I,
Section A(3) (PMN Page 3) of the form.
If you are submitting on two or more materials made in the same synthetic operation
and for which you do not intend separation, the Agency considers this to be a ‘one-pot
mixture’. These materials can be submitted in the same application, and the submitter
does not need to get approval from a Prenotice Coordinator for this. The chemical
identities are given on a single page, rather than one identity per page as is the practice
for consolidated submissions. These materials need not be chemically nor
toxicologically similar. As well, LVE, LoREX, and TMEA applications, which are not
eligible for consolidations, are appropriate for one-pot single submissions. Please
identify the submission as a one-pot mixture in a cover letter, to ensure it is treated
appropriately at our pre-screen phase.

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10. Submission of Information by Others
a.

Submission by an agent

For information on submissions by agents, see 40 CFR 720.40(e).
b. Letter of support/ Joint submissions
You may also prepare and submit a PMN with another person. A letter of support or
joint submission may be useful where different persons have information required in
the notice, including a situation when another person has information fundamental to
the notice, but wishes to keep it confidential to the other party. For example, you may
have information on the identity and the physical and chemical properties of the new
substance and another person may know its manufacturing process and its intended
use.
Because signatures are required by each party of a joint/Letter of Support submission,
each party will need to complete its own sections of information and submit as two
separate notices (note: this requires both parties of the joint submission to register to
submit to EPA via CDX). The TS number should be the same for each notice. The person
sending in the document should be listed in section 1a and the joint submitter will be
listed in section 1c; the Letter of Support submitter will be listed on a continuation page.
Each submission (primary submission as well as the joint/Letter of Support
submissions) should have a cover letter in which the primary submitter for the chemical
is identified and the secondary submitter(s) is also identified; also, in the cover letter
enter comments regarding what information will be supplied in this secondary
submission.
Due to validation requirements, each joint submitter may need to enter “see joint
submitter” in required text fields, add an attachment which says “see joint submitter”
for required structure fields, and enter “1” for any required number fields like
production volume (and they can attach the “see joint submitter” attachment to the
section as an explanation).
To create a secondary submission, log into CDX and select Secondary Authorized
Official as your user role. Launch the “TSCA Section 5 Notices and Supports – ePMN”
program and from the Forms screen, select to “Start New Form”. The Authorized
Official of the primary submission should send an email to the secondary party(ies)
which contains a system generated unique identifier. The secondary Authorized
Official enters the unique identifier to create the second party submission.
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Each joint submitter must sign the certification on the form. Each person must also
assert all confidentiality claims as described in 40 CFR 720.80 and in Section A.1 of this
manual. However, you are not relieved of statutory notice requirements by arranging a
joint submission. You are required to complete all mandatory sections of the form to the
extent that you know or can reasonably ascertain the information, even if another
person also submits information for a certain section.
If you submit a joint notice, the review period will not begin until EPA has received all
required parts of the notice. You should identify the joint submitter in your notice and
identify the section(s) which the person is submitting. See 40 CFR 720.40(e) for
additional information on joint submissions.

11. Consultation with EPA Concerning the Premanufacture Notice
a.

Before notice submission
i. General inquiries

General inquiries concerning the premanufacture notification program which are not
related to a specific chemical or notice should be directed to the TSCA hotline (see
Contact List, Appendix B). Copies of the TSCA section 5 rules, this Instruction Manual,
and other materials relating to the TSCA Section 5 New Chemicals Program are
available on the New Chemicals web site, http://www.epa.gov/oppt/newchems/.
ii. Specific inquiries
Specific inquiries concerning the TSCA section 5 notification requirements,
confidentiality, joint submissions, consolidated notices, etc., should be directed to the
Prenotice Coordinator. You can contact the Prenotice Coordinator by telephone,
facsimile, or email (see Contact List, Appendix B).
b. During notice review
Upon receipt of the notice by the OPPT Document Control Officer (DCO), the Agency
will make an initial determination whether the notice is complete. The initial
determination looks to see that the notice contains all the items required on PMN Pages
4 through 8 of the form and for apparent chemical identity problems. If no problems are
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seen, your form is initially determined to be "complete", goes on for further review, and
Day 1 of the 90-day review period is assigned as the date of receipt by the DCO. A more
detailed review can, however, discover other additional information that has not been
provided, and you can be contacted to provide additional information at any time
during the review period.
You will receive written notification if your notice is declared "incomplete" as described
at 40 CFR 720.65. If your notice is initially considered complete, you will receive an
acknowledgment letter telling you your notice number and the Day 1 for the review
period. The Inventory is searched to ensure that the substance for which the notice is
submitted is not already included on the TSCA Chemical Substance Inventory. If your
chemical substance is on the Inventory, you will be notified that your substance is not
subject to premanufacture notification, and that you are free to begin manufacture
immediately, subject to any conditions which may have been established for the
material. If the substance is not on the Inventory, and if the substance is not dropped
from further review at the Agency's initial review meeting ("Focus Meeting", which
takes place at approximately Day 20), a Program Manager will be assigned to
coordinate the review of the notice and to be your official contact with the Agency
throughout the remainder of the review period. Based on decisions made at the Focus
Meeting, it is possible that EPA may declare the PMN to be "incomplete." Also during
the review period, the Program Manager may contact you for clarification of
information you have provided in the notice or if the Agency identifies issues of
concern. If you are not contacted prior to the expiration of the review period, you are
free to commence manufacture of the substance identified in your notice after the
review period has expired. You can check the status of your submission at the New
Chemicals Internet site (http://www.epa.gov/oppt/newchems/tools/status1.htm) after
approximately day 30.
The Program Manager will also notify you before the review period expires if he/she
will extend the review period under TSCA §5(c) or if regulatory action is being
considered on the new substance under TSCA §5(a), §5(e) or 5(f). TSCA §5(e) Consent
Orders are typically issued with a follow-up TSCA §5(a) SNUR subsequently
promulgated. In addition, a Program Manager will contact you if the Agency plans to
develop a non-§5(e) SNUR (a case in which a 5(e) Consent Order does not precede the
development of a SNUR) on the chemical substance identified in your notice.
12. Notice of Commencement (NOC) of Manufacture (or Import)
If EPA has not taken any action to regulate the new chemical substance during the
review period, you may begin manufacturing the new chemical substance upon
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expiration of the review period. For a PMN, EPA requires that you notify the Agency by
using EPA electronic form 7710-56, no later than 30 calendar days after the first day of
such domestic manufacture or import for non-exempt commercial purposes (for import,
Day 1 is the date the material clears US Customs) (see 40 CFR 720.102).
Your NOC must be submitted electronically by CDX to EPA even if it is a NOC for a
PMN filed before the CDX enabled electronic submissions. In your NOC, you must
provide the specific chemical identity of the substance, its PMN number, the site of first
domestic manufacture or import, and the date when domestic manufacture or import
began. You must also substantiate a confidentiality claim for chemical identity in your
letter if you want EPA to maintain the claim after you begin domestic manufacture or
import, by answering the questions shown below:
(A) What harmful effects to your competitive position, if any, do you think
would result if EPA publishes on the Inventory the identity of the chemical
substance? How could a competitor use such information given the fact that the
identity of the substance otherwise would appear on the Inventory of chemical
substances with no link between the substance and your company or industry?
How substantial would the harmful effects of disclosure be? What is the causal
relationship between the disclosure and the harmful effects?
(B) For what period of time should confidential treatment be given? Until a
specific date, the occurrence of a specific event, or permanently? Why?
(C) Has the chemical substance been patented? If so, have you granted licenses to
others with respect to the patent as it applies to the chemical substance? If the
chemical substance has been patented and therefore disclosed through the
patent, why should it be treated as confidential for purposes of the Inventory?
(D) Has the identity of the chemical substance been kept confidential to the
extent that your competitors do not know it is being manufactured or imported
for a commercial purpose by anyone?
(E) Is the fact that someone is manufacturing or importing this chemical
substance for commercial purposes available to the public, e.g., in technical
journals or other publications; in libraries; or in State, local or Federal agency
public files?

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(F) What measures have you taken to prevent undesired disclosure of the fact
that you are manufacturing or importing this substance for a commercial
purpose?
(G) To what extent has the fact that you are manufacturing or importing this
chemical substance for a commercial purpose been disclosed to others? What
precautions have you taken in regard to these disclosures? Has this information
been disclosed to the public or to competitors?
(H) In what form does this particular chemical substance leave the site of
manufacture, e.g., as part of a product; in an effluent or emission stream? If so,
what measures have you taken to guard against discovery of its identity?
(I) If the chemical substance leaves the site of manufacture in a product that is
available to either the public or your competitors, can they identify the substance
by analyzing the product?
(J) For what purpose do you manufacture or import the substance?
(K) Has EPA, another Federal agency, or any Federal court made any pertinent
confidentiality determinations regarding this chemical substance? If so, copies of
such determinations must be included in the substantiation.
(L) If the notice includes a health and safety study concerning the new chemical
substance, the submitter must also answer the questions in 40 CFR 720.90(b)(2).
(Persons must answer this question if a health and safety study was provided
at any time in the new chemical process.)
See 40 CFR 720.85(b) for further information on substantiating confidentiality claims.
13. Recordkeeping
Recordkeeping requirements for submissions under §5 of TSCA are found in several
different sections of the CFR.

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a. PMN or SNUN
40 CFR 720.78(a) requires that you retain documentation of information for a PMN or
SNUN for five years from the date of commencement of manufacture. You are not
required to develop information solely for recordkeeping purposes, but only to retain
information you have obtained or developed in the course of completing your
submission.
The records you must retain include (1) information supporting the information
supplied on the notice form, (2) other data, as defined in 40 CFR 720.50(b), in your
possession or control, (3) production volume for the first three years of domestic
production or import, and documentation to support your stated production volume,
and (4) date of commencement of manufacture, and documentation to support your
stated date.
b. Research and Development
40 CFR 720.78(b) requires that if you manufacture a new chemical substance under the
exemption for substances manufactured solely for research and development, you must
retain documentation of compliance with the exemption until five years after they are
developed.
c. Test-Marketing Exemption
40 CFR 720.78(c) requires that, if you manufacture under a test-marketing exemption
under TSCA, you must retain documentation of information in the application and
documentation of your compliance with any restrictions imposed by EPA when it
granted the application until five years after the final date of manufacture under the
exemption.
d. LVE or LoREX
40 CFR 723.50(n) requires that each manufacturer of a new substance reported under
the terms of a LVE or LoREX exemption must maintain records of (1) the annual
production volume of the new chemical substance under the exemption, and (2)
documentation of information in the exemption notice in compliance with the terms of
the exemption. Records must be retained for five years after date of their preparation.
e. Polymer Exemption
40 CFR 723.250(j) requires that a manufacturer of a polymer made under the terms of
the polymer exemption must maintain records for five years from the date of
commencement of manufacture for: the production volume for the first three years of
manufacture, the date of commencement of manufacture, documentation of the
information provided above, documentation of any other information provided in the
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notice, such as information that demonstrates that the new polymer is not specifically
excluded from the exemption and the polymer meets the exemption criteria.
14. Recognition of Pollution Prevention and Recycling Benefits
During the course of its review, the Agency will be considering whether the activities
surrounding the manufacture, processing, distribution in commerce, use, or disposal of
the substance identified in the notice may present an unreasonable risk of injury to
human health or the environment.
It is also important that EPA be provided with any information regarding technological,
risk reduction, or environmental benefits which may be realized if the new chemical
being notified is introduced into commerce in the United States. By submitting
information describing the positive pollution prevention aspects of your PMN
substance, you may achieve two possible benefits: first, the pollution prevention
information may enable EPA to regulate the substance less stringently than it would
have absent the information, and second, the pollution prevention information may be
chosen by the Agency for affirmative recognition as part of the EPA New Chemicals
Pollution Prevention Recognition Project. Therefore, PMN submitters are encouraged to
complete and provide the optional information on pollution prevention on PMN Page
11 of form 7710-25.
In the Agency's EPA New Chemicals Pollution Prevention Recognition Project, EPA
seeks to promote safer new chemicals and processes, providing several forms of
recognition, including a letter from the Director of OPPT, inclusion in a listing of
recognized chemical substances on the OPPT Internet Homepage, and other positive
publicity. If you want the Agency to consider your PMN substance for this recognition,
you must explicitly request to be considered in your response on the (OPTIONAL)
POLLUTION PREVENTION AND RECYCLING INFORMATION page of the PMN
form and identify the pollution prevention merits of your PMN substance. To the extent
that you think it helpful for Agency consideration, EPA strongly encourages you to (1)
submit actual test data on the PMN substance to substantiate any pollution prevention
claims you assert and (2) minimize claims of confidentiality claims to facilitate publicity
regarding the PMN substance.
For example, the EPA will consider any information on methods used to minimize
potential risks associated with the new substance through source reduction or recycling.
Some of the benefits for which information may be provided are a reduction in the
volume manufactured, a reduction in the generation of waste materials, a reduction in
exposure and/or environmental release or increased performance and/or operation
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efficiency of the new chemical substance in comparison to existing chemical substances
used in similar applications. Recycling activities include reclamation of useful chemical
components from wastes that would otherwise be released as air emissions, water
discharges or land releases during manufacture, process or use. All descriptions may be
quantitative or qualitative.
The "Optional Pollution Prevention Information" page of the PMN requests optional
information that will be used in the evaluation of the new chemical substance and to
compare the relative risks and benefits of the substance as a substitute for substances
with similar uses currently on the market. PMN submitters are encouraged to report
any and all relevant information not reported elsewhere in the PMN which they believe
to be important to a thorough regulatory decision. The page provides submitters with
the opportunity to describe pollution prevention and risk reduction options considered
by the company in regard to the submission. A useful format for presenting such
information is provided Part B, Section 4 of this Manual. Providing this pollution
prevention information to EPA may benefit PMN submitters by reducing regulatory
controls and/or testing requirements, if the pollution prevention information
sufficiently mitigates EPA's concerns for the toxicity, human exposure, or
environmental releases of the PMN substance. EPA considers this information in line
with the strictures of the Pollution Prevention Act of 1990.
Under the Pollution Prevention Act of 1990 (PPA), Congress established a national
policy that: (a) pollution should be prevented or reduced at the source whenever
feasible, (b) pollution that cannot be prevented should be recycled in an
environmentally safe manner whenever feasible, and, (c) disposal or other release into
the environment should be employed only as a last resort and should be conducted in
an environmentally safe manner.
EPA defines "pollution prevention" to mean "source reduction," as defined under the
PPA, and other practices that reduce or eliminate the creation of pollutants through; (a)
increased efficiency in the use of raw materials, energy, water, or other resources, or, (b)
protection of natural resources by conservation.
The PPA defines "source reduction" to mean any practice which: (a) reduces the amount
of any hazardous substance, pollutant, or contaminant entering any waste stream or
otherwise released into the environment (including fugitive emissions) prior to
recycling, treatment, or disposal, and, (b) reduces the hazards to workers, public health,
and the environment associated with the release of such substances, pollutants, or
contaminants.
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The term includes: equipment or technology modifications, process or procedure
modifications, reformulation or redesign of products, substitution of raw materials, and
improvements in housekeeping, maintenance, training, or inventory control. The term
"...does not include any practice which alters the physical, chemical, or biological
characteristics or the volume of a hazardous substance, pollutant, or contaminant
through a process which itself is not integral to and necessary for the production of a
product or the providing of a service" (Sec. 3(5)(B)). Thus, end of pipeline controls, such
as thermal oxidizers, incinerators, or waste water treatment systems are not defined as
"source reduction".
EPA is interested in information on how improved processes for handling individual
new chemical substances may reduce potential exposures and releases of specific PMN
substances. Submitters may include a discussion of Pollution Prevention/Risk
Reduction measures actually selected for implementation and the rationale for the
selection. Submitters are encouraged to consider and include information comparing
the releases and exposures for various process options considered but not selected,
anticipated reductions in releases and exposures which can be expected in the
production of the PMN substance as compared to an existing chemical substance, and
how the PMN substance and/or the product in which it is used may compare favorably
with existing chemicals in terms of pollution prevention. Submitters may also describe
other pollution prevention-related advantages, such as process modifications, increases
in product life or durability, or decreased energy consumption, etc. A set of questions to
address these concerns is put forward in Section II of this Manual.
EPA is also interested in information describing possible reductions in toxicity, and
human exposure, as well as environmental release of a new chemical substance, as
compared to those of already commercialized chemical substances for which the new
substance may substitute. Such information may demonstrate that the new chemical
substance is a viable safer substitute for an existing chemical substance.
Voluntary submission of pollution prevention information is not intended to negatively
affect the outcome of EPA's review of the Premanufacture Notification. When risk
reductions are documented, the information will be carefully considered during EPA's
review of the PMN.
Useful reference material on pollution prevention are available on EPA’s P2 website at:
http://www.epa.gov/p2/.

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B.

PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5
NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE (PMN)
FORM 7710-25
1. Administrative Information
a. Identify Type of Notice, Your Submission (PMN Page 1)

Total pages: In order for the e-PMN software to calculate number of pages, you must
provide the total number of pages for each attachment.
TS-number: The submitter chooses this number. It is used by the bank which receives
money for EPA (“drop-box service”) when it notifies the Agency that the fee has been
received, and also to enable EPA to assemble the parts of a submission when additional
communications (letters of support, joint submissions, and corrections) are sent before a
tracking number (e.g., a PMN or LVE number) has been assigned by EPA to the
notification. There are six spaces in the TS-number block on Form 7710-25. We have
actually had duplication of TS-numbers, and these instructions have been revised to
add some new requirements to make duplication less likely in future: your TS-number
must be a 6-character alphanumeric. It should include 2, 3, or 4 letters. One or more
numerals must be interposed between two letters (that is, LLNNLL, LNNNLL,
NNLLNL, NLNLNL are okay, LLLNNN, NNNNLL are not). We recommend against
company names, recognizable words and numerical series (ROY01X, X01DOW are not
good ideas). The TS-number should be unique to this submission from your company,
do not give this number to a subsequent submission.
Confidentiality Claims: Check this box if ANY information in the form is claimed
confidential.
Test and Other Data: Indicate which types of data are included with the notice by
checking the appropriate boxes.
Type of Notice: Please identify the type of notice being submitted by checking the
appropriate box.
Check "PMN" if the application is for a standard, new chemical substance for placement
on the TSCA Inventory. Also check "PMN" if this notice is for a chemical substance
which is an intermediate used in the direct production of another chemical intermediate
or a final product for which a separate notice is submitted simultaneously, and for
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which the submitter has no intention of making a non-intermediate use. In addition, the
intermediate PMN must identify the final product. Separate user fee identification
numbers must be generated for and appear on each notice; although a single check may
be remitted bearing all user fee identification numbers for a sequence of intermediate(s)
and final product. "Certification", below, discusses fees paid by small manufacturers.
For further information on "intermediate PMNs" see 40 CFR 700.43 and 40 CFR
700.45(b)(2)(ii).
The "Significant New Use Notice" (SNUN) box should be marked for any notice that is
submitted in accordance with a SNUR.
The "Test Marketing Exemption Application" (TMEA) box should be marked for any
notice submitted in accordance with the criteria listed in 40 CFR 720.38. You are now
required to use form 7710-25 to submit a TMEA; however you may provide the
information in a cover letter or attachment.
Boxes are also provided to identify your submission as an application for either a "Low
Volume Exemption" (LVE) [see 40 CFR 723.50(c)(1)] or a "Low Release/ Low Exposure
Exemption" (LoREX) [see 40 CFR 723.50(c)(2)]. These exemptions must be requested
through use of the PMN form. Modifications for earlier approved requests for either of
these exemptions are requested by checking the modification box on the first page of
the PMN form.
For an application to modify an LVE or LoREX exemption, a submitter is not required
to provide again information which was submitted in a previously approved
exemption. Each data element for which information has changed, must be provided.
Any application to modify an LVE for a substance which had been the subject of an LVE
which had been submitted before the amendments of March 29, 1995, however, is a new
application and the full notice must be submitted.
Consolidated PMN: If this notice is for a consolidated PMN, the number of chemicals
(two or more, but no more than six) included in the notice should be entered on page
one in the space provided. A separate PMN number is assigned by EPA to each
chemical substance identified in a consolidated notice. Approval for a consolidated
PMN notice must have been obtained from the Prenotice Coordinator prior to
submission. You are required to identify the Prenotice Communication number you
were given when your consolidation was approved on PMN Page 3, question 3 of the
form. Further information on submitting a consolidated notice is provided at Section I,
Part I of this manual.
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b. Certification (PMN Page 2)
The official named in Part I, Section A of the form as the person submitting the notice
must select the certification statements on PMN Page 2 of the notice form. This official is
responsible for the truth and accuracy of each statement in the certification, and signs
electronically.
In addition, the submitter must check certain "user fee" certification statements as
appropriate as required at 40 CFR 700, Subpart C. For a PMN, consolidated PMN or
SNUN, a fee is required. If the submitter is a small business, it must remit the fee
identified in 40 CFR 700.45(b)(1) (small business concerns remit a fee of $100). If the
submitter is not a small business, it must remit the fee identified at 40 CFR 700.45(b)(2)
(all non-"small" submitters remit a fee of $2,500 for final products, $1,000 if the
submission is for an intermediate and is submitted with the application for the final
product).
A small business concern is one whose total annual sales (include all sites, including
those owned or controlled by a foreign or domestic parent company) are below $40
million for the fiscal year preceding the date of the submission of the applicable §5
notice (see 40 CFR 700.43).
When using the PMN form to submit a LVE or LOREX application in accordance with
40 CFR 723.50, all three of the corresponding certification statement boxes must be
checked to acknowledge that you will manufacture under the terms of the exemption.
In addition, a submitter of an LVE application must certify that the manufacturer
intends to commence manufacture of the proposed exempted substance for commercial
purposes within 1 year of the date of expiration of the 30 day review period. There is no
fee for an LVE or LOREX.
2. GENERAL INFORMATION-- (Part I)
a. Submitter Identification (Section A, PMN Page 3)
(1a). Person Submitting Notice - This information will populate from your e-PMN
registration.
(1b). Agent - Complete only if you authorize an agent to assist you in preparing this
notice.

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If you mark the "Confidential" box next to items 1a or b, all information in the item will
be treated as confidential.
(1c). Joint Submitter - Mark the box if your submission is a joint submission. Identify in
Part I, Section A (1)(c) the name of the joint submitter who is authorized by the U.S.
submitter to provide some of the information required in the notice. For additional
information on joint submissions, see Section A.10 of this Manual. A notice will not be
considered complete until all information is received by the Agency. If information
from multiple parties will not be sent to the Agency in the same package, use your TS
user identification number to link multiple notices. You can generate a TS-number
solely to link submissions, even for a no-fee exemption.
Mark the "Confidential" box next to item 1c if you wish this information to be treated as
confidential.
If you authorize another person (e.g., a foreign manufacturer or supplier) to provide
information directly to EPA, such as confidentially held trade name chemical substance
identification, indicate which information will be supplied by the other person. Identify
that person by name, company, and address in a continuation sheet. That person's
identity may be claimed as confidential. Review period for a notice will not begin until
this information is provided. Use your TS-User Identification Number to link this
information.
(2). Technical Contact - Identify a person who can provide EPA with additional
information on the new chemical substance during the notice review period. The
technical contact identified should be located in the United States and be available to be
reached by telephone during normal business hours. If you mark the "Confidential" box
next to this subsection, all information in it will be treated as confidential.
(3). Prenotice communication number Provide any prenotice communication number
assigned to your prenotice inquiry. In addition, see Section A.9 of this Manual for
further information on submission of a consolidated PMN that requires a prenotice
consultation.
(4). Previous exemption application Provide the exemption number assigned for any
previous exemption application submitted for the chemical substance covered by this
notice. It is especially important for an exemption modification request that you provide
the EPA assigned exemption number from your original exemption application. Also,
provide a previously assigned PMN number, if any, for the chemical substance.
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(5). Previous Submission of Statement of Bona Fide Intent to Manufacture. Selfexplanatory.
(6). Manufacture or import Mark to indicate whether you intend to domestically
manufacture or import the new chemical substance or both domestically manufacture
and import. Use the optional binding box to indicate your willingness to be bound to
either import or domestic manufacture only.
b. Chemical Identity Information (Section B, PMN Pages 4-6)
Submitters of PMN and exemption notices are required to provide the currently correct
Chemical Abstract (CA) name for the substance(s) identified in the notice based on the
current CA Index of CA nomenclature rules and conventions, and consistent with
listings for similar substances in the Inventory. EPA must receive complete and
unambiguous identification of the new chemical substance. If the substance is not
adequately identified, the submission will not meet statutory requirements and the
notice review period will not begin. If a principal importer does not know the specific
identity of the new substance, the submitter must contact the foreign manufacturer or
supplier and have the specific chemical identity information required in the PMN
provided directly to EPA. In this way, foreign manufacturers can protect confidential
business information. The same holds true for U.S. manufacturers reporting chemical
substances using a generic or trade name to identify a component of the new chemical
substance. The submitter of the new chemical substance must have the supplier provide
chemical identity information directly to EPA before the notice can be considered
complete. This information may be provided in a letter of support from the supplier or
as a joint submission between the two companies. A letter of support should be
provided on the supplier company's letterhead. See Section A.10 of this manual on how
and when to file a joint submission. Since a letter of support or a joint submission may
be received separately by the Agency, an identification number such as a TS-user fee
number should be used to link a PMN with information from a supplier or foreign
manufacturer. The TS- number should appear on both pieces of correspondence
submitted to EPA; otherwise, there can be a delay in processing the PMN.
The type of chemical identity information required in the notice depends on whether
the substance is a Class 1 or Class 2 substance or a polymer. A Class 1 chemical
substance is a substance whose composition, except for impurities, can be represented
by a definite chemical structural diagram. For Class 1 substances, a name that is
consistent with the nomenclature rules and conventions of the current Index of the
Chemical Abstracts Service (CAS) and with current TSCA Inventory listings must be
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provided. Examples of such substances are 1,3- butadiene, benzene, and sodium
chloride.
A Class 2 chemical substance is a substance whose composition cannot be easily
represented by a definite chemical structural diagram. Such a substance is generally
derived from natural sources or complex reactions. Its composition may be complex,
difficult to characterize, and variable. For Class 2 substances and polymers, a CA Index
Name or CA Preferred Name must be provided. In addition, for a Class 2 substance, the
notice must identify the immediate chemical precursors and reactants by specific
chemical name and Chemical Abstracts Service Registry Number (CASRN), if the
number is available. Trade names or generic names of chemical precursors or reactants
are not acceptable as substitutes for specific chemical names. Unacceptable names
would include, e.g., "chlorinated naphthalene", "glycerol monoester of hydrogenated
cottonseed oil acids", or a "reaction product of x, y, z".
A polymer is a substance composed of molecules characterized by the regular or
irregular repetition of one or more types of identical monomeric units. In most cases,
the number of monomeric units is quite large and not precisely known.
If the substance is clearly a Class 1 or 2 substance, then items a-d of Question 1 on PMN
Page 4 must be properly completed. If the substance has been named as a polymer
(whether the Exemption Rule requirements are met, or not), then items a-c of Question
2 on PMN Page 5 must be addressed and answered completely. If you are uncertain
whether the chemical substance is a Class 1 or 2 substance or a polymer, contact the
Prenotice Coordinator for further assistance. If the variability of the composition of a
reaction product is too complex to be described as distinct individual components, then
reaction product nomenclature is employed. If, however, components of a reaction
product can be readily identified and will always be present in the reaction product,
then the components should be specifically identified and may be listed individually on
the TSCA Inventory. All reaction products may be reported as Class 2 substances.
Submitters may obtain the correct chemical identity of the PMN substance through the
Chemical Abstracts Service (CAS) Inventory Expert Service (so-called Method 1) or
from any other source (so-called Method 2). Consolidations MUST be submitted with
Method 1 names. A notice submitter must identify in the chemical identity section
which method they used to report the substance's identity. For Method 1, a copy of the
CAS report must be attached to the notice.
Submitters who choose to develop their own chemical identity are cautioned that the
Agency will consider submissions incomplete and thus delay their review if incorrect
nomenclature is received from a source other than CAS. If the Inventory Expert Service
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has been used and all identity information was properly supplied to CAS, the Agency
will work with the IES to agree on a name, and the review period will not be affected.
Use of CAS services other than the Inventory Expert Service, including CAS' Registry
Service or CAS Client Services, will also be considered Method 2. In all cases, each
chemical substance in a consolidated submission must be identified by Method 1 except
in cases where third party identity information has been confidentially provided to the
Agency.
i. Class 1 or Class 2 chemical substances (PMN Page 4)
a. Mark the appropriate class.
b. Enter the specific chemical name of the new chemical substance.
For a Class 1 substance, the name must be a clear description of a unique substance. In
describing the chemical substance, the EPA requires Chemical Abstracts Service (CAS)
chemical nomenclature be used for identification purposes when it is available. There is
a separate box in question one, item c on PMN Page 4 for entry of the CAS number. You
are required to enter the CAS registry number, if one has been assigned to the
substance. The Agency encourages submitters to have contact with CAS prior to
submission in order to obtain concise chemical identity information. Use the CAS
standard rules of chemical nomenclature to identify the new substance. Identify the
positions of attachment of chemical groups or of unsaturation, if any, by using locants.
The chemical name should contain all of the information known about the details of the
structure and should permit the drawing of an unambiguous chemical structural
diagram.
The chemical name of a Class 2 substance must describe the chemical substance as
completely as possible. In some cases, the name may be similar to the names used to
describe Class 1 compounds, but it should indicate the substance's multiple
components. For example, "polychlorinated biphenyl" indicates a composition that has
multiple components varying both in the number and the placement of the substituent
chlorine atoms. In other cases, the best possible name may only identify the substance
as a reaction product of specified reactants, for example, "anhydrosorbitol monoester of
hydrogenated castor oil acids".
c. Provide a molecular formula that gives the identity and number of atoms of each
element contained in the molecule. For example, C6H6 is the molecular formula for
benzene. When the substance is not molecular or when the exact number of atoms in
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the molecule is indefinite, such as the infinite crystal sodium chloride, give the relative
numbers of each element's atoms.
d. For a Class 1 substance, provide a structural diagram. The diagram should clearly
indicate the identity of the atoms and the nature of bonds joining the atoms. Any ionic
charges or stereochemistry should be shown clearly. In the description of the nature of
the reaction or process, as much specific detail as possible should be provided on the
reaction conditions, (i.e. temperature, time, etc.) and on the relative amounts of
reactants. All known stereochemical details should be provided. Carbon atoms in ring
systems and their attached hydrogen atoms need not be explicitly shown. Where
applicable, specify the proportions of isomers or tautomeric forms, degree of
neutralization, etc.
For a Class 2 substance:
(1) List the immediate precursor substances by chemical name and CAS Registry
Number (if known).
(2) For substances prepared by chemical reaction, describe the nature of the reaction or
process. A description should appear in the form of a reaction scheme:
A + B ---------> C
The nature of the reaction must be described as specifically as possible (e.g., acetylation,
alkaline hydrolysis, diazotization). For substances that have been produced without
chemical reaction (e.g., by chemical extraction from a natural source), specify the
source, the production process, and the nature of the product.
(3) If you intend to manufacture a Class 2 chemical substance within a limited range of
possible compositions, report the range. For example, a manufacturer filing a notice for
chlorinated naphthalene might specify a compositional range of 20-40 percent chlorine
by weight. In determining the range, you may have to consider the reaction conditions,
the catalyst, or the purification process that may be used to produce the substance, and
other factors. You should provide the range of composition in weight percent for each
specific component or class of components that you intend to manufacture for
commercial purposes. Indicate the typical composition or any actual values for samples.
(4) Provide as complete a structural diagram as possible. The diagram should indicate
the characteristic structure or variable compositional elements of the substance.
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ii. Polymers (PMN Page 5)
Submitters should be aware of the PMN filing exemption applicable to some polymers
and useful to some manufacturers. The regulations for this exemption are at 40 CFR
723.250. Persons intending to manufacture polymers, and who have determined that
their polymers do not meet the requirements of the exemption should file a PMN or
LVE/LoREX. Persons intending to manufacture polymers, and who have determined
that, for business reasons, an Inventory listing for their substance is desirable, should
file a PMN.
a. Indicate the lowest number-average molecular weight of any composition of the
polymer you intend to manufacture. Identify the method you used to make this
determination (e.g., vapor pressure osmometry or other colligative property
determinations, gel-permeation chromatography, light scattering, or various correlative
techniques). If you have not determined number-average molecular weight by
analytical methods, briefly explain the basis for your estimate. Indicate the maximum
weight percent of low molecular weight species below 500 and below 1,000 absolute
molecular weight. Include the weight of oligomeric reaction products (including
molecules formed that are not polymer molecules) in your determination but do not
include the weight of residual monomers or other reactants. Attach test data supporting
your estimate. If you do not have actual test data, provide an estimate and describe the
basis for the estimate. NOTE: The lowest number-average molecular weight is NOT the
lowest MW of any component of the polymer mixture, but the lowest number average
of several samples of the same polymer, run over time.
b. Column (1) - Monomer or other reactant and CAS Registry Number You are
required to provide the chemical name and CAS Registry Number of each reactant used
in the manufacture of the polymer or incorporated into the polymer, including those
used or incorporated at 2 weight percent or less. Trade names are not acceptable if the
chemical identity is known by the submitter. Reactants include monomers, free radical
initiators, and cross-linking, chain transfer, and other reactive agents that are used
intentionally to become chemically a part of the polymer composition. If a prepolymer
is used in the manufacture of the polymer, list the prepolymer and its CASRN as
charged into the reaction vessel. If prepolymer compositional information is available to
the submitter, identify by bracketing or another method the monomers which are
components of the prepolymer. If compositional information of the prepolymer is not
available to the submitter or if the prepolymer is represented for purposes of TSCA by a
structural repeating unit (SRU) name (examples include silicones and polyethoxylated
and –propoxylated substances), you should identify the prepolymer as it is listed in the

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TSCA Inventory. Solvents, emulsifiers, and non-reacting components should not be
listed.
Column (2) - CBI claim.
Column (3) - % of reactant, typical composition: For each reactant (including
monomers), indicate its typical weight percent in the polymer. The weight percent can
be determined in one of two ways: according to the weight of the reactant charged to
the reaction vessel or the weight of the chemically combined (incorporated) reactant in
the polymer. For the first method, the weight percent of a reactant is the weight of the
reactant charged to the reactor divided by the weight of the polymeric chemical
manufactured (times 100). Thus, the weight percent of reactant A of a polymer
manufactured from reactants A, B, and C is the weight of A charged to the reactor
divided by the dry weight of the polymer A-B-C (times 100). For the second method, the
weight percent of the reactant using the "incorporated method" is determined using
theoretical calculations of the minimum weight of monomer or other reactant necessary
to account for the polymer's actual weight. Manufacturers must maintain analytical data
or theoretical calculations to demonstrate their determination.
Please note that a zero percent value is NEVER an acceptable value of percent
composition for a monomer or other reactant that is to be part of the polymer chemical
identity. To report a polymeric substance as including, for example, “0 – 30%” of a
given monomer or other reactant will only result in the PMN being declared incomplete
due to an uncertain chemical identity. If you are reporting a polymer for which a given
monomer or other reactant will vary at very low levels, you can enter, for example, “>0
– 5%”, “trace – 5%”, or some range having a known, finite lower limit, such as “0.1 –
5%”, without causing a chemical identity uncertainty with respect to that
monomer/reactant that would occur if you reported it at “0 - 5%.” Note, however, that
a zero-containing range, such as “0 – 1.5%” would be acceptable for a monomer or other
reactant that is not to be part of the polymer’s chemical identity because of your
application of the so-called “two percent rule.” On the other hand, if you have a certain
monomer or other reactant which you intend to sometimes include at over 2% and at
other times omit or include at less than or equal to 2%, this would likely be an
appropriate circumstance for a consolidated PMN.
Please note that ranges are not allowed in the table for PMN page 5; please enter the
typical composition value and the maximum residual value in the reactant table and
include an attachment with range information if necessary.

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If you use a prepolymer in the manufacture of the polymer, you must determine the

weight percent of its component reactants. For example, the weight percent of E used in
the manufacture of a polymer (using the "amount charged" method) from reactants A,
B, and C and prepolymer D-E is the total weight of monomer E in the prepolymer D-E
used divided by the weight of the polymer A-B-C-D-E manufactured (times 100). You
must provide the identity and typical weight percent of each monomer and other
reactant used in the manufacture of the polymer regardless of the weight percent at
which it is used. If you will typically manufacture the polymer using a reactant in a
range of weight composition, you may indicate the range of weight percent instead of
the typical weight percent.
Column (4) - Identity Mark: Reactants used or incorporated at greater than 2 weight
percent in the manufacture of the polymer are included as part of the description of the
polymer listed on the TSCA Chemical Substance Inventory. However, you can choose
to include a reactant used or incorporated at 2 weight percent or less in the Inventory
description of the polymer by marking this column. Mark the identity column if you
want a reactant present or incorporated at 2 weight percent or less to be included in the
description of the polymer which is added to the Inventory.
Column (5) - CBI claim.
Column (6) - maximum weight percent present: Indicate the maximum weight percent
of each reactant that may be present as a residual (unreacted material) in the polymer as
manufactured for commercial purposes.
Column (7) - CBI claim.
Note that you must make separate confidentiality claims for reactant identity,
composition information, and residual reactant information.
c. Identify which method you used to develop or obtain the specified chemical identity Method 1, CAS Inventory Expert Service (a copy of the identification report obtained
from CAS Inventory Expert Service must be submitted as an attachment to the notice),
or Method 2, other than CAS Inventory Expert Service.
d. Correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA
Inventory listings for similar polymers.
e. Provide a simple, representative structural diagram that illustrates what you know or
can reasonably ascertain concerning the key structural features of the polymer
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molecules. For example, you could identify the linkages formed during polymerization,
the functional groups present, the range and typical values for the number of repeating
structural units, and the relative molar ratios of the precursors. Indicate if the repeating
substructures are arranged in a nonrandom order such as in graft or block
arrangements. For example:
HO-R(=O)-O-(C(=O)-R'-C-O-R-O)n-H
3File Typeapplication/pdfFile TitleInstruction Manual 2015AuthorKathy SchechterFile Modified2015-09-22File Created2015-05-27