This draft for the Manual is posted for submitters’ convenience. The Manual has 

been through internal review in EPA’s New Chemicals Program, but has not 

completed OMB review. It is being posted on our Web page to assist submitters, 

but will not be published until OMB review is completed. Slightly Revised 

February 2003 - new staff listings and TS-number instructions. 

INSTRUCTION MANUAL FOR REPORTING UNDER THE 

TSCA §5 NEW CHEMICALS PROGRAM 

How this Manual is organized: 

I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TOXIC SUBSTANCES

CONTROL ACT §5 NEW CHEMICALS PROGRAM - PREMANUFACTURE NOTICE

FORM

A. Substances Which Must Be Reported ("New" Chemicals)

B. Who Must Submit A Premanufacture Notice

C. Substances Excluded from Notification

D. When to Submit a Notice

E. Filling Out and Submitting the Form

F. Binding Boxes

G. Test Data and Other Data

H. Confidentiality

I. Consolidated Notices

J. Submission of Information by Others

K. Consultation with EPA Concerning the Premanufacture Notice

L. Notice of Commencement (NOC) of Manufacture (or Import) (40 CFR §720.102)

M. Recordkeeping

N. Recognition of Pollution Prevention and Recycling Benefits
II. PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5 NEW CHEMICALS 

PROGRAM PREMANUFACTURE NOTICE FORM 

1. Type of Notice (Page 1) 

2. Certification (Page 2) 

Part I -- GENERAL INFORMATION

Section A - Submitter Identification (Page 3)

Section B - Chemical Identity Information (Pages 4-6)

1. Class 1 or Class 2 chemical substances (Page 4) 

2. Polymers (Page 5) 

3. Impurities (Page 6) 

4. Synonyms 

5. Trade Identification 

6. Generic chemical name 

7. Byproducts -

Section C - Production, Import, & Use Information (Page 7) 

1. Production volume 

2. Use information 

3. Hazard information 

Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Pages 8-10) 

Section A - Industrial Sites Controlled by the Submitter (Pages 8-9) 

Section B - Industrial Sites Controlled by Others (Page 10) 

(OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION (Page 11) -

Technical Information 

a. Process Chemistry 

b. Product Substitution/ Source Reduction 

c. Process Modifications 

d. Operating Practices 

h. Alternative Waste Disposal Methods 

i. Toxicity Information 

Part III - LIST OF ATTACHMENTS (Page 12) 

Physical and Chemical Properties Worksheet (Optional - page 13) 

Appendix A: Types of test data for submission 

Appendix B: Contact Persons 
I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE 

TSCA §5 NEW CHEMICALS PROGRAM -

PREMANUFACTURE NOTICE FORM 

A. Substances Which must Be Reported ("New" Chemicals) 

1. General - You are responsible for determining whether a substance you intend to 

manufacture or import 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 

premanufacture notice (PMN) 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. To submit a PMN, you must use Form EPA 7710-25. Part II of 

this Manual is a step-by-step guide to form 7710-25 (rev 5-95). 

2. 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 or import is not on the 

published Inventory but falls within one of the generic categories in the Appendix, 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 or import 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. 

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; and a description of R&D activities that 

have already been conducted (include, for example, years research conducted, end use 

application, toxicity data, etc.). Three additional information requirements established in the 

PMN Rule Amendments, published March 29, 1995 (60 Federal Register (FR) 60 pp. 

16298-16351) for a TSCA Inventory search include: 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 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. 

The address to which to send bonafide submissions (by US mail) is: 
OPPT Document Control Officer

Mail Stop 7407 

USEPA 1200 Pennsylvania Avenue, North West

Washington, DC 20460

The room at which bonafides are accepted is only open until 4 PM, and if a courier service 

comes after that time it will be turned away. You need the physical address for sending a bona

fide by courier. You can give the courier the phone number (202) 564-8940 to call if there are 

delivery problems: 

OPPT Document Control Officer

Mail Stop 7407 

TSCA Data Processing Center

Room 6428 EPA East

USEPA 1201 Constitution Avenue, North West

Washington, DC 20004-3302

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. 

B. Who Must Submit A PMN 

If you intend to manufacture or import a new chemical substance for a commercial 

purpose, you must submit a PMN 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 §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 

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 joint submission in these situations. 

This manual does not discuss biotechnology submission information requirements for uses 

of microorganisms subject to the Toxic Substances Control Act (TSCA). For specific information 

on submitting notices for biotechnology products please contact the Biotechnology Program in 

the New Chemicals Notice Management Branch: 

Biotechnology Program

New Chemicals Notice Management Branch

Chemical Control Division

Mail Stop 7405

USEPA, 1200 Pennsylvania Avenue, North West

Washington, D.C. 20460

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 C) are staff in the 

New Chemicals Program who specialize in assisting with status questions and questions on how 

to properly complete the notifications. 

C. Substances Excluded from Notification 

1. Statutory Excluded Categories - §3(b) of the 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 

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 §§720.30(h)(3)-(h)(7). 

2. 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 or imported 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. 

To qualify for the exemption, your research and development activities must be conducted 

under the supervision of a technically qualified individual. Persons who engage in R&D for, or 

obtain an R&D chemical from, a manufacturer must be notified of any risk to health which may 

be associated with the chemical. However, R&D conducted entirely in laboratories under prudent 

laboratory practices is exempted from the requirement for risk evaluation. 

In accordance with 40 CFR §720.78, the following R&D records must be retained (also 

see I-M, Recordkeeping): information reviewed and evaluated to determine the need to make any 

notification of risk, documentation of the nature and method of risk notification, documentation 

of prudent lab practices, if used instead of risk notification and evaluation and, if an R&D 

substance is manufactured at greater than 100 kg/yr, records regarding the chemical identity of 

the substance to the extent known, the production volume, and the disposition of the R&D 

chemical substance must also be retained. 

Manufacturers and importers who distribute an R&D substance to other persons must 

provide those persons with written notification of known hazards and of the requirement that the 

substance be used solely for R&D. For additional information on R&D requirements see the New 

Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing 

available from the TSCA Assistance Information Service (TAIS, TSCA Hotline) (see Contact 

List, Appendix C). 

3. Test-marketing exemptions (TME) - You may apply for an exemption from premanufacture 

notification if you plan to manufacture or import 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 provide sufficient information for EPA to 

make its determination, the Agency will deny the request. You should send applications for test-
marketing exemptions to the OPPT Document Control Officer (7407). You are not required, but 

are encouraged, to use the PMN form for a TME application. For additional information on test 

marketing requirements see the New Chemical Information Bulletin: Exemptions for Research 

and Development and Test Marketing available from the TSCA hotline. Recordkeeping 

requirements for a test-marketing exemption are discussed at I-M, Recordkeeping. 

4. §5(h)(4) exemptions - Under §5(h)(4) of the Act, 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 §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. 

You should send applications for §5(h)(4) exemptions to the OPPT Document Control Officer 

(7407). The following exemptions have been promulgated under §5(h)(4): 

a. 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 to 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 (importers) 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. 

Recordkeeping requirements are discussed at I-M, Recordkeeping. 

b. Polymer Exemption - Requirements for a Polymer Exemption can be found at 40 

CFR §723.250. The exemption was first published at 60 Federal Register (FR) 60 pp. 

16316-16336, and there is a useful discussion in the Preamble to that publication. 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 for new materials 

first manufactured in the preceding calendar year. Recordkeeping requirements are 

discussed at I-M, Recordkeeping. 

c. Low Release and Exposure (LoREX) Exemption - Eligibility for this exemption 
category is independent of production volume level. 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 upon 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 I-M, Recordkeeping. 

D. When to Submit a Notice 

You must submit a PMN at least 90 days before you begin to manufacture or import 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 or import a new chemical 

substance, and 45 days before manufacture or importation under 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/import at the 

end of these review periods. It is prudent for submitters who think their substances may be 

subjected to required 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. 

E. Filling Out and Submitting the Form 

Complete the §5 notice form EPA 7710-25 (rev. 5-95) using a typewriter or by printing 

legibly in black ink. Information which is not submitted on a photocopy of the form available 

from EPA (e.g., an electronically generated form created by utilizing form-making software) must 

be in a format pre-approved by the Agency. Approval can be obtained by contacting: 

OPPT Document Control Officer

Mail Stop 7407 

USEPA 1200 Pennsylvania Avenue, North West

Washington, DC 20460

All information provided must be in English (Except 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. The submitter can assist 

the Agency by providing a photocopy of the article, if desired. 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 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 non-responding site until you got a response. You should review all 

applicable information on the substance, such as the 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. 

You may submit continuation sheets for any subsection or item on the form. Head any 

continuation sheet with: the TS-number or PC-number, if any; submitter name; and the number of 

the question to which it is a supplement. Mark the appropriate box on the notice form if you 

attach continuation sheets. You may photocopy the notice form, sections of the form, or this 

manual as frequently as you need. 

Form 7710-25 (rev. 5-95) is used for several different types of submissions. These 

instructions are designed to guide submitters for each of them. Send your completed notice to the 

Document Control Officer (DCO) for Office of Pollution Prevention and Toxics. If the notice is a 

PMN or Significant New Use Notice (SNUN), send with original signatures and two copies (an 

additional copy is required if any information is claimed to be confidential, and should be 

submitted with the claimed-confidential information deleted ("redacted copy", "sanitized copy"). 

No copies are required if it is an application for a Test Market Exemption (TME), Low Volume 

Exemption (LVE), or Low Release-Low Exposure Exemption (LoREX), except that if it contains 

confidential business information (CBI) you must submit a redacted copy, which will be placed 

for public viewing in the TSCA Nonconfidential Information Center, 202-566-0280 (open from 

12m - 4pm daily): 

TSCA Nonconfidential Information Center

Mail Stop 7407

EPA West, B-146
USEPA 1201 Constitution Avenue, North West 

Washington DC 20460 

The US Mail address for the DCO appears on page 1 of the form. The room at which 

submissions are accepted is open from 8 am until 4 pm daily, and if a courier service arrives after 

that time it will be turned away. For sending a notice by courier the address should include the 

physical location: 

OPPT Document Control Officer

Mail Stop 7407 

TSCA Data Processing Center

Room 6248 EPA East

USEPA 1201 Constitution Avenue, North West

Washington, DC 20004-3302

You can give the courier the phone number (202) 564-8940 to call if there are delivery 

problems. 

A user fee must be remitted for PMN and SNUN §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 which is sent to: 

EPA, Washington Financial Management Center (Mail Stop 3303)

P.O. 360399M

Pittsburgh, PA 15251-6399

Attn. TSCA User Fee

EPA uses a private bank in Pittsburgh to receive these fees. The bank will accept certified 

checks, money orders and bank drafts only; after the bank has processed the payment, the TSNumber 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. 

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 Ninth Collective Index (9CI) 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 review period has not begun no matter when in the initial review period 

the notice is declared incomplete. Therefore, the review period begins again at day one when a 
complete notice is received. However, EPA can 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). 

F. Binding Boxes 

The purpose of the binding option is to enable EPA (if necessary) to efficiently negotiate 

with a PMN submitter the development of §5(e) consent orders and 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. This option is intended to 

reduce delays that can slow the development of consent orders absent such agreement. At one 

time, SNURs were limited to environmental release activities and certain industrial, commercial, 

or consumer activities, but now they can include other important activities, such as protection in 

the workplace and hazard communications. 

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. By indicating your willingness to 

make these commitments, you would be indicating an interest in future negotiations if the Agency 

deems them necessary. In order to make your intentions known to EPA, mark in the "Binding 

Option" box on the form located to the right of the appropriate information. 

Should the Agency wish to discuss development of binding control measures for your 

PMN, you will be contacted by a Program Manager and negotiations may ensue. Therefore, 

indicating a willingness to be bound by the terms of your notice does not by itself prohibit the 

submitter from deviating from the information (except chemical identity) reported in the form. In 

the case of exemption applications (i.e. Test Market, Low Volume/Low Release, Low Exposure), 

however, certain statements are automatically binding on the submitter when the Agency 

approves the exemption applications. 

G. Test Data and Other Data 

You are required to provide three copies of 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 

E, 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. 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 now appears on the last 

page of the form. For additional information on health and safety studies and on submitting test 

data, see 40 CFR §§720.3 and 720.50 of the Premanufacture Notification Rule. Attach test data 

to the notice form and reference it by page number 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. 

H. Confidentiality 

1. 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 the form located to the right of the information. Also mark the box at the bottom of 

page 1 of the form if any information in the notice was claimed as confidential in the form. As 

noted above, a redacted copy of any §5 notice must be submitted with the notice, or it will be 

declared incomplete by the Agency and returned to the submitter. 

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 or bracketing) 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. 

Do not simply stamp "Confidential" on the page which contains that property. You must also 

clearly and specifically mark any confidentiality claims you wish to make for information or 

correspondance subsequently submitted to EPA about your PMN, and you must 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 the 

appropriate sections of the form. Guidance on developing generic names is given in Part 2 of this 

manual in the Chemical Identity Information Section at Item 6. 
To ensure that no confidential information is disclosed to the public, you must submit an 

additional copy of the notice form, including attachments, which does not contain confidential 

information. 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 the Act. 

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.) If you do not provide the sanitized copy with your 

submission, the submission will be incomplete and the review period will not begin. If you 

provide a subsequent amendment to your PMN or additional information/data, you must also 

provide a non-confidential version for the public file. 

2. 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 this manual.) To substantiate that claim, you must provide 

EPA with detailed answers to the following questions which appear in the Premanufacture 

Notification Rule [40 CFR §720.85(b)(3)(iv)]: 

(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? 

(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 720.90(b)(2). 

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. 

I. Consolidated Notices 

If you are manufacturing two or more, but no more than six, structurally similar new 

substances, you may contact a Prenotice Coordinator to obtain approval to submit a single 

consolidated 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 open-ended category. A separate chemical identity page must be 

provided for each substance. A distinct Agency "PMN" number is assigned to each chemical. 

You may not submit a consolidated notice for a series of intermediates and a final product (they 

will not share common uses, test data, and other information). 

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. Prenotice coordinators are 

committed to quickly responding to a request for a consolidated notice; however, this will not 

always be possible. Remember to enter your prenotice communications number in Part I, Section 

A (3) (page 3) of the form. 

J. Submission of Information by Others 

1. Submission by an agent - You may designate an agent to submit a §5 notice for you. Both 

you and the agent must sign the certification on the form. You are responsible for ensuring that 

all information known or reasonably ascertainable by you and all test data in your possession or 

control are submitted to EPA. For information on submissions by agents, see 40 CFR §720.40(e). 

2. Joint submissions - You may also prepare and submit a PMN with another person. A 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. 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. 

Each joint submitter must use a notice form and sign the certification on the form. Each 

person must also assert all confidentiality claims as described in 40 CFR §720.80 and Part I 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. 

K. Consultation with EPA Concerning the Premanufacture Notice 

1. Before notice submission 
a. 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 C). Copies of the PMN Rule, Instructions 

Manual, notice form, and other materials relating to the Rule are available by contacting 

the hotline. (These materials are also available at EPA regional offices.) 

b. Specific inquiries - Specific inquiries concerning the PMN Rule, 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 C) 

2. 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 pages 4 through 8 of 

the form and for apparent chemical identity problems. If no problems are 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. Later and 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 complete, you will receive an acknowledgment 

letter telling you your notice number and the date of expiration of 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 therefore you are free to begin manufacture immediately. If the substance is not on the 

Inventory, and if the substance is not dropped from consideration 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 the Focus Meeting, it is possible to 

declare the PMN "incomplete", usually for missing test data. 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 ("www.epa.gov/opptintr/newchms") 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(e) or 5(f). 5(e) Consent Orders are typically issued with a follow-up 

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. 

L. Notice of Commencement (NOC) of Manufacture (or Import) (40 CFR §720.102) 
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 expiration of the review 

period. EPA requires that you notify the Agency by using EPA form 7710-56, no later than 30 

calendar days after the first day of such manufacture or import for non-exempt commercial 

purposes (for import, Day 1 is the date the material clears US Customs). 

Your NOC must be sent to the OPPT Document Control Officer (Mail Stop 7407). In 

your NOC, you must provide the specific chemical identity of the substance, its PMN number, the 

site of first manufacture or import, and the date when manufacture or import began. You must 

also substantiate a confidentiality claim for chemical identity in your letter, as described above at 

"2. Substantiating Claims" if you want EPA to maintain the claim after you begin manufacture or 

import. See 40 CFR §720.85(b) for further information on substantiating confidentiality claims. 

M. Recordkeeping 

Recordkeeping requirements for submissions under §5 of TSCA, and for exemptions from 

submission, are found in several different sections of the CFR. 

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. 

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 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. 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. 

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. 

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 or import under the 

exemption. 

LVE or LoREX: 40 CFR §723.50(n) requires that each manufacturer of a new substance 

reported under the terms of a low volume 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. 

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 notice, such as 

information that demonstrates that the new polymer is not specifically excluded from the 

exemption and the polymer meets the exemption criteria. 

N. 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, use, and disposal of the substance identified in the 

notice may present an unreasonable risk of injury to human health or the environment. 

It is important, also, that EPA acquire information regarding any technological, risk 

reduction, or environmental benefits which may be possible if the new chemical being reported is 

introduced in commerce, and this information can in some cases enable the Agency to approve 

substances otherwise doubtful. Therefore, PMN submitters are encouraged to complete and 

provide the optional information on pollution prevention on page 11 of the form. 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. 

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 at (OPTIONAL) POLLUTION PREVENTION AND RECYCLING 

INFORMATION 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 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 at Section II 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. 

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. 

Based on the information, EPA may reduce or eliminate anticipated exposure controls and testing 

requirements which would ordinarily have been imposed by the Agency. Completion of this 

section is also important if you wish your substance to be considered for the EPA New Chemicals 

Pollution Prevention Recognition Project. 

Reference Material 

EPA's new "Facility Pollution Prevention Guide", a successor to the 1988 "Waste 

Minimization Opportunity Assessment Manual", is available to help firms develop broad-based 

multimedia pollution prevention programs. Worksheets and other information are included to 

help facilities identify, assess, and implement opportunities for preventing pollution, including 

methods of controlling waste creation during the production process, as well as product design 

and redesign. Developed by EPA's Pollution Prevention Research Branch, and Office of Solid 

Waste, the Guide (Doc. No. EPA/600/R-92/088) can be ordered by mail from: 

EPA Center for Environmental Research

Information Publications Unit

26 W. Martin Luther King Drive

Cincinnati, OH, 45268

(800) 490-9198
II. PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING EPA FORM 7710-25 (rev. 5-95) 

THE TSCA §5 NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE FORM 

Page 1: Identify Type of Notice, Your Submission 

Total Number of Pages: Give total pages as submitted, including attachments. 

TS-number: The submitter chooses this number. It is used by the bank which receives money for 

EPA when it notifies the Agency that the fee has been received, and also to enable us to assemble 

the parts of a submission when additional communications (letters of support, joint submissions, 

corrections) are sent before a PMN/LVE number has been assigned. There are six spaces in the 

TS-number block on the PMN form. 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. If we get a TS-number with a submission and it does not comport with 

this guidance, we will call the submitter and ask for a new number which does. 

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 PMN. 

Type of Notice: Please check the type of notice submitted. 

Check "PMN" if the application is for a standard, final-product new chemical substance 

for placement on the TSCA Inventory. 

The "Intermediate PMN" box should be checked if this notice is for a chemical substance 

which is an intermediate used in the production of a final product for which a separate notice is 

submitted simultaneously, and for which the submitter has no intention of making a separate, nonintermediate 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 

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 not required 

to use form 7710-25 (rev. 5-95) to submit a TMEA, but it is encouraged. 

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 page 

from the application on which some information has changed, and a new signature page, must be 

provided. An application for an LVE for a substance which had been the subject of a prior LVE 

which had been submitted before the amendments of March 29, 1995, however, is a new 

application and the full form 7710-25 must be submitted. 

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 to each chemical substance identified in a consolidated notice. 

Approval for a consolidated PMN notice must be 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 page 3, question 3 of the form. Further information on 

submitting a consolidated notice is provided at Section I, Part I of this manual. 

Page 2 Certification 

The official named in Part 1, Section A of the form, as the person submitting the notice, 

must sign the certification on page 2 of the notice form. This official is responsible for the truth 

and accuracy of each statement in the certification. If an agent assists you in preparing the notice, 

the agent must also sign the certification. All signatures must be original, and in ink. 

In addition, the submitter must check certain "user fee" certification statements as 

appropriate as required at 40 CFR §700. 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 either 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. 

Part I -- GENERAL INFORMATION 

Section A - Submitter Identification (Page 3) 

1a. Person submitting notice - Enter information on the official who signed the general 

certification. 

b. Agent - Complete only if you authorize an agent to assist you in preparing this notice. The 

agent must also sign the certification as noted above. 

If you mark the "Confidential" box next to items a or b, all information in the item will be 

treated as confidential. 

c. 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 part I, 

section J 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. If you don't generate a TSnumber you should ask a prenotice coordinater to issue a prenotice communication number for 

this purpose. 

Mark the "Confidential" box next to item c 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, such as, confidentially held tradename chemical substance identification directly to 

EPA, 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. A letter of support for your notice should be provided by the joint submitter on its 

company letterhead. A notice will be considered incomplete until this information is provided. 

Whenever possible 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. Provide any prenotice communication number assigned to your prenotice inquiry. In addition, 

see Section II, Part E of this manual for further information on submission of a consolidated PMN 
that requires a prenotice consultation. 

4. 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. 

5. Self-explanatory. 

6. Mark to indicate whether you intend to manufacture or import the new chemical substance or 

both manufacture and import. Use the optional binding box to indicate your willingness to be 

bound to either import or domestic manufacture only. 

Section B - Chemical Identity Information (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 Ninth 

Collective Index (9CI) 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 Part 

I, Section J(2) 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 or a Prenotice Communications number should be used to link a 

PMN with information from a supplier or foreign manufacturer. The identical identification 

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 9th Collective Index of the Chemical Abstracts Service (CAS) and with 

current TSCA Inventory listings must be 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 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 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, then both Questions 1 and 2 on Pages 4 and 5 should be 

completed in full, or 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 has been used, 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, will also be 

considered Method 2. In all cases, each chemical substance in a consolidated submission must be 

identified by Method I. 

1. Class 1 or Class 2 chemical substances (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 page 4 for entry of the CAS number. 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 the molecule is 

indefinite, such as the infinite crystal sodium chloride, give the relative numbers of each element's 

atoms. You are required to enter the CAS registry number, if one has been assigned to the 

substance. 

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. 

2. Polymers (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 with two copies 

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. 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 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 zero per cent is NEVER an acceptable level of a feedstock, if that 

feedstock is part of the chemical identity. To describe a substance as including "0-30%" of a 

given feedstock will only result in getting the PMN returned for a better identity. If you are 

notifying for a substance for which a feedstock will vary from very low levels you can enter ">0-

30%" or "trace-30%" without, as you will if you enter "0-30%", forcing a new identity. "0 - 2%", 

however, would be acceptable for a chemical that is not part of the ID and is not marked in the ID 

field). 

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 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: 
 O O 

2 2

HO-R-O-(C-R'-C-O-R-O)n-H 

 3<n<10, where R may be either 

-CH2CH2-or -CH2CHCH3 

and R' may be either a 1,4-substituted benzene ring or -(CH2)4-

Provide approximate relative mole ratios of precursors, e.g.: 

diethyl terephthalate: 2.0 

adipic acid 1.5 

ethylene glycol 1.0 

propylene glycol 3.0 

3. Impurities (Page 6) 

a. Identify each impurity you reasonably anticipate will be present in the substance as 

manufactured for commercial purposes. An impurity is any chemical substance that is 

unintentionally present in the new chemical substance. List all impurities (regardless of weight 

percent). If the substance contains some unidentified impurities, also enter "unidentified" in 

column (a). Do not include any substances that are mixed with the new substance after 

manufacture. 

In addition to impurities, list in this section other chemical substances, such as solvents, 

inhibitors, etc., that also may be reasonably anticipated to be present in the chemical substance as 

manufactured for commercial purposes. 

You should consider the following in identifying impurities: 

(1) Chemical and instrumental analyses - often performed on the chemical substance 

during research and development to characterize the substance before it undergoes health effects 

or environmental effects testing, to optimize product performance, or to understand process 

chemistry and optimize output. 

(2) Manufacturing process chemistry - including feedstocks, feedstock impurities, 

byproducts, and intermediates both from the major reaction pathway and from significant side 

reactions. 

(3) Quality control operations - operations which determine the nature and level of 

impurities that may be present in the chemical substance. 
Identify impurities as specifically as possible. You should provide the following 

information: 

(1) the specific chemical name; or 

(2) a class or range of structures (e.g., C6 - C18 fatty acid salts or polychlorinated cyclic 

and acyclic hydrocarbons in the range C5 - C12); or 

(3) the source (e.g., pyrolysis products of cellulose or coal tar residues). 

Include the CAS Registry Number if available. 

b. Enter the maximum weight percent of each impurity in the new chemical substance in 

column (b). If the substance contains unidentified impurities, enter the total weight percent of 

unidentified impurities in column (b). 

confidentiality claim: must be made separately for each impurity. 

4. Synonyms - Enter common chemical names by which the new chemical substance may be 

identified in the scientific or technical literature, including the names or codes used to identify the 

new chemical in test data or other data which are attached to the notice. 

5. Trade Identification - Enter any trade name under which the new substance has been or will 

be marketed. Report all trade names or brand names, even if they are not registered. 

6. Generic chemical name -- If the new substance's identity is claimed as confidential, enter a 

generic chemical name. This name should be only as generic as is necessary to protect the 

confidential chemical identity, and should reveal the chemical identity of the substance to the 

maximum extent possible. The generic name will be published in the FEDERAL REGISTER 

notice on the new substance. EPA will review the adequacy of the generic chemical name when 

the NOC for the substance is submitted. If the name seems more generic than necessary, EPA 

will contact you to develop an adequate name. 

Generic chemical names are created for Class 1 chemical substances by masking 

structurally descriptive parts of their specific chemical names. Masking can be accomplished by 

substituting non-descriptive terms (e.g., “substituted”) for descriptive parts of the name. Here is 

an example with the oil source masked: hydrogenated palm-oil fatty acids, esters with Dmannitol, ethoxylated, could become: hydrogenated fatty acids, esters with hexahydroxyalkane, 

ethoxylated. Guidelines for developing a generic name are provided in Appendix B of the TSCA 

Chemical Substance Inventory, Volume 1, 1985. This document is available in any Federal 

Depositary Library or through the TSCA hotline (see Contact List, Appendix B). 

7. Byproducts - List the byproducts that you reasonably anticipate will result from the 

manufacture, processing, use, and disposal of the new chemical substance at sites you control. 

Identify the byproducts as specifically as possible by name and CAS Registry Number (if 

available). You should give the following information: 
(1) the specific chemical name; or 

(2) a class or range of structures (e.g., C6 - C18 fatty acid salts or polychlorinated cyclic 

and acyclic hydrocarbons in the range C5 - C12); or 

(3) the source (e.g., pyrolysis products of cellulose or coal tar residues). If there are no 

byproducts, enter "None." 

Section C - Production, Import, & Use Information (Page 7) 

1. Production volume 

Estimate the production volume for the first 12 months of production. Also estimate the 

maximum production volume for any consecutive 12-month period during the first 3 years of 

manufacture. Provide your estimates in kilograms. Maximum production volume is the maximum 

amount of the new chemical substance on a 100% basis. Report the amount of pure new chemical 

substance, not including solvents or other components if the new chemical substance is in a 

mixture that you expect to produce during any 12-month period (e.g., June 1990 through May 

1991). Include in this total amounts produced by persons under contract to you. If part of the 

amount manufactured is for export, include this amount in your estimates. (You are not allowed 

to exclude exports from LVE quantity limits after any of the substance is manufactured for 

domestic use) If you submit a consolidated PMN, make your production volume estimates on a 

per chemical basis. 

For an LVE, the Agency will generally perform the risk assessment under the exemption 

as if the total amount permissible under the exemption (10,000 kg) were being produced. 

However, submitters wishing their exemption to be based upon annual production volumes lower 

than 10,000 kg may so indicate in their exemption notice by marking the binding box adjacent to 

the production volume space on the form. Submitters who so elect are bound by their election, 

and if they subsequently wish to increase their maximum production volume under the exemption 

must submit a new exemption notice cross-referencing the original exemption number on the 

cover of the notice. If the new exemption is granted, it will supersede the previous exemption. 

2. Use information 

a. Column (1) category of use: Identify the intended category of use of the new chemical 

substance by describing its function and application. "Function" is related to the inherent 

physical and chemical properties of the substance (e.g., degreaser, catalyst, plasticizer, ultraviolet 

absorber). "Application" refers to the use of the substance in particular processes or products 

(e.g., a degreaser may be used for cleaning of fabricated metal parts). 

Following are some examples of appropriate categories of use: 

! a disperse dye carrier for finishing polyester fibers 

! a cross-linking agent for epoxy-type coatings for metal surfaces 

! a flame retardant for surface application on cotton apparel, textile home 
furnishings, and exterior canvas products 

! a surfactant in automobile spray wax 

! a colorant for paper and other cellulosics 

! fiber-reactive dye for nylon carpeting and upholstery 

! an antioxidant in fuels oils and lubricants 

Column (2) CBI claim. 

Column (3) Binding option for category of use (binding option is described at I-F). 

Column (4) Estimate the percent of the total production volume that you anticipate will be 

manufactured for each category of use. 

Column (5) CBI claim. 

Column (6) Estimate the weight percent of the new chemical substance that will be contained in 

any formulated mixture, suspension, emulsion, solution, or gel associated with each category of 

use as manufactured for commercial purposes at sites under your control. Where the substance is 

distributed from your site in a pure state, enter 100%. 

In the example below, a PMN substance will be used for several different uses, including a crosslinking agent where the substance is distributed in a pure state and as a surfactant where the 

substance is manufactured, then formulated at a weight percent of 4%. Eighty percent of the 

production volume goes to the first use and twenty percent of the production volume will be used 

for the second use. 

Category of use CBI Binding 

Option 

% of 

Production 

CBI % in Formulation CBI 

Cross-linking Agent X X 80 X 100 X 

Surfactant in Automobile Spray Wax X X 20 X 4 X 

Column (7) CBI claim. 

Column (8) Mark to indicate if the category of use is site-limited or, if the substance is intended 

for industrial, commercial, and/or consumer use, as defined below, estimate the percent of the 

production volume expected for each category. 

Site-limited - The substance will be used only on the contiguous property unit where it is 

manufactured and not intentionally distributed outside that site except for waste disposal. This 

includes all factories, storage places, and warehouses at the site. In most cases, this would be an 

intermediate which is further reacted on-site. If the substance is transported across a public road 

which bisects a site, it can still be site-limited. 

Consumer - The new chemical substance or products containing the substance will be used by 
private individuals in or around a residence, or during recreation, or for any other personal use or 

enjoyment, e.g., automotive polish, dyed wearing apparel, household cleaners, hunting lure, etc. 

If a consumer use is identified, then the EPA requests the following information to be provided on 

an attached continuation sheet: a detailed description of the use of the new chemical substance 

expected in consumer products and any reactions that occur causing the substance to lose its 

identity in the consumer product. This section does not apply to situations where the PMN 

substance has clearly reacted away and lost its identity before the final article is used by 

consumers (e.g., coatings). 

Industrial - The new chemical substance or products containing the substance will be used at 

the site of other manufacturers or processors, e.g., textile dyeing, paint formulation, use of a 

curable resin to manufacture an article. 

Commercial - The new chemical substance or products containing the substance will be used 

by a commercial enterprise providing a consumer service, e.g., use by commercial dry cleaning 

establishments, use by painting contractors, or use by roofers in commercial building 

construction. 

Mark all boxes, as appropriate. For example, a surfactant in an automobile wax may have a 

consumer use in liquid wax, a commercial use in auto washes, and an industrial use by 

automobile manufacturers. Mark the binding option statement where applicable. 

Note: You must make separate confidentiality claims for the description of the category of use, 

the percent of production devoted to each category, the percent in formulation, and category of 

use information. 

The information in this section is used to evaluate potential exposure and release of the new 

substance. If you wish to provide any additional information which would assist in this analysis, it 

may be submitted as optional information. You should be aware that the Agency uses 

conservative default assumptions to estimate exposure in the absence of specific information. 

c. Generic use description - includes degree of containment - For each category of use 

description which is claimed as confidential, provide a generic description of the category. If 

such a generic description does not provide a sufficient indication of potential exposure, the 

description can also describe the degree of containment of the new chemical substance, as shown 

in the list below; however, a generic use description that solely describes the degree of 

containment such as "open, non-dispersive use" is not acceptable. 

Identify the category of use to which the generic description applies. The generic use 

should reveal the intended category of use to the maximum extent possible. For example, the 

specific use of a new substance as an antioxidant in a lubricant could be described generically as a 

lubricant additive; a fiber-reactive dye for nylon carpeting could be described generically as a dye 

for fibers. 

Degree of Containment 
(a) destructive use (e.g., fuels, fuel additives, chemical intermediates) 

(b) contained use (e.g., catalysts used in closed processes, certain photographic chemicals, capacitor 

fluids) 

(c) open, non-dispersive (e.g., printing inks, textiles, dyes, plasticizers, adhesives, liquid paints, resins) 

use 

(d) dispersive use (e.g., cutting fluids, fabric softeners, automobile tire rubber) 

(e) highly dispersive use (e.g., fertilizers, salt for de-icing, paint solvents, spray paints) 

(f) other (describe) 

3. Hazard information - Include in the notice a copy or reasonable facsimile of any hazard 

warning statement, label, material safety data sheet (MSDS), or other information which will be 

provided to any person regarding protective equipment, engineering controls, or practices for the 

safe transport, use, or disposal of the new chemical substance. If hazard warning information is 

not yet prepared, describe the statement you intend to provide, if any. You are not required to 

develop hazard warning statements for this notice if you do not otherwise intend to do so. 

Identify copies of hazard warning statements or other hazard information that you attach in Part 

III, List of Attachments. 

Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Pages 8-10) 

In sections A and B, you must provide information on manufacturing, processing, and use 

operations involving the new chemical substance or products containing the new substance. 

Preparing a chemical for an end use application typically involves several production steps, or 

operations, where potential human exposure and environmental release could occur. Use section 

A to provide information on operations that occur at industrial sites you control. Typically, this 

will involve manufacturing and processing operations. Use section B to describe operations that 

occur at industrial sites controlled by others. Typically, this will involve processing and end use 

applications, e.g., dyeing of nylon carpeting, paint spraying of automobiles. 

As an example, for a solvent used in automotive paint for automobile manufacture, there 

are solvent manufacture, paint manufacture, and industrial paint spraying operations. Paint 

manufacture may occur at a site you control or at a site you do not control. If paint manufacture 

occurs at a site you control, describe that operation in section A. If paint manufacture occurs at a 

site you do not control, describe that operation in section B. If processing or end use operations 

occur at industrial sites you control, they should be described in section A. 

In most cases, you will have more specific information on sites you control than sites you 

do not control. If you do not have specific information on sites controlled by others, describe a 

typical operation involving the particular processing or end use application based on information 

available to you and on your experience with similar chemicals. Provide all information 

requested to the extent to which it is known to or reasonably ascertainable by you. Where EPA 

has available only limited information on worker exposure and environmental release, its 

evaluation will be based on reasonable worst case assumptions. 
Note that if you are an importer, although you do not have to complete section A or B for 

operations outside the United States, you may still have to report information in these sections. If 

there are further industrial processing or use operations after import of the substance, you must 

describe these operations in section A or B as appropriate. 

Because EPA assesses the potential domestic manufacture and processing of imported 

chemicals, you may choose to complete section A or B for operations outside the United States to 

assist EPA with this assessment. Providing this information is optional and is not required. 

Section A - Industrial Sites Controlled by the Submitter (Pages 8-9) 

Complete a separate section A for each type of manufacturing, processing, or use 

operation involving the new chemical substance at sites you control. If the same operation is 

performed at more than one site, you are not required to complete a separate section A for each 

operation, but simply describe the typical operation common to these sites. However, if 

operations or production rates vary substantially among the different sites, you must provide a 

separate section A for each different operation. 

1. Operation Description 

a. Identity - Identify the site which the section describes. If this section describes more than 

one site, provide additional site identities on a continuation sheet. Indicate the total number of 

sites at which the operation this section describes will occur. If you mark the confidential box 

next to this item, all information in it will be treated as confidential. 

b. Type - Mark the appropriate box. 

c. Amount and duration - Estimate the maximum amount of the new substance (on a 100% 

new chemical substance (i.e. pure) basis) manufactured, processed, or used in the operation and 

the duration of the operation. Provide information per batch for batch operations and per day for 

continuous operations. Base the estimates on the maximum 12 month production provided on 

page 7 of the PMN form. 

d. Process description - Provide a process flow diagram which describes the manufacturing, 

processing, or use operation involving the new chemical substance. 

(1) Identify the major unit operation steps and chemical conversions, including secondary 

operations involving the new chemical substance, such as interim storage and shipping 

containers. "Unit operation" means a functional step in a manufacturing, processing, or use 

operation where substances undergo chemical changes and/or changes in location, temperature, 

pressure, physical state, or similar characteristics. Include steps in which the new substance is 

formulated into gels, mixtures, suspensions, solutions, etc. Specify the shipping containers, 

including expected capacities (e.g. 5 gallon pails, 55 gallon drums, 5,000 gallon tank trucks, 

20,000 gallon rail cars). 

(2) Indicate in your diagram the entry and exit point of all feedstocks (e.g., reactants, solvents, 

catalysts) used in the operation, products, recycle streams, and wastes. Identify each feedstock 
and specify its approximate weight (by kg/day for continuous operations or kg/batch for batch 

operations). Include cleaning chemicals, and state how often they are used (e.g., every day, every 

batch, monthly). 

(3) Number all points from which the new chemical substance and substances containing the new 

chemical substance will be released to the environment or to control equipment, including small 

or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the 

new chemical substance. Do not include accidental releases. Including fugitive emissions is 

optional. 

(4) Mark the box if you wish to indicate your willingness to have your process description 

binding. 
Sample Process Description for a Manufacturing Operation:

2. Occupational Exposure 

Column (1) - worker activity: Describe each specific activity in the operation during which 

workers may be exposed to the new chemical substance. Such activities may include charging 

reactor vessels, sampling for quality control, transferring materials from one work area to another, 

drumming, bulk loading, changing filters, and cleaning equipment, etc.. Activities must be 

described even if workers wear protective equipment. (Material Safety Data Sheets indicating 

recommended protective equipment should be submitted as part of Hazard Information in part I, 

section C, subsection 3 of the notice form.) 

Column (2) - CBI claim for worker activity. 

Column (3) - protective equipment and engineering controls: provide information on the 

specific types of protective equipment and engineering controls that will be employed to protect 

the worker from potential exposure to the new chemical substance, i.e., gloves, goggles, 21c 

respirator, 19c respirator, closed containment system, nitrogen blanket, etc.. 

Column (4) - Binding option for protective equipment and engineering controls. 

Column (5) - physical form: Indicate the physical form [e.g., solid (crystals, granules, powder, 

dust), liquid (solution, paste, slurry, emulsion, mist, spray), gas (vapor, fume), wet press cake] of 

the new substance and its weight percentage (if in a mixture) at the time of exposure, even if 

workers wear protective equipment. 

Column (6) - Binding option for physical forms. 

Column (7) - CBI claim for physical form. 

Column (8) - maximum number of workers exposed: Estimate the maximum number of 

workers involved in each specific activity, based on the estimated maximum 12-month production 

volume. 

Column (9) - CBI claim. 

Column (10) - maximum duration in hours/day: Enter the maximum duration that any one 

worker will engage in the activity in hours/day, e.g., 8 hours/day. 

Column (11) - maximum duration in days/year: Enter the maximum duration that any one 

worker will engage in the activity in days/year, e.g., 200 days/year, based on the estimated 

maximum production volume. 

Column (12) - CBI claim. 

Note that you must make separate confidentiality claims for the description of worker activity, 

physical form of the new substance, number of workers exposed, and duration of exposure. (See 

2, 7, 9, 12). 
3. Environmental Release and Disposal 

Column (1) - release point number: For each release point indicated in the process description 

(Part II, Section A, subsection 1d(3) of the notice form, enter the corresponding number. If you 

indicated more than 5 release points, make a continuation sheet to cover them. 

Column (2) - amount of new chemical released at release point: 

Estimate the amount of new chemical (in kg/day for continuous operations or kg/batch for batch 

operations) that will be released from the release point directly into either (a) the environment or 

(b) into control technology (in kg/day or kg/batch). Base your estimate on the expected 

maximum twelve-month production volume. EPA is particularly interested in the amounts of 

chemicals used and frequencies of cleaning of equipment and releases from transport containers, 

including the location (if different from that of manufacture or processing) of drum recyclers, 

tank truck cleaning facility, etc.) 

Column (3) - CBI claim. 

Column (4) - medium of release: Enter the medium [stack air, fugitive air (optional), surface 

water, on-site or off-site land or incineration, POTW, or other (specify)] into which the release 

stream discharges (whether or not control technology is used). You do not have to identify 

fugitive air releases, but if EPA reviewers consider that such air releases are likely and estimates 

are not provided in the submission the reviewers will estimate reasonable worst-case fugitive air 

releases. In estimating reasonable worst-case releases we generally consider vapor pressure and 

type of use, including the location if different from that of site manufacture or processing. 

Column (5)(a) release / control technology / efficiency: For a release to air or water, describe 

the type of technology used to control the release of the new chemical and the efficiency of the 

control technique. Examples of control technologies include carbon filter, scrubber and 

biological treatment (primary, secondary, etc.). Use the optional binding box to indicate your 

willingness to be bound to control technology described. Attach optional information such as 

data and methods of waste treatment or purification efficiency studies. 

(5)(b) release after control technology: Enter the estimated amount released to the environment 

after control technology (in kg/day). Enter "none" if no control technology is used and the 

substance is released directly into the environment. 

For disposal on land, describe the landfill site construction (including liners) and handling 

procedures. Describe landfill containers. 

You may wish to optionally attach efficiency data for control technologies used. For example, 

carbon adsorption removal efficiency of the new chemical substance from an aqueous stream 

could help EPA estimate release of the new chemical substance from a facility using carbon 

adsorption treatment. 

Column (6) - CBI claim. 

(7) - destination of water releases: Mark the appropriate box and/or specify other destinations of 

water releases. [i.e., POTW (Publicly Owned Treatment Works), navigable waterway or specify 
other]. Provide the name of the POTW receiving water releases and the NPDES (National 

Pollutant Discharge Elimination System) number for the POTW, navigable waterway or other 

direct discharger. This 9-digit number is assigned by EPA or the State under the authority of the 

Clean Water Act. When appropriate, contact your POTW to obtain its NPDES number. 

Note that you must make separate confidentiality claims for the release number, amount of new 

chemical substance released, control technology disposal information, and the destination of the 

releases to water. 

Section B - Industrial Sites Controlled by Others (Page 10) 

Complete a separate Section B (continuation pages for second and subsequent) for each 

type of processing or use operation associated with each category of use specified in Part 1, 

Section C, subsection 2(a) at industrial sites you do not control. If the same operation is 

performed at more than one site, then describe the typical operation and enter the number of sites 

in the space provided. 

Describe each typical processing or use operation to the maximum extent possible from 

information known to or reasonably ascertainable by you. Information may be provided as ranges 

or estimates. 

1. Operation Description - Generally self-explanatory - the information requested here 

differs from that requested for Section A Operation Description only by the additional worker 

activity information requested. EPA is particularly interested in the chemicals used and 

frequencies of cleaning of equipment and transport containers. 

2. Worker Exposure/Environmental Release 

Column (1) - Activity Letter: Provide the letter for each activity from the diagram above and 

complete columns 2-8 for each worker activity associated with the letter. 

Column (2) - maximum number of workers exposed: Estimate the maximum number of 

workers exposed to the new substance during the activity. 

Column (3) - CBI claim. 

Column (4)(a) - duration of exposure - hours/day: Estimate the duration of exposure of the 

new chemical substance per worker in hours per day. 

Column (4)(b) - duration of exposure - days/year: Estimate the duration of exposure of the new 

chemical substance per worker in days per year. 

Column (5) - CBI claim. 

Column (6) - Physical Form, Protective Eqpt, Eng'g Controls: Provide information on the 

physical form [e.g., solid (crystals, granules, powder, dust), liquid (solution, paste, slurry, 

emulsion, mist, spray), gas (vapor,fume), wet press cake] of exposure and percent new chemical 

substance (if in a mixture), and protective equipment and engineering controls employed to 
safeguard the worker from potential exposure associated with the new chemical substance, i.e., 

gloves, goggles, respirators, etc.. 

Column (7) - Percent in the Product Formulation: Estimate the percent in the product 

formulation of the new chemical substance to which the worker is potentially exposed during the 

activity. 

Column (8) - CBI claim. 

Column (9) - release points Enter the number given to each release point in reference to the 

process diagram above and complete 9-13 for each release point identified (use continuation 

pages if necessary). 

Column (10) - maximum release Provide an estimate for the maximum amount of new chemical 

substance in kg per year that may be released to the media specified in Column (12) (see below) 

under typical operating conditions. Provide this information for releases (a) directly to the 

environment or (b) into control technology to the environment in kg per day for continuous 

operations or kg per batch for batch operations. EPA is particularly interested in the amounts of 

chemicals used and frequencies of cleaning of equipment and releases from transport containers. 

Column (11) - CBI claim. 

Column (12) - medium of release: Describe medium of release [stack air, fugitive air (optional), 

surface water, on-site or off-site land or incineration, POTW, or other (specify)] and the control 

technology(ies) used to limit the release of the new substance to the environment to the extent 

that the information is known to you. 

Column (13) - CBI claim. 

(14) - byproducts: Identify all byproducts resulting from the reaction to the extent that the 

information is available to you. 

Note that you must make separate confidentiality claims for the numbers of workers exposed, the 

duration of exposure, the percentage of the product in formulation, the amount of new substance 

released, and the control technology. 

(OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION (Page 

11) 

On the form itself and in Section I of this Manual we describe the Agency's goals in providing 

this mechanism to inform us of environmental benefits which may be available from your new 

substance. Below are suggestions for organizing such information to be most useful to improve 

the review of your substance: part of the material to provide is about characteristics of the 

substance and part relates to your process description and calls for a discussion of how a shift to 
the new chemical substance may enable the use of the more desirable process. If you wish your 

PMN substance to be considered for the Agency's EPA New Chemicals Pollution Prevention 

Recognition Project, you should tell us so in this information. 

I. Product Information 

Will this substance be produced to address an environmental problem or in response to 

environmental regulation? (One example would be CFC substitutes.) Do you wish your substance 

to be considered for the Agency's EPA New Chemicals Pollution Prevention Recognition Project? 

II. Toxicity Information 

EPA is interested in information describing possible reductions in toxicity of a new 

chemical substance as compared to that of already commercialized chemical substances for 

which the new substance may substitute. Such information may demonstrate that the new 

chemical substance may be a viable safer substitute. 

III. Technical Information 

a. Process Chemistry

Chemical approaches which may minimize waste production include the following:

1. Selection of synthetic method: high yield, minimal side reactions, minimization of coproducts 

unless they are of commercial value. 

2. Choice and purity of feedstocks, reagents, catalysts, solvents, etc. Reduction/ elimination of 

undesirable feedstocks, solvents (e.g. VOC's), catalysts, etc. 

3. Optimization of reaction conditions to minimize side reactions. 

4. Optimization of stoichiometry to minimize presence of excess reactants. 

5. Product Purification. 

6. Use of advanced chemical technology such as shape-selective zeolite catalysts, stereoselective 

synthesis, and permselective membranes for molecular separations (liquid phase). 

b. Product Substitution/ Source Reduction 

1. Perceived advantages related to the use of the new chemical substance compared to existing 

substances. Comparison of the relative risk of the new chemical to existing chemicals (for 

example, volumes, releases, exposure, human health effects and ecotoxicity) of the substances. A 

new chemical that causes less pollution may nonetheless be more toxic than an existing chemical 

and therefore the risk to health and the environment may be higher. 

2. Changes in product composition or physical state. 
Consider potential changes in product compositions or physical states which may reduce releases 

and exposures. For example: using a more concentrated product may decrease the amount of 

release or waste generated; or reformulating a powder into a paste to mitigate inhalation concerns. 

3. Enhanced product life or durability. 

Improvements which may be expected from enhancements to product life or durability of 

new chemical substances over existing substances. For example, a more durable product could 

result in less solid waste going to landfills. 

4. Changes in product effectiveness/ Effect of product performance at lower concentrations 

(significant orders of magnitude). 

New chemical substances which may be more effective than existing substances, or that may be 

as effective at significantly lower concentrations than an existing chemical may result in reduced 

releases and exposures. 

5. Packaging (transportation, concentration, disposal, life-cycle analysis, weight loss, etc.). 

Examples of packaging with pollution prevention in mind may include (A) reusable 

packaging materials, or (B) making the new chemical substance more concentrated to minimize 

size or volume of packaging. 

c. Process Modifications 

1. Engineering technology changes. 

In some cases, existing equipment which may be used to produce new chemicals may not 

be the best technology from the standpoint of pollution prevention. 

Consider alternative technologies for the major unit operations (i.e. separation, filtration, 

etc.) in the process and their potential impacts on releases and exposures. Some examples of 

alternative technologies include: (A) stream stripping instead of air stripping, (B) pan filter versus 

rotary drum filter or centrifuge or, (C) flash dryer versus spray dryer. 

2. Equipment/piping/ layout changes 

Equipment/piping/ layout alternatives can have an effect on releases and exposures. Some 

examples of these changes include: (A) redesigning equipment and piping to reduce the volume 

of material drained for batch changes and for cleaning operations, (B) installing bellow-sealed 

valves versus conventional valves to reduce VOC emissions and worker exposure, or, (C) use of 

new resources such as by-product steam from another process. 

3. Operating Conditions 

Optimize operating conditions at major unit operations (including reactors and separation 

equipment). Available supporting laboratory information (i.e. experimental design data) may be 

collected and submitted describing reduction of chemical exposure using the new PMN 
substance, reduced emissions to the workplace or environment, etc. An example might be use of 

a new surfactant to reduce the amount of solvent needed in cleanup operations. 

4. Automation 

Potential automation/control steps may have pollution prevention or exposure 

implications. For example, a batch process can be successfully automated to reduce off-spec. 

product and spillage, which reduces waste. A manual packaging system can be automated to 

reduce worker exposures. 

5. Closed systems 

Reduced exposures, emissions, or elimination of isolated intermediates. 

d. Operating Practices 

Examples of operational and administrative changes which could reduce pollution and exposure 

are: 

1. Procedural measures 

Increasing drain time from 15 to 20 minutes could reduce leftover material in a tank. 

2. Loss prevention 

Installing overflow alarms in tanks could reduce overflows or releases. 

3. Management practices 

Reducing inventories of toxics to minimize the consequences of emergencies. 

4. Waste stream segregation 

Segregating waste streams to avoid cross-contaminating hazardous and non-hazardous 

materials could allow recycling of some waste. For example, changing waste segregation to 

separate organics from an aqueous waste stream. 

5. Material handling improvements 

Changing from small-volume containers to bulk or reusable containers could reduce 

releases of residue. 

6. Production scheduling 

Larger batch sizes can be made, which could reduce number of production runs, cleanup 

waste, and worker exposure. 

7. Safety 
Examples would be use of substances which are less explosive, less flammable, or less 

corrosive. Use of less corrosive substances may also serve to decrease cost and maintenance, as 

well as increase life, of equipment. 

e. Reuse/Recycling/Reclamation 

Identify potential reuse/ recycling/ reclamation (both on-site and off-site opportunities) of 

the waste streams. Some examples of the reuse/ recycling/ reclamation opportunities are: 

1. Use of recycled materials in original process 

Returning recovered solids from a filtrate (through the use of a settling tank) to the 

reactor. Wastes from unrelated processes may be used in feedstock to make new substances. 

2. Recovery and recycling of resources utilized in the process 

Installing vapor recovery systems to capture and return vaporous emissions. Feedstock or 

off-spec. substance previously discarded may be recycled back into the process. 

3. Reuse or processing of by-products/coproducts of the original process for other processes. 

The off-acid gas from a reactor could be absorbed with water to convert it into dilute acid 

and sold as a by-product. 

f. Energy Savings 

Almost any change in an industrial process will entail some change in the amount and 

form of energy consumed in that process. How might the new chemical substance result in 

savings of energy resources in any phases of manufacture, processing, or use? 

Energy conservation is a form of pollution prevention. For example, reduced energy use 

decreases the quantity of fossil fuels burned and the amount of air pollutants generated. Reduced 

boiler operation also reduces the discharge of waste cooling water blowdown and boiler 

blowdown. Purification of raw water to produce boiler feedwater by ion exchange or other 

processes produces wastes such as regeneration chemicals. Reduced boiler operation could also 

reduce this waste stream. Another example might be shifting from thermal polymerization/ 

curing to radiation polymerization/ curing. 

g. Alternative Treatment Methods 

Consider efficiency of alternative treatment methods and the compositions and quantities 

of the input PMN waste streams and output release streams. For example: 

1. Use of ammonia instead of sodium hydroxide to neutralize a process, allowing the excess to be 

vacuum stripped and possibly recycled, rather than removal by water washes which create a 

caustic waste requiring treatment and/or disposal as a hazardous waste. 

2. Replacement of organic solvents with water, eliminating VOC emissions. 
h. Alternative Waste Disposal Methods 

Compare release media (land, air, water) in light of the PMN waste streams being 

disposed, including quantity of release, composition of the waste, and applicable regulatory 

limitations. For example, an aqueous ammonia waste stream may be converted into fertilizer for 

agricultural use. 

Part III - LIST OF ATTACHMENTS (Page 12) 

Attach any continuation sheets for sections of the form, test data and other data (including 

structure-activity information), and optional information after the last page of the form. Clearly 

identify the attachment and the section to which it relates, if appropriate. Number consecutively 

the pages of the attachments. Enter the inclusive page numbers of each attachment. Enter the 

total number of pages in the notice on page 1 of the form. 

Mark the "Confidential" box next to any attachment name you claim as confidential. 

Read "E" and "H" in Section I of this manual for guidance on how to claim any information in an 

attachment as confidential. You must include with the sanitized copy of the notice a sanitized 

version of any attachment in which you claim information as confidential. 

Physical and Chemical Properties Worksheet (Optional) 

A worksheet which assists EPA's review of the physical/chemical property information 

you submit is provided on the last page of the form. Providing physical/chemical property 

information in this format is optional. However, all physical/chemical properties data in your 

possession or control must be submitted with your notice. If you submit this worksheet, identify 

it on the List of Attachments. 
Appendix A

EXAMPLES OF TEST DATA

Following is a list of the types of test data which you must attach to the notice form if it is in your

possession or control. This list is illustrative, not exhaustive. 

Physical and Chemical 

Properties and Environmental 

Fate Data 

Ë Chromatograms

Ë Spectra (ultraviolet, 

visible, infrared)

Ë Density / relative density

Ë Solubility in water

Ë Melting temperature

Ë Boiling / sublimation

temperature

Ë Softening point

Ë Vapor pressure

Ë Dissociation constant

Ë Particle size distribution

Ë Octanol / water partition

coefficient

Ë Henry’s law constant

Ë Volatilization from soil

Ë pH

Ë Flammability

Ë Explodability

Ë Adsorption / desorption

characteristics

Ë Photochemical degradation

Ë Viscosity

Ë Odor

Ë Hydrolysis

Ë Thermal analysis

Ë Chemical analysis

Ë Chemical oxidation

Ë Chemical reduction

Ë Biodegradation

Ë Transformation to persistent

or toxic products

Health Effects Data 

Ë Mutagenicity

Ë Carcinogenicity

Ë Teratogenicity

Ë Neurotoxicity / behavioral

effects

Ë Pharmocological effects

Ë Mammalian absorption

Ë Distribution

Ë Metabolism and excretion

Ë Cumulative, additive and

synergistic effects

Ë Acute, subchronic and chronic

effects

Ë Structure / activity

relationships

Ë Epidemiology

Ë Reproductive effects

Ë Clinical studies

Ë Dermatoxicity

Ë Phototoxicity

Ë Irritation

Ë Sensitization

Ë Allergy

Ë Skin staining

Environmental 

Effects Data 

Ë Microbial bioassay

Ë Algal bioassay

Ë Aquatic macrophyte bioassay

Ë Seed germination and root

elongation

Ë Seedling growth

Ë Plant uptake

Ë Acute toxicity to invertebrates

Ë Life cycle test on

invertebrates

Ë Acute toxicity to fish

Ë Early life stage (fish)

Ë Avian dietary / reproduction

Ë Bioaccumulation /

bioconcentration

Ë Model ecosystem studies

Ë Physical environment 

impairment effects

Ë Flesh staining of aquatic

organisms
Appendix B - CONTACT LIST: 

The New Chemicals Program is organized in two Branches within the Chemical Control Division in EPA. 

They are the New Chemicals Pre-Notice Branch and the New Chemicals Notice Management Branch. The Notice 

Management Branch coordinates review of submissions and negotiations with submitters on Section 5 Consent 

Orders, etc. 

Staff in the Notice Management Branch include: 

New Chemicals Notice Management Staff Member 

Becky Cool, Branch Chief (202) 564-9138 

Flora Chow, Biotech Specialist (202) 564-8983 

Rose Allison, Senior Notice Specialist (202) 564-8970 

Jim Alwood, SNUR and Bio-Tech Specialist (202) 564-8974 

Jeff Bauer, Notice Manager (202) 564-9042 

Mary Begley, Notice Manager (202) 564-8976 

Audrey Binder, Notice Manager (202) 564-9033 

Geraldine Hilton, Notice Manager (202) 564-8986 

Shirley Howard, Notice Manager (202) 564-8988 

Darlene Jones, Notice Manager (202) 564-9047 

Loraine Passe, Notice Manager (202) 564-9064 

Edna Pleasants, Notice Manager (202) 564-9144 

Jamesine Rogers, Notice Manager (202) 564-3453 

The New Chemicals Prenotice Branch gives guidance for persons considering a submission through 

Prenotice Coordinators. Prenotice Coordinators are staff in the New Chemicals Program who specialize in assisting 

with status questions and questions on how to properly complete the notifications. At the time of this writing (Feb 

2003) staff in the New Chemicals Pre-Notice Branch include: 

New Chemicals Pre-Notice Branch Staff Member Telephone Number 

Linda Gerber, Branch Chief (202) 564-3452 

Anna Coutlakis, Senior Policy Analyst (202) 564-9207 

Dave Schutz, Prenotice Coordinator (Schutz.David@epa.gov) (202) 564-9262 

Adella Watson, Prenotice Coordinator 

(Watson.Adella@epa.gov) 

(202) 564-9364 

Miriam Wiggins-Lewis, Prenotice Coordinator 

(Wigginslewis.Miriam@epa.gov) 

(202) 564-9373 

Roy Seidenstein, Lawyer 

(Seidenstein.Roy@epa.gov) 

(202) 564-9274 
Written inquiries may be sent by mail to:

Prenotice Coordinator, New Chemicals Program

Chemical Control Division

Mail Stop 7405

USEPA, 1200 Pennsylvania Ave., NW

Washington, D.C. 20460

or by facsimile at (202) 564-9490. Persons considering using facsimile to send confidential information to the 

Agency have to be aware that the 564-9490 telephone line is not a secured line, however the facsimile machine itself 

is in a secured area. EPA does not regard email as an appropriate way to transmit confidential information to or from 

the Agency. 

EPA uses a contractor, the TSCA Assistance Information Service (TAIS, TSCA Hotline) to distribute forms and to 

answer some questions. TAIS can be reached on (voice) (202) 554-1404, (facsimile) (202) 554-5603, (email) tscahotline@epa.gov. 

Mail inquiries may be sent to: 

TSCA Assistance Information Service 

Mail Stop 7408

USEPA, 1200 Penna. Ave., NW

Washington, D.C. 20460