INSTRUCTION MANUAL 2003



# This 2003 version will be

updated to account for the

e

- PMN.INSTRUCTION MANUAL 2003

2 

# INSTRUCTION MANUAL FOR

REPORTING UNDER THE

TSCA §5 NEW CHEMICALS PROGRAMINSTRUCTION MANUAL 2003

3 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 BenefitsINSTRUCTION MANUAL 2003

4 II. PAGE

- BY

- PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5 NEW CHEMICALS

PROGRAM PREMANUFACTURE NOTICE FORM

1. Type of Notice (Page 1)

2. Certific ation (Page 2)

Part I

-- GENERAL INFORMATION

Section A

- Submitter Identification ( PMN Page 3)

Section B

- Chemical Identity Information ( PMN Pages 4

- 6)

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

2. Polymers ( PMN Page 5)

3. Impurities ( PMN Page 6)

4. Synonyms

5. Trade Identification

6. Generic chemical name

7. Byproducts

-

Section C

- Production, Import, & Use Information ( PMN Page 7)

1. Production volume

2. Use information

3. Hazard information

Part II

- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE ( PMN Pages 8

- 10)

Section A

- Industrial Sites Controlled by the Submitter ( PMN Pages 8

- 9)

Section B

- Industrial Sites Controlled by Others ( PMN Page 10)

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

-

Technical Informat ion

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 ( PMN Page 12)

Physical and Chemical Properties Worksheet (Optional

– PMN page 13)

Appendix A: Types of test data for submission

Appendix B: Contact PersonsINSTRUCTION MANUAL 2003

5 I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE

TSCA §5 NEW CHEMICALS PROGRAM

–

PREMANUFACTURE NOTICE FORM

A. Substances w hich 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 d iscussed 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 Inv entory 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 d emonstrate a bona fide intent to manufacture or import the subs tance. 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

structur e 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 estab lished 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 d ate 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)

w hether 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 WestINSTRUCTION MANUAL 2003

6 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 n otification 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 requiremen ts

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 §72 0.3 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 dur ing 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 requiremen ts. 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. Als o, 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.INSTRUCTION MANUAL 2003

7 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 perso n 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 basi c 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 a nd 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 revi ew 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 s taff in the

New Chemicals Program who specializes 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 certa in 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 pr oducts; 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.INSTRUCTION MANUAL 2003

8 You do not have to submit a notice for a new substance manufactured or imported in

small quantities solely for research a nd 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 activ ities. 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 dev elopment

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 accordanc e 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, documen tation

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, an d 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

subs tance be used solely for R&D. For additional infor mation on R&D requirements see T he

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 int ended 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 presen t 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 da ys. 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 notINSTRUCTION MANUAL 2003

9 required, but are enco uraged, 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. Recordkeepin g 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 marketi ng, 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 a pplications 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 permi tted 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 informa tion 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 f or 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

- Requiremen ts 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 p receding calendar year. Recordkeeping requirements are

discussed at I

- M, Recordkeeping.INSTRUCTION MANUAL 2003

10 c. Low Release and Exposure (LoREX) Exemption

- Eligibility for this exemption

category is independent of production volume level. Performance standards for this

exemp tion 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. Record keeping 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 require 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 ini tiate 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 t he 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 P ennsylvania 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

s ubmitter 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 doINSTRUCTION MANUAL 2003

11 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 supp lier 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 in spector 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 corporat e

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

o f 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, secti ons 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 Contr ol 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 Nonconfident ial Information Center

Mail Stop 7407

EPA West, B

- 146

USEPA 1201 Constitution Avenue, North West

Washington DC 20460INSTRUCTION MANUAL 2003

12 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 6428 EPA East

U SEPA 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 mu st 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 wi th 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 n otice 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 m ost 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 c hoose 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 BoxesINSTRUCTION MANUAL 2003

13 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

a n 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 cert ain 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 th e

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, pro duction 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 mak e 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 M anager 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 exe mption 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 a scertainable 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;

p rogress 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 infor mation 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 th e review period, you must immediately inform EPA by

telephone. Examples of the types of test data you must submit are provided in Appendix A ofINSTRUCTION MANUAL 2003

14 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 Attachment s.

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 li terature 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 fo r 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 bo ttom 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 sub mitter.

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 "Confide ntial" on the page which contains that property. You must also

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

correspondence 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 a ny effect of a chemical substance or mixture on health or the

environment or on both, including underlying data and epidemiological studies, studies ofINSTRUCTION MANUAL 2003

15 occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological,

or ot her 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 woul d 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 wh ich 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 substanc e

o n 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 inform ation/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 th is 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, d o 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 tr eatment 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?INSTRUCTION MANUAL 2003

16 (D) Has the identity of the chemical substance been kept confidential to the extent that your

c ompetitors 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 o r 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

g uard 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 c onfidentiality 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).INSTRUCTION MANUAL 2003

17 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 co nsolidation, 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 an other 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

pr ocess 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 relieve d 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. S ee 40 CFR §720.40(e)

f or 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, InstructionsINSTRUCTION MANUAL 2003

18 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.

Yo u 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

contac ted 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 acknowledg ment

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 c hemical 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 y ou 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

i dentified 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 revi ew 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 i f 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)INSTRUCTION MANUAL 2003

19 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 f orm 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 (M ail 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 ch emical 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. Record keeping

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 contro l, (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 fi ve 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

ann ual 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.INSTRUCTION MANUAL 2003

20 P olymer 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 ye ars 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 excl uded 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 env ironmental 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 preventio n 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 Pol lution 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 OPP T, 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 respon se 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) m inimize 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 red uction 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.INSTRUCTION MANUAL 2003

21 The "Optional Pollution Prevention Inform ation" 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

preven tion 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 submitte rs 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 i n 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 resource s, 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 t he 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 in cludes: 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 handl ing 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 th e selection. Submitters are encouraged to

consider and include information comparing the releases and exposures for various processINSTRUCTION MANUAL 2003

22 options considered but not selected, anticipated reductions in r eleases and exposures which can

be expected in the productio n 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 pollut ion 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

subst itute. 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 re view 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 requi rements which would ordinarily have been imposed by the Agency. Completion of

this section is also important if you wish your substance t o 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

hel p 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 Bra nch, 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

- 9198INSTRUCTION MANUAL 2003

23 II. PAGE

- BY

- PAGE I NSTRUCTIONS 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 suppo rt, joint

submissions, and 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 ne w 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 sub mission. 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 Inve ntory.

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,

non

- intermediate use. In addition, the intermediate PMN must identify the final product.

Separate user fee identification numbers must be generated for and appear on each notice;

although a single check may be remitted bearing all user fee identification numbers for a

sequence of intermediate(s) and final product. "Certification", below, discusses fees paid by

small manufacturers. For further information on "intermediate PMNs" see 40 CFR §§700.43 and

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.INSTRUCTION MANUAL 2003

24 The "Test Marketing Exemption Application" (TMEA) box should be marked for any

notice submitted in accordance with the criteria liste d 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)] o r 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 modificat ion 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 so me 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 t o 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 y our 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 sig n 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

thos e 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).INSTRUCTION MANUAL 2003

25 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 ma nufacturer 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

na me 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 unt il 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 TS

- number you should ask a prenotice coordinator 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

co nfidential.

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 ot her 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.INSTRUCTION MANUAL 2003

26 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 provi de 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 ne w 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 exempti on 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 be gin. 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 t he 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 Colle ctive Index of the Chemical Abstracts Service (CAS) and withINSTRUCTION MANUAL 2003

27 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 can not 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 polyme rs, 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 t he 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 me t, 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, co mponents 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 a s 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 de velop 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 w ill 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.INSTRUCTION MANUAL 2003

28 b. Enter the specific chemical name of the new chemical substance.

For a Class 1 substance, the name must be a c lear 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 chemica l 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 s ubstance 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 exa mple, 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 r equired 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 amo unts 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 neutral ization, 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

--------- > CINSTRUCTION MANUAL 2003

29 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, repor t 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

p urification 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 the ir 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 PM N.

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, ge l

- 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 mol ecular 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 o ther reactive agents that are used intentionally to become chemically a part of theINSTRUCTION MANUAL 2003

30 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 composi tional

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 represe nted 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

- reac ting 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

o f 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 act ual 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 des cribe 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

I D field).

If you use a prepolymer in the manufacture of the polymer, you must d etermine 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 pre polymer 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 incorp orated 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 markingINSTRUCTION MANUAL 2003

31 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

- M ethod

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 (C A) 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 p olymer molecules. For

example, you could identify the linkages formed during polymerization, the functional groups

present, the range and typical values for the number of repeating structural units, and the relative

molar ratios of the precursors. Indicate if the repeating substructures are arranged in a

nonrandom order such as in graft or block arrangements. For example:

HO

- R (=O)

- O

- (C (=O)

- R'

- C

- O

- R

- O)

n - H

3<n<10, where R may be either

- CH 2 CH 2

- or

- CH 2 CH

- CH 3

and R' may be either a 1,4

- substituted benzene ring or

- (CH 2 ) 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)INSTRUCTION MANUAL 2003

32 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

perc ent). 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 s ubstances, 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 instru mental 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

chemist ry 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

- operation s 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., C 6

- C 18 fatty acid salts or polychlorinated cyclic

and acyclic hydrocarbons in the range C 5

- C 12 ); 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.INSTRUCTION MANUAL 2003

33 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 n ame

-- 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

- d escriptive 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

hexahydroxya lkane, 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,

Ap pendix 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 a nd 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., C 6

- C 18 fatty acid salts or polychlorinated cyclic

and acyclic hydrocarbons in the range C 5

- C 12 ); 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 f irst 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

m aximum 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. IfINSTRUCTION MANUAL 2003

34 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 subst ance 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

th e 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 exem ption 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 fu nction 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 prod ucts

(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 surfac es

 a flame retardant for surface application on cotton apparel, textile hom e f urnishings, 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 fo r 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 manufactur ed for commercial purposes at sites under your control. Where the substance is

distributed from your site in a pure state, enter 100%.INSTRUCTION MANUAL 2003

35 In the example below, a PMN substance will be used for seve ral 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 u sed

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 cont iguous 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 furt her 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

provid ed 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 u se in liquid wax, a commercial use in auto washes, and an industrial use by

automobile manufacturers. Mark the binding option statement where applicable.INSTRUCTION MANUAL 2003

36 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 inf ormation 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

descrip tion 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 ge nerically 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 s ofteners, 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 haz ard 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 statemen ts or other hazard information that you attach in Part

III, List of Attachments.

Part II

- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Pages 8

- 10)INSTRUCTION MANUAL 2003

37 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 sect ion

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, a nd 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 d o 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 che micals. 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 wo rst 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 o r 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 f or 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 t he 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 DescriptionINSTRUCTION MANUAL 2003

38 a. Identity

- Identify the s ite 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 confiden tial 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) manufact ured, 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 gal lon 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. Id entify 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 f

rom 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 amo unts 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.INSTRUCTION MANUAL 2003

39 Sample Process Description for a Manuf acturing Operation:INSTRUCTION MANUAL 2003

40 Sample Processing OperationINSTRUCTION MANUAL 2003

41 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 equipm ent. (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 eq uipment 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 op tion 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.

Colu mn (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.INSTRUCTION MANUAL 2003

42 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 amo unt 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 t he 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 manufactu re 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 submi ssion 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 processin g.

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 includ e 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 in to 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 streamINSTRUCTION MANUAL 2003

43 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 Pollut ant 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

nu mber.

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 Controlle d 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 d o 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

inform ation 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.INSTRUCTION MANUAL 2003

44 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, granu les, 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 wor ker 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 w orker 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 in cineration, 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 byproduct s 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.INSTRUCTION MANUAL 2003

45 (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 Chemic als 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 sub stitutes.) Do you wish your

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

R ecognition 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. Proce ss 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 fe edstocks, 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.INSTRUCTION MANUAL 2003

46 6. Use of advanced chemical technology such as shape

- selective zeolite catalysts, stereoselective

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

b. Product Substitu tion/ 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 hea lth 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 phys ical 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 pr oduct 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 su bstances, or th yy

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 ofINSTRUCTION MANUAL 2003

47 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 batc h 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

Reduc ed 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.INSTRUCTION MANUAL 2003

48 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 p rocess

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

Inst alling 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 process es.

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 SavingsINSTRUCTION MANUAL 2003

49 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 f ossil 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

Co nsider 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)INSTRUCTION MANUAL 2003

50 A worksheet which assists EPA's review of the physical/chemical property in formation

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.INSTRUCTION MANUAL 2003

51 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 Health Effects Data Environmental Effects Data

 Chromatograms  Mutagenicity  Microbial bioassay

 Spectra (ultraviolet, visible,

infrared)  Carcinogenicity  Algal bioassay

 Density / relative density  Teratogenicity  Aquatic macrophyte

bioassay

 Solubility in water  Neurotoxicity / behavioral

effects  Seed germination and root

elongation

 Melting temperature  Pharmocological effects  Seedling growth

 Boiling / sublimation

temperature  Mammalian absorption  Plant uptake

 Softening point  Distribution  Acute toxicity to

invertebrates

 Vapor pressure  Metabolism and excretion  Life cycle test on

invertebrates

 Dissociation constant  Cumulative, additive and

synergistic effects  Acute toxicity to fish

 Particle size distribution  Acute, subchronic and

chronic effects  Early life stage (fish)

 Octanol / water partition

coefficient  Structure / activity

relationships  Avian dietary /

reproduction

 Henry’s law constant  Epidemiology  Bioaccumulation /

bioconcentration

 Volatilization from soil  Reproductive effects  Model ecosystem studies

 pH  Clinical studies  Physical environment

impairment effects

 Flammability  Dermatoxicity  Flesh staining of aquatic

organisms

 Explodability  Phototoxicity

 Adsorption / desorption

characteristics  Irritation

 Photochemical degradation  Sensitization

 Viscosity  Allergy

 Odor  Skin staining

 Hydrolysis

 Thermal analysis

 Chemical analysis

 Chemical oxidation

 Chemical reduction

 Biodegradation

 Transformation to

persistent or toxic productsINSTRUCTION MANUAL 2003

52 Appendix B

- CONTACT LIST (2014) :

The New Chemicals Program is managed by the New Chemicals Management Branch

(Greg Schweer, Branch Chief, 202/564

- 8469) in OPPT's chemical Control Division. This branch is

comprised of three teams: the Pre

- Notice and Exemptions Management Team, the Notice and Regulations

Management Team #1, and the Notice and Regulations Management Team #2.

The Pre

- Notice and Exemptions Ma nagement Team facilitates all pre

- notice

communications/activities and assists potential submitters in determining whether their chemical

substances require premanufacture notice. This branch is also responsible for outreach, TSCA section 5

policy formulat ion and interpretation, coordinating the review of all section 5 exemption notices (i.e., low

volume (LVE), low releases and low exposures (LoREX), and test marketing (TME)),

coordination/outreach with international groups, and various administrative suppo rt activities.

Routine questions about forms, publications, general policies, etc. are handled by the TSCA Hotline (by

telephone at 202/554

- 1404 and facsimile at 202/554

- 5603.) To check on the EPA review status of a

particular exemption notice, click on the "Premanufacture Notice Status" link in the left margin of the

New Chemicals Program web page.

If you have techni cal issues or problems regarding the e

- PMN software or CDX registration , please

contact the CDX Help Desk at helpdesk@epacdx.net or 888

- 890

- 1995. International callers who wish to

contact the Help Desk should call 970

- 494

- 5500. If you have programmatic questions, please contact

Kathryn Schechter at 202

- 564

- 8589 or e

- mail Schechter.Kathryn@epa.gov , Anna Coutlakis at 202

- 564

-

9207 or e

- mail Coutlakis.Anna@epa.gov , or Loraine Passe at 202

- 564

- 9064 or e

- mail

Passe.Loraine@epa.gov

.

For answers to questions about procedural, technical, or regulatory requirements prior to submitting a

P MN, or to request consolidation in PMN notice review, submitters can contact a PMN prenotice

coordinator:

David Schutz, 202/564

- 9262 ( Schutz.David@epa.gov )

Adella Underdown, 202/564

- 9364 ( Underdown.Adella@epa.gov )

Jesse A. Miller, 202/564

- 2976 ( Miller.Jesse@epa.gov )

Other members of the New Chemicals Prenotice Branch are:

Brian Lee, Team Leader, 202/564

- 6293 ( Lee.Brian@epa.gov )

Anna Coutlakis, Senior Policy Analyst 202/564

- 9207 ( Coutlakis.Anna@epa.gov )

The Pre

- Notice and Exemptions Management Team is also responsible for this manual.

We a re eager to hear from our users if they have input on how it can be improved. If you

have suggestions, please send to Dave Schutz or Brian Lee.INSTRUCTION MANUAL 2003

53 The Notice and Regulations Management Teams are charged with managing the process for

Premanufacture Notices (P MNs) submitted under TSCA. Submissions which are under active review

post

- FOCUS meeting are generally the subject of active communication between the EPA notice manager

and the submitter (The FOCUS meeting is where risk management decisions occur, at appro ximately day

20 of the PMN review process). To check on the EPA review status of a particular PMN, click on the

"Premanufacture Notice Status" link in the left margin of this page.

The focus of Notice and Regulations Management Team #1 is the risk manageme nt of

conventional new chemical (including PFC substitutes) PMNs. The roster of the Notice and Regulations

Management Team #1 is:

Rose Allison, Team Leader 202/564

- 8970

Jeff Bauer, 202/564

- 9042

Geraldine Hilton, 202/564

- 8986

Virginia Lee, 202/564

- 0883

Lorr aine Passe, 202/564

- 9064

Edna Pleasants, 202/564

- 9114

The focus of Notice and Regulations Management Team #2 is the risk management of new

nanomaterials, microorganisms, and Significant New Alternatives Policy (SNAP) chemicals, as well as

the development o f batch Significant New User Rules and other regulations. The roster of the Notice and

Regulations Management Team #2 is:

Ken Moss, Team Leader, 202/564

- 9232

James Alwood, 202/564

- 8974

Audrey Binder, 202/564

- 9033

Tracey Klosterman, 202/564

- 2209

Zofia Kosim , 202/564

- 8733

Kristan Markey, 202/564

- 8716

Written inquiries may be sent by US mail to:

Prenotice Coordinator, New Chemicals Program

Chemical Control Division

Mail Stop 7405M

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. If you wish to use email to transmit a non

- confidential

question, address it to Brian Lee.INSTRUCTION MANUAL 2003

54 EPA uses a contractor, the TSCA Assistance Information Service (TAIS, TSCA Hotline) 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 7408M

USEPA, 1200 Pennsylvania Ave., NW

Washington, D.C. 20460

Use the following direct address to send material by courier. (The building guards will need a New

Chemicals Program staff contact phone and room number):

U.S. EPA

Office of P ollution Prevention & Toxics (New Chemicals Program)

EPA East Building, Room 4133

1201 Constitution Avenue, NW

Washington, DC 20004

- 3302.