### This draft for the Manual is posted for subm itters’ convenience. The Manual has been through internal review in EP A’s New Chem icals Program , but has not com p leted OMB review. It is being poste d on our Web page to assist subm itters, but will not be published until OMB review is com p leted. Slightly Revised February 2003 - new staff listings and TS-num ber instructions.

INSTRUCTION MANUAL FOR REPORTING UNDER THE TSCA §5 NEW CHEMICALS PROGRAM
How this Manual is organized:
I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TOXIC SUBSTANCES CONTROL ACT §5 NEW CHEMICALS PROGRAM - PREMANUFACTURE NOTICE FORM
A. Substances Which Must Be Reported ("New " Chemicals) B. Who Must Submit A Premanufacture Notice C. Substances Excluded from Notification D. When to Submit a Notice E. Filling Out and Submitting the Form F. Binding Boxes G. Test Data and Other Data H. Confidentiality I. Consolidated Notices J. Submission of Information by Others K. Consultation w i th 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 BenefitsII. PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5 NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE FORM
1. Type of Notice (Page 1) 2. Certification (Page 2)
Part I -- GENERAL INFORMATION
Section A - Submitter Identification (Page 3) Section B - Chemical Identity Information (Pages 4-6)
1. Class 1 or Class 2 chemical substances (Page 4) 2. Polymers (Page 5) 3. Impurities (Page 6) 4. Synonyms 5. Trade Identification 6. Generic chemical name 7. Byproducts - Section C - Production, Import, & Use Information (Page 7)
1. Production volum e 2. Use information 3. Haz a rd information
Part II - H UMAN EX POSURE AND ENVIRONMENTAL RELEASE (Pages 8-10) Section A - Industrial Sites Controlled by the Submitter (Pages 8-9) Section B - Industrial Sites Controlled by Others (Page 10) (OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION (Page 11) - Technical Information

a. Process Chemistry b. Product Substitution/ Source Reduction c. Process Modifications d. Operating Practices h. Alternative Waste Disposal Methods i. Toxicity Information
Part III - LIST OF ATTACHMENTS (Page 12) Physical and Chemical Properties Worksheet (Optional - page 13) Appendix A: Types of test data for submission Appendix B: Contact PersonsI. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TSCA §5 NEW CHEMICALS PROGRAM - PREMANUFACTURE NOTICE FORM
A. Substances Which must Be Reported ("New " Chemicals)
1. General - You are responsible for determ ining whether a substance you intend to m anufacture or im port is a "new" chem ical substance as defined by the Toxic Substances Control Act (TSCA, the Act) and 40 Code of Federal Regulations (CFR) §720.3. You m u st subm it a prem anufacture notice (PMN) if you intend to m anufacture (im port is considered m a nufacture) any new chem ical substance which is not on th e TSCA Inventory or otherwise excluded from notification, as discussed below. To subm it a PMN, you m u st 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 specif i c identities of som e chem ical substances on the Inventory are confidential and therefore do not appear on the Inventory available to the public. Such substances are described by generic nam e s in the Appendix to the Inventory. If a substance you intend to m anufacture or im port is not on the published Inventory but falls within one of the generic categories in the Appendix, you m ay request that EPA search the Inventory' s conf idential f ile. EPA will search the conf idential f ile only if you can dem onstrate a bona fide intent to m anufacture or im port the substance. This policy is to ensure that this search procedure cannot be used for, essentially, industrial espionage. The procedure for dem onstrating such a bona fide intent is codified at 40 CFR §720.25. Certain inform ation m u st be subm itted with a bona fide request: an infrared spectrum m u st be supplied unless this analysis is not suitable for the particular substance, in which case a spectrum or instrum e nt readout from a m o re appropriate m e thod m u st be subm itted; a currently correct Chem ical Abstracts (CA) Index nam e or CA preferred nam e , whichever is appropriate; a currently correct Chem ical Abstracts Service (C AS) register num ber (CASRN) (if the substance already has a CASRN assigned to it); m o lecular form ula and a com p lete or partial chem ical structure diagram if known or reasonably ascertainable; and a description of R&D activities that have already been conducted (include, for exam ple, years research conducted, end use application, toxicity data, etc.). Three additional inform ation requirem e nts established in the PMN Rule Am endm ents, published March 29, 1995 (60 Federal Register (FR) 60 pp. 16298-16351) for a TSCA Inventory search incl ude: the m o st probable m a nufacturing site, "m ajor intended application or use" of the substance, and the approxim a te date when the subm itter would be likely to subm it a §5 notice for the substance if it is not found in the Inventory. If the substance is being im ported, a statem ent should include: a) how long the substance has been used outside of the U.S., b) nam e of the country(ies) in which the substance is being used, and c) whether the substance has been used outside the U.S. for the sam e use as that intended after proposed im portation. No specific form is required to be used.

The address to which to send bonafide subm issions (by US m a il) is:OPPT Docum e nt Control Officer Mail Stop 7407 USEPA 1200 Pennsylvania Avenue, North W e st W a shington, DC 20460 The room at which bonafides are accepted is only open until 4 PM, and if a courier service com e s after that tim e it will be turned away. You need the physical address for sending a bona fide by courier. You can give the courier the phone num ber (202) 564-8940 to call if there are delivery problem s: OPPT Docum e nt Control Officer Mail Stop 7407 TSCA Data Processing Center Room 6428 EPA East USEPA 1201 Constitution Avenue, North W e st W a shington, DC 20004-3302 After conducting its search, EPA will tell you if the substance is included on the Inventory and therefore not subject to prem anufactur e notification or if you m u st subm it a PMN.
B. Who Must Submit A PMN If you intend to m anufacture or im port a new chem ical substance for a comm e rcial purpose, you m u st subm it a PMN to EPA. You m u st subm it a notice if you intend to im port a new substance in bulk form or as part of a m i xture, but not if you intend to im port the substance only as part of an article. The use of the term "m anufacture" in this m anual includes both m anuf acture and im port. Im porters m u st f u lly com p ly with the inf o rm ation requirem e nts outlined at 40 CFR §720. However, im porters are not required, under §720.50(d)(3), to subm it any data which relates solely to exposure to hum ans or the environm ent outside the United States. Im porters m u st subm it non-exposure data such as data on health effects (including epidem iological studies), ecological effects, physi cal and chem ical properties, or environm ental fate characteristics and (on sites under their control within the United States) exposure inf o rm ation. "Article" is defined at 40 CFR §720.3 as a m a nufactured item which: (1) is form ed to a specific shape or design during m anufacture; (2) ha s 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 chem ical com position during its end-use or only those changes in com position which have no comm e rcial purpose separate from the article of which it is a part and that m ay occur as described in 40 CFR §710.4(d)(5) and 40 CFR §720.30(h)(5). Articles are excluded from PMN requirem e nts. Fluids and particles do not m eet the definition of anarticle and are therefore not excluded from inventory reporting requirem e nts. Therefore, all particles or fluids m u st be reported for the purposes of TSCA unless they can be considered m i xtures. Also, OPPT will consider item s being im ported to be "articles" only if they are m anufactured in a specific shape or design for a particular end use application, and this design is m a intained as an essential feature in the finished product.PMNs for im ported new chem ical substances should be subm itted by the principal im porter. "Principal im porter" is defined at 40 CFR §720.3(z). It is not necessarily the sam e as "Im porter of Record" under custom s regulations. Generally, when you contract with another person to m anufacture a new chem ical substance, that person m u st subm it the notice. However, if you request another person to m anufacture a new chem ical substance, and if you specify the identity and total am ount of the substance to be m a nufactured and the basic technology and controls under which the substance will be produced, and if that person m anufactures the substance exclusively for you, that person is considered a "toll m anufacturer", and you m u st subm it the notice. Inform ation regarding hum an exposure and environm ental release should be subm itted on EPA form 7710.25 in Part II, Section A, Industrial Sites Controlled by the Subm itter. EPA recognizes that in this and sim ilar instances, the other m anufacturer m ay have inform ation useful to the Agency' s review of the new chem ical. Therefore, EPA strongly encourages joint subm ission in these situations. This m anual does not discuss biotechnology subm ission inform ation requirem e nts for uses of m i croorganism s subject to the Toxic Substances Control Act (TSCA). For specific inform ation on subm itting notices for biotechnology products please contact the Biotechnology Program in the New Chem icals Notice Managem e nt Branch: Biotechnology Program New Chem icals Notice Managem e nt Branch Chem ical Control Division Mail Stop 7405 USEPA, 1200 Pennsylvania Avenue, North W e st W a shington, D.C. 20460

For additional inform ation on who m u st subm it a notice, see 40 CFR §720.22 or consult a Prenotice Coordinator. Prenotice Coordinators (see Contact List, Appendix C) are staff in the New Chem icals Program who specialize in assis ting with status questions and questions on how to properly com p lete the notifications.
C. Substances Excluded from Notification
1. Statutory Excluded Categories - §3(b) of the TSCA excludes certain substances from prem anufacture notification. These include m i xtures (individual substances com p rising the m i xtures are NOT exem pted), substances m anufactured solely for use as pesticides, food, food additives, drugs, or cosm etics; tobacco and tob acco products; nuclear source m a terials; firearm s and amm unition; im purities; byproducts which have no comm e rcial use; non-isolated interm ediates; and new chem ical substances m anufactured 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 chem ical substances for analysis, experim e ntation, or research on new or existing chem ical substances, including product developm ent activities. R&D m ay include tests of the physical, chem ical,production, and perform ance characteristics of a substance. You do not have to subm it a notice for a new substance m anufactured or im ported in sm all quantities solely for research and developm ent as specified in 40 CFR §720.36. "Sm a ll quantities" are those not greater than reasonably necessary for research and developm ent purposes. The quantity which is reasonable m ay vary depending on the nature of the research and developm ent activities. It is your responsibility to determ ine what is reasonable in your situation. You do not have to apply for this exem ption. However, you m u st subm it a PMN 90 days before you intend to m anufacture the substance for a purpose other than research and developm ent undertaken in com p liance with §720.36. To qualify for the exem ption, your research and developm ent activities m u st be conducted under the supervision of a technically qualified i ndividual. Persons who engage in R&D for, or obtain an R&D chem ical from , a m anufacturer m u st be notified of any risk to health which m ay be associated with the chem ical. However, R&D conducted entirely in laboratories under prudent laboratory practices is exem pted from the requirem e nt for risk evaluation. In accordance with 40 CFR §720.78, the following R&D records m u st be retained (also see I-M, Recordkeeping): inform ation reviewed and evaluated to determ ine the need to m a ke any notification of risk, docum entation of the nature and m e thod of risk notification, docum entation of prudent lab practices, if used instead of risk notification and evaluation and, if an R&D substance is m anufactured at greater than 100 kg/yr, records regarding the chem ical identity of the substance to the extent known, the production volum e, and the disposition of the R&D chem ical substance m u st also be retained. Manufacturers and im porters who distribute an R&D substance to other persons m u st provide those persons with written notification of known hazards and of the requirem e nt that the substance be used solely for R&D. For additional inform ation on R&D requirem e nts see the New Chem ical Inform ation Bulletin: Exem ptions for Research and Developm ent and Test Marketing available f r om the TSCA Assistance Inf o rm a tion Service (TAIS, TSCA Hotline) (see Contact List, Appendix C). 3. Test-marketing exemptions (TME) - You m ay apply for an exem ption from prem anufacture notification if you plan to m anufacture or im port a new chem ical substance for test-m arketing. Test-m arketing involves the distribution of a predeterm i ned lim ited am ount of a chem ical substance, or of a m i xture or article containing the chem ical substance, to specified num ber of custom ers to explore m arket acceptability before general distribution. The subm itter needs to show that the intended activity is not comm e rcial production and is not appropriately considered to be research and developm ent. To approve a test-m arketing exem ption application, the Agency m u st m a ke an affirm ative f i nding that the new chem ical substance will not present an unreasonable risk to health or the environm ent during the test-m arketing activities. 40 CFR §720.38 identifies the type of inform ation you should subm it with a test-m arketing exem ption application. EPA m u st approve or deny the application within 45 days. If you do not provide sufficient inform ation for EPA to m a ke its determ ination, the Agency will deny the request. You should send applications for test-m arketing exem ptions to the OPPT Docum e nt Control Officer (7407). You are not required, but are encouraged, to use the PMN form for a TME application. For additional inform ation on test m arketing requirem e nts see the New Chem ical Inf o rm ation Bulletin: Exem ptions f o r Research and Developm ent and Test Marketing available f r om the TSCA hotline. Recordkeeping requirem e nts for a test-m arketing exem ption are discussed at I-M, Recordkeeping.
4. §5(h)(4) exemptions - Under §5(h)(4) of the Act, you m ay apply to EPA for an exem ption from som e or all prem anufacture notification requirem e nts. EPA m ay grant an exem ption if it m a kes an affirm ative finding that the m a nufacture, processing, distribution in comm e rce, use, or disposal of the new substance will not present an unreasonable risk to health or the environm ent. Unlike other exem ptions, such as test m arketing, EPA m ay only grant a §5(h)(4) exem ption by rule. In the rulem a king proceeding, the applicant should provide inform ation sufficient to show that the chem ical substance will not present an unreasonable risk to health or the environm ent. You should send applications for §5(h)(4) exem ptions to the OPPT Docum e nt Control Officer (7407). The following exem ptions have been prom ulgated under §5(h)(4):

a. LowVolume Exemption (LVE) - Requirem e nts for a LVE application are found at 40 CFR §723.50. This exem ption is available for substances m anufactured in quantities of 10,000 kg or less per year. Multiple LVEs can be issued to several m a nufacturers of a single substance, however, second and subsequent applications will be evaluated in the context of existing perm itted exposures. Low volum e substances are not added to the TSCA Inventory. The notice m u st include the site of m anufacture and proposed use of the new chem ical substance; these are legally binding upon the com p any. The m anufacturer m ay also provide inform ation on exposure controls. If provided, any controls specified in the notice are binding throughout the period of the exem ption. EPA will grant the LVE if it determ ines that the substance will not present an unreasonable risk of injury. The review period for an LVE is 30 days, which can be extended if m o re inform ation is required.
Com p anies m u st notif y the Agency within 30 days of a change of the site of m anufacture or application. Manufacturers (im porters) m u st notify processors and industrial users that the substance can be used only for the uses specified in the exem ption notice. Manufacturers m u st also notify processors and users of any exposure controls. Recordkeeping requirem e nts are discussed at I-M, Recordkeeping.
b. Polymer Exemption - Requirem e nts for a Polym e r Exem ption can be found at 40 CFR §723.250. The exem ption was first published at 60 Federal Register (FR) 60 pp. 16316-16336, and there is a useful discussion in the Pream ble to that publication. This exem ption is available for certain classes of polym ers which are not chem ically active or bioavailable. The m anufacturers are not required to subm it a polym er exem ption notice to EPA prior to m a nufacture, but m u st notify the Agency by 31 January for new m a terials first m a nufactured in the preceding calendar year. Recordkeeping requirem e nts are discussed at I-M, Recordkeeping.

c. LowRelease and Exposure (LoREX) Exemption - Eligibility f o r this exem ptioncategory is independent of production volum e level. Perform ance standards for this exem ption are set out in 40 CFR §723.50 (c) and include both absolute criteria (e.g., an upper lim it on surface water releases) and goals (e.g., no worker exposure). The notice m

u st include the site of m anufacture and proposed use of the new chem ical substance which are legally binding upon the com p any. The applicant' s exem ption notice m u st describe how exposures and releases of the new chem ical substance com p are to the criteria of 40 CFR §723.50 (c). If the exem ption is granted the applicant is responsible for com p lying with the standards and with any controls or lim itations specified in this exem ption notice. These requirem e nts m u st be followed throughout the period of exem ption. LoREX exem ption notices are subject to 30-day review periods by the Agency. Recordkeeping requirem e nts are discussed at I-M, Recordkeeping.
D. When to Submit a Notice
You m u st subm it a PMN at least 90 days before you begin to m anufacture or im port a new chem ical substance for a comm e rcial purpose. You are required to subm it a notice for LVE or LoREX exem ptions 30 days before you begin to m anufacture or im port a new chem ical substance, and 45 days before m anufacture or im portation under TME. If inform ation 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 m anufacture/im port at the end of these review periods. It is prudent f o r subm itters who think their substances m ay be subjected to required additional testing during PMN review to confer with the Agency before subm itting and to subm it further in advance of their hoped-for start dates than the m i nim um num ber of days f o r review, as additional testing will extend the Agency review period f o r the PMN. To initiate this process contact a prenotice coordinator.
E. Filling Out and Submitting the Form
Com p lete the §5 notice form EPA 7710-25 (rev. 5-95) using a typewriter or by printing legibly in black ink. Inform ation which is not subm itted on a photocopy of the form available from EPA (e.g., an electronically generated form created by utilizing form -m aking software) m u st be in a form at pre-approved by the Agency. Approval can be obtained by contacting:

OPPT Docum e nt Control Officer Mail Stop 7407 USEPA 1200 Pennsylvania Avenue, North W e st W a shington, DC 20460 All inform ation provided must be in English (Except that open-literature reports can be subm itted in their original languages: if data appears in the open scientific literature, the subm itter need only provide a standard literature citation. A standard literature citation includes author, title, periodical nam e , date of publication, volum e, and page num bers. The subm itter can assist the Agency by providing a photocopy of the article, if desired. This is the only exception to the requirem e nt that all inf o rm ation m u st be subm itted in English). Provide all inf o rm ation requestedon the notice form to the extent that you know or can reasonably ascertain it. If you do not know or cannot reasonably ascertain the inform ation, enter "NK" ("not known"). Many subm itters want to know what is m eant by "reasonably ascertainable". In general, the Agency views inform ation in the current literature, held by the subm itter or a parent or subsidiary com p any, or held by a supplier to be reasonably ascertainable.
Som e staff m e m b ers in large corporations have expressed concern for their personal liability on inf o rm ation subm ission - that there can be inf o rm ation held by their organization which a reasonable search will not uncover. As an exam ple, a branch of f i ce of a parent com p any m ay 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 fam ily of substances undertaken for comm e rcialization of one of them m a y not be found when comm e rcialization of another of those substances is later undertaken. If you think you are in som e danger that you m i ght not find all of your com p any' s inform ation about a substance on which you are preparing notification, you should docum ent that you m a de a serious search for inform ation, which should have yielded all reasonably ascertainable inform ation, and keep a record of your search with your records of the subm ission. You should be able to m a ke available to an EPA inspector records showing: that you identified where in your corporate organization (or your suppliers) the inform ation m i ght be, that you sent requests for inform ation to each site where you think the inform ation m i ght be kept, and that you followed up with any non-responding site until you got a response. You should review all applicable inf o rm ation on the substance, such as the Material Saf e ty Data Sheet (MSDS) f o r the existence of testing on the new chem ical substance. It is helpful if there is a corporate inform ation policy to ensure that this sort of inform ation is available to a responsible PMN subm itter.
You m ay subm it continuation sheets for any subsection or item on the form

. Head any continuation sheet with: the TS-num ber or PC-num ber, if any; subm itter nam e ; and the num ber of the question to which it is a supplem ent. Mark the appropriate box on the notice form if you attach continuation sheets. You m ay photocopy the notice form , sections of the form , or this m anual as frequently as you need.
Form 7710-25 (rev. 5-95) is used for several different types of subm issions. These instructions are designed to guide subm itters for each of them

. Send your com p leted notice to the Docum e nt Control Officer (DCO) for Office of Pollution Prevention and Toxics. If the notice is a PMN or Significant New Use Notice (SNUN), send w ith original signatures and two copies (an additional copy is required if any inform ation is claim e d to be confidential, and should be subm itted with the claim e d-confidential inform ation deleted ("redacted copy", "sanitized copy"). No copies are required if it is an application for a Test Market Exem ption (TME), Low Volum e Exem ption (LVE), or Low Release-Low Exposure Exem ption (LoREX), except that if it contains confidential business inform ation (CBI) you m u st subm it a redacted copy, which will be placed for public viewing in the TSCA Nonconfidential Inform ation Center, 202-566-0280 (open from 12m - 4pm daily): TSCA Nonconfidential Inform ation Center Mail Stop 7407 EPA W e st, B-146USEPA 1201 Constitution Avenue, North W e st W a shington DC 20460
The US Mail address for the DCO appears on page 1 of the form . The room at which subm issions are accepted is open from 8 am until 4 pm daily, and if a courier service arrives after that tim e it will be turned away. For sending a notice by courier the address should include the physical location:
OPPT Docum e nt Control Officer Mail Stop 7407 TSCA Data Processing Center Room 6248 EPA East USEPA 1201 Constitution Avenue, North W e st W a shington, DC 20004-3302 You can give the courier the phone num ber (202) 564-8940 to call if there are delivery problem s. A user fee m u st be rem itted for PMN and SNUN §5 notices in accordance with 40 CFR §700.45. You m u st create a unique alpha-num eric identification num ber ("TS-num ber") to identify and link your notice with the rem ittance fee. This six digit num ber m u st be placed on the first page of the form in the boxes that have been provided. This num ber m u st also be placed on your fee rem ittance which is sent to: EPA, W a shington Financial Managem e nt 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, m oney orders and bank drafts only; after the bank has processed the paym ent, the TSNum b er is sent to EPA Headquarters with certification that paym ent has been m a de. EPA Headquarters then verifies that the appropriate rem ittance with a TS identification num ber corresponds to a user fee identification num ber on a PMN and further processing of the notice comm e nces. However, if a problem arises in the paym ent procedure, (i.e., insufficient funds, im proper usage of the TS-num ber), the notice will be given incom p lete notice status in accordance with 40 CFR §720.65(c). The EPA will inform the subm itter in writing if this action is taken. 40 CFR §720.65 specifies adm i nistrative procedures applicable to incom p lete notices in general. The m o st frequent reason for a subm ission to be incom p lete is a nam e which is not in conform ance with the Ninth Collective Index (9C I) of Chem ical Abstracts nom enclature rules and conventions (this definitive guide to CA nom enclature has been used since 1972.) If the notice is declared incom p lete, the review period has not begun no m a tter when in the initial review period the notice is declared incom p lete. Therefore, the review period begins again at day one when acom p lete notice is received. However, EPA can choose to restart the clock on the day the notice was declared incom p lete if it determ ines that its review can be com p leted within the rem a ining period. This decision is m a de case-by-case. See 40 CFR §720.65(c).
F. Binding Boxes The purpose of the binding option is to enable EPA (if necessary) to efficiently negotiate with a PMN subm itter the developm ent of §5(e) consent orders and prom ulgate Signif i cant New Use Rules (SNURs) for those new chem ical substances that the Agency determ ines m ay present an unreasonable risk if certain control actions are notim plem ented. This option is intended to reduce delays that can slow the developm ent of consent orders absent such agreem ent. At one tim e, SNURs were lim ited to environm ental release activities and certain industrial, comm e rcial, or consum er activities, but now they can include other im portant activities, such as protection in the workplace and hazard comm unications. Control m easures instituted by the subm itter to reduce exposures and/or releases of the substance m ay have a direct bearing on the Agency' s conclusions regarding risk. Therefore, you m ay wish to indicate your willingness to be bound to certain subm itted inform ation on the form which is related to the issue of potential risk such as use, production volum e, protective equipm ent, engineering controls, and/or process description. By indicating your willingness to m a ke these comm itm ents, you would be indicating an interest in future negotiations if the Agency deem s them necessary. In order to m a ke your intentions known to EPA, m ark in the "Binding Option" box on the form located to the right of the appropriate inform ation. Should the Agency wish to discuss developm ent of binding control m easures for your PMN, you will be contacted by a Program Manager and negotiations m ay ensue. Therefore, indicating a willingness to be bound by the term s of your notice does not by itself prohibit the subm itter f r om deviating f r om the inf o rm ation (except chem ical identity) reported in the f o rm
. In the case of exem ption applications (i.e. Test Market, Low Volum e /Low Release, Low Exposure), however, certain statem ents are autom a tically binding on the subm itter when the Agency approves the exem ption applications.

G. Test Data and Other Data You are required to provide three copies of any test data on the health and environm ental effects of the new chem ical substance, including data on physical/chem i cal properties, in your possession or control, and a description of any other health and environm ental effects data on the substance known to or reasonably ascertainable by you. Data in the possession or control of either a parent com p any or an af f iliated subsidiary located outside the U.S. are considered by the Agency to be data that should be known to or reasonably ascertainable by a subm itter (see section E, above). Data m u st be subm itted in English. Standard literature citations m ay be subm itted for data in the open scientif ic literature. Com p lete test data (not summ aries) m u st be subm itted if they do not appear in the open literature. Incom p lete reports (e.g., from ongoing studies) are exem pt from full reporting. However, you m u st describe the nature and objective of any incom p lete study, report, or test, the nam e and address of any laboratory developing the data;progress to date; type of data collected; signif i cant prelim inary results; and an anticipated com p letion date. If significant prelim inary results or final results are obtained prior to the com p letion of the notice review period or any other additional inform ation significant to the review of the notice becom e s available to you, you m u st subm it this inform ation within 10 days of receipt, but no later than 5 days before the end of the review period. If inform ation becom e s available during the last 5 days of the revi ew period, you m u st imm e diately inform EPA by telephone. Exam ples of the types of test da ta you m u st subm it are provided in Appendix A of this m anual. In addition, a Physical and Chem ical Properties W o rksheet now appears on the last page of the f o rm
. For additional inf o rm ation on health and saf e ty studies and on subm itting test data, see 40 CFR §§720.3 and 720.50 of the Prem anufacture Notification Rule. Attach test data to the notice form and reference it by page num ber in Part III, List of Attachm e nts. You are not required to subm it any data previously subm itted to EPA with no claim s of confidentiality if you identify in your subm ission the office or person to whom you subm itted the data, the date it was subm itted, and, if appropriate, a standard literature citation. If, however, you subm itted data with claim s of confidentiality, you m u st resubm it the data with the notice and any claim of confidentiality under 40 CFR §720.80. You also are not required to subm it data related solely to product efficacy. This exception does not apply to inform ation required in the notice, test data, or other data.
H. Confidentiality
1. Asserting claims
You m ay assert a claim of conf identiality f o r any inf o rm ation subm itted to EPA. To assert confidentiality for specific inform ation on the form (e.g., subm itter identity, chem ical identity, or use inf o rm ation), m ark in the "Conf idential" or Conf idential Business Inf o rm ation (CBI) box on the form located to the right of the inform ation. Also m ark the box at the bottom of page 1 of the form if any inform ation in the notice was claim e d as confidential in the form

. As noted above, a redacted copy of any §5 notice m u st be subm itted with the notice, or it will be declared incom p lete by the Agency and returned to the subm itter. To assert conf identiality claim s f o r inf o rm ation in attachm e nts to the f o rm , provide a com p lete copy of the attachm e nt that clearly indicates (e.g., by circling or bracketing) the inform ation you wish to claim as confidential. Bracket only the specific inform ation you claim as confidential. For exam ple, if you subm it a study which contains a physical or chem ical property, and it is only that property which you wish to cl aim as confidential, bracket only that property. Do not sim p ly stam p "Confidential" on the page which contains that property. You m u st also clearly and specifically m ark any confidentiality claim s you wish to m a ke for inform ation or correspondance subsequently subm itted to EPA about your PMN, and you m u st provide a redacted version for the public file. If you claim the identity of the new chem ical substance or its category of use as confidential, you m u st provide a generic description of this inform ation, as indicated in the appropriate sections of the form

. Guidance on developing generic nam e s is given in Part 2 of this m anual in the Chem ical Identity Inf o rm ation Section at Item 6.To ensure that no confidential inform ation is disclosed to the public, you m u st subm it an additional copy of the notice form , including attachm e nts, which does not contain confidential inform ation. This version ("sanitized", "redacted") will be placed in the public file. It m u st contain all non-confidential inform ation, including health and safety studies. A health and safety study m eans any study of any effect of a chem ical substance or m i xture on health or the environm ent or on both, including underlying dataand epidem iological studies, studies of occupational exposure to a chem ical substance or m i xture, toxicological, clinical, and ecological, or other studies of a chem ical substance or m i xture, and any test perform e d under the Act. Inform ation from health and safety studies which can be claim e d confidential is quite lim ited - this is discussed at 40 CFR §720.90. Chem ical identity is assum e d to be part of a health and safety study. 40 CFR §720.90(b)(2) discusses the claim s which m u st be m a de and substantiated for chem ical identity in a health study to be confidential: that disclosure would reveal m anufacturing or processing inform ation, th at it would disclose the fraction of a m i xture which the substance com p rises, that the study could be interpreted without knowing the identity of

the substance, and that disclosure would have harm f u l com p etitive ef f ects on the subm itter. Not only is inform ation which arises as a result of a form al, disciplined study included, but other inform ation relating to the effects of a chem ical substance or m i xture on health or the environm ent is also included. In sum , any data that bear on the effects of a chem ical substance on health or the environm ent would be included.) If you do not provide the sanitized copy with your subm ission, the subm ission will be incom p lete and the review period will not begin. If you provide a subsequent am endm ent to your PMN or additional inform ation/data, you m u st also provide a non-confidential version for the public file.
2. Substantiating claims You are not required to provide substantiation of any conf identiality claim when you subm it your notice. However, you m u st substantiate your claim of confidentiality for chem ical identity at the tim e you subm it a Notice of Co mm e ncem ent of Manufacture (NOC), if you want EPA to m a intain your confidentiality claim after you begin m anufacture. (NOC requirem e nts are described in 40 CFR §720.102 and in this m a nual.) To substantiate that claim , you m u st provide EPA with detailed answers to the following questions which appear in the Prem anufacture Notification Rule [40 CFR §720.85(b)(3)(iv)]: (A) Wh at harm ful effects to your com p etitive position, if any, do you think would result if EPA publishes on the Inventory the identity of the chem ical substance? How could a com p etitor use such inf o rm ation given the f act that the identity of the substance otherwise would appear on the Inventory of chem ical substances with no link between the substance and your com p any or industry? How substantial would the harm ful effects of disclosure be? Wh at is the causal relationship between the disclosure and the harm ful effects? (B) For what period of tim e should confidential treatm e nt be given? Until a specific date, the occurrence of a specific event, or perm anently? Why? (C) Has the chem ical substance been patented? If so, have you granted licenses to others withrespect to the patent as it applies to the chem ical substance? If the chem ical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for purposes of the Inventory? (D) Has the identity of the chem ical substance been kept confidential to the extent that your com p etitors do not know it is being m anufactured or im ported for a comm e rcial purpose by anyone? (E) Is the fact that som e one is m anufacturing or im porting this chem ical substance for comm e rcial 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) Wh at m easures have you taken to prevent undesired disclosure of the fact that you are m anufacturing or im porting this substance for a comm e rcial purpose? (G) To what extent has the fact that you are m anufacturing or im porting this chem ical substance for a comm e rcial purpose been disclosed to others? Wh at precautions have you taken in regard to these disclosures? Has this inf o rm ation been disclosed to the public or to com p etitors? (H) In what form does this particular chem ical substance leave the site of m a nufacture, e.g., as part of a product; in an effluent or em ission str eam ? If so, what m easures have you taken to guard against discovery of its identity? (I) If the chem ical substance leaves the site of m anufacture in a product that is available to either the public or your com p etitors, can they identify the substance by analyzing the product? (J) For what purpose do you m anufacture or im port the substance? (K) Has EPA, another Federal agency, or any Federal court m a de any pertinent conf identiality determ inations regarding this chem ical substance? If so, copies of such determ inations m u st be included in the substantiation. (L) If the notice includes a health and safety study concerning the new chem ical substance, the subm itter m u st also answer the questions in 720.90(b)(2). This substantiation m u st accom p any your NOC. You m ay be required to substantiate other confidentiality claim s if EPA receives a Fr eedom of Inform ation Act (FOIA) request on that inf o rm ation.
I. Consolidated Notices If you are m a nufacturing two or m o re, but no m o re than six, structurally sim ilar new substances, you m a y contact a Prenotice Coordinator to obtain approval to subm it a single consolidated notice. A consolidated notice is suitable for chem ical substances of similar structure with the sam e or sim ilar uses and which share sim ilar test data and other inform ation. A consolidated notice m u st identify each new substance individually; you m ay not subm it aconsolidated notice f o r an open-ended category. A separate chem ical identity page m u st be provided for each substance. A distinct Agency "PMN" num ber is assigned to each chem ical. You m ay not subm it a consolidated notice for a series of interm ediates and a final product (they will not share comm on uses, test data, and other inf o rm ation). EPA encourages you to subm it consolidated notices when appropriate. You m ay subm it a consolidated notice only after you have received prior approval from a Prenotice Coordinator. This request should concisely describe the chem ical identity of each substance to be included in your consolidated notice (note: you need not use na m e s from the Inventory Expert Service of the CAS to request approval for a consolidation, you need only to describe the chem ical substances well enough that EPA personnel can determ ine whether they are sim ilar enough for com b ined review. You m u st, however, use separately obtained Method I nam e s for each substance in a consolidation when PMN is subm itted). Many requestors provide this inf o rm ation using the chem ical identity pages of the f o rm or in a one page table f o rm at. Prenotice coordinators are comm itted to quickly responding to a request for a consolidated notice; however, this will not always be possible. Rem e m b er to enter your prenotice comm unications num ber in Part I, Section A (3) (page 3) of the form

. J. Submission of Information by Others
1. Submission by an agent - You m ay designate an agent to subm it a §5 notice for you. Both you and the agent m u st sign the certification on the form

. You are responsible for ensuring that all inform ation known or reasonably ascertainable by you and all test data in your possession or control are subm itted to EPA. For inform ation on subm issions by agents, see 40 CFR §720.40(e).

2. Joint submissions - You m ay also prepare and subm it a PMN with another person. A joint subm ission m ay be useful where different persons have inform ation required in the notice, including a situation when another person has inform ation fundam e ntal to the notice, but wishes to keep it confidential. For exam ple, you m ay have inform ation on the identity and the physical and chem ical properties of the new substance and another person m ay know its m anufacturing process and its intended use. Each joint subm itter m u st use a notice f o rm and sign the certif ication on the f o rm
. Each person m u st also assert all confidentiality claim s as described in 40 CFR §720.80 and Part I of this m anual. However, you are not relieved of statutory notice requirem e nts by arranging a joint subm ission. You are required to com p lete all m andatory sections of the form to the extent that you know or can reasonably ascertain the inform ation, even if another person also subm its inform ation for a certain section. If you subm it a joint notice, the review period will not begin until EPA has received all required parts of the notice. You should identify the joint subm itter in your notice and identify the section(s) which the person is subm itting. See 40 CFR §720.40(e) for additional inform ation on joint subm issions.
K. Consultation w i th EPA Concerning the Premanufacture Notice
1. Before notice submissiona. General inquiries - General inquiries concerning the prem anufacture notification program which are not related to a specific chem ical or notice should be directed to the TSCA hotline (see Contact List, Appendix C). Copies of the PMN Rule, Instructions Manual, notice form , and other m a terials relating to the Rule are available by contacting the hotline. (These m a terials are also available at EPA regional of f i ces.)
b. Specific inquiries - Specific inquiries concerning the PMN Rule, confidentiality, joint subm issions, consolidated notices, etc., should be directed to the Prenotice Coordinator. You can contact the Prenotice Coordinator by telephone, facsim ile, or em ail (see Contact List, Appendix C)
2. During notice review- Upon receipt of the notice by the OPPT Docum e nt Control Officer (DCO), the Agency will m a ke an initial determ ina tion whether the notice is com p lete. The initial determ ination looks to see that the notice contains all the item s required on pages 4 through 8 of the form and for apparent chem ical identity problem s. If no problem s are seen, your form is initially determ ined to be "com plete", goes on f o r f urther review, and Day 1 of the 90-day review period is assigned as the date of receipt by the DCO. Later and m o re detailed review can, however, discover other additional inform ation that has not been provided, and you can be contacted to provide additional inform ation at any tim e during the review period. You will receive written notification if your notice is declared "incom plete" as described at 40 CFR §720.65. If your notice is initially com p lete, you will receive an acknowledgm ent letter telling you your notice num ber and the date of expiration of the review period. The Inventory is searched to ensure that the substance f o r which the notice is subm itted is not already included on the TSCA Chem ical Substance Inventory. If your chem ical substance is on the Inventory, you will be notified that your substance is not subject to prem anufacture notification, and that therefore you are free to begin m anufactur e imm e diately. If the substance is not on the Inventory, and if the substance is not dropped from consideration at the Agency' s initial review m eeting ("Focus Meeting", which takes place at approxim a tely Day 20), a Program Manager will be assigned to coordinate the review of the noti ce and to be your official contact with the Agency throughout the rem a inder of the review period. Based on the Focus Meeting, it is possible to declare the PMN "incom plete", usually for m i ssing test data. Also during the review period, the Program Manager m ay contact you for clarification of inform ation you have provided in the notice or if the Agency identifies issues of concern. If you are not contacted prior to the expiration of the review period, you are free to comm e nce m anufacture of the substance identified in your notice after the review period has expired. You can check the status of your subm ission at the New Chem icals Internet site ("www.epa.gov/opptintr/newchm s ") after approxim a tely day 30. The Program Manager will also notify you before the review period expires if he/she will extend the review period under TSCA §5(c) or if regulatory action is being considered on the new substance under TSCA §5(e) or 5(f). 5(e) Consen t Orders are typically issued with a follow-up SNUR subsequently prom ulgated. In addition, a Program Manager will contact you if the Agency plans to develop a non-5(e) SNUR (a case in which a 5(e) Consent Order does not precede the developm ent of a SNUR) on the chem ical substance identified in your notice.
L. Notice of Commencement (NOC) of Manufacture (or Import) (40 CFR §720.102)If EPA has not taken any action to regulate the new chem ical substance during the review period, you m ay begin m anufacturing the new chem ical substance upon expiration of the review period. EPA requires that you notify the Agency by using EPA form 7710-56, no later than 30 calendar days after the first day of such m anufacture or im port for non-exem pt comm e rcial purposes (for im port, Day 1 is the date the m a terial clears US Custom s).
Your NOC m u st be sent to the OPPT Docum e nt Control Officer (Mail Stop 7407). In your NOC, you m u st provide the specific chem ical identity of the substance, its PMN num ber, the site of first m anufacture or im port, and the date when m anufacture or im port began. You m u st also substantiate a confidentiality claim for chem ical identity in your letter, as described above at "2. Substantiating Claim s " if you want EPA to m a intain the claim after you begin m anufacture or im port. See 40 CFR §720.85(b) for further inform ation on substantiating confidentiality claim s
. M. Recordkeeping Recordkeeping requirem e nts for subm issions under §5 of TSCA, and for exem ptions from subm ission, are found in several different sections of the CFR.
PMN or SNUN : 40 CFR §720.78 (a) requires that you retain docum entation of inform ation for a PMN or SNUN for five years from the date of comm e ncem ent of m anufacture. The records you m u st retain include (1) inform ation supporting the inform ation supplied on the notice form , (2) other data, as defined in 40 CFR §720.50 (b), in your possession or control, (3) production volum e for the first three years of production or im port, and docum entation to support your stated production volum e, and (4) date of comm e ncem ent of m anufacture, and docum entation to support your stated date. You are not required to develop inform ation solely for recordkeeping purposes, but only to retain info rm ation you have obtained or developed in the course of com p leting your subm ission. Research and Development: 40 CFR §720.78 (b) requires that if you m anufacture a new chem ical substance under the exem ption for substances m a nufactured solely for research and developm ent, you m u st retain docum entation of com p liance with the exem ption until five years after they are developed. Test-Marketing Exemption : 40 CFR §720.78 (c) requires that if you m anufacture under a test-m arketing exem ption under TSCA, you m u st retain docum entation of inform ation in the application and docum entation of your com p liance with any restrictions im posed by EPA when it granted the application until five years after the final date of m anufacture or im port under the exem ption.
LVE or LoREX: 40 CFR §723.50(n) requires that each m anufacturer of a new substance reported under the term s of a low volum e or LoREX exem ption m u st m a intain records of 1) the annual production volum e of the new chem ical substance under the exem ption, and 2) docum entation of inf o rm ation in the exem ption notice in com p liance with the term s of the exem ption. Records m u st be retained for five years after date of their preparation. Polymer Exemption: 40 CFR §723.250(j) requires that a m anufacturer of a polym erm a de under the term s of the polym er exem ption m u st m a intain records for five years from the date of comm e ncem ent of m anufacture for: the production volum e for the first three years of m anufacture, the date of comm e ncem ent of m anufacture, docum entation of the inform ation provided above, docum entation of any other inform ation provided in the notice, such as inform ation that dem onstrates that the new polym er is not specifically excluded from the exem ption and the polym er m eets the exem ption 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 m anufacture, processing, use, and disposal of the substance identified in the notice m ay present an unreasonable risk of injury to hum an health or the environm ent. It is im portant, also, that EPA acquire inform ation regarding any technological, risk reduction, or environm ental benefits which m ay be possible if the new chem ical being reported is introduced in comm e rce, and this inform ation can in som e cases enable the Agency to approve substances otherwise doubtful. Therefore, PMN subm itters are encouraged to com p lete and provide the optional inf o rm ation on pollution prevention on page 11 of the f o rm . By subm itting inform ation describing the positive pollution prevention aspects of your PMN substance, you m a y achieve two possible benefits: first, the pollution prevention inform ation m ay enable EPA to regulate the substance less stringently than it would have absent the inform ation, and second, the pollution prevention inform ation m a y be chosen by the Agency for affirm ative recognition as part of the EPA New Chem icals Pollution Prevention Recognition Project. In the Agency' s EPA New Chem icals Pollution Prevention Recognition Project, EPA seeks to prom ote safer new chem icals and processes, providing several form s of recognition, including a letter from the Director of OPPT, inclusion in a listing of recognized chem ical substances on the OPPT Internet Hom e page, and other positive publicity. If you want the Agency to consider your PMN substance for this recognition, you m u st explicitly request to be considered in your response at (OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION and identify the pollution prevention m e rits of your PMN substance. To the extent that you think it helpful for Agency consideration, EPA strongly encourages you to (1) subm it actual test data on the PMN substance to substantiate any pollution prevention claim s you assert and (2) m i nim i ze claim s of confidentiality claim s to facilitate publicity regarding the PMN substance.
For exam ple, the EPA will consider any inform ation on m e thods used to m i nim i ze potential risks associated with the new substance through source reduction or recycling. Som e of the benefits for which inform ation m ay be provided are a reduction in the volum e m anufactured, a reduction in the generation of waste m a terials, a reduction in exposure and/or environm ental release or increased perform ance and/or operation efficiency of the new chem ical substance in com p arison to existing chem ical substances used in sim ilar applications. Recycling activities include reclam ation of useful chem ical com ponent s from wastes that would otherwise be released as air em issions, water discharges or land releases during m anufacture, process or use. All descriptions m ay be quantitative or qualitative.The "Optional Pollution Prevention Inform ation" page of the PMN requests optional inf o rm ation that will be used in the evaluation of the new chem ical substance and to com p are the relative risks and benef its of the substance as a substitute f o r substances with sim ilar uses currently on the m arket. PMN subm itters are encouraged to report any and all relevant inform ation not reported elsewhere in the PMN which they believe to be im portant to a thorough regulatory decision. The page provides subm itters with the opportunity to describe pollution prevention and risk reduction options considered by the com p any in regard to the subm ission. A useful form at for presenting such inform ation is provided at Section II of this Manual. Providing this pollution prevention inf o rm ation to EPA m ay benef it PMN subm itters by reducing regulatory controls and/or testing requirem e nts, if the pollution prevention inf o rm ation suf f i ciently m itigates EPA' s concerns for the toxicity, hum an exposure, or environm ental releases of the PMN substance. EPA considers this inf o rm ation in line with the strictures of the Pollution Prevention Act of 1990. Under the Pollution Prevention Act of 1990 (PPA), Congress established a national policy that: (a) pollution should be prevented or reduced at the source whenever feasible, (b) pollution that cannot be prevented should be recycled in an environm entally safe m a nner whenever feasible, and, (c) disposal or other release into the environm ent should be em ployed only as a last resort and should be conducted in an environm entally safe m anner. EPA defines "pollution prevention" to m ean "source reduction," as defined under the PPA, and other practices that reduce or elim inate the creation of pollutants through; (a) increased efficiency in the use of raw m a terials, energy, water, or other resources, or, (b) protection of natural resources by conservation. The PPA defines "source reduction" to m ean any practice which: (a) reduces the am ount of any hazardous substance, pollutant, or contam inant entering any waste stream or otherwise released into the environm ent (including fugitive em issions) prior to recycling, treatm e nt, or disposal, and, (b) reduces the hazards to workers, public health, and the environm ent associated with the release of such substances, pollutants, or contam inants. The term includes: equipm ent or technology m odifications, process or procedure m odifications, reform ulation or redesign of products, substitution of raw m a terials, and im provem e nts in housekeeping, m a intenance, training, or inventory control. The term "...does not include any practice which alters the physical, chem ical, or biological characteristics or the volum e of a hazardous substance, pollutant, or contam inant 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 therm a l oxidizers, incinerators, or waste water treatm e nt system s are not defined as "source reduction". EPA is interested in inform ation on how im proved processes for handling individual new chem ical substances m a y reduce potential exposures and releases of specific PMN substances. Subm itters m ay include a discussion of Pollution Prevention/Risk Reduction m easures actually selected for im plem entation and the rationale for the selection. Subm itters are encouraged to consider and include inform ation com p aring the releases and exposures for various process options considered but not selected, anticipated reductions in releases and exposures which can beexpected in the production of the PMN substance as com p ared to an existing chem ical substance, and how the PMN substance and/or the product in which it is used m ay com p are favorably with existing chem icals in term s of pollution prevention. Subm itters m ay also describe other pollution prevention-related advantages, such as process m odifications, increases in product life or durability, or decreased energy consum ption, etc. A set of questions to address these concerns is put forward in Section II of this Manual. EPA is also interested in inform ation describing possible reductions in toxicity, and hum an exposure, as well as environm ental release of a new chem ical substance, as com p ared to those of already comm e rcialized chem ical substances for which the new substance m ay substitute. Such inf o rm ation m ay dem onstrate that the new chem ical substance is a viable saf e r substitute f o r an existing chem ical substance. Voluntary subm ission of pollution prevention inform ation is not intended to negatively affect the outcom e of EPA' s review of the Prem anufacture Notification. Wh en risk reductions are docum ented, the inf o rm ation will be caref ully considered during EPA' s review of the PMN. Based on the inform ation, EPA m ay reduce or elim inate anticipated exposure controls and testing requirem e nts which would ordinarily have been im posed by the Agency. Com p letion of this section is also im portant if you wish your substance to be considered for the EPA New Chem icals Pollution Prevention Recognition Project.
Reference Material
EPA' s new "Facility Pollution Prevention Guide", a successor to the 1988 "W aste Minim i zation Opportunity Assessm ent Manual", is available to help firm s develop broad-based m

u ltim edia pollution prevention program s. W o rksheets and other inf o rm ation are included to help facilities identify, assess, and im plem ent opportunities for preventing pollution, including m e thods of controlling waste creation during th e production process, as well as product design and redesign. Developed by EPA' s Pollution Prev ention Research Branch, and Office of Solid W a ste, the Guide (Doc. No. EPA/600/R-92/088) can be ordered by m a il from : EPA Center for Environm ental Research Inform ation Publications Unit 26 W

. Martin Luther King Drive Cincinnati, OH, 45268 (800) 490-9198II. PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING EPA FORM 7710-25 (rev. 5-95) THE TSCA §5 NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE FORM Page 1: Identify Type of Notice, Your Submission Total Number of Pages: Give total pages as subm itted, including attachm e nts. TS-number: The subm itter chooses this num ber. It is used by the bank which receives m oney for EPA when it notifies the Agency that the fee has been received, and also to enable us to assem b le the parts of a subm ission when additional comm unications (letters of support, joint subm issions, corrections) are sent before a PMN/LVE num ber has been assigned. There are six spaces in the TS-num ber block on the PMN form

. W e have actually had duplication of TS-num bers, and these instructions have been revised to add som e new requirem e nts to m a ke duplication less likely in future: your TS-num ber m u st be a 6-character alphanum eric. It should include 2, 3, or 4 letters. One or m o re num erals m u st be interposed between two letters (that is, LLNNLL, LNNNLL, NNLLNL, NLNLNL are okay, LLLNNN, NNNNLL are not). W e recomm e nd against com p any nam e s, recognizable words and num erical series (ROY01X, X01DOW are not good ideas). The TS-num ber should be unique to this subm ission fr om your com p any, do not give this num ber to a subsequent subm ission. If we get a TS-num ber with a subm ission and it does not com port with this guidance, we will call the subm itter and ask f o r a new num ber which does. Confidentiality Claims : Check this box if ANY inform ation in the form is claim e d confidential.
Test and Other Data : Indicate which types of data are included with the PMN. Type of Notice : Please check the type of notice subm itted. Check "PMN" if the application is for a standard, final-product new chem ical substance for placem ent on the TSCA Inventory. The "Interm e diate PMN" box should be checked if this notice is for a chem ical substance which is an interm ediate used in the production of a final product for which a separate notice is subm itted sim u ltaneously, and for which the subm itter has no intention of m a king a separate, noninterm ediate use. In addition, the interm ediate PMN m u st identify the final product. Separate user fee identification num bers m u st be generated for and appear on each notice; although a single check m ay be rem itted bearing all user f ee identif ication num bers f o r a sequence of interm ediate(s) and final product. "Certification", below, discusses fees paid by sm all m anufacturers. For further inform ation on "interm e diate PMNs" see 40 CFR §§700.43 and 700.45(b)(2)(ii). The "Significant New Use Notice" (SNUN) box should be m arked for any notice that is subm itted in accordance with a SNUR. The "Test Marketing Exem ption Application" (TMEA) box should be m arked for anynotice subm itted in accordance with the criteria listed in 40 CFR §720.38. You are not required to use form 7710-25 (rev. 5-95) to subm it a TMEA, but it is encouraged. Boxes are also provided to identify your subm ission as an application for either a "Low Volum e Exem ption" (LVE) [see 40 CFR §723.50(c)(1)] or a "Low Release/ Low Exposure Exem ption" (LoREX) [see 40 CFR §723.50(c)(2)]. These exem ptions m u st be requested through use of the PMN form

. Modifications for earlier approved requests for either of these exem ptions are requested by checking the m odification box on the first page of the PMN form

. For an application to m odify an LVE or LoREX exem ption, a subm itter is not required to provide again inform ation which was subm itted in a previously approved exem ption. Each page from the application on which som e inform ation has changed, and a new signature page, m u st be provided. An application for an LVE for a substance which had been the subject of a prior LVE which had been subm itted before the am endm ents of March 29, 1995, however, is a new application and the full form 7710-25 m u st be subm itted. If this notice is for a consolidated PMN, the num ber of chem icals (two or m o re, but no m o re than six) included in the notice should be entered on page one in the space provided. A separate PMN num ber is assigned to each chem ical substance identified in a consolidated notice. Approval for a consolidated PMN notice m u st be obtained from the Prenotice Coordinator prior to subm ission. You are required to identify the Prenotice Comm unication num ber you were given when your consolidation was approved on page 3, question 3 of the form

. Further inform ation on subm itting a consolidated notice is provided at Section I, Part I of this m anual. Page 2 Certification The of f i cial nam e d in Part 1, Section A of the f o rm , as the person subm itting the notice, m

u st sign the certification on page 2 of the notice form

. This official is responsible for the truth and accuracy of each statem ent in the certification. If an agent assists you in preparing the notice, the agent m u st also sign the certification. All signatures m u st be original, and in ink. In addition, the subm itter m u st check certain "user fee" certification statem ents as appropriate as required at 40 CFR §700. For a PMN, consolidated PMN or SNUN, a fee is required: if the subm itter is a sm all business it m u st rem it the f ee identif ied in either 40 CFR §700.45(b)(1) (sm a ll business concerns rem it a fee of $100). If the subm itter is not a sm all business it m u st rem it the fee identified at 40 CFR §700.45(b)(2) (all non-"sm a ll" subm itters rem it a fee of $2,500 for final products, $1,000 if the subm ission is for an interm ediate and is subm itted with the application for the final product).
A sm all business concern is one whose total annual sales (include all sites, including those owned or controlled by a foreign or dom estic parent com p any) are below $40 m illion for the fiscal year preceding the date of the subm ission of the applicable §5 notice (see 40 CFR §700.43).
Wh en using the PMN form to subm it a LVE or LOREX application in accordance with 40 CFR §723.50, all three of the corresponding certification statem ent boxes m u st be checked to acknowledge that you will m anufacture under the term s of the exem ption. In addition, asubm itter of an LVE application m u st certif y that the m anuf acturer intends to comm e nce m anufacture of the proposed exem pted substance for comm e rcial 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 inform ation on the official who signed the general certif ication. b. Agent - Com p lete only if you authorize an agent to assist you in preparing this notice. The agent m u st also sign the certification as noted above. If you m ark the "Confidential" box next to ite m s a or b, all inform ation in the item will be treated as confidential.

c. Mark the box if your subm ission is a joint subm ission. Identify in Part I, Section A (1)(c) the nam e of the joint subm itter who is authorized by the U.S. subm itter to provide som e of the inform ation required in the notice. For additional inform ation on joint subm issions, see part I, section J of this Manual. A notice will not be considered com p lete until all inf o rm ation is received by the Agency. If inform ation from m u ltiple parties will not be sent to the Agency in the sam e package, use your TS user identification num ber to link m u ltiple notices. You can generate a TS-num ber solely to link subm issions, even for a no-fee exem ption. If you don' t generate a TSnum ber you should ask a prenotice coordinater to issue a prenotice comm unication num ber for this purpose. Mark the "Confidential" box next to item c if you wish this inform ation to be treated as conf idential. If you authorize another person (e.g., a foreign m anufacturer or supplier) to provide inform ation, such as, confidentially held tradenam e chem ical substance identification directly to EPA, indicate which inform ation will be supplied by the other person. Identify that person by nam e , com p any, and address in a continuation sheet. That person' s identity m ay be claim e d as confidential. A letter of support for your notice should be provided by the joint subm itter on its com p any letterhead. A notice will be considered incom p lete until this inf o rm ation is provided. Wh enever possible use your TS-User Identification Num b er to link this inform ation.
2. Technical contact - Identify a person who can provide EPA with additional inform ation on the new chem ical 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 norm a l business hours. If you m ark the "Confidential" box next to this subsection, all inform ation in it will be treated as conf idential.
3. Provide any prenotice comm unication num ber a ssigned to your prenotice inquiry. In addition, see Section II, Part E of this m anual for further inform ation on subm ission of a consolidated PMNthat requires a prenotice consultation.
4. Provide the exem ption num ber assigned f o r any previous exem ption application subm itted f or the chem ical substance covered by this notice. It is especially im portant for an exem ption m odification request that you provide the EPA assigned exem ption num ber from your original exem ption application. Also, provide a prev iously assigned PMN num ber, if any, for the chem ical substance.
5. Self-explanatory.
6. Mark to indicate whether you intend to m anufacture or im port the new chem ical substance or both m anufacture and im port. Use the optional binding box to indicate your willingness to be bound to either im port or dom estic m anufacture only. Section B - Chemical Identity Information (Pages 4-6) Subm itters of PMN and exem ption notices are required to provide the currently correct Chem ical Abstract (CA) nam e for the substance(s) identified in the notice based on the Ninth Collective Index (9CI) of CA nom enclature rules and conventions, and consistent with listings for sim ilar substances in the Inventory. EPA m u st receive com p lete and unam b iguous identification of the new chem ical substance. If the substan ce is not adequately identif ied, the subm ission will not m eet statutory requirem e nts and the notice review period will not begin. If a principal im porter does not know the specific identity of the new substance, the subm itter m u st contact the f o reign m anuf acturer or supplier and have the specif i c chem ical identity inf o rm ation required in the PMN provided directly to EPA. In this way, foreign m anufacturers can protect confidential business inform ation. The sam e holds true for U.S. m a nufacturers reporting chem ical substances using a generic or trade nam e to identify a com ponent of the new chem ical substance. The subm itter of the new chem ical substance m u st have the supplier provide chem ical identity inform ation directly to EPA before the notice can be considered com p lete. This inform ation m a y be provided in a letter of support from the supplier or as a joint subm ission between the two com p anies. A letter of support should be provided on the supplier com p any' s letterhead. See Part I, Section J(2) of this m a nual on how and when to file a joint subm ission. Since a letter of support or a joint subm ission m ay be received separately by the Agency, an identification num ber such as a TS-user fee num ber or a Prenotice Comm unications num ber should be used to link a PMN with inform ation from a supplier or foreign m anufacturer. The identical identification num ber should appear on both pieces of correspondence subm itted to EPA; otherwise, there can be a delay in processing the PMN. The type of chem ical identity inf o rm ation required in the notice depends on whether the substance is a Class 1 or Class 2 substance or a polym er. A Class 1 chemical substance is a substance whose com position, except for im purities, can be represented by a definite chem ical structural diagram

. For Class 1 substances, a nam e that is consistent with the nom enclature rules and conventions of the 9th Collective Index of the Chem ical Abstracts Service (CAS) and with current TSCA Inventory listings m u st be provided. Exam ples of such substances are 1,3- butadiene, benzene, and sodium chloride.A Class 2 chemical substance is a substance whose com position cannot be easily represented by a definite chem ical structural diagram

. Such a substance is generally derived from natural sources or com p lex reactions. Its com position m ay be com p lex, difficult to characterize, and variable. For Class 2 substances and polym ers, a CA Index Nam e or CA Preferred Nam e m

u st be provided. In addition, for a Class 2 substance, the notice m u st identify the imm e diate chem ical precursors and reactants by specific ch em ical nam e and Chem ical Abstracts Service Registry Num b er (CASRN), if the num ber is available. Trade nam e s or generic nam e s of chem ical precursors or reactants are not acceptable as substitutes for specific chem ical nam e s. Unacceptable nam e s would include, e.g. , "chlorinated naphthalene", "glycerol m onoester of hydrogenated cottonseed oil acids", or a "reaction product of x, y, z".
A polymer is a substance com posed of m o lecules characterized by the regular or irregular repetition of one or m o re types of identical m onom eric units. In m o st cases, the num ber of m onom eric units is quite large and not precisely known. If the substance is clearly a Class 1 or 2 substance, then item s a-d of Question 1 on Page 4 m

u st be properly com p leted. If the substance has been nam e d as a polym er (whether the Exem ption Rule requirem e nts are m e t, or not), then item s a-c of Question 2 on Page 5 m u st be addressed and answered com p letely. If you are uncertain whether the chem ical substance is a Class 1 or 2 substance or a polym er, then both Questions 1 and 2 on Pages 4 and 5 should be com p leted in f u ll, or contact the Prenotice Coordinator f o r f urther assistance. If the variability of the com position of a reaction product is too com p lex to be described as distinct individual com ponents, then reaction product nom enclature is em ployed. If, however, com ponents of a reaction product can be readily identified and will always be present in the reaction product, then the com ponents should be specifically identified and m a y be listed individually on the TSCA Inventory. All reaction products m ay be reported as Class 2 substances. Subm itters m a y obtain the correct chem ical identity of the PMN substance through the Chem ical Abstracts Service (CAS) Inventory Expert Service (so-called Method 1) or from any other source (so-called Method 2). Consolidations MUST be subm itted with Method 1 nam e s. A notice subm itter m u st identify in the chem ical identity section which m e thod they used to report the substance' s identity. For Method 1, a copy of the CAS report m u st be attached to the notice. Subm itters who choose to develop their own chem i cal identity are cautioned that the Agency will consider subm issions incom p lete and thus delay their review if incorrect nom enclature is received from a source other than CAS. If the Inventory Expert Service has been used, the Agency will work with the IES to agree on a nam e , and the review period will not be af f e cted. Use of CAS services other than the Inventory Expert Servi ce, including CAS' Registry Service, will also be considered Method 2. In all cases, each chem ical substance in a consolidated subm ission m u st be identified by Method I. 1. Class 1 or Class 2 chemical substances (Page 4)

a. Mark the appropriate class. b. Enter the specific chem ical nam e of the new chem ical substance.For a Class 1 substance, the nam e m u st be a clear description of a unique substance. In describing the chem ical substance, the EPA requires Chem ical Abstracts Service (CAS) chem ical nom enclature be used for identification purposes when it is available. There is a separate box in question one, item c on page 4 f o r entry of the CAS num ber. The Agency encourages subm itters to have contact with CAS prior to subm ission in order to obtain concise chem ical identity inform ation. Use the CAS standard rules of chem ical nom enclature to identify the new substance. Identify the positions of attachm e nt of chem i cal groups or of unsaturation, if any, by using locants. The chem ical nam e should contain all of the inform ation known about the details of the structure and should perm it the drawing of an unam b iguous chem ical structural diagram

. The chem ical nam e of a Class 2 substance m u st describe the chem ical substance as com p letely as possible. In som e cases, the nam e m ay be sim ilar to the nam e s used to describe Class 1 com pounds, but it should indicate the substance' s m u ltiple com ponents. For exam ple, "polychlorinated biphenyl" indicates a com positi on that has m u ltiple com ponents varying both in the num ber and the placem ent of the substituent chlorine atom s. In other cases, the best possible nam e m ay only identify the substance as a reaction product of specified reactants, for exam ple, "anhydrosorbitol m onoester of hydrogenated castor oil acids".

c. Provide a m o lecular form ula that gives the identity and num ber of atom s of each elem ent contained in the m o lecule. For exam ple, C6H6 is the m o lecular form ula for benzene. Wh en the substance is not m o lecular or when the exact num ber of atom s in the m o lecule is indefinite, such as the infinite crystal sodium chloride, give the relative num bers of each elem ent' s atom s. You are required to enter the CAS registry num ber, if one has been assigned to the substance.

d. For a Class 1 substance, provide a structur al diagram

. The diagram should clearly indicate the identity of the atom s and the nature of bonds joining the atom s. Any ionic charges or stereochem istry should be shown clearly. In the description of the nature of the reaction or process, as m u ch specific detail as possible should be provided on the reaction conditions, (i.e. tem p erature, tim e, etc.) and on the relative am ounts of reactants. All known stereochem ical details should be provided. Carbon atom s in ri ng system s and their attached hydrogen atom s need not be explicitly shown. Wh ere applicable, specify the proportions of isom ers or tautom eric form s, degree of neutralization, etc. For a Class 2 substance: (1) List the imm e diate precursor substances by ch em ical nam e and CAS Registry Num b er (if known). (2) For substances prepared by chem ical reaction, describe the nature of the reaction or process. A description should appear in the form of a reaction schem e : A + B

)))))))) > C The nature of the reaction m u st be described as specifically as possible (e.g., acetylation, alkaline hydrolysis, diazotization). For substances that have been produced without chem icalreaction (e.g., by chem ical extraction from a natural source), specify the source, the production process, and the nature of the product.

(3) If you intend to m anufacture a Class 2 chem ical substance within a lim ited range of possible com positions, report the range. For exam ple, a m anufacturer filing a notice for chlorinated naphthalene m i ght specify a com positional range of 20-40 percent chlorine by weight. In determ ining the range, you m ay have to consider the reaction conditions, the catalyst, or the purification process that m ay be used to produce the substance, and other factors. You should provide the range of com position in weight percent for each specific com ponent or class of com ponents that you intend to m anufacture for comm e rcial purposes. Indicate the typical com position or any actual values for sam p les. (4) Provide as com p lete a structural diagram as possible. The diagram should indicate the characteristic structure or variable com positional elem ents of the substance. 2. Polymers (Page 5) Subm itters should be aware of the PMN filing exem ption, applicable to som e polym ers and useful to som e m anufacturers. The regulations for this exem ption are at 40 CFR §723.250. Persons intending to m a nufacture polym ers, and who have determ ined that their polym ers do not m eet the requirem e nts of the exem ption should file a PMN or LVE/LoREX. Persons intending to m anufacture polym ers, and who have determ ined that, for business reasons, an Inventory listing for their substance is desirable, should file a PMN.

a. Indicate the lowest num ber-average m o lecular weight of any com position of the polym er you intend to m anufacture. Identify the m e thod you used to m a ke this determ ination (e.g., vapor pressure osm om e try or other colligative property determ inations, gel-perm eation chrom a tography, light scattering, or various correlative techniques). If you have not determ ined num ber-average m o lecular weight by analytical m e thods, briefly explain the basis for your estim ate. Indicate the maximum weight percent of low m o lecular weight species below 500 and below 1,000 absolute m o lecular weight. Include the weight of oligom eric reaction products (including m o lecules form ed that are not polym er m o lecules) in your determ ination but do not include the weight of residual m onom ers or other reactants. Attach test data with two copies supporting your estim ate. If you do not have actual test data, provide an estim ate and describe the basis for the estim ate. NOTE: The lowest num ber-average m o lecular weight is NOT the lowest MW of any com ponent of the polym er m i xture, but the lowest num ber average of several sam p les of the sam e polym er, run over tim e. b. Column (1) - Monomer or other reactant and CAS Registry Number You are required to provide the chem ical nam e and CAS Registry Num b er of each reactant used in the m anufacture of the polym er or incorporated into the polym er, in cluding those used or incorporated at 2 weight percent or less. Reactants include m onom ers, free radical initiators, and cross-linking, chain transfer, and other reactive agents that are used in tentionally to becom e chem ically a part of the polym er com position. If a prepolym er is used in the m a nufacture of the polym er, list the prepolym er and its CASRN as charged into the reaction vessel. If prepolym er com positional inform ation is available to the subm itter, identify by bracketing or another m e thod the m onom erswhich are com ponents of the prepolym er. If com positional inform ation of the prepolym er is not available to the subm itter or if the prepolym er is represented f o r purposes of TSCA by a structural repeating unit (SRU) nam e (exam p les include silicones and polyethoxylated and -propoxylated substances), you should identify the prepolym er as it is listed in the TSCA Inventory. Solvents, em ulsifiers, and non-reacting com ponents should not be listed. Column (2) - CBI claim

. Column (3) - % of reactant, typical composition: For each reactant (including m onom ers), indicate its typical weight percent in the polym er. The weight percent can be determ ined in one of two ways: according to the weight of the reactant charged to the reaction vessel or the weight of the chem ically com b ined (incorporated) reactant in the polym er. For the first m e thod, the weight percent of a reactant is the weight of the reactant charged to the reactor divided by the weight of the polym eric chem ical m anufactured ( tim es 100). Thus, the weight percent of reactant A of a polym er m a nufactured from reactants A, B, and C is the weight of A charged to the reactor divided by the dry weight of the polym er A-B- C (tim es 100). For the second m e thod, the weight percent of the reactant using the "incorporated m e thod" is determ ined using theoretical calculations of the m i nim um weight of m onom er or other reactant necessary to account for the polym er' s actual weight. Manufacturers m u st m a inta in analytical data or theoretical calculations to dem onstrate their determ ination. Please note that zero per cent is NEVER an acceptable level of a feedstock, if that feedstock is part of the chem ical identity. To describe a substance as including "0-30%" of a given feedstock will only result in getting the PMN returned for a better identity. If you are notifying for a substance for which a feedstock will vary from very low levels you can enter ">0- 30%" or "trace-30%" without, as you will if you enter "0-30%", forcing a new identity. "0 - 2%", however, would be acceptable for a chem ical that is not part of the ID and is not m a rked in the ID field). If you use a prepolym er in the m anufacture of the polym er, you m u st determ ine the weight percent of its com ponent reactants. For exam ple, the weight percent of E used in the m anufacture of a polym er (using the "am ount charged" m e thod) from reactants A, B, and C and prepolym er D-E is the total weight of m onom er E in the pr epolym er D-E used divided by the weight of the polym er A-B-C-D-E m anufactured (tim es 100). Y ou m u st provide the identity and typical weight percent of each m onom er and other reactant used in the m a nufacture of the polym er regardless of the weight percent at which it is used. If you will typically m anufacture the polym er using a reactant in a range of weight com position, you m ay indicate the range of weight percent instead of the typical weight percent. Column (4) - Identity Mark : Reactants used or incorporated at greater than 2 weight percent in the m anufacture of the polym er are included as part of the description of the polym er listed on the TSCA Chem ical Substance Inventory. However, you can choose to include a reactant used or incorporated at 2 weight percent or less in th e Inventory description of the polym er by m arking this column. Mark the identity columnif you want a reactant present or incorporated at 2 weight percent or less to be included in the description of the polym er which is added to the Inventory.Column (5) - CBI claim

. Column (6) - maximum w e ight percent present : Indicate the maximum weight percent of each reactant that m a y be present as a residual (unreacted m a terial) in the polym er as m anufactured for comm e rcial purposes. Column (7) - CBI claim

. Note that you m u st m a ke separate confidentiality claim s for reactant identity, com position inform ation, and residual reactant inform ation.

c. Identify which m e thod you used to develop or obtain the specified chem ical identity - Method 1, CAS Inventory Expert Service (a copy of the identification report obtained from CAS Inventory Expert Service m u st be subm itted as anattachm e nt to the notice), or Method 2, other than CAS Inventory Expert Service.
d. Correct Chem ical Abstracts (CA) nam e for the polym er that is consistent with TSCA Inventory listings for sim ilar polym ers.

e. Provide a sim p le, representative structural diagram that illustrates what you know or can reasonably ascertain concerning the key structural features of the polym er m o lecules. For exam ple, you could identify the linkages form ed during polym erization, the functional groups present, the range and typical values for the num ber of repeating structural units, and the relative m o lar ratios of the precursors. Indicate if the repeating substructures are arranged in a nonrandom order such as in graft or block arrangem e nts. For exam ple:O O 

### 2 2 HO-R-O-(C-R'

- C-O-R-O) n -H 3< n < 10, where R m ay be either -CH 2 CH 2 -or -CH 2 CHCH 3 and R' m ay be either a 1,4-substituted benzene ring or -(CH 2 ) 4 - Provide approxim a te relative m o le ratios of precursors, e.g. :

diethyl terephthalate: 2.0 adipic acid 1.5 ethylene glycol 1.0 propylene glycol 3.0
3. Impurities (Page 6)

a. Identify each im purity you reasonably anticipate will be present in the substance as m anufactured for comm e rcial purposes. An im purity is any chem ical substance that is unintentionally present in the new chem ical substance. List all im purities (regardless of weight percent). If the substance contains som e unidentif ied im purities, also enter "unidentif ied" in column(a). Do not include any substances that are m i xed with the new substance after m anufacture. In addition to im purities, list in this section other chem ical substances, such as solvents, inhibitors, etc., that also m ay be reasonably anticipated to be present in the chem ical substance as m anufactured for comm e rcial purposes. You should consider the following in identifying im purities: (1) Chemical and instrumental analyses - often perform e d on the chem ical substance during research and developm ent to characterize the substance before it undergoes health effects or environm ental effects testing, to optim ize product perform ance, or to understand process chem istry and optim ize output. (2) Manufacturing process chemistry - including f eedstocks, f eedstock im purities, byproducts, and interm ediates both from the m a jor reaction pathway and from significant side reactions. (3) Quality control operations - operations which determ ine the nature and level of im purities that m ay be present in the chem ical substance.Identif y impurities as specifically as possible. You should provide the following inf o rm ation: (1) the specific chem ical nam e ; 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 Num b er if available.
b. Enter the maximum weight percent of each im purity in the new chem ical substance in column(b). If the substance contains unidentif ied im purities, enter the total weight percent of unidentif ied im purities in column(b). confidentiality claim : m u st be m a de separately for each im purity.
4. Synonyms - Enter comm on chem ical nam e s by which the new chem ical substance m a y be identif ied in the scientif ic or technical literature, including the nam e s or codes used to identif y the new chem ical in test data or other data which are attached to the notice.
5. Trade Identification - Enter any trade nam e under which the new substance has been or will be m arketed. Report all trade nam e s or brand nam e s, even if they are not registered.
6. Generic chemical name -- If the new substance' s identity is claim e d as conf idential, enter a generic chem ical nam e
. This nam e should be only as generic as is necessary to protect the confidential chem ical identity, and should reveal the chem ical identity of the substance to the m a xim um extent possible. The generic nam e will be published in the FEDERAL REGISTER notice on the new substance. EPA will review the adequacy of the generic chem ical nam e when the NOC f o r the substance is subm itted. If the nam e seem s m o re generic than necessary, EPA will contact you to develop an adequate nam e
. Generic chem ical nam e s are created for Class 1 chem ical substances by m a sking structurally descriptive parts of their specific chem ical nam e s. Masking can be accom p lished by substituting non-descriptive term s (e.g., “substituted”) for descriptive parts of the nam e
. Here is an exam ple with the oil source m a sked: hydrogenated palm -oil fatty acids, esters with D

m annitol, ethoxylated, could becom e : hydrogenated fatty acids, esters with hexahydroxyalkane, ethoxylated. Guidelines for developing a generic nam e are provided in Appendix B of the TSCA Chem ical Substance Inventory, Volum e 1, 1985. This docum ent is available in any Federal Depositary Library or through the TSCA hotline (see Contact List, Appendix B).
7. Byproducts - List the byproducts that you reasonably anticipate will result from the m anufacture, processing, use, and disposal of the new chem ical substance at sites you control. Identify the byproducts as specifically as possible by nam e and CAS Registry Num b er (if available). You should give the following inform ation:(1) the specific chem ical nam e ; 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 Estim ate the production volum e for the first 12 m onths of production. Also estim ate the m a xim um production volum e for any consecutive 12-m onth period during the first 3 years of m anufacture. Provide your estim ates in kilogram s. Maxim um production volum e is the m a xim um am ount of the new chem ical substance on a 100% basis. Report the am ount of pure new chem ical substance, not including solvents or other com ponents if the new chem ical substance is in a m i xture that you expect to produce during any 12-m onth period ( e.g. , June 1990 through May 1991). Include in this total am ounts produced by persons under contract to you. If part of the am ount m anufactured is for export, include this am ount in your estim ates. (You are not allowed to exclude exports from LVE quantity lim its after any of the substance is m anufactured for dom estic use) If you subm it a consolidated PMN, m a ke your production volum e estim ates on a per chem ical basis. For an LVE, the Agency will generally perf orm the risk assessm ent under the exem ption as if the total am ount perm issible under the exem ption (10,000 kg) were being produced. However, subm itters wishing their exem ption to be based upon annual production volum es lower than 10,000 kg m ay so indicate in their exem ption notice by m arking the binding box adjacent to the production volum e space on the form

. Subm itters who so elect are bound by their election, and if they subsequently wish to increase their m a xim um production volum e under the exem ption m

u st subm it a new exem ption notice cross-referencing the original exem ption num ber on the cover of the notice. If the new exem ption is granted, it will supersede the previous exem ption. 2. Use information

a. Column (1) category of use: Identify the intended category of use of the new chem ical substance by describing its function and application. "Function" is related to the inherent physical and chem ical properties of the substance (e.g., degreaser, catalyst, plasticizer, ultraviolet absorber). "Application" refers to the use of the substance in particular processes or products (e.g., a degreaser m ay be used for cleaning of fabricated m e tal parts).

Following are som e exam ples of appropriate categories of use: 

### ! a disperse dye carrier for finishing polyester fibers 

### ! a cross-linking agent for epoxy-type coatings for m e tal surfaces 

### ! a flam e retardant for surface application on cotton apparel, textile hom efurnishings, and exterior canvas products 

### ! a surfactant in autom obile 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) Estim ate the percent of the total production volum e that you anticipate will be m anufactured for each category of use. Column (5) CBI claim

. Column (6) Estim ate the weight percent of the new chem ical substance that will be contained in any form ulated m i xture, suspension, em ulsion, so lution, or gel associated with each category of use as m anufactured for comm e rcial purposes at sites under your control. Wh ere the substance is distributed from your site in a pure state, enter 100%. In the exam ple below, a PMN substance will be used f o r several dif f e rent uses, including a crosslinking agent where the substance is distributed in a pure state and as a surfactant where the substance is m anufactured, then form ulated at a weight percent of 4%. Eighty percent of the production volum e goes to the first use and twenty percent of the production volum e will be used for the second use.

Cate gor y of us e C B I B i ndi ng Op t i on % o f Pr oduc ti on CBI % in Form ulation C BI

Cross-linking Agent X X 80 X 100 X
S ur f actant in Autom obile S pr ay Wax X X 20 X 4 X Column (7) CBI claim

. Column (8) Mark to indicate if the category of use is site-lim ited or, if the substance is intended for industrial, comm e rcial, and/or consum er use, as defined below, estim ate the percent of the production volum e expected for each category.
Site-limited - The substance will be used only on the contiguous property unit where it is m anufactured and not intentionally distributed outsi de that site except for waste disposal. This includes all factories, storage places, and warehouses at the site. In m o st cases, this would be an interm ediate which is further reacted on-site. If the substance is transported across a public road which bisects a site, it can still be site-lim ited.
Consumer - The new chem ical substance or products containing the substance will be used byprivate individuals in or around a residence, or during recreation, or for any other personal use or enjoym ent, e.g., autom o tive polish, dyed wearing apparel, household cleaners, hunting lure, etc. If a consum er use is identified, then the EPA requests the following inform ation to be provided on an attached continuation sheet: a detailed description of the use of the new chem ical substance expected in consum er products and any reactions that occur causing the substance to lose its identity in the consum er 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 consum ers (e.g., coatings).
Industrial - The new chem ical substance or products containing the substance will be used at the site of other m a nufacturers or processors, e.g., textile dyeing, paint form ulation, use of a curable resin to m anufacture an article.
Commercial - The new chem ical substance or products containing the substance will be used by a comm e rcial enterprise providing a consum er service, e.g., use by comm e rcial dry cleaning establishm ents, use by painting contractors, or use by roofers in comm e rcial building construction. Mark all boxes, as appropriate. For exam ple, a surfactant in an autom obile wax m ay have a consum er use in liquid wax, a comm e rcial use in auto washes, and an industrial use by autom obile m a nufacturers. Mark the binding option statem ent where applicable.
Note: You m u st m a ke separate conf identiality claim s f o r the description of the category of use, the percent of production devoted to each category, the percent in form ulation, and category of use inform ation. The inform ation in this section is used to evaluate potential exposure and release of the new substance. If you wish to provide any additional inform ation which would assist in this analysis, it m ay be subm itted as optional inform ation. You should be aware that the Agency uses conservative default assum p tions to estim ate exposure in the absence of specific inform ation.

c. Generic use description - includes degree of containment - For each category of use description which is claim e d as confidential, provide a generic description of the category. If such a generic description does not provide a sufficient indication of potential exposure, the description can also describe the degree of containm ent of the new chem ical substance, as shown in the list below; however, a generic use description that solely describes the degree of containm ent 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 m a xim um extent possible. For exam ple, the specific use of a new substance as an antioxidant in a lubricant could be described generically as a lubricant additive; a fiber-reactive dye for nylon carpeting could be described generically as a dye for fi bers. Degree of Containment(a) destructive use ( e.g., fuels, fuel additives, chem ical interm ediates)
(b) contained use ( e.g., catalysts used in closed processes, certain photographic chem icals, capacitor fluids) (c) open, non-dispersive (e.g., printing inks, textiles, dyes, plastic izers, adhesives, liquid paints, resins) use (d) dispersive use ( e.g., cutting fluids, fa bric softeners, autom obile tire rubber) (e) highly dispersive use ( e.g., fertilizers, sa lt for de-icing, paint solvents, spray paints) (f) other ( describe)

3. Haz a rd information - Include in the notice a copy or reasonable facsim ile of any hazard warning statem ent, label, m a terial saf e ty data sheet (MSDS), or other inf o rm ation which will be provided to any person regarding protective equipm en t, engineering controls, or practices for the safe transport, use, or disposal of the new chem ical substance. If hazard warning inform ation is not yet prepared, describe the statem ent you intend to provide, if any. You are not required to develop hazard warning statem ents for this notice if you do not otherwise intend to do so. Identify copies of hazard warning statem ents or other hazard inform ation that you attach in Part III, List of Attachm e nts.
Part II - H UMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Pages 8-10) In sections A and B, you m u st provide in form ation on m anufacturing, processing, and use operations involving the new chem ical substan ce or products containing the new substance. Preparing a chem ical for an end use applicati on typically involves several production steps, or operations, where potential hum an exposure and environm ental release could occur. Use section A to provide inform ation on operations that occur at industrial sites you control. Typically, this will involve m anufacturing 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 autom obiles.
As an exam ple, for a solvent used in autom o tive paint for autom obile m anufacture, there are solvent m anufacture, paint m anufacture, and industrial paint spraying operations. Paint m anufacture m ay occur at a site you control or at a site you do not control. If paint m anufacture occurs at a site you control, describe that operation in section A. If paint m anufacture occurs at a site you do not control, describe that operation insection B. If processing or end use operations occur at industrial sites you control, they should be described in section A.
In m o st cases, you will have m o re specific inform ation on sites you control than sites you do not control. If you do not have specific info rm ation on sites controlled by others, describe a typical operation involving the particular processi ng or end use application based on inform ation available to you and on your experience with sim ilar chem icals. Provide all inform ation requested to the extent to which it is known to or reasonably ascertainable by you. Wh ere EPA has available only lim ited inform ation on worker exposure and environm ental release, its evaluation will be based on reasonable worst case assum p tions.Note that if you are an im porter, although you do not have to com p lete section A or B for operations outside the United States, you m ay still have to report inform ation in these sections. If there are further industrial processing or use operations after im port of the substance, you m u st describe these operations in section A or B as appropriate. Because EPA assesses the potential dom estic m anufacture and processing of im ported chem icals, you m ay choose to com p lete section A or B for operations outside the United States to assist EPA with this assessm ent. Providing this inform ation is optional and is not required. Section A - Industrial Sites Controlled by the Submitter (Pages 8-9)
Com p lete a separate section A for each type of m anufacturing, processing, or use operation involving the new chem ical substance at sites you control. If the sam e operation is perform e d at m o re than one site, you are not required to com p lete a separate section A for each operation, but sim p ly describe the typical operation comm on to these sites. However, if operations or production rates vary substantially am ong the different sites, you m u st provide a separate section A for each different operation.
1. Operation Description

a. Identity - Identify the site which the section describes. If this section describes m o re than one site, provide additional site identities on a continuation sheet. Indicate the total num ber of sites at which the operation this section describes will occur. If you m ark the confidential box next to this item , all inf o rm ation in it will be treated as conf idential.
b. Type - Mark the appropriate box.

c. Amount and duration - Estim ate the m a xim um am ount of the new substance (on a 100% new chem ical substance (i.e. pure) basis) m a nuf actured, processed, or used in the operation and the duration of the operation. Provide inform ation per batch for batch operations and per day for continuous operations. Base the estim ates on the m a xim um 12 m onth production provided on page 7 of the PMN form

. d. Process description - Provide a process flow diagram which describes the m anufacturing, processing, or use operation involving the new chem ical substance. (1) Identify the m a jor unit operation steps and chem ical conversions, including secondary operations involving the new chem ical substance, such as interim storage and shipping containers. "Unit operation" m eans a functional step in a m anufacturing, processing, or use operation where substances undergo chem ical changes and/or changes in location, tem p erature, pressure, physical state, or sim ilar characteristics. Include steps in which the new substance is form ulated into gels, m i xtures, suspensions, solutions, etc. Specify the shipping containers, including expected capacities (e.g. 5 gallon pails, 55 gallon drum s, 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 stream s, and wastes. Identify each feedstockand specify its approxim a te weight (by kg/day for continuous operations or kg/batch for batch operations). Include cleaning chem icals, and state how often they are used (e.g., every day, every batch, m onthly). (3) Num b er all points from which the new chem ical substance and substances containing the new chem ical substance will be released to the environm ent or to control equipm ent, including sm all or interm ittent releases (e.g. som e cleaning releases, drum residues, etc.) and trace am ounts of the new chem ical substance. Do not include accidental releases. Including fugitive em issions is optional. (4) Mark the box if you wish to indicate your willingness to have your process description binding.Sam p le Process Description for a Manufacturing Operation:2. Occupational Exposure Column (1) - w o rker activity: Describe each specific activity in the operation during which workers m ay be exposed to the new chem ical substance. Such activities m ay include charging reactor vessels, sam p ling for quality control, transf erring m a terials from one work area to another, drumm i ng, bulk loading, changing filters, and cleaning equipm ent, etc.. Activities m u st be described even if workers wear protective equipm ent. (Material Safety Data Sheets indicating recomm e nded protective equipm ent should be subm itted as part of Hazard Inform ation in part I, section C, subsection 3 of the notice form .) Column (2) - CBI claim for worker activity. Column (3) - protective equipment and engineering controls: provide inform ation on the specif i c types of protective equipm ent and engineering controls that will be em ployed to protect the worker from potential exposure to the new chem ical substance, i.e., gloves, goggles, 21c respirator, 19c respirator, closed containm ent system , nitrogen blanket, etc.. Column (4) - Binding option for protective equipm ent and engineering controls. Column (5) - physical form: Indicate the physical form [e.g., solid (crystals, granules, powder, dust), liquid (solution, paste, slurry, em ulsion, m i st , spray), gas (vapor, fum e ), wet press cake] of the new substance and its weight percentage (if in a m i xture) at the tim e of exposure, even if workers wear protective equipm ent. Column (6) - Binding option for physical form s. Column (7) - CBI claim for physical form

. Column (8) - maximum number of w o rkers exposed: Estim ate the m a xim um num ber of workers involved in each specific activity, based on the estim ated m a xim um 12-m onth production volum e. Column (9) - CBI claim

. Column (10) - maximum duration in hours/day: Enter the m a xim um 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 m a xim um duration that any one worker will engage in the activity in days/year, e.g., 200 days/year, based on the estim ated m a xim um production volum e. Column (12) - CBI claim

. Note that you m u st m a ke separate confidentiality claim s for the description of worker activity, physical form of the new substance, num ber 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 num ber. If you indicated m o re than 5 release points, m a ke a continuation sheet to cover them

. Column (2) - amount of newchemical released at release point: Estim ate the am ount of new chem ical (in kg/day for continuous operations or kg/batch for batch operations) that will be released f r om the release point directly into either (a) the environm ent or (b) into control technology (in kg/day or kg/batch). Base your estim ate on the expected m a xim um twelve-m onth production volum e. EPA is particularly interested in the am ounts of chem icals used and frequencies of cleaning of e quipm ent and releases from transport containers, including the location (if different from that of m anufacture or processing) of drum recyclers, tank truck cleaning f acility, etc.) Column (3) - CBI claim

. Column (4) - medium of release: Enter the m e dium [ s tack air, f ugitive air (optional), surf ace 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 f ugitive air releases, but if EPA reviewers consider that such air releases are likely and estim ates are not provided in the subm ission the reviewers will estim ate reasonable worst-case f ugitive air releases. In estim ating reasonable worst-case releases we generally consider vapor pressure and type of use, including the location if different from that of site m anufacture or processing. Column (5)(a) release / control technology / efficiency: For a release to air or water, describe the type of technology used to control the release of the new chem ical and the efficiency of the control technique. Exam ples of control technologies include carbon filter, scrubber and biological treatm e nt (prim ary, secondary, etc.). Use the optional binding box to indicate your willingness to be bound to control technology described. Attach optional inform ation such as data and m e thods of waste treatm e nt or purification efficiency studies. (5)(b) release after control technology: Enter the estim ated am ount released to the environm ent after control technology (in kg/day). Enter "none" if no control technology is used and the substance is released directly into the environm ent. For disposal on land, describe the landfill site construction (including liners) and handling procedures. Describe landf ill containers.
You m ay wish to optionally attach efficiency data for control technologies used. For exam ple, carbon adsorption rem oval efficiency of the new chem ical substance from an aqueous stream could help EPA estim ate release of the new chem ical substance f r om a f acility using carbon adsorption treatm e nt. Column (6) - CBI claim

. (7) - destination of w a ter releases: Mark the appropriate box and/or specify other destinations of water releases. [i.e., POTW (Publicly Owned Treatm e nt W o rks), navigable waterway or specifyother]. Provide the nam e of the POTW recei ving water releases and the NPDES (National Pollutant Discharge Elim ination System ) num ber for the POTW , navigable waterway or other direct discharger. This 9-digit num ber is assi gned by EPA or the State under the authority of the Clean W a ter Act. Wh en appropriate, contact your POTW to obtain its NPDES num ber. Note that you m u st m a ke separate confidentiality claim s for the release num ber, am ount of new chem ical substance released, control technology disposal inform ation, and the destination of the releases to water. Section B - Industrial Sites Controlled by Others (Page 10)
Com p lete a separate Section B (continuation pages for second and subsequent) for each type of processing or use operation associated with each category of use specified in Part 1, Section C, subsection 2(a) at industrial sites you do not control. If the sam e operation is perform e d at m o re than one site, then describe the typical operation and enter the num ber of sites in the space provided. Describe each typical processing or use ope ration to the m a xim um extent possible from inform ation known to or reasonably ascertainable by you. Inform ation m ay be provided as ranges or estim ates. 1. Operation Description - Generally self-explanatory - the inform ation requested here differs from that requested for Section A Op eration Description only by the additional worker activity inf o rm ation requested. EPA is particularly interested in the chem icals used and frequencies of cleaning of equipm ent and transport containers.
2. Worker Exposure/Environmental Release Column (1) - Activity Letter : Provide the letter for each activity from the diagram above and com p lete column s 2-8 for each worker activity associated with the letter. Column (2) - maximum number of w o rkers exposed: Estim ate the m a xim um num ber of workers exposed to the new substance during the activity. Column (3) - CBI claim

. Column (4)(a) - duration of exposure - hours/day: Estim ate the duration of exposure of the new chem ical substance per worker in hours per day. Column (4)(b) - duration of exposure - days/year: Estim ate the duration of exposure of the new chem ical substance per worker in days per year. Column (5) - CBI claim

. Column (6) - Physical Form, Protective Eqpt, Eng'g Controls: Provide inform ation on the physical form [e.g., solid (crystals, granules, powder, dust), liquid (solution, paste, slurry, em ulsion, m i st, spray), gas (vapor,fum e), wet press cake] of exposure and percent new chem ical substance (if in a m i xture), and protective equipm ent and engineering controls em ployed tosafeguard the worker from potential exposure associated with the new chem ical substance, i.e., gloves, goggles, respirators, etc.. Column (7) - Percent in the Product Formulation: Estim ate the percent in the product form ulation of the new chem ical substance to which the worker is potentially exposed during the activity. Column (8) - CBI claim

. Column (9) - release points Enter the num ber given to each release point in reference to the process diagram above and com p lete 9-13 for each release point identified (use continuation pages if necessary). Column (10) - maximum release Provide an estim ate for the m a xim um am ount of new chem ical substance in kg per year that m ay be released to the m e dia specified in Column(12) (see below) under typical operating conditions. Provide this inform ation for releases (a) directly to the environm ent or (b) into control technology to the environm ent in kg per day for continuous operations or kg per batch for batch operations. EPA is particularly interested in the am ounts of chem icals used and frequencies of cleaning of e quipm ent and releases from transport containers. Column (11) - CBI claim

. Column (12) - medium of release: Describe m e dium of release [ s tack air, f ugitive air (optional), surface water, on-site or off-site land or incineration, POTW , or other (specify)] and the control technology(ies) used to lim it the release of the new substance to the environm ent to the extent that the inform ation is known to you. Column (13) - CBI claim

. (14) - byproducts: Identify all byproducts resulting from the reaction to the extent that the inform ation is available to you. Note that you m u st m a ke separate confidentiality claim s for the num bers of workers exposed, the duration of exposure, the percentage of the product in form ulation, the am ount of new substance released, and the control technology.

(OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION (Page 11) On the form itself and in Section I of this Manual we describe the Agency' s goals in providing this m echanism to inform us of environm ental benefits which m ay be available from your new substance. Below are suggestions for organizing such inform ation to be m o st useful to im prove the review of your substance: part of the m a terial to provide is about characteristics of the substance and part relates to your process description and calls for a discussion of how a shift tothe new chem ical substance m ay enable the use of the m o re desirable process. If you wish your PMN substance to be considered for the Agency' s EPA New Chem icals Pollution Prevention Recognition Project, you should tell us so in this inform ation.
I. Product Inform ation
W ill this substance be produced to address an environm ental problem or in response to environm ental regulation? (One exam ple would be CFC substitutes.) Do you wish your substance to be considered for the Agency' s EPA New Chem icals Pollution Prevention Recognition Project?
II. Toxicity Inform ation EPA is interested in inform ation describing possible reductions in toxicity of a new chem ical substance as com p ared to that of already comm e rcialized chem ical substances for which the new substance m ay substitute. Such inf o rm ation m ay dem onstrate that the new chem ical substance m a y be a viable saf e r substitute.
III. Technical Inform ation

a. Process Chem istry Chem ical approaches which m ay m i nim i ze waste production include the following:
1. Selection of synthetic m e thod: high yield, m i nim a l side reactions, m i nim i zation of coproducts unless they are of comm e rcial value.
2. Choice and purity of feedstocks, reagents, catalysts, solvents, etc. Reduction/ elim ination of undesirable feedstocks, solvents (e.g. VOC' s ), catalysts, etc.
3. Optim ization of reaction conditions to m i nim i ze side reactions.
4. Optim ization of stoichiom e try to m i nim i ze presence of excess reactants.
5. Product Purification.
6. Use of advanced chem ical technology such as shape-selective zeolite catalysts, stereoselective synthesis, and perm selective m e m b ranes for m o lecular separations (liquid phase). b. Product Substitution/ Source Reduction
1. Perceived advantages related to the use of the new chem ical substance com p ared to existing substances. Com p arison of the relative risk of the new chem ical to existing chem icals (for exam ple, volum es, releases, exposure, hum an health effects and ecotoxicity) of the substances. A new chem ical that causes less pollution m ay nonetheless be m o re toxic than an existing chem ical and therefore the risk to health and the environm ent m ay be higher.
2. Changes in product com position or physical state.Consider potential changes in product com positions or physical states which m ay reduce releases and exposures. For exam ple: using a m o re concentrated product m ay decrease the am ount of release or waste generated; or ref o rm ulating a powder into a paste to m itigate inhalation concerns.
3. Enhanced product life or durability.
Im provem e nts which m ay be expected from enhancem ents to product life or durability of new chem ical substances over existing substances. For exam ple, a m o re durable product could result in less solid waste going to landf ills.
4. Changes in product effectiveness/ Effect of product perform ance at lower concentrations (significant orders of m a gnitude). New chem ical substances which m ay be m o re effective than existing substances, or that m ay be as effective at significantly lower concentrations than an existing chem ical m ay result in reduced releases and exposures.
5. Packaging (transportation, concentration, dis posal, life-cycle analysis, weight loss, etc.).
Exam ples of packaging with pollution prevention in m i nd m ay include (A) reusable packaging m a terials, or (B) m a king the new chem ical substance m o re concentrated to m i nim i ze size or volum e of packaging.

c. Process Modifications
1. Engineering technology changes.
In som e cases, existing equipm ent which m ay be used to produce new chem icals m a y not be the best technology from the standpoint of pollution prevention. Consider alternative technologies for the m a jor unit operations (i.e. separation, filtration, etc.) in the process and their potential im pacts on releases and exposures. Som e exam ples of alternative technologies include: (A) stream stripping instead of air stripping, (B) pan filter versus rotary drum f

ilter or centrif uge or, (C) f l ash dryer versus spray dryer.
2. Equipm ent/piping/ layout changes Equipm ent/piping/ layout alternatives can have an effect on releases and exposures. Som e exam ples of these changes include: (A) redesigning equipm ent and piping to reduce the volum e of m a terial drained for batch changes and for cleaning operations, (B) installing bellow-sealed valves versus conventional valves to reduce VOC em issions and worker exposure, or, (C) use of new resources such as by-product steam from another process.
3. Operating Conditions Optim ize operating conditions at m a jor unit operations (including reactors and separation equipm ent). Available supporting laboratory info rm ation (i.e. experim e ntal design data) m ay be collected and subm itted describing reduction of chem ical exposure using the new PMNsubstance, reduced em issions to the workplace or environm ent, etc. An exam ple m i ght be use of a new surfactant to reduce the am ount of solvent needed in cleanup operations.
4. Autom a tion Potential autom a tion/control steps m ay have pollution prevention or exposure im plications. For exam ple, a batch process can be successfully autom a ted to reduce off-spec. product and spillage, which reduces waste. A m anual packaging system can be autom a ted to reduce worker exposures.
5. Closed system s Reduced exposures, em issions, or elim ination of isolated interm ediates. d. Operating Practices
Exam ples of operational and adm i nistrative changes which could reduce pollution and exposure are: 1. Procedural m easures Increasing drain tim e from 15 to 20 m i nutes could reduce leftover m a terial in a tank.
2. Loss prevention Installing overflow alarm s in tanks could reduce overflows or releases.
3. Managem e nt practices Reducing inventories of toxics to m i nim i ze the consequences of em ergencies.
4. W a ste stream segregation Segregating waste stream s to avoid cross-contam inating hazardous and non-hazardous m a terials could allow recycling of som e waste. For exam ple, changing waste segregation to separate organics from an aqueous waste stream

. 5. Material handling im provem e nts Changing from sm all-volum e containers to bulk or reusable containers could reduce releases of residue.
6. Production scheduling Larger batch sizes can be m a de, which could reduce num ber of production runs, cleanup waste, and worker exposure.
7. SafetyExam ples would be use of substances which are less explosive, less flamm able, or less corrosive. Use of less corrosive substances m a y also serve to decrease cost and m a intenance, as well as increase life, of equipm ent.

e. Reuse/Recycling/Reclam ation Identify potential reuse/ recycling/ reclam ati on (both on-site and off-site opportunities) of the waste stream s. Som e exam ples of the reuse/ recycling/ reclam ation opportunities are:
1. Use of recycled m a terials in original process Returning recovered solids from a filtrate (through the use of a settling tank) to the reactor. W a stes from unrelated processes m ay be used in feedstock to m a ke new substances.
2. Recovery and recycling of resources utilized in the process Installing vapor recovery system s to capture and return vaporous em issions. Feedstock or off-spec. substance previously discarded m ay be recycled back into the process.
3. Reuse or processing of by-products/coproducts of the original process for other processes. The off-acid gas from a reactor could be absorbed with water to convert it into dilute acid and sold as a by-product. f. Energy Savings
Alm o st any change in an industrial process will entail som e change in the am ount and form of energy consum ed in that process. How m i ght the new chem ical substance result in savings of energy resources in any phases of m a nufacture, processing, or use? Energy conservation is a form of pollution prevention. For exam ple, reduced energy use decreases the quantity of fossil fuels burned and the am ount of air pollutants generated. Reduced boiler operation also reduces the discharge of waste cooling water blowdown and boiler blowdown. Purification of raw water to produ ce boiler feedwater by ion exchange or other processes produces wastes such as regeneration chem icals. Reduced boiler operation could also reduce this waste stream

. Another exam ple m i ght be shifting from therm a l polym erization/ curing to radiation polym erization/ curing.
g. Alternative Treatm e nt Methods Consider efficiency of alternative treatm e nt m e thods and the com positions and quantities of the input PMN waste stream s and output release stream s. For exam ple:
1. Use of amm onia instead of sodium hydroxide to neutralize a process, allowing the excess to be vacuum stripped and possibly recycled, rather than rem oval by water washes which create a caustic waste requiring treatm e nt and/or disposal as a hazardous waste.
2. Replacem ent of organic solvents with water, elim inating VOC em issions.h. Alternative W a ste Disposal Methods
Com p are release m e dia (land, air, water) in light of the PMN waste stream s being disposed, including quantity of release, com position of the waste, and applicable regulatory lim itations. For exam ple, an aqueous amm onia waste stream m ay 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 inform ation), and optional inform ation after the last page of the form

. Clearly identif y the attachm e nt and the section to which it relates, if appropriate. Num b er consecutively the pages of the attachm e nts. Enter the inclusive page num bers of each attachm e nt. Enter the total num ber of pages in the notice on page 1 of the form

. Mark the "Confidential" box next to any attachm e nt name you claim as confidential. Read "E" and "H" in Section I of this m anual fo r guidance on how to claim any inform ation in an attachm e nt as confidential. You m u st include with the sanitized copy of the notice a sanitized version of any attachm e nt in which you claim inform ation as confidential. Physical and Chemical Properties Worksheet (Optional) A worksheet which assists EPA' s review of the physical/chem i cal property inform ation you subm it is provided on the last page of the form

. Providing physical/chem i cal property inform ation in this form at is optional. However, all physical/chem i cal properties data in your possession or control m u st be subm itted with your notice. If you subm it this worksheet, identify it on the List of Attachm e nts.Appendix A
EXAMPLES OF TEST DATA Following is a list of the types of test data which you m u st attach to the notice form if it is in your possession or control. This list is illustrative, not exhaustive.

Physical and Chemical Properties and Environmental Fate Data Ë Chrom a togram s Ë Spectra (ultraviolet, visible, infrared) Ë Density / relative density Ë Solubility in water Ë Melting tem p erature Ë Boiling / sublim ation tem p erature Ë Softening point Ë Vapor pressure Ë Dissociation constant Ë Particle size distribution Ë Octanol / water partition coefficient Ë Henry’s law constant Ë Volatilization from soil Ë pH Ë Flamm ability Ë Explodability Ë Adsorption / desorption characteristics Ë Photochem i cal degradation Ë Viscosity Ë Odor Ë Hydrolysis Ë Therm a l analysis Ë Chem ical analysis Ë Chem ical oxidation Ë Chem ical reduction Ë Biodegradation Ë Transform a tion to persistent or toxic products Health Effects Data Ë Mutagenicity Ë Carcinogenicity Ë Teratogenicity Ë Neurotoxicity / behavioral effects Ë Pharm o cological effects Ë Mamm a lian absorption Ë Distribution Ë Metabolism and excretion Ë Cum u lative, additive and synergistic effects Ë Acute, subchronic and chronic effects Ë Structure / activity relationships Ë Epidem iology Ë Reproductive effects Ë Clinical studies Ë Derm atoxicity Ë Phototoxicity Ë Irritation Ë Sensitization Ë Allergy Ë Skin staining Environmental Effects Data Ë Microbial bioassay Ë Algal bioassay Ë Aquatic m acrophyte bioassay Ë Seed germ ination and root elongation Ë Seedling growth Ë Plant uptake Ë Acute toxicity to invertebrates Ë Life cycle test on invertebrates Ë Acute toxicity to fish Ë Early life stage (fish) Ë Avian dietary / reproduction Ë Bioaccum u lation / bioconcentration Ë Model ecosystem studies Ë Physical environm ent im pairm e nt effects Ë Flesh staining of aquatic organism sAppendix B - CONTACT LIST: The New Chem icals Program is organized in two Branch es within the Chem ical Control Division in EPA. They are the New Chem icals Pre-Notice Branch and the New Chem icals Notice Managem e nt Branch. The Notice Managem e nt Branch coordinates review of subm issions and negotiations with subm itters on Section 5 Consent Orders, etc. Staff in the Notice Managem e nt Branch include:

New Chem icals Notice Managem e nt Staff Mem b er Becky Cool, Branch Chief ( 202) 564-9138 Flora Chow, Biotech Specialist ( 202) 564-8983 Rose Allison, Senior Notice Specialist ( 202) 564-8970 Jim Alwood, SNUR and Bio-Tech Specialist ( 202) 564-8974 Jeff Bauer, Notice Manager ( 202) 564-9042 Mary Begley, Notice Manager ( 202) 564-8976 Audrey Binder, Notice Manager ( 202) 564-9033 Geraldine Hilton, Notice Manager ( 202) 564-8986 Shirley Howard, Notice Manager ( 202) 564-8988 Darlene Jones, Notice Manager ( 202) 564-9047 Loraine Passe, Notice Manager ( 202) 564-9064 Edna Pleasants, Notice Manager ( 202) 564-9144 Jam e sine Rogers, Notice Manager ( 202) 564-3453
The New Chem icals Prenotice Branch gives guida nce for persons considering a subm ission through Prenotice Coordinators. Prenotice Coordinators are staff in the New Chem icals Program who specialize in assisting with status questions and questions on how to properly com p lete the notifications. At the tim e of this writing (Feb 2003) staff in the New Chem icals Pre-Notice Branch include:

New Chem icals Pre-Notice Branch Staff Mem b er Telephone Num b er Linda Gerber, Branch Chief ( 202) 564-3452 Anna Coutlakis, Senior Policy Analyst ( 202) 564-9207

Dave Schutz, Prenotice Coordinato r (Schutz.David@epa.gov) (202) 564-9262 Adella W a tson, Prenotice Coordinator (W atson.Adella@epa.gov) (202) 564-9364

Miriam W i ggins-Lewis, Prenotice Coordinator (W igginslewis.Miriam @epa.gov) (202) 564-9373
Roy Seidenstein, Lawyer (Seidenstein.Roy@epa.gov) (202) 564-9274W r itten inquiries m a y be sent by m a il to: Prenotice Coordinator, New Chem icals Program Chem ical Control Division Mail Stop 7405 USEPA, 1200 Pennsylvania Ave., NW W a shington, D.C. 20460
or by facsim ile at (202) 564-9490. Persons considering us ing facsim ile to send confidential inform ation to the Agency have to be aware that the 564-9490 telephone line is not a secured line, however the facsim ile m achine itself is in a secured area. EPA does not regard em ail as an a ppropriate way to transm it confidential inform ation to or from the Agency. EPA uses a contractor, the TSCA Assistance Inform ation Service (TAIS, TSCA Hotline) to distribute form s and to answer som e questions. TAIS can be reached on ( voice) (202) 554-1404, (facsim ile) (202) 554-5603, (em a il) tsca

hotline@epa.gov. Mail inquiries m a y be sent to: TSCA Assistance Inform ation Service Mail Stop 7408 USEPA, 1200 Penna. Ave., NW W a shington, D.C. 20460