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INSTRUCTION MANUAL FOR REPORTING UNDER THE TSCA § 5 NEW CHEMICALS PROGRAM EPA mQ 25( I) ( May 1999) Office of Pollution Prevention and Toxics Washington, DC 20460 The US Environmenral Protection Agel ¥ : Y ( EPA) has prepared this document to assist submitters of premanufacture mace wxier section S of the Toxic Substances Control Act ( TSCA). The manual provides instructions on submitting a prernanufacRlre notice, asserting confidentiality claims, completing fonn 7710 25, and submitting test data and optional infornlation. It provides some information about exemptions am exclusions from reporting which do not require notice. This manual explains the requirements of the Pre manufacture Notice Requirements and Review Proc~ res ( premanufacture Notification Rule) at 40 Code of Federal Regulations 720.

How this Manual is organized:

I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TOXIC SUBSTANCES CONTROL ACT IS NEW CHEMICALS PROGRAM  PREMANUFACTURE NOTICE FORM A. B. C. D. E. F. G. H. I. J. K. L. M. N. Substances Which Must Be Reported (" New" Chemicals) Who Must Submit A Premanufacture Notice Substances Excluded from Notification When to Submit a Notice Filling Out and Submitting the Form Binding Boxes Test Data and Other Data Confidentiality Consolidated Notices Submission of Infonnation by Others Consultation with EP A Concerning the Premanufacture Notice Notice of Commencement ( NO C) of Manufacture ( or Import) ( 40 CFR § 720.102) Recordkeeping Recognition of Pollution Prevention and Recycling Benefits ll. PAGE BY  PAGE INSTRUCTIONS FOR COMPLETING THE TSCA § 5 NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE FORM Type of Notice ( page 1) Certification ( page 2) 2.

Part I  GENERAL INFORMATION Section A  Submitter Identification ( page 3) Section B  Chemical Identity Information ( Pages 4 6)

2. 3. 4. S. 6. 7. Class 1 or Class 2 chemical substances ( page 4) Polymers ( Page 5) Impurities ( page 6) Synonyms Trade Identification Generic chemical name Byproducts Section C  Production, Import, & Use InfOlomation ( page 7)

Production volume Use infonnation Hazard infonnation 2. 3.

Part n  HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE ( Pages 8 10)

Section A  Industrial Sites Controlled by the Submitter ( Pages 8 9) Section B  Industrial Sites Controlled by Others ( Page 10)

( OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMAfiON ( Page 11)  Technical InfonnatioD 8. b. C. d. h. I. Process Chemistry Product Substitution/ Source Reduction Process Modifications Operating Practices Alternative Waste Disposal Methods Toxicity Information Part ill  liST OF ATTACHMENTS ( page 12) Physical and Chemical Properties Worksheet ( Optional)

Ap~ ndi't A: Types of test data for submission Appendix B: Annotated version of form 7710 25 distributed internally by the 3M Co. Appendix C: Contact Persons  2 I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TSCA § 5 NEW CHEMICALS PROGRAM  PREMANUF A CTURE N aTI CE FaRM A. Substances Which must Be Reported (" New" Chemicals)

1. General You are responsible for determining whether a substance you intend to manufacture or import is a " new" chemical substance as defmed by the Toxic Substances Control Act ( TSCA, the Act) and 40 Code of Federal Regulations ( CFR) § 720.3. You must submit a premanufacture notice ( PMN) if you intend to manufacture ( import is considered manufactUre) any new chemical substance which is not on the TSCA Inventory or otherwise excluded from notification, as discussed below. To submit a PMN, you must use Form EPA 7710 25. Part II of this Manual is a step by step guide to form 7710 25 ( rev 5 95).

1. Bona fide request for a TSCA Illventory search The specific identities of some chemical substances on the Inventory are confidential and therefore do not appear on the Inventory available to the public Such substances are described by generic names in the Appendix to the Inventory. If a substance you intend to manufacture or import is not on the published Inventory but falls within one of the generic categories in the Appendix, you may request that EPA search the Inventory's confidential file. EPA will search the confidential file only if you can demonstrate a bona fide intent to manufacture or import the substance. This policy is to ensure that this search procedure cannot be used for, essentially, industrial espionage.

The procedure for demonstrating such a bona fide intent is codified at 40 CFR § 720.2S. Certain information must be submitted with a bona fide request: an infrared spectrum must be supplied unless this analysis is not suitable for the particular substance. in which case a spectrum or instrument readout from a more appropriate method must be submitted; a currently correct Chemical Abstracts ( CA) Index name or CA preferred name, whichever is appropriate; a currently correct Chemical Abstracts Service ( CAS) register number ( CASRN) ( if the substance already has a CASRN assigned to it); molecular formula and a complete or partial chemical structure diagram if known or reasonably ascertainable; and a description of R& D activities that have already been conducted ( include, for example, years research conducted, end use application, toxicity data, etC.). Three additional information requirements established in the PMN Rule Amendments, published March 29, 1995 « ( Jj Federal Register ( FR) ( Jj pp. 16298 16351) for a TSCA inventory search include: the most probable manufacturing site,  major intended application or use of the substance, and the approximate date when the submitter would be likely to submit a § 5 notice for the substance if it is not found in the inventory. If the substance is being imported, a statement should include: a) how long the substance has been used outside of the U. S., b) name of the country( ies) in which the substance is being used, and c) whether the substance has been used outside the U. S. for the same use as that intended after proposed importation. No specific form is required to be used.

The address to which to send bonafide submissions ( by US mail) is:

OPPT Document Control Officer Mail Stop 7407 USEPA 401 M Street, South West Washington, DC 20460 The room at which bonafides are accepted is only open until 4 PM, and if a courier service comes after that time it will be turned away. You need the physical address for sending a bona fide by courier. You can give the courier the phone number ( 202) 260 1768 to call if there are delivery problems:

~ OPPT Document Control Officer Mail Stop 7407 TSCA Data Processing Center 0099 East Tower, Waterside Mall USEPA 401 M Street, South West Washington, DC 20460 After conducting its search, EP A will tell you if the substance is included on the Inventory and therefore not subject to premanufacture notification or if you must submit a PMN.

B, Who Must Submit A PMN If you intend to manufacture or import a new chemical substance for a commercial purpose, you must submit a PMN to BPA. You must submit a notice if you intend to import a new substance in bulk form or as part of a mixttlre, but not if you intend to import the substance only as part of an article. The use of the term " manufacttlre" in this manual includes both manufacture and import. Importers must fully comply with the infonnation requireme~ ts outlined at 40 CFR § 720. However. importers are not required, under § 720.5O( d)( 3), to submit any data which relates solely to exposure to humans or the environment outside the United States. Importers must submit non exposure data such as data on health effects ( including epidemiological studies), ecological effects, physical and chemical properties. or environmental fate characteristics and ( on sites under their control within the United States) exposure information.

" Article" is defined at 40 CFR § 720.3 as a manufactured item which: ( 1) is formed to a specific shape or design during manufacture; ( 2) has an end use function( s) dependent in whole or in part upon its shape or design during end use; and ( 3) either has no change of chemical composition during its end use or only those changes in composition which have no commercial purpose separate from the article of which it is a part and that may occur as descn" bed in 40 CFR § 7l0.4( d)( S) and 40 CFR § 720.30( h)( S). Articles are excluded from PMN requirements. Fluids and particles do not meet the defmition of an article and are therefore not excluded from inventory reporting requirements. Therefore, all particles or fluids must be reported for the purposes of TSCA unless they can be considered mixtures. Also, OPPT will consider items bein~ imported to be " articles" only if they are manufactured in a specific shape or design for a particular end use application, and this design is maintained as an essential feature in the finished product.

PMNs for imported new chemical substanceshould be submitted by the principal importer. " Principal importer" is defined at 40 CPR § 720.3( z). It is not necessarily the same as " Importer of Record" under customs regulations.

Generally, when you contract with another person to manufacture a new chemical substance, that person must submit the notice. However, if you request another person to manufacture a new chemical substance, and if you specify the identity and total amount of the substance to be manufactured and the basic technology and controls under which the substance will be produced, and if that person manufactures the substance exclusively for you, that person is considered a " toll manufacturer", and you must submit the notice. Information regarding human exposure and environmental release should be submitted on EPA form 7710.25 in Part II, Section A, Industrial Sites Controlled by the Submitter. EP A recognizes that in this and sinlilar instances, the other manufacturer may have information useful to the Agency's review of the new chemical. Therefore, EPA strongly encourages joint submission in these situations.

This manual does not discuss uses of microorganisms subject to the Toxic Substances Control Act ( TSCA). For specific information on submitting notices for biotechnology products please contact the Biotechnology Program in the New Chemicals Notice Management Branch:

 4 Biotechnology Program New Chemicals Notice Management Branch Chemical Control Division Mail Stop 7405 USEPA, 401 M Street, S. W. Washington, D. C. 20460 For additional information on who must submit a notice, see 40 CFR § 720.22 or consult a Prenotice Coordinator. Prenotice Coordinators ( see Contact List, Appendix C) are staff in the New Chemicals Program who specialize in assisting with status questions and questions on how to properly complete the notifications.

c. Substances Excluded from Notification 1. Statutory Excluded Categories  § 3( b) of the TSCA excludes certain substances from premanufacture notification. These include mixtures ( individual substances comprising the mixtures are NOT exempted), substanceS manufactured solely for use as pesticides, food, food additives, drugs, or cosmetics; tobacco aDd tobacco products; nuclear source materials: firearms and ammunition; impurities; byproducts which have no commercial use; non isolated intermediates; and new chemical substances manufactured solely for export. Statutory exclusions are covered also at 40 CFR § 720.3( e) and ( u) and through criteria at § § 720.3O{ hX3)( h)( 7)

2. Research and development ( R& D) exemption  R& D includes synthesis of new chemical substances for analysis, experimentation, or research on new or existing chemical substances, including product development activities. R& D may include tests of the physical, chemical, production, and performance characteristics of a substa1 ¥ : e.

You do not have to submit a notice for a new substance manufactured or imported in small quantities solely for research and development as specified in 40 CFR § 720.36. . Small quantities. arc those not greater than reasonably necessary for research and development purposes. The quantity which is reasonable may vary depending on the nature of the research and development activities. It is your respoDSloility to determine what is reasonable in your situation. You do not have to apply for this exemption. However, you must submit a PMN 90 days before you intend to manufacture the substance for a purpose other than research and development ulxicrtaken in compliance with 1720.36.

To qualify for the exemption. your research and development activities m~ t be conducted uDder the supervision of a technically qualified individual. Persons who engage in R& D for, or obtain an R& D chemical from, a manufacturer must be notified of any risk to health which may be associated with the chemical. However. R& D conducted entirely in laboratories under prudent laboratory practices is exempted from the requirement for risk evaluation.

In accordance with 40 CFR § 720.78, the following R& D records must be retained ( also see I M, Recordkeeping): information reviewed and evaluated to determine the need to make any notification of risk, doc1~ nwion of the nature and method of risk notification, documentation of prudent lab practices, if used instead of risk notification and evaluation and, if an R& D substance is manufactured at greater than 100 kg/ yr records regarding the chemical identity of the substance to the extent known, the production volume, and the disposition of the R&. D chemical substance must also be retained.

Manufacturers and importers who distribute an R& D substance to other persons must provide those persons with written notification of known hazards and of the requiremem that the substaIK: e be used solely for  5 R& D. For additional information on R& D requirements see the New Chemical Information Bulletin: Exemotions for Research and Develooment and Test Marketing available from the TSCA Assistance Information Service ( TAIS, TSCA Hotline) ( see Contact List, Appendix C).

3. Test marketing exemptions ( TME)  You may apply for an exemption from premanufacture notification if you plan to manufacture or import a new chemical substance for test marketing. Test marketing involves the distribution of a predetermined limited amount of a chemical substance, or of a mixture or article co~ taining the chemical substance, toa specified number of customers to explore market acceptability before general distribution. The submitter needs to show that the intended activity is not commercial production and is not appropriately considered to be research and development.

To approve a test marketing exemption application, the Agency must make an affIrIDative fInding that the new chemical substance will not present an unreasonable risk to health or the environment during the testmarketing activities. 40 CFR § 720.38 identifies the type of information you should submit with a test marketing exemption application. EPA must approve or deny the application within 45 days. If you do not provide sufficient information for EP A to make i( s determination, the Agency will deny the request. You should send applications for test marketing exemptions to the OPPT Document Control Officer ( 7407). You are not required, but are encouraged, to use the PMN form for a TME application. For additional information on test marketing requirements see the New Chemical Information Bulletin: Exemotions for Research and Develooment and Test Marketin2 available from the TSCA hotline. Recordkeeping requirements for a test marketing exemption are discussed at I M, Recordkeeping.

4. § S( b)( 4) exemptions  § 5( h)( 4) of the Act allows EPA to exempt a substance, or a category of substances, from the requirement for premanufacture notification if it makes an affirmative finding that the manufacture, processing, distribution in commerce, use, or disposal of the new substance or category of substances will not present an unreasonable risk to health or the environment. EPA has established 3 exemptions under § 5( h)( 4), described below. For the Low Volume and Low Release, Low Exposure exemptions, you should send applications to the OPPT Document Control Officer ( 7407) using form 7710 25. For substances qualifying for the Polymer Exemption, notify the Agency at the end of the year of first manufacture.

a. Low Volume Exemption ( LVE)  Requirements for a LVE application are found at 40 CFR § 723.50. This exemption is available for substances manufactured in quantities of IO, IXX> kg or less per year. Multiple L VEs can be issued to several manufacturers of a single substance, however, second and subsequent applications will be evaluated in the context of existing permitted exposures. Low volume substances are not added to the TSCA Inventory. The notice must include the site of manufacture and proposed use of the new chemical substance; these are legally binding upon the company. The manufacturer may also provide information on exposure controls. If provided, any controls specified in the notice are binding throughout the period of the exemption. EP A will grant the L VE if it determines that the substance will not present an unreasonable risk of injury. The review period for an L VE is 30 days, which can be extended if more information is required.

Companies must notify the Agency within 30 days of a change of the site of manufacture or application. Manufacturers ( importers) must notify processors and industrial users that the substance can be used only for the uses specified in the exemption notice. Manufacturers must also notify processors and users of any exposure controls. Recordkeeping requirements are discussed at I M. Recordkeeping.

b. Low Release and Exposure ( LoREX) Exemption  Eligibility for this exemption category is independent of production volume level. Performance standards for this exemption are set out in 40 CPR § 723.50 ( c) and include both absolute criteria ( e. g., an upper limit on surface water releases) and goals ( e. g., no worker exposure). The notice must include the site of manufacture and proposed use of the new chemical substance which are legally binding upon the company. The applicant's exemption notice  6.. must describe how exposures and releases of the new chemical substance compare to the criteria of 40 CPR § 723.50 ( c). If the exemption is granted the applicant is responsible for complying with the standards and widl any controls or limitations specified in this exemption notice. These requirements must be followed throughout the period of exemption. loREX exemption notices are subject to 3O day review periods by the Agency. Recordkeeping requirements are discussed at I M, Recordkeeping.

c. Polymer Exemption  Requirements for a Polymer Exemption can be found at. 40 CFR § 723.250. The exemption was first published at 60 Federal Register ( FR) pp. 16316 16336, and there is a useful discussion in the Preamble to that publication. This exemption is available for certain classes of polymers which are not chemically active or bioavailable. The manufacturers are not required to submit a polymer exemption notice to EPA prior to manufacture, but must notify the Agency by 31 January for new materials first manufactured in the preceding calendar year. Recordkeeping requirements are discussed at I M, Recordkeeping.

D. When to Submit a Notice You must submit a PMN at least 90 days before you begin to manufacture or import a new chemical substance for a commercial purpose. You are required to submit a notice for LVE or LoREX exemptions 30 days before you begin to manufacture or import a new chemical substance, and 45 days before manufacture or importation under TME. If information additional to that provided with the application is needed, these periods can be extended through suspension requests. If your application is not denied, you will be able to initiate manufacture/ import at the end of these review periods. It is prudent for submitters who think their substances may be subjected to required additional testing during PMN review to confer with the Agency before submitting and to submit further in advance of their hoped for start dates than the minimum number of days for review, as additional testing will extend the Agency review period for the PMN. To initiate this process contact a prenotice coordinator.

E. Filling Out and Submitting the Form Complete the § 5 notice form EP A 7710 25 ( rev. 5 95) using a typewriter or by printing legibly in black ink. Information which is not submitt~ d on a photocopy of the form available from EPA ( e. g., an electronically generated form created by utilizing form making software) must be in a format pre approved by the Agency. Approval can be obtained by contacting:

OPPT Document Control Officer Mail Stop 7407 USEPA 401 M Street. South West Washington. DC 20460 All information provided must be in English ( Except that open literature reports can be submitted in their original languages: if data appears in the open scientific literature, the submitter need only provide a standard literahlre citation. A standard literature citation includes author, title, periodical name, date of publication, volume, and page numbers. The submitter can assist the Agency by providing a photocopy of the article, if desired. This is the only exception to the requirement that all information must be submitted in English). Provide all information requested on the notice form to the extent that you know or can reasonably ascertain it. If you do not know or cannot reasonably ascertain the information, enter " NK" (" not known"). Many submitters want to know what is meant by " reasonably ascertainable". In general, the Agency views inforxnation in the current literature, held by the submitter or a parent or subsidiary company, or held by a supplier to be reasonably ascertainable.

_ 7 Some staff members in large corporations have expressed concern for their personal liability on information submission  that there can be information held by their organization which a reasonable search will not uncover. As an example, a branch office of a parent company may have called for a study of a substance and not have retained its results in the ordinary or expected record locations, or a study of a family of substances undertaken for commercialization of one of them may not be found when commercialization of another of those substances is later undertaken. If you think you are in some danger that you might not find all of your company's information about a substance on which you are preparing notification, you should document that you made a serious search for information. which should have yielded all reasonably ascertainable infonriation, and keep a record of your search with your records of the submission. You should be able to make available to an EP A inspector records showing: that you identified where in your corporate organization ( or your suppliers) the information might be, that you sent requests for information to each site where you think the information might be kept, and that you followed up with any non responding site until you got a response. You should review all applicable information on the substance, such as the Material Safety Data Sheet ( MSDS) for the existence of testing on the new chemical substance. It is helpful if there is a corporate information policy to ensure that this son of information is available to a responsible PMN submitter.

You may submit continuation sheets for any subsection or item on the form. Head any continuation sheet with: the TS number or PC number, if any; submitter name; and the number of the question to which it is a supplement. Mark the appropriate box on the notice form if you attach continuation sheets. You may photocopy the notice form, sections of the form, or this manual as frequently as you need.

Form 7710 25 ( rev. 5 95) is used for several different types of submissions. These instructions are designed to guide submitters for each of tl1em. Send your completed notice to the Document Control Officer ( DCO) for Office of Pollution Prevention and Toxics. If the notice is a PMN or Significant New Use Notice ( SNUN), send with original signatures and two copies ( an additional copy is required if any information is claimed to be confidential, and should be submitted with the claimed confidential information deleted (" redacted copy", " sanitized copy"). No copies are required if it is an application for a Test Market Exemption ( TME), Low Volume Exemption ( LVE), or Low Release Low Exposure Exemption ( LoREX), except that if it contains confidential business information ( CBI) you must submit a redacted copy. which will be placed for public viewing in the TSCA Nonconfidential Information Center, 202 260 7099 ( open from 12m  4pm daily):

TSCA Nonconfidential Information Center Mail Stop 7407 Room B607. Northeast Mall 401 M Street SW. Washington DC 20460 The US Mail address for the DCa appears on page 1 of the form. The room at which submissions are accepted is open from 8 am until 4 pm daily. and if a courier service arrives after that time it will be turned away. For seOOing a notice by courier the address should include the physical location:

OPPT Document Control Officer Mail Stop 7407 TSCA Data Processing Center GO99 East Tower, Waterside Mall USEPA 401 M Street. South West Washington, DC 20460 You can give the courier the phone number ( 202) 260 1768 to call if there are delivery problems  8 A user fee must be remitted for PMN and SNUN § 5 notices in accordance with 40 CFR § 700.45. You must create a unique alpha numeric identification number {" TS number"} to identify and link your notice with the remittance fee. This six digit number must be placed on the first page of the form in the boxes that have been provided. This number must also be placed on your fee remittance which is sent to:

EPA, Washington Financial Management Center ( Mail Stop 3303) P. O. 360399M Pittsburgh, PA 15251 6399 Attn. TSCA User Fee EPA uses a private bank in Pittsburgh to receive these fees. The bank will accept certified checks, money orders and bank drafts only; after the bank has processed the payment, the TS Number is sent to EPA Headquarters with certification that payment has been made. EP A Headquarters then verifies that the appropriate remittance with a TS identification number corresponds to a user fee identification number on a PMN and further processing of the notice commences. However, if a problem arises in the payment procedure, ( i. e., insufficient funds, improper usage of the TS number), the notice will be given incomplete notice status in accordance with 40 CFR § 720.65( c). The EPA will inforn1 the submitter in writing if this action is taken.

40 CPR § 720.65 specifies administrative procedures applicable to incomplete notices in general. The most frequent reason for a submission to be incomplete is a name which is not in conformance with the Ninth Collective Index ( 9CI) of Chemical Abstracts nomenclature rules and conventions ( this defmitive guide to CA nomenclature has been used since 1972.) If the notice is declared incomplete, the review period has not begun no matter when in the initial review period the notice is declared incomplete. Therefore, the review period begins again at day one when a complete notice is received. However, EPA can choose to restart the clock on the day the notice was declared incomplete if it determines that its review can be completed within the remaining period. This decision is made case by case. See 40 CFR § 720.6S( c).

F. Binding Boxes The purpose of the binding option is to enable EP A ( if necessary) to efficiently negotiate with a PMN submitter the development of § 5( e) consent orders and promulgate Significant New Use Rules ( SNURs) for those new chelnical substances that the Agency deternlines may present an unreasonable risk if certain control actions are !! Q! implemented. This option is intended to reduce delays that can slow the development of consent orders absent such agreement. At one tinle, SNURs were limited to environmental release activities and certain industrial, commercial, or consumer activities, but now they oan include other important activities, such as protection in the workplace and hazard communications.

Control measures instituted by the submitter to reduce exposures arid/ or releases of the substance may have a direct bearing on the Agency's conclusions regarding risk. Therefore, you may wish to indicate your willingness to be bound to certain submitted information on the form which is related to the issue of potential risk such as use, production volume, protective equipment, engineering controls, and/ or process description. By indicating your willingness to make these commitments, you would be indicating an interest in future negotiations if the Agency deems them necessary. In order to make your intentions known to EP A, mark in the " Binding Option" box on the form located to the right of the appropriate information.

Should the Agency wish to discuss development of binding control measures for your PMN, you will be contacted by a Program Manager and negotiations may ensue. Therefore, indicating a willingness to be bound by the terms of your notice does not by itself prohibit the submitter from deviating from the information ( except chemical identity) reported in the form. In the case of exemption applications ( i. e. Test Market, Low Volume/ Low Release, Low Exposure), however. certain statements are automatically binding on the submitter when the Agency approves the exemption applications.

 9 G. Test Data and Other Data You are required to provide three copies of any test data. on the health and environmental effects of the new chemical substance, including data on physical/ chemical properties, in your possession or control, and a description of any other health and environmental effects data on the substance known to or reasonably ascertainable by you. Data in the possession or control of either a parent company or an affiliated subsidiary located outside the U. S. are considered by the Agency to be data that should be known to or reasonably ascertainable by a submitter ( see section E, above). Data must be submitted in English. Standard literature citations may be submitted for data in tl1e open scientific literature. Complete test data ( not summaries) must be submitted if they do not appear in the open literature. Incomplete reports ( e. g., from ongoing studies) are exempt from full reporting. However, you must describe tl1e nature and objective of any incomplete study, report, or test, the name and address of aI1Y laboratory developing the data; progress to date; type of data collected; significant preliminary results; and an anticipated completion date: If significant preliminary results or fmal results are obtained prior to the completion of the notice review period or any other additional information significant to the review of the notice becomes available to you, you must submit tllis information within 10 days of receipt, but no later than 5 days before the end of the review period. If information becomes available during the last 5 days of the review period, you must immediately inform EP A by telephone. Examples of the types of test data you must submit are provided in Appendix A of this manual. In addition, a Physical and Chemical Properties Worksheet now appears on the last page of the form. For additional information on health and safety studies and on submitting test data, see 40 CFR § § 720.3 and 720.50 of the Pre manufacture Notification Rule. Attach test data to the notice form and reference it by page number in Part III, List of Attachments.

You are not required to submit any data previously submitted to EPA with no claims of confidentiality if you identify in your submission the office or person to whom you submitted the data, the date it was submitted, and, if appropriate, a standard literature citation. If. however, you submitted data with claims of confidentiality , you must resubmit the data with the notice and any claim of confidentiality under 40 CFR § 720.80. You also are not required to submit data related solely to product efficacy. This exception does not apply to information required in the notice, test data, or other data.

B. Confidentiality Asserting claims You may assert a claim of confidentiality for any information ( other than health/ safety studies) submitted to EPA. To assert confidentiality for specific information on the form ( e. g., submitter identity, chemical identity, or use information), mark in the " Confidential" or Confidential Business Information ( CBI) box on the form located to the right of the information. Also mark the box at the bottom of page I of the form if any information in the notice was claimed as confidential in the foml. As noted above, a redacted copy of any § 5 notice must be submitted with the notice, or it will be declared incomplete by the Agency and returned to the submitter.

To assert confidentiality claims for information in attachments to the form, provide a complete copy of the attachment that clearly indicates ( e. g., by circling or bracketing) the information you wish to claim as confidential. Bracket only the specific information you claim as confidential. For example, if you submit a study which contains a physical or chemical. property, and it is only that property which you wish to claim as confidential, bracket only that property. Do not simply stamp " Confidential" on the page which contains that property. You must also clearly and specifically mark any confidentiality claims you wish to make for information or correspondence subsequently submitted to EPA about your PMN, and you must provide a redacted version for the public file. If you claim the identity of the new chemical substance or its category of use as confidential, you must provide a generic description of this information, as indicated in the appropriate sections of the form. Guidance on developing generic names is given in Part 2 of this manual in the Chemical Identity Information Section at Item 6.

 10.. To ensure that no confidential inforn1ation is disclosed to the public, you must submit an additional copy of the notice form, including attachments. which does not contain confidential information. This version (" sanitized", " redacted") will be placed in the public file. It must contain all non confidential information, including health and safety studies. A hcalth and safety study means any study of any effect of a chemical substance or mixture on health or the environment or on both. including underlying data and epidemiological studies, studies of occupational exposurc to a chemical substance or mixture. toxicological, clinical, and ecological, or other studies of a chemical substance or mixture, and any test performed under the Act.

Information from health and safety studies which can be claimed confidential is quite limited  this is discussed at 40 CPR § 720.90. Chemical identity is assumed to be part of a health and safety study. 40 CFR § 720.90( b)( 2) discusses the claims which must be made and substantiated for chemical identity in a health study to be confidential: that disclosure would reveal manufacturing or processing information, that it would disclose the fraction of a mixture which the substance comprises, that the study could be interpreted without knowing the identity of the substance, and that disclosure would have harmful competitive effects on the submitter.

Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixtUre on health or the environment is also included. In sum, any data that bear on the effects of a chemical substance on health or the environment would be included. If you do not provide the sanilized copy with your submission, the submission will be incomplete and the review period will not begin. If you provide a subsequent amendmento your PMN or additional information/ data, you must also provide a non confidential version for the public file.

2. Substantiating claims You are not required to provide substantiation of any confidentialitY claim when you submit your notice. However, you must substantiate your claim of confidentiality for chemical identity at the time you submit a Notice of Conunencement of Manufacture ( NOC). if you want EPA to maintain your confidentialitY claim after you begin manufacture. ( NOC requirements are described in 40 CFR § 720.102 and in this manual.) To substantiate that claim, you must provide EPA with detailed answers to the following questions which appear in the Premanufacture Notification Rule [ 40 CFR § 720.85( b)( 3)( iv)]. This substantiation must accompany your NOC. You may be required to substantiate other confidentiality claims if EPA receives a Freedom of Information ACt ( FOIA) request on that information:

( A) What harmful effects to your competitive position, if any, do you think would result if EP A publishes on dle Inventory the identity of the chemical substance? How could a competitor use such information given dle fact that the identity of the substance otherwise would appear on the Inventory of chemical substances widl no link between the substance and your company or industry? How substantial would the harmful effects of disclosure be? What is the causal relationship between the disclosure and the harmful effects?

( B) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

( C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for purposes of the Inventory?

( D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?

( E) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing or importing this substance for a commercial purpose?

 11 ( F) Is the fact that someone is manufacturing or importing this chemical substance for commercial purposes available to the public, e. g., in technical journals or other publications; in libraries; or in State, local, or Federal agency public ftIes?

( G) To what extent has the fact that you are manufacturing or importing this chemical substance for a commercial purpose been disclosed to others? What precautions have you taken in regard to these disclosures? Has this information been disclosed to the public or to competitors?

( H) In what form does this particular chemical substance leave the site of manufacture, e. g., as part of a product; in an effluent or emission stream? If so, what measures have you taken to guard against discovery of its identity?

( I) If the chemical substance leaves the site of manufacture in a product that is available to either the public or your competitors, can they identify the substallCC by analyzing the product?

( 1) For what purpose do you manufacture or import the substance'?

( K) Has EPA, another Federal agency. or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, copies of such determinations must be included in the substantiation.

( L) If the notice includes a health and safety study concerning the new chemical substance, the submitter must also answer the questions in 720.90( b)( 2).

Consolidated Notices If you are manufacturing two or more. but no more than six, structurally similar new substances, you may contact a Prenotice Coordinator to obtain approval to submit a single consolidated notice. A consolidated notice is suitable for chemical substances of similar structure with the same or similar uses and which share similar test data and other information. A consolidated notice must identify each new substance individually; you may not submit a consolidated notice for an open ended category. A separate chemical identity page must be provided for each substance. A distinct Agency " PMN" number is assigned to each chemical. You may not submit a consolidated notice for a series of intermediates and a final product ( they will not share common uses, test data, and other information).

EPA encourages you to submit consolidated notices when appropriate. You may submit a consolidated notice only after you have received prior approval from a Prenotice Coordinator. This request should concisely describe the chemical identity of each substance to be included in your consolidated notice ( note: you need not use names from the Inventory Expert Service of the CAS to request approval for a consolidation, you need only to describe the chemical substances well enough that EP A personnel can determine whether they are similar enough for combined review. You must, however, use separately obtained Method I names for each substance in a consolidation when PMN is submitted). Many requestors provide this information using the chemical identity pages of the form or in a one page table format. Remember to enter your prenotice communications number in Part I, Section A ( 3) ( page 3) of the form.

J. Submission of Information by Others 1. Submbsion by an agent  You may designate an agent to submit a § 5 notice for you. Both you and the agent must sign the certification on the form. You are responsible for ensuring that all information known or reasonably ascertainable by you and all test data in your possession or control are submitted to EPA. For information on submissions by agents, see 40 CFR § 720.40( e).

l~ 2. Joint submissions  You may also prepare and submit a PMN with another person. A joint submission may be useful where different persons have information required in the notice. including a situation when another person has information fundamental to the notice. but wishes 10 keep it confidential. For example. you may have information on the identity and the physical and chemical properlies of the new substance and another person may know its manufacturing process and ilS intended use.

Each joint submitter must use a notice Conn and sign the certification on the form. Each person must also assert all confidentiality claims as described in 40 CFR § 720.80 and Part I of this manual. However, you are not relieved of statutory notice requirements by arranging a joint submission. You are required to complete all mandatory sections of the form to the extent tl1at you know or can reasonably ascertain the information, even if another person also submits infom1ation for a certain section. If you submit a joint notice, the review period will not begin until EPA bas received all required parts of the notice. You should identify the joint submitter in your notice and identify the section( s) which the person is submitting. See 40 CFR § 720.40( e) for additional information on joint submissions.

K. Consultation with EP A Concerning thc Premanufacture Notice 1. Before notice submission 8. General inquiries  General inquiries concerning the premanufacture notification program which are not related to a specific chemical or notice should be directed to the TSCA hotline ( see Contact List, Appendix C). Copies of the PMN Rule, Instructions Manual, notice form, and other materials relating to the Rule are available by contacting the hotline. ( These materials are also available at EP A regional offices.)

b. Specific inquiries  Specific inquiries concerning tIle PMN Rule, confidentiality, joint submissions, consolidated notices, etc.. should be directed to the Prenotice Coordinator. You can contact the Prenotice Coordinator by telephone, facsimile, or email ( see Contact List, Appendix C)

2. During notice review  Upon receipt of the notice by the OPPT Document Control Officer ( DCO), the Agency will make an initial determination whether the notice is complete. The initial determination looks to see that the notice contains all the items required on pages 4 through 8 of the form and for apparent chemical identity problems. If no problems are seen, your form is initially determined to be . complete., goes on for further review, and Day 1 of the 9O day review period is assigned as the date of receipt by the DCO. Later and more detailed review can, however, discover other additional information that has not been provided, and you can be contacted to provide additional information at any time during the review period.

You will receive written notification if your notice is declared " incomplete" as described at 40 CFR § 720.65. If your notice is initially complete, you will receive an acknowledgment letter telling you your notice number and the date of expiration of the review period. The Inventory is searched to ensure that the substance for which the notice is submitted is not already included on the TSCA Chemical Substance Inventory. If your chemical substance is on the Inventory, you will be notified that your substance is not subject to premanufacture notification, and that therefore you are free to begin manufacture immediately. If the substance is not on the Inventory, and if the substance is not dropped from consideration at the Agency's initial review meeting (" Focus Meeting", which takes place at approximately Day 20), a Program Manager will be assigned to coordinate the review of the notice and to be your official contact with the Agency throughout the remainder of the review period. Based on the Focus Meeting, it is possible to declare the PMN " incomplete", usually for missing test data. Also during the review period, the Program Manager may contact you for clarification of information you have provided in the notice or if the Agency identifies issues of concern. If you are not contacted prior to the expiration of the review period, you are free to commence manufacture of the substance identified in your notice after the review period has expired.

 13 You can check the status of your submission at the New Chemicals Internet site (" www. cpa. gov/ opptintr/ newchms") aftcr approximately day 30.

The Program Manager will also notify you before the review period expires if he/ she will extend the review period under TSCA § 5( c) or if regulatory action is being considered on tile new substance under TSCA § 5( e) or 5( t) and a suspension of the review period is needed. 5( e) Consent Orders are typically issued with a follow up SNUR subsequently promulgated. In addition, a Program Manager will contact you if the Agency plans to develop a non 5( e) SNUR ( a case in which a 5( e) Consent Order does not precede the development of a SNUR) on the chemical substance identified in your notice.

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

If EPA has not taken any action to regulate the new chemical substance during the review period, you may begin manufacturing the new chemical substance upon expiration of the review period. EPA requires that you notify the Agency ~ y using EP A form 7710 56. no later than 30 calendar days after the first day of such manufacture or import for non exempt commercial pul poses ( for import. Day I is the date the material clears US Customs).

Your NOC must be sent to the OPPT Document Control Officer ( Mail Stop 7407). In your NOC. you must provide the specific chemical identity of the. substance , its PMN number, the site of first manufacture or impon. and the date when manufacture or import began. You must also substantiate a confidentiality claim for chemical identity in your letter, as described above at  2. Substantiating Claims" if you want EPA to maintain the claim after you begin manufacture or import. See 40 CFR § 720.85( b) for further information on substantiating confidentiality claims.

M. Recordkeeping Recordkeeping requirements for submissions under § 5 of TSCA, and for exemptions from submission, are found in several different sections of the CFR.

PMN or SNUN: 40 CFR § 720.78 ( a) requires that you retain documentation of information for a PMN or SNUN for five years from the date of commencement of manufacture. The records you must retain include ( 1) information supporting the information supplied on the notice form, ( 2) other data, as defined in 40 CFR § 720.50 ( b), in your possession or control, ( 3) production volume for the first three years of production or import, and documentation to support your stated production volume, and ( 4) date of commencement of manufacture, and documentation to support your stated date. You are not required to develop information solely for recordkeeping purposes, but only to retain information you have obtained or developed in the course of completing your submission.

Research and Development: 40 CFR § 720.78 ( b) requires that if you manufacture a new chemical substance under the exemption for substances manufactured solely for research and development, you must retain documentation of compliance with the exemption until five years after they are developed.

Test Marketing Exemption: 40 CFR § 720.78 ( c) requires that if you manufacture under a testmarketing exemption under TSCA, you must retain documentation of information in the application and documentation of your compliance with any restrictions imposed by EP A when it granted the application until five years after the fmal date of manufacture or import under the exemption.

LVE or LoREX: 40 CFR § 723.50( n) requires that each manufacturer of a new substance reported under the terms of a low volume or LoREX exemption must maintain records of 1) the annual production volume of the new chemical substance under the exemption, and 2) documentation of information in the exemption notice in  14 compliance with the terms of the exemption. Records must be retained for fIVe years after date of their preparation.

Polymer Exemption: 40 CFR * 723.25O( j) requires that a manufacturer of a polymer made under the terms of the polymer exemption must maintain rccords for five years from the date of commencement of manufacture for: the production volume for the first three years of manufacture, the date of commencement of manufacture, documentation of the information provided above, documentation of any other information provided in the notice, such as information that demonstrates that the new polymer is not specifically excluded from the exemption and the polytner meets the exemption criteria.

N. Recognition of Pollution Prevention and Recycling Benefits During the course of its review. the Agency will be considering whether the activities surrounding the manufacture, processing, use, and disposal of the substance identified in the notice may present an unreasonable risk of injury to human health or the environment.

It is important, also, that EPA acquire information regarding any technological, risk reduction, or environmental benefits which may be possible if the new chemical being reported is introduced in commerce, and this information can in some cases enable the Agency to approve substances otherwise doubtful. Therefore, PMN submitters are encouraged. to complete and provide the optional information on pollution prevention on page 11 of the form. By submitting information describing the positive pollution prevention aspects of your PMN substance, you may achieve two possible benefits: first, the pollution prevention information may enable EPA to regulate the substance less stringently than it would have absent the infom1ation, and second, the pollution prevention information may be chosen by the Agency for affirmative recognition as part of the EPA New Chemicals Pollution Prevention Recognition Project.

In the Agency's " EPA New Chemicals Pollution Prevention Recognition Project", EPA seeks 10 promote safer new chemicals and processes, providing several forms of recognition, including a letter from the Director of OPPT, inclusion in a listing of recognized chemical substances on the OPPT Internet Homepage, and other positive publicity. If you want the Agency to consider your PMN substance for this recognition, you should explicitly request to be considered in your response at ( OPrIONAL) POLLUTION PREVENTION AND RECYCUNG INFORMATION and identify the pollution prevention merits of your PMN substance. To the extent d1at you think it helpful for Agency consideration, EPA strongly encourages you to ( 1) submit actual test data on the PMN substance to substantiate any pollution prevention claims you assert and ( 2) minimi7. e claims of confidentiality claims to facilitate publicity regarding the PMN substance.

For example, the EP A will consider any information on methods used to minimize potential risks associated with the new substance through source reduction or recycling. Some of d1e benefits for which information may be provided are a reduction in the volume manufactured. a reduction in d1e generation of waste materials, a reduction in exposure and/ or environmental release or increased performance and/ or operation efficiency of d1e new chemical substance in comparison to existing chemical substances used in similar applications. Recycling activities include reclamation of useful chemical components from wastes d1at would od1erwise be released as air emissions. water discharges or land releases during manufacture, process or use. All descriptions may be quantitative or qualitative.

The " Pollution Prevention Information" page of the PMN requests optional infonnation that will be used in the evaluation of the new chemical substance and to compare the relative risks and benefits of the substance as a substitute for substances with similar uses currently on the market. PMN submitters are encouraged to report any and all relevant information not reported elsewhere in tile PMN which they believe to be important to a thorough regulatory decision. The page provides submitters with the opportunity to describe pollution prevention and risk reduction options considered by the company in regard to the submission. A useful fonnat for presenting such  15 information is provided at Section II of this Mat1ual. Providing this pollution prevention information to EPA may benefit PMN submitters by reducing regulatory controls and/ or testing requirements, if the pollution prevention information sufficiently mitigates EPA's concerns for [ he toxicity. human exposure, or environmental releases of the PMN substance. EPA considers [ his information in line with [ he strictures of the Pollution Prevention Act of I~.

Under the Pollution Prevention Act of 1990 ( PPA), Congress established a national policy that: ( a) pollution should be prevented or reduced at the source whenever feasible, ( b) pollution that cannot be prevented should be recycled in an environmentally safe manner whenever feasible, and, ( c) disposal or other release into the environment should be employed only as a last resort and should be conducted in an environmentally safe manner.

EPA defines ' pollution prevention" to mean " source reduction," as defined under the PPA, and other practices that reduce or eliminate the creation of pollutants through; ( a) increased efficiency in the use of raw materials, energy, water, or other resources, or, ( b) protection of namral resources by conservation.

The PPA defmes " source reduction" to mean any practice which: ( a) reduces the amount of any hazardous substance, pollutant, or contaminant entering any waste stream or otherwise released into the environment ( including fugitive emissiol1S) prior to recycling, treatment, or disposal, and, ( b) reduces the hazards to workers, public health, and the environment associated with the release of such substances, pollutants, or contaminant,

The term includes: equipment or technology l1} odifications, process or procedure modifications, reformulation or redesign of products, substitUtion of raw materials, and iniprovements in housekeeping, maintenance, training, or inventory control. The term "" , does not include any practice which alters the physical, chemical, or biological characteristics or the volume of a hazardous substance, pollutant, or contaminant through a process which itself is not integral to and necessary for the production of a product or the providing of a service" ( Sec, 3( 5)( B » , Thus, end of pipeline controls, such as thermal oxidizers, incinerators. or waste water treatment systems are not defmed as " source reduction",

EP A is interested in information on how improved processes for handling individual new chemical substances may reduce potential exposures and releases of specific PMN substances. Submitters may include a discussion of Pollution Prevention/ Risk Reduction measures actually selected for implementation and the rationale for the selection. Submitters are encouraged to consider and include information comparing the releases and exposures for various process options considered but not selected, anticipated reductions in releases and exposures which can be expected in the production of the PMN substance as compared to an existing chemical substance, and how the PMN substance and/ or the product in which it is used may compare favorably with existing chel; nicals in terms of pollution prevention. Submitters may also describe other pollution prevention related advantages, such as process modifications, increases in product life or durability, or decreased energy consumption, etc. A set of questions to address these concerns is put forward in Section II of this Manual.

EPA is also interested in information describing possible reductions in toxicity, and human exposure, as well as environmental release of a new chemical substance, as compared to those of already commercialized chemical substances for which the new substance may substitute. Such infom1ation may demonstrate that the new chemical substance is a viable safer substitute for an existing chemical substance. Voluntary submission of pollution prevention information is not intended to negatively affect the outcome of EP A I S review of the Premanufacture Notification. When risk reductions are documented, the information will be carefully considered during EP A's review of the PMN. Based on the information, EP A may reduce or eliminate anticipated exposure controls and testing requirements which would ordinarily have been imposed by the Agency. Completion of this section is also important if you wish your substance to be considered for the EP A New Chemicals Pollution Prevention Recognition Project.

 lG Reference Material EPA's new  Facility Pollution Prevention Guide", a succcssor to the 1988 " Waste Minimization Opportunity Assessment Manual", is available to help firn1S develop broad based multimedia pollution prevention programs. Worksheets and other information are included to help facilities identify, assess, and implement opportUnities for preventing pollution. including methods of controlling waste creation during the production process, as well as product design and redesign. Developed by EPA's Pollution Prevention Research Branch, and Office of Solid Waste, the Guide ( Doc. No. EPA/ 600/ R 92/ 088) can be ordered by mail from:

EP A Center for Environmental Research Information Publications Unit 26 W. Martin Luther King Drive Cincinnati. OH. 45268 ( 800) 490 9198 II. PAGE BY PAGE INSTRUCTIONS FOR COMPLETING EPA FORM 7710 25 ( rev. 5 95), THE TSCA § 5 NEW CHEMICALS PROGRAM PREMANUFACTURE NOTICE FORM ( Besides the page by page instructions below. we have attached as Appendix B an annotated version of the form distributed internally by the 3M Co.. for its personnel. which submitters may fmd useful as an adjunct to these instructions. )

Page 1: Identify Type of Notice. Your Submission Total Number of Pages: Give total pages as submitted, including attachments TS number: The submitter chooses tl1is number. It should be an alphanumeric. Most repeat submitters use some variant of their initials and the number of submissions they have made ( Widget Corp. might pick WIDOOl, WlDOO2, for example). The Agency uses the number to track notification from its bank in Pittsburgh, Pennsylvania that the money has been received, and it can be useful to the sublnitter in identifying the submission to EPA personnel before a P number has been assigned by the Agency. The TS number should be unique to this submission from your company; do not give the same number to a subsequent submission.

Confidentiality Claims: Check this box if ANY information in the form is claimed confidential Test and Other Data: Indicate which types of data are included with the PMN Type of Notice: Please check the type of notice submitted.

Check . PMN" if the application is for a standard, final product new chemical substance for placement on the TSCA Inventory.

The " Intermediate PMN" box should be checked if this notice is for a chemical substance which is an intermediate used in the production of a final product for which a separate notice is submitted simultaneously, and for which the submitter has no intention of making a separate, non intem1ediate use. In addition, the intermediate PMN must identify the fmal product. Separate user fee identification numbers must be generated for and appear  17 on each notice; although a single check may be remitted bearing all user fee identification numbers for a sequence of intermediate( s) and final product. . Certification", below, discusses fees paid by small manufacturers. For further information on " intermediate PMNs" see 40 CFR § § 700.43 ~ 700.45( b)( 2)( ii).

The . Significant New Use Nolice" ( SNUN) box. should be marked for any notice that is submitted in accordance with a SNUR.

The " Test Marketing Exemption Application" ( TMEA) box should be marked for any notice submitted in accordance with the criteria listed in 40 CFR § 720.38. You are not required to use form 7710 25 ( rev. 5 95) to submit a TMEA, but it is encouraged.

Boxes are also provided to identify your submission as an application for either a " Low Volume Exemption ( LYE) [ see 40 CFR § 723.50( c)( 1)] or a " Low Release! Low Exposure Exemption" ( LoREX) [ see 40 CFR § 723.50( c)( 2)]. These exemptions must be requested through use of the PMN form. Modifications for earlier approved requests for either of these exemptions are requested by checking the modification box on the first page of the PMN form.

For an application to modify an L VE or LoREX exemption. a submitter is not required to provide again infonnation which was submitt~ d in a previously approved exemption. Each page from the application on which some information has changed, and a new signature page. must be provided. An application for an LVE for a substance which had been the subject of a prior L VE which had been submitted before the amendments of March 29. 1995. however. is a new application and the full form 7710 25 must be submitted.

If this notice is for a consolidated PMN. the number of chemicals ( two or more, but no more than six) included in me notice should be entered on page one in the space provided, A separate PMN number is assigned to each chemical substance identified in a consolidated notice. Approval for a consolidated PMN notice must be obtained from the Prenotice Coordinator prior to submission. You are required to identify the Prenotice Communication number you were given when your consolidation was approved on page 3, question 3 of the form Further information on submitting a consolidated notice is provided at Section I, Part I of this manual.

Page 2 Certification The official named in Part 1, Section A of the form, as the person submitting the notice, must sign die cenification on page 2 of the notice form. This official is responsible for the truth and accuracy of each statement in the certification. If an agent assists you in preparing the notice, the agent must also sign the cenification. All signatures must be original, and in ink.

In addition, the submitter must check certain " user fee" certification statements as appropriate as required at 40 CFR § 700. For a PMN, consolidated PMN or SNUN, a fee is required: if the submitter is a small business it must remit the fee identified in either 40 CFR § 700.4S( b)( 1) ( small business concerns remit a fee of $ 100). If the submitter is not a small business it must remit the fee identified at 40 CFR § 700.4S( b)( 2) ( all non." small" submitters remit a fee of $ 2,500 for final products, $ 1,000 if the submission is for an intermediate and is submitted with the application for the final product).

A small business concern is one whose total annual sales ( include all sites, including those owned or controlled by a foreign or domestic parent company) are below $ 40 million for the fiscal year preceding the date of the submission of the applicable § 5 notice ( see 40 CFR § 700.43).

When using the PMN form to submit a LYE or LOREX application in accordance with 40 CPR § 723.50, all three of the corresponding certification statement boxes must be checked to acknowledge that you will manufacture under the terms of the exemption. In addition, a submitter of an L VE application must certify that le the manufacturer intends to commence manufacture of the proposed exempted substance for commercial purposes within 1 year of the date of expiration of the 30 day review period. There is no fee for an L VE or LOREX.

Part I  GENERAL INFORl\ IATION Section A  Submitter Identification ( Page 3)

la. Person submitting notice  Enter information on the official who signed the general certification.

The agent must also b. Agent  Complete only if you authorize an agent to assist you in preparing this notice. sign the certification as noted above.

If you mark the " Confidenlial" box ne~ l to items a or b. all infonnalion in tIle item will be treated as confidential.

c. Mark the box if your submission is a joint submission. Identify in Part I, Section A ( l)( c) the name of the joint submitter who is autll0rized by the U. S. submitter to provide some of the information required in the notice. For additional information on joint submissions, see part I, section J of this Manual. A notice will not be considered complete until all information is received by the Agency. If information from multiple parties will not be sent to the Agency in the same package, use your TS user identification number to link multiple notices. You can generate a TS number solely to link submissions, even for a no fee exemption. If you don't generate a TSnumber you should ask a prenotice coordinator to issue a prenotice communication number for this purpose.

Mark the . Confidential" box next to item c if you wish this information to be treated as confidential.

If you authorize another person ( e. g., a foreign manufacturer or supplier) to provide information, such as, confidentially held tradename chemical substance identification directly to EPA, indicate which information will be supplied by the other person. Identify that person by name, company, and address in a continuation sheet. That person's identity may be claimed as confidential. A letter of support for your notice should be provided by the joint submitter on its company letterhead. A notice will be considered incomplete until this information is provided. Whenever possible use your TS User Identification Number to link this information.

2. Technical contact  Identify a person who can provide EPA with additional information on the new chemical substance during the notice review period. The technical contact identified should be located in the United States and be available to be reached by telephone during normal business hours. If you mark the " Confidential" box next to this subsection, all information in it will be treated as confidential.

3. Provide any prenotice communication number assigned to your prenotice inquiry. In addition, see Section II, Pan E of this manual for further information on submission of a consolidated PMN that requires a prenotice consultation.

4. Provide the exemption number assigned for any previous exemption application submitted for the chemical substance covered by this notice. It is especially important for an exemption modification request that you provide the EPA assigned exemption number from your original exemption application. Also, provide a previously assigned PMN number, if any, for the chemical substance.

5. Self explanatory .

6. Mark to indicate whether you intend to manufacture or import the new chemical substance or both manufacNre and import. Use the optional binding box to indicate your willingness to be bound to either import or domestic manufacture only.

 19 Section B  Cbemicalldentity Inforlllation ( Pages 4 6)

Submitters of PMN and exemption notices are required to provide thc currently correct Chemical Abstract ( CA) name for the substance( s) identified in the notice based on the Ninth Collective Index ( 9CI) of CA nomenclature rules and conventions, and consistent with listings for similar substances in the Inventory. EPA must receive complete and unambiguous identification of the new chemical substance. If the substance is not adequately identified, the submission will not meet statutory requirements and the notice review period will not begin. If a principal imponer does not know the specific identity of the new substance, the submitter must contact the foreign manufacturer or supplier and have the specific chemical identity information required in the PMN provided directly to EP A. In this way, foreign manufacturers Cat} protect confidential business information. The same bolds true for U. S. manufacturers reponing chemical substances using a generic or trade name to identify a compo~ nt of the new chemical substance. The submitter of the new chemical substance must have the supplier provide chemical identity information directly to EPA before the notice can be considered complete. This information may be provided in a letter of support from the supplier or as a joint submission between the two companies. A letter of suppon should be provided on the supplier company's letterhead. See Part I, Section 1( 2) of this manual on how and when to file a joint submission. Since a letter of suppon or a joint submission may be received separately by the Agency, an identification number such as a TS user fee number or a Prenotice Communications number should be used 10 link a PMN with iluormation from a supplier or foreign manufacturer. The identical identification number should appear on both pieces of correspondence submitted to EPA; otherwise, there can be a delay in processing the PMN.

The type of chemical identity information required in the notice depends on whether the substance is a Class 1 or Class 2 substance or a polymer. A Class 1 chemical substance is a substance whose composition, except for impurities, can be representcd by a definite chemical structural diagram. For Class 1 substaoces, a name that is consistent with the nomenclature rules and conventions of the 9th Collective Index of the Chemical Abstracts Service ( CAS) and with current TSCA Inventory listings must be provided. Examples of such substaIx: eS are l, 3 butadiene, benzene, and sodium chloride.

A C. 2 chemical substance is a substance whose composition cannot be easily represeD1ed by a definite chemical structural diagram. Such a substance is generally derived from natural sources or complex reactions. Its composition may be complex, difficult to characterize, and variable. For Class 2 substances and JX} lymers, a CA Index Name orCA Preferred Name must be provided. In addition, for a Class 2 substance, the ootice must identify the immediate chemical precursors and reactants by specific chemical name aM Chemical Abstracts Service Registry Number ( CASRN), if the number is available. Trade names or generic names of chemical precursors or reactants are not acceptable as substitutes for specific chemical names. Unacceptable names would include, e. g., " chlorinated naphthalene", " glycerol monoester of hydrogenated cottonseed oil acids", or a "~ tion product of x, y, z".

A polymer is a substance COml)() sed of molecules characterized by the regular or irregular repetition of one or more types of identical monomeric units. In most cases, the number of monomeric units is quite large and DOt precisely known.

If the substance is clearly a Class 1 or 2 substance, then items a d of Question 1 on Page 4 must be properly completed. If the substance has been named as a polymer ( whether the Exemption Rule requirements are met, or not), then items a c of Question 2 on Page S must be addressed and answered completely. If you are uncertain whether the chemical substance is a Class 1 or 2 substance or a polymer, then both Questions 1 and 2 on Pages 4 and S should be completed in full, or contact the Pre notice Coordinator for further assistalK: e. If the variability of the composition of a reaction product is too complex to be described as distinct individual components, then reaction product nomenclature is employed. If components of a reaction product can be readily identified and will always be present in the reaction product, then the components should be specifically identified and may be listed individually on the TSCA Inventory. Any reaction product may be reponed as Class 2.

 20 Submitters may obtain the correct chemical identity of the PMN substance through the Chemical Abstracts Service ( CAS) Inventory Expert Service ( so called Method 1) Q[ from any other sowce ( so called Method 2). Consolidations MUST be submitted with Method I names. A nolice submitter must identify in the chemical identity section which method lhey used to report the substance's identity. For Method 1, a copy of the CAS report must be attached to the Iloti.: c. Submitters who choose to develop their own chemical identity are cautioned that the Agency will consider submissions incomplete and thus delay their review if incorrect nomenclatwe is received from a sourcc other than CAS. If the Inventory Expert Service has been used, the Agency will work with the IES to agrec on a name, and the review period will not be affected. Use of CAS services other than the Inventory Expert Service, including CAS' Registry Service, will also be considered Method 2. In all cases, each chemical substance in a consolidated submission n1ust be identified by Method I.

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

a. Mark the appropriate class b. Enter the specific chemical name of the new chemical substance.

For a Class I substance, tl1e name must be a clear description of a unique substance. In describing the chemical substance, the EP A requires Chemical Abstracts Service ( CAS) chemical nomenclature be used for identification purposes when it is available. There is a separate box in question one, item c on page 4 for entry of the CAS number. The Agency encourages submitters to have contact with CAS prior to submission in order to obtain concise chemical identity information. Use the CAS standard rules of chemical nomenclature to identify the new substance. Identify the positions of attachment of chemical groups or of unsaturation. if any, by using locants. The chemical name should contau1 all of the information known about ! he details of ! he structure and should permit the drawing of an unambiguous chemical structural diagratn.

The chemical name of a Clas$ 1 substance must describe the chemica! substance as completely as possible. In some cases. the name may be similar to the names used to describe Class 1 compounds, but it should indicate the substance's multiple compon~ nts. For example, " polychlorinated biphenyl" indicates a composition that has multiple components varying b<.) th in the number and the placement of the substituent chlorine atoms. In other cases, the best possible name may only identify the substance as a reaction product of specified reactants, for example, " anhydrosorbitol monoester of hydrogenated castor oil acids".

c. Provide a molecular formula tllat gives the identity and number of atoms of each element contained in the molecule. For example, C6H6 is the molecular formula for benzene. When the substance is not molecular or when the exact number of atoms in the molecule is indefinite, such as the infinite crystal sodium chloride, give the relative numbers of each element I s atoms. You are required to enter the CAS registry number, if one has been assigned to the substance.

d. For a Class 1 substance, provide a s( ruCnlral diagram. The diagram should clearly indicate the identity of the atoms and the nanlre of bonds joining the atoms. Any ionic charges or stereochemistry should be shown clearly. In the description of the nature of the reaction or process, as much specific detail as possible should be provided on the reaction conditions, ( i. e. temperature, time, etc.) and on the relative amounts of reactants. All known stereochemical details should be provided. Carbon atoms in ring systems and their attached hydrogen atoms need not be explicitly shown. Where applicable, specify the proportions of isomers or tautomeric forms, degree of neutralization, etc.

For a Class 2 substance:

( 1) List the immediate precursor suhstances by chemical name and CAS Registry Number ( if known)

 21 ( 2) For substances prepared by chemical reaction, describe the nature of the reaction or process. A description should appear in the form of a reaction scheme:

A+ B+ C The nature of the reaction mu~ t be described as specifically as possible ( e. g., acetylation, alkaline hydrolysis, diazotizatio~). For substances that have been produced without chemical reaction ( e. g., by chemical extr~ tiOD from a natural source), specify the source, the production process, and the nature of the product.

( 3) If you intend to manufacture a Class 2 chemical substance within a limited range of possible coDllX> Sitions, report the range. For example, a manufacturer filing a notice for chlorinated naphthalene might specify a compositional range of 20 40 percent chlorine by weight. In determining the range, you may have to consider the reaction ~ tions, the catalyst. or the puriflcation process that may be used to produce the substaoce, aDd other facton. You should provide the range of composition in weight percent for each specific component or class of components that you intend to manufacture for commercial purposes. Indicate the typical composition or any actual values for samples.

( 4) Provide as complete a structural diagram as possible. The diagran1 should indicate the characteristic stnx: ture or variable composilional elements of the subslance 2. Polymers ( page 5)

Submitters should be aware or the PMN filing exemption, applicable to some polymers and useful to some manufacturers. The regulations for this exemption are at 40 CFR § 723.250. Persons intending to manufKture polymers, and who have determined that their polymers do not meet the requirements of the exemption should file a PMN or LYE/ LoREX. Persons intending to manufacture polymers, and who have determined that, for business reasons, an Inventory listing for their substance is desirable, should file a PMN.

a. IOOicate the lowest number average molecular weight of any composition of the polymer you inteod to manufacture. Identify the method you used to make this determination ( e. g., vapor pressure osmometry or other colligative property determinations, gel permeation chromatography, ' light scattering, or various correlative techniques). If you have not determined number average molecular weight by analytical methods, briefly explain the basis for your estimate. Indicate the maximum weight percent of low molecular weight species below 500 and below 1,< XX> absolute molecular weight. Include the weight of oligomeric reaction products ( including molecules foroled that are not polyn1er molecules) in your determination but do not include the weight of residual mono~ or other reactants. Attach test data with two copies supporting your estimate. If you do oot have actual test data, provide an estimate and describe the basis for the estimate. NOTE: The lowest number average molecular weight is NOT the lowest MW of any component of the polymer mixture, but the lowest number average of several samples of the same polymer, run over time.

b. Column ( 1)  Monomer or othcr reactant and CAS Registry Number You are required to provide the chemical name and CAS Registry Number of each reactant used in the manufacture of the polymer or incorporated into the polymer, including those used or incorporated at 2 weight percent or less. Reactants include monomers, free radical initiators, and cross linking, chain transfer, and other reactive agents that are used intcntiooally to become chemically a part of the polymer composition. If a prepolymer is used in the manufacture of the polymer, list the prepolymer and its CASRN as charged into the reaction vessel. If prepolymer compositional information is available ( 0 ( he submitter, identify by bracketing or another method the IDOnomers which are components of the prepolymer. If compositional information of the prepolymer is not available to the submitter or if the prepolymer is represented for purposes of TSCA by a structural repeating unit ( SRU) name ( e. g., silicones and polyethoxylated and  propoxylated substances), you should identify the prepolymer as it is listed in the TSCA Inventory. Solvents. emulsifiers, and non reacting components should not be listed.

 22 Column ( 2)  CBI claim Column ( 3)  % of reactant, typic." composition: For each reactant ( includulg monomers), indicate its typical weight percent in the polymer. TIle weight percent can be determined in one of two ways: according to the weight of the reactant charged to the reaction vessel or the weight of tIle chemically combined ( incorporated) reactant in the polymer. For the first mclhod, the weight percent of a reactant is the weight of the reactant charged to the reactor divided by the weight of the polymeric chemical manufactured ( times 100). Thus, the weight percent of reactant A of a polymer manufactured from reactants A, B, and C is the weight of A charged to the reactor divided by tIlt dry weight of the polynler A B C ( times 100). For the second method, the weight percent of the reactant using the " incorl) Orated method" is determined using theoretical calculations of the minimum weight of monomer or other reactant necessary to account for the polymer's actual weight. Manufacturers must maintain analytical data or theoretical calculations to denlonstrate their determination.

Please note that zero per cent is NEVER an acceptable level of a feedstock, if that feedstock is part of the chemical identity. To describe a substance as including " 0 30%" of a given feedstock will only result in getting the PMN rewrned for a better identity. If you are notifying for a substance for which a feedstock will vary from very low levels you can enter" > 0 30%. or " trace 30%" without, as you will if you enter " 0 30%.. forcing a new identity. .0  2 % ", however, would be acceptable for a chemical that is not part of the ID and is not marked in the 10 field.

If you use a prepolymer in the manufacture of the polymer, you must determine the weight percent of its component reactants. For example. the weight percent of E used in the manufacture of a polymer ( using the " amount charged" method) from reactants A, B, and C and prepolymer D E is the total weight of monomer E in the prepolymer D E used divided by the weight of the polymer A B C D E n1< U1ufactured ( times 100). You must provide the identity and typical weight percent of each monomer and other reactant used in the manufacture of the polymer regardless of the weight percent at which it is used. If you will typically manufacture the polymer using a reactant in a range of weight composition, you may indicate the range of weight percent instead of the typical weight percent.

Column ( 4)  Identity Mark: Reactants used or incorporated at greater than 2 weight percent in the manufacture of the polymer are included as part of the description of the polymer listed on the TSCA Chemical Substance Inventory. However, you can choose to include a reactant used or incorporated at 2 weight percent or less in the Inventory description of the polymer by marking this column. Mark the identity column if you want a reactant present or incorporated at 2 weight percent or less to be included in the description of the polymer which is added to the Inventory.

Column ( 5)  CBI claim.

Column ( 6)  maximum weight percent present: Indicate the maximum weight percent of each reactant that may be present as a residual ( unreacted material) in the polymer as manufactured for commercial purposes.

Column ( 7)  CHI claim.

Note that you must make separate confidentiality claims for reactant identity, composition information, and residual reactant information.

c. Identify which method you used to develop or obtain tl1e specified chemical identity  Method I, CAS Inventory Expert Service ( a copy of the identification report obtained from CAS Inventory Expert Service must be submitted as an attachmento the notice). or Method 2. other than CAS Inventory Expert Service.

 23 d. Correct Chemical Abstracts ( C A) name for the polymer tl1atis consistent with TSCA Inventory listings for similar polymers.

e. Provide a simple, representative strllctural diagram tl1at illustrates what you know or can reasonably ascertain concerning the key structural features of the polymer molecules. For example. you could identify die linkages formed during polymerization, the functional groups present, the range and typical values for the number of repeating structural units, and the relative molar ratios of the precursors. Indicate if the repeating substructures are arranged in a nonrandom order such as in graft or block arrangements. For example:

0 o.

HO R O( C R' C O R O) n H 3~ n~ 10, where R may be either  CH2CH2 or  CH2~

HCH

and R' may be either a 1,4 substituted benzene ring or ( CHV..

Provide approximate relative mole ratios of precursors, e. g 1,0 diethyl terephthalate adipic acid ethylene glycol propylene glycol . S .0 3.0 3. Impurities ( page 6)

a. Identify each impurity you reasonably anticipate will be present in the substance as manufactured for commercial purposes. An impurity is any chemical substance that is unintentionally present in the new chemical substance. List all impurities ( regardless of weight percent). If the substance contains some unidentified impurities. also enter " unidentified" in column ( a). Do not include any substances that are mixed with the new substance after manufacture.

In addition to impurities, list in this section other chemical substances, such as solvents, inhibitors, etc., that also may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purposes.

You should consider the following in identifying unpurities ( 1) Chemical and ulStrumcnttll analyses  often performed on the chemical substance during research and development to characterize the substance before it undergoes health effects or environmental effects testing, to optimize product performance. or ( 0 understand process chemistry and optimize output.

( 2) Manufacturing process chCDlistry  including feedstocks. feedstock impurities. byproducts. and intermediates both from the major reaction pathway and from significant side reactions.

~ 4 ( 3) Quality control operations  operations which determine the nature and level of impurities that may be present in the chemical substance.

Identify impurities as specifically as possible. You should provide tile following information:

( 1) the specific chemical naml:: or ( 2) a class or range of structurcs ( e. g., C6  CIS faIry acid salts or polychlorinated cyclic and acyclic hydrocarbons in the range Cs  C IV; or ( 3) the source ( e. g.. pyrolysis products of cellulose or coal tar residues).

Include the CAS Registry Number if available b. Enter the maximum weight percent of each impurity in the new chemical substance in column ( b). If the substance contains unidentified impurities. enter the total weight percent of unidentified impurities in column ( b).

confidentiality claml: must be made separately for each impurity.

4. Synonyms  Enter common chemical names by which tlle new chemical substance may be identified in the scientific or technical literature, including tlle names or codes used to identify the new chemical in test data or oilier data which are attached to the notice.

S. Trade Identification  Enter any trade name under which the new substance has been or will be marketed. Repon all trade names or brand names, even if they are not registered.

6. Generic chemical name  If the new substancc's idcntity is claimcd as confidcntial. enter a generic chemical name. This name should be only as generic as is necessary to protect the confidential chemical identity. and should reveal the chemical identity of the substance to the maximum extent possible. The generic name will be published in the FEDERAL REGISTER notice on the new substance. EPA will review the adequacy of the generic chemical name when the NOC for the substance is subnutted. If the name seems more generic than necessary. EPA will contact you to devclop an adequate name.

Generic chemical names are created for Class 1 chemical substances by masking structurally descriptive parts of their specific chemical names. Masking can be accomplished by substituting non descriptive terms ( e. g., . substituted") for descriptive parts of the name. Here is an example with the oil source masked: hydrogenated palm oil fatty acids, esters with D mannitol, ethoxylated, could become: hydrogenated fatty acids, esters with hexahydroxyalkane, ethoxylated. Guidelines for developing a generic name are provided in Appendix B of the TSCA Chemical Substance Inventory, Volume 1, 1985. This document is available in any Federal Depositary library or through the TSCA hotline ( see Contact List, Appendix C).

7. Byproducts  List the byproducts that you reasonably anticipate will result from the manufacture, processing,

use, and disposal of the new chemical substance at sites you control. Identify the byproducts as specifically as possible by name and CAS Registry Number ( if available). You should give the following information:

( 1) the specific chemical name; or ( 1) a class or range of structures ( e. g.. C6  CIS fatty acid salts or polychlorinated cyclic and acyclic hydrocarbons in the range Cs  CIV; or 25 ( 3) the source ( e. g., pyrolysis products of cellulose or coal tar residues). If there are no byproducts, enter " None."

Section C  Production, Import, & Ust' Information ( Pagc 7)

Production volume 1.

Estimate the production volume for the first 12 months of production. Also estimate the maximum. production volume for any consecutive l2 montl1 period d~ ring the first 3 years of manufacture. Provide your estimates in kilograms. Maximum production volume is the maximum amount of the new chemical substance on a 100% basis Report the amount of pure new chemical substance, not including solvents or other components if the new chemical substance is in a mixture that you expect to produce during any l2 month period ( e. g., June 19W through May 1991). Include in this total amounts produced by persons under contract to you. If part of the amount manufactured is for export, include this amount in your estimates. ( You are not allowed to exclude exports from L VE quantity limits after any of the substance is manufactured for domestic use) If you submit a consolidated PMN, make your production volume estilnates on a per chemical basis.

For an L VE, the Agency will gc.: nerally perform the risk assessment under the exemption as if the total amount permissible under the exemptioll ( 10,000 kg) were being produced. However, submitters wishing their exemption to be based upon arulual protluction volumes lower than 10,000 kg may so indicate in their exemption notice by marking the binding box adjact: llt to the production volume space on the form. Submitters who so elect are bound by their election, and if they subsequently wish to increase their maximum production volume under the exemption must submit a new exemption notice cross referencing the original exemption number on the cover of the notice. If the new exemption is granted. it will supersede the previous exemption.

2. Use information a. Column ( 1) category of use: Identify the intended category of use of the new chemical substance by describing its function and application. " Function" is related to the inherent physical and chemical properties of the substance ( e. g., degreaser, catalyst. plasticizer, ulttaviolet absorber). " Application" refers to the use of the substance in particular processes or products ( e. g.. a degreaser may be used for cleaning of fabricated metal parts).

Following are some examples of appropriate categories of use: . a disperse dye carrier for fmishing polyester fibers . a cross linking agent for epoxy type coatings for metal surfaces . a flame retardant for surface application on cotton apparel, textile home furnishings, and exterior canvas products . a surfactant in automobile spray wax . a colorant for paper and other cellulosics . fiber reactive dye for nylon carpeting and upholstery . an antioxidant in fuels oils and lubricants Column ( 2) CBI claim,

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

Column ( 4) Estimate the percent of the total production volume that you anticipate will be manufactured for each category of use.

Column ( 5) CBI claim  26 Column ( 6) Estimate the weight percent of the new chemical substance that will be contained in any formulated mixture, suspension. emulsion. solution. or gel associated with each category of use as manufactured for commercial purposes at sites under your control. Where tile substance is distributed from your site in a pure state, enter 100%.

In the example below, a PMN substance will be used for several different uses, including a cross linking agent where the substance is distributed in a pllre state and as a surfactant where the substance is manufactured, then formulated at a weight percent of 4 %. Eighty percent of the production volume goes to the first use and twenty percent of the production volume will bc used for the second use.

c ,.~ ' fll BIudIuc OIJlIon .. . of I'r. oductlon CIII '* In ronn1alal1l) r CRI CI. t8* jJIa A , W x ~ 8IA., obileS" r..., W... x Column ( 7) CBI claim Column ( 8) Mark to indicate if the category of use is site limited or. if the substance is intended for iOOustrial, commercial, and/ or consumer use. as defmed below, estimate the percent of the production volume expected for each category.

Site limited  The substance will be used only on the contiguous property unit where it is manufactured aOO oot intentionally distributed outside that site except for waste disposal. This includes all factories, storage places, and warehouses at the site. In most cases. this would be an intermediate which is further reacted on site. If the substance is transported across a public road which bisects a site, it can still be site limited.

Cousumer  The new chemical substance or products containing the substance will be used by private individuals in or around a residence, or during recreation, or for any other personal use or enjoyment, e. g., automotive polish. dyed wearing apparc.: l. household cleaners. hunting lure, etc. If a consumer use is identified, then the EPA requests the following intormation to be provided on an attached continuation sheet: a detailed description of the use of the new chemical substance expected in consumer products and any reactions that occur causing the substance to lose its idernity in the consumer product. This section does not apply to situations where the PMN substance has clearly reacted away and lost its identity before the final article is used by consumers ( e. g., coatings).

Industrial  The new chemical substance or products containing the substance will be used at the site of other manufacturers or processors, e. g., textile dyeing, paint formulation, use of a curable resin to manufacture an article.

Commercial  The new chemical substance or products containing the substance will be used by a commercial enterprise providing a consumer service. e. g., use by commercial dry cleaning establishments, use by painting contractors, or use by roofers in commercial building construction.

Mark all boxes, as appropriate. For example, a surfactant in an automobile wax may have a consumer use in liquid wax, a commercial use in auto washes, and an industrial use by automobile manufacturers. Mark the binding option statement where applicable.

c27 Note: You must make separate conlidcntiality claims for the description of tile category of use, the percent of production devoted to each category. the percent in formulation. and category of use information.

The information in this section is used 10 evaluate potential exposure and release of the new substance. If you wish to provide any additional information which would assist in this analysis. it may be submitted as optional information. You should be aware that the Agency uses conservative default assumptions to estimate exposure in the absence of specific information.

c. Generic use dcscription  includes degree of containment  For each category of use description which is claimed as confidential, provide a generic description of the category. If such a generic description does not provide a sufficient indication of potential exposure, tile description can also describe the degree of con~ jrJo T!! ent of the new chemical substance, as shown in the list below; however, a generic use description that solely describes the degree of contairu11ent such as . open, non dispersive use" is not acceptable.

Identify the category of use to which the generic description applies. The generic use should reveal the intended category of use to the maximum extent possible. For example, the specific use of a new substance as an antioxidant in a lubricant could be described generically as a lubricant additive; a fiber reactive dye for nylon carpetjng could be described generically as a dye for fibers.

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

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

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

( e. g. cutting fluids, fabric softeners, automobile tire rubber) ( d) dispersive use ( e) highly dispersive use ( f) other ( e. g., fertilizers, salt for de icing, paint solvents, spray paints)

( describe)

3. Hazard information  Include in the notice a copy or reasonable facsimile of any hazard warning statement, label, material safety data sheet ( MSDS), or other information which will be provided to any person regarding protective equipment, engineering controls, or practices for the safe transport, use, or disposal of the new chemical substance. If hazard warning information is not yet prepared, describe the statement you intend to provide, if any. You are not required to develop hazard warning statements for this notice if you do not otherwise intend to do so. Identify copies of hazard warning statements or other hazard information that you attach in Part ill, Ust of Attachments.

Part D  HUl\ IAN EXPOSURE AND ENVIRONl\ 1ENTAL RELEASE ( pages 8 10)

In sections A and B. you must provide information on manufactUring, processing, and use operations involving the new chemical substance or products containing the new substance. Preparing a chemical for an end use application typically involves several production steps, or operations, where potential human exposure and environmental release could occur. Use section A to provide information on operations that occur at industrial sites you control. Typically, this will involve manufacturing and processing operations. Use section B to describe  28 operations that occur at industrial sites controlled by others. Typically. this will involve processing and end use applications. e. g., dyeing of nylon carpcting, paint spraying of automobiles.

As an example, for a solvent used in automotive paint for automobile manufactUre, there are solvent manufacture, paint manufacture; and industrial paint spraying operations. Paint manufactUre may occur at a site you control or at a site you do not control. If paint manufaclure occurs at a site you control, describe that operation in section A. If paint n1anufacture occurs at a site you do not control, describe that operation in section B. If processing or end use operatiol1S occur at industrial sites you control, they should be described in section A. . In most cases, you will have more specific information on sites you control than sites you do not control. If you do not have specific information on sites controlled by others, describe a typical operation involving the particular processing or end use appl ical ion based on information available to you and on your experience with similar chemicals. Provide all information requesled to lhe extent to which il is known to or reasonably ascertainable by you. Where EPA has available only limiled information on worker exposure and environmental release, its evaluation will be based 011 rcasonableworsl case assumptions.

Note that if you are an importer. although you do not have to complete section A or B for operations outside the United States, you ma)' still have to report information in these sections. If there are further industrial processing or use operations after import of the substance, you must describe these operations in section A or B as appropriate,

Because EPA assesses the potential domestic manufacture and processing of imported chemicals, you may choose to complete section A or B for operations outside the United States to assist EPA with this assessment. Providing this infonnation is optional and is not required.

Section A  Industria! Sites Controlled by the Submitter ( Pages 8 9)

Complete a separate section A for each type of manufacturing, processing, or use operation involving the new chemical substance at sites you control. If the same operation is performed at more than one site, you are not required to complete a separate section A for each operation, but simply describe the typical operation common to these sites. However, if operations or production rates vary substantially among the different. sites, you must provide a separate section A for each different operation.

1. Operation Description a. Identity  Identify tIle site which the section describes. If this section describes more than one site, provide additional site identities on a continuation sheet. Indicate the total number of sites at which the operation this section describes will occur. If you mark the confidential box next to this item, all information in it will be treated as confidential.

b. Type  Mark the appropriate box c. Amount and duration  Estimate the maximum amount of the new substance ( on a 100% new chemical substance ( i. e. pure) basis) manufactured, processed, or used in the operation and the duration of the operation. Provide information per batch for batch operations and per day for continuous operations. Base the estimates on the maximum 12 month production provided on page 7 of the PMN form.

d. Process description  Provide a process flow diagram which describes the manufacturing, processing, or use operation involving the new chemical substance.

( 1) Identify the major unit operation steps and chemical conversions, including secondary operations involving the new chemical substance, such as interim storage and shipping containers. . Unit operation" means a functional step in a manufacttlring, processing. or use operation where substances undergo chemical changes and/ or changes in 29 SAMPLE MANUFACTURING OPERATK) N location, temperature, pressure. physical slate. or similar characteristics. Include steps ill which the new substance is formulated into gels. mixtures. suspensions, solutions. etc. Specify rhc shipping containers, including expccled capacilicx ( c. g. 5 gallon pails, 55 gallon drums. 5,000 gallon tank trucks, 2O,< XX> gallon rail cars). 2 ( 2) Indicate in your diagram the entry and exit point of all feedstocks ( e. g., reactants, solvents. catalysts) used in the operation. products, recycle streams, and wastes. Identify each feedstock and specify its approximate weight ( by kg/ day for continuous operations or kg/ batch for batch operations). Include cleaning chemicals, and state how often they are used ( e. g., every day, every batch, monthly). 3 DistiRation " Column . 45 To Rec: yde +

( 3) Number all points from which the new chemical substance and substances containing the new chemical substance will be released to the environment or to control equipment, including small or intermittent releases ( e. g. some cleaning releases, drum residues, etc.) and trace amounts of the new chemical substaJ ¥ : e. Do not include accidental releases. Including fugitive emissiol1S is optional. SAMPLE PROCESSING OPERA~

New Sub'ta~ ( 500 Kg/ daYJ 1 ' T WalBr

( 1~ day) ( 4) Mark die box if you wish to indicate your willingness to have your process description binding Pigment ( 250 Icg/ day) 2 2. Occupational Exposure Diatomaceoos

( Ear1h ( 100 kg/ day)

DMnming or Par* aging ~ Column ( 1)  worker activity: Describe each specific activity in the operation during which workers may be exposed to the new chemical j substance. Such activities may include charging reactor vessels, sampling for quality control, . transferring materials from one work area to another, ... drumming, bulk loading, changing ftIters, and cleaning equipment, etc.. Activities must be described even if workers wear protective equipment. ( Material Safety Data Sheets indicating recommended protective equipment should be submitted as part of Hazard Information in part I, section C. subsection 3 of the notice form.)

Column ( 2)  CBI claim fl) r worker activity Column ( 3)  protective equipment alld engineering controls: provide information on the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the new chemical substance, i. e.. gloves. goggles, 2lC respirator, 19C respirator, closed containment system, nitrogen blanket, etc..

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

Column ( 5)  physical form: Indicate the physical form [ e. g., solid ( crystals, granules, powder, dust), liquid ( solution, paste, slurr)'. emulsion. mist, spray), gas ( vapor. fume), wet press cake] of tlle new substance and its weight percentage ( if in a mixture) at the time of exposure. even if workers wear protective equipment.

Column ( 6)  Binding option for physical forms Column ( 7)  CBI claim for physical form Column ( 8)  maximum number or workers exposed: Estimate the maximum number of workers involved in each specific activity based on thc estimated maximum l2 month production volume.

Column ( 9)  CBI claim.

Column ( 10)  maximum duration in houl s/ day: Enter the maximum duration that anyone worker will engage in the activity in hours/ day. e. g.. 8 hours/ day.

Column ( 11)  maximum duration in days/ year: Enter the maximum duration that anyone worker will engage in the activity in days/ year. e. g.. 200 days/ year. based on the estimated maximum production volume.

Column ( 12)  CBI claim Note dlat you must make separate confidentiality claims for the description of worker activity, physical form of the new substance, number of workers exposed, and duration of exposure. ( See 2, 7,9, 12).

3. Environmental Release and Disposal Column ( 1)  release point number: For each release point indicated in the process description ( part Dt Section A, subsection Id( 3) of the notice form, enter the corresponding number. If you indicated more than S release points, make a continuation sheet to cover them.

Column ( 2)  amount of new chemical released at release point: Estimate the amount of new chemical ( in kg/ day for continuous operations or kg/ batch for batch operations) that will be released from the release }) Qint directly into either ( a) the environment or ( b) into control technology ( in kg/ day or kg/ batch). Base your estimate on the expected maximum twelve month production volume. EPA is particularly interested in the amounts of chemicals used and frequencies of cleaning of equipment and releases from transport containers, including the location ( if different from that of manufacture or processing) of drum recyclers, tank truck cleaning facility, etc.)

Column ( 3)  CBI claim.

Column ( 4)  medium of release: Enter the medium [ stack air, fugitive air ( optional), surface water, on site or off site land or incineration, POTW, or other ( specify)] into which the release stream discharges ( whether or not control technology is used). You do not have to identify fugitive air releases, but if EP A reviewers consider that such air releases are likely and estimates are not provided in the submission the reviewers will estimate reasonable worst case fugitive air releases. In estimating reasonable worst case releases we generally consider vapor pressure and type of use, including the location if different from that of site manufacture or processing.

Column ( 5)( a) release I control technology I efficiency: For a release to air or water, describe the type of technology used to control the re1. ease of the new chemical and the efficiency of the control technique. Examples of control technologies include carbon filter. scrubber and biological treatment ( primary, secondary, etc.). Use the optional binding box to indicate your willingness to be bound to control technology descn" bed. Attach optional  31 information such as data and methods of waste treatment or purification efficiency studies ( 5)( b) release after control tcchnology: Enter the estilnatcd amount released to tl1e environment after control technology ( in kg/ day). Entcr " none" if no control technology is used and thc substance is released directly into the environment.

For diSposal on laIld. descrille the landfill site construction ( including liners) and handling procedures. Describe landfill containers.

You may wish to optiol'lally attach efficiency data for control technologies used. For example, carbon adsorption removal efficiency of the new chemical substance from an aqueous stream could help EP A estimate release of the new chemical substance from a facility using carbon adsorption treatment.

Column ( 6)  CBI claim.

( 7)  destination of water releases: Mark the appropriate box and/ or specify other destinations of water releases. [ i. e., POTW ( Publicly O\ vned Treatment Works), navigable waterway or specify other]. Provide the name of the POTW receiving water releases and the NPDES ( National Pollutant Discharge Elimination System) number for the POTW, navigable waterway or other direct discharger. This 9 digit number is assigned by EPA or the State under the authority of the Clean Water Act. When appropriate, contact your POTW to obtain its NPDES number.

Note that you must make separate confidentiality claims for the release number, amount of new chemical substance released, control technology disposal information, and the destination of the releases to water.

Section B  Industri. ll Sites Controlled by Others ( page 10)

Complete a separate Section B ( continuation pages for second and subsequent) for each type of processing or use operation associated with each category of use specified in Part I, Section C, subsection 2( a) at industrial sites you do not control. If the same operation is perforDled at more than one site, then describe the typical operation and enter the number of sites in the space provided.

Describe each typical processing or use operation to the maximum extent possible from information known to or reasonably ascertainable by you. Information may be provided as ranges or estimates.

1. Operation Dcscription  Generally self explanatory  the information requested here differs from that requested for Section A Operation Description only by the additional worker activity information requested. EP A is particularly interested in the chemicals used and frequencies of cleaning of equipment and transport containers.

2. Worker Exposure/ Environmental Release Column ( 1)  Activity Letter: Provide the letter for each activity from tile diagram above and complete columns 2 8 for each worker activity associated with the letter.

Column ( 2)  maximum number of workers exposed: Estimate the maximum number of workers exposed to the new substance during the activity.

Column ( 3)  CBI claim Column ( 4)( a)  duration of exposure  hours/ day: Estimate the duration of exposure of the new chemical substance per worker in hours per day.

days/ year: Estimare the durarion of exposure of the new chemical Column ( 4)( b)  duration of exposurl: substance per worker ill days per year.

~ 3% Column ( 5)  CBI claim Column ( 6)  Physical Form, Protectivc Eqpt, Eng'g Controls: Provide information on the physical form [ e. g. solid ( crystals, granules, l)() wder. dusl). liquid ( solution, paste, slurry, emulsion, mist, spray), gas ( vapor, fume), wet press cake] of exposure and percenl new chemical substance ( if in a mixture), and protective equipment and engineering controls ~ mployed to safeguard the worker from potential exposure associated willi the new chemical substance, i. e., gloves, goggles, respirators, etc..

Column ( 7)  Percent in the Pt'oduct Fot, nulation: Estimate the percent in the product formulation of the new chemical substance to which the worker is potentially exposed during the activity.

Column ( 8)  CBI claim.

Column ( 9)  release points Enter the number given to each release point in reference to the process diagram above and complete 9 13 for each release point identified ( use continuation pages if necessary).

Column ( 10)  maximum rclcasc Provide an estimate for the maximum amount of new chemical substance in kg per year that may be released to the media specified in Column ( 12) ( see below) under typical operating conditions. Provide this information for releases ( a) directly to the environment or ( b) into control technology to the environment in kg per day for corninuous operations or kg per batch for batch operations. EPA is particularly interested in the amounts of chemicals used and frequencies of cleaning of equipment and releases from transport containers .

Column ( 11)  CBI claim.

Column ( 12)  medium of release: Dcscribe medium of release [ stack air, fugitive air ( optional), surface water, on site or off site laIld or incineration, POTW. or other ( specify)] and the control technology( ies) used to limit the release of the new substance to the environment to the extent that the information is known to you.

Column ( 13)  CBI claim.

( 14)  byproducts: Identify all byproducts resulting from the reaction to the extent that the information is available to you.

Note that you must make separate confidentiality claims for the numbers of workers exposed, the duration of exposure, the percentage of the product in formulation, the amount of new substance released, and the control technology .

( OPnONAL) POLLln'ION PREVENTION AND RECYCLING INFORMA110N ( page 11)

On the form itself and in Section J of this Manual we describe the Agency's goals in providing this mechanism to inform us of environmental benefits which may be available from your new substance. Below are suggestions for organizing such information to be most useful to improve the review of your substance: part of the material to provide is about characteristics of the substance and part relates to your process description and calls for a discussion of how a shift to the new chemical substance may enable the use of the more desirable process. If you wish your PMN substance to be considered for the Agency's EPA New Chemicals Pollution Prevention Recognition Project, you should tell us so in this information.

I. Product Information Will this substance be produced to address an environmental problem or in response to environmental regulation? ( One example would be CFC substitutes.) Do you wish your substance to be considered for the Agency's BPA New Chemicals Pollution Prevention Recognition Projecr?

.. 33 ll. Toxicity Information BPA is interested in infornlation describing possible reductions in toxicity of a new chemical substance as compared to that of alread)' commercialized chemical substances for which the new substance may substitute. Such information may demonstrate thaI the new chemical substance may be a viable safer substitute.

m Technical Informal ion Process Chemistry I.

Chemical approaches which may minimize waste production include tile following 1. Selection of synthetic method: high yield, minimal side reactions. minimization of coproducts unless they are of commercial value.

2. Choice and purity of feedstocks. reagents, catalysts, solvents, etc. Reduction! elimination of undesirable feedstocks, solvents ( e. g. VOC's), catalysts, etc.

3. Optimization of reaction conditions to minimize side reactions 4. Optimization of stoichiometry to minimize presence of excess reactants,

S. Product Purification.

6. Use of advanced chemical techcology such as shape selective zeolite catalysts, stereoselective synthesis, and permselective menlbranes for molecular separations ( liquid phase).

b. Product Substitutiolv Source Reduction 1. Perceived advantages related to the use of the new chemical substance compared to existing substances. Comparison of the relative risk of the new chemical to existing chemicals ( for example, volumes, releases, exposure, human health effect~ and ecotnxicity) of the ~ uh~ tances. A new chemical that causes less pollution may nonetheless be more toxic than an exisling chemical and therefore the risk to health and the environment may be higher.

2. Changes in product composition or physical state.

Consider potential changes in product compositions or physical states which may reduce releases and exposures. For example: using a more concentrated product to decrease the amount of release or waste generated; or reformulating a powder into a paste to mitigate inhalation concerns.

3. Enhanced product life or durability Improvements which may be expected from enhancements to product life or durability of new chemical substances over existing substances. For example. a more durable product could result in less solid waste going to landfills.

4. Changes in product effectiveness/ Effect of product performance at lower concentrations ( significant orders of magnitude).

New chemical substances which may 1:> e more effective than existing substances. or that may be as effective at significantly lower concentrations than an existing chemical may result in reduced releases and exposures.

 34 S. Packaging ( transportation. conccntr3tion, disposal. life cycle analysis. weight loss, etc.).

Examples of packaging with pollution prevention in mind may include ( A) reusable packaging materials, or ( B) making the ne\ v chemical $ ubst: tnce more concentrated to minimize size or volume of packaging.

Process Modifications c.

1. Engineering technology changes.

In some cases, existing equipment which may be used to produce new chemicals may not be the best technology from the standpoint of pollution prevention.

Consider alternative technologics for the major unit operations ( i. e. separation, filtration, etc.) in the process and d1eir potential impacts on releases and exposures. Some examples of alternative technologies include ( A) stream stripping instead of air stripping. ( 8) pan filter versus rotary drum filter or centrifuge or, ( C) flash dryer versus spray dryer.

2. Equipment/ piping/ layout changes Equipment/ piping/ layout alternatives can have an effect on releases and exposures. Some examples of these changes include: ( A) redesigning equipment and piping to reduce the volume of material drained for batch changes and for cleaning operations, ( B) installing bellow sealed valves versus conventional valves to reduce VOC emissions and worker exposure, or, ( C) use of new resources such as by product steam from another process.

3. Operating Conditions Optimize operating conditions at major unit operations ( including reactors and separation equipment). Available supporting laboratory information ( i. e. experimental design data) may be collected and submitted describing reduction of chemical exposure using the new PMN substance. reduced emissions to the workplace or environment, etc. An example might be use of a new surfactant to reduce the amount of solvent needed in cleanup operations.

4. Automation Potential automation/ control steps may have pollution prevention or exposure implications. For example, a batch process can be successfully automated to reduce off spec. product and spillage, which reduces waste. A manual packaging system can be automated to reduce worker exposures.

s. Closed systems Reduced exposures, emissions, or elimination of isolated intermediates d. Operating Practices Examples of operational and administrative changes which could reduce pollution and exposure are Procedural measures Increasing drain time from 15 to 20 minutes could reduce leftover material in a tank.

2. Loss prevention Installing overflow alarms in tanks could reduce overflows or releases.

 35 3. Management practices Reducing inventories of toxics to minimize the consequences of emergencies.

4. Waste stream segregation Segregating waste streams to avoid cross contaminating hazardous and non hazardous materials could allow recycling of some waste. For cxample, changing waste segregation to separate organics from an aqueous waste stream.

S. Material handling improvements Changing from small volume containers to bulk or reusable containers could reduce releases of residue 6. Production scheduling Larger batch sizes Cat1 be made, which could reduce number of production runs, cleanup waste, and worker exposure.

7. Safety Examples would be use of substances which are less explosive, less flammable, or less corrosive. Use of less corrosive substances may also serve to decrease cost and maintenance, as well as increase life, of equipment.

e. Rcuse/ Recycl ing/ Rec 1 amation Identify potential reuse/ recycling/ reclamation ( both on site and off site opportunities) of the waste streams. Some examples of the reuse/ recycling/ reclamation oppornmities are:

1. Use of recycled materials in origin," process Returning recovcrcd solids from a filtrate ( through the use of a settling tank) to the reactor. Wastes from unrelated processes may ~ used in feeds £ ock £ 0 make new substances.

2. Recovery and recycling of resources utilized in the process Installing vapor recovery systems to capture and return vaporous emissions. Feedstock or off spec. substance previously discarded may be recycled back into the process.

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

The off acid gas from a reactor could be absorbed with water to convert it into dilute acid and sold as a by product.

f. Eocrgy Savings Almost any change in an industrial process will entail some change in the amount and form of energy consumed in that process. How might the new chemical substance result in savings of energy resources in any phases of manufacture, processing, or use?

Energy conservation is a form of pollution prevention. For example, reduced energy use decreases the quantity of fossil fuels burned and the amount of air pollutants generated. Reduced boiler operation also reduces the discharge of waste cooling water blowdown and boiler blowdown. Purification of raw water to produce boiler  3' 6 feedwater by ion exchange I.) r other processes produces wastes such as regeneration chemicals. Reduced boiler operation could also reduce this \ vaste stream. Another example might be shifting from thermal polymerization! curing to radiation polymerization! curing.

Alternative Treatment Methods g.

Consider efficiency of alternative treatment methods and tile compositions and quantities of the input PMN waste streams and output release streams. For example:

1. Use of ammonia instead of sodium hydroxide to neutralize a process, allowing the excess to be vacuum stripped and possibly recycled, rather than removal by water washes which create a caustic waste requiring treatment and/ or disposal as a hazardous waste. .

2. Replacement of organic solvents with water. eliminating VOC emissions h. Alternative Waste Dis\: I() sal Methods Compare release media ( land, air. water) in light of the PMN waste streams being disposed, including quantity of release, composition of the waste, and applicable regulatory limitations, For example, an aqueous ammonia waste stream may be converted into fertilizer for agricultural use.

Part m  LIST OF A Tf ACmlENrS ( Page 12)

Attach any continuation sheets for sections of the form, test data and o[ her data ( including strucwreactivity information), and optional information after the last page of the form. Clearly identify the attachment and the section to which it relates, if appropriate. Number consecutively the pages of the attachments. Enter the inclusive page numbers of each attachment. Enter the total number of pages in the notice on page 1 of the form.

Mark the . Confidential" box next to any attachment nante you claim as confidential. Read RER and RHR in Section I of this manual for guidance on how to claim any information in an attachment as confidential. You must include with the sanitized copy of the notice a sanitized version of any attachment in which you claim information as confidential.

Physical and Chemical Properties Worksheet ( Optional)

A worksheet which assists EP A . s review of the physical/ chemical property information you submit is provided on the last page of the form. Providing physical/ chemical property information in this format is optional. However. all physical/ chemical properties data in your possession or control must be submitted with your notice. If you submit this worksheet. identify it on the List of Attachments.

.37 .' c' Appendix A EXAMPLES OF TEST DATA Following is a list of the Iypes 01' test data which you mu... t attach to the notice form if it is in your possession or control. This list is illustrative. 11\)[ l: XhaUslive.