Questions & Answers for the New Chemicals Program ( Q& A)

U. S. Environmental Protection Agency Office of Pollution Prevention and Toxics Washington, DC 20460 ii TABLE OF CONTENTS Page 1. GENERAL PROGRAM INFORMATION 100. General ............................................................................................................ 1 1 101. Guidance for Completion of § 5 Submission Form ......................................... 1 6 102. Inventory Searches/ Bona Fides ....................................................................... 1 17 103. Chemical Identification ................................................................................... 1 22 104. Nomenclature .................................................................................................. 1 26 105. Inventory Issues ................................................................................................ 1 31 106. Review Process ............................................................................................... 1 31 107. Notice of Commencement .............................................................................. 1 33 108. User Fee .......................................................................................................... 1 35 109. Consolidated Notices ...................................................................................... 1 39 110. Joint Submissions ........................................................................................... 1 41 111. Toll Manufacturer ........................................................................................... 1 42 112. Foreign Supplier .............................................................................................. 1 43 113. Trade Mark Reactant ( TMR) Supplier ............................................................ 1 43 114. Analytical Method Recommendations ............................................................ 1 44 115. Test Data Requirements .................................................................................. 1 45 116. Environmental Fate Data ................................................................................ 1 50 117. Health and Safety Data ..................................................................................... 1 50 118. Ecotoxicity Data ............................................................................................... 1 53 119. Polymer Issues ( not concerning exemptions) ................................................... 1 55 120. Principal Importer ........................................................................................... 1 59 121. Import Issues ................................................................................................... 1 59 122. Biotechnology ................................................................................................. 1 60 123. Significant New Use Rule ( SNUR) ................................................................ 1 61 124. Pollution Prevention ....................................................................................... 1 64 125. Recycling ....................................................................................................... 1 64 126. New Chemical Exposure Limits ( NCELs) ..................................................... 1 65 2. EXCLUSIONS 201. Impurities ........................................................................................................ 2 1 202. Mixtures .......................................................................................................... 2 2 203. Non isolated Intermediates ............................................................................. 2 3 204. Byproducts ...................................................................................................... 2 5 205. End Use Reactions .......................................................................................... 2 7 206. Modifier of Physicochemical Characteristics ................................................. 2 7 207. Articles ............................................................................................................ 2 7 208. The Two Percent Rule for Polymers ............................................................... 2 11 iii 209. Chemicals Manufactured Solely for Export .................................................... 2 14 210. Uses Covered by FIFRA ................................................................................ 2 17 211. Pesticide Inerts ................................................................................................ 2 18 212. Pesticide Ingredients ....................................................................................... 2 19 213. Pesticide Intermediates ..................................................................................... 2 19 214. Uses Covered by FDA .................................................................................... 2 20 215. Naturally Occurring Substances ...................................................................... 2 22 216. Precipitation Inhibitors .................................................................................... 2 22 217. pH Adjustment ................................................................................................ 2 22 218. 40 CFR § 720.30( h)( 7) ...................................................................................... 2 23 219. New Chemical Formed Incidental to Storage .................................................. 2 24 3. EXEMPTIONS 301. Research and Development ............................................................................. 3 1 302. Test Marketing Exemption ............................................................................. 3 5 303. Low Volume Exemption ................................................................................. 3 7 304. Polymer Exemption ........................................................................................ 3 12 305. LoREX Exemption ......................................................................................... 3 13 4. COMPLIANCE AND ENFORCEMENT 401. Compliance Issues ........................................................................................... 4 1 402. Enforcement Issues ......................................................................................... 4 1 403. European Community ..................................................................................... 4 2 404. Canada ............................................................................................................. 4 4 iv HIGHLIGHTS OF THE NEW CHEMICALS PROGRAM Q& A Interested parties have asked many questions of the New Chemicals Program over the years. While responsive to the specific individuals asking the questions, EPA recognizes that it would be useful to a broader array of stakeholders to provide one, easily referenced document which compiles this guidance information. This Questions and Answers document ( the Q& A) is derived from these compiled questions, rather than having been designed as an overall explanation of the program. ° A general program description is provided at the New Chemicals Website, at www. epa. gov/ oppt/ newchems/, and in the New Chemicals Brochure, available from the TSCA Hotline at ( 202) 554 1404, or e mail at tsca hotline@ epa. gov. ° In addition, the Instruction Manual for submission of § 5 notices ( also available at the New Chemicals Website) discusses program policy and intent in the context of the PMN form.

This Q& A document is available both in hard copy and electronically. Although the content is the same, we believe the electronic version will be easier to use, utilizing a search function, if a computer is available to you. The electronic version can be downloaded from the New Chemicals Website. The paper version is also available from the TSCA Hotline by mail.

This Q& A document is intended only to explain the requirements of TSCA § 5 and selected EPA regulations implementing § 5, and to provide useful information to persons subject to these requirements. It is not a substitute for applicable legal requirements, nor is it a regulation itself. Thus, it does not impose legally binding requirements on any party, including EPA or the regulated community. Section 1: General Program Information 1 1 1. GENERAL PROGRAM INFORMATION 100. General 100 1. Q. How can I obtain a copy of the printed § 5 Pre Manufacture Notice ( PMN) form?

A. The § 5 PMN form ( EPA Form 7710 25) is available from the TSCA Hotline upon request by voice ( 202 554 1404), facsimile ( 202 554 5603) or by e mail ( tsca hotline@ epa. gov). An instruction manual is also available from the Hotline to assist you in filling out the § 5 submission form. There is a printable copy (. pdf) of the form at the New Chemicals Website ( www. epa. gov/ oppt/ newchems/).

The TSCA Hotline is a source of general program information.

100 2. Q. When does EPA expect to publish a format for electronic submissions so that I can submit my PMNs electronically?

A. As of this writing, EPA has developed an early version of an electronic form. This current version and further instruction are available at the New Chemicals website ( www. epa. gov/ oppt/ newchems). Submitters are invited to download this form and fill it out on their computers. At this time, we are only accepting paper copies made using this form. In the near future, we intend to develop the procedures to accept CD ROMs containing the PMN form. Input on such a form is welcomed, and you may send comments to:

Anna Coutlakis New Chemicals Program Chemical Control Division, Mail Stop 7405M United States Environmental Protection Agency EPA East Building ( ICC) 1200 Pennsylvania Avenue, NW Washington, DC, 20460 email: coutlakis. anna@ epa. gov 100 3. Q. A PMN has completed review, but when actual production starts, the manufacturing process must be changed. Is notification to EPA required?

A. TSCA § 5 requires submission of a PMN for a chemical substance or mixture that is not on the TSCA Inventory ( unless exempt). Thus, if the change in the manufacturing process results in a chemical substance or mixture whose identity is different from that specified in the PMN and is not on the Inventory, a new PMN is required. 40 CFR 720.40( f) requires the PMN submitter to report to EPA new information that materially changes the information included in Section 1: General Program Information 1 2 the PMN, if the information comes to light during the PMN review period. Therefore, if, during the PMN review period, the submitter decides that the manufacturing process will change from the process described in the original submission, EPA must be notified. EPA may require additional time to review the change.

PMN regulations at 40 CFR part 720 do not provide for notification to EPA of changes to information reported in the PMN that occur after the review period. Therefore, if the decision to change was made after the review period, and there is no change in chemical identity, a new PMN is not required. In this case, if the process change takes place soon after close of the PMN review period, it is recommended that the submitter keep a record of its decision process which led to the change, to clearly show that this change was not decided before the close of the PMN review period.

100 4. Q. If there is a change of sites after submission and review of the PMN by EPA, can that change be made without further review by EPA?

A. Yes. The change of sites can be made without notice to EPA.

100 5. Q. When a PMN is submitted, or when the review period for a PMN expires, does EPA publish a notice in the Federal Register?

A. EPA regularly publishes monthly status reports in the Federal Register under the title " Certain Chemicals; Premanufacture Notices". These reports give notice of PMNs received and their projected expiration dates. EPA does not publish a notice when the review period expires, but information on Notices of Commencement ( NOCs) received is included in these status reports. PMN status for notifications received in 1999 and beyond is also posted on the New Chemicals website approximately midway through the review period and can be viewed at www. epa. gov/ oppt/ newchems/ dropstat. htm.

100 6. Q. Will I be notified that my PMN has been approved? Denied?

A. If, by the expiration of the PMN review period, EPA does not notify you that your chemical will be subject to regulation, under § 5, you are free to commence manufacture of the substance after the review period expires. During the PMN review period, the EPA Program Manager or other EPA personnel may contact you if EPA identifies concerns or seeks clarification of information provided in the PMN.

The EPA Program Manager will also notify you before the review period expires if the review period will be extended under TSCA § 5( c) or if regulatory action is being considered on the new substance under TSCA § 5( e) or § 5( f). You may also refer to the New Chemicals Program website at www. epa. gov/ oppt/ newchems/ dropstat. htm to obtain the status of PMNs or Section 1: General Program Information 1 3 Low Volume Exemptions ( LVEs) currently under review by EPA.

100 7. Q. What if EPA believes that the scenario described in the PMN may present unreasonable risk?

A. If the EPA review finds that there is insufficient information to adequately assess the risk from a chemical, and that human exposures and/ or environmental releases associated with the manufacture, processing, distribution, use, or disposal of a new chemical substance as described in the PMN may pose unreasonable risk, EPA may:

° require testing, under § 5( e), before manufacture to assess the risk, if the risk cannot otherwise be adequately mitigated ° impose regulatory restrictions via a combination of § 5 ( e) Consent Order and Significant New Use Rule ( SNUR) to control exposures or uses pending development of test data; or ° request the submitter to amend its PMN to include appropriate exposure controls and issue a " non § 5 ( e) SNUR."

A § 5( e) Consent Order places requirements on the manufacture, processing, distribution, use or disposal of the new chemical substance to reduce the risk. The Order may also require the manufacturer to submit testing to EPA before exceeding a specified production volume. A 5( e) SNUR normally mirrors the terms of the Consent Order and extends those terms to any person who may manufacture, process or use the subject chemical. In those cases where EPA does not determine that the use/ exposure scenario for a new chemical substance as described in a PMN may present an unreasonable risk or have the potential for substantial production volume and substantial or significant human exposure or substantial environmental release, but where EPA has concerns about other uses, EPA may issue a non 5( e) SNUR. If the submitter wishes to engage in a " significant new use( s)" as specified in either type of SNUR, under § 5( a)( 1)( B) notice to EPA is required to provide for an EPA review.

100 8. Q. How do " expedited § 5( e) Orders" work?

A. The procedures that EPA uses to develop § 5( e) Consent Orders provide for expedited handling in certain circumstances. Much time can be consumed by negotiations concerning deviations from standardized or " boilerplate" § 5( e) Order language, particularly because EPA officials must carefully consider and approve any deviations from previously approved language. Elimination of this negotiation can greatly accelerate preparation and review of a § 5( e) Consent Order. An expedited procedure can be used when both parties are expected to accept and sign the Order ( as developed by EPA), without any modifications.

The expedited procedure has two primary differences from a negotiated procedure. First, instead of EPA sending a draft Order to the submitter for comment, EPA sends an " Action Section 1: General Program Information 1 4 Letter" intended to provide the submitter with an understanding of the terms of the proposed § 5( e) Order. The Action Letter utilizes the most appropriate model or generic § 5( e) Consent Order on EPA's website ( www. epa. gov/ newchems/ boilerpl. htm) and describes in some detail the specific terms intended for the individual case. Second, EPA signs the Order before the submitter signs it. These procedures eliminate certain internal and external review procedures and can halve the time necessary for the negotiated, non expedited Consent Order process.

This expedited procedure for developing § 5( e) Orders has been used by EPA since 1988. This option has been made available in the standard Action Letters EPA sends to PMN submitters for every PMN which EPA intends to regulate by Order under § 5( e) of TSCA.

100 9. Q. Why do non" expedited" Consent Orders require so much review?

A. Most Consent Orders are " expedited", and require little review, because they are developed using one of several standard templates based on EPA's risk or exposure findings. If the expedited process is not used, negotiation of the terms of the § 5( e) Order invariably delays completion of the Order since additional consideration and approval by EPA personnel is required for terms that differ from those previously approved. The large variety of different chemicals and factual circumstances creates enough complexity to require that additional scrutiny be given to cases which deviate from the norm. In cases where EPA or the submitter find that they cannot agree to the standard language or other terms, EPA's development of § 5( e) Orders to achieve the appropriate balance between legal, risk management, economic, and other interests can become lengthy.

100 10. Q. How do I request a modification of an existing § 5( e) Order?

A. Pursuant to the terms of a § 5( e) Order, the submitting company may petition EPA at any time to modify the terms of the Order. The petition should be based on new information about the health or environmental effects of, human exposure to, or environmental release of the PMN substance. In making a determination of whether to grant or deny a modification, under § 5( e)( 1) EPA must find that the activities proposed will not increase the exposures or risk to a level that is unacceptable or may be unreasonable. To petition for a modification, a submitter should send a letter with supporting information to the Chief of the New Chemicals Notice Management Branch. Although OPPT does act on petitions for modifications to existing § 5( e) Orders, Order modification petitions generally rank relatively low in the Agency's priorities.

To avoid the need to request a modification based on newly developed data, submitters are encouraged to ensure that any ongoing study is completed before submission of the PMN, in which case the study would be provided along with the PMN in accordance with 40 CFR § 5720.50. In cases where the submitter hopes for new market opportunities, it is suggested that testing be planned based on an optimistic sales scenario and anticipated new market opportunities Section 1: General Program Information 1 5 to avoid losing time involved in modification of a Consent Order.

100 11. Q. Is there a production volume limit for PMNs?

A. Unless EPA takes regulatory action ( such as a § 5( e) Order or SNUR) in response to a PMN, there is no production volume limit for the PMN. The anticipated production volumes listed in the PMN by the submitter do not establish production volume limits for a substance. EPA may, however, place a production limit on a PMN substance through a § 5( e) Order or a SNUR at the time of review where appropriate under § 5. Production volume limits are often used in § 5( e) Orders and SNURs to trigger testing requirements. Production volume limits are often used in § 5( e) Orders and SNURs when EPA identifies potential risk from use of the substance. These limits can often be lifted if EPA recommended testing is completed and mitigates the risk identified in the review process.

100 12. Q. What is EPA's exposure based policy and has any information on it been published?

A. EPA's exposure based policies for new chemical substances are based on § 5( e)( 1)( A)( ii)( II) of TSCA and are described on the New Chemicals Website at www. epa. gov/ oppt/ newchems/ expbased. htm.

TSCA Section 5( e) provides EPA with the authority to regulate new substances pending development of health and environmental effects data based on either the potential risk presented by the substance (" risk based") or the potential for substantial production volume and substantial or significant human exposure or substantial environmental release (" exposure based"). Action under Section 5( e) for a new chemical substance is taken based under either or both of these authorities. In 1988, EPA developed internal guidelines to assist in identifying new chemical substances received as PMNs which would meet the " exposure based" finding. These guidelines were announced to the chemical industry in a letter to Geraldine V. Cox of the Chemical Manufacturers Association ( now the American Chemistry Council). See www. epa. gov/ opptintr/ newchems/ cmaxpltr. htm.

Limited test data are submitted or otherwise available on new chemical substances, and as a result EPA often relies on Structure Activity Relationship ( SAR) predictions to evaluate potential effects associated with these substances. Data obtained from PMN submitters by EPA using the exposure based finding, can better characterize the tested chemical, confirm or refute a " negative" prediction of no risk or low risk, and supplement and validate the use of SAR in the review of PMNs. Expanded use of this finding was warranted for these reasons and because Congress intended that a greater priority for testing exists for high volume/ exposure chemicals. Exposure based testing is usually required via a negotiated 5( e) consent order. These exposure based guidelines capture all PMN chemicals with estimated production volumes Section 1: General Program Information 1 6 greater than or equal to 100,000 kilograms per year, and include specific exposure/ release criteria ( such as > 10,000 kg/ year total release to environmental media or > 0.003 mg/ kg/ day exposure via air). The objectives of this approach were to encourage fair and consistent decisions across numerous chemical categories and uses, to provide clear guidance to the public and industry about EPA's policy and expectations, and to implement the policy in the simplest, least resourceintensive way.

EPA's exposure based policies for new chemical substances are based on § 5( e)( 1)( A)( ii)( II) of TSCA and are described on the New Chemicals Website at www. epa. gov/ oppt/ newchems/ expbased. htm.

100 13. Q. What will happen if the submitter refuses to agree to conditions EPA regards as necessary if the PMN substance is to be used without unreasonable risk, or under an exposurebased Consent Order?

A. If EPA and the submitter cannot agree on EPA's specified conditions where EPA has predicted that the activities proposed for the PMN substance may present or will present an unreasonable risk, or projected production and exposure exceed EPA's exposure based policy criteria, EPA can unilaterally issue a non consensual Order banning or otherwise controlling the substance under § 5( e) or § 5( f) of TSCA. If the submitter objects, further proceedings may be necessary to enforce the order. This is not a typical scenario usually EPA and the submitter agree to a Consent Order under § 5( e). In order to be effective, a § 5( e) Order must be issued before expiration of the 90 day review period.

Usually a unilateral " extension" ( under TSCA § 5( c)) or a consensual " suspension" ( under 40 CFR § 720.75( b)  requested by the submitter) of the 90 day statutory review period is necessary to allow sufficient time for development of an EPA response when EPA review suggests that activities proposed for the PMN substance may or will present an unreasonable risk or have the potential for substantial production volume and substantial or significant human exposure or substantial environmental release. An EPA Program Manager will notify the submitter if regulatory action is being considered on the new substance under TSCA § 5( a), 5( e) or 5( f). The EPA Program Manager will contact the submitter before the review period expires to request a consensual suspension. If this is not granted, EPA can unilaterally extend the review period under § 5( c). If an extension under § 5( c) is required, it can be up to and usually is granted for 90 days. The § 5( e) or § 5( f) Order must be issued by day 135, which gives the submitter time to respond.

101 Guidance for Completion of § 5 Submission Form 101 1. Q. Can I use commercially available software to generate the § 5 submission form? Section 1: General Program Information 1 7 A. Yes, if the format generated by the software has been pre approved by EPA's TSCA Document Control Officer. One such form is sold by the American Chemistry Council, of Arlington, Virginia, and another is sold by the Bureau of National Affairs, of Washington, D. C. Please note that EPA cannot endorse the purchase of a particular company's products or services, and identification of these forms as sufficient for PMN use should not be taken as an endorsement of the software products. EPA is willing to identify any other forms once such forms are approved by the Document Control Officer. Information on potential approval is available from the Chief of the Records and Dockets Management Branch at 202 564 8952.

101 2. Q. How does the New Chemicals Program assess completeness of PMNs?

A. Completeness of PMN submissions is determined by compliance with EPA regulations at 40 CFR § 720.45 and EPA's PMN user fee requirements at 40 CFR § 700. These regulations are available to all PMN submitters on the New Chemicals website or the Government Printing Office ( GPO) web site.

Once a submission is received, it is first prescreened. In the prescreen, pages 4 8 are reviewed for completeness ( is all the information provided), correctness ( is the provided information right), and consistency ( does the information provided contradict itself). The chemical name, structure and CAS Registry Number are reviewed as are lists of impurities and byproducts. The method of chemical nomenclature determination, the presence of a generic name when identity is claimed as confidential business information ( CBI), production volume and TSCA use, and process diagram information are examined. Additional information required for polymers is reviewed on page5.

When a submitted form does not fulfill the above requirements, EPA will notify the submitter.

The checklist used to notify submitters of the specific problems in their submissions is presented below, and reflects the common errors EPA has seen in PMN submissions. The most frequent reason for an incomplete submission is a chemical name which does not conform with the Chemical Abstracts Ninth Collective Index ( 9CI) nomenclature rules and conventions, as required by 40 CFR § 720.45( a)( 1)( i). ( This definitive guide to Chemical Abstracts nomenclature has been used since 1972.)

§ 5 SUBMITTER ERROR CHECKLIST ( REV 1/ 7/ 98 VER 51)

Your chemical identity information as submitted according to Method 1 or Method 2 is not acceptable because:

________( a) The correct Chemical Abstracts name has not been provided. ________( b) The correct CAS Registry Number, if one already exists for the substance, has not been provided. ________( c) The correct molecular formula has not been provided, where applicable. ________( d) A complete, correct chemical structure diagram for a Class 1 substance has not been provided. Section 1: General Program Information 1 8 ________( e) A correct partial or representative chemical structure diagram has not been provided for a Class 2 substance or polymer, where such information is known or reasonably ascertainable. ________( f) There is an inconsistency among two or more parts of the chemical identity information, which involves the: _____ reported chemical name, _____ CAS Registry Number, _____ molecular formula, _____ chemical structure diagram, _____ identity of immediate chemical precursor or monomer _____ manufacturing process information, or _____ other: ________( g) Because the reported substance is polymeric, page 5 of the § 5 submission form ( concerning information on polymers) must be completely filled out. ________( h) Correct chemical names and CAS Registry Numbers ( where numbers are available) have not been provided for all monomers and other reactants used to manufacture a reported polymer. ________( I) Correct chemical names and CAS Registry Numbers ( where numbers are available) have not been provided for all immediate chemical precursors used to manufacture a Class 2 substance. ________( j) For a Class 2 substance, information about the nature of the manufacturing reaction/ process or the typical ( or range of) product composition ( where appropriate) has not been provided. ________( k) A letter of support has not been received from the supplier of the reported substance or a chemical precursor in order to provide the required specific chemical identity information not included in the notice. ________( l) Supporting information from a prior notice ( PMN, bona fide Intent Notice, etc.) you reference is not consistent with your reported chemical identity information. ________( m) The reported generic chemical name is misleading or does not provide a sufficient level of chemical identity information. ________( n) The manufacturing process information does not include specific chemical names and/ or weights for all starting materials. ________( o) Method 1 was used, but the information provided to the CAS Inventory Expert Service is not identical to that included in the PMN. ________( p) Not all of the chemical names reported for substances in a consolidated PMN have been obtained from the CAS Inventory Expert Service. ________( q) Other:

101 3. Q. If a PMN submission is judged to be incomplete well into the 90 day review period, will the 90 day clock be stopped and restarted when the additional information is received, or will a new 90 day period begin upon receipt of the new information?

A. When a notice is declared incomplete, the review period is not considered to have started, regardless of when in the review period the notice is declared incomplete. Day 1 of the review period begins when EPA receives a complete notice. See 40 CFR § 720.65( c)( 2)( ii).

101 4. Q. What are some common errors made in filling out the § 5 submissions form or a Notice of bona fide Intent? How can I avoid having my § 5 notice declared incomplete?

A. The administrative procedures applicable to incomplete notices are specified at 40 CFR § 720.65. For more detail on EPA's review for completeness, see Q& A # 101 2. One of the most frequent errors is incomplete chemical identity information. Another very common error in a Section 1: General Program Information 1 9 submission is an inconsistency between the chemical name, the CAS Registry Number, the structure, the molecular formula, and/ or the manufacturing process information. There can be other deficiencies with respect to the form that could cause EPA to consider a notice incomplete. See Q& A # 101 7 The following is a list of chemical identity errors which under 40 CFR § § 720.45 and 720.65 can result in incomplete notices.

A § 5 submission form ( EPA Form 7710 25) or a Notice of bona fide Intent to Manufacture/ Import will be considered incomplete if any of the following problems ( 1 10) exist with respect to chemical identity information submitted via Method 1 or Method 2 ( see Q& A # 103 1 below), according to the Premanufacture Notification Regulations at 40 CFR 720.45.

3. The correct Ninth Collective Index ( 9CI) Chemical Abstracts ( CA) name of the reported substance and the corresponding Chemical Abstracts Service ( CAS) Registry Number ( if a CAS Registry Number exists for the substance) are not included in the Chemical Identity Information section of the notice form ( Part I, Section B).

2. The correct molecular formula of the reported substance ( if a single molecular formula is known to exist for the substance or is reasonably ascertainable) is not included in the chemical identity information section of the notice form ( Part I, Section B).

3. The complete, correct chemical structure diagram for a reported Class I substance is not included in the chemical identity information section of the notice form ( Part I, Section B).

4. A correct representative or partial chemical structure diagram for a reported polymer or Class 2 substance ( as complete as possible, based on what is known or reasonably ascertainable) is not included in the chemical identity information section of the notice form ( Part I, Section B).

5. A non CA name, a generic chemical name, a chemical synonym, a CAS Registry Number, a trade name, or the PMN, Exemption, or bona fide Intent notice number/ User Fee number/ TSCA accession number of another notice is written in the chemical name box of the notice form in place of the correct CA name.

6. When reporting a polymer, the submitter does not provide all of the information required in the chemical identity information section for polymers ( Part I, Section B. 2) comprising page 5 of the § 5 submission form.

Note: ( 1) A " polymer" includes an oligomeric substance having a molecular weight distribution as well as any substance that is or incorporates a polymer, even if the last reactions did not involve further polymerization. For example, persons who intend to manufacture salts, adducts, or other derivatives or reaction products from polymers must fill out page 5 of the § 5 submission Section 1: General Program Information 1 10 form. ( 2) Not all polymers contain the word " polymer", " polymers", or " poly" in their CA names; for example, siloxanes and silicones. These conventions have been in place largely without changes since the inception of the Inventory, and can be found in " TSCA Inventory Representation for Polymeric Substances" at www. epa. gov/ oppt/ newchems/ polymers. txt.

7. The specific chemical name and corresponding CAS Registry Number ( if such a number exists) for ( 1) each monomer or other reactant used to make a reported polymer, or ( 2) each immediate precursor substance used to make a reported Class 2 substance, is not included in Part I, section B of the notice. Note: The notice is considered incomplete even if the reported CA name of the PMN substance itself is correct. The specific chemical names used to identify such monomers, reactants, or chemical precursors do not have to be CA names although correct CAS Registry Numbers must be provided if they exist.

8. There is at least one discrepancy or inconsistency in the reported chemical identity information that could possibly cause some ambiguity about the correct chemical identity. This discrepancy or inconsistency may involve the chemical name, CAS Registry Number, molecular formula, chemical structure diagram, immediate chemical precursors, monomers, or manufacturing process information.

9. A letter of support has not been submitted by a chemical supplier in order to provide required chemical identity information not included in the notice.

10. The submitter indicates as part of the manufacturing process information or precursor substance/ reactant/ monomer information that a neutralizing reagent is used, but neither represents the reported substance as a salt nor provides a reasonable explanation for why the substance should not be considered a salt, even though the process information or list of reactants would indicate the formation of a salt. This description is inconsistent with the Ninth Collective Index ( 9CI) of Chemical Abstracts nomenclature rules and conventions as required by 40 CFR 720.45( a).

101 5. Q. When does the PMN review period begin? Are the review periods of 90 days for PMNs, 30 days for Low Volume and Low Release/ Low Exposure Exemptions ( LVEs/ LoREXs), and 45 days for Test Marketing Exemptions ( TMEs) based on calendar days or working days?

A. TSCA § 5 submissions review periods are based on calendar days. If EPA determines that your notice is " complete," the review period begins on the date that the submission ( PMN, LVE, LoREX, or TME) is received and logged in by EPA's Document Control Officer ( DCO). You will receive an acknowledgment letter indicating the identification number assigned to your notice by EPA and the expiration date of the review period. If your notice is declared " incomplete" as described at 40 CFR 720.65, you will receive written notification, and your review period will not begin until EPA receives a complete notice. Section 1: General Program Information 1 11 In addition, following receipt of a PMN, LVE, LoREX, or TME, EPA searches the TSCA Chemical Inventory to ensure that the substance for which the notice is submitted is not already listed. If your chemical substance is on the Inventory, you will be notified that your substance is not subject to premanufacture notification requirements and you are free to begin manufacture immediately.

During the review period, status information on your PMN, LVE, LoREX, or TME submission can be obtained at www. epa. gov/ oppt/ newchems/ dropstat. htm. The EPA Program Manager or other EPA technical personnel may contact you to clarify information you have provided in the notice, or if concerns are identified. If you are not contacted before expiration of the review period, you are free to begin manufacture of the substance identified in your notice once the review period expires.

101 6. Q. If a submitter objects to a finding that the PMN is incomplete, how many days will EPA take to decide on the appeal?

A. As required at 40 CFR 720.65( c)( 5), EPA will notify the submitter in writing within 10 days of receiving the objections. Please note that objections must be received within ten days of EPA notification of the submitter for a submission that is determined to be incomplete. See 40 CFR § 720.65( c)( 4).

101 7. Q. May I claim information submitted on a § 5 submission form to be confidential?

A. Under TSCA § 14 as specified in regulations at 40 CFR Part 720 Subpart E, you may assert a claim of confidentiality for any § 5 related information submitted to EPA. Note, however, that information in health and safety studies is normally not entitled to confidentiality, except as provided in 40 CFR 720.90. Under 40 CFR § 720.90( c) confidentiality claims for chemical identity in a health an safety study may be denied unless 1) disclosure would reveal manufacturing or processing information, 2) would disclose the fraction of a mixture which the substance comprises, or 3) 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 in EPA's definition of health and safety studies, but other information relating to the effects of a chemical substances or mixture on health or the environment is also included.

Confidentiality claims must be made at the time your information is submitted. 40 CFR 720.80( b). After the 90 day review, you will be required to accompany your Notice of Commencement ( NOC) with substantiation of your confidentiality claims for the chemical identity, 40 CFR 720.90( b), and may be required to substantiate other confidentiality claims in the future if, for example, EPA receives a Freedom of Information Act ( FOIA) request concerning that information. Dealing with TSCA confidential business information is a substantial burden for Section 1: General Program Information 1 12 EPA, and we discourage submitters from claiming confidentiality unless they have sound business reasons for doing so. TSCA § 14 describes circumstances under which EPA shall disclose information even though it has been claimed confidential by its submitter. See also EPA confidentiality regulations at 40 CFR 2.209 and 2.306. See Q& A # 107 6 to obtain the requirements for substantiation at the time a NOC form is submitted to EPA for a PMN substance which can serve to guide your considerations about the appropriateness of making a CBI claim.

To ensure that confidential information is not disclosed to the public, you must submit an additional copy of the notice form, including attachments, which does not contain confidential information. This " sanitized" or redacted version will be placed in the public file. It must contain all non confidential information, including health and safety studies. " Health and safety study" is defined at TSCA § 3( b) and 40 CFR 720.3( k) ( see also Q& A # 117 1, # 117 2, and # 117 3). You are responsible for ensuring that all information claimed as confidential is removed from the sanitized version; EPA does not double check this.

To assert confidentiality for specific information on the form e. g., submitter identity, chemical identity, or use information, mark the " Confidential" or Confidential Business Information ( CBI) box located to the right of the information on the form. Also mark the box at the bottom of page 1 of the form if you claimed any information in the notice as confidential.

If you do not provide the " sanitized" or redacted copy with your submission, the submission will be considered incomplete and the review period will not begin. Also any subsequent amendment to your PMN or additional information/ data you provide to EPA must be accompanied with a non confidential version for the public file.

101 8. Q. What should I do to ensure that EPA will treat my submission as confidential?

A. See Q& A # 101 7. You must take the following actions to meet EPA's requirements regarding submission of confidential information:

( 1) Mark the appropriate boxes on the § 5 submission form, to indicate confidential information.

( 2) Submit appropriate numbers of copies of each notice form and the attachments ( three for PMNs and SNUNs, one for LVEs, LoREXs, TMEs). If any information is claimed confidential, an additional " sanitized" or redacted copy of the relevant documents must also be submitted. The " sanitized" or redacted copy will be placed in the public file.

( 3) When submitting information in an attachment, also state any confidentiality claim in the relevant attachment. Section 1: General Program Information 1 13 101 9. Q. How many copies of the § 5 submission form must be sent to EPA?

A. You must submit an original and two complete copies of the § 5 submission form, including all test data and any other information attached to the notice form, for a PMN or a SNUN ( Significant New Use Notice). 40 CFR 720.40( d)( 2). For a Low Volume Exemption ( LVE) or Low Release, Low Exposure Exemption ( LoREX) submission, you need only file one copy of the form. 40 CFR 723.50( e).

If any information is claimed as confidential, however, you must also include a " sanitized" or redacted copy of the notice for any § 5 submission ( PMN, LVE, SNUN, etc). 40 CFR 720.80( b)( 2). Information claimed as confidential must be deleted from the " sanitized" or redacted copy and replaced with generic information, e. g., generic chemical identity, use, production volume, etc.

101 10. Q. What is the definition of an authorized official? Must it be a company officer?

A. An authorized official is one who according to company documents, policy or interpretation, is responsible for the truth and accuracy of each statement in the PMN notice. Depending on the size and organization of the submitting company, this person may be, for example, the president or vice president, or director or manager of a division. The submitter determines who will act as the authorized official.

101 11. Q. How can a submitter use an agent to submit a PMN? What role and responsibility does the agent assume?

A. An agent is someone whom the submitter designates to submit a PMN, who may have more knowledge or experience in completing PMN notices. Both the submitter and the agent must sign the certification on the form. The agent may speak for, and bind, the person submitting the PMN . Responsibility, however, is generally with the submitter. The submitter is responsible for ensuring accuracy, and that all information known to or reasonably ascertainable by the submitter, and all test data in the submitter's possession or control, are submitted to EPA. See 40 CFR 720.( e).

101 12. Q. I have a new site limited chemical intermediate that requires a PMN. My normal practice is not to prepare a Material Safety Data Sheet ( MSDS) for site limited intermediates. Do I have to prepare one to be included with this PMN?

A. Submitters are not required to develop a MSDS solely for the purpose of submitting a PMN. If it is not your practice to develop a MSDS, you need not do so to accompany a PMN. However, as indicated on page 12 of the PMN form, if a MSDS is developed for the material, EPA strongly recommends that you should attach the MSDS to the completed PMN form. An Section 1: General Program Information 1 14 MSDS aids EPA reviewers in the assessment of the chemical. It enables EPA reviewers to understand the precautions the submitter employs for worker safety and environmental release. If you have prepared no MSDS, it can be helpful to prepare a summary statement on these subjects for EPA's consideration. OSHA's hazard communication requirements appear at 29 CFR 1910.

101 13. Q. In my early research, I will be using a batch process. Later on, during manufacture, I plan to use a continuous process. This could lead to different by products, impurities, etc. However, the only data I have at the time of the PMN submission is batch data. Do I use this for my PMN or speculate on what I hope to do in manufacture?

A. Both can be useful to EPA's PMN reviewers. You should provide information concerning your intended commercial activities to the extent that is known or reasonably ascertainable to you ( see 720.40( d)). You should estimate the identity of by products and impurities to the best of your ability based on information available to you, such as the results of R& D activity.

101 14. Q. If one site operates a batch type process and another site operates a continuous process, which process is described in Section A?

A. You must describe both processes in Section A. See 40 CFR 720.45( g)( 2). Use a separate sheet for each description and clearly indicate your intended operations.

101 15. Q. What is the difference between industrial use and commercial use?

A. A use is industrial if the new chemical substance or products containing it will be used at a facility where chemical substances or mixtures are manufactured, imported or processed, e. g., textile dyeing or paint formulation. The use is " commercial" if the chemical substance or products containing it will be used by a commercial enterprise providing saleable goods or a consumer service, e. g., use by painting contractors or commercial dry cleaning establishments. See 40 CFR 721.3.

101 16. Q. Must information on the trade name of formulated products which contain the new chemical substance as part of a mixture be reported on page 5 of the § 5 submission form?

A. No, trade names of formulated products are helpful in the PMN review, but not required. However, the trade name for the PMN substance is required. 40 CFR 720.45( c).

101 17. Q. Should I list a pilot plant operation as an industrial site on Page 7 of the § 5 submission form?

A. If the pilot plant will continue to produce the chemical after R& D is complete, it Section 1: General Program Information 1 15 should be listed on the § 5 submission form; if not, no. See 40 CFR 720.36.

101 18. Q. In the process description, does the product containing the PMN material constitute an environmental release? Does it have to be numbered on the diagram and listed on Page 8 of the § 5 submission form? Is a waste stream a release to the environment? Incineration? At page 10 " industrial sites controlled by others"  should pesticide application be considered a release to the environment?

A. EPA is asking here that you identify releases to the environment in the course of manufacturing and processing of the material, as required by 40 CFR 720.45 ( g) and ( h). This includes waste streams, process losses, incineration, etc. To enable EPA to assess these releases, you must clearly identify the steps in the process description at which the new chemical substance is susceptible to release. Clearly, the end product can have environmental impacts, depending on its use, and EPA will consider environmental impacts of dispersive uses in EPA's review ( an example of a dispersive use would be as an ingredient in artificial smoke or in a fragrance formulation for outdoor use). The PMN Instruction Manual discusses dispersive use/ degree of containment in the " Use information" section ( pp. 8 9). See www. epa. gov/ oppt/ newchems/ tscaman2. pdf. The use will be assessed by Agency reviewers, based on the detailed description you provide at I. C. 2. on page 7 of the PMN form. It does not need to be numbered and listed on Page 8, however.

Release to the environment during use as a pesticide is not considered under TSCA PMN review. Pesticides are excluded from the definition of " chemical substance" at 40 CFR 720.3( e)( 2) and in Section 3( 2)( b)( ii) of the TSCA. Pesticides are reviewed under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). FIFRA reviewers will consider the potential harm which can be caused by dispersion of pesticides in the environment. Intermediates used in pesticide manufacture are not excluded from consideration as chemical substances, however, so TSCA PMN review is provided for intermediates used in pesticide manufacture, and this will include their dispersion into the environment. For more on TSCA jurisdiction over pesticides, see Q& A # 213 2.

101 19. Q. For Environmental Release and Disposal, the manufacturers must identify the media to which the new substance will be released from the " release point." Does that release point refer to release before or after control technology?

A. The PMN form provides specific places for the submitter to provide environmental release information as required by 40 CFR 720.45 ( g) and ( h). For sites controlled by the submitter, the PMN form at item II. A. 3. calls for identification of release directly to the environment ( item 2a) and after technology ( item 2b), identification of control technology at ( 5a) and amount released after technology at ( 5b). For sites controlled by others, similar information is requested at item II. B. 2. This enables reviewers to assess release of the substance both before Section 1: General Program Information 1 16 and after control technology.

101 20. Q. Our company has a problem finding our old file copy of a PMN we submitted to you as confidential in 1984. Since we filed the PMN, we have merged with another company, the person who filed the PMN has left, and our company name has changed. We want to get a copy of the confidential PMN we filed at that time. How can we do it?

A. For EPA to send confidential information it must be certain that it is sending the information to the legitimate owner of the information. This includes successors to the companies and individuals who originally filed. EPA needs evidence that the requester is legitimately entitled to the information. To initiate this request, a corporate officer should send a signed letter ( signature notarized) with as clear a description as possible of the information sought ( original submitter identity required, PMN numbers and accession numbers are important, if available) on company letterhead to:

TSCA Records and Dockets Management Branch Information Management Division ( 7407M) Office of Pollution Prevention and Toxics United States Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460.

If there is a succession situation, describe corporate changes which have happened since the original information was submitted to EPA ( mergers, buy outs, etc.) and how, if we need assurance on the situation, EPA can check the validity of the succession.

101 21. Q. What does the " binding option" mean in legal terms when filing a PMN?

A. In filing a PMN, the " binding option" enables you to indicate your willingness, if EPA review finds it to be necessary, to be bound to certain submitted information on the form. By indicating your willingness to make these commitments, you would be indicating an interest in future negotiations if EPA deems them necessary, generally in working to a § 5( e) Consent Order and/ or a SNUR. The binding option is offered for questions related to the potential risks  such as use, production volume, protective equipment, engineering controls, and/ or process description.

Marking the binding boxes helps EPA ( if necessary) to efficiently negotiate with a PMN submitter the development of § 5( e) Consent Orders and promulgate Significant New Use Rules ( SNURs) for those new chemical substances that EPA determines may present an unreasonable risk, substantial exposures, or significant new uses, if certain control actions are not implemented. This option is intended to reduce delays that can slow the development of consent orders absent such agreement. Should EPA wish to discuss development of binding control measures for your Section 1: General Program Information 1 17 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. Low Volume/ Low Release, Low Exposure), however, certain statements are automatically binding on the submitter when EPA approves the exemption applications. See Q& A # 303 5 and 40 CFR 723.50( j).

102 Inventory Searches/ Bona Fides 102 1. Q. A potential manufacturer of a substance needs to find out whether the chemical substance is included on the Inventory. If the chemical is on the Inventory, a PMN would not be required. How is a submitter to determine whether the chemical it wants to manufacture is on the Inventory?

A. The potential manufacturer (" manufacture" includes import) should check the public version of the TSCA Inventory, which lists chemicals submitted non confidentially for the Inventory. The Inventory is maintained at Federal depositary libraries throughout the country. The TSCA Inventory can be purchased from the National Technical Information Service ( NTIS).

Email info@ ntis. gov. Or visit their website at www. ntis. gov. Then click on " NTIS Products and Services". Click on " Simple Search". Type in TSCA Inventory. Choose from several Inventory products to buy.

A submitter can also consult a commercial service which has the NTIS computeraccessible TSCA Inventory. These services include:

i. Scientific and Technical Network International ( STN), maintained by Chemical Abstract Service ( CAS) telephone 1 800 848 6538 x3731 ii. Dialog Information Services ( Lockheed) File 52, telephone 1 800 334 2564;

The Inventory is carried, as well, by Cornell University, at http:// msds. pdc. cornell. edu/ tscasrch. asp EPA cannot be responsible for the quality of Inventory data in these outside services.

If no listing for the substance is found on the public Inventory, the submitter may request that EPA check the confidential portion of the Inventory. Before EPA will do so, the submitter must establish a " bona fide intent" to manufacture or import the chemical pursuant to 40 CFR 720.25. Section 1: General Program Information 1 18 102 2. Q. How may a bona fide intent to manufacture or import a chemical be established?

A. In order to establish a bona fide intent to manufacture or import a chemical, information must be submitted to EPA, as described at 40 CFR § 720.25. EPA in 1995 revised certain provisions of the bona fide procedures to establish a genuine intent to manufacture or import a substance. ( 60 FR 16298, March 29, 1995) This amendment reduced and simplified the then existing analytical information requirements, modified and clarified other existing information requirements, and requires submitters to provide some additional types of information in bona fide submissions.

Broadly, the amendments identify an infrared spectrum as the usual practice for characterizing the new chemical substance. Requirements for chemical identity information, and the description of research and development ( R& D) activities and use were modified and/ or clarified. Three new information requirements were established regarding the most probable manufacturing site and process to be used, as well as an approximate date when the submitter would be likely to submit a § 5 notice for the substance if it is not found in the Inventory. The amendments enable submitters to demonstrate a bona fide intent and EPA to better protect the CBI of the original submitters of Inventory substances.

Submitters of a bona fide must provide:

( 1) The CA Index Name, and a correct CASRN ( if the substance already has a CASRN assigned to it) ( correct CA nomenclature is not required when a reported substance involves the use of a purchased proprietary reactant. This is due to logistical obstacles involved in generating correct CA identifications for substances based on multiple submissions of parts of the overall identity from different sources. However, the submitter must coordinate with the supplier to ensure that the remaining specific chemical identity information is sent by the chemical supplier directly to EPA in a timely manner, to complete the bona fide request and initiate review by EPA. If the appropriate supporting document from the supplier is not received within 30 days after EPA receives the submitter's bona fide, the bona fide will be considered incomplete).

( 2) A molecular formula and a complete or partial chemical structure diagram if these are  known or reasonably ascertainable.' ( Failure to fully comply with the chemical identification elements of this requirement will result in the bona fide being declared incomplete by EPA and returned to the submitter.)

( 3a) A brief description of the research and development activities conducted to date related to the substance, including the year in which the person first started to conduct research or development activity on the substance, and the general types of research and development activities conducted thus far ( e. g., synthesis, substance isolation/ purification, Section 1: General Program Information 1 19 formulating, product development, process development, end use application, toxicity testing, etc.). The submitter must also indicate whether any pilot plant or production scale plant evaluations have been conducted involving the manufacture or processing of the substance.

( 3b) ( alternative to 3a, above) If an importer is unable to provide the information described in ( 3a) from a foreign manufacturer or supplier, the following information shall be submitted instead: ( i) A brief statement indicating how long the substance has been in commercial use outside of the United States. ( ii) The name of a country in which it has been commercially used. ( iii) Whether the importer believes that the substance has already been used commercially, in any country, for the same purpose or application that the importer is intending.

( 4) A specific description of the major intended application or use of the substance.

( 5) An infrared spectrum of the substance, or alternative spectra or other data which identify the substance if infrared analysis is not suitable for the substance or does not yield a reasonable amount of structural information. When using alternative spectra or instrumental analysis, the person must submit a spectrum or instrumental readout for the substance.

( 6) The estimated date ( month/ year) in which the requestor intends to submit a Premanufacture Notice ( PMN) or exemption request under § 5 for this substance if EPA informs the notice submitter that the substance is not on the Inventory.

( 7) The address of the facility under the control of the submitter at which the manufacture or processing of the substance would most likely occur. For an imported substance, the facility under the control of the importer at which processing of the substance would likely occur, if any.

( 8a) For substances intended to be manufactured in the United States, a description of the most probable manufacturing process that would be used by the submitter to produce the substance for non exempt commercial purposes.

( 8b) ( alternative to 8a, above) For substances intended to be imported, a brief description of how the submitter is most likely to process or use the substance for a commercial purpose. If the substance is not expected to be processed or used at any facility under the importer's control, a statement to this effect must be included along with a description of how the substance will be processed or used at sites controlled by others, if this Section 1: General Program Information 1 20 information is known or reasonably ascertainable.

If an importer cannot provide the chemical identity information required because it is claimed confidential by its foreign manufacturer or supplier, the foreign manufacturer or supplier must supply the required information directly to EPA in accordance with § 720.45( a)( 4) and reference the importer's notice. If the appropriate supporting document from the foreign party is not received within 30 days after EPA receives the importer's notice, the notice will be considered incomplete.

If a manufacturer cannot provide all of the required information in accordance with § 720.45( a)( 1), ( 2), and ( 3) because the new chemical substance is manufactured using a reactant that has a specific chemical identity claimed as confidential by its supplier, the notice must contain chemical identity information that is as complete as known by the manufacturer. In addition, a letter of support for the notice must then be sent to EPA by the chemical supplier of the confidential reactant, providing the specific chemical identity of the proprietary reactant, in accordance with 40 CFR 720.45( a)( 5). The letter of support must reference the manufacturer's notice. If the appropriate supporting document from the supplier is not received within 30 days after EPA receives the manufacturer's notice, the notice will be considered incomplete.

On receipt of an adequate statement of bona fide intention, EPA will search both the non confidential and the confidential portions of the Inventory for the substance; and will notify the intended submitter whether the substance can be found on the Inventory.

102 3. Q. What are the benefits of filing a Statement of bona fide Intent To Manufacture instead of a full PMN or LVE or LoREX application?

A. For the submitter, there are benefits to each: there is no fee for filing a bona fide, and the review period is shorter ( 30 days). It is frequently less costly to develop the Statement of bona fide Intent than it is to develop a PMN or exemption application. On the other hand, EPA will search the Inventory on receipt of a PMN or exemption application, and will reject the PMN and return your fee if it is found to be already listed on the Inventory. If the material was not on the Inventory the 90 day review period for the PMN will start on receipt of the PMN. See 40 CFR 720.65( a).

102 4. Q. How soon will EPA notify the requester of the results regarding an Inventory search?

A. The submitter will be notified within 30 days after the submission is considered by EPA to be complete and without chemical identity problems.

102 5. Q. Is EPA capable of recognizing if a chemical substance covered by a submitted PMN is identical to one already submitted by another submitter? What would be done in this case? Section 1: General Program Information 1 21 A. Yes. EPA has put substantial effort into developing unambiguous naming rules for chemical substances, so that Inventory listings will be unique and consistent. Using these rules, an Inventory search upon receipt of a § 5 submission would identify other submissions for the identical chemical substance. If a chemical was on the initial Inventory or if a Notice of Commencement has been received for a previously identified new chemical, the PMN substance would be viewed as an existing chemical substance, the PMN substance would be declared excluded from reporting, and the PMN submitter would be notified. In such instances, any user fee submitted with the PMN would be refunded.

102 6. Q. How can a submitter find out whether: ( a) a particular polymer is on the confidential TSCA Inventory? or, ( b) a reactant in a particular polymer is on the confidential Inventory?

A. The Inventory status of your polymer can be determined by filing a Notice of bona fide Intent to Manufacture ( see 40 CFR § 720.25 or contact the TSCA Hotline on 202 554 1404). You may not file a Notice of bona fide Intent to Manufacture on the reactant unless you have a bona fide intent to manufacture or import it. It is the responsibility of the manufacturer or importer of the reactant to determine the Inventory status of the reactant. If you file a PMN on your polymer EPA will check its Inventory status and, if it is on the Inventory, will notify you that you are free to proceed with manufacture of the polymer.

102 7. Q. I wish to import a polymer under the Polymer Exemption containing greater than two percent of a reactant ( monomer) not on the public TSCA Inventory, but which may be on the confidential Inventory. On what do I file a bona fide? If all I plan to import is the final polymer, how do I know whether it now qualifies for the new Polymer Exemption criteria or if I need to file a PMN for the polymer?

A. If the monomer is on the confidential Inventory, your polymer may be eligible for exemption. See 40 CFR 723.250( d)( 4). If it is not, a party that intends to manufacture or import the monomer must have it go through the PMN review process and commence its manufacture or importation to allow it to be used in an otherwise exemptible polymer. You may not file a Notice of Bona Fide Intent to Manufacture on the reactant ( monomer) unless you have a bona fide intent to manufacture or import it. Your supplier, if in the U. S., could file a bona fide on the monomer. If your supplier is not in the US, it does not have standing to file a bona fide on the monomer.

There is really no way to find out whether a substance is on the confidential Inventory unless you intend to import or manufacture that substance itself. Therefore, the only substance for which you can file a Notice of bona fide Intent is the final polymer. If the polymer is on the Inventory, no PMN will be needed. If not, you will need to file a PMN for the polymer. See www. epa. gov/ oppt/ newchems/ polyguid. pdf.

102 8. Q. Is there a required form to use in submitting a Notice of bona fide Intent? Section 1: General Program Information 1 22 A. No.

102 9. Q. Can a bona fide intent notice be sent by courier service? I had a bona fide notice returned by my courier service. What went wrong?

A. The room at which bona fide submissions are accepted is only open until 4 pm. If a courier service comes after that time it will be turned away. The address for sending a bona fide by courier is:

Confidential Business Information Center OPPT Document Control Office ( DCO) EPA East Building ( old ICC) 1201 Constitution Avenue, NW Room # 6428 Washington, DC 20004 You can give the courier the phone number ( 202) 564 8930, to call if there are delivery problems.

103 Chemical Identification 103 1. Q. As required by the 1995 amendments, how can a correct Ninth Collective Index ( 9CI) Chemical Abstracts ( CA) name for a new chemical substance be obtained?

A. This is governed by 40 CFR 720.45( a)( 3). A CA name can be obtained directly from the Chemical Abstracts Service ( CAS) Inventory Expert Service ( CAS IES, IES), by using an alternative source, or by developing your own CA name. If a source other than the CAS IES is used and any chemical identity information is determined by EPA to be incorrect, the notice will be declared incomplete and the submitter will be responsible for correcting the chemical name prior to the start of the review period.

( NOTE: non IES CAS personnel, including other Registry Services employees, assign CA names and numbers. They are not specifically trained in TSCA Inventory requirements and policies, and the requirements of Method 1 are not satisfied by giving a CAS name and number assigned by any non IES source. See www. epa. gov/ oppt/ newchems/ guideman. htm and choose the link titled " Revisions of Premanufacture Notification Regulations; Final Rules" ( 60 FR 16298; March 29, 1995)" for the complete mechanism for obtaining the CA nomenclature under Method 1 or Method 2.)

Persons who use the CAS Inventory Expert Service must submit a copy of the chemical identification report from CAS with their notice. The person must also identify in the § 5 submission form which method was used to develop or obtain the specified chemical identity Section 1: General Program Information 1 23 information. Mark Method 1 for the CAS Inventory Expert Service. Mark Method 2 for any other source.

You must provide the correct CA name for the substance, based on the Ninth Collective Index ( 9CI) of CA nomenclature rules and conventions, and consistent with listings for similar substances in the Inventory. For each substance having a chemical composition that can be represented by a specific, complete chemical structure diagram ( a Class 1 substance), a CA Index Name must be provided. For each chemical substance that cannot be fully represented by a complete, specific chemical structure diagram ( a Class 2 substance), or if the substance is a polymer, a CA Index Name or CA Preferred Name must be provided ( whichever is appropriate based on CA 9CI nomenclature rules and conventions). In addition, for a Class 2 substance, the notice must identify the immediate chemical precursors and reactants by specific chemical name and Chemical Abstracts Service Registry Number ( CASRN), if the number is available. Tradenames or generic names of chemical precursors or reactants are not acceptable as substitutes for specific chemical names.

EPA only considers a submitter to have used Method 1 if a copy of the CAS IES report is attached to the notice submitted to EPA. If a CAS IES report is not attached to the notice, EPA considers the chemical identity information to have been obtained under Method 2, even if the Method 1 box is marked on the notice.

103 2. Q. How can I obtain information about CAS Inventory Expert Service?

A. Information on this service including available resource materials is available via telephone ( 614 447 3600 or 800 848 6538 ext. 2308) or by facsimile ( 614 447 3747).

103 3. Q. I am manufacturing a new chemical substance using my supplier's proprietary chemical as a reagent. How can I obtain a CA name for the new substance when I only possess partial information?

A. You can't, and in this case, you need not obtain a CA name. You should provide all the information you have on the chemical identity of the new substance ( including the specific identities of the reactants you know, the nature of the reaction, and the types of products formed) and the proprietary reactant directly to EPA and also have your supplier submit a letter of support with the specific chemical identity of the confidential reactant to EPA, referencing your company's name and either a prenotice communication ( PC) number or the TSCA user fee identification number. See 40 CFR 720.40( e)( 2). The notice will not be considered complete until the supplier has provided the proprietary chemical information to EPA, appropriately referencing your notice. EPA will develop the name for its own use on the Confidential Inventory, but will not divulge the name to you. Section 1: General Program Information 1 24 103 4. Q. How does a submitter obtain a CAS Registry Number for a PMN substance when the PMN substance identity is confidential? Does EPA assign a CAS Registry Number to every chemical which has gone through the PMN process and for which a Notice of Commencement has been received?

A. EPA itself does not assign CAS Registry Numbers, they are developed by the Chemical Abstracts Service. PMNs for chemicals whose specific chemical identities are claimed as CBI in a § 5 submission, and which have no existing CAS Registry Number, can be submitted without a CAS Registry Number. For such a confidential substance, EPA will develop an Accession Number. See 40 CFR 720.25( b)( 1). An Accession Number is a five or six digit number used to identify CBI chemicals listed in the Inventory by their generic chemical names.

If a CAS Registry Number is obtained for a substance, CAS will in all cases publish that chemical name and the number. The existence of the substance will then be public knowledge through CAS's publicly available databases. However, a submitter can ( but need not) request a CAS Registry Number for the substance in the course of getting a name from the Inventory Expert Service, and can claim that CAS Registry Number confidential in the filing. This can keep the association of that substance with the submission of the PMN a secret. It is also possible for a submitter to file a PMN on a substance which received a CAS Registry Number long before ( for R& D use, for example, or for commerce in other countries), and have the association of that number with the PMN be kept confidential. If there is a CAS Registry Number for a substance, the submitter must include it in the PMN, at least in the CBI version of the PMN.

In filing a non confidential PMN for a chemical, the submitter need not report a CAS Registry Number unless one already exists for that substance. If the PMN successfully completes review and the submitter files a Notice of Commencement, EPA will then have CAS develop a CAS Registry Number for the substance.

103 5. Q. How can I obtain a Ninth Collective Index ( 9CI) Chemical Abstracts ( CA) name for an imported substance whose identity is claimed as confidential by its foreign manufacturer?

A. Your foreign supplier must follow the same procedures as a U. S. submitter to obtain a CA name and provide the correct chemical identity to EPA as a letter of support, clearly referencing your notice and the PMN user fee identification number or a prenotice communication number, if one has been obtained. Information can be obtained from the CAS Inventory Expert Service by telephone ( 614 447 3600 or 800 848 6538 x2308) or by facsimile ( 614 447 3747). See 40 CFR 720.40( e)( 2) and the PMN Instructions Manual for further information on joint submissions or letters of support.

103 6. Q. To what extent must Chemical Abstracts Service ( CAS) nomenclature be used in an exemption application considering these substances are not on the TSCA Inventory? Section 1: General Program Information 1 25 A. Correct CAS nomenclature is required in exemption applications. See generally 40 CFR part 723. The efficient characterization and assessment of associated risks of a substance proposed for exemption in a short time period relies on the receipt of accurate and consistent nomenclature. EPA must make the finding that the substance proposed for exemption will not present an unreasonable risk before EPA may approve an exemption. A correct Ninth Collective Index ( 9CI) Chemical Abstracts ( CA) name must be provided in an exemption notice. Submitters may directly use CAS Inventory Expert Service or develop a name on their own or through another source.

103 7. Q. If a chemical substance is claimed confidential, must a generic chemical name be submitted?

A. Yes. A generic name must be submitted. The name must be only as generic as necessary to protect the confidential chemical identity and must reveal chemical identity to the maximum extent possible. See 40 CFR 720.85( a)( 2).

103 8. Q. What would happen if the PMN chemical identity is claimed as CBI but the generic name submitted in the PMN is too broad? Would EPA declare the PMN incomplete?

A. Typically we wouldn't declare the PMN incomplete. However, the PMN may be declared incomplete if the generic chemical name is so insufficient as to reveal little or nothing about the chemical composition. EPA will not usually review the adequacy of the generic name or generic description of uses during the review period. We may choose to review the generic name/ use at the time we receive a Notice of Commencement under 40 CFR 720.102. More importantly, if EPA decides to regulate a PMN substance, we would notify the submitter that she will have to negotiate with us the generic chemical identity for Inventory purposes if that name is not considered adequate.

103 9. Q. What is EPA's procedure when EPA develops a replacement generic name for the Inventory? Will the manufacturer or importer have an opportunity for input prior to publication?

A. If the generic name submitted on the PMN is too general, as determined by EPA, the submitter is contacted and encouraged to work with EPA to develop a generic name acceptable to both. See 40 CFR 720.85( a)( 3).

103 10. Q. I am intending to submit a PMN on a material which I will make with a confidential supplied feedstock, which will be identified to EPA in a Letter of Support. However, I have a pretty good idea what is in this material, and I do not want to be tied to this supplier indefinitely to make my material. What do I need to do to be able to use alternate sources for my feedstock? In a similar situation, I am using a process stream ( byproduct) material bought from another company as a raw material. What should I call it? If I call it by the name its maker sells it under, Section 1: General Program Information 1 26 am I going to be committed to purchasing their material only, even though other materials ( currently higher priced) would serve my needs?

A. If you are unable to reach an agreement with your supplier to divulge to you a chemical identity, or if you are using a material which has a chemical name specific to that provider, you can file a consolidated PMN with EPA. See 48 FR 21734, May 13, 1983, and www. epa. gov/ oppt/ newchems/ consix. htm. One of your filings will include the current intended feedstock, and your other filing( s) will include other feedstock( s) or reactants ( either other confidential materials or fully identified material[ s]) that can be used to make the PMN substance you want to manufacture. When you purchase a fully identified feedstock or reactant, you must use the same name for it as is used by its manufacturer for TSCA purposes.

In the case of a confidential material, EPA clearly cannot offer you any information about such a consolidated PMN which would enable you to determine that the PMN substance you plan to manufacture from a proprietary reactant is the same as one you would make from a reactant that is fully identified to you. Thus, EPA cannot respond to a consolidation in a way that would provide information which could help you determine the specific chemical identity of the confidential feedstock.

103 11. Q. I intend to submit a PMN on a product which as synthesized will contain an impurity which is difficult to remove, and therefore will remain in the product as sold. What should be tested, the intended sale product or the product with the impurity removed?

A. Test the product as it is intended to be sold. See 40 CFR 720.45( a)( 1). It is important that, in the PMN, you ensure that the description of the product tested is unambiguous.

104 Nomenclature 104 1. Q. What method does EPA prefer a submitter use when describing a chemical substance?

A. 40 CFR § 720.45( a) requires that submitters of § 5 notices provide the correct Chemical Abstracts ( CA) Name or CA Preferred Name for each chemical substance included in the notice (" reported substance") that is consistent with TSCA Inventory listings for similar substances.

Persons who request a search of the confidential Inventory by demonstrating a bona fide intent to manufacture or import a chemical substance for commercial purposes (" bona fide") are also required to provide correct CA nomenclature and chemical identity information in accordance with 40 CFR § 720.25. EPA also requires that a valid Chemical Abstracts Service ( CAS) Registry Number ( CASRN) consistent with the CA name be reported in a Section 5 notice or Notice of bona fide Intent to Manufacture for the substance if a CASRN already exists for that Section 1: General Program Information 1 27 substance.

Before the 1995 amendments, the PMN regulations indicated that CA nomenclature was the preferred chemical nomenclature system for PMN reporting, but it was not required. Therefore, submitters were able in the past to identify the PMN substance using alternative nomenclature. Currently, however, having the correct CA identification for a substance is important to EPA because the reporting of incorrect, inconsistent, ambiguous, or obsolete chemical names, molecular formulas, or chemical structure information, or names that are not CA Index or CA Preferred Names, causes extra resources to be spent by EPA to search the Inventory and establish the best descriptions for substances under TSCA.

Although the amended regulations only require that CASRNs be reported for substances that already have them, EPA strongly recommends that submitters provide CASRNs for all reported substances, especially when the chemical identity is not being claimed as confidential business information ( CBI). The fact that a CASRN exists does not prohibit a submitter from claiming this information as confidential. Having more substances reported with CASRNs will save EPA resources involved with chemical review and Inventory searching.

Submitters must provide a CA Index Name or CA Preferred Name that is consistent with the application of the Ninth Collective Index ( 9CI) of CA nomenclature rules and conventions. ( This definitive set of rules and conventions for CA nomenclature has been used since 1972.) Whether to report a CA Index Name or Preferred Name for a substance depends on whether the chemical identity of the substance is well defined, indefinitely described, or poorly defined.

All of the chemical identification requirements described above should be satisfied if the submitter uses the CAS Inventory Expert Service, which is a special service of CAS for identifying substances to be submitted under TSCA. Submitters may also choose to use the services of another chemical information service or consultant that the submitter considers capable of generating correct CA names, chemical structure diagrams or molecular formulas where appropriate, and obtaining existing CASRNs. Alternatively, the submitter can search publicly available databases to retrieve this information, if available, or attempt to generate a name without assistance from another person or organization, if the submitter has sufficient knowledge about the Ninth Collective ( 9CI) Index of CA nomenclature rules and conventions and about how similar substances are named for the Inventory.

Information describing CA nomenclature rules and conventions can be obtained from CAS. In addition, EPA has prepared a series of Inventory nomenclature guidance documents that are intended to generate better understanding of how various classes of substances or types of complex product combinations are identified for TSCA purposes. Several of these guidance documents have been posted to the New Chemicals Program's Internet site: New Chemicals Program Website, which can be found at www. epa. gov/ oppt/ newchems. The Inventory guidance documents provide informal technical guidance that is intended solely to illustrate how various Section 1: General Program Information 1 28 types of substances are represented on the TSCA Inventory based on the information provided by the submitters. The guidance documents are not intended to be used for identifying substances for reporting purposes or for determining the need to report. Generally, EPA has attempted to maintain a consistent Inventory by closely following the guidance contained in the guidance documents . However, EPA cannot guarantee that the guidance discussed in these guidance documents has been applied to all substances listed on the Inventory.

These guidance documents are also available from the TSCA Hotline at ( 202) 554 1404, TTD ( 202) 554 0551, or tsca hotline@ epa. gov For well defined substances appropriately named using CA Index nomenclature, the specific chemical name chosen as most accurately describing the substance should be based on all information that the submitter can reasonably ascertain about its chemical structure, including, where applicable, the degree of structural specificity of the substance ( e. g., whether a specific isomer is intended to be manufactured in the reaction that produces the substance). For poorly defined substances properly named using CA Preferred nomenclature, the specific name of choice should be based on the submitter's knowledge of the identities and sources ( synthetic, isolated by processing from certain naturally occurring materials, etc.) of the chemical precursors used, the nature of the reaction or method of isolation, and the types of chemical substances constituting the product combination, etc. For naming any kind of substance, the submitter's knowledge of impurities or byproducts is also a consideration.

When more than one substance results from a reaction, one should determine whether the product combination can be viewed for TSCA purposes as a mixture of separately reportable substances. For example, when the intended product combination is known to always be completely composed of a specific number of identified substances that do not react with one another, the combination can be represented as a mixture of individual components. If this is not the case, a single chemical name must be used to collectively describe the product combination as one substance. See 40 CFR § 720.3( e). Where the chemical components can be represented as a mixture, they may be reported in a single PMN as long as the components are all produced in the same reaction. Otherwise, multiple PMNs or a consolidated PMN ( requiring pre approval by EPA) must be submitted.

Other chemical identity information required at 40 CFR § 720.45( a) includes molecular formula and chemical structure information. However, for substances not able to be characterized by a single chemical structure, the regulations require the submitted representative or partial structural diagram to be as complete as known to or reasonably ascertainable by the submitter. Failure to fully comply with the chemical identification elements of this requirement will result in the notice being declared incomplete by EPA pursuant to 40 CFR § 720.65( c)( 1). Such incomplete notices will not be processed or reviewed by EPA until the chemical identification requirement is satisfied, and in some cases EPA will require that the notices be re submitted. Section 1: General Program Information 1 29 Concerning the degree of chemical structure information that can be reasonably ascertained for a given substance, submitters should understand that, for TSCA Inventory purposes, all substances are categorized by EPA into two groups according to the degree of certainty about the chemical structure of a substance: Class 1 and Class 2. Class 1 substances are those of precisely known chemical composition for which a single, complete structural diagram can be drawn. Class 2 substances are those having chemical compositions not completely definite or known; therefore, a Class 2 substance cannot be characterized by one definite, complete chemical structure diagram. The amended regulations require complete structural diagrams to be provided for Class 1 substances; for Class 2 substances, representative or partial structure diagrams are required that are as complete as can be reasonably ascertained from the Class 2 chemical identity.

104 2. Q. When a prepolymer is one of the precursors of a polymer, what should be considered to be the constituents of the final polymer: the ultimate reactants from which the prepolymer was manufactured, the prepolymer itself, or what?

A. The choice should follow Chemical Abstracts ( CA) nomenclature rules and conventions for its Ninth Collective Index ( 9CI). See 40 CFR 720.45( a)( 1)( i). With relatively few exceptions, polymers are named on the basis of their starting monomers/ reactants. Thus the name of a prepolymer derived from dimethyl terephthalate and 1,4 butanediol would be based on those particular reactants. As an example of an exception to this generalization, although polyethylene glycol may be thought of as a homopolymer of ethylene oxide, it is not named as a homopolymer under CA naming practices, but rather according to the structural repeating unit ( SRU) and end groups present: " alpha Hydro omega hydroxy poly( oxy 1,2 ethanediyl)." Similarly, polydimethylsiloxane is named on the basis of its structural unit: di Me Siloxanes and Silicones ( and is considered to be end capped with trimethylsilyl groups). If a prepolymer is named so as to represent a certain structural feature or definite repeating unit, its name cannot be decomposed into ultimate monomers for the purpose of naming the final polymer. EPA's conventions for representation of polymeric substances are discussed in greater detail in a 1995 nomenclature guidance document, " Toxic Substances Control Act Inventory Representation for Polymeric Substances" which can be retrieved at www. epa. gov/ opptintr/ newchms/ polymers. txt and is also available from the TSCA Hotline: voice ( 202) 554 1404; facsimile ( 202) 554 5603.

104 3. Q. Does the " Two Percent Rule" apply to the actual reactants used, or to the ultimate or putative reactants?

A. With relatively few exceptions ( such as when polymers or prepolymers having SRU names are used), the ultimate reactants should be the basis of the applicability of the 2% rule to the chemical identity of the polymer, if their weight percent values are all known. Thus, if a new polymer is made from the polymer of dimethyl terephthalate and 1,4 butanediol in the answer Section 1: General Program Information 1 30 above, plus additional dimethyl terephthalate and ethylene glycol, the final polymer name would be based on three constituents ( assuming each is used at over 2%), and the total amount of dimethyl terephthalate would be the sum of the separate contributions. If the weight percentage is known for each of the starting monomers, those contributing no more than two percent by weight to the final polymer may be omitted from the identity. If a homopolymer is used as a prepolymer constituent, the identity of the derived polymer should be based on the ultimate monomer, except where CA practice differs due to the applicability of SRU or other structure based nomenclature ( see the document referenced in the answer to the previous question). Although calculation of the percentage composition of a polymer may be based either on your determination involving the amount incorporated or from the amount charged to the reactor, the identity should be based on the ultimate monomers or other reactants if their weight percentages are all known.

When a charged polymer ( or prepolymer) is named using SRU or other structure based ( e. g., siloxanes and silicones) nomenclature, the 2% rule is applied to the charged polymer as a whole, because one doesn't know exactly which ultimate monomers were used to make that polymer. On the other hand, if the charged polymer or prepolymer has a monomer based name and one knows the percentage which each of the ultimate monomers constitutes in the charged polymer, then the 2% rule applies to the ultimate monomers. Where one does not know the percent composition of each of the ultimate monomers, the 2% rule should be applied to the charged polymer as a whole entity.

104 4. Q. Is a substance which is chemically identical to one on the Inventory, except that one of the elements present has been isotopically enriched, covered by the Inventory listing of the material made with the corresponding non enriched ( natural isotopic ratio) element?

A. No, it is not covered. For such substances the depletion/ enrichment process is generally accomplished chemically, not by nuclear reactions. Consequently, it is differences in chemical properties which allow the depletion/ separation. Nuclear source materials, as defined at § 720.3( a)( 3), are excluded from the definition of a chemical substance at 40 CFR 720.3( e), and if there were a specific case of enrichment accomplished by nuclear reactions we would consider whether this policy applied. Consequently, EPA considers a substance of which the isotopic composition has been modified to be a different chemical substance, and if it does not have a separate Inventory listing it will be " new," regardless of how similar its chemistry is to that of the ordinary ratio ( non depleted, non enriched) substance.

The Inventory contains a number of listings for substances enriched for specific isotopes ( e. g., Zinc oxide ( ZnO), Zn 64 depleted [ CASRN 175449 32 8].) There are also a number of isotopes which have different chemical properties, which are separately listed on the Inventory ( e. g., hydrogen, deuterium, tritium), as well as chemical compounds which differ only in the isotopes used to make them ( deuterosulfuric acid, D 2 O 4 S, deuterotrifluoroacetic acid, C 2 DF 3 O 2). Section 1: General Program Information 1 31 104 5. Q. We will be making an isotopically engineered product. We may change our views on which level of enrichment is optimal. Can we cover the range from the lowest to highest contemplated level of enrichment in one submission?

A. Yes, unless the enrichment level is so high that the substance should be considered and named as containing just one isotope ( that is, the other isotopes would be appropriately considered to be impurities.)

105 Inventory Issues 105 1. Q. When the notice period expires without specific action by EPA, is the chemical automatically listed on the Inventory?

A. No. A new chemical substance is added to the TSCA Inventory only after a Notice of Commencement ( NOC) of manufacture or import is submitted to EPA under 40 CFR 720.102. The PMN submitter must submit the NOC to EPA no later than 30 days after the first day of nonexempt commercial manufacture or import. The NOC may NOT be submitted before manufacture or import commences.

105 2. Q. If the non hydrated form of a chemical substance is on the Inventory, must I file a PMN on the hydrated form?

A. A hydrate of a chemical substance or a hydrate ion, formed by association of a substance with water, is considered a mixture and not reportable as such under TSCA. Only the non hydrated form is included in the TSCA Inventory, and this non hydrated form will represent all hydrated forms of that substance. However, this provision does not apply to the products of discrete chemical reactions in which water is a reactant; for example. a metal hydroxide formed by the reaction of a metal oxide and water [ See 40 CFR 720.3( u)( 2).]

106 Review Process 106 1. Q. What is the review process for a PMN or exemption notice?

A. Briefly, a PMN, LVE, LoREX, or TME submission is received by EPA and initially checked for completeness. The Inventory is checked to see if the subject material has already been listed. If the material is found on the TSCA Inventory, EPA will inform the submitter that they are free to commence non exempt commercial manufacture of the new chemical substance.

If the substance is not on the Inventory, it will be presented at the Chemical Review Meeting, which will consider the substance. " Early review drops" can take place at this stage, if the substance is similar to already reviewed substances for which EPA has little concern. EPA Section 1: General Program Information 1 32 uses the term " drop" to mean that the chemical will not be regulated with a § 5( e) Consent Order or SNUR.

Most substances move forward through a Structure Activity meeting ( and development of profiles of exposure and releases) to a Focus meeting at approximately Day 23 27, which, for a PMN, can result in the following regulatory decisions:

1. request for up front testing, 2. a risk or exposure based § 5( e) Consent Order, 3. a non § 5( e) SNUR, 4. a decision that the PMN should move forward for a " Standard Review" for further analysis by a team of experts in various disciplines, 5. a request for a small amount of additional information to enable one of the decisions above ( called a " short question"), or 6. drop, or a drop with a " drop letter" expressing EPA's concern and recommending certain precautions.

( Focus meeting decisions are available on the PMN Status Report, posted within 2 weeks of decision at www. epa. gov/ oppt/ newchems/ pmnstat. htm).

It should be noted that in recent years, less than 5% of cases continue on from Focus through the " Standard Review" process. For such substances, there is a meeting of multi disciplinary staff, followed by intensive hazard exposure risk assessment for the substance. At Day 79 82, an interdisciplinary Decision Meeting is held and one of the following regulatory actions is chosen:

1. request for up front testing, 2. a risk or exposure based § 5( e) Consent Order, 3. a non § 5( e) SNUR, or 4. drop or drop with a " drop letter" expressing EPA's concern and recommending certain precautions.

PMN exemptions, such as the 45 day review test market exemptions, the 30 day review low volume exemptions, and the 30 day review low release/ low exposure exemptions, are either granted, granted with conditions, or denied at the Focus Meeting. Regardless of the point during the review at which a regulatory decision is made, pursuant to TSCA § 5 the submitter is not free to begin manufacture or import until the review period expires.

107 Notice of Commencement 107 1. Q. What information is required for a Notice of Commencement ( NOC)? Section 1: General Program Information 1 33 A. A submitter is required to use the NOC form ( EPA Form 7710 56) to provide all the information required for a Notice of Commencement. The form must be signed and dated by an authorized official. If the chemical identity of the PMN substance was claimed confidential and the submitter wishes to maintain that claim of identity as CBI, the submitter is required to substantiate the CBI claim when submitting the NOC. Please refer to 40 CFR § 720.102 for NOC requirements and 40 CFR § 720.85( b) for CBI substantiation.

107 2. Q. To whom is a Notice of Commencement ( NOC) submitted?

A. The completed NOC form should be submitted to the TSCA Document Control Office. The mail address is:

United States Environmental Protection Agency Office of Pollution Prevention and Toxics Document Control Office ( 7407M) 1200 Pennsylvania Avenue, NW Washington, D. C. 20460 Attention: Notice of Commencement If delivering in person or sending by a courier service:

United States Environmental Protection Agency Office of Pollution Prevention and Toxics Confidential Business Information Center ( CBIC) EPA East Building, Room 6428 1201 Constitution Avenue, NW Washington, DC 20004 3302 If using a courier service, please instruct the courier that the Confidential Business Information Center closes its doors at 4 pm, and delivery will not succeed if attempted after 4: 00 PM.

107 3. Q. Where can a copy of the Notice of Commencement ( NOC) form be obtained?

A. The NOC form ( EPA Form 7710 56) is available from the TSCA Hotline at ( 202) 554 1404, by facsimile ( 202 554 5603), or on EPA New Chemicals Website at www. epa. gov/ oppt/ newchems/ pmnforms. htm.

107 4. Q. For Notice of Commencement ( NOC), when does Day 1 start for manufacturing? Is it the day the reactor is first charged or the date of completion of the first lot? When does Day 1 start for importation? Section 1: General Program Information 1 34 A. For a new chemical substance manufactured for nonexempt commercial purposes for the first time after expiration of the PMN review period, the first day of manufacture for NOC purposes (" Day 1") is described at 40 CFR 720.102( c)( iv) as the date of completion of the first lot, and for importation as the date the new chemical substance clears US Customs. ( For more detail regarding import, see US Customs Service regulations at 19 CFR Part 101 and § 141.68.)

107 5. Q. Is a Notice of Commencement ( NOC) required for the first batch of a new chemical substance, after the PMN review period is over, if it is manufactured for R& D?

A. If the first batch of a new chemical substance manufactured after expiration of the PMN review period is " solely for R& D purposes" and the research is conducted in compliance with the R& D regulations, the submitter need not file a NOC. See 40 CFR 720.102( a).

A NOC must be submitted within 30 days of manufacture for a nonexempt commercial purpose; " nonexempt commercial purpose" includes commercial R& D not in compliance with the R& D regulations at 40 CFR 720.36. Thus, under 720.102( a) if the manufacturer does not comply with the R& D regulations and record keeping requirements, a NOC must be filed.

107 6. Q. If you substantiate your confidentiality claims up front when you submit your PMN must you repeat that substantiation at the time of the Notice of Commencement ( NOC)?

A. Yes. You must substantiate your claim of confidentiality for chemical identity at the time you submit a NOC, if you want EPA to maintain your confidentiality claim after you begin manufacture. According to 40 CFR 720.85( b), other types of CBI claims need not be substantiated at time of NOC.( Notice of Commencement requirements are described in 40 CFR § 720.102.) To substantiate that claim, you must provide EPA with detailed answers to the questions listed at 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 request on that information.

107 7. Q. A submitter is required to submit a Notice of Commencement ( NOC) on or no later than 30 days after the first day of manufacture or import. What is the official reporting date of the NOC, the date the letter is postmarked or the date EPA acknowledges receipt?

A. The date that EPA's Document Control Officer receives the letter is the reporting date of the NOC. ( This is consistent with the rule for receipt of PMNs at 40 CFR 720.75( a)).

107 8. Q. Does the Notice of Commencement ( NOC) only apply to PMN chemicals or does it also apply to the first time a submitter manufactures or imports an existing chemical?

A. The NOC is used by EPA to determine that a chemical substance which has been Section 1: General Program Information 1 35 through PMN review has actually gone into nonexempt commercial manufacture. Once a NOC is received, the substance is put onto the Inventory. Thus, the requirement for a NOC only applies to new chemicals manufactured or imported for the first time for a nonexempt commercial purpose by the PMN submitter after expiration of the PMN review period.

107 9. Q. Can excess material produced for R& D purposes be used for commercial purposes after the PMN review period expires? How does this impact Notice of Commencement ( NOC) requirements? Must such use be precleared with EPA?

A. Excess R& D substance can be used for commercial purposes after the PMN review period expires without any additional authorization from EPA. However, no NOC may be filed until the new chemical substance is first manufactured for a nonexempt commercial purpose after expiration of the PMN review period. In other words, a NOC may not be filed solely on the basis of quantities previously manufactured under the R& D exemption.

40 CFR § 720.30( e) and ( f) allow certain commercial uses of excess R& D materials, without the submission of a PMN prior to such use. Additional information on the R& D exemption is provided in EPA's Chemical Information Bulletin " Exemptions for R& D and Test Marketing" ( 1986 1, November 1986, Office of Toxic Substances), which is available from the TSCA Hotline and on EPA's New Chemicals Website at www. epa. gov/ oppt/ newchems.

107 10. Q. Is it true that no Notice of Commencement ( NOC) is required for chemicals whose use has been approved under an exemption ( LVE, TME, LoREX)

A. Yes. No NOC is required to initiate use of chemicals approved under an exemption. This is because the NOC is used to trigger entry of PMN substances onto the Inventory, and exempted substances are not entered onto the Inventory.

108 User Fee 108 1. Q. What are the fees for submitting Premanufacture Notices and consolidated Premanufacture Notices?

A. Persons other than small businesses are charged a fee of $ 2,500 for each PMN or consolidated PMN submitted. The same fee is required for a Significant New Use Notice ( SNUN). See 40 CFR 700.45.

108 2. Q. What is the fee for small businesses submitting a Premanufacture Notice or consolidated Premanufacture Notice?

A. Small business concerns pay a fee of $ 100 for each PMN, consolidated PMN, or Section 1: General Program Information 1 36 SNUN submitted ( small is defined at 40 CFR § 700.43 as a company having less than $ 40 million in annual sales, where the amount includes sales of any parent or subsidiary company as well as those of the submitting company. This includes a parent company's overseas sales as well as those of the United States subsidiary company. See 40 CFR 700.45).

108 3. Q. What are the fees for exemption applications and exemption notices?

A. There is no fee for a Test Market Exemption, a Low Volume Exemption, or a Low Release Low Exposure ( LoREX) exemption.

108 4. Q. What is the fee for Premanufacture Notices ( PMN) involving intermediates in a synthetic sequence?

A. The fee for each intermediate PMN is $ 1,000, except that small business concerns are charged a fee of $ 100 for each intermediate as well as each final PMN. The PMN for the final product ( except for a small business) is $ 2,500. Intermediates MUST be in a direct sequence with the final product  the reduced fee for each chemical intermediate in a synthetic pathway when accompanied by PMN for the final substance on that pathway only applies for a sequence. That is, if a submitter chooses to file for " a", " b", " c", and " e" of a synthetic sequence " a"

" b"

" c"

" d"

" e", the submitter can file as an intermediate for " a" and " b", must file as a final for " c", and as a final again for " e", because " d" is missing from the sequence. Each final product is subject to a full user fee. See 40 CFR 700.43 and 700.45.

108 5. Q. Does a pesticide intermediate qualify for the intermediate user fee?

A. Most do not. A single pesticide intermediate can never qualify for the intermediate user fee of $ 1,000 because the final pesticide product does not come under the jurisdiction of TSCA, but rather FIFRA. See 40 CFR 700.43. Therefore a substance which will be transformed directly into a pesticide is a final product in relation to TSCA, and does not meet the definition of an intermediate Premanufacture Notice, at 40 CFR § 700.43 because the final product and intermediate( s) cannot be submitted simultaneously to the New Chemicals Program. Thus a submitter of a PMN for a substance which will be made into a pesticide in a single synthetic step pays the full PMN review fee. If, however, a submitter is filing for " a", " b", " c", and " d" of a synthetic sequence " a"

" b"

" c"

" d"

" e", where " e" is a pesticide, the submitter can file intermediate PMNs for " a" and " b" and " c", and must file a final product PMN for " d", because " d" is the final product subject to TSCA jurisdiction.

108 6. Q. What is the fee for a significant new use notice ( SNUN)?

A. The fee for each SNUN is $ 2,500, except for small businesses the fee is $ 100. See 40 CFR 700.45. Section 1: General Program Information 1 37 108 7. Q. What is the fee for a joint PMN submission?

A. Joint submitters of a § 5 notice are required to remit one appropriate fee for the type of notice being submitted, e. g., a PMN, a consolidated PMN, an intermediate PMN, or a SNUN, regardless of the number of joint submitters for that notice. To qualify for the reduced fee for small businesses, each joint submitter of a § 5 notice must qualify as a small business concern under 40 CFR § 700.43  if any submitter is not " small", the non reduced fee must be paid. The small business definition includes a parent company's overseas sales as well as those of the United States subsidiary company. See 40 CFR 700.45.

108 8. Q. When does EPA refund a fee?

A. EPA will refund any fee paid for a § 5 notice whenever EPA determines that the notice or fee was not required. See, e. g., 40 CFR 720.62. This can happen, for example, when the intended use described in the PMN is not actually subject to TSCA jurisdiction or when the substance is already on the Inventory. In addition, EPA will refund when it determines that a notice is incomplete.

108 9. Q. Are separate alpha numeric identification numbers used to identify and link a notice with the remittance fee otherwise known as " TS numbers" needed when submitting an intermediate notice and a final product PMN?

A. Yes. A separate TS User Identification number is needed when submitting for each intermediate and the final product PMN, since they are separate notices. However, both/ all numbers may be used to identify a single check.

108 10. Q. We are developing a 3 step process to make a new chemical. An Inventory substance in step # 1 will yield new substance " A" that will only be used ( Step # 2) as our intermediate to make new chemical substance " B", then " B" will be used to make new chemical substance " C" ( Step # 3). " B" will predominantly be used as an intermediate for chemical " C" but a small portion will be sold to other companies. " C" is entirely a final product that will be sold externally. All PMNs will be filed at the same time. If the PMN filing fee for intermediates is $ 1,000 if filed concurrently with the final product, and the fee is $ 2,500 for a final product, what filing fee must we pay for chemical " B"?

A. If any portion of a PMN chemical is intended for sale or use as a final product, you must pay the $ 2,500 fee. You can file for " A" as an intermediate at $ 1000, but " B" and " C" cost the full fee for each. See 40 CFR 720.45.

108 11. Q. How do I submit the user fee for PMNs and other § 5 submissions? Section 1: General Program Information 1 38 A. A user fee must be remitted for PMN and SNUN § 5 notices in accordance with 40 CFR § 700.45. You must create a unique alpha numeric identification number (" TS number") to identify and link your notice with the remittance fee. This six digit number must be placed on the first page of the form in the boxes that have been provided. This number must also be placed on your fee remittance which is sent to:

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

The notice and the fee are sent separately. Send your completed notice with original signatures and two copies to the OPPT Document Control Officer ( DCO), whose address appears on page 1 of the form. If you claim any confidential business information ( CBI), a fourth, " sanitized" or redacted copy is also required.

108 12. Q. How do I choose a user fee number (" TS number")? What is it used for?

A. The submitter chooses this number. It is used by the bank which receives money for EPA when it notifies EPA that the fee has been received, and also to enable us to assemble the parts of a submission when additional communications ( letters of support, joint submissions, corrections) are sent before a PMN/ LVE number has been assigned. There are six spaces in the TS number block on the PMN form. In the past, we have actually had duplication of TS numbers, and these instructions should make duplication less likely in the future: your TS number should be a 6 character alphanumeric string. It should include 2, 3, or 4 letters. One or more numerals must be interposed between two letters ( that is, LLNNLL, LNNNLL, NNLLNL, NLNLNL are okay, LLLNNN, NNNNLL are not). We recommend against company names, recognizable words and numerical series ( ROY01X, X01DOW are not good ideas). The TS number should be unique to this submission from your company. Do not give this number to a subsequent submission. If we get a TS number with a submission and it does not comport with this guidance, we will call the submitter and ask for a new number which does. Section 1: General Program Information 1 39 109 Consolidated Notices 109 1. Q. Is there an abbreviated procedure for submitting PMNs on structurally related new chemical substances?

A. EPA allows consolidation of PMN notices for up to six chemical substances with similar use, structure, and probable toxicology at the same time and for the same fee as a single substance. See 48 FR 21734, May 13, 1983. Consolidated PMNs benefit submitters by reducing the administrative burden of developing multiple § 5 submission forms for manufacture of two or more structurally related new chemical substances which have similar use, exposure, environmental release, and test data. EPA's review process is also facilitated by reviewing similar substances simultaneously.

EPA limits the number of substances that may be included in a consolidated PMN to six. See www. epa. gov/ oppt/ newchems/ consix. htm.

Persons who intend to submit a consolidated notice shall first contact the Prenotice Coordinator in the New Chemicals Prenotice Branch ( refer to New Chemicals Program Contacts List) for approval before submission of the notice. The Prenotice Coordinator will determine if the criteria for consolidation are met.

In the consolidated notice, the submitter shall identify new chemical substances individually by submitting a separate chemical identity page for each new chemical substance, and each identification must be supported by a separate report from the CAS Inventory Expert Service since Method 1 must be used to name each substance. When other pages of the § 5 submission form differ between the substances in the consolidated submission, they should be submitted separately as well ( generally identified as, e. g., page 6a, 6b, 6c,, etc). See www. epa. gov/ oppt/ newchems/ confaq. htm for more details. This is not an abbreviated procedure: the 90 day statutory notice review period applies for consolidated PMNs as it does for singular ones.

109 2. Q. Where is the consolidated PMN described in the Federal Register or in other publications? What is the justification for the six member limit on consolidations?

A. EPA announced a policy that it would accept submission of consolidated notices, subject to the approval of each submission by a Prenotice Coordinator, in the preamble of the May 13, 1983 Federal Register ( Part III ( C)( 1)( b), 48 FR 21722, 21734 35) and discusses procedures for acceptance of consolidated notices in Section II ( E) of the Instruction Manual for Premanufacture Notification of New Chemical Substances.

When EPA initially accepted consolidations there was no limit on the number of Section 1: General Program Information 1 40 substances which could be submitted in one consolidation. A consolidation, though less demanding of EPA's resources than the same number of separate submissions of related chemicals, still requires a substantially increased amount of effort over the assessment of a single submission. EPA has decided that it is appropriate to limit the number of substances in a consolidation to six.

109 3. Q. Why must a submitter get a name from the Chemical Abstracts Service Inventory Expert Service ( CAS IES) for each substance in a consolidation? Often, if one name has been bought from the Inventory Expert Service, the others can be easily determined. The additional reports from the IES seem to be an unnecessary additional expense to the submitter.

A. Consolidations are a two step process: the intending submitter requests ( from the Prenotice Coordinators) approval to consolidate the PMN submissions for two to six substances. The Coordinators approve or do not approve that request in consultation with New Chemicals Program chemists. For that initial request, the names used for requesting consolidation need not be from the IES. They should be specific enough that our chemists and other review personnel can decide whether the materials are similar enough ( chemically and toxicologically) that their reviews can be conducted concurrently with resulting savings of review costs.

For the PMN itself, however, the submission can lead to inclusion in the Inventory. Sources other than the IES have a higher, overall, error rate in generating names, and this includes submitters who try to develop additional names by analogy to that of one member of an approved consolidation. Though it has not been required, EPA encourages that any PMN submission covering a single substance be named by Method 1 ( i. e., CAS IES; see 40 CFR 720.45( a)( 3)). If a submission is incorrectly named, the process of declaring it incomplete and returning it to the submitter diverts EPA resources from other important work of the New Chemicals Program. The New Chemicals Program will not review any consolidated PMN submission which does not include a complete and correct CAS IES ( that is, Method 1) name for each substance, to prevent EPA from having to deal with one or more nomenclature errors. See www. epa. gov/ oppt/ newchems/ confaq. htm. The Method 1 requirement for consolidations is not satisfied by simply giving a CAS name and registry number to substances which have been previously examined by non IES CAS personnel.

Information on the CAS IES service including available resource materials is available through 614 447 3600 or 800 848 6538 ( ask for the Inventory Expert Service).

109 4. Q. How should a new chemical which, in aqueous solution, exists in equilibrium with a " similar species" ( also a new chemical) be reported on the § 5 submission form?

A. If you have structurally related substances in the situation described above, you will likely be given permission to submit a consolidated PMN notice ( contact a Prenotice Section 1: General Program Information 1 41 Communications Coordinator for a PC number.) If there is no intent to sell any of the components separately, and if they are synthesized together, such a material can also be reported as a Class II chemical substance per 40 CFR 720.45( a)( 2).

109 5. Q. If production of a series of metal salts of a modified organic acid is intended does each salt require a PMN or can the entire series be declared in one PMN?

A. Each salt that is intended to be manufactured must be reported in a PMN, and a Notice of Commencement is required for each salt that is manufactured. It may also be possible, however, to submit a consolidated PMN for up to six such salts. Please note that consolidations will not be granted for substances which are of different toxicological concern even if they are chemically similar. Consult a Prenotice Communications Coordinator for further assistance.

110 Joint Submissions 110 1. Q. May persons submit PMN notices jointly?

A. Yes. For example, a manufacturer may submit jointly with a toll manufacturer, or an importer with a customer. The person responsible for the PMN requirements under § 5( a) is required to complete all mandatory sections of the form, to the extent that he or she knows or can reasonably ascertain the required information, even if another person also submits a certain section. If a joint notice is submitted, the notice review period will not begin until EPA has received all required parts of the notice. Therefore, the person subject to the notice requirements should indicate to EPA who else will be submitting parts of the notice and identify those parts. EPA will acknowledge receipt of the notice when it has received parts from all of the joint submitters. Each person submitting the notice must also assert all confidentiality claims according to the procedures specified in the rule. See 40 CFR 720.40( e)( 2).

110 2. Q. How would a submitter file a PMN for an imported substance whose identity is claimed as confidential by its foreign manufacturer? How would the submitter obtain a Chemical Abstract ( CA) name?

A. The PMN would be submitted with a letter of support from the foreign supplier. The foreign supplier must follow the same procedures as a U. S. submitter to obtain a CA name and provide the correct chemical identity. Both submissions must clearly reference the PMN notice and PMN user fee identification number or a prenotice communication number.

A letter of support should be provided on the supplier's company letterhead. Since a letter of support may be received separately by EPA, an identification number such as a TS user fee number or a Prenotice Communications number should be used to link a PMN with information from a supplier or foreign manufacturer. The identical identification number should appear on Section 1: General Program Information 1 42 both pieces of correspondence submitted to EPA; otherwise, there may be a delay in processing the PMN. They may be submitted no more than 30 days apart. See 40 CFR 720.40( e)( 2) and the Instructions Manual for further information on joint submissions or letters of support.

Information on the CAS Inventory Expert Service ( CAS IES) including available resource materials is available through 614 447 3600 or by facsimile ( 614 447 3747). For general Chemical Abstracts Services call 800 848 6538.

110 3. Q. What should I do to ensure that EPA correctly identifies the parts of my joint PMN submission? Can a TS number ( the alpha numeric identification number used to identify and link a notice with the remittance fee) be used instead of a prenotice communication number to identify parts of a joint PMN submission?

A. Identify the joint submitter in your notice and identify the section( s) which the person will submit. We need an identifier which can be used to associate the different parts and it can be a TS number ( check ID number) or a prenotice communication number. The TS number is required for use in associating a PMN or SNUN with its fee, and can also be used to associate the parts of a joint submission. A TS number will not ordinarily be generated in the case of a no fee exemption application ( LVE, LoREX, etc.), however in cases where no fee is required the submitter can still generate a TS number and use it to associate the parts of a joint submission, or can call a Prenotice Coordinator to have a prenotice communication ( PC) number assigned specifically to identify parts of a joint submission.

111 Toll Manufacture 111 1. Q. What is the definition of a " toll manufacturer?"

A. According to 40 CFR 720.22( a)( 2), " If a person contracts with a manufacturer to manufacture or produce a new chemical substance, and ( i) the manufacturer manufactures or produces the substance exclusively for that person, and ( ii) that person specifies the identity of the substance, and controls the total amount produced and the basic technology for the plant process, that person must submit the notice. If it is unclear who must report, EPA should be contacted to determine who must submit the notice." The " customer" who contracts for the specific material and who has basic control over the process, amount made, etc., is for purposes of TSCA § 5 the manufacturer, and files the PMN, etc., and takes responsibility for the activity. The toll manufacturer who actually produces the chemical for the " customer", does not file the PMN, though the toll manufacturer can in some cases have proprietary process information, etc., which will come to EPA with the PMN in the form of a letter of support or joint submission.

112 Foreign Supplier Section 1: General Program Information 1 43 112 1. Q. How is the chemical identity determined when the substance is received from a foreign supplier?

A. If a principal importer does not know the specific identity of the new substance, the submitter must contact the foreign manufacturer or supplier and have the specific chemical identity information required in the PMN provided directly to EPA by the foreign party. See 40 CFR 720.25( a)( 3)( i). In this way, foreign manufacturers can protect confidential business information. The same holds true for U. S. manufacturers reporting chemical substances made from reactants identified only by a generic or trade name. The submitter of the new chemical substance must have the supplier provide specific 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 ( discussed in 40 CFR 720.40( e)( 2), the PMN Instruction Manual, and in Q& A section 110, Joint Submissions, above).

112 2. Q. Does a letter of support allow the supplier or foreign manufacturer to keep information confidential?

A. Yes, a letter of support allows the supplier or foreign manufacturer to keep information confidential. The PMN submitter can substitute information not in their possession or control with a trade name or brand name. However, the specifics of the unknown information must be provided by the supplier or foreign manufacturer in order for the PMN review period to begin.

112 3. Q. How can I obtain a CA name for an imported substance whose identity is claimed confidential by its foreign manufacturer?