# TSCA	Section	5	Premanufacture	and

**Significant	New	Use	Notification Electronic	Reporting;	Revision	to**  **Notification	Regulations:** Questions	and	Answers	Document

**US EPA 9**  **/ 10/2014** ePMN 2.0: Questions and Answers Sept 2014

2 

### Contents A. CDX Related Questions

................................ ................................ ................................ ........... 6 1. Do I need to register with CDX to submit or to work on section 5 notices?

....................... 6 2. Where do I go to register with CDX?

................................ ................................ .................. 6 3. Can Ibe registered under more than o ne company name? What company

name should I register for?

................................ ................................ ................................ ................................ . 6 4. What is LexisNexis?

................................ ................................ ................................ ............ 6 5. What if Ido not pass ID proofing with LexisNexis? What do Ihave to do?

...................... 6 6. If I have been approved for the TSCA workflow, do Ineed to reregister in CDX to work in the new ePMN under CSPP workflow?

................................ ................................ .................. 7 7. What role should Iregister for in CDX?

................................ ................................ .............. 7 8. Can Ihave more than one role in CDX?

................................ ................................ .............. 7 9. Do Support persons need their identities validated?

................................ ............................ 7 10. What does Primary mean (AO, Agent/Consultant or Support)?

................................ ...... 7 11. What does Secondary mean (AO, Agent/Consultant or Support)?

................................ .. 7 B. Role Function Questions

................................ ................................ ................................ ......... 8 12. What functions can Authorized Officials (AO) perform in Section 5 Notices and Supports (ePMN)?

................................ ................................ ................................ ...................... 8 13. Who can submit an original/initial submission of the PMN form, biotech form, NOC for m, or Bona Fide form?

................................ ................................ ................................ ........... 8 14. What functions can an Agent/Consultant perform in Section 5 Notices and Supports (ePMN)?

................................ ................................ ................................ ................................ ...... 8 15. What functions can a Support person perform in Section 5 Notices and Supports (ePMN)?

................................ ................................ ................................ ................................ ...... 8 16. Who can create and submit a support form?

................................ ................................ .... 8 17. What can I submit using the Support form?

................................ ................................ ..... 9 C. Security

Questions

................................ ................................ ................................ ................... 9 18. What is a passphrase?

................................ ................................ ................................ ....... 9 19. Who creates the passphrase?

................................ ................................ ............................ 9 20. Where is my

data stored?

................................ ................................ ................................ . 9 21. Is the data encry

pted?

................................ ................................ ................................ ..... 10 D. Document Access Questions

................................ ................................ ................................ . 10 22. How do I assign support persons to work on a document?

................................ ............ 10 23. Do I have to give access to a support person for each document separatel y?

................ 10 24. I am an Authorized official who created a form in the new s ys tem. Who has access to my data, i.e., can open the document with the passphrase?

................................ ...................... 10ePMN 2.0: Questions and Answers Sept 2014

3 25. I am an Agent/Consultant who created a form in the new s ys tem. Who has access to my data, i.e., can open the document with the passphrase?

................................ ...................... 11 26. Who can only

see my forms in the forms view?

................................ ............................ 11 27. If I am an Authorized Official (AO) and I leave the compan y, how can another AO from the same compan y have access to m y documents?

................................ .......................... 11 28. If my

company changes name, how do I access old company files?

............................. 11 29. What if my

company bought rights from another company 's chemicals, how will Iget access to the submission?

................................ ................................ ................................ .......... 11 E. Result of Submission Questions

................................ ................................ ............................ 12 30. When is the Case number assigned?

................................ ................................ .............. 12 31. Will Istill receive an acknowledgement letter?

................................ ............................. 12 32. How do I know that EPA has received m y submission?

................................ ................ 12 33. Why

is it important to download my COR?

................................ ................................ ... 12 F. Document Creation/Population Questions

................................ ................................ ............ 12 34. How is a Section 5 notice created?

................................ ................................ ................. 12 35. How do I create a Letter of Support or Joint Submission?

................................ ............ 13 36. In the Thick client, there was a Profiler to store contact information which allowed for eas y download of that information. Does the new online version of the ePMN have something equivalent?

................................ ................................ ................................ ................................ 13 37. What is a form Alias? How is it used?

................................ ................................ .......... 13 38. For sections of the ePMN displayed in an accordion style, do I hav e to fill in all required fields to save the form?

................................ ................................ ............................... 14 39. How do I enter the Authorized Official information on the form?

................................ 14 40. How do I create a multicomponent (discrete mixture) submission?

.............................. 14 41. How do I create a consolidated submission?

................................ ................................ . 14 42. How do I delete a consolidated chemical?

................................ ................................ ..... 15 43. How do I "cop y" m y submission in the new version of the ePMN ?

.............................. 15 44. How do I enter microorganinsm data into the Bona Fide form?

................................ .... 15 G. Amend Questions

................................ ................................ ................................ .................. 15 45. When c an I "amend" a submission versus when do Ihave to create a new submission? 15 46. What if Iforget m y passphrase to m y original notice and then need to make an amendment?

................................ ................................ ................................ .............................. 15 47. How do I amend “new” submissions? How do Iamend an “older” submission?

........ 15 H. Modifications Questions

................................ ................................ ................................ ........ 16 48. When do Icreate a Modification to an LVE or LoREX instead of "amending" the original submission?

................................ ................................ ................................ ................. 16ePMN 2.0: Questions and Answers Sept 2014

4 49. I need to submit a Modification to EPA. When do I use a PMN form to modify an LVE or L oREX and when do I use a support form (Communication) to EPA (e.g., a j(6) letter)?

.. 16 I. Attachment Questions

................................ ................................ ................................ ............ 16 50. Do I need to upload m y s anitized attachments at the same time that I upload my CBI attachments?

................................ ................................ ................................ .............................. 16 51. Is there a file size limitation for my attachments?

................................ ......................... 17 52. Will the software sanitize my attachments?

................................ ................................ ... 17 J. XMLQuestions

................................ ................................ ................................ ..................... 17 53. When Iam working online, can I save m y work in progress locall y?

........................... 17 54. Can Iuse the eTSCA Client software to create m y documents?

................................ ... 17 55. What is an XMLs chema?

................................ ................................ .............................. 17 56. Where can the XML schema be found?

................................ ................................ ......... 18 57. Can Iimport m y data which was created from the thick client?

................................ .... 18 58. Can my

forms created in CDX which are in progress be stored locall y?

...................... 18 59. Can Iwork behind m y firewall?

................................ ................................ ..................... 18 60. Will CBIbe designated with the curvy brackets in some text fields?

........................... 18 61. What is an original Notice submission?

................................ ................................ ......... 18 62. Is there a cop y of the PMN form available outside of the software for informational purposes and not for submission?

................................ ................................ ............................. 18 63. If I find m y substance in SRS, does this mean my chemical is on the TSCA Inventory? 18ePMN 2.0: Questions and Answers Sept 2014

5 Disclaimer: This Q&A document is not a rule and is not legall y enforceable. The document explains some of the electronic reporting requirements in 40 CFR parts 720, 723 and 725 applicable to documents submitted pursuant to those provisions. The document also discusses recommended practices for such submission. The document neither creates any new requirements nor replaces existing established laws or regulations. The use of the word "should" in this document means that something is suggested or recommended, but not required.ePMN 2.0: Questions and Answers Sept 2014

6 **A. CDX	Related	Questions**  **1. Do I need to register with CDX to submit or to work on section 5 notices?**  Yes, you must be registered with CDX to work online or to submit Section 5 Notices and Supports forms. You can use the eTSCA Client to work on PMN files locally . The form data .xml for the PMN form can then be exported and uploaded into the online application. Please refer to the CDX CSPP registration user guide for an y other questions you may have. **2. Where do I go to register with CDX**  **?** http://cdx.epa.gov is the website to register and access the Section 5 Notices and Supports submission software. There are also a variety

of user guides available for quick tutorials regarding the CDX registration process. **3. Can I be registered under more than one company name?**  **What company name should I register for**  **?** Yes, you may register for more than one compan y name, and can select which organization you will be working under when logging into CDX. In addition, multi

- Authorized O fficial (AO) functionality means that all AOs registered under the same compan y name will be able to view the forms that other AOs within that company create. The role sponsorship functionality means that if Agents/Consultants create a form, all sponsors of the compan y he/she represents can also see the form as well as the Agent that created the form. To keep the forms secure, select a unique company name to work under. But remember, that compan y name will populate on the forms when su bmitting. **4. What is LexisNexis?**  LexisNexis is a third

- party identit y proofing service that verifies a user's identity

. It does not verify organization information or an association to an organization. **5. What if I do not pass ID proofing with LexisNexis? What**  **do I have to do?** If the LexisNexis identity validation fails, the user is required to sign and mail a paper electronic signature agreement (ESA) which may take ten (10) business day s to process.ePMN 2.0: Questions and Answers Sept 2014

7 **6. If I have been approved for the TSCA workflow, do I need to**  **reregister in CDX to work in the new ePMN under CSPP workflow?**  If you have been approved for the TSCA workflow, you do not need to re

- register in CDX. You will , however, need to update your user role and workflow. If you have already been identity

- proofe d and have an ESA approved on

- file, you can add the CSPP workflow and add a user role under that workflow since the ESA can be reused for certain workflows. All persons registered and approved for TSCA have already been identity

- proofed, but must electroni call y sign an ESA. It is not necessary

for legacy

CDR persons to re

- register in CDX. **7. What role should I register for in CDX?**  There are six user roles: 3 roles are associated with the main forms and its supporting forms (Primary Authorized Official, Primary Support, Primary Agent/Consultant) and 3 roles are associated with the secondary forms (i.e. Joint or Letter of Support) (Secondary Authorized Official, Secondary Support, and Secondary

Agent/Consultant). To determine which role is best for you, p lease refer to the appropriate user guide on the 'Resources' screen within the Section 5 Notices and Supports application, or refer to the user guides posted on the New Chemicals website; http ://www.epa.gov/oppt/newchems/epmn/epmn

- index.htm

. **8. Can I have more than one role in CDX?**  It is possible to register for more than one role under a single user ID. You can register under all 6 roles, but under different user IDs. However, when you access the application, you can only access the application under one user role at a time. **9. Do Support person**  **s need their identities validated?**  Since a Support user will not have the ability to sign/submit data to EPA, they do not need to undergo the same level of validation as Authorized Officials or Agents/Consultants. **10. What does Primary mean (AO**  **, Agent/Consultant or Support)?**  Primary is a term used to designate CDX registrants who wish to access and submit main submissions and support document. Main submissions include: the PMN form, the Biotechnology form, the NOC form, the Bona Fide form and the Alternative Control Measures form. **11. What does Secondary mean (AO**  **, Agent/Consultant or Support)?**  Secondary

is a term used to designate CDX registrants who wish to access and submit Joint and Letter of Support submissions.ePMN 2.0: Questions and Answers Sept 2014

8 **B. Role	Function	Questions**  **12. What functions can A**  **uthorized Officials (AO) perform in Section 5 Notices**  **and Supports (ePMN)?** All AOs can create, edit, d elete, designate Agents/Consultants, designate Supports, unlock, and download the Copy of Record (CoR). The submitting AO is the person from the submitting company who legall y signs, certifies, and submits the initial Notice forms: PMN, NOC, Biotechnology , or Bona Fide

. The AO can also submit the Alternative Control Measures (ACM) form and the support form. All persons can save, validate to check for errors, and preview documents in progress. **13. Who can submit an original/initial submission of the PMN form,**  **biotech form ,**  **NOC form ,**  **or Bona Fide form?**  The initial submission for these t ypes of notices must be submitted by a Primary Authorized Official from the compan y who is authorized to legall y sign, certify , and submit the initial notice. Any subsequent ame ndments to these forms may be submitted by

an y AO of the submitting company

or Agent/Consultant assigned under that company name. **14. What functions can**  **an Agent/Consultant perform in Section 5 Notices and**  **Supports (ePMN)?** Agents/Consultants can create, edit, delete, unlock, and download the Cop y of Record (CoR) for all forms

. The Agents/Consultants **cannot** submit the initial Notice forms: PMN, NOC, Biotechnology , or Bona Fide fo rms. The Agent /Consultant **can** submit the initial ACM form, all amended forms and Support forms. All persons can save, validate to check for errors, and preview documents in progress. **15. What functions can**  **a Support person perform in Section 5 Notices and**  **Supports (ePMN) ?**  Support persons can onl y edit document s that are in progress which have been assigned to them b y their Authorized Official. All persons can save, validate to check for errors, and preview documents in progress. **16. Who can create and submit a support form?**  The role of the Support person has changed with the Section 5 Notices and Supports thin client application. The Support person will no longer have the ability to create and submit Support forms in the new Section 5 Notices andePMN 2.0: Questions and Answers Sept 2014

9 Supports application. Only Authorized Officials or Primary Agents/Consultants can create and submit Support forms. Registered Support persons will only be able to edit form information once they have been assigned to and given access to the form b y an AO. **17. What can I submit using the**  **S upport form?**  A Support form includes the following subt ypes: 'Amendment,' 'Suspension Request,' 'Test Data,' 'Transfer of Ownership,' 'Withdrawal Request,' and 'Other Correspondence.' The purpose of the Support form is to provide additional information, or supplement information to the PMN form. For the most part, the Support form has not changed except with regards to submitting amendments to the PMN and Biotechnology form. If you submitted an original Notice form using the thin client, you cannot ame nd the original using the Support form; you must unlock the original notice and resubmit.
**C. Security	Questions**  **18. What is a passphrase?**  The passphrase is a text string used to encry pt a form (e.g. PMN, Biotechnology , NOC, Support, Bona Fide, or ACM). If you want to edit a form, unlock a submission, or download a Copy of Record (CoR), you will need the passphrase. Only Authorized Officials or Agents/Consultants can create passphrase for forms. This passphrase can be shared with whomever they would like to provid e access to the forms. If you forget the passphrase for a submission in progress, you must recreate the form and resubmit. If yo u want to download the CoR of a particular document and you forgot the passphrase, you will need to contact EPA and request a copy . Also, a passphrase is reusable, so the same passphrase can be used on all forms. **19. Who creates the passphrase**  **?** The person who creates the form creates the passphrase for that form. A passphrase is created or entered on the 'Create Passphrase' or 'Enter Passphrase' screens, respectively

. Since the passphrase cannot be changed once it has been assigned to a form, the passphrase should be decided upon before the form is created amongst members who will be working on the form. You are encouraged to cre ate a passphrase that is easy to remember because it cannot be recovered if lost or forgotten. The same passphrase can be reused for multiple forms. For example, you may want to use the same passphrase for all forms associated with a case. **20. Where is my data**  **stored?** The data will be stored encry pted on the EPA server when logged into the Section 5 Notices and Supports application.ePMN 2.0: Questions and Answers Sept 2014

10 Otherwise, if you are using an XML file, or saving a Cop y of Record, this will be stored on your local hard drive, and you are r esponsible for the security of these items via your computer's security measures. **21. Is the data encrypted?**  Data stored on the EPA server is encry pted b y a passphrase. Once the Cop y or Record is downloaded, it can be stored locall y unencrypted.
**D. Document**  **Access	Questions 22.**  **How do I assign support persons to work on a document?** If an Authorized Official (AO) wants one of his/her Support persons (as designated within CDX) to work on a form, the AO must assign the form to this person. Forms are assigned using the 'User Management' tab in the Section 5 Notices and Supports applicati on. The AO can select the form alias from the 'Form Alias' drop

- down menu on the 'User Management' screen and then select the specific Support person(s) from the 'Unassigned' list. Once the specific Support person(s) is/are assigned, the assigned form wi ll appear in a Support person's view when they log into the Section 5 thin client. The AO will need to provide the Support person with the passphrase in order for the Support person to access the form for editing. Agents / Consultants are not able to as sign Support persons to a form. **23. Do I have to give access to a support person for**  **each document**  **separately ?**  Yes. If the AO wants a Support person to have access to one or more forms, the AO must assign access to each form, one at a time, via the 'User Mana gement' tab. It is not possible to assign a Support to multiple forms at one time. **24. I am an Authorized official who created a form in the new system.**  **Who has access to my data, i.e., can open the document with the passphrase?**  1) An y Authorized Officials re gistered under the submitting compan y. 2) Agents/Consultants who are associated with you under the submitting company may also be assigned to work on the form. 3) Support persons who are associated with you may

be assigned to work on the form that is in p rogress. This multi

- AO functionality allows other Authorized Officials within a submitting compan y to view forms that other AOs have created.ePMN 2.0: Questions and Answers Sept 2014

11 **25. I am an Agent/Consultant who created a form in the new system.**  **Who has access to my data, i.e., can open the do**  **cument with the passphrase ?**  When an Agent/Consultant logs into CDX, they must select which company they will be they

want to work under. When the Agent/Consultant creates a new document, he/she and any Authorized Official from the selected company can the n open the document with the passphrase. **26. Who can only see my forms in the forms view?**  a. If you are an Authorized official for Compan y A, you can see all forms created under Compan y A. b. If you are an Agent/Consultant for an AO from Company A, you can see all f orms that you created and all forms created by your AO to which you were assigned. c. If you are a Support person for an AO from Company A, you can see all forms which were assigned to you by your AO. **27. If I am an A**  **uthorized Official (AO) and I leave the compan**  **y, how can another AO from the**  **same company have access to my documents?**  Any AO registered under the same company has access to all forms created by any AO of that company

(i.e., the forms will be listed in the forms view). To open a form, the AO will need to have the passphrase. Remember, passphrases cannot be recovered once lost or forgotten. It is alway s a good practice to download the Copy of Record to your local hard drive for each form sent to EPA for future reference. In addition, if the sponsorin g AO of an Agent/Consultant leaves the company , then the Agent/Consultant must find another sponsoring AO from the company as their role sponsorship will have been revoked. **28. If my company changes name, how do I access old company files?**  Users should maintain old compan y names within CDX registration and keep the passphrase for all documents . Make sure you download the Copy of Record and securel y maintain records outside of CDX in case access to the files online is no longer available

. **29. Wha**  **t if my company bought rights from another company's chemicals, how will I get access to the submission?**  The second compan y (company B) that bought the chemical should request information that was saved locall y ( i.e., the Copy of Record) from the company whose chemical rights were purchased (compan y A). Company B will not have access to Company

A’s documents in the Section 5 Notices and Supports application. If compan y B wants is not able to obtain this information from Company A, please request this information from EPA.ePMN 2.0: Questions and Answers Sept 2014

12 **E. Result	of	Submission	Questions**  **30. When is the Case number assigned?**  After a form is submitted to EPA, the Section 5 Notices and Supports application will assign a case number within minutes. The case number will appear within the 'Section 5 Notices and Supports Forms' screen, but it may be necessary

to refresh the page b y selecting the Browser refresh button. For non

- consolidated submissions a single case number is assigned; for consolidated submissions, multiple case numbers are assigned. After you submit a form to EPA and the submission has been successfull y received, the s ys tem will provide a Cop y of Record (CoR) represented b y a green arrow icon. **31. Will I still receive an acknowledgement letter?**  Acknowledgement letters will continue to b e sent by U.S. mail. **32. How do I know that EPA has received my submission?**  In the previous process using the PMN thick client, users would receive emails regarding the CDX transaction ID, and another email with a confirmation of the Copy of Record. With the new Section 5 Notices and Supports thin client, the application generates a Copy of Record ( obtained by

selecting the green arrow icon) within several minutes of submitting a form, which indicates that EPA has received the form. The application will also generate a single case number for a non

- consolidated submission, or multiple case numbers for a consolidated submission. No emails will be generated in this process. **33. Why is it important to download my COR**  **?** It is very important to download the Copy of Reco rd (CoR). The information stored on EPA’s server is encry pted using the passphrase. If something happens to the form on the EPA server, or to the passphrase, or to the Authorized Official , etc. users will need to have copies of the forms submitted to EPA f or your records. A downloaded file is not encry pted and easily

shared.
**F. Document	Creation/Population	Questions**  **34. How is a**  **Section 5 notice created?**  The Authorized Official or Agent/Consultant logs into CDX and selects the Primary Authorized Official or Agent/ Consultant role within the CSPP workflow. Select 'TSCA Section 5 Notices and Supports

- ePMN' from the CISS drop

- down menu. Users will then have the option to create the following notices and support forms from the Forms screen: 'Premanufacture Notice (PMN),' 'Biotechnology ,' 'NoticeePMN 2.0: Questions and Answers Sept 2014

13 of Commencement (NOC),' 'Support,' 'Bona Fide,' and/or 'Alternative Control Measures (ACM)' b y selecting the form t ype from the drop

- down menu and clicking the 'Start New Form' button. For specific steps on creating a new notice or support form, refer to the applicable Section 5 Notices and Supports user guide. **35. How**  **do I create a Letter of Support or Joint Submission**  **?** Third part y submitters will receive an email from the main submitter. In the email will be a unique identifier that Secondary Authorized Officials will use to create the Letter of Support or Joint Submission. The Secondary AO will launch the TSCA Section 5 Notices and Supports thin client application and from the forms screen, select to create a new document. The sy stem will ask for the unique identifier

– it is suggested that this identifier be copied from the email as it can be quite complex. After entering the identifier and a passphrase, the form will appear where the Secondary AO can then either fill out the PMN information, attach supporting information in a file, or enter the supporting information in the cover letter. **36. In the Thick client, there was a Profiler to store contact information which**  **allowed for easy**  **downlo ad of that information. Does th**  **e new online version of**  **the ePMN have something equivalent?**  The TSCA Section 5 Notices and Supports thin client application does not have an equivalent profiler feature. However, there is an option for the person logged into a form to populate the agent or technical contact information with their CDX registration information. If the person filling out the form is not the agent/technical contact then this information will need to be entered manually

. The submitting person's information will automatically populate within the form during the submission process. Note: a user may

use Google Chrome as a browser which allows you to auto
populate information that is consistently re - used. **37. What is a form Alias? How is it used?**  When you create a form, you will be given the option to provide a user defined alias for the form. The form alias is a text description entered b y a user into a field in the form to assist other user in locating and organizing multiple forms within the application. The form alias can be edited by any user who has access to the form. As a hint, you may

want to define a naming convention to be used for all docum ents under one case number. Within the application you may view forms in a dashboard view. The form alias is also used on the 'User Management' page to identify and assign specific forms to Support users or company registered Agents/Consultants

.ePMN 2.0: Questions and Answers Sept 2014

14 **38. For secti** **ons of the ePMN displayed in an accordion style, do I have to fill in all required fields to save the**  **form ?**  There are several screens within the Section 5 Notices and Supports application which will not allow you to move forward without filling out all req uired data. This is especially

true for sections of the form which utilize expandable/collapsible field sets. All required data must be entered in the expandable/collapsible field set before the field set data can be saved. Screens without expandable/colla psible field sets can be saved and users can move to another screen using the links within the navigation tree instead of using the 'Previous' and 'Next' buttons. However, there are some forms within the application (i.e., Letters of Support or Joint Sub missions) where the validation varies, and not all fields may be required within an expandable/collapsible field set. **39. How do I enter the**  **Authorized Official information on the form?**  The submitting compan y Authorize Official’s information is not manually entered; the information will be pre

- populated on the 'Submitting Official In formation' page during the submission process. The only field that a user can edit on this page is the 'Job Title' field. All other data changes must be made within CDX registrati on information. If you are not the correct person to submit data to EPA or if the CDX registration data is incorrect, you may cancel the submission process at an y time. **40. How do I create a multicomponent (**  **discrete mixture**

**) submission?** The new Section 5 Notices and Supports application can easily accommodate multi

- component chemical submissions. A multi

- component chemical submission is one where two or more chemicals are **always** generated together in one pot and are **never** isolated. Add each chemical component by clicking the 'Add Chemical Component' button on the 'Class 1 or 2 Chemical Substances' or 'Polymer Identification Information' screen. **41. How do I create a consolidated submission?**  In order to create a consolidated submission, the user needs to create a file folder for the first chemical. Subsequent consolidated chemicals are generated b y clicking the 'Add Consolidated Chemical' link to add a new set of chemical screens within the navigation tree. Chemicals with similar chemical I D information (PMN pages 4, 5 and 6) can be copied b y clicking the 'Copy' link within the navigation tree. However, neither the chemical name nor CASRN will be copied. Attachments are also removed and must be uploaded again.ePMN 2.0: Questions and Answers Sept 2014

15 **42. How do I delete a consolidated**  **chemical?** To delete a chemical within a consolidated submission, click the 'Remove' link (red 'X' icon) within the navigation tree within the folder for the particular chemical you would like to remove. After clicking the 'Remove' link there is no way to r ecover the deleted chemical folder. Please note: the 'Remove' link is only available if the user is not currently working on one of the selected chemical's screens. **43. How do I "copy" my submission in the new version of the ePMN?**  After a case is submitted t o EPA, the Section 5 Notices and Supports application will generate a Copy

of Record. The Copy

of Record includes: submission XML , form PDF, and attachments. The submitter should download the Copy of Record to their local hard drive. To create a cop y of the downloaded submission in the Section 5 Notices and Supports application, the user should create a new PMN form, upload the XML file from the Cop y of Record, re

- attach the document files, and make changes as needed.
**44. How do I**  **enter microorganinsm data into the Bona Fide form**  **?** To enter microorganism data into the Bona Fide form of the software, select the Class 1 or 2 option then fill out the rest of the form as if the substance was a Class 2 substance.
**G. Amend	Questions**  **45. When can I "amend" a submission ve** **rsus when do I have to create a new submission?**  EPA will notify

the submitter to say

if the submission can be amended or if the submission is incomplete. A submission marked as incomplete by EPA cannot be "revised" or "amended" ; a new form must be created and submitted. The resubmission will be given a new day 1 and a new case number. **46. What if I forget my passphrase**  **to my original notice and then need to make an**  **amendment?** If a form was created online in the Section 5 Notices and S upports application, and the passphrase was forgotten, the form cannot be opened or recovered. To create an amendment, create a Support form and designate it as "Other Correspondence." Attach or describe an y amended information. **47. How do I amend**  **“**

**new ”**  **submi**

**ssions? How do I amend an “older”**  **submission?** The procedure for amending a form is dependent on how the original form was created and submitted to EPA

.ePMN 2.0: Questions and Answers Sept 2014

16 1) Amendments to submissions originally created and submitted using the online Section 5 Notices and Supports application are made by unlocking submissions on the 'Section 5 Notices and Supports Forms' screen, making changes, providing a reason for the amendment and resubmitting. 2) Amendments to submissions sent t o EPA using the eTSCA EPA thick client are submitted via a Support form and selecting 'Amendment' as the ty pe of support.
**H. Modifications	Questions**  **48. When do I create a Modification to an LVE or LoREX instead of "amending"**  **the original submission?** An amendment is ty

pically a change to an original notice during the 30

- day review period for an LVE or a LoREX submission. After the 30

- day review period has expired and the changes constitute a Modification as defined b y 40 CFR 723, the submitter must create a new Pr emanufacture Notice (PMN) form and select LVE Modification or L oREX Modification as the form ty pe. These Modifications will receive a new case number (LM or XM) and a new 30

- day review period. If there are questions, contact the TSCA hotline at 202

- 554

- 1 404 or facsimile at 202

- 554

- 5603. **49. I need to submit a Modification to EPA.**  **When do I**  **use a PMN form to modify an LVE or LoREX and when do I use a suppor**  **t form (Communication) to EPA (e.g., a j(** 

**6 )**  **letter)?** For an already - approved LVE, you can send a notifi cation in the form of a letter as a support document (select Other Correspondence as the Support form subty pe) to the existing LVE and need not file a request for modification requiring 30

- day review b y the Agency if your site change meets the criteria of 40 CFR Sec. 723.50(j)(6). The (j)(6) notification must be received by the Agency

before the 30th day after first manufacture at the new site. If your changes to the LVE or LoREX do not meet the criteria for 40 CFR Sec. 723.50(j)(6) , use the PMN form an d select LVE Modification or LoREX Modification as your PMN form subty pe. These modifications receive a new case number and will go through the full 30

- day review.
**I. Attachment	Questions**  **50. Do I need to upload my sanitized attachments at the same time that I u**  **pload my CBI attachments?**  The online application performs immediate validation to ensure that the CBI files have sanitized files attached. If a user does not want to upload the sanitized file along with the CBI file, the user may mark the file as non

- CBI and then laterePMN 2.0: Questions and Answers Sept 2014

17 change the CBI status when the user is ready to upload the sanitized file. However, do not forget to go back and change the CBI status of the attachment if yo u choose to do this option

. **51. Is there a file size limitation for my attachments?**  Ther e is no actual file size limit, but you are limited to your network bandwidth and the application timeout of ten (10) minutes per upload. **52. Will the software sanitize my attachments?**  No, the application will not sanitize attachments; the software onl y sanitizes fielded data. Sanitized attachment files will need to be created outside of the Section 5 Notices and Supports application. In order for data to be sanitized, you will need to f

lag the specific data fields as CBI by checking the associated 'CBI' checkbox. **J. XML	Questions**  **53. When I am working online, can**  **I save my work in progress locally?** Within the current eTSCA thick client, users are able to save their working files to their hard drive. With the new thin client, in

- progress forms will be created and saved online. A user can save a partial XMLin the thin client, and export it. Only the fields that were populated in the thin client were exported

– not any attachments. Please not e that, if the field was not populated in the thin client, blank fields will not be available in the exported XMLfile. **54. Can I use the eTSCA Client software to create my documents**  **?** The eTSCA thick client will not be removed from a person’s computer if was previously

installed. The option to download the eTSCA Client lite will also be available from the New Chemicals website. However, this software will not be maintained. Users will be able t o save forms created within the thick client, export the fielded data as an XMLfile (PMN form onl y) and upload them to the thin client using the upload XMLfunctionality . Attachments uploaded within the thick client will not be imported and must be reatta ched in the thin client. **55. What is an XML schema?**  According to WIKIPEDIA, **Extensible Markup Language** ( **XML** ) is a markup language that defines a set of rules for encoding documents in a format that is both human

- readable and machine

- readable. The data fields defined in the XML schema can allow users to upload XMLdata into a blank PMN form, or export in

progress PMN form data into an XMLfile. The XML file allows users to work on forms outside of the thin client application, or to populate forms for similar chemicals.ePMN 2.0: Questions and Answers Sept 2014

18 **56. Where can the XML schema be found?**  The Section 5 Notices and Supports extensible markup language (XML) schema for the PMN form will be available on the New Chemical Programs website : http://www.epa.gov/oppt/newchems/epmn/epmn

- index.htm **57. Can I import my data which was created from the thick client?**  Yes, but only

for the PMN form ; PMN forms created in the thick client can be exported as XMLfiles and uploaded into a blank PMN form within the thin client using the upload XML functionality . Attachments will need to be re

- uploaded one at a time. **58. Can my forms created in CDX which are in progress be stored locally?**  Yes, partial XML files can be downloaded and saved locall y. **59. Can I work b**  **ehind my firewall?** Yes; the purpose of the XMLschema for the PMN form is for users to work locally and offline. The XMLcan then be uploaded into a PMN form, attachments can be uploaded, and the form can be validated to make sure that there are no error s, and then submitted to EPA. **60. Will CBI be designated with the curvy brackets in some text fields?**  Some of the large text fields in the eTSCA downloaded software allowed CBI to be designated within the field by surrounding the text with braces { e.g., enter CBI here}). With the new Section 5 Notices and Supports application thin client , these fields are now considered to be entirel y CBI or entirely non

- CBIby selecting a single CBI checkbox for the field. **61. What is an original**  **Notice submission?**  An original Notice submission is defined as the first time a Premanufacture Notice (PMN), Biotechnology , Notice of Commencement (NOC), or Bona Fide form is ever submitted to EPA. Subsequent changes to these forms are referred to as amended or modified noti ces. Support forms or Alternative Control Measure (ACM) forms will never be considered an original form. **62. Is there a copy of the PMN form available outside of the software for**  **informational purposes and not for submission?** The Premanufacture Notice (PMN) PDF will be included as a link on the New Chemicals Program website ( http://www.epa.gov/oppt/newchems/epmn/epmn

index.htm ). A Notice of Commencement (NOC) PDF will also be posted on the website

. **63. If I find my substance in SRS, does this mean my chemical is on the TSCA**  **Inventory?** No. If you find your chemical in the Substance Registry Services (SRS), this does not necessaril y mean that the chemical is on the TSCA Inventory
.ePMN 2.0: Questions and Answers Sept 2014

19 If you are searching b y C AS number on the public TSCA Inventory or SRS and the chemical is not found, it could be located on the confidential portion of the TSCA Inventory . In which case, a Bona Fide form can be created and submitted within the Section 5 Notices and Su pports application to have EPA determine whether or not a chemical is located on the confidential portion of the TSCA Inventory

.