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Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations This Rule document was issued by the Environmental Protection Agency (EPA) For related information, Open Docket Folder Show agency attachment(s) ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2008-0296; FRL-8794-5]
SummaryEPA is amending Toxic Substances Control Act (TSCA) section 5 reporting regulations at 40 CFR parts 700, 720, 721, 723, and 725. The amendments establish electronic reporting requirements for TSCA section 5 submissions. This action is intended to streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA by establishing standards and requirements for the use of EPA’s Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs) and other TSCA section 5 notices and support documents to the Agency. EPA is also amending TSCA section 5 user fee regulations by adding a new User Fee Payment Identity Number field to the PMN form, to enable the Agency to match more easily a particular user fee with its notice submission. Lastly, EPA is amending the PMN form by removing the Agent signature block field, and thus the requirement for designated agents to sign the form.
DatesThis final rule is effective April 6, 2010.
AddressesEPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2008-0296. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
For Further Information Contact For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov. For technical information contact: Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8469; e-mail address: schweer.greg@epa.gov.
Supplementary InformationI. Does this Action Apply to Me?You may be affected by this action if you manufacture, import, or process chemical substances for commercial purposes that are subject to TSCA. Potentially affected entities may include, but are not limited to: Manufacturers, importers, and processors of chemical substances or mixtures (NAICS codes 325 and 324110, e.g., chemical manufacturing and processing and petroleum refineries).This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR parts 700, 720, 721, 723, and 725 for TSCA section 5-related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.II. BackgroundA. What Action is the Agency Taking?EPA is issuing these amendments pursuant to TSCA section 5, 15 U.S.C. 2604. The amendments are to the TSCA Section 5 Premanufacture and Significant New Use Notification regulations and related provisions. This final rule was proposed in theFederal Registerissue of December 22, 2008 (Ref. 1). The purpose of the amendments is to require use of an electronic reporting mechanism for TSCA section 5 notices.
The Government Paperwork Elimination Act (GPEA) (Public Law 105-277 (44 U.S.C. 3504)) requires Federal agencies to provide for the:
2. Use and acceptance of electronic signatures, when practicable. EPA’s Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), published in theFederal Registerissue of October 13, 2005 (Ref. 2) provides that any requirement in title 40 of the CFR to submit a report directly to EPA can be satisfied with an electronic submission that meets certain conditions once the Agency publishes a notice that electronic document submission is available for that requirement (See Unit III.F. for more information on electronic signatures.).
In light of GPEA and CROMERR, EPA is issuing these amendments to require manufacturers (including importers) and processors of TSCA chemical substances to use the Internet, through EPA’s CDX, to submit TSCA section 5 notices and related documents to the Agency. These include PMNs (40 CFR part 720), Significant New Use Notices (SNUNs) (40 CFR part 721), Test Market Exemption Applications (TMEAs) (40 CFR part 720), Low Volume Exemption notices (LVEs) (40 CFR 723.50), Low Exposure/Low Release Exemption (LoRex) notices (40 CFR 723.50), biotechnology notices for genetically modified microorganisms (40 CFR part 725), Notices of Commencement of Manufacture or Import (NOCs) (40 CFR 720.102), and other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data).
The Agency is introducing CDX reporting in three phases over a 2-year period. During the first year following the effective date of this final rule, the Agency will allow submissions via CDX, optical disc (CD or DVD), and paper. Regardless of the method of submission, EPA will require that all submissions be generated using the new electronic-PMN (e-PMN) software. One year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs), though optical discs may continue to be used. Two years after the effective date of this final rule, optical discs will no longer be accepted, and all submitters must submit the notices and support documents identified in Table 1 of Unit III.I. via CDX. The phased approach allows submitters to gain experience in using the e-PMN software and the submission delivery system.
EPA is also amending the TSCA section 5 User Fee regulations at 40 CFR 700.45 to add a new User Fee Payment Identity Number field to the PMN form. This new field will enable the Agency to more easily match a particular user fee with its notice submission. The second new information element on the amended PMN form will be optional and consist simply of the e-mail address for the Authorized Official (AO) submitting the notice listed on the “Submitter Identification” section on page 3 of the PMN form. EPA is also removing the required Agent signature block field on page 2 of the form.B. What is the Agency’s Authority for Taking this Action?Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 90 days before manufacturing a new chemical substance for commercial purposes (under TSCA manufacture includes import). Section 3(9) of TSCA defines a “new chemical substance” as any substance that is not on the TSCA Inventory of Chemical Substances compiled by EPA under section 8(b) of TSCA. Section 5(a)(2) of TSCA authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA at least 90 days before manufacturing or processing the chemical substance for that use. GPEA requires Federal agencies to provide for the:
2. Use and acceptance of electronic signatures, when practicable.C. How are Premanufacture Notices and Other TSCA Section 5 Notices Currently Submitted and Processed by the Agency?Currently, TSCA section 5 submissions must be sent to EPA on paper through the U.S. mail or delivered by courier. Submitters are able to use electronic means to generate hard copies for certain TSCA section 5 notices, using the PMN form available on EPA's TSCA New Chemicals Program website (https://cdx.epa.gov/ssl/pmn/download.asp). The form can be filled out using the free Adobe Reader, whichallows submitters to complete the form electronically and then print out and mail it to EPA as hard copy. The Adobe Reader allows the user to complete and print the form, but it does not allow the user to save the form. Approximately 35% of TSCA section 5 notices are currently generated using this software. Most of the remaining submissions are generated using other software that has been developed by industry trade groups or individual notice submitters. A very small percentage of submitters choose to fill out the PMN form by hand or typewriter, using a version of the form downloaded from EPA's TSCA New Chemicals Program website (See http://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf and http://www.epa.gov/opptintr/newchems/pubs/pmnpart2.pdf.).
If the submitter marks anything on the PMN form as CBI, then the submitter must submit one version of the form containing the CBI and another version of the form without CBI. The latter version is referred to as the sanitized or non-CBI version and is required for the public docket.
Upon receipt at EPA, paper submissions are assigned a “mail received” number, which is used to identify the submission until an official document control number (DCN) is generated, which does not occur until EPA verifies that the notice is complete. Once the mail information is captured, the submission is sent for prescreening. During prescreening, the submission is checked for completeness using criteria listed at 40 CFR 720.65. If the notice does not pass prescreening, EPA declares the original notice “Incomplete” and notifies the submitter that information is missing or incorrect, and that the submitter must correct the package and provide a new submission to EPA. If a new notice is not submitted, EPA will return the user fee.
After a successful prescreening, EPA generates a DCN and barcode for the submission. EPA also generates a DCN and barcode for the non-CBI version of a CBI submission and places the non-CBI version in the public docket. The original CBI submission is then kept in a hard copy case file folder in a TSCA CBI storage area for reference. Any supporting documents for the CBI submission are also assigned DCNs and barcodes, and placed in the hard copy case file folder.III. Description of Changes for TSCA Section 5 ReportingThis unit provides a detailed description of EPA’s electronic reporting software, the changes to the reporting process, the benefits of electronic reporting to both industry and EPA, and how EPA is phasing-in the electronic reporting.A. What is CDX?EPA’s CDX is the point of entry on the Environmental Information Exchange Network (Exchange Network) for environmental data submissions to the Agency. CDX provides the capability for submitters to access their data through the use of web services. CDX enables EPA and participating program offices to work with stakeholders-including State, tribal, and local governments and regulated industries-to enable streamlined electronic submission of data via the Internet. For more information about CDX, go to http://www.epa.gov/cdx.B. What is the e-PMN Software?EPA has developed e-PMN software for use in preparing and submitting PMNs and other TSCA section 5 notices and support documents electronically to the Agency. EPA is providing two different variations of the e-PMN software, one with encryption and one without encryption. The e-PMN software with encryption, available on EPA’s CDX website (http://cdx.epa.gov/epa_home.asp), accommodates electronic submission through CDX. The e-PMN software without encryption is available through EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). Both variations of the e-PMN software are available free of charge as Internet downloads. The e-PMN software without encryption will also be available on optical discs provided by the Agency upon request (See Unit III.H. for more details.).
The e-PMN software works with Windows, Macs, Linux, and UNIX-based computers, using Extensible Markup Language (XML) specifications for more efficient data transmittal across the Internet. The e-PMN software operates using the Java 6 programming language, which can be downloaded free from http://www.java.com, if it is not already installed on your computer. The e-PMN software provides user-friendly navigation, works with CDX to secure on-line communication, and can create a completed Portable Document Format (PDF) file using the PMN form to accommodate internal company review prior to submission or for submission to EPA during the 2-year period before which CDX submission is required.
The e-PMN software includes features intended to be helpful for preparing PMNs and other notices using the PMN form, such as SNUNs. A validation mechanism alerts users when a field on the form, required by regulation, is either missing information or contains certain kinds of potentially incorrect information. For example, if “use” information is claimed CBI, then the e-PMN software indicates that the form is not complete unless the submitter has provided both specific use information on the CBI version of the form and generic use information on the non-CBI version of the form. The e-PMN software includes header pages for biotechnology notices (i.e., Microbial Commercial Activity Notices (MCANs), TSCA Experimental Release Applications (TERAs), TMEAs, and Tier I or Tier II Exemption Requests), support documents, and attachments—any document not submitted on the PMN form itself—that identify submitters and the nature of their communications.
Guidance documents developed by EPA for TSCA section 8(a) Inventory Update Rule (IUR) reporting via CDX are available at http://www.epa.gov/opptintr/iur/pubs/factsheet.pdf and http://www.epa.gov/opptintr/iur/pubs/cdx_qanda.pdf. These documents provide background information on reporting via CDX that is relevant and useful for TSCA section 5 reporting as well. EPA has developed similar specific guidance for TSCA section 5 reporting via CDX, along with the e-PMN submission software, available on EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). C. What Are the Benefits of CDX Reporting and Use of the e-PMN Software, Compared to the Existing Paper Method?The change to phase-out paper-based submissions in favor of CDX reporting, including use of the e-PMN reporting software, is in concert with broader government efforts to move to modern, electronic methods of information gathering. The use of CDX for submission of TSCA section 5 notices and support documents is consistent with GPEA, that requires Federal agencies to provide for the:
2. Use and acceptance of electronic signatures, when practicable.
The e-PMN software and electronic submission via CDX will change the way that companies interact with the Agency regarding many TSCA section 5 submissions. Companies will register with EPA to submit their data electronically to the Agency via CDX and the Agency will benefit fromreceiving electronic submissions. Data systems that once were populated manually will now be populated electronically, reducing the potential for error that exists when data are entered by hand.
Agency personnel will also be able to communicate more efficiently with submitters electronically, compared to using U.S. mail or courier services. PMN electronic reporting software allows for more efficient data transmittal, and the software’s validation mechanism should help industry users submit fewer incomplete notices, which ultimately will save EPA and industry processing resources and reduce transaction times. EPA believes the adoption of electronic communications will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit, and transmit data to the Agency (See Unit V. for more detail.). It also will allow submitters to share a draft notice within the company during the creation of a notice and to save a copy of the final file for future use. A “Profiler,” available in the software, will also allow for certain information to be kept on file by the submitter to avoid re-entering the same information into a new form.
Please note that although submitters will be able to communicate to EPA via CDX after the effective date of this final rule, the capacity will not initially be available for EPA to communicate back to submitters via CDX at the time this final rule becomes effective (except for e-mails related to CDX registration and copy of record notifications). Two examples of routine communications from EPA that are planned to be sent via CDX rather than the U.S. mail are the “Acknowledgement Letter” (acknowledging receipt of a notice) and the “Incomplete Letter” (stating why a notice has been declared incomplete by EPA). EPA will continue sending these letters by paper until approximately 1 year after the effective date of this final rule. EPA will issue a document in theFederal Registerwhen EPA has the ability to send these letters electronically.
All information sent by the submitter via CDX will be transmitted securely to protect CBI. Furthermore, if anything in the submission has been claimed CBI, a non-CBI copy of the notice must be provided by the submitter. The new e-PMN software will facilitate the creation of this non-CBI version, eliminating the need for the submitter to do this manually.D. What Are the Changes to the Existing PMN Form?EPA is amending the PMN form in order to collect two new information elements. First, 40 CFR part 700 requires submitters to pay a fee when they submit PMNs, MCANs, certain PMN exemption application notices, and SNUNs to the Agency. The amended PMN form will include a new User Fee Payment Identity Number field to enable the Agency to match more easily a particular user fee with a particular notice submission. A User Fee Payment Identity Number will be required and may be a check number, a wire transfer number, or a “Pay.gov” transaction number used to transmit the user fee electronically. The second new information element on the amended PMN form will be optional and consist simply of the e-mail addresses for the AO or AOs listed on the Submitter Identification section on page 3 of the PMN form. The e-mail address will enable the Agency to contact the submitter through e-mail, facilitating communications related to the submission.
EPA is also removing the required Agent signature block field on page 2 of the PMN form. On the existing PMN form, if a manufacturer/importer subject to the notice requirements in 40 CFR part 720 designates an agent to submit the form pursuant to 40 CFR 720.40(e), both the manufacturer/importer and the agent must sign the form. EPA is removing the requirement that agents sign the PMN form because few agents have submitted forms in the past, and the Agent signature block is rarely used by the Agency. Eliminating the second signature also simplifies development of the e-PMN form. Note that a form submitted by an agent will still have to be signed by the manufacturer/importer’s AO (an electronic signature if submitted via CDX), and the agent’s name and contact information will still be provided on page 3 of the PMN form. The AO remains responsible for false or misleading statements in the notice.
The e-PMN software will allow users to print paper copies for internal company use. The printed version of the amended e-PMN form will have the same general look of the current paper PMN form, i.e., containing the same fields (with the modifications to the form discussed in Unit III.D.) and the same pagination. However, fields have been expanded to make more room for submitter information, resulting in a larger total number of pages, and realigned to make the form easier to scan. Persons who choose to submit PMNs on paper during the first year after the effective date of this final rule will be required to use the new e-PMN software to generate the paper form for each PMN or other TSCA section 5 notices they submit. EPA is requiring use of the new paper form because the Agency has incorporated into the form many scanning efficiencies for the electronic capturing of data that will be lost if a blank PMN form is printed, photocopied, and used for another submission.E. How Will PMNs be Submitted via the Internet Using CDX?In order to submit TSCA section 5 notices via the Internet, submitters will have to register with EPA’s CDX and use the e-PMN software to prepare a data file for submission through CDX.
1. Registering with CDX. To register with CDX, the submitter can click on the website, http://cdx.epa.gov/epa_home.asp. The submitter will be asked to agree to terms and conditions, provide information about the submitter and his or her organization, select a user name and password, and download, complete, and mail an electronic signature agreement to EPA (discussed further in Unit III.F.). The electronic signature agreement is needed to identify an authorized person and establish a method to electronically sign the submission. Once EPA receives the electronic signature agreement, the submitter’s user name and password will be activated, and only then will the submitter be able to send a submission to EPA through CDX. For planning purposes, please allow up to 1 week for EPA to process the electronic signature agreement and activate the submitter’s user name and password.
EPA has established a 90-day time-frame between the publication date and effective date of this final rule. Companies can use this time to register with CDX so they are prepared to submit notices to EPA via CDX on the effective date of this final rule.
2. Preparing the submission. All submitters must use the new e-PMN software to prepare their submissions of TSCA section 5 notices. EPA is providing two different variations of the e-PMN software, one with encryption and one without encryption. The e-PMN software with encryption, available on EPA’s CDX website (http://cdx.epa.gov/epa_home.asp), accommodates electronic submission through CDX. The e-PMN software without encryption is available through EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). Both variations of the e-PMN software are available free of charge as Internet downloads. The e-PMN softwarewithout encryption will also be available on optical discs provided by the Agency upon request (See Unit III.H. for more detail.).
The e-PMN software guides users through the process of creating a PMN submission on their computers. Once a user completes the relevant data entry, the software will validate the submission by performing basic error checks and making sure all the required fields are completed, allow the user to create and save the submission for company records, and prompt users to choose a submission method.
3. Completing the submission to EPA. During the 2-year phase-in period when paper and/or optical disc submission will still be allowed, the software will, as appropriate, also allow the user to choose “Print,” “Save as a PDF,” “Save as an XML file” for a submission on an optical disc, or “Transmission through CDX.” While permitted, submissions made in paper or using an optical disc will need to be mailed or delivered to EPA in the same manner that they are currently. When “Transmission through CDX” is selected, the user will be asked to provide the user name and password that were created during the CDX registration process. The software will then encrypt the file and submit it via CDX to EPA.F. What is the Electronic Signature Agreement for the e-PMN?In order to submit electronically to EPA via CDX, submitters of all TSCA section 5 documents must first register with CDX. One must register either as:
1. An AO of a company who can send all types of TSCA section 5 documents to EPA via CDX or
2. Someone authorized by the AO to send TSCA section 5 supporting documents to EPA via CDX. Note, however, that AOs are the only persons allowed to send TSCA section 5 notices and Letters of Support to EPA via CDX.
There are two ways that joint submissions can be submitted to EPA via CDX. The first way is for each joint submitter to fill out his or her portion of the submission in separate notice forms. These forms are linked to each other within EPA via a common identifying number—a “TS” number (See regulatory text language in 40 CFR 700.45(e)(3).)—which both companies are required to develop together and put on their respective forms. The second way is for one of the joint submitters to provide supporting information in a Letter of Support. Both will require the AOs of the joint submitting companies to register in order to submit to EPA via CDX.
To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) downloads two forms: The Electronic Signature Agreement and the “Verification of Company Authorizing Official” form. Registration enables CDX to perform two important functions: Authentication of identity and verification of authorization. Within the “Electronic Signature Agreement” form, the AO agrees to certain CDX security conditions. On the “Verification of Company Authorizing Official” form, the AO designates himself or herself as the AO and attests to the completeness and accuracy of the submitted information.
There is a third form generated by CDX that the AO needs to fill out if the AO wants to authorize other persons to submit support documents on his or her behalf, including a paid employee of the company, an outside consultant for the company, or an authorized representative agent for the company. This form is entitled, “Authorization and Verification for Section 5 Notice Support Submitter by Company Authorizing Official.” On this form, the AO designates various persons to submit support documents on his or her behalf, and attests to the completeness and accuracy of the submitted information. Persons designated by the AO to submit on his or her behalf must also sign this form along with the Electronic Signature Agreement form, in order to be “linked” to the AO by EPA; and therefore, be able to submit support documents via CDX on the AO’s behalf.
When these forms described in Unit III.F. are received, EPA activates the submitter’s registration in CDX and sends him or her an e-mail notification. Submitters will need to complete and sign these forms only once.G. Will CBI be Protected When Submitting via CDX?Yes. EPA will ensure secure transmission of PMN data sent from the user’s desktop through the Internet via the Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 is a widely used approach for securing Internet transactions, and is endorsed by the National Institute of Standards and Technology (NIST) for protecting data sent over the Internet. See NIST Special Publication 800-52, “Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations,”http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf.
In addition, e-PMN software supports EPA’s CROMERR requirements, as described under 40 CFR part 3, by enabling the submitter to electronically sign, encrypt, and submit submissions which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA. The current version of the e-PMN encrypts using Federal Information Processing Standards (FIPS)-validated RSA BSAFE Crypto-J. EPA may incorporate other encryption modules into future versions of e-PMN. Information submitted via CDX is processed within EPA by secure systems certified for compliance with FIPS.H. Will EPA Make a Version of the Software Without Encryption Available for Users Who Want to Obtain the Software Without Registering via CDX?Yes. EPA is providing two different variations of the e-PMN software, one with encryption and one without encryption. The e-PMN software with encryption, available on EPA’s CDX website (http://cdx.epa.gov/epa_home.asp), accommodates electronic submission through CDX. This software contains an application program interface that allows the submitter to interact with CDX to encrypt the submission using FIPS-validated RSA BSAFE Crypto-J. The encryption software is subject to restrictions under the Export Administration Act of 1979, Public Law 96-72, 93 Stat. 503, as amended. Making this e-PMN software with encryption available only through EPA’s CDX website will enable EPA to restrict and monitor the issuance of this “Encryption Software” according to export control requirements by requiring CDX registration before the controlled software can be downloaded.
The e-PMN software without encryption, available through EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems), does not contain FIPS-validated RSA BSAFE Crypto-J or the application programming interface to enable the submitter to interact with CDX to encrypt the submission.
The e-PMN software, both with and without encryption, produce identical e-PMN files; however, only by registering through CDX can the e-PMN software with encryption (containing the application program interface to encrypt submissions) be downloaded and used for sending files to EPA via CDX. Users of the e-PMN software without encryption do not have to register with CDX. The e-PMN software without encryption can be used to create a paper PMN form for submission during the first year after the effective date of this final rule, or to create a PMN file thatcan be saved to an optical disc and submitted to EPA during the first 2 years after the effective date of this final rule. The software without encryption also allows users to create an e-PMN file that can be uploaded to the e-PMN software with encryption, to send to EPA via CDX.
The variations of the e-PMN software, both with and without encryption, are accessible through EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). There is a link on EPA's TSCA New Chemicals Program website to EPA’s CDX website (http://cdx.epa.gov/epa_home.asp), where users can download the e-PMN software with encryption after they register with CDX and EPA approves their registration. Units III.E. and III.F. describe how to register with CDX and the information that is necessary to provide to EPA for approval consideration. It will take EPA approximately 1 week to process and approve CDX registrations. The e-PMN software without encryption can be downloaded directly from EPA's TSCA New Chemicals Program website without CDX registration or EPA approval.
If and when EPA makes changes to the e-PMN software, an automatic download of the updated software will be triggered when a submitter opens their existing variation of the software (i.e., the with and without encryption variations). Submitters will then be required to validate their submissions with this new version before submitting to EPA. e-PMN software installed from optical discs will not automatically be updated with new versions of the software. However, EPA will keep a list of all submitters that request optical discs. If major revisions to the software are made during the first two years after the effective date of the final rule, EPA will notify these submitters of the availability of the updated software.I. Must I Use the e-PMN Software for Any Paper or Optical Disc Submissions During the 2-Year Phase-In Period?Yes. On the effective date of this final rule, submitters must use the e-PMN software to generate TSCA section 5 notices, NOCs, and support documents regardless of whether they are submitted via CDX, on optical disc, or in paper form (40 CFR part 720.3 defines “support documents” as materials and information submitted to EPA in support of a TSCA section 5 notice, including but not limited to, correspondence, amendments, and test data. The term “support documents” does not include orders under TSCA section 5(e) (either consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B))). EPA will not accept paper submissions that use either the old version of the paper PMN form or the amended form filled in by hand or typewriter. The Agency will make available free Internet downloads or, upon request, optical discs that contain the version of e-PMN software lacking encryption. All e-PMN software users, regardless of how a document is submitted, must undergo a “finalization” step in generating a document. During the finalization step, the e-PMN software checks that all required fields contain information and provides warnings for certain kinds of missing, incomplete, or incorrect data. Notices submitted on paper or optical disc containing data which have not undergone finalization will be declared “Incomplete” by EPA. This step is necessary to allow for an accurate and efficient transfer of data from an optical disc or a paper form to the EPA data systems, and also enables the generation of a non-CBI version.
Anyone submitting the paper form generated using the e-PMN software must submit the notice to the Agency via U.S. mail or a courier service. The paper form must be hand signed on page 2. If the submitter makes any CBI claims, the original submission needs to include both the CBI version and a non-CBI version.
Optical discs must be submitted with an original hand-signed hard copy of page 2 (Certification page) and a hard copy of page 3 (a copy of page 3 is needed for contact information in the event that the optical disc is not readable). Optical discs must be delivered only by courier service, to avoid damage to the disk from the Agency’s mail screening equipment.J. How Will Electronic Submission of TSCA Section 5 Notices that Currently Have No Required or Official Forms be Handled by CDX or the e-PMN Software?Certain TSCA section 5 notices such as LVE modifications, LoREX modifications, TMEAs, and biotechnology notices currently have no required or official forms. In order to allow for electronic and paper submission of these notices using the e-PMN software and CDX, the Agency is requiring the following:
1. For exemption modifications, submitters must use the e-PMN form by checking the “modification” box on page 1, filling in contact information on page 3, and including the previous exemption number and chemical identity information. A submitter may send a cover letter with the new revisions to the original exemption notice or the pertinent pages of the e-PMN form.
2. For a TMEA, the submitter will check the “TMEA” box on page 1 of the e-PMN form, and either fill out the form or attach a cover letter for the submission containing the information required by 40 CFR 720.38.
3. Biotechnology notices (Form 6300-07) will have their own menu option. Instead of selecting “Premanufacture Notice,” a submitter will select “Biotechnology,” which will prompt the software to present a header page to the submitter with choices of biotechnology notices, and space to fill in contact information. The information required by 40 CFR part 725 must be submitted as an attachment(s).
The notices listed in Unit III.I.1.-3. must undergo the “finalization” step (See Unit III.H.). An exemption submission on an optical disc must be accompanied by a complete signed hard copy of page 2 and a complete hard copy of page 3 of the e-PMN form for contact information in case the optical disc is not readable. The TMEA will only need a complete page 3. The optical discs for both types of submissions will need to be delivered by courier to the Agency to avoid damage to the optical disc from the Agency's mail screening equipment. If submitted by paper, the forms must be generated using the e-PMN software and sent to the Agency. For biotechnology notices, a signed hard copy of a biotechnology certification must accompany the optical disc. The printed form must follow the same procedures: Use the e-PMN software to generate a finalized “header” sheet with contact data, add an attachment with notice information, and include a signature page.
The submission process for completing the various notice and document types is summarized in Table 1 of this unit. After the effective date of this final rule, all of these notices must be prepared using the new e-PMN software.
Table 1.—Process for Preparing TSCA Section 5 Notices and Support Documents
TSCA Section 5 DocumentProcess
PMNs and SNUNsForm 7710-25 generated and finalized by e-PMN software.
LVEForm 7710-25 generated and finalized by e-PMN software.
LoREXForm 7710-25 generated and finalized by e-PMN software.
TMEAe-PMN software to generate finalized submission either using Form 7710-25 or cover letter and attached information.
NOCe-PMN software to generate finalized submission using Form 7710-56.
Biotechnology noticese-PMN software to generate finalized “header” sheet with contact data, add attachment with notice information, include signature page using Form 6300-07.
Modifications to previous noticesForm 7710-25 generated and finalized by e-PMN software. Fill in pages 1, 2, and 3 of the Form, plus either applicable pages of Form, cover letter, or attachment.
Support documentse-PMN software to generate finalized “header” sheet identifying reason for submission and contact data.
K. How Will Submission Requirements and Delivery Methods to EPA Vary for Submissions via Paper, Optical Disc, or CDX?Depending upon how a notice is submitted, the following submission requirements and delivery methods must be used:
1. Paper. Printed, signed, and “header” sheets for attachments; delivered by U.S. mail or courier. Allowed for the first year.
2. Optical discs. Data must be saved as XML files rather than as PDF files. Optical discs submitted with an original signed hard copy of page 2 (Certification page) and a hard copy of page 3. Delivered by courier only. Allowed for the first 2 years only.
3. CDX. Document developed on-line; simply hit “send button” to deliver to EPA via CDX.L. Over What Time-Frame Will the Internet-Based CDX Reporting Requirement be Phased-In?The Agency is introducing electronic reporting in three phases. In the first phase, the Agency is allowing the submission of TSCA section 5 notices and support documents via CDX, on optical disc, and on paper. All submissions (whether submitted via CDX, on optical disc, or on paper) must be generated using the new e-PMN software.
In the second phase, occurring 1 year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs). In the third phase, at the end of the second year after the effective date of this final rule, optical disc submissions for all new notices and support documents will no longer be accepted. Thereafter, EPA will accept TSCA section 5 notices and support documents only through CDX. TSCA section 5 notices and support documents not submitted in the appropriate manner as set forth in 40 CFR parts 720, 721, and 725 will be considered invalid by EPA and returned to the submitter.
Note that NOCs and support documents whose original notices were submitted before the effective date of this final rule will still need to be mailed as hard copy to the Agency. This is necessary because, although the notices received after implementation of the new system will be entered into the newly created EPA database, notices submitted before the effective date of this final rule will only exist in EPA’s “legacy” database, i.e., the database used prior to the effective date of this final rule, and so a subsequent support document will not be able to be linked up with its parent notice within EPA’s new database. The phase-in schedule for submissions is displayed in Table 2 of this unit.
Table 2.—e-PMN Phase-In Schedule for TSCA Section 5 Notices and Support Documents 1 SubmissionMethodBefore Effective Date of Final RuleFirst Year After Effective Date of Final RuleSecond Year After Effective Date of Final RuleThird Year After Effective Date of the Final Rule, and Thereafter
PaperExisting PMN formScanner-friendly paper form, generated and finalized using e-PMN softwareInvalidInvalid
Optical discNot applicableElectronic submissiongenerated and finalized using e-PMN software with hard copies of pages 2 and 3Electronic submissiongenerated and finalized using e-PMN software with hard copies of pages 2 and 3Invalid
CDX/InternetNot applicableAvailable and optionalAvailable and optionalMandatory
M. Will EPA Offer Any Exceptions to the e-PMN Requirements?No. After careful consideration, the Agency has concluded that the overall benefits from everyone using the e-PMN software and submission through CDX exceed those associated with maintaining a multi-optioned reporting approach (Ref. 3). The Agency recognizes that there is the potential for costs and burden associated with predictable or unanticipated technical difficulties in electronic filing or with conversion to an electronic CDX reporting format. However, EPA expects that reduced reporting costs to submitters will ultimately exceed the transition costs and that any transition difficulties will be mitigated by:
1. The phase-in periods.
2. EPA’s planned outreach and training sessions prior to the effective date of this final rule. The Agency has allowed ample time between the date of publication and the effective date of this final rule for submitters to install and become proficient with the e-PMN software.
3. EPA’s technical support following the effective date of this final rule.N. Will All Types of TSCA Section 5 Notices and Communications be Submitted via e-PMN Software?At this time, the Agency does not have electronic reporting capability for all TSCA section 5-related notices (i.e., Bona Fide Intent to Manufacture (bona fide) notices and polymer exemption annual reports); support documents (i.e., TSCA section 5(e) consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)); and certain communications (e.g., pre-notice communications and TSCA Inventory Correspondence), due to the variability and infrequent nature of these types of submissions. EPA may consider offering electronic reporting of these and other submissions in the future.IV. Response to CommentsThe Agency received comments from three persons on the proposed rule. Copies of all comments received are available in the public docket for this action. The comments received on the proposed rule did not result in EPA making significant changes to the final rule. A discussion of the comments germane to the rulemaking and the Agency’s responses follow:
1. Comment—i. Response to Two Questions Listed in Unit V. of the Proposed Rule. Unit V. of the proposed rule identified two issues on which the Agency was specifically requesting public comment. These issues were: Whether the proposed 2-year phase-in period following the effective date of the final rule, during which time paper and/or optical disc submissions would be accepted, is reasonable or necessary to allow sufficient time to transition to the new Internet-based method.
Did industry have information that could further inform EPA’s estimate regarding burden. For example, EPA asked whether submitters intended on submitting notices via CDX as soon as it becomes available, or if not, when during the 2-year phase-in period would they expect to begin using CDX?The public comments overwhelmingly supported the 2-year phase-in period following the effective date of the final rule. Commenters agreed that the 2-year phase-in period is reasonable and necessary to allow sufficient time for transition to the new electronic reporting method.
Although, EPA did not receive any comments directly related to its burden estimate, EPA did receive positive feedback on the proposed electronic submittal system. Commenters strongly supported the Agency’s effort to move to electronic methods of information gathering. Commenters agreed with the Agency’s statements that this change will allow for more effective and efficient reviews of TSCA section 5 notices and that the changes will improve communication with submitters. One commenter appreciated aspects of the e-PMN software such as the ability of the e-PMN software to check for completeness of a PMN submission and create non-CBI versions of notices. Another commenter was pleased to see the addition of the new User Fee Payment Identity Number field to track payments.
ii. Response. EPA retained the 2-year phase-in period for electronic submissions which is supported by the comments received. EPA did not receive any comments directly related to its burden estimate and therefore did not revise the estimate.
2. Comment—i. Dedicated technical assistance. EPA received comments regarding the importance of providing robust technical assistance both during and after the 2-year transition period. Commenters requested that Agency resources be available for quickly resolving any software problems. One commenter asked that the technical assistance contacts be knowledgeable about both the system software as well as the PMN TSCA section 5 process.
ii. Response. EPA will provide dedicated technical assistance to help submitters. For help with CDX registration, submitters can contact the CDX Help Desk. Submitters will be able to call the TSCA Hotline for help with basic questions on the TSCA section 5 process. For answers to more complex questions, the TSCA Hotline will be equipped to refer callers to EPA technical staff experienced with the e-PMN software and TSCA section 5. Contact information for the TSCA Hotline, CDX Help Desk, and relevant EPA staff are available through EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). EPA will not, however, have a designated hotline staffed with experts who can provide both system software assistance on CDX and the e-PMN and respond to detailed TSCA section 5 process questions.
3. Comment—i. Non-routine information and the e-PMN form. One commenter asked how EPA would handle non-routine information that the submitter may need to report on the electronic form, but for which there is no standardized field. The commenter asked that EPA provide consistent and informed guidance for handling these situations for which a workaround may be needed.
ii. Response. A submitter who is unable to enter the necessary information on the e-PMN form can contact the TSCA Hotline and/or EPA technical experts for assistance. EPA will work with submitters on how to express non-routine information on the e-PMN form on a case-by-case basis. The “Helpful Hints: Q and A for Use of the e-TSCA/e-PMN Submission Software,” accessible via EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems), addresses workaround issues that EPA has encountered to date. EPA will update the Q and A on a regular basis with new issues and solutions to those issues as they arise.
4. Comment—i. Who will be able to use the electronic submission process? One commenter requested that EPA clarify whether the e-PMN form will be available only to the manufacturer or importer, or whether consultants will be able to prepare and submit PMNs and other TSCA section 5 submissions on behalf of clients as well.
ii. Response. Consultants will not be able to submit PMN notices or Letters of Support. Only the AO for the client, registered with CDX, can submit PMN notices and/or Letters of Support. However, a consultant will be able to submit all other support documents on behalf of the client as long as the consultant is: Registered in CDX.
Authorized by the AO in CDX to submit documents onthe client’s behalf.EPA will be using a two-tiered approach for registration and submission of PMNs. The first tier is the company AO, who, for the purposes of EPA’s CROMERR and this final rule, is the person who certifies and signs the notice. The second tier will be comprised of persons designated and authorized by the company’s AO to submit supporting documents.
The AO has the ability to submit all documents on the company’s behalf via CDX. During CDX registration, all AOs will be required to fill out two forms: The “Electronic Signature Agreement” form in which the AO agrees to certain CDX security conditions and the “Verification of Company Authorizing Official” form in which the AO designates himself or herself as the AO and attests to the completeness and accuracy of the submitted information.
There is a third form generated by CDX that the AO needs to fill out if the AO wants to authorize other persons to submit support documents on his or her behalf. This form is entitled, “Authorization and Verification for Section 5 Notice Support Submitter by Company Authorizing Official.” On this form, the AO designates various persons to submit support documents on his or her behalf, and attests to the completeness and accuracy of the submitted information. Persons designated by the AO to submit on his or her behalf must also sign this form in order to be “linked” to the AO by EPA; and therefore, be able to submit support documents via CDX on the AO’s behalf. Note, that a client, or company, can have multiple AO’s.
The approach described in Unit IV.4. was discussed in the preamble of the proposed rule. To clarify the different responsibilities of the AO and persons designated to submit support documents on the AO’s behalf, EPA has added regulatory text at 40 CFR 720.40(e)(3)(i) and (ii).
5. Comment—i. Downloading e-PMN software. One commenter had a question about downloading the e-PMN software. The commenter was concerned that only individuals within a company could download the software from the EPA site onto their individual computers, as opposed to a single download onto a company network. The commenter expressed the opinion that the system should allow for shared software on a computer network.
ii. Response. The e-PMN software is designed to be used either as a stand-alone program on an individual’s computer or as a shared system on a company’s LAN. Many users may access the program at the same time. Upon request, EPA will also provide the software to a company on optical disc.
6. Comment—i. Barrier for small and foreign businesses. One commenter suggested that for smaller companies, especially those outside the United States where English is not the primary language, the requirements to register on EPA’s CDX and to use the electronic reporting software could be overly burdensome. They recommended that EPA develop an on-line training module to help address this potential problem.
ii. Response. EPA has options to aid small and foreign businesses. These companies can utilize the 2-year phase period to familiarize themselves with sending documents via CDX, during which time they may still submit information on paper or optical disc for the first year, and on optical disc for the second year. These companies will also be able to call the TSCA Hotline, CDX Help Desk, and EPA technical staff for help with basic questions. Note, that 40 CFR 720.22(a)(3) states that, “Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a notice.” Foreign entities not meeting the requirement of 40 CFR 720.22(a)(3), however, may submit Letters of Support (See also response to comment 7. in this unit.).
7. Comment—i. Capability for collaborative efforts with third parties. Many companies, particularly smaller businesses, use third parties, such as consultants or law firms, in the preparation of TSCA section 5 notices. As such, one commenter suggested that the e-PMN process should be capable of allowing collaborative efforts with these parties and should be as “user-friendly” as possible. The commenter was concerned that the process could increase burden for smaller companies by requiring the company to cut and paste input from the third party into the company’s final electronic submission.
ii. Response. EPA believes the new e-PMN form is as “user-friendly” for collaborating with third parties as the current form. To work with a third party, the notice preparer will create the draft e-PMN file. This file is essentially a folder, i.e., one unit made up of many documents. The preparer may send the file (which includes the attachments as a part of the file structure) to the third party electronically, via e-mail, or they can save the file onto an optical disc for mailing. This is similar to the current way of doing business using the electronic Adobe PMN. There is, however, no process in place to use CDX to exchange files between e-PMN users, i.e., the preparer and a third party. CDX is only for exchange of information between a submitter and EPA.
8. Comment—i. Linkage with computer models. One commenter recommended that the program have the ability to link the output of the Sustainable Future’s computer modeling and other EPA modeling directly into the e-PMN form.
ii. Response. The xml schema for the e-PMN is available for anyone to use to create a program to download data from other models or databases into the e-PMN form. Upon installation of the e-PMN software a program folder called “eTSCA” is created. Within the eTSCA program folder is another folder called “user.” The schema is available in the eTSCA/user folder, entitled “eTSCA_v1.0.xsd.”
9. Comment—i. Unique circumstances that may not easily fit within electronic reporting requirements. One commenter noted that there are unique circumstances that may not easily fit within electronic reporting requirements. An example given by the commenter was in regards to submitters that work with companies who file Letters of Support for a PMN, where the information provided by the supporting company is not revealed to the PMN submitter. Under current business practices, the company providing the Letter of Support discloses the trade secret information that is necessary to complete the PMN directly to the Agency. The commenter expressed concern that if those companies have difficulty with the requirement to register for CDX, and need to gain expertise with the software only to submit what may be a few data points, it could impede or block the PMN completion process.
ii. Response. EPA will remain attentive to these unique circumstances and work to develop workable processes. EPA will consider providing additional outreach tailored to answer the questions and meet of the needs of unique submitter groups. For assistance with CDX, submitters can call the CDX Help Desk. For e-PMN or TSCA section 5 process questions, submitters can call either the TSCA Hotline or the appropriate EPA technical experts.V. Estimated Economic ImpactThe Agency’s evaluation of the economic impact of this final rule is present in a document entitled “Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule” (Ref. 3), a copy of which is available in the docket and is briefly summarized in this unit. EPA estimatesthat the electronic submission of TSCA section 5 notices and support documents will reduce the burden and cost currently associated with the paper-based reporting of TSCA section 5 notices and support documents. The burden estimation of 95 to 114 hours to complete the currently existing paper PMN form includes the time spent reading and becoming familiar with the form, gathering the required information and preparing the report, producing non-CBI responses for items claimed as CBI, and maintaining a file of the submission (Ref. 4).
In its economic analysis for the final rule (Ref. 3), EPA estimated cost and burden savings at the industry level, at the individual company level, and on a per-form basis. Estimates presented in this unit are for all TSCA section 5 notices; estimates for PMNs separately can be found in the economic analysis.
At the industry level for all TSCA section 5 notices, EPA estimates a net total burden decrease of 14,972 hours in the first year of the final rule, 15,700 hours in the second year of the final rule, and 16,178 hours in the third year of the final rule. Industry savings are estimated at 16,187 hours per year for subsequent years of the final rule. At the company level for all TSCA section 5 notices, EPA estimates an average net total burden decrease of 50.4 hours in the first year of the final rule, 51.2 hours in the second and third years of the final rule, and 50.4 hours per year for subsequent years of the final rule.
At the industry level for all TSCA section 5 notices, EPA estimates a net cost savings of $379,271 in the first year of the final rule, $424,863 in the second year of the final rule, and $457,066 in the third year of the final rule. Industry savings are estimated at $457,628 per year for subsequent years of the final rule. When taking into account the lower total number of TSCA section 5 notices expected during this 3-year Information Collection Request (ICR) period in addition to savings attributable to the final rule, the average annual reduction in industry costs is $5.7 million. At the company level for all TSCA section 5 notices, EPA estimates an average cost savings of $1,352 in the first year of the final rule, $1,396 in the second and third years of the final rule, and $1,352 in subsequent years of the final rule.
EPA estimates that the Agency also will experience a reduction in both burden and cost to administer the TSCA section 5 premanufacture notification program as a result of the final rule. Specifically, EPA expects to experience a net burden reduction of 4,521 hours in the first year of the final rule, a reduction of 9,042 hours in the second year of the final rule, and a reduction of 13,563 hours in the third and subsequent years of the final rule. The Agency expects to experience a net savings of $214,377 in the first year of the final rule, a net savings of $586,108 in the second year of the final rule, and a net savings of $1,057,838 in the third and subsequent years of the final rule.
EPA recognizes that information and feedback received during the 2-year phase-in period, along with experience gained during this phase-in period, can be used to further improve the use of the new Internet-based reporting mechanism. This information will also inform the Agency’s estimates, which will be reflected in the ICR, which EPA must complete every 3 years under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.VI. ReferencesThe following is a listing of the documents referenced in this preamble that have been placed in the public docket for this final rule under docket ID number EPA-HQ-OPPT-2008-0296, which is available for inspection as specified underADDRESSES.
1. EPA. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations; Proposed Rule.Federal Register(73 FR 78261, December 22, 2008) (FRL-8395-8). Available on-line at: http://www.gpoacess.gov/fr/index.html.
2. EPA. Cross-Media Electronic Reporting; Final Rule.Federal Register(70 FR 59847, October 13, 2005) (FRL-7977-1). Available on-line at: http://www.gpoacess.gov/fr/index.html.
3. EPA. Economic and Policy Analysis Branch, Office of Pollution Prevention and Toxics (OPPT). Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule. July 13, 2009.
4. EPA. Regulatory Impacts Branch, OPPT. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. September 9, 1994.
5. EPA. Supporting Statement for a Request for OMB Review Under The Paperwork Reduction Act. Information Collection Request (ICR): New Information Collection Activities Related to Electronic Submission of Certain TSCA Section 5 Notices EPA ICR No. 2327.02. OMB Control No. 2070-0173.VII. Statutory and Executive Order ReviewsA. Executive Order 12866This action is not a “significant regulatory action” under the terms of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.B. Paperwork Reduction ActThe information collection requirements contained in this final rule have been submitted for OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. The ICR document prepared by EPA, identified under EPA ICR No. 2327.02 and OMB control number 2070-0173, is available in the docket for the final rule (Ref. 5). The information collection requirements described in the final rule are not enforceable until OMB approves them.
This rule-related ICR covers amendments to existing reporting and recordkeeping programs that are approved under OMB control numbers 2070-0012 and 2070-0038. The final rule amends these existing information collections in two ways. First, respondents will be required to use the e-PMN software to generate TSCA section 5 notices and support documents. After a 2-year phase-in period following the effective date of this final rule, respondents will be required use the e-PMN software to submit this information to EPA electronically via the Agency’s CDX. Second, respondents will be required to provide a new data element, a User Fee Payment Identity Number, when preparing and submitting TSCA section 5 notices and support documents.
The information collection activities contained in this final rule are designed to assist the Agency in meeting its responsibility under TSCA to receive, process, and review TSCA section 5 notices and support documents in a timely manner and further the proper performance of the functions of the Agency. Information collection for review of PMNs and all other TSCA section 5 notices and support documents is authorized by TSCA section 5 and confidentiality of submitted information is protected under TSCA section 14.
Responses to the collection of information are mandatory. Respondents will be required to use the e-PMN software to generate, complete, and, ultimately, submit the form. The methods for submitting the completed form to EPA will change over a 2-year period following the effective date ofthis final rule to allow for the new required submission through CDX to be fully implemented. In the third year after the effective date of this final rule, all TSCA section 5 notices and support documents must be submitted to EPA electronically via CDX using the e-PMN software.
The ICR document for this final rule provides a detailed presentation of the estimated burden and costs for 3 years of the program. The aggregate burden varies by year during the first 3 years of the final rule because of the phase-in schedule of the requirements. The rule-related burden and cost to chemical manufacturers, importers, and processors who would submit notices to the Agency for review is summarized here. The projected total burden to industry is 363 hours per year for the first 3 years of the final rule. This includes an estimated average burden per response of 0.9 hours for CDX registration, 1.8 hours for requesting a CDX electronic signature, 0.1 hours for establishing an account for electronic fee payments, and 0.8 hours for final rule familiarization. Burden is defined at 5 CFR 1320.3(b).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9. After approval of this rule-related ICR by OMB, the Agency will amend the existing ICRs (OMB control numbers 2070-0012 and 2070-0038) to reflect the new information collection activities and resulting changes in burden. Upon OMB’s approval of the amendments to the existing, approved ICRs, EPA will discontinue the ICR approved under OMB control number 2070-0173.C. Regulatory Flexibility ActPursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant adverse economic impact on a substantial number of small entities, due to the burden-reducing nature of this action which will benefit all submitters regardless of the size of the entity.
Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this action on small entities, small entity is defined as:
In determining whether a rule has a significant adverse economic impact on a substantial number of small entities, among other reasons, an agency may certify that a rule will not have a significant adverse economic impact on a substantial number of small entities if the rule relieves regulatory burden or otherwise has a positive economic effect on all of the small entities subject to the rule. This final rule is expected to reduce the existing regulatory burden. The factual basis for the Agency’s certification under the RFA is presented in the small entity impact analysis prepared as part of the Economic Analysis for this final rule (Ref. 3), and is briefly summarized in Unit IV.D. Unfunded Mandates Reform ActBased on EPA’s experience with past PMNs and SNUNs, State, local, and tribal governments have not been affected by these reporting requirements, and EPA does not have any reason to believe that any State, local, or tribal government will be affected by this final rule. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).E. Executive Order 13132Under Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this final rule does not have “federalism implications” because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Executive Order. This final rule will establish electronic notification requirements that apply to manufacturers (including importers) and processors of certain chemical substances. This final rule will not apply directly to States and localities and will not affect State and local governments. Thus, Executive Order 13132 does not apply to this final rule.F. Executive Order 13175Under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this final rule does not have tribal implications because it will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in the Executive Order. EPA has no information to indicate that any tribal government manufactures or imports the chemical substances covered by this action. Thus, Executive Order 13175 does not apply to this final rule.G. Executive Order 13045This final rule will not require special consideration pursuant to the terms of Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it is not likely to have an annual effect on the economy of $100 million or more, nor does it establish an environmental standard, or otherwise have a disproportionate effect on children.H. Executive Order 13211This final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this final rule does not have any significant adverse effect on the supply, distribution, or use of energy.I. National Technology Transfer and Advancement ActSection 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, etc.) that are developed or adopted by voluntary consensus standards bodies. This final rule will not impose any technical standards that will require EPA to consider any voluntary consensus standards.J. Executive Order 12898This final rule will not have an adverse impact on the environmentaland health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency does not need to consider environmental justice-related issues.VIII. Congressional Review ActThe Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Parts 700 720 721 723 and 725Environmental protection, Chemicals, Electronic reporting, Hazardous substances, Reporting and recordkeeping requirements.
Part 700 Amended
Authority:15 U.S.C 2625 and 2665, 44 U.S.C. 3504.
2. Section 700.45 is amended by revising paragraphs (e)(1) through (e)(3); (e)(4)(i), (ii), and (iv); and (e)(5)(i), (ii), and (iv) to read as follows:
§ 700.45 Fee payments.
(1) Each remittance under this section shall be in United States currency and shall be paid by money order, bank draft, wire transfer, Pay.gov service provided through the Department of the Treasury, or check drawn to the order of the Environmental Protection Agency.
(2) Each paper remittance shall be sent to the Environmental Protection Agency, Washington Finance Center, Toxic Substances Control Act User Fees, P.O. Box 979073, St. Louis, MO 63197-9000.
(3) Persons who submit a TSCA section 5 notice shall place an identifying number and a payment identity number on the front page of each TSCA section 5 notice submitted. The identifying number must include the letters “TS” followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a check number, a wire transfer number, or a “Pay.gov” transaction number used to transmit the user fee. The same TS number and the submitter’s name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one TSCA section 5 notice, the person shall include the name of the submitter and a new TS number for each TSCA section 5 notice to which the remittance applies, and the amount of the remittance that applies to each notice. Any remittance not having the identifying name and numbers described in this paragraph will be returned to the remitter.
(4)(i) Each person who remits the fee identified in paragraph (b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall insert a check mark for the statement, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” under “CERTIFICATION” on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
(ii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption application under TSCA section 5(h)(2) shall insert a check mark for the statement, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the exemption application.
(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall insert a check mark for the statement, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the certification required in § 725.25(b) of this chapter.
(5)(i) Each person who remits a fee identified in paragraph (b)(2) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall insert a check mark for the statement, “The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b).” under “CERTIFICATION” on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
(ii) Each person who remits a fee identified in paragraph (b)(2) of this section for an exemption application under TSCA section 5(h)(2) shall insert a check mark for the statement, “The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45(b).” in the exemption application.
(iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN for a microorganism shall insert a check mark for the statement, “The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).” in the certification required in § 725.25(b) of this chapter.Part 720 AmendedRegulatory Text
3. The authority citation for part 720 continues to read as follows:
Authority:15 U.S.C 2604, 2607, and 2613.
4. Section 720.3 is amended by adding paragraphs (ii), (jj), (kk), and (ll) to to read as follows:
§ 720.3 Definitions.
(ii) Central Data Exchange or CDX means EPA’s centralized electronic document receiving system, or its successors.
(kk) Optical disc means compact disc (CD) or digital video disc (DVD).
(ll) Support documents means materials and information submitted to EPA in support of a TSCA section 5 notice, including but not limited to, correspondence, amendments, and test data. The term “support documents” does not include orders under TSCA section 5(e) (either consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).
5. Section 720.40 is amended by revising paragraphs (a)(2), (c), (d)(2), and (e) to read as follows:
(i) Paper-based submissions. Notices, and any support documents related to these notices, may be submitted on paper on or before April 6, 2011. All paper-based notices must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print EPA Form 7710-25 for submission to EPA. Paper notices, and any support documents related to such notices, must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(A) Support documents for notices that are submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Submissions on optical disc—(A) Notices may be submitted as electronic files on optical disc on or before April 6, 2012. All notices submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B) Persons submitting on optical disc must also complete and submit on paper the Certification and Submitter Identification sections of EPA Form 7710-25.
(iii) Submissions via CDX. Notices and any related support documents may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices must be generated and completed on EPA Form 7710-25 using e-PMN reporting software. To obtain a version of e-PMN software that contains an encryption module you must register with CDX. A version without encryption may be downloaded without registering with CDX.
(iv) You can obtain the e-PMN software as follows:
(C) E-mail. HelpDesk@epacdx.net.
(c) Where to submit a notice or support documents. For submitting notices or support documents via CDX, use the e-PMN software. Paper notices or support documents must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. Optical discs containing electronic notices or support documents must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. Persons submitting on optical disc must also complete and submit on paper the Certification and Submitter Identification sections of EPA Form 7710-25.
(2) If information is claimed as confidential pursuant to § 720.80, a person who submits a notice to EPA in the manner set forth in § 720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a sanitized copy.
(e) Agency or joint submissions—(1) A manufacturer or importer may designate an agent to assist in submitting the notice. If so, only the manufacturer or importer, and not the agent, signs the certification on the form.
(3) Only the Authorized Official (AO) of a company can submit all TSCA section 5 documents.
(i) The AO can authorize other persons to submit only support documents on their behalf.
(ii) To authorize a support registrant to submit support documents, both the AO and support registrant must sign the “Authorization and Verification for Section 5 Notice Support Submitter by Company Authorizing Official” available from the CDX website at http://cdx.epa.gov/epa_home.asp.
6. Section 720.65 is amended by revising the section heading and paragraphs (a) and (c)(1)(iv) and adding paragraph (c)(x) to read as follows:
7. Section 720.75 is amended by revising paragraphs (b)(2) and (e)(1) and adding paragraphs (b)(3) and (b)(4) to read as follows:
(2) A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, to the submitter’s EPA contact for that notice, subject to paragraph (b)(3) of this section.
(i) Older notices. Requests for suspension for premanufacture notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Newer notices. For notices submitted on or after April 6, 2010, EPA will accept requests for suspension only if submitted in accordance with this paragraph:
(A) Requests for suspension may be submitted on paper on or before April 6, 2011. All paper-based requests for suspension must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B) Requests for suspension may be submitted as electronic files on optical disc on or before April 6, 2012. All requests for suspension submitted as electronic files on optical disc generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(C) Requests for suspension may be submitted electronically to EPA via CDX. Such requests must be generated and completed using e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
(3) An oral request for suspension may be granted by EPA for a maximum of 15 days only. Requests for a longer suspension must only be submitted in the manner set forth in this paragraph.
(4) If the submitter has not made a previous oral request, the running of the notice review period is suspended as of the date of receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA.
(1) A submitter may withdraw a notice during the notice review period by submitting a statement of withdrawal in a manner set forth in this paragraph. The withdrawal is effective upon receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA.
(i) Older notices. Statements of withdrawal for premanufacture notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Newer notices. For notices submitted on or after April 6, 2010, EPA will accept statements of withdrawal only if submitted in accordance with this paragraph:
(A) Statements of withdrawal may be submitted on paper on or before April 6, 2011. All paper-based statements of withdrawal must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the statement of withdrawal for submission to EPA. Paper statements of withdrawal must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B) Statements of withdrawal may be submitted as electronic files on optical disc on or before April 6, 2012. All statements of withdrawal submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic statements of withdrawal must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(C) Statements of withdrawal may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such statements of withdrawal must be generated and completed using e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
8. Section 720.80 is amended by revising paragraph (b)(2)(i) to read as follows:
§ 720.80 General provisions.
(i) The notice and attachments must be complete. The submitter must designate that information which is claimed as confidential in the manner prescribed on the notice form, via EPA’s e-PMN software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
9. Section 720.102 is amended by revising paragraphs (c)(1) introductory text and (d) to read as follows:
(1) The notice must be submitted on EPA Form 7710-56, which is available as part of EPA’s e-PMN software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software. The form must be signed and dated by an Authorized Official (AO). All information specified on the form must be provided. The notice must contain the following information:
(d) Where to submit. All notices of commencement must be submitted to EPA on EPA Form 7710-56. Notices may only be submitted in a manner set forth in this paragraph.
(1) Older notices. Notices of commencement for premanufacture notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Newer notices. For premanufacture notices submitted on or after April 6, 2010, EPA will accept notices of commencement only if submitted in accordance with this paragraph:
(i) Notices of commencement may be submitted on paper on or before April 6, 2011. All paper-based notices of commencement must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the notice of commencement for submission to EPA. Paper notices of commencement must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Notices of commencement may be submitted as electronic files on optical disc on or before April 6, 2012. All notices of commencement submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices of commencement must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(iii) Notices of commencement may be submitted electronically to EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices of commencement must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices of commencement must be generated and completed using e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software.Part 721 AmendedRegulatory Text
11. Section 721.25 is amended by revising paragraph (c) to read as follows:
§ 721.25 Notice requirements and procedures.
(c) EPA will process the notice in accordance with the procedures of part 720 of this chapter, except to the extent they are inconsistent with this part.
12. Section 721.30 is amended by revising paragraph (b) introductory text to read as follows:
(b) Persons submitting a request for a determination of equivalency to EPA under this part, unless allowed by 40 CFR 720.40(a)(2)(i), (ii), or (iii), must submit the request to EPA via EPA’s Central Data Exchange (CDX) using EPA-provided e-PMN software in the manner set forth in 40 CFR 720.40(a)(2). See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software. Support documents related to these requests must be submitted in the manner set forth in 40 CFR 720.40(a)(2)(i), (ii), or (iii). If submitted by paper, requests must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: SNUR Equivalency Determination or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. Optical discs containing electronic requests must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. A request for a determination of equivalency must contain:Part 723 AmendedRegulatory Text
13. The authority citation for part 723 continues to read as follows:
14. Section 723.50 is amended by revising paragraph (e)(1) to read as follows:
(1) A manufacturer applying for an exemption under either paragraph (c)(1) or (c)(2) of this section must submit an exemption notice to the EPA at least 30 days before manufacture of the new chemical substance begins. Unless allowed as described by § 723.50(e)(1)(i), (e)(1)(ii), or (e)(1)(iii), exemption notices and modifications must be submitted to EPA on EPA Form No. 7710-25 via EPA’s Central Data Exchange (CDX) using EPA-provided e-PMN reporting software in the manner set forth in this paragraph. Support documents related to these notices must also be submitted to EPA via CDX using e-PMN software in the manner set forth in this paragraph. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
(i) Paper-based submissions—(A) Such notices, and any support documents related to these notices, submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B) All other notices and related support documents may be submitted on paper on or before April 6, 2011. All paper-based notices must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print EPA Form 7710-25 for submission to EPA. Paper notices must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency,OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Submissions on optical disc—(A) Notices may be submitted as electronic files on optical disc on or before April 6, 2012. Notices submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(B) Persons submitting on optical disc must still complete and submit on paper the Certification and Submitter Identification sections of EPA Form 7710-25 accompanying the optical disc.
(iii) Submissions via CDX—(A) On or after April 6, 2010, notices, and any related support documents, may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, notices must be generated and completed on EPA Form 7710-25 using e-PMN reporting software.
(B) On or after April 6, 2012, all notices must be generated and completed on EPA Form 7710-25 using e-PMN reporting software and submitted electronically, along with any support documents related to these notices, to EPA via CDX.
(iv) Support documents for notices that are submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.Part 725 AmendedRegulatory Text
15. The authority citation for part 725 continues to read as follows:
Authority:15 U.S.C 2604, 2607, 2613, and 2625.
16. Section 725.25 is amended by revising paragraphs (c), (e)(1), and (e)(2) to read as follows:
(c) Where to submit information under this part. MCANs and exemption requests, and any support documents related to these submissions, may only be submitted in a manner set forth in this paragraph.
(1) Paper-based submissions. MCANs and exemption requests, and any support documents related to these submissions, may be submitted on paper on or before April 6, 2011. All paper-based submissions must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the biotechnology notice submission to be sent to EPA. Paper notices must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Submissions on optical disc—(i) MCANs and exemption requests may be submitted as electronic files on optical disc on or before April 6, 2012. MCANs and exemption requests submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic notices must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Persons submitting on optical disc must still prepare, sign, and submit on paper, the Certification statement in 40 CFR 725.25(b) along with submitter identification and contact information.
(iii) Support documents for MCANs or exemption requests that are submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(3) Submissions via CDX. MCANs and exemption requests, and any related support documents, may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, notices must be generated and completed on EPA Form 6300-07 using e-PMN reporting software.
(1) A manufacturer or importer may designate an agent to assist in submitting the MCAN. If so, only the manufacturer or importer, and not the agent, signs the certification on the form.
17. Section 725.29 is amended by revising paragraph (a) to read as follows:
18. Section 725.33 is amended by adding paragraphs (a)(10) and (a)(11) to read as follows:
(10) The submitter does not include an identifying number and a payment identity number as required by § 700.45(e)(3) of this chapter.
(11) The submitter does not submit the notice in the manner set forth in § 725.25(c).
19. Section 725.36 is amended by revising paragraph (a) to read as follows:
(a) During the review period, if a submitter possesses, controls, or knows of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the MCAN or exemption request, the submitter must send that information within 10 days of receiving the new information, but no later than 5 days before the end of the review period. The new information must be sent in the same manner the original notice or exemption was sent, as described in § 725.25(c)(1), (c)(2), and (c)(3).
20. Section 725.54 is amended by revising paragraph (b) and adding paragraphs (c) and (d) to read as follows:
(b) A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, to the submitter’s EPA contact for that notice, subject to paragraph (c) of this section.
(1) Older notices. Requests for suspension for notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Newer notices. For notices submitted on or after April 6, 2010, EPA will accept requests for suspension only if submitted in accordance with this paragraph:
(i) Requests for suspension may be submitted on paper on or before April 6, 2011. All paper-based requests for suspension must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Requests for suspension may be submitted as electronic files on optical disc on or before April 6, 2012. All requests for suspension submitted as electronic files on optical disc generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the request for suspension for submission to EPA. Paper requests for suspension must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(iii) Requests for suspension may be submitted electronically to EPA via CDX. Such requests must be generated and completed using e-PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
(d) If the submitter has not made a previous oral request, the running of the notice review period is suspended as of the date of receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA.
21. Section 725.60 is amended by revising paragraph (a) to read as follows:
(a) A submitter may withdraw a notice during the notice review period by submitting a statement of withdrawal in a manner set forth in this paragraph. The withdrawal is effective upon receipt of the written paper request, electronic request on optical disc, or CDX submission by EPA.
(1) Older notices. Statements of withdrawal for notices submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Newer notices. For notices submitted on or after April 6, 2010, EPA will accept statements of withdrawal only if submitted in accordance with this paragraph:
(i) Statements of withdrawal may be submitted on paper on or before April 6, 2011. All paper-based statements of withdrawal must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the statement of withdrawal for submission to EPA. Paper statements of withdrawal must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(ii) Statements of withdrawal be submitted as electronic files on optical disc on or before April 6, 2012. All statements of withdrawal submitted as electronic files on optical disc must be generated using e-PMN reporting software and be completed through the finalization step of the software. Optical discs containing electronic statements of withdrawal must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(iii) Statements of withdrawal may be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such statements of withdrawal must be generated and completed using e-PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
22. Section 725.67 is amended by revising paragraph (a)(1) to read as follows:
(1) Any manufacturer or importer of a new microorganism may request, under TSCA section 5(h)(4), an exemption, in whole or in part, from this part bysending a Letter of Application in the manner set forth in § 725.25(c).
23. Section 725.190 is amended by revising paragraph (d) to read as follows:
(d) Where to submit. All notices of commencement must be submitted to EPA in a manner set forth in this paragraph.
(1) Older notices. Notices of commencement for a MCAN submitted before April 6, 2010 must be submitted on paper either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(2) Newer notices. For MCANs submitted on or after April 6, 2010, EPA will accept notices of commencement only if submitted in accordance with this paragraph:
(i) Notices of commencement may be submitted on paper on or before April 6, 2011. All paper-based notices of commencement must be generated using e-PMN reporting software and be completed through the finalization step of the software, and e-PMN software must be used to print the statement of withdrawal for submission to EPA. Paper notices of commencement must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
(iii) Notices of commencement may be submitted electronically to EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices of commencement must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, such notices of commencement must be generated and completed using e-PMN reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
24. Section 725.975 is amended by revising paragraph (b) introductory text to read as follows:
(b) Persons submitting a request for a determination of equivalency to EPA under this part, unless allowed by § 725.25(c) (1), (2), or (3), must submit the request to EPA via EPA’s Central Data Exchange (CDX) using EPA-provided e-PMN software in the manner set forth in § 725.25(c). See 40 CFR 720.40(a)(2)(iv) for information on how to obtain e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software. If submitted on paper, requests must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: SNUR Equivalency Determination or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. Optical discs containing electronic requests must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency Determination. A request for a determination of equivalency must contain:
25. Section 725.984 is amended by revising paragraph (b)(1) to read as follows:
(1) Any affected person may request modification or revocation of significant new use notification requirements for a microorganism that has been added to subpart M of this part using the procedures described in § 725.980 by writing to the Director, or a designee, and stating the basis for such request. The request must be accompanied by information sufficient to support the request. Persons submitting a request to EPA under this part, unless allowed by § 725.25(c)(1), (c)(2), or (c)(3), must submit the request to EPA via EPA’s Central Data Exchange (CDX) using EPA-provided e-PMN reporting software in the manner set forth in § 725.25(c). See 40 CFR 720.40(a)(2)(iv) for information on how to obtain the e-PMN software. Support documents related to these requests must also be submitted to EPA via CDX using e-PMN software. Paper requests must be submitted either via U.S. mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: Request to Amend SNUR or submitted via courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR. Optical discs containing electronic requests must be submitted by courier to the Environmental Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR.[FR Doc. E9-31004 Filed 1-5-10; 8:45 am]BILLING CODE 6560-50-S
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed ID: EPA-HQ-OPPT-2008-0296-0008 Tracking Number: View original printed format: Document Information Date Posted: Jan 6, 2010RIN: Not AssignedCFR: 40 CFR 700, 720, 721, 723 and 725Federal Register Number: E9-31004 Show More Details Submitter Information Comments0 Comments Received* Docket Information This document is contained in EPA-HQ-OPPT-2008-0296 Related Dockets: NoneRelated RINs: NoneRelated Documents: Requests for Modification or Revocation of Toxic Substances...TSCA Section 5 Premanufacture and Significant New Use... Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!