TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations, 773-790 [E9-31004]

Download as PDF Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes, or otherwise have any unique impacts on local governments. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Although this action does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population. cprice-sewell on DSK2BSOYB1PROD with RULES The 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 to 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 this rule in the Federal 14:05 Jan 05, 2010 Jkt 220001 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 7, 2009. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: ■ PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In §180.960, the table is amended by adding alphabetically the following polymers to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * Polymer * * * CAS No. * Acrylic acid-benzyl methacrylate-1propanesulfonic acid, 2-methyl-2[(1-oxo-2-propenyl)amino]-, monosodium salt, minimum number average molecular weight (in amu), 1500. * * * * * 1152297-42-1 * * [FR Doc. E9–31174 Filed 1–5–10; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 700, 720, 721, 723, and 725 XI. Congressional Review Act VerDate Nov<24>2008 Register. This rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). [EPA–HQ–OPPT–2008–0296; FRL–8794–5] RIN 2070–AJ41 TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 773 SUMMARY: EPA 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. DATES: This final rule is effective April 6, 2010. ADDRESSES: EPA 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 https://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 https://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. E:\FR\FM\06JAR1.SGM 06JAR1 774 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 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 INFORMATION: I. 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 under FOR FURTHER INFORMATION CONTACT. II. Background cprice-sewell on DSK2BSOYB1PROD with RULES A. 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 the Federal Register issue of December 22, 2008 (Ref. 1). The purpose of the amendments is to require use of an electronic VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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: 1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper. 2. Use and acceptance of electronic signatures, when practicable. EPA’s Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), published in the Federal Register issue 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 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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: 1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper. 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, which E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations allows 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 https://www.epa.gov/opptintr/ newchems/pubs/pmnpart1.pdf and https://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 nonCBI 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 Reporting This unit provides a detailed description of EPA’s electronic reporting software, the changes to the reporting process, the benefits of VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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 https:// 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 (https://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 (https:// 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 UNIXbased 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 https://www.java.com, if it is not already installed on your computer. The e-PMN software provides userfriendly 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 775 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 ePMN 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 https://www.epa.gov/ opptintr/iur/pubs/factsheet.pdf and https://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 ePMN submission software, available on EPA’s TSCA New Chemicals Program website (https://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: 1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper. 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 from E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES 776 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations receiving 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 the Federal Register when 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 ePMN software will facilitate the creation of this non-CBI version, eliminating the need for the submitter to do this manually. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 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, https://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 timeframe 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 (https://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 (https:// www.epa.gov/oppt/newchems). Both variations of the e-PMN software are available free of charge as Internet downloads. The e-PMN software E:\FR\FM\06JAR1.SGM 06JAR1 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations without 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. cprice-sewell on DSK2BSOYB1PROD with RULES 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. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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,’’ https://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 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 777 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 (https://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 FIPSvalidated 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 (https://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 ePMN 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 that E:\FR\FM\06JAR1.SGM 06JAR1 778 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations can 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 (https:// www.epa.gov/oppt/newchems). There is a link on EPA’s TSCA New Chemicals Program website to EPA’s CDX website (https://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. cprice-sewell on DSK2BSOYB1PROD with RULES 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, VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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 nonCBI 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- PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 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 ePMN 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. E:\FR\FM\06JAR1.SGM 06JAR1 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 779 TABLE 1.—PROCESS FOR PREPARING TSCA SECTION 5 NOTICES AND SUPPORT DOCUMENTS TSCA Section 5 Document Process PMNs and SNUNs Form 7710–25 generated and finalized by e-PMN software. LVE Form 7710–25 generated and finalized by e-PMN software. LoREX TMEA Form 7710–25 generated and finalized by e-PMN software. e-PMN software to generate finalized submission either using Form 7710–25 or cover letter and attached information. NOC e-PMN software to generate finalized submission using Form 7710–56. Biotechnology notices e-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 notices Form 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 documents e-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 DOCUMENTS1 First Year After Effective Date of Final Rule Existing PMN form Scanner-friendly paper form, generated and finalized using e-PMN software Invalid Invalid Optical disc Not applicable Electronic submission generated and finalized using e-PMN software with hard copies of pages 2 and 3 Electronic submission generated and finalized using e-PMN software with hard copies of pages 2 and 3 Invalid CDX/Internet Not applicable Available and optional Available and optional Mandatory 1 NOCs Second Year After Effective Date of Final Rule Third Year After Effective Date of the Final Rule, and Thereafter Before Effective Date of Final Rule Paper cprice-sewell on DSK2BSOYB1PROD with RULES Submission Method and support documents for notices originally submitted on paper before the effective date of this final rule must still be mailed as hard copy. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\06JAR1.SGM 06JAR1 780 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 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. cprice-sewell on DSK2BSOYB1PROD with RULES IV. Response to Comments The 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: VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 • 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 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 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 ePMN 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 (https://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 (https:// 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 on the client’s behalf. E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 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 standalone 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 VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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 ePMN 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 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 781 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 ePMN form. Upon installation of the ePMN 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 Impact The 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 estimates E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES 782 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations that the electronic submission of TSCA section 5 notices and support documents will reduce the burden and cost currently associated with the paperbased 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 VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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. References The 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 under ADDRESSES. 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: https:// www.gpoacess.gov/fr/. 2. EPA. Cross-Media Electronic Reporting; Final Rule. Federal Register (70 FR 59847, October 13, 2005) (FRL– 7977–1). Available on-line at: https:// www.gpoacess.gov/fr/. 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. PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 VII. Statutory and Executive Order Reviews A. Executive Order 12866 This 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 Act The 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 of E:\FR\FM\06JAR1.SGM 06JAR1 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 2. A small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000. 3. A small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. 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. C. Regulatory Flexibility Act cprice-sewell on DSK2BSOYB1PROD with RULES this 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 rulerelated 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. Under 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. Pursuant 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: 1. A small business as defined by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 D. Unfunded Mandates Reform Act Based 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 13132 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 783 F. Executive Order 13175 Under 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 13045 This 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 13211 This 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 Act Section 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 12898 This final rule will not have an adverse impact on the environmental E:\FR\FM\06JAR1.SGM 06JAR1 784 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations and 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 Act The 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 the Federal 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 725 Environmental protection, Chemicals, Electronic reporting, Hazardous substances, Reporting and recordkeeping requirements. Dated: December 22, 2009. Stephen A. Owens, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR chapter I is amended as follows: ■ PART 700—[AMENDED] 1. The authority citation for part 700 is revised to read as follows: ■ 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. cprice-sewell on DSK2BSOYB1PROD with RULES * * * * * (e) * * * (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. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 (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 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 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—[AMENDED] 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. (jj) e-PMN software means electronicPMN software created by EPA for use in preparing and submitting Premanufacture Notices (PMNs) and other TSCA section 5 notices and support documents electronically to the Agency. (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: § 720.40 General. (a) * * * E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations (2) All notices must be submitted on EPA Form 7710–25. Notices, and any support documents related to these notices, may only be submitted in a manner set forth in this paragraph. (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. (B) [Reserved] (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 VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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: (A) Website. Go to EPA’s TSCA New Chemicals Program website at https:// www.epa.gov/oppt/newchems and follow the appropriate links. (B) Telephone. Call the EPA CDX Help Desk at 1–888–890–1995. (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. (d) * * * (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. (2) A manufacturer or importer may authorize another person, (e.g., a supplier or a toll manufacturer) to report some of the information required in the notice to EPA on its behalf. The manufacturer or importer should indicate in a cover letter accompanying the notice which information will be supplied by another person and must identify that other person as a joint submitter where indicated on their notice form. The other person supplying PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 785 information (i.e., the joint submitter) may submit the information to EPA using either the notice form or a Letter of Support, except that if the joint submitter is not incorporated, licensed, or doing business in the United States, the joint submitter must submit the information to EPA in a Letter of Support only, not in a notice form. The joint submitter must indicate in the notice or Letter of Support the identity of the manufacturer or importer. Any person who submits a notice form or Letter of Support for a joint submission must sign and certify the notice form or Letter of Support. (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 https://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: § 720.65 Acknowledgement of receipt of a notice; errors in the notice; incomplete submissions; and false and misleading statements. (a) Notification to the submitter. EPA will acknowledge receipt of each notice by sending a letter via CDX or U.S. mail to the submitter that identifies the premanufacture notice number assigned to the new chemical substance and date on which the review period begins. The review period will begin on the date the notice is received by the Office of Pollution Prevention and Toxics Document Control Officer. The acknowledgment does not constitute a finding by EPA that the notice, as submitted, is in compliance with this part. * * * * * (c) * * * (1) * * * (iv) The submitter does not submit the notice in the manner set forth in § 720.40(a)(2). * * * * * (x) The submitter does not include an identifying number and a payment identity number as required by 40 CFR 700.45(e)(3). * * * * * E:\FR\FM\06JAR1.SGM 06JAR1 786 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 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: ■ § 720.75 Notice review period. cprice-sewell on DSK2BSOYB1PROD with RULES * * * * * (b) * * * (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 ePMN 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) VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 (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. * * * * * (e) * * * (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 ePMN 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) PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 (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. * * * * * (b) * * * (2) * * * (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: § 720.102 Notice of commencement of manufacture or import. * * * * * (c) * * * (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: * * * * * E:\FR\FM\06JAR1.SGM 06JAR1 cprice-sewell on DSK2BSOYB1PROD with RULES Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations (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 VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 e-PMN reporting software. See § 720.40(a)(2)(iv) for information on how to obtain e-PMN software. 787 PART 723—[AMENDED] 13. The authority citation for part 723 continues to read as follows: ■ PART 721—[AMENDED] Authority: 15 U.S.C. 2604. 10. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). 14. Section 723.50 is amended by revising paragraph (e)(1) to read as follows: ■ 11. Section 721.25 is amended by revising paragraph (c) to read as follows: § 721.25 Notice requirements and procedures. § 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures. * ■ * * * * * (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: ■ § 721.30 EPA approval of alternative control measures. * * * * * (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: * * * * * PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 * * * * (e) * * * (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 ePMN 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, E:\FR\FM\06JAR1.SGM 06JAR1 788 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 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—[AMENDED] 15. The authority citation for part 725 continues to read as follows: ■ cprice-sewell on DSK2BSOYB1PROD with RULES 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: ■ § 725.25 General administrative requirements. * * * * * (c) Where to submit information under this part. MCANs and exemption VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 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 ePMN 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 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 EPA Form 6300-07 using e-PMN reporting software. * * * * * (e) * * * (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. (2) A manufacturer or importer may authorize another person, (e.g., a supplier or a toll manufacturer) to report some of the information required in the MCAN to EPA on its behalf. The manufacturer or importer should indicate in a cover letter accompanying the MCAN which information will be supplied by another person and identify that other person as a joint submitter where indicated in their MCAN. The other person supplying information (i.e., the joint submitter) may submit the information to EPA either in the MCAN or a Letter of Support, except that if the joint submitter is not incorporated, licensed, or doing business in the United States, the joint submitter must submit the information to EPA in a Letter of Support only, rather than the MCAN. The joint submitter must indicate in the MCAN or Letter of Support the identity of the manufacturer or importer. Any person who submits the MCAN or Letter of Support for a joint submission must sign and certify the MCAN or Letter of Support. * * * * * 17. Section 725.29 is amended by revising paragraph (a) to read as follows: ■ § 725.29 EPA acknowledgement of receipt of submission. (a) EPA will acknowledge receipt of each submission by sending a letter via CDX or U.S. mail to the submitter that identifies the number assigned to each MCAN or exemption request and the date on which the review period begins. The review period will begin on the date the MCAN or exemption request is received by the Office of Pollution Prevention and Toxics Document Control Officer. * * * * * 18. Section 725.33 is amended by adding paragraphs (a)(10) and (a)(11) to read as follows: ■ § 725.33 Incomplete submissions. (a) * * * (10) The submitter does not include an identifying number and a payment identity number as required by § 700.45(e)(3) of this chapter. E:\FR\FM\06JAR1.SGM 06JAR1 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations (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: § 725.36 New information. (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: § 725.54 Suspension of the review period. cprice-sewell on DSK2BSOYB1PROD with RULES * * * * * (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 ePMN 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) VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 (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. (c) An oral request for suspension may be granted by EPA for a maximum of 15 days only. Requests for longer suspension must only be submitted in the manner set forth in this paragraph. (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: § 725.60 Withdrawal of submission by the submitter. (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 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 789 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 ePMN 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: § 725.67 Applications to exempt new microorganisms from this part. (a) * * * (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 by E:\FR\FM\06JAR1.SGM 06JAR1 790 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations sending 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: § 725.190 Notice of commencement of manufacture or import. cprice-sewell on DSK2BSOYB1PROD with RULES * * * * * (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. (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. VerDate Nov<24>2008 14:05 Jan 05, 2010 Jkt 220001 (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: § 725.975 EPA approval of alternative control measures. * * * * * (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 EPAprovided 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: § 725.984 Modification or revocation of certain notification requirements. * * * * * (b) * * * (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 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 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 GENERAL SERVICES ADMINISTRATION 41 CFR Part 301–10 [FTR Amendment 2010–01; FTR Case 2010– 301; Docket Number 2009–0020, Sequence 1] RIN 3090–AJ01 Federal Travel Regulation; Privately Owned Vehicle Mileage Reimbursement AGENCY: Office of Governmentwide Policy, General Services Administration (GSA). ACTION: Final rule. SUMMARY: GSA is amending the Federal Travel Regulation (FTR) to update the mileage reimbursement rates for using a privately owned automobile (POA), motorcycle or airplane for official travel. The new rates reflect the current vehicle operating costs as determined by E:\FR\FM\06JAR1.SGM 06JAR1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Rules and Regulations]
[Pages 773-790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31004]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 700, 720, 721, 723, and 725

[EPA-HQ-OPPT-2008-0296; FRL-8794-5]
RIN 2070-AJ41

TSCA Section 5 Premanufacture and Significant New Use
Notification Electronic Reporting; Revisions to Notification
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA 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.

DATES: This final rule is effective April 6, 2010.

ADDRESSES: EPA 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 https://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 https://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.

[[Page 774]]

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 INFORMATION:

I. 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 under FOR
FURTHER INFORMATION CONTACT.

II. Background

A. 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 the Federal Register issue
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:
1. Option of electronic maintenance, submission, or disclosure of
information, when practicable as a substitute for paper.
2. Use and acceptance of electronic signatures, when practicable.
EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR
part 3), published in the Federal Register issue 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:
1. Option of electronic maintenance, submission, or disclosure of
information, when practicable as a substitute for paper.
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, which

[[Page 775]]

allows 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 https://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf and https://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 Reporting

This 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 https://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
(https://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 (https://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 https://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 https://www.epa.gov/opptintr/iur/pubs/factsheet.pdf and https://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 (https://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:
1. Option of electronic maintenance, submission, or disclosure of
information, when practicable as a substitute for paper.
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
from

[[Page 776]]

receiving 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 the Federal Register when 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, https://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 (https://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 (https://www.epa.gov/oppt/newchems). Both
variations of the e-PMN software are available free of charge as
Internet downloads. The e-PMN software

[[Page 777]]

without 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,''
https://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 (https://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 (https://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 that

[[Page 778]]

can 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 (https://www.epa.gov/oppt/newchems). There is a link on EPA's
TSCA New Chemicals Program website to EPA's CDX website (https://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.

[[Page 779]]

Table 1.--Process for Preparing TSCA Section 5 Notices and Support
Documents
------------------------------------------------------------------------
TSCA Section 5 Document Process
------------------------------------------------------------------------
PMNs and SNUNs Form 7710-25 generated and
finalized by e-PMN software.
------------------------------------------------------------------------
LVE Form 7710-25 generated and
finalized by e-PMN software.
------------------------------------------------------------------------
LoREX Form 7710-25 generated and
finalized by e-PMN software.
TMEA e-PMN software to generate
finalized submission either using
Form 7710-25 or cover letter and
attached information.
------------------------------------------------------------------------
NOC e-PMN software to generate
finalized submission using Form
7710-56.
------------------------------------------------------------------------
Biotechnology notices e-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 notices Form 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 documents e-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\
----------------------------------------------------------------------------------------------------------------
Third Year After
Before Effective First Year After Second Year After Effective Date of
Submission Method Date of Final Rule Effective Date of Effective Date of the Final Rule,
Final Rule Final Rule and Thereafter
----------------------------------------------------------------------------------------------------------------
Paper Existing PMN form Scanner-friendly Invalid Invalid
paper form,
generated and
finalized using e-
PMN software
----------------------------------------------------------------------------------------------------------------
Optical disc Not applicable Electronic Electronic Invalid
submission submission
generated and generated and
finalized using e- finalized using e-
PMN software with PMN software with
hard copies of hard copies of
pages 2 and 3. pages 2 and 3.
----------------------------------------------------------------------------------------------------------------
CDX/Internet Not applicable Available and Available and Mandatory
optional optional
----------------------------------------------------------------------------------------------------------------
\1\ NOCs and support documents for notices originally submitted on paper before the effective date of this final
rule must still be mailed as hard copy.

[[Page 780]]

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 Comments

The 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 (https://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 (https://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 on the
client's behalf.

[[Page 781]]

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 Impact

The 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 estimates

[[Page 782]]

that 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

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