80 FR 42739 - TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 138 (July 20, 2015)
Federal Register Volume 80, Issue 138 (July 20, 2015)
| Page Range | 42739-42747 | |
| FR Document | 2015-17737 |
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)] [Rules and Regulations] [Pages 42739-42747] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17737] [[Page 42739]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 720, 721, 723, and 725 [EPA-HQ-OPPT-2013-0385; FRL-9927-79] RIN 2070-AJ98 TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting AGENCY: Environmental Protection Agency (EPA). ACTION: Direct Final Rule. ----------------------------------------------------------------------- SUMMARY: EPA is taking direct final action to amend the Toxic Substances Control Act (TSCA) section 5 electronic reporting regulations. These electronic reporting regulations establish standards and requirements for use of EPA's Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs), other TSCA section 5 notices, and support documents to the Agency. This rule provides the user community with new methods for accessing the e-PMN software, new procedures for completing the electronic-PMN (e-PMN) form, changes to the CDX registration process, adds the requirement to submit ``bona fide intents to manufacture'' electronically, and changes to the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. DATES: This direct final rule is effective January 19, 2016 without further notice, unless EPA receives adverse comment on or before August 19, 2015. If EPA receives adverse comments on this action, EPA will withdraw the rule before its effective date. EPA will then issue a proposed rule, providing a 30-day period for public comment. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0385, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Greg Schweer, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; MC 7405M; telephone number: (202) 564- 8469; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? You may be affected by this action if you manufacture (which includes import) or process chemicals for commercial purposes that are subject to TSCA. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide for readers regarding industries within which entities are likely to be affected by this action. Potentially affected entities may include, but are not limited to: Manufacturers and processors of chemical substances or mixtures (NAICS codes 325 and 32411). Full descriptions of these NAICS codes and related establishments are maintained by the U.S. Census Bureau online at https://www.census.gov/eos/www/naics/index.html. Other types of entities not listed in this unit could also be affected. 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. B. What is the agency's authority for taking this action? TSCA gives EPA broad authority to regulate the manufacture (including import) and processing of chemical substances. It is the expressed intent of Congress that EPA carry out TSCA in a reasonable and prudent manner, and in consideration of the impacts that any action taken under TSCA may have on the environment, the economy, and society (TSCA section 2). The underlying requirements promulgated under this broad authority and amended by this final rule require manufacturers (including importers) and processors of chemical substances and mixtures to: Notify EPA at least 90 days before manufacturing a new chemical substance for commercial purposes (TSCA section 5(a)(1)(A)). Notify EPA at least 90 days before manufacturing or processing the chemical substance for any use of a chemical substance that EPA has determined to be a ``significant new use'' (TSCA section 5(a)(1)(B)). Section 5(h)(4) of TSCA authorizes EPA, upon application and by rule, to exempt the manufacturer of any new chemical substance from part or all of the provisions of TSCA section 5. In addition, the Paperwork Reduction Act (PRA) requires Federal agencies to manage information resources to reduce information collection burdens on the public; increase program efficiency and effectiveness; and improve the integrity, quality, and utility of information to all users within and outside an agency, including capabilities for ensuring dissemination of public information, public access to Federal Government information, and protections for privacy and security (44 U.S.C. 3501 et seq.). Finally, the Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277 (44 U.S.C. 3504)) instructs Federal agencies to use and accept from the public, when practicable, electronic forms, electronic filings, and electronic signatures in the conduct of official business with the public. C. What action is the agency taking? This direct final rule amends the TSCA Section 5 Premanufacture and Significant New Use Notification regulations at 40 CFR parts 720, 721, 723 and 725, by mandating the use of an updated version of the e-PMN reporting software. In the Federal Register of January 2010 (75 FR 773) (FRL-8794-5), EPA issued a final rule requiring the use of the e-PMN reporting software for the submission of PMNs and other TSCA section 5 notices and support documents to the Agency using the Internet through CDX. This new version of the e-PMN software will operate as a ``cloud'' software system (``Thin Client Version'') rather than as a downloadable software system (``Thick [[Page 42740]] Client Version''). In addition, the direct final rule extends electronic reporting requirements to notices of ``bona fide intent to manufacture'' (bona fides); corrects certain regulatory cross- references in 40 CFR parts 720 and 721; standardizes the use of ``manufacture'' and similar language in 40 CFR parts 720, 721, and 725; and specifies electronic reporting procedures for the notification of new manufacturing sites pursuant to 40 CFR 723.50(j)(6)(ii). D. Why is the agency taking this action? The Agency is taking this action to further facilitate electronic reporting under TSCA and to streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. This change will eliminate certain firewall and file submission size limitations that exist with the current version of the software. This change will also enable submitters to work directly online within the Thin Client Version which provides a more efficient way of accessing the e-PMN software and transmitting data to EPA. In addition, the extension of the electronic reporting requirements ensures that submitters are able to use a single method of submission for related TSCA section 5 notifications. E. What are the impacts of this action? EPA believes that both the transition from the Thick Client Version to the Thin Client Version of the e-PMN software, as well as the changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, will streamline and reduce slightly the administrative costs and burdens associated with TSCA section 5 notifications for both industry and EPA; the only burden expected is the time it takes a submitter to familiarize themselves with the rule. EPA believes that submitters of bona fide intents to manufacture will experience burden and cost savings because the time required to enter, review, and edit their notices using the e-PMN software and transmit their submissions to EPA electronically will be less than that for the existing paper-based process. See also the discussion in Unit IV. II. Direct Final Rule Procedures A. Why is EPA using a direct final rule? EPA is publishing this rule without a prior proposed rule because the Agency views this as a noncontroversial action and anticipates no adverse comment. As addressed in Unit I.A., this action requires the use of a new version of the e-PMN software that is easier to access, features enhanced submission security, and eliminates size limitations on the submitted files. The action also corrects certain outdated regulatory cross-references, and standardizes terminology across certain regulatory provisions. If EPA receives adverse comment, the agency will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. If EPA does not receive any timely adverse comment, this amendment will become effective as indicated under DATES without any further action by EPA. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting any comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. III. Overview of the CDX, CISS, and the Thin Client Version of the e- PMN Software A. What is CDX? CDX is EPA's electronic system for environmental data exchange to the Agency. CDX also provides the capability for submitters to access their data through the use of web services. CDX enables EPA to work with stakeholders, including governments, regulated industries, and the public, to enable streamlined, electronic submission of data via the Internet. For more information about CDX, go to http://epa.gov/cdx. TSCA section 5 submissions will be prepared and submitted through Chemical Information Submission System (CISS) in CDX. B. What is CISS? CISS is a web-based reporting tool developed by EPA for use in submitting data, reports, and other information under certain sections of TSCA electronically to the Agency. CISS provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. C. What is the thin client version of the e-PMN software? The thin client version of the e-PMN software is a submission module within CISS. Following promulgation of the e-PMN final rule in 2010, EPA launched submission modules in CISS for TSCA Chemical Data Reporting, TSCA section 4 test data submissions, TSCA section 8(a) preliminary assessment information rules, TSCA section 8(d) health and safety data reporting rules, and mandatory notifications of substantial risk under TSCA section 8(e) along with related, voluntary ``For Your Information'' submissions. EPA has enhanced the e-PMN software in the thin client version to incorporate several functions already available to submitters in the other CISS submission modules, including: 1. Enhanced CDX Registration and Submission Process. When submitters complete new CDX registration activities, they are prompted to choose 5 out of 20 offered questions and provide answers to each of those 5 questions. In order to electronically sign and submit data to the EPA or to download the Copy of Record in CDX, a user must correctly answer 1 randomly selected question of the 5 questions chosen by that user (i.e., a ``20-5-1'' security question) before the transaction can be completed. When the 20-5-1 security question is answered correctly, the thin client version of the software then encrypts the information and transaction is completed. 2. Optional online Electronic Signature Agreement (ESA) and identity validation. The thin client version of the e-PMN software enables electronic submitters who are newly applying for the Authorized Official (AO) role in CDX to validate their personal identities electronically via LexisNexis. Those submitters applying for the AO role who choose to not use LexisNexis, or for whom LexisNexis could not validate their identities, will need to follow the current, paper-based e-PMN identity [[Page 42741]] validation process. In CDX, these submitters will instead select the ``Sign Paper Form'' option. CDX will then instruct the user to print, sign, and mail the ESA (ESA processing by EPA may take up to 10 business days from the date of receipt). Since support persons are not able to sign and complete submissions or download the Copy of Record for a submission, they will be able to register with CDX without authentication of identity. 3. AO Role Expansion. The role of the AO has been expanded. Not only does the AO of the submitting company certify initial notices and submit all types of section 5 documents to EPA via CDX, the role has been broadened to allow non-certifying AOs (e.g., technical contacts, consultants etc.) to conduct all TSCA section 5 business on behalf of the company except for certifying and submitting initial notices including joint submissions and letters of support. The role for the registered support person has also changed. Support persons will have the ability only to edit information in forms to which they have been granted access by the AO. 4. Updated user roles/designations. For joint submissions and/or letters of support, there are new designations/roles assigned in registration referred to as ``secondary'' (for both AOs and support persons). The ``primary'' role designation is for persons who will create and submit the main PMN and supporting documents. The ``secondary'' role designation is for persons who will create and submit joint submissions and letters of support. D. What are the benefits of the thin client version of the e-PMN software? EPA developed the Thin Client Version of the e-PMN software to provide a more efficient way of accessing the e-PMN software and completing the e-PMN form. The Thin Client Version of the software was also designed to enable more efficient data transmittal, including increasing the size of files that can be submitted to EPA. By moving from the Thick Client Version of the e-PMN software to the Thin Client Version, the Agency has eliminated the roadblocks associated with firewalls that were encountered by some users of the Thick Client Version by allowing submitters to work directly online within the Thin Client Version or, if they choose, to work offline using an XML schema which allows them to later upload their information to the Thin Client Version. When preparing and completing submissions in the thin client version, submitters will find that sharing files within the software makes the information readily accessible to registrants of the submitting company and their designated support persons. Also, once a user completes the relevant data fields and attaches appropriate PDF files or other allowable file types, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Finally, the Thin Client Version assures that submitters will always use the most up-to-date version of the e-PMN software when initiating, updating, and/or completing their submissions in CISS. In addition, the thin client version improves EPA data management by altering the process for submitting amendments to a valid notice. Currently, submitters would electronically submit only the amended sections of the form. Under the new procedure, companies will revise the necessary information in the initial notice or a previously modified version of the notice and an entire updated notice will then be resubmitted to EPA. This provides EPA with a complete, updated version of the entire submission in one document. E. Will CBI be protected when using the thin client version of the e- PMN software? Yes. The application has been designed to support TSCA CBI needs by providing a secure environment that meets Federal standards. The application uses Transportation Layer Security with 256-bit digital encryption, and the data is encrypted at rest using a key that only a user knows. All data remains encrypted until it is behind several EPA firewalls and within the EPA CBI LAN, and all encryption algorithms are compliant with Federal Information Processing Standards. In addition, users must have valid CDX credentials (user name and password combination) to access the application, and they choose and provide answers to 5 of the 20 offered questions in CDX. In order to access the CDX account and submit data to the EPA or to download the Copy of Record, a user must correctly answer one of the 5 chosen questions associated with the CDX account. F. How do I submit TSCA section 5 notifications and support documents using CDX and the ``Thin Client Version'' of the e-PMN software? EPA has prepared a comprehensive user guide for CISS users that addresses CDX registration and electronic signatures, general submission preparation and completion, and submission status tracking notifications (Ref. 1). This user guide is available through EPA's Web page at http://www.epa.gov/oppt/chemtest/ereporting. EPA has also prepared a separate user guide for the e-PMN software module in CISS (i.e., the Thin Client Version) (Ref. 2) which is available through EPA's Web page at http://epa.gov/oppt/newchems/epmn/epmn-index.htm. IV. Description of Changes to Required Reporting Procedures A. What are the new requirements for ``Bona Fide Intents to Manufacture''? This direct final rule extends the electronic reporting requirement to submit PMNs, other TSCA section 5 notices, and support documents to the Agency electronically to include the submissions of bona fides. A person who intends to manufacture a chemical substance not listed by specific chemical name in the public portion of the Inventory of Chemical Substances may ask EPA, through submission of a bona fide intent to manufacture, whether the substance is included in the confidential portion of the Inventory and, thus, be able to determine whether submission of a Premanufacture Notice or Significant New use Notice in accordance with TSCA section 5(a)(1) is required. Bona fides were not included within the scope of the January 2010 final rule due to the variability and frequency of these types of submissions. However, in that rule, EPA stated that this and other types of submissions could be considered for electronic reporting in the future. Bona fides are currently submitted in paper form only according to the requirements of 40 CFR 720.25, 721.11 and 725.15 which do not prescribe a format, only required content. This direct final rule requires that submitter to submit this information electronically using the Thin Client Version of the e-PMN software. B. What are the new requirements for notification of new manufacturing sites? As required under 40 CFR 723.50(j)(6)(ii), a manufacturer (including importer) must notify EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. Under the existing regulation, companies may use, but are not required to use, the Notice of Commencement (NOC) to report manufacturing site changes to EPA. Under the existing regulation, however, if the NOC form is used for this purpose, the manufacturer must add a statement to the NOC form that the notification is an amendment to the original [[Page 42742]] exemption. The electronic version of the NOC in the e-PMN software has been designed to solely deal with NOCs and will not accommodate notifications of manufacturing site changes. Therefore, this direct final rule requires that such notifications of changes in manufacturing sites be submitted electronically to EPA via CDX as a ``support document'' to the original notification. C. How has the required method of submission changed? EPA's electronic reporting program has evolved significantly following the promulgation of the e-PMN final rule in 2010. Following promulgation of that rule, EPA announced web-based electronic reporting workflows for TSCA Chemical Data Reporting, TSCA section 4 test data submissions, TSCA section 8(a) preliminary assessment information rules, TSCA section 8(d) health and safety data reporting rules, and mandatory notifications of substantial risk under TSCA section 8(e) along with related, voluntary ``For Your Information'' submissions. Under the current e-PMN rule requirements, TSCA section 5 submitters already must register in CDX and complete an electronic signature agreement before submitting any information to EPA electronically via CDX using the e-PMN software. This direct final rule requires all persons who will be working online on a submission to register with EPA's CDX and to use the e-PMN module within CISS to prepare data for submission. EPA expects that most TSCA section 5 submitters are already registered in CDX. Those users do not need to re-register with CDX, nor will they need to re-verify their identities. In order to use the Thin Client Version of the e-PMN software required under this direct final rule, users who have previously registered with CDX under the TSCA workflow to submit TSCA section 5 submissions, or other CDX workflows such as the Toxics Release Inventory TRI-ME web reporting, will only need to add the ``Submission for Chemical Safety and Pesticide Program (CSPP)'' CDX workflow to their user profiles. D. Will EPA offer any exceptions to the transition to the thin client version? No. The Agency has concluded that the overall benefits from everyone using the more efficient Thin Client Version of 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 unpredictable or unanticipated technical difficulties in electronic filing or with the conversion to the ``Thin Client Version.'' However, EPA expects that the transition costs and any transition difficulties will be mitigated by: 1. EPA's planned outreach and training sessions prior to the effective date of this direct final rule. EPA believes that the six- month phase-out period for the Thick Client Version between the date of publication and the effective date of this direct final rule provides submitters with ample time to register to use and become proficient with the Thin Client Version of the e-PMN software. EPA will accept submissions using the Thin Client Version of the e-PMN software beginning on September 3, 2015. After January 19, 2016, use of the Thin Client Version of the e-PMN software becomes mandatory. 2. EPA's offering of an XML schema to those submitters who choose to work on their submissions offline rather than online, which allows them to later upload their information to the Thin Client Version of the e-PMN software for submission using CDX. The six-month phase-out period for the period between the date of publication and the effective date of the final rule should provide these users adequate time to implement the XML schema on their systems. 3. EPA's technical support following the effective date of this final rule. E. Will all types of TSCA section 5 notices and communications be submitted via e-PMN software? At this time, the Agency lacks electronic reporting capability for some TSCA section 5-related notices (e.g., polymer exemption annual reports); certain 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. V. Corrections to 40 CFR Parts 720, 721, 723 and 725 The direct final rule also corrects certain regulatory cross- references in 40 CFR parts 720 and 721 and standardizes the use of ``manufacture'' and similar language in 40 CFR parts 720, 721, and 725. 1. Minor change to definition of ``article'' in 40 CFR 720.3. The current definition of ``article'' at 40 CFR 720.3(c) incorrectly references 40 CFR 720.36(g)(5) concerning changes in chemical composition which have no commercial purpose separate from that of the article. This rulemaking corrects the cross-reference to 40 CFR 720.30(h)(5). 2. Removal of the cross-reference to 40 CFR 710.7(e)(2)(v) in 40 CFR 720.25(b)(4) and 40 CFR 721.11(d). The CFR at Sec. 720.25(b)(4) and Sec. 721.11(d) currently cross-references both 40 CFR 710.7(e)(2)(v) and 40 CFR 720.85(b)(3)(iii). These cross-references should only be to 40 CFR 720.85(b)(3)(iii); 40 CFR 710.7(e)(2)(v) no longer exists. 3. Use of ``manufacture or import'' and similar language in 40 CFR 720.25(b), 40 CFR 721.11 and 40 CFR 725.15. The definition of ``manufacture'' in section 3(7) of TSCA includes both manufacture and import. However, in many places in TSCA section 5 regulations in parts 720, 721, 725 and elsewhere the terms ``manufacture or import'' or ``manufacture, import or process'' are used. EPA is revising ``manufacture'' and ``manufacturer'' in some of the provisions affected by this rule to clarify that import is included in manufacture under TSCA. This is not intended to make any substantive change to the regulations. As EPA amends other TSCA regulations with similar language in the future, the Agency intends to make corresponding changes. 4. Removal of the definition of ``optical disc'' in 40 CFR 720.3. The January 2010 (75 FR773) final rule phased out the electronic submission of TSCA section 5 notices to EPA via optical disc as a valid method of submission as of April 6, 2012. Therefore, the definition currently presented at 40 CFR 720.3(kk) is obsolete and will be removed. 5. Use of CDX to submit written requests for suspension of the notice review period in 40 CFR 720.75. The January 2010 final rule phased out paper submissions of TSCA section 5 notices to EPA as of April 6, 2011, and the electronic submission of TSCA section 5 notices to EPA via optical disc as a valid method of submission as of April 6, 2012. However, 40 CFR 720.75(b)(4) continues to provide that written requests for suspension of the notice review period may be submitted to EPA on paper, on optical disc, or in CDX. This final rule corrects 40 CFR 720.75 to specify that written suspension requests must be submitted to EPA via CDX. [[Page 42743]] VI. Estimated Economic Impact The Agency's estimated economic impact of this direct final rule is presented in a document entitled ``Economic Analysis of the TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations'' (Economic Analysis) (Ref. 3), a copy of which is available in the docket and is briefly summarized in this unit. In the economic analysis supporting the January 6, 2010 (75 FR 773) e-PMN final rule, EPA estimated that the electronic submission of TSCA section 5 notices and support documents would reduce the burden and cost associated with the paper- based reporting process of TSCA section 5 notices and support documents (Ref. 4). This direct final rule amends the existing premanufacture notification regulation to mandate the use of the Thin Client Version of the e-PMN reporting software, require use of electronic reporting of TSCA section 5 bona fides, and amends the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. These amendments are expected to further streamline and reduce the administrative costs and burdens associated with TSCA section 5 notifications for both industry and EPA. The Thin Client Version of the e-PMN software will reside as a module within CISS in CDX. The Thin Client Version will eliminate certain firewall and file submission size limitations, as well as reduce the potential for invalid submissions through built-in validation procedures. Use of the Thin Client Version also assures that should revisions be made by EPA, submitters will always use the most up-to-date version of the e-PMN software when initiating, updating, and/or completing their submission in CISS. Making the software available to industry is expected to result in cost savings for both industry and EPA. However, this direct final rule, which includes a new requirement for electronic submission of bona fide notices and changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, may result in some temporary increase in cost to some industry users as they make the transition to the new method of submission. As a result of making the software available, EPA believes that submitters of bona fide notices will experience burden and cost savings because the time required to enter, review, and edit their notices using the e-PMN software and transmit their submissions to EPA electronically will be less than that for the existing paper-based process. In EPA's economic analysis (Ref. 3), estimated burden and cost savings are presented in comparison to the burden and costs that will be incurred if industry were to continue submitting notices via paper, as was outlined in the previous Information Collection Request (ICR) (Ref. 5). OMB has already approved the underlying information collection requirements described in this direct final rule under OMB control numbers 2070-0012 and 2070-0038 (EPA Information Collection Request (ICR) No. 0574.15, Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Ref. 5) and EPA ICR No. 1188.11, TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Ref. 6)), respectively. EPA has submitted requests for additional approval to OMB under PRA (Refs. 8 and 9) because the direct final rule alters the required form and format of the existing, approved collections of information. Once the rule is fully implemented, EPA estimates a net burden savings to industry of 180 hours and a net cost of approximately $4,000 in the first year. In subsequent years, EPA estimates an annual net burden savings to industry of 489 hours and annual net cost savings of approximately $17,000. The Agency is projected to experience an annual net burden savings of 40 hours and annual net cost savings of $3,000 for these same submissions once the rule is fully implemented. Requiring use of the e-PMN software for submission of bona fides (40 CFR 720.25, 40 CFR 721.11 and 40 CFR 725.15), suspension requests (40 CFR 720.75), and changes in manufacturing sites (40 CFR 723.50(j)(6)) eliminates the option of submitting paper. To the extent that any firms would otherwise submit these notices on paper, these firms may incur some costs in order to meet these mandatory submission requirements. For example, some industry users may incur costs related to adjustments to internal processes or recordkeeping systems, and investments in compatible information technology. At this time, EPA is unable to estimate what these costs might be. However, firms have generally been required to file section 5 notifications electronically using the e-PMN software since April 2012, and a final rule published in the Federal Register of December 4, 2013(78 FR 72818) (FRL-9394-6) requires that any new NOCs for PMNs filed in paper prior to April 2012 be submitted electronically using the e-PMN software (Ref. 7). Firms expected to submit bona fides, suspension requests, and changes in manufacturing sites are believed by EPA to primarily be the same firms that are already complying with the existing regulations. EPA therefore does not believe that many, if any, firms would incur such costs only for the electronic submission of bona fides or notifications of manufacturing site changes for a previously submitted PMN. The total annual burden to society (industry plus EPA) from the e- PMN software is expected to decrease by 57 hours in the first year and 529 hours in subsequent years. The total cost to society is expected to increase by $1,000 in year one and decrease by $20,000 in future years. These cost savings may be diminished by any transactions costs that firms compelled to switch to the new software system might face for submission of bona fides. EPA believes that both the transition from the Thick Client Version to the Thin Client Version, as well as the changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, will have a negligible impact on industry or Agency burden or costs, and, therefore, the cost savings associated with these changes are only described qualitatively in the Economic Analysis (Ref. 3). VII. References The public docket for this final rule has been established. 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-2013-0385, which is available for inspection as specified under ADDRESSES. 1. EPA. Central Data Exchange CSPP CDX Registration Guide, December 12, 2011. 2. EPA. Section 5 Notices and Supports Users Guide. December 20, 2013 (available at: http://www.epa.gov/oppt/newchems/epmn/epmn-index.htm). 3. EPA. Economic and Policy Analysis Branch, Office of Pollution Prevention and Toxics (OPPT). Economic Analysis of the TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revision to Notification Regulations. November 17, 2014. 4. 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 [[Page 42744]] Notification Requirements Final Rule. July 13, 2009. 5. EPA Information Collection Request (ICR) No. 0574.15, Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. 6. EPA ICR No. 1188.12, TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals. 7. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL- 9394-6). 8. EPA. Supporting Statement for a Request for OMB Review under The Paperwork Reduction Act. Revision to Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Direct Final Rule; RIN 2070-AJ98). EPA ICR No. 0574.16. OMB Control Number 2070-0012. 9. EPA. Supporting Statement for a Request for OMB Review under The Paperwork Reduction Act. Request for a Non-Substantive Change to an Existing Approved Information Collection, TSCA Section 5(a)(2) Significant New Use rules for Existing Chemicals. EPA ICR No. 1188.12; OMB Control Number 2070-0038. VIII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is not a significant regulatory action as defined by Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, this action was not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). EPA has prepared an Economic Analysis for this action (Ref. 3), which is available in the docket for this final rule and is summarized in Unit VI. B. Paperwork Reduction Act The information collection activities in this direct final rule been submitted for approval to OMB under the PRA (44 U.S.C. 3501 et seq.) pursuant to the procedures at 5 CFR 1320.5(c)(1) and 1320.10(a). The underlying requirements are approved under OMB control numbers 2070-0012 and 2070-0038. However, EPA has submitted requests for additional approval to OMB under PRA because the direct final rule alters the required form and format of the existing, approved collections of information. The Information Collection Request (ICR) document that EPA prepared to address the direct final rule requirements related to EPA's New Chemicals Program has been assigned EPA ICR number 0574.16 (Ref. 8). This ICR addresses the required use of the Thin Client version of the e-PMN software system in CDX to complete their TSCA section 5 submissions to EPA's New Chemicals Program instead of a downloadable Thick Client version of the e-PMN software system. In addition, this ICR addresses the mandatory electronic submission of bona fide notices and notifications of new manufacturing sites of chemical substances for which an exemption was granted by EPA under 723.50. As addressed in EPA ICR No. 0574.16, the total burden to industry is expected to decrease 182 hours and the total cost is expected to increase by $3,988 in the first year of the rule, for a total burden of 2,312 hours and $155,699. This includes an average per firm burden of 0.82 hours for rule familiarization for 336 TSCA section 5 submitters, a per-submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions, a per-registrant burden 0.43 hours for 93 new technical labor CDX registrations, and a-per registrant burden of 1.07 hours for 23 new managerial CDX registrants. In all subsequent years of the rule the total industry burden is expected to decrease by 485 hours and $17,199. This includes a per submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions, a per-registrant burden 0.43 hours for 46 new technical labor CDX registrations, and a per-registrant 1.07 hours for 12 new managerial CDX registrants. In addition, EPA has been assigned EPA ICR number 1188.12 (Ref. 9) to the ICR document that addresses the direct final rule requirements related EPA's Existing Chemicals Program (i.e., the required use of the Thin Client version of the e-PMN software system in CDX to complete their TSCA section 5 submissions to EPA's Existing Chemicals Program instead of a downloadable Thick Client version of the e-PMN software system). The direct final rule would only require firms who must already submit significant new use notices for existing chemicals to use the new electronic reporting tool. EPA, therefore, did not estimate any rule-related burden changes for this ICR. You can find a copy of these ICR documents in the docket for this direct final rule. Any comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden must be to the EPA using the docket identified at the beginning of this direct final rule by August 19, 2015. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than August 19, 2015. Responses to the collection of information are mandatory, pursuant to EPA's authority under TSCA and PRA (as described in Unit I.C.). However, the changes to the information collection requirements in this direct final rule are not enforceable until OMB approves them. 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. C. Regulatory Flexibility Act I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C Sec. 601 et seq. In making this determination, the impact of concern is any significant adverse economic impact on small entities, because the primary purpose of a final regulatory flexibility analysis is to identify and address regulatory alternatives that ``minimize the significant economic impact on small entities'' 5 U.S.C. 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule has no net burden effect on the small entities subject to the rule. As indicated previously, this final rule is expected to reduce the existing regulatory burden. The factual basis for the Agency's certification under the RFA is presented in the small entity impact analysis prepared as part of the Economic Analysis for this final rule (Ref. 3), and is briefly summarized in Unit IV. D. Unfunded Mandates Reform Act and Executive Orders 13132 and 13175 This action will not have substantial direct effects on State, local, or tribal governments, on the relationship between the Federal Government and States or Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and States or Indian Tribes. As a result, no action is required under Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999), or under Executive Order 13175, [[Page 42745]] entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Nor does it impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531- 1538). E. Executive Orders 13045, 13211, and 12898 As indicated previously, this action is not a ``significant regulatory action'' as defined by Executive Order 12866. As a result, this action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) and Executive Order 13211 entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). In addition, this action also 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). F. National Technology Transfer and Advancement Act (NTTAA) Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action. IX. Congressional Review Act Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Parts 720, 721, 723, and 725 Environmental protection, Chemicals, Electronic reporting, Hazardous substances, Reporting and recordkeeping requirements. Dated: July 10, 2015. Louise P. Wise, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention. Therefore, 40 CFR chapter I is amended as follows: PART 720--[AMENDED] 0 1. The authority citation for part 720 continues to read as follows: Authority: 15 U.S.C 2604, 2607, and 2613. 0 2. In Sec. 720.3: 0 a. Revise paragraph (c). 0 b. Remove paragraph (kk). 0 c. Redesignate paragraph (ll) as (kk). 0 d. Revise newly redesignated paragraph (kk). The revisions read as follows: Sec. [emsp14]720.3 Definitions. * * * * * (c) Article means a manufactured item: (1) Which is formed to a specific shape or design during manufacture; (2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in Sec. 720.30(h)(5), except that fluids and particles are not considered articles regardless of shape or design. * * * * * (kk) Support documents means material and information submitted to EPA in support of a TSCA section 5 notice, including but not limited to, correspondence, amendments (if notices for these amendments were submitted prior to January 19, 2016), 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)). 0 3. In Sec. 720.25, revise paragraphs (b)(1), (b)(2) introductory text, (b)(2)(i) and (ii), and (b)(4), (5), (6), and (7) to read as follows: Sec. 720.25 Determining whether a chemical substance is on the Inventory. * * * * * (b) * * * (1) A chemical substance is listed in the public portion of the Inventory by a specific chemical name (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry Number if its identity is not confidential. If its identity is confidential, it is listed in the public portion of the Inventory by a TSCA Accession Number and a generic chemical name that masks the specific substance identity. The confidential substance is listed by its specific chemical name only in the confidential portion of the Inventory, which is not available to the public. A person who intends to manufacture (including import) a chemical substance not listed by specific chemical name in the public portion of the Inventory may ask EPA whether the substance is included in the confidential Inventory. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture (including import) the chemical substance for commercial purposes. (2) To establish a bona fide intent to manufacture (including import) a chemical substance, the person who proposes to manufacture the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) must be generated and completed using e-PMN software. See Sec. 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) must contain: (i) Except as provided in paragraphs (b)(3)(i) and (ii) of this section, the specific chemical identity of the substance that the person intends to manufacture (including import), using the currently correct CA Index name for the substance and the other correct chemical identity information in accordance with Sec. 720.45(a) (1), (2), and (3). (ii) A signed statement that the person intends to manufacture (including import) that chemical substance for commercial purposes. * * * * * (4) EPA will review the information submitted by the proposed manufacturer (including importer) under this paragraph to determine whether it has a bona fide intent to manufacture (including import) the chemical substance. If necessary, EPA will compare this information to the information requested for the confidential chemical substance under Sec. 720.85(b)(3)(iii). (5) If the proposed manufacturer (including importer) has shown a bona fide intent to manufacture (including import) the substance, and has provided sufficient unambiguous chemical identity information so EPA can make a conclusive determination of the chemical substance's Inventory status, EPA will search the confidential Inventory and inform the proposed manufacturer (including importer) whether the chemical substance is on the confidential Inventory. (6) If the chemical substance is found on the confidential Inventory, EPA will notify the person(s) who originally reported the chemical substance that another person has demonstrated a bona fide intent to manufacture (including import) the substance and therefore was told that the chemical substance is on the Inventory. (7) A disclosure of a confidential chemical identity to a person with a bona fide intent to manufacture [[Page 42746]] (including import) the particular chemical substance will not be considered a public disclosure of confidential business information under section 14 of the Act. * * * * * 0 4. In Sec. 720.40, revise paragraphs (a)(2)(i), (a)(2)(ii) introductory text, and (e)(1) and (3) to read as follows: Sec. 720.40 General. (a) * * * (2) * * * (i) Submission via CDX. TSCA section 5 notices and any related support documents must 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 software. (ii) You can access the e-PMN software as follows: * * * * * (e) Agency or joint submissions--(1) A manufacturer (including importer) may designate an agent to assist in submitting the notice. If so, only the manufacturer (including importer), and not the agent, signs the certification on the form. (2) * * * (3) Only the Authorized Official (AO) of a submitting company can certify initial notices and submit all TSCA section 5 documents. (i) An AO can authorize other persons to be non-certifying AOs who may conduct all section 5 business on behalf of the submitting company except for certifying and submitting initial notices to EPA via CDX. (ii) An AO may grant access to a support registrant to edit section 5 documents. * * * * * 0 5. In Sec. 720.75: 0 a. Revise paragraph (b)(2). 0 b. Remove paragraphs (b)(3) and (4). 0 c. Revise paragraph (e)(2). The revisions read as follows: Sec. 720.75 Notice review period. * * * * * (b) * * * (2)(i) Oral requests. A request for a suspension of 15 days or less may be made orally, including by telephone, to the submitter's EPA contact for that notice. Any request for a suspension exceeding 15 days must be submitted in the manner set forth in paragraph (b)(2)(ii) of this section. The running of the notice review period will be suspended upon approval of the oral request by the Director or her or his delegate. (ii) Written requests. Requests for suspensions exceeding 15 days must be submitted electronically to EPA via CDX using e-PMN software. Requests for suspensions of 15 days or less may also be submitted electronically to EPA via CDX using e-PMN software. See Sec. 720.40(a)(2)(ii) for information on how to access the e-PMN software. The running of the notice review period will be suspended upon approval of the written request by the Director or her or his delegate. * * * * * (e) * * * (2) If a manufacturer (including importer) which withdrew a notice later resubmits a notice for the same chemical substance, a new notice review period begins. PART 721--[AMENDED] 0 6. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 7. In Sec. 721.11, revise paragraphs (a), (b) introductory text, (b)(1), (2), and (3), (d), (e) and (f) to read as follows: Sec. 721.11 Applicability determination when the specific chemical identity is confidential. (a) A person who intends to manufacture (including import) or process a chemical substance which is described by a generic chemical name in subpart E of this part may ask EPA whether the substance is subject to the requirements of this part. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture (including import) or process the chemical substance for commercial purposes. (b) To establish a bona fide intent to manufacture (including import) or process a chemical substance, the person who proposes to manufacture (including import) or process the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) or process must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) or process must contain: (1) The specific chemical identity of the chemical substance that the person intends to manufacture (including import) or process. (2) A signed statement that the person intends to manufacture (including import) or process the chemical substance for commercial purposes. (3) A description of the research and development activities conducted to date, and the purpose for which the person will manufacture (including import) or process the chemical substance. * * * * * (d) EPA will review the information submitted by the manufacturer (including importer) or processor under paragraph (b) of this section to determine whether that person has shown a bona fide intent to manufacture (including import) or process the chemical substance. If necessary, EPA will compare this information to the information requested for the confidential chemical substance under Sec. 720.85(b)(3)(iii) of this chapter. (e) If the manufacturer (including importer) or processor has shown a bona fide intent to manufacture (including import) or process the substance and has provided sufficient unambiguous chemical identity information to enable EPA to make a conclusive determination as to the identity of the substance, EPA will inform the manufacturer (including importer) or processor whether the chemical substance is subject to this part and, if so, which section in subpart E of this part applies. (f) A disclosure to a person with a bona fide intent to manufacture (including import) or process a particular chemical substance that the substance is subject to this part will not be considered public disclosure of confidential business information under section 14 of the Act. * * * * * PART 723--[AMENDED] 0 8. The authority citation for part 723 continues to read as follows: Authority: 15 U.S.C. 2604. 0 9. In Sec. 723.50: 0 a. Revise paragraph (j)(6)(ii)(B). 0 b. Remove paragraph (j)(6)(ii)(C). The revision reads as follows: Sec. 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. * * * * * (j) * * * (6) * * * (ii) * * * (B) The notification must be submitted electronically to EPA via CDX as a support document to the original notification. Prior to submission to EPA via CDX, such notices must be generated and completed using the e-PMN software. See 40 CFR 720.40(a)(2)(ii) for [[Page 42747]] information on how to access the e-PMN software. * * * * * PART 725--[AMENDED] 0 10. The authority citation for part 725 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, 2613 and 2625. 0 11. In Sec. 725.15, revise paragraphs (a)(2), (b)(2) introductory text, (b)(2)(ii) and (iii), (d), (e), (f), and (g) to read as follows: Sec. 725.15 Determining applicability when microorganism identity or use is confidential or uncertain. (a) * * * (2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture (including import) or process are equivalent to specific microorganisms described on the Inventory, in Sec. 725.239, or in subpart M of this part. (b) * * * (2) To establish a bona fide intent to manufacture (including import) or process a microorganism, the person who proposes to manufacture (including import) or process the microorganism must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture (including import) or process must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture (including import) or process must contain the following information: * * * * * (ii) A signed statement certifying that the submitter intends to manufacture (including import) or process the microorganism for commercial purposes. (iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture (including import) or process the microorganism. * * * * * (d) EPA will review the information submitted by the manufacturer (including importer) or processor under this paragraph to determine whether that person has shown a bona fide intent to manufacture (including import) or process the microorganism. If necessary, EPA will compare this information to the information requested for the confidential microorganism under Sec. 725.85(b)(3)(iii). (e) In order for EPA to make a conclusive determination of the microorganism's status, the proposed manufacturer (including importer) or processor must show a bona fide intent to manufacture (including import) or process the microorganism and must provide sufficient information to establish identity unambiguously. After sufficient information has been provided, EPA will inform the manufacturer (including importer) or processor whether the microorganism is subject to this part and if so, which sections of this part apply. (f) If the microorganism is found on the confidential version of the Inventory, in Sec. 725.239 or in subpart M of this part, EPA will notify the person(s) who originally reported the microorganism that another person (whose identity will remain confidential, if so requested) has demonstrated a bona fide intent to manufacture (including import) or process the microorganism and therefore was told that the microorganism is on the Inventory, in Sec. 725.239, or in subpart M of this part. (g) A disclosure to a person with a bona fide intent to manufacture (including import) or process a particular microorganism that the microorganism is on the Inventory, in Sec. 725.239, or in subpart M of this part will not be considered a public disclosure of confidential business information under section 14 of the Act. * * * * * [FR Doc. 2015-17737 Filed 7-17-15; 8:45 am] BILLING CODE 6560-50-P
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ENVIRONMENTAL PROTECTION • Hand Delivery: To make special import) and processing of chemical
AGENCY arrangements for hand delivery or substances. It is the expressed intent of
delivery of boxed information, please Congress that EPA carry out TSCA in a
40 CFR Parts 720, 721, 723, and 725 follow the instructions at http:// reasonable and prudent manner, and in
[EPA–HQ–OPPT–2013–0385; FRL–9927–79] www.epa.gov/dockets/contacts.html. consideration of the impacts that any
Additional instructions on commenting action taken under TSCA may have on
RIN 2070–AJ98 or visiting the docket, along with more the environment, the economy, and
information about dockets generally, is society (TSCA section 2). The
TSCA Section 5 Premanufacture and available at http://www.epa.gov/ underlying requirements promulgated
Significant New Use Notification dockets. under this broad authority and amended
Electronic Reporting by this final rule require manufacturers
FOR FURTHER INFORMATION CONTACT: For
AGENCY: Environmental Protection technical information contact: Greg (including importers) and processors of
Agency (EPA). Schweer, Chemical Control Division, chemical substances and mixtures to:
Office of Pollution Prevention and • Notify EPA at least 90 days before
ACTION: Direct Final Rule.
Toxics, Environmental Protection manufacturing a new chemical
SUMMARY: EPA is taking direct final Agency, 1200 Pennsylvania Ave. NW., substance for commercial purposes
action to amend the Toxic Substances Washington, DC 20460–0001; MC (TSCA section 5(a)(1)(A)).
Control Act (TSCA) section 5 electronic • Notify EPA at least 90 days before
7405M; telephone number: (202) 564–
reporting regulations. These electronic manufacturing or processing the
8469; email address: Schweer.greg@
reporting regulations establish standards chemical substance for any use of a
epa.gov.
and requirements for use of EPA’s For general information contact: The chemical substance that EPA has
Central Data Exchange (CDX) to TSCA-Hotline, ABVI-Goodwill, 422 determined to be a ‘‘significant new
electronically submit premanufacture South Clinton Ave., Rochester, NY use’’ (TSCA section 5(a)(1)(B)).
notices (PMNs), other TSCA section 5 Section 5(h)(4) of TSCA authorizes
14620; telephone number: (202) 554–
notices, and support documents to the EPA, upon application and by rule, to
1404; email address: TSCA-Hotline@
Agency. This rule provides the user exempt the manufacturer of any new
epa.gov.
community with new methods for chemical substance from part or all of
SUPPLEMENTARY INFORMATION: the provisions of TSCA section 5.
accessing the e-PMN software, new
I. Executive Summary In addition, the Paperwork Reduction
procedures for completing the
Act (PRA) requires Federal agencies to
electronic-PMN (e-PMN) form, changes A. Does this action apply to me? manage information resources to reduce
to the CDX registration process, adds the
You may be affected by this action if information collection burdens on the
requirement to submit ‘‘bona fide
you manufacture (which includes public; increase program efficiency and
intents to manufacture’’ electronically,
import) or process chemicals for effectiveness; and improve the integrity,
and changes to the procedure for
commercial purposes that are subject to quality, and utility of information to all
notifying EPA of any new
TSCA. The following list of North users within and outside an agency,
manufacturing site of a chemical
American Industrial Classification including capabilities for ensuring
substance for which an exemption was
System (NAICS) codes is not intended dissemination of public information,
granted by EPA. This action is intended
to be exhaustive, but rather provides a public access to Federal Government
to further streamline and reduce the
guide for readers regarding industries information, and protections for privacy
administrative costs and burdens of
within which entities are likely to be and security (44 U.S.C. 3501 et seq.).
TSCA section 5 notifications for both Finally, the Government Paperwork
industry and EPA. affected by this action. Potentially
affected entities may include, but are Elimination Act (GPEA) (Pub. L. 105–
DATES: This direct final rule is effective 277 (44 U.S.C. 3504)) instructs Federal
not limited to:
January 19, 2016 without further notice, • Manufacturers and processors of agencies to use and accept from the
unless EPA receives adverse comment chemical substances or mixtures public, when practicable, electronic
on or before August 19, 2015. If EPA (NAICS codes 325 and 32411). forms, electronic filings, and electronic
receives adverse comments on this Full descriptions of these NAICS signatures in the conduct of official
action, EPA will withdraw the rule codes and related establishments are business with the public.
before its effective date. EPA will then maintained by the U.S. Census Bureau
issue a proposed rule, providing a 30- C. What action is the agency taking?
online at https://www.census.gov/eos/
day period for public comment. www/naics/index.html. Other types of This direct final rule amends the
ADDRESSES: Submit your comments, entities not listed in this unit could also TSCA Section 5 Premanufacture and
identified by docket identification (ID) be affected. To determine whether you Significant New Use Notification
number EPA–HQ–OPPT–2013–0385, by or your business may be affected by this regulations at 40 CFR parts 720, 721,
one of the following methods: action, you should carefully examine 723 and 725, by mandating the use of
• Federal eRulemaking Portal: http:// the applicability provisions in 40 CFR an updated version of the e-PMN
www.regulations.gov. Follow the online parts 700, 720, 721, 723, and 725 for reporting software. In the Federal
instructions for submitting comments. TSCA section 5-related obligations. If Register of January 2010 (75 FR 773)
Do not submit electronically any you have any questions regarding the (FRL–8794–5), EPA issued a final rule
information you consider to be applicability of this action to a requiring the use of the e-PMN reporting
Confidential Business Information (CBI) particular entity, consult the technical software for the submission of PMNs
mstockstill on DSK4VPTVN1PROD with RULES
or other information whose disclosure is person listed under FOR FURTHER and other TSCA section 5 notices and
restricted by statute. INFORMATION CONTACT. support documents to the Agency using
• Mail: Document Control Office the Internet through CDX. This new
(7407M), Office of Pollution Prevention B. What is the agency’s authority for version of the e-PMN software will
and Toxics (OPPT), Environmental taking this action? operate as a ‘‘cloud’’ software system
Protection Agency, 1200 Pennsylvania TSCA gives EPA broad authority to (‘‘Thin Client Version’’) rather than as a
Ave. NW., Washington, DC 20460–0001. regulate the manufacture (including downloadable software system (‘‘Thick
VerDate Sep<11>2014 16:02 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\20JYR1.SGM 20JYR1](https://thefederalregister.org/doc/80_FR_42877/page/1.svg)
![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 42745
entitled ‘‘Consultation and Coordination ■ c. Redesignate paragraph (ll) as (kk). manufacture (including import) the
with Indian Tribal Governments’’ (65 FR ■ d. Revise newly redesignated chemical substance for commercial
67249, November 9, 2000). Nor does it paragraph (kk). purposes.
impose any enforceable duty or contain The revisions read as follows: (2) To establish a bona fide intent to
any unfunded mandate as described manufacture (including import) a
§ 720.3 Definitions.
under Title II of the Unfunded Mandates chemical substance, the person who
Reform Act (UMRA) (2 U.S.C. 1531– * * * * * proposes to manufacture the substance
1538). (c) Article means a manufactured must submit the request to EPA via
item: CDX. Prior to submission to EPA via
E. Executive Orders 13045, 13211, and (1) Which is formed to a specific
CDX, such bona fide intents to
12898 shape or design during manufacture;
manufacture (including import) must be
As indicated previously, this action is (2) Which has end use function(s)
generated and completed using e-PMN
not a ‘‘significant regulatory action’’ as dependent in whole or in part upon its
software. See § 720.40(a)(2)(ii) for
defined by Executive Order 12866. As a shape or design during end use; and
(3) Which has either no change of information on how to access the e-PMN
result, this action is not subject to software. A bona fide intent to
chemical composition during its end
Executive Order 13045, entitled manufacture (including import) must
use or only those changes of
‘‘Protection of Children from contain:
composition which have no commercial
Environmental Health Risks and Safety (i) Except as provided in paragraphs
purpose separate from that of the article
Risks’’ (62 FR 19885, April 23, 1997) (b)(3)(i) and (ii) of this section, the
and that may occur as described in
and Executive Order 13211 entitled specific chemical identity of the
§ 720.30(h)(5), except that fluids and
‘‘Actions Concerning Regulations That substance that the person intends to
particles are not considered articles
Significantly Affect Energy Supply, manufacture (including import), using
regardless of shape or design.
Distribution, or Use’’ (66 FR 28355, May the currently correct CA Index name for
22, 2001). In addition, this action also * * * * * the substance and the other correct
does not require any special (kk) Support documents means
chemical identity information in
considerations under Executive Order material and information submitted to
accordance with § 720.45(a) (1), (2), and
12898 entitled ‘‘Federal Actions to EPA in support of a TSCA section 5
(3).
Address Environmental Justice in notice, including but not limited to,
(ii) A signed statement that the person
Minority Populations and Low-Income correspondence, amendments (if notices
intends to manufacture (including
Populations’’ (59 FR 7629, February 16, for these amendments were submitted
import) that chemical substance for
1994). prior to January 19, 2016), and test data.
commercial purposes.
The term ‘‘support documents’’ does not
F. National Technology Transfer and include orders under TSCA section 5(e) * * * * *
Advancement Act (NTTAA) (either consent orders or orders imposed (4) EPA will review the information
pursuant to TSCA section 5(e)(2)(B)). submitted by the proposed
Since this action does not involve any
■ 3. In § 720.25, revise paragraphs (b)(1),
manufacturer (including importer)
technical standards, NTTAA section
(b)(2) introductory text, (b)(2)(i) and (ii), under this paragraph to determine
12(d), 15 U.S.C. 272 note, does not
and (b)(4), (5), (6), and (7) to read as whether it has a bona fide intent to
apply to this action.
follows: manufacture (including import) the
IX. Congressional Review Act chemical substance. If necessary, EPA
Pursuant to the CRA, 5 U.S.C. 801 et § 720.25 Determining whether a chemical will compare this information to the
seq., EPA will submit a rule report to substance is on the Inventory. information requested for the
each House of the Congress and to the * * * * * confidential chemical substance under
Comptroller General of the United (b) * * * § 720.85(b)(3)(iii).
States. This action is not a ‘‘major rule’’ (1) A chemical substance is listed in (5) If the proposed manufacturer
as defined by 5 U.S.C. 804(2). the public portion of the Inventory by a (including importer) has shown a bona
specific chemical name (either a fide intent to manufacture (including
List of Subjects in 40 CFR Parts 720, Chemical Abstracts (CA) Index Name or import) the substance, and has provided
721, 723, and 725 a CA Preferred Name) and a Chemical sufficient unambiguous chemical
Environmental protection, Chemicals, Abstracts Service (CAS) Registry identity information so EPA can make a
Electronic reporting, Hazardous Number if its identity is not conclusive determination of the
substances, Reporting and confidential. If its identity is chemical substance’s Inventory status,
recordkeeping requirements. confidential, it is listed in the public EPA will search the confidential
portion of the Inventory by a TSCA Inventory and inform the proposed
Dated: July 10, 2015.
Accession Number and a generic manufacturer (including importer)
Louise P. Wise, chemical name that masks the specific whether the chemical substance is on
Acting Assistant Administrator, Office of substance identity. The confidential the confidential Inventory.
Chemical Safety and Pollution Prevention. substance is listed by its specific (6) If the chemical substance is found
Therefore, 40 CFR chapter I is chemical name only in the confidential on the confidential Inventory, EPA will
amended as follows: portion of the Inventory, which is not notify the person(s) who originally
available to the public. A person who reported the chemical substance that
PART 720—[AMENDED]
intends to manufacture (including another person has demonstrated a bona
mstockstill on DSK4VPTVN1PROD with RULES
■ 1. The authority citation for part 720 import) a chemical substance not listed fide intent to manufacture (including
continues to read as follows: by specific chemical name in the public import) the substance and therefore was
portion of the Inventory may ask EPA told that the chemical substance is on
Authority: 15 U.S.C 2604, 2607, and 2613.
whether the substance is included in the the Inventory.
■ 2. In § 720.3: confidential Inventory. EPA will answer (7) A disclosure of a confidential
■ a. Revise paragraph (c). such an inquiry only if EPA determines chemical identity to a person with a
■ b. Remove paragraph (kk). that the person has a bona fide intent to bona fide intent to manufacture
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![42746 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations
(including import) the particular submitted electronically to EPA via CDX (3) A description of the research and
chemical substance will not be using e-PMN software. Requests for development activities conducted to
considered a public disclosure of suspensions of 15 days or less may also date, and the purpose for which the
confidential business information under be submitted electronically to EPA via person will manufacture (including
section 14 of the Act. CDX using e-PMN software. See import) or process the chemical
* * * * * § 720.40(a)(2)(ii) for information on how substance.
■ 4. In § 720.40, revise paragraphs to access the e-PMN software. The * * * * *
(a)(2)(i), (a)(2)(ii) introductory text, and running of the notice review period will (d) EPA will review the information
(e)(1) and (3) to read as follows: be suspended upon approval of the submitted by the manufacturer
written request by the Director or her or (including importer) or processor under
§ 720.40 General. his delegate. paragraph (b) of this section to
(a) * * * * * * * * determine whether that person has
(2) * * * (e) * * * shown a bona fide intent to manufacture
(i) Submission via CDX. TSCA section (2) If a manufacturer (including (including import) or process the
5 notices and any related support importer) which withdrew a notice later chemical substance. If necessary, EPA
documents must be submitted resubmits a notice for the same will compare this information to the
electronically to EPA via CDX. Prior to chemical substance, a new notice information requested for the
submission to EPA via CDX, such review period begins. confidential chemical substance under
notices must be generated and § 720.85(b)(3)(iii) of this chapter.
completed on EPA Form 7710–25 using PART 721—[AMENDED] (e) If the manufacturer (including
e-PMN software. importer) or processor has shown a
(ii) You can access the e-PMN ■ 6. The authority citation for part 721 bona fide intent to manufacture
software as follows: continues to read as follows: (including import) or process the
* * * * * Authority: 15 U.S.C. 2604, 2607, and substance and has provided sufficient
(e) Agency or joint submissions—(1) A 2625(c). unambiguous chemical identity
manufacturer (including importer) may information to enable EPA to make a
■ 7. In § 721.11, revise paragraphs (a),
designate an agent to assist in conclusive determination as to the
(b) introductory text, (b)(1), (2), and (3),
submitting the notice. If so, only the identity of the substance, EPA will
(d), (e) and (f) to read as follows:
manufacturer (including importer), and inform the manufacturer (including
not the agent, signs the certification on § 721.11 Applicability determination when importer) or processor whether the
the form. the specific chemical identity is chemical substance is subject to this
(2) * * * confidential. part and, if so, which section in subpart
(3) Only the Authorized Official (AO) (a) A person who intends to E of this part applies.
of a submitting company can certify manufacture (including import) or (f) A disclosure to a person with a
initial notices and submit all TSCA process a chemical substance which is bona fide intent to manufacture
section 5 documents. described by a generic chemical name in (including import) or process a
(i) An AO can authorize other persons subpart E of this part may ask EPA particular chemical substance that the
to be non-certifying AOs who may whether the substance is subject to the substance is subject to this part will not
conduct all section 5 business on behalf requirements of this part. EPA will be considered public disclosure of
of the submitting company except for answer such an inquiry only if EPA confidential business information under
certifying and submitting initial notices determines that the person has a bona section 14 of the Act.
to EPA via CDX. fide intent to manufacture (including
(ii) An AO may grant access to a * * * * *
import) or process the chemical
support registrant to edit section 5 PART 723—[AMENDED]
substance for commercial purposes.
documents.
(b) To establish a bona fide intent to
* * * * * manufacture (including import) or ■ 8. The authority citation for part 723
■ 5. In § 720.75: process a chemical substance, the continues to read as follows:
■ a. Revise paragraph (b)(2). person who proposes to manufacture Authority: 15 U.S.C. 2604.
■ b. Remove paragraphs (b)(3) and (4). (including import) or process the ■ 9. In § 723.50:
■ c. Revise paragraph (e)(2).
substance must submit the request to ■ a. Revise paragraph (j)(6)(ii)(B).
The revisions read as follows:
EPA via CDX. Prior to submission to ■ b. Remove paragraph (j)(6)(ii)(C).
§ 720.75 Notice review period. EPA via CDX, such bona fide intents to The revision reads as follows:
* * * * * manufacture (including import) or
§ 723.50 Chemical substances
(b) * * * process must be generated and manufactured in quantities of 10,000
(2)(i) Oral requests. A request for a completed using e-PMN software. See kilograms or less per year, and chemical
suspension of 15 days or less may be 40 CFR 720.40(a)(2)(ii) for information substances with low environmental
made orally, including by telephone, to on how to access the e-PMN software. releases and human exposures.
the submitter’s EPA contact for that A bona fide intent to manufacture * * * * *
notice. Any request for a suspension (including import) or process must (j) * * *
exceeding 15 days must be submitted in contain: (6) * * *
the manner set forth in paragraph (1) The specific chemical identity of (ii) * * *
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(b)(2)(ii) of this section. The running of the chemical substance that the person (B) The notification must be
the notice review period will be intends to manufacture (including submitted electronically to EPA via CDX
suspended upon approval of the oral import) or process. as a support document to the original
request by the Director or her or his (2) A signed statement that the person notification. Prior to submission to EPA
delegate. intends to manufacture (including via CDX, such notices must be generated
(ii) Written requests. Requests for import) or process the chemical and completed using the e-PMN
suspensions exceeding 15 days must be substance for commercial purposes. software. See 40 CFR 720.40(a)(2)(ii) for
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![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 42747
information on how to access the e-PMN (d) EPA will review the information DEPARTMENT OF COMMERCE
software. submitted by the manufacturer
* * * * * (including importer) or processor under National Oceanic and Atmospheric
this paragraph to determine whether Administration
PART 725—[AMENDED] that person has shown a bona fide intent
to manufacture (including import) or 50 CFR Part 648
■ 10. The authority citation for part 725 process the microorganism. If necessary, [Docket No. 130822745–5611–02]
continues to read as follows:
EPA will compare this information to
Authority: 15 U.S.C. 2604, 2607, 2613 and RIN 0648–BD64
the information requested for the
2625. confidential microorganism under Fisheries of the Northeastern United
■ 11. In § 725.15, revise paragraphs § 725.85(b)(3)(iii). States; Atlantic Surfclam and Ocean
(a)(2), (b)(2) introductory text, (b)(2)(ii) Quahog Fisheries
(e) In order for EPA to make a
and (iii), (d), (e), (f), and (g) to read as
follows: conclusive determination of the AGENCY: National Marine Fisheries
microorganism’s status, the proposed Service (NMFS), National Oceanic and
§ 725.15 Determining applicability when manufacturer (including importer) or Atmospheric Administration (NOAA),
microorganism identity or use is processor must show a bona fide intent Commerce.
confidential or uncertain. to manufacture (including import) or ACTION: Final rule.
(a) * * * process the microorganism and must
(2) Uncertain microorganism identity. provide sufficient information to SUMMARY: This final rule implements an
The current state of scientific establish identity unambiguously. After information collection program for the
knowledge leads to some imprecision in sufficient information has been Atlantic surfclam and ocean quahog
describing a microorganism. As the state provided, EPA will inform the fisheries. The information collection
of knowledge increases, EPA will be manufacturer (including importer) or program is intended to obtain more
developing policies to determine processor whether the microorganism is detailed information about individuals
whether one microorganism is subject to this part and if so, which and businesses that hold fishery quota
equivalent to another. Persons intending allocation in these individual
sections of this part apply.
to conduct activities involving transferable quota fisheries. This action
microorganisms may inquire of EPA (f) If the microorganism is found on is necessary to ensure that the Mid-
whether the microorganisms they intend the confidential version of the Atlantic Fishery Management Council
to manufacture (including import) or Inventory, in § 725.239 or in subpart M has the information needed to develop
process are equivalent to specific of this part, EPA will notify the a future management action intended to
microorganisms described on the person(s) who originally reported the establish an excessive share cap in these
Inventory, in § 725.239, or in subpart M microorganism that another person fisheries.
of this part. (whose identity will remain DATES: Effective January 1, 2016.
(b) * * * confidential, if so requested) has ADDRESSES: Written comments
(2) To establish a bona fide intent to demonstrated a bona fide intent to regarding the burden-hour estimates or
manufacture (including import) or manufacture (including import) or other aspects of the collection-of-
process a microorganism, the person process the microorganism and information requirements contained in
who proposes to manufacture (including therefore was told that the this final rule may be submitted to the
import) or process the microorganism microorganism is on the Inventory, in Greater Atlantic Regional Fisheries
must submit the request to EPA via § 725.239, or in subpart M of this part. Office and by email to OIRA_
CDX. Prior to submission to EPA via Submission@omb.eop.gov, or fax to
CDX, such bona fide intents to (g) A disclosure to a person with a
bona fide intent to manufacture (202) 395–7285.
manufacture (including import) or FOR FURTHER INFORMATION CONTACT:
process must be generated and (including import) or process a
particular microorganism that the Douglas Potts, Fishery Policy Analyst,
completed using e-PMN software. See (978) 281–9341.
40 CFR 720.40(a)(2)(ii) for information microorganism is on the Inventory, in
§ 725.239, or in subpart M of this part SUPPLEMENTARY INFORMATION:
on how to access the e-PMN software.
A bona fide intent to manufacture will not be considered a public Background
(including import) or process must disclosure of confidential business
Section 402(a)(1) of the Magnuson-
contain the following information: information under section 14 of the Act. Stevens Fishery Conservation and
* * * * * * * * * * Management Act (Magnuson-Stevens
(ii) A signed statement certifying that [FR Doc. 2015–17737 Filed 7–17–15; 8:45 am] Act) authorizes the Secretary of
the submitter intends to manufacture BILLING CODE 6560–50–P Commerce to implement an information
(including import) or process the collection program if a fishery
microorganism for commercial management council determines that
purposes. additional information would be
(iii) A description of research and beneficial for developing,
development activities conducted with implementing, or revising a fishery
the microorganism to date, management plan (FMP). The Mid-
mstockstill on DSK4VPTVN1PROD with RULES
demonstration of the submitter’s ability Atlantic Fishery Management Council
to produce or obtain the microorganism formally requested that NMFS
from a foreign manufacturer, and the implement an information collection
purpose for which the person will program in the Atlantic surfclam and
manufacture (including import) or ocean quahog individual transferable
process the microorganism. quota (ITQ) fisheries. The purpose of
* * * * * this information collection is to better
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Document Created: 2015-12-15 12:58:25
Document Modified: 2015-12-15 12:58:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct Final Rule. | |
| Dates | This direct final rule is effective January 19, 2016 without further notice, unless EPA receives adverse comment on or before August 19, 2015. If EPA receives adverse comments on this action, EPA will withdraw the rule before its effective date. EPA will then issue a proposed rule, providing a 30-day period for public comment. | |
| Contact | For technical information contact: Greg Schweer, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; MC 7405M; telephone number: (202) 564- | |
| FR Citation | 80 FR 42739 | |
| RIN Number | 2070-AJ98 | |
| CFR Citation | 40
CFR
720 40 CFR 721 40 CFR 723 40 CFR 725 | |
| CFR Associated | Environmental Protection; Chemicals; Electronic Reporting; Hazardous Substances and Reporting and Recordkeeping Requirements |
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