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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules
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templates are accessible to the public online at https www.oecd.org/ehs/
templates/harmonised-templates.htm Ref. 11. A standardized format such as the OECD templates will improve the efficiency of review and organization of the submitted data. EPA believes that some of the data will already be in the OECD template if the company had already submitted the studies under the European Unions Registration, Evaluation, Authorization and Restriction of Chemicals REACH
regulation. In addition to the required template format, those subject to this rulemaking must submit any associated full study reports or underlying data as support documents. The full study reports and support documents are necessary for EPA to understand the full context and evaluate the quality of the data, which is necessary for the Agency to review if data were to be used for any future Agency actions.
EPA is requesting comments on what environmental and health effects information should be within the scope of this rule. EPA is also requesting comment on whether any information proposed to be requested is duplicative of information collected by EPA under other federal statutes and, thus, should be excluded. Please identify the information that you believe is duplicative and the statute under which it is submitted.
E. How would information be submitted to EPA?
EPA is proposing to require electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA see 40 CFR
704.20e. EPA is proposing to require submitters to use EPAs CDX, the Agencys electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8a and 8d Ref. 12, page 72818. The final rule followed two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA
CDR and for PMNs. In proposing to require similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency.
EPA developed the Chemical Information Submission System CISS
for use in submitting data electronically to the Agency for TSCA sections 4, 5, 6, 8a, 8b, 8d, 8e, and Title VI. CISS, a web-based reporting tool housed within the CDX environment, provides submitters with user-friendly
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applications to build and submit data packages to EPA within a secure, encrypted environment. CISS
applications provide for the capture of both fielded data as well as the attachment of additional information using a wide variety of file types.
Submitted information is rendered into PDF and XML formats, which are provided to submitters in the form of a Copy of Record.
EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPAs CDX and use CISS to prepare a data file for submission. Registration enables CDX to authenticate user identity. To submit electronically to EPA via CDX, individuals must first register with CDX at http cdx.epa.gov/
. To register in CDX, the CDX registrant also referred to as Electronic Signature Holder or Public/Private Key Holder agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at https
cdx.epa.gov/FAQCSPP.
Within CDX, CISS is available under the Submission for Chemical Safety and Pesticide Program CSPP CDX
flow. Users who have previously submitted under TSCA through CDX, including submitting information under sections 4 and 5, CDR, or reporting under the TSCA Inventory Notification Active-Inactive Requirements rule 82
FR 37520, Aug. 11, 2017 FRL9964
22, will already have the CSPP flow linked to their account. Users reporting to EPA using other CDX housed applications, including the Toxics Release Inventory TRIMEweb, would be able to add the CSPP flow to their existing CDX accounts.
All submitters would be required to use CISS to prepare their submissions.
CISS guides users through a hands-on process of creating an electronic submission. Once a user completes the relevant data fields and attaches appropriate PDF files, or other file types, such as XML files, 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.
Further instructions for uploading PDF
attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.
CISS, a web-based reporting tool, also allows the user to choose to Preview, Save, or Submit the data package.
Once the submission process is
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initiated, the user is asked to certify the information and provide requested information to complete the submission process. The data package is then sent, in an encrypted state, to the Agency.
The user can login to the application and check the submission status of their data package. Upon successful receipt of the submission by EPA, the submission status of the submissions will be flagged as Completed and a confirmation email will be sent to the submitters CDX inbox. The CDX inbox is used to notify the users when submissions are received by EPA or to notify users when a submission-specific communication has been received and how to locate and access the communication. Information on accessing the CDX user inbox is provided in the guidance document for CDX at https cdx.epa.gov/FAQCSPP.
To access CISS log into CDX using the link: https cdx.epa.gov/ and click on the appropriate user role associated with the CSPP data flow. For further instructions, visit https www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/electronic-reportingrequirements-certain-information Ref.
12. Procedures for reporting chemical substances under this proposed rule would be similar.
EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. Additionally, EPA
believes that many of the anticipated reporters under this proposed rule have experience with reporting electronically to EPA through CDX. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving electronic submissions and communicating electronically with submitters.
F. What can a submitter claim as confidential?
The 2016 amendments to TSCA
included new procedural requirements for the submission and Agency management of CBI claims, including new substantiation requirements, generic name requirements, a certification requirement, and a requirement for Agency review of specified CBI claims within 90 days after receipt of the claim, 15 U.S.C.
2613. The Agency recently finalized a rule amending the CDR reporting requirements that implemented the new requirements for confidentiality claims
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