By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing
Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online. This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.
On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”). EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance. EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity. More information on this guidance is available in our full memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA). EPA lists the following milestones that it has completed at the two-year anniversary:
In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.” Speakers will include:
- Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
- Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
- Michael Gould, EH&S Committee Chairman, RadTech North America; and
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:
EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA. A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.
On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced it is releasing a third alternative approach for assigning and applying unique identifiers (UID) to reconcile the competing requirements of Toxic Substances Control Act (TSCA) Section 14(g) for comment. 83 Fed. Reg. 5623. EPA’s first and second alternative approaches were released for comment in its notice on May 8, 2017 (82 Fed. Reg. 21386). Under amended TSCA, EPA is required to develop a system to assign a “unique identifier” whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance, to apply this unique identifier to other information concerning the same substance, and to ensure that any non-confidential information received identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure.
Under the third alternative approach, EPA would assign one UID per chemical substance. EPA states that in most cases it would apply the UID to all non-confidential information concerning the same chemical substance from any company except in cases where doing so might reveal the identity of confidential substance. In those cases, which EPA expects to be rare, EPA would not apply the UID to non-confidential documents if doing so would result in a linkage that undermines the CBI claim. EPA reiterates that the basic criterion for application of the UID to submissions made by different submitters is that EPA’s act of applying the UID must not disclose to the public the confidential specific chemical identity that the UID was assigned to protect.
Comments are due by March 12, 2018. More information on CBI under TSCA is available on our blog.
By Charles M. Auer and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system. The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements. The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many substance identities in a batch. The template file is a comma separated value (CSV) file, CSV-NAA.csv, that is readable by most spreadsheet and database programs. The change means that if submitters attempt to use the old template, the CSV file will not upload properly and will generate errors in CDX.
The template was updated by adding a new field name. The new field name that will be added to the CSV file is “Isjoint,” and the field explanation is “NOA is joint with another submitter;” which permits filers to upload and start multiple joint submissions in a batch. The field names required, along with their field explanations, are:
- Isjoint: NOA is joint with another submitter.
- CASRN: CASRN with our without dashes; after upload, dashes will be present. Must be “TRUE” or “FALSE”;
- Accession Number: Accession number for substances listed on the confidential portion of the Inventory;
- Chemical Cbi: Submitter seeking to maintain CBI claim for substance identity. Must be “TRUE” or “FALSE”;
- Submitter Cbi: Submitter claiming CBI for submitter identity. Must be “TRUE” or “FALSE”;
- Company Details Cbi: Submitter claiming CBI for submitting company details. Must be “TRUE” or “FALSE”;
- Technical [Contact] Cbi: Submitter claiming CBI for technical contact identity. NB: “Contanct” is misspelled in the template. Must be “TRUE” or “FALSE”;
- Substantiation CBI: Submitter claiming CBI for substantiation statement(s). Must be “TRUE” or “FALSE”; and
- ShowCbiQuestions: Set to TRUE to substantiate CBI claims. This is required for submitter, company, and technical contact claims. Must be “TRUE” or “FALSE.”
By Lynn L. Bergeson and Margaret R. Graham
On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2). 82 Fed. Reg. 43964. The new deadline for substantiation of these claims is October 19, 2017. EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.” Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.”
More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.
Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule. The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers. Registration for the webinars is not required. EPA’s TSCA Inventory webpage contains the information on how to access the webinar.
More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
By Lynn L. Bergeson and Margaret R. Graham
On March 10, 2017, the U.S. Environmental Protection Agency (EPA) announced that its Office of Pollution Prevention and Toxics (OPPT) would be hosting two webinars covering the use of the Central Data Exchange (CDX) for upfront confidential business information (CBI) substantiation. Per EPA’s notice on January 19, 2017, the statutory requirements for substantiation of CBI claims will change effective March 21, 2017, for Toxic Substances Control Act (TSCA) submissions. In preparation for this change, OPPT revised the CDX TSCA reporting applications to allow for upfront substantiation of CBI claims.
OPPT’s first webinar will be March 15, 2017, at 1:00 p.m. (EDT) and the second will be on March 21, 2017, at 1:00 p.m. (EDT). EPA states that these webinars will cover technical aspects of making upfront substantiations within the CDX reporting applications, and that OPPT would appreciate help in identifying participants that currently use CDX reporting applications or will do so under the new requirements to participate in these events.
Registration is available online. The webinars will be limited to the first 1,000 registrants and registration will close at 11:00 a.m. (EDT) on the date of each webinar. After the webinar, OPPT will post the webinar materials on its Confidential Business Information under TSCA webpage. More information on the statutory requirements for substantiation of CBI claims is available in our blog item EPA Issues Guidance On Substantiation Requirements For CBI Claims Under TSCA.
By Lynn L. Bergeson
On February 21, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice delaying the effective date from March 20, 2017, to March 21, 2017, of the notice issued on January 19, 2017. 82 Fed. Reg. 11218. The February 21 notice appears to correct a miscalculation of the 60-day freeze period required under the Regulatory Freeze Pending Review memorandum issued on January 20, 2017, to the notice EPA issued on January 19, 2017, titled Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA). 82 Fed. Reg. 6522. Counting calendar days is never easy.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning confidential business information (CBI) claims for information submitted to EPA. 82 Fed. Reg. 6522. Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA. In the notice, EPA also states that the action will “facilitate [its] implementation of TSCA section 14(g) to review all CBI claims for chemical identity, with limited exceptions, as well as to review a representative sample of at least 25% of other non-exempt claims.” Information that is (or will be) submitted and claimed as CBI between June 22, 2016, and March 19, 2017 (inclusive), must be substantiated by September 19, 2017. CBI claims made as part of an existing submission in EPA’s Central Data Exchange (CDX), such as a premanufacture notice (PMN), must be substantiated by amending the CDX submission. Other information should be substantiated using the same mechanism (e.g., substantiate claims made on paper by submitting substantiations on paper). This action will become effective on March 20, 2017. More information on this notice will be available in our forthcoming memorandum on our website under the key phrase TSCA.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
The topics from Section 8 of TSCA, regarding reporting and retention of information, included: Small Manufacturer Definition; Reporting by Processors; Inorganic Byproduct Rulemaking and Reporting; TSCA Inventory; and Nomenclature. The key points from this portion included:
- The sales thresholds for small manufacturers are likely to rise from the current level that was set in 1986;
- TSCA Inventory “reset” will require companies to report for substances manufactured or imported in the last 10 years and there will be no exemptions for polymers or low volume substances;
- EPA may impose different requirements for CDR reporting by manufacturers and processors;
- EPA must enter into negotiated rulemaking to reduce CDR reporting for recycling and reprocessing inorganic byproducts; and
- Interested parties should be aware of rulemaking on these issues as well as rules that EPA will be promulgating to implement other sections of TSCA.
The topics from Section 14 of TSCA, regarding CBI, included: Information Not Protected; Asserting CBI; Presumptive CBI; Requirements for CBI Claims; Exemptions to Protection from Disclosure; Review and Resubstantiation; Duties of Administrator; and Criminal Penalties. The key points from this portion included:
- Most CBI claims made prior to enactment of TSCA reform will not require substantiation, but claims going forward, including chemical identity for substances notified as “active” on the TSCA Inventory will require substantiation;
- EPA must review all CBI claims for chemical identity;
- CBI protection that requires substantiation will sunset after ten years; claimants may reassert and resubstantiate claims to continue protection for another ten year period;
- EPA must disclose CBI upon request from state, municipal, and tribal officials who demonstrate the need for the information and agree to protect CBI;
- EPA must also disclose CBI upon request from medical professionals if it is reasonable to believe the information is necessary to treat a patient; and
- In most cases, EPA will notify CBI claimants prior to disclosing CBI to persons that are not federal employees or federal contractors.
The panel speakers were, from B&C: Charles M. Auer, Senior Regulatory and Policy Advisor, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA); Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Senior Chemist, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program; and Kathleen M. Roberts, Vice President, B&C Consortia Management, L.L.C.; and from Chemical Watch: Kelly Franklin, North America Reporter & Editor.
The fourth and final webinar in the series, “Other Provisions -- PBTs, Preemption, and Green/Sustainable Chemistry” will be presented on September 27, 2016.