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.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The “key changes” that EPA notes are:
New Certification Requirement. Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several statements. The certification language is incorporated into electronic reporting tools for TSCA submissions requiring or permitting electronic reporting. Entities who make TSCA submissions on paper must now also include the following statements in the submission:
- I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
- I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that:
- (i) My company has taken reasonable measures to protect the confidentiality of the information;
- (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
- (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
- (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
- Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.
Substantiation Requirements. Existing substantiation requirements for certain types of CBI claims continue to remain in effect. EPA notes that it may develop further guidance and require additional requirements in the future.
Generic Names. A structurally descriptive generic name is now required where specific chemical identity is claimed as CBI. EPA will be relying on existing generic name guidance for the creation and approval of generic names until updated guidance is developed.
EPA’s Review of Claims. EPA will be reviewing and approving or denying a CBI claim for specific chemical identity and a proportion of CBI claims for other types of information in accordance with TSCA § 14. EPA states that it may contact submitters of CBI to corroborate their CBI claims to the extent that substantiation has not already been provided.
While the guidance is welcomed and useful, it sheds no light on how best to corroborate a claim of CBI and how best to respond to an EPA allegation that the CBI claim is lacking. These questions will continue to be debated; when in doubt, consult legal counsel.
More information is available on EPA’s website. Please also join Bergeson & Campbell, P.C. (B&C®) and Chemical Watch on September 12, 2016, for the third complementary webinar in the series on “‘The New TSCA -- What You Need to Know,” featuring information on the TSCA Inventory, Chemical Data Reporting (CDR), and CBI.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.
All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.
Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."
Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)
- Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
- Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
- Kelly Franklin, Chemical Watch
- Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.
- Section 8 Reporting and Retention of Information
- Small Manufacturer Definition
- Reporting by Processors
- Byproduct Rulemaking and Reporting
- Toxic Substances Control Act (TSCA) Inventory
- Section 14 Confidential Business Information (CBI)
- Information Not Protected
- Asserting CBI
- Presumptive CBI
- Requirements for CBI Claims
- Exemptions to Protection from Disclosure
- Review and Resubstantiation
- Duties of Administrator
- Criminal Penalties
Additional Webinars in "The New TSCA" Series:
||Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
||Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
||Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.
By Sheryl L. Dolan, Kathleen M. Roberts, James V. Aidala, and Lynn L. Bergeson
On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA). Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016.
During the meeting, EPA solicited public comment in particular on the following five issues:
- To be able to defray 25 percent of costs of administering Sections 4, 5 and 6, and Confidential Business Information (CBI), does industry have considerations of weight amongst the three areas of fee collection?
- Does industry have thoughts on the types of factors (types of submissions, numbers of submissions, level of difficulty, etc.) that EPA should consider when structuring the fees?
- Has industry considered how to distribute payment amongst multiple manufacturers and/or processors?
- Does industry have thoughts on how to identify the whole universe of manufacturers, including importers and processors affected?
- Does industry have thoughts on how to arrive at an appropriate balance between manufacturers and processors?
In its presentation, EPA stated that it intends to publish a proposed rule by mid-December 2016, and a final rule in time for its statutory June 22, 2017, deadline.
Four industry trade associations gave prepared remarks during the meeting: the American Chemistry Council; the American Petroleum Institute; the Society of Chemical Manufacturers and Affiliates; and the American Fuel & Petrochemical Manufacturers. Their comments reflected several common but competing themes, including:
- EPA needs to share its expectations of internal costs as a starting point for discussions of the fee structure.
- The fee system should be straightforward to implement.
- EPA should be mindful in developing a fee structure so as not to stifle innovation; for example, placing too high of fees for review of new chemistries under Section 5 or confidentiality claims under Section 14.
- Not all sections should be given equal weight; in particular, as industry will pay for Section 4 data development, it should not be double-charged by assessing a fee for EPA’s review of these data.
- EPA must provide adequate consideration for the effect on small businesses.
- Consideration should be given to incremental fees, tied to EPA milestones.
- A business should have a way to exit from a Section 6 risk evaluation process if it elects to exit the market.
Congress recognized that the new TSCA tasks EPA with significant additional responsibilities, and included Section 26 as a venue to ensure adequate resources would be available to develop the infrastructure to meet these responsibilities according to the specified timelines and in conformity with sound science. Input from all affected stakeholders will be needed to devise a workable TSCA fee system, particularly in the compressed timeframe for rule development.
EPA and industry stakeholders are supportive of a simple framework, but the complexities and current unknowns of how new TSCA will operate will make this goal challenging. Many questions exist that will not be answered before next week’s comment deadline:
- Should a company have to pay fees for a Section 6 risk evaluation on uses that it does not support?
- Should there be fees associated with Section 6 prioritization actions? If not, does that mean that only high priority chemicals will have Section 6 fees assessed on them?
- Given the new threshold for affirmative findings under Section 5, will EPA complete the same number of new chemical notifications that it has in the past? If not, should that anticipated reduction in notification reviews be reflected in the fees proposal?
- Most industry stakeholders recognize that the current PMN fee of $2,500 will be increased, but how much is too much?
- As previously noted, is it appropriate to require industry to pay for testing under Section 4, and then charge for EPA review of that test data?
- To ensure that sufficient funds are raised, will we need to assess a fee for every “touch” that EPA has within Sections 4, 5, and 6? How can that cost be fairly allocated among all industry players, including small businesses?
While EPA did not offer to share information on budgets at the August 11, 2016, meeting, the Office of Pollution Prevention and Toxics (OPPT) presumably has pertinent information supporting its annual budgets that must be shared in the near term if it hopes to receive any meaningful ideas on a proposed fee structure. Although past program outputs done under old TSCA may bear little resemblance to the duties EPA now has under new TSCA, EPA’s new policies and responsibilities will be some scale of past program capabilities and budget.
Of more relevance will be the experience of OPPT’s sister program, the Office of Pesticide Programs (OPP). OPP has had a dedicated stream of user fees since the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and additional fees were imposed in 2004 with enactment of the Pesticide Registration Improvement Act (PRIA) fee-for-service program. While the FIFRA product licensing program is different in many respects from TSCA, there are relevant commonalities that OPPT should find helpful. OPP has a time accounting system, for example, that provides a principled basis on which to estimate the time required for study report review and risk evaluation.
With estimates derived from the time accounting system, OPP (and presumably OPPT) can estimate how much it costs EPA to review toxicity studies individually. For example, there is an estimate of how much it costs EPA to review a 90-day subchronic study, or how much to review a genotoxicity study. These calculations form the basis of the PRIA fee scheme, as PRIA is designed to generate one-third of the program costs involved. The “simple” general rule underlying a now elaborate fee schedule with almost 200 categories is that the more science review involved, the greater the required fee. The new law may not need or want to have so many different categories, but the operating principle can remain the same.
For OPPT, the dollar amounts could vary from OPP given the statutory limitation of the maximum amount to be generated, but the more difficult question will be how OPPT calculates its expected workload under the new law. Given the wealth of information available through OPP’s experience, sharing this information would further inform the public about what to expect in, or options for how to fashion, a fee scheme.