By Lynn L. Bergeson and Margaret R. Graham
On February 8, 2018, the U.S. Environmental Protection Agency (EPA) issued the prepublication version of its long-anticipated fees rule under amended Toxic Substances Control Act (TSCA) Section 26(b) entitled User Fees for the Administration of the Toxic Substances Control Act. EPA states that the proposed rule will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).
EPA’s notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years. In proposing these new TSCA user fees, the Agency also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.
EPA states the proposed fees on certain chemical manufacturers, including importers, would go towards developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and information; reviewing Confidential Business Information (CBI); and making determinations regarding the safety of new chemicals before they enter the marketplace.
Comments on the proposed rule will be due 60 days after its publication in the Federal Register.
An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) will soon be available on our Regulatory Developments webpage.
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 Zameer Qureshi
Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), presented at Chemical Watch Enforcement Summit Europe in Brussels on November 4, 2016. Topics covered by Ms. Bergeson included “A New [Toxic Substances Control Act (TSCA)] and Expanded Enforcement and Product Liability Opportunities,” “Next Generation Compliance and Implications for Businesses,” and “eDisclosure -- The New Normal?”
Ms. Bergeson informed attendees of the significant amendments made to chemical regulation in the U.S. by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). She indicated that new TSCA amends TSCA in a number of ways and provided delegates with useful detail on the significant amendments made by new TSCA, stating that new TSCA:
- Resets the Chemical Inventory based on industry-supplied data;
- Requires screening assessments for all “active substances”;
- Mandates risk evaluation for all “high-priority” substances and risk management for some substances;
- Compels substantiation of confidential business information (CBI) claims; and
- Authorizes testing order authority (i.e., the U.S. Environmental Protection Agency (EPA) can compel chemical testing in addition to the more traditional test rule and consent order testing procedures).
Ms. Bergeson utilized a slide entitled “New Compliance Mandates = New Enforcement Opportunities” to address EPA’s expanded authority under new TSCA (e.g., Section 4 test orders, Section 5 new chemical safety “determinations,” and Section 6 prioritization). She expressed that EPA’s expanded authority under new TSCA gives rise to significant opportunities for enforcement of allegations of non-compliance when Section 4 test orders are issued.
Regarding testing, Ms. Bergeson stated “the [U.S.] testing program has relevance for people anywhere in the world” as chemical manufacturers can be expected to be ordered to test, and manufacturers include importers. Ms. Bergeson expressed that more testing will trigger an enhanced need to consider reporting under new TSCA Section 8(e). She described the possible outcomes of new chemical safety “determinations” by EPA under Section 5 and indicated that as a consequence of new TSCA “we’re going to see lots and lots of new [Significant New Use Rules (SNUR)].” Additionally, Ms. Bergeson stated “[Chemical Data Reporting (CDR)] requirements and Section 8 requirements are much more robust now.”
Drawing on her experience and current information from EPA, Ms. Bergeson analyzed “Next Generation Compliance” and provided insights to attendees on what it means for industry. She relied on a diagram from EPA that indicates Next Generation Compliance encompasses an intersection of “Regulation and Permit Design,” “Advanced Monitoring,” “Electronic Reporting,” “Transparency,” and “Innovative Enforcement.” Ms. Bergeson stated “Next Gen Compliance is an Obama Administration initiative” and emphasized the relevance of the U.S. presidential election for the future of Next Generation Compliance by stating “Next Generation Compliance will likely grow under the Clinton Administration or may die on the vine under a Trump Administration.” She then discussed each of the individual components of Next Generation Compliance.
Regarding Regulation and Permit Design, Ms. Bergeson stated that EPA’s goals were to “make permits clearer,” promote self-monitoring and third-party reporting, make compliance easier than non-compliance, and leverage market forces and incentives.
Ms. Bergeson stated that the expansion of “Advanced Monitoring Technologies” means there are new tools that can assist industry. She described the usefulness of real-time monitoring (i.e., knowing about releases into the environment on a real-time basis), facility feedback loops, fenceline and community monitoring, and remote sensing. Ms. Bergeson noted, as a potential drawback of Advanced Monitoring, that “technologies that have not necessarily been vetted” are finding their way into enforcement consent agreements. She then indicated that while this may be fine, the reliability of such technologies for regulatory purposes is untested and reliance on such technologies in regulatory contexts should not replace more traditional notice and comment rulemaking.
Ms. Bergeson stated “Electronic Reporting is a huge part of Next Generation Compliance; the era of submitting paper [is over],” and informed delegates that “information technologies enable new solutions, but invite concerns regarding accuracy and regulatory reliability.” She stated “Electronic Reporting does not always go as intended and greatly facilitates finding non-compliance.” Ms. Bergeson referenced the relevant EPA memorandum and informed attendees that Electronic Reporting is the default mechanism for providing information under new TSCA, and stated that Ohio Discharge Monitoring Report Electronic Reporting “checks submissions overnight and sends notices” if there are problems, thereby allowing the permittee to make corrections and resubmit.
Regarding Innovative Enforcement, Ms. Bergeson expressed that EPA is using Next Generation tools in enforcement settlements, and that Innovative Enforcement enhances targeting and data analysis to identify and address the most serious violations. She stated “we really like new technologies, but if a technology is new it may not be standardized, making reliance on it necessarily more focused to enforcement and not rulemaking purposes.” Additionally, Ms. Bergeson informed delegates that there is “a little concern in the regulated community in the U.S.” that some of the new technologies evolving from Innovative Enforcement efforts could undermine the notice and comment rulemaking process if these technologies are used for purposes beyond consent orders.
Ms. Bergeson stated that EPA’s “eDisclosure” portal provides companies with a new way to self-report violations of environmental law and is intended to “streamline confessions” by the “legal and corporate community,” and described the two-tier system within EPA’s eDisclosure portal and stated that for some violations “you can get on with your life.”
Ms. Bergeson stated “we always urge [B&C] clients to fix the problem immediately … The issue arises in some contexts of ‘do we tell EPA?’” She then informed delegates of the underpinning principles of eDisclosure by stating “it is believed that self-confessing should be rewarded.” Ms. Bergeson advised that companies can seek to reduce penalties by self-confessing, but the decision to self-confess is always fact dependent, and then indicated that the future of eDisclosure could be significantly impacted by the outcome of the U.S. presidential election.
Ms. Bergeson addressed “Design and Use of Safer Chemicals” and told attendees that EPA has “tried very hard” to promote Safer Chemicals through Green Chemistry, Safer Choice Labels, and the Safer Chemical Ingredient List, and that “creative technologies that are better, cheaper, and less toxic” are actively encouraged by EPA and welcomed by the U.S. chemical regulatory community.
Ms. Bergeson expressed that the implications of new TSCA are significant for the chemical manufacturing, importing, and downstream user sectors and provided beneficial “Closing Thoughts” to attendees. She stated that chemical manufacturers, importers, and downstream users need to:
- Read and understand the law and engage in “trade associations’ implementation activities”;
- Assess chemical product inventories;
- Manage the “business and optics” of chemical assessment, management, and substitution;
- Assess CBI options; and
- Manage chemical data information carefully.
Ms. Bergeson stated that the “implications of new TSCA are paradigm shifting … In the next two to five years we’re going to see opportunities for non-compliance.” Regarding CBI, Ms. Bergeson stated “we need to be very cognizant … Some of the changes are very subtle and it is an area ripe for enforcement … Assertion of CBI is at a higher standard -- EPA will be very vigilant.” Ms. Bergeson emphasized EPA’s “much richer implementation authority” under new TSCA and informed delegates that Next Generation enforcement and eDisclosure tools “add to the pressure” on the U.S. chemical industry to monitor carefully chemical portfolios.
Ms. Bergeson answered a number of questions on new TSCA and EPA’s likely enforcement of it. In response to a delegate’s question relating to the capacity of EPA to manage enforcement of new TSCA, she stated that EPA requires greater resources and is currently recruiting. Ms. Bergeson answered questions from attendees on timelines for pending rules from EPA and highlighted EPA’s interest in expediting its rulemaking on fees. She indicated that fees will be higher under new TSCA. Ms. Bergeson responded to a question regarding the scope of new TSCA by clarifying that new TSCA relates to industrial chemicals and that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) will continue to maintain their previous regulatory scope. Ms. Bergeson indicated that the only exception is found under TSCA Section 8(b)(10), which requires any or all mercury or mercury compounds, or any intentional use of mercury in a manufacturing process to be reported to EPA under the mercury inventory and reporting provisions, regardless of whether the use of the mercury or mercury compound is regulated under FIFRA or FFDCA.
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.