By Lynn L. Bergeson and Margaret R. Graham
On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” The Framework Document, as it has come to be called, is the “final rule” at issue and was posted in EPA’s docket opened for comments related to its two Toxic Substances Control Act (TSCA) public meetings that took place in December. It is reasonable to assume that the Framework Document is not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a conceptual approach to how EPA may go about making decisions on new chemicals. EPA specifically states the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” and includes EPA’s “general decision framework for new chemicals” and a breakdown of how EPA “intends to approach each of the five types of new-chemical determinations required under the statute.”
The citizen action petition raises novel and interesting legal questions, and is quite different from the other petitions for review, one for each framework final rule, that are pending. Whether the newest legal challenge will survive procedural motions that EPA can be expected to file to dismiss the action remains to be seen. More information on the framework rule petitions for review is available on our blog under key phrases framework rules and petition for review.
By Richard E. Engler, Ph.D., Lynn L. Bergeson, Kathleen M. Roberts, and Lauren M. Graham, Ph.D.
On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA). EPA offered brief prepared remarks and previously solicited questions from stakeholders. Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues. For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.” Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).
Conditions of Use, SNURs, and PMNs: EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding. EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible. Several commenters requested clarification and examples on the information that will support such identifications. This is plainly an area of intense interest and on which EPA pledged to clarify.
EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns. In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews. Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.
NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot. Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency. Several NGOs also voiced concern with the delay of EPA getting PMN information posted online. Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).
Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs. Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs. The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final. Industry representatives also suggested that EPA seek to scale its information needs appropriately. For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical. Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.
Chemical Categories: EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews. These are:
- Lung Effects Categories: Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
- Photo-Acid Generators (PAG) Category;
- Tracer Chemical; and
- Perfluorinated Chemicals.
EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).
OSHA Focus: On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language. Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits. In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.
Sustainable Futures Program: EPA asked for input as to whether it should continue the Sustainable Futures Program. Some commenters supported the Sustainable Futures Program; no commenters spoke against it.
The presentations from the meeting are listed below and available online:
- New Chemical Review under Amended TSCA -- Jeff Morris, Ph.D., Director, OPPT
- Points to Consider (PtC) When Preparing TSCA New Chemical Notifications -- David A. Tobias, Ph.D., Risk Assessment Division, OPPT
- New Chemicals Decision Guidelines Manual Detailed Outline
- Chemical Categories -- Tala R. Henry, Ph.D., Director, Risk Assessment Division, OPPT
- Other Advance Questions -- Tanya Hodge Mottley, Acting Deputy Director of Programs, OPPT
EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017. More information on this upcoming meeting is available on our blog under key phrase public meeting.
By Lynn L. Bergeson and Margaret R. Graham
On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting. NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future. EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework. The meeting materials include:
- Agenda for Public Meeting. The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods. Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
- New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA. EPA states that this document includes EPA’s general decision framework for new chemicals and a breakdown of how EPA intends to approach each of the five types of new-chemical determinations required.
- Points to Consider When Preparing TSCA New Chemical Notifications (Draft). This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice. EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
- Overview of Comments Received on the Draft "Points to Consider" Document. This document summarizes 151 comments received on the draft Points to Consider document. It organizes them by topic. The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings. These comments have not been posted in the docket for this meeting.
- New Chemicals Decision Guidelines Manual – Detailed Outline. EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5. It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.
More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.
By Lynn L. Bergeson and Margaret R. Graham
On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments. The meetings are:
- New Chemicals Review Program Implementation Meeting: December 6, 2017, from 9:00 a.m. to 5:00 p.m. (EST). EPA’s first meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework. EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions. EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA. EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017. Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov. Registration for this meeting is available online.
- Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting: December 11, 2017, from 9:00 a.m. to 5:00 p.m. (EST). EPA’s second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA. As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances. EPA will describe and take comment on a number of possible approaches that could guide it in the identification of potential candidate chemical substances. EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017. Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.gov. Registration for this meeting is available online.
Online requests to participate in either meeting must be received on or before December 5, 2017. Both meetings will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.
By Lynn L. Bergeson
On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition. That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016. What is less clear is how EPA is making these determinations. The coalition’s mission is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process.
Joining the coalition is easy. We are asking for a flat fee of $1,000 per company for a 12 month period. We are not currently allowing trade associations to join. The chemical community has participated in ad hoc coalitions for years, so the drill is familiar. Dues will be used to:
- Convene meetings and calls;
- Develop advocacy positions on crucial issues to be decided and prioritized, including preparing for EPA’s Fall 2017 release of documents on how it reviews new chemicals; and
- Provide informed and effective comment on these issues and meet with EPA leadership to advocate for the Coalition’s views on these issues.
More information is available in our memorandum Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition.”
On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management. On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing processes. This article summarizes key changes to TSCA and explains their likely impacts on the manufacturing sector.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.” 82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017). The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA). The notices listed in the December 2016 statement of findings are:
- EPA Case Number (MCAN): J-16-0033: Chemical identity: Saccharomyces cerevisiae modified to express glucoamylase activity (generic name);
- EPA Case Number (MCAN): J-16-0034: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (MCAN): J-16-0035: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Numbers (MCANs): J-16-0036 to J-16-0041: Chemical identity: Biofuel producing modified microorganism(s), with chromosomally-borne modifications (generic name);
- EPA Case Number (PMN): P-17-0009: Chemical identity: Depolymerized waste plastics (generic name);
- EPA Case Numbers (PMNs): P-17-0016, P-17-0017, P-17-0019, and P-17-0020: Chemical identity: Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated (generic name); and
- EPA Case Numbers (PMNs): P-17-0018 and P-17-0021: Chemical identity: Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis [aliphatic nitrile] initiated (generic name).
The notices listed in the February 2017 statement of findings are:
- EPA Case Numbers (MCANs): J-17-0001 to J-17-0005: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (MCAN): J-17-0006: Chemical identity: Saccharomyces cerevisiae modified (generic name);
- EPA Case Number (PMN): P-17-0144: Chemical identity: Amines, C36- alkylenedi-, polymers with octahydro- 4,7-methano-1H-indenedimethanamine and pyromellitic dianhydride, maleated (CASRN: 2020378-57-6);
- EPA Case Number (PMN): P-17-0158: Chemical identity: Perylene bisimide (generic name);
- EPA Case Number (PMN): P-17-0160: Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2- propenoate, dialkyloxoalkyl-2- propenamide and alkyl 2-propenoate (generic name);
- EPA Case Number (PMN): P-17-0161: Chemical identity: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2- propenoate, dialkyloxoalkyl-2- propenamide, ethenylbenzene and alkyl 2-propenoate (generic name);
- EPA Case Number (PMN): P-17-0182: Chemical identity: Alkyldioic acid, polymer with 2,2-dimethyl-1,3- propanediol, heteropolycyclic carboxy acid anhydride and 1,3-propanediol (generic name); and
- EPA Case Number (PMN): P-17-0185: Chemical identity: Fatty acids, C18- unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid trimers, alkylenediamine and hydroxyalkanoic acid (generic name).
The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website. It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website. We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices. We are pleased to see new chemicals cleared for production.
Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform. Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues. To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards. With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.
By Lynn L. Bergeson and Molly R. Blessing
As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA). Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m. Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.
EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.” Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.” Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”
In-person and webinar registration is available now. EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.
More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.
As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders. Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting. This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.
One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”
Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.
This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B)) that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).” The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination. We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).
While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.” During the meeting, interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMN), microbial commercial activities notices (MCAN), and significant new use notices (SNUN), under TSCA Section 5. EPA states that information obtained during this meeting and from submitted written comments will be considered as it works to implement the new requirements and increase efficiency in its review process under TSCA.
There has been considerable concern with the impact of new TSCA on EPA’s New Chemicals Program. EPA is to be recognized for seeking stakeholder input, and interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can reasonably achieve from the meeting. This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.
In-person and webinar registration is available now. EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658. More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended 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.