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 May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval. In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations. EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation. Comments were due March 20, 2017; 70 comments were filed. Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017.
More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, released today by the American Bar Association (ABA). This new book is a comprehensive guide to the substantial revisions to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, to produce “new TSCA,” amending and replacing “old TSCA” as of that date. B&C Managing Partner Lynn L. Bergeson and Senior Regulatory and Policy Advisor Charles M. Auer are editors and co-authors, with contributions from B&C’s outstanding TSCA practice group, including Timothy D. Backstrom, Lisa R. Burchi, Lisa M. Campbell, Sheryl L. Dolan, Richard E. Engler, Ph.D., Margaret R. Graham, Oscar Hernandez, Ph.D., Carla N. Hutton, and Kathleen M. Roberts.
Readers of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation will gain an appreciation of the fundamental shifts in the requirements and approach to chemical management under new TSCA, and will benefit from thorough analysis of a number of the provisions, including those relating to definitions, testing, review and regulation of new and existing chemicals, information reporting, confidential business information (CBI), preemption, fees, and others. A 15-page Executive Summary of the book is available on the ABA website.
Reflecting on the book, Ms. Bergeson stated: “New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation reflects the expert counsel and advice of seasoned scientific and regulatory professionals and, of course, the essential views of former U.S. Environmental Protection Agency regulators and scientists, each of whom knows intimately the law, policy, and science of TSCA. Collectively, there is no stronger, more experienced TSCA team in the country to assist the regulated community tackle the challenges posed and seize the opportunities presented by the new law."
New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation is available for purchase via the ABA online bookstore.
By Lynn L. Bergeson
On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency. Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals. As stated in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan, this rule is the first of three “Framework Action” rules that the Frank L. Lautenberg Chemical Safety for the 21st Century Act (new TSCA) has directed EPA to issue in final within one year of enactment, or by mid-June 2017. For all three of these rules, the interim milestone for the proposed rules is mid-December 2016; therefore, it is anticipated that the three other rules will soon be sent to OMB for review as well. The two others are:
- Risk Evaluation Process Rule: A Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals; and
- Inventory Rule: Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.
There is a fourth Framework Action rule that new TSCA has directed EPA to issue as well, but it does not have a deadline for issuance in final; new TSCA only species the mid-June 2017 date as a goal:
- Fees Rule: EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.
More information on the implementation of new TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.
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 Zameer Qureshi
On October 4, 2016, Bergeson & Campbell, P.C. (B&C®) hosted its fourth and final webinar in its series of webinars on the new Toxic Substances Control Act (TSCA) in collaboration with Chemical Watch. The webinar addressed numerous important issues for a wide array of stakeholders. The webinar was moderated by Lynn L. Bergeson, Managing Partner at B&C, and the expert panel included Charles M. Auer, Richard E. Engler, Ph.D., Lisa R. Burchi, and Sheryl L. Dolan.
Mr. Auer, Senior Regulatory and Policy Advisor at B&C, addressed “Administration of the Act” and described important changes between old and new TSCA. Mr. Auer’s presentation consisted of three segments: (1) “Section 26 Science Requirements”; (2) “Section 26 Information and Guidance”; and (3) “Section 26 ‘Savings’ Provision.”
Mr. Auer addressed the “Scientific Standards” requirements of new TSCA Section 26(h), the “Weight of Scientific Evidence” requirements of Section 26(i), and the Section 26(o) provisions of new TSCA relating to Consultation with the Science Advisory Committee on Chemicals (SACC). Mr. Auer addressed a number of additional rules and requirements in Section 26, including the U.S. Environmental Protection Agency’s (EPA) obligation to submit a report to Congress and issue an Annual Plan under Sections 26(m)-(n).
Ms. Burchi, Of Counsel at B&C, discussed “Preemption” under Section 18 of new TSCA. Ms. Burchi described preemption as “one of the most debated subjects in [the TSCA reform] debate” and stated that she had heard it referred to as a “linchpin” in terms of reaching agreement on provisions for TSCA reform to occur. Ms. Burchi stated “Everything in the new Section 18 is new or very significantly changed from what we were used to with regard to preemption … The final provisions are fairly complicated … It will remain to be seen whether states continue to act with regard to chemical substances in the way that they have been.”
Ms. Burchi addressed the three “main” provisions related to preemption under new TSCA Sections 18(a)(1)(A)-(C), and analyzed more specific issues (e.g., pause preemption) and the related exceptions. Ms. Burchi described the TSCA Section 18(d)-(e) provisions relating to “Exceptions” and “Preservation of Certain Laws.” Ms. Burchi also addressed new TSCA’s Section 18(f) “Waivers” provisions and concluded her segment of the presentation with the following statement: “It remains to be seen whether states are going to be jumping in to [take action] when EPA has already identified a chemical for prioritization and review … [There will be some interesting provisions and interplay] to be seen as we move forward under new TSCA.”
Ms. Dolan, Senior Regulatory Consultant at B&C, analyzed “Fees” under new TSCA and addressed EPA’s obligations to: (1) set lower fees for small business concerns; (2) consider balance between manufacturers and processors; and (3) consult with the regulated community. Ms. Dolan stated “new TSCA directs EPA to review its fee program on a three-year cycle and revise it as needed to raise the target fees … While new TSCA did not set a deadline for developing the fees program, it really didn’t have to -- EPA, of course, has every incentive to knock this rulemaking out quickly.”
Ms. Dolan indicated that a final rule is expected on fees under new TSCA by June 2017, and provided an overview of comments received on the proposed rule. Ms. Dolan stated that “overarching themes” in the comments included that: (1) fees should be tied to the level of required effort; (2) fees should encourage innovation; and (3) fees should not be overly complex or difficult to administer. In relation to (3), Ms. Dolan quoted a commenter that stated “don’t give us the [Internal Revenue Service (IRS)] Code.”
Ms. Dolan stated “everyone seems to want to know how much will a [pre-manufacture notice (PMN)] cost in the future … I think the answer to that [will come with a big red bow] in December. Specifically, EPA states that it will send a proposal to [the Office of Management and Budget (OMB)] in mid-October … EPA may well set a comment period of at least 60 days for this proposed rule.”
Dr. Engler, Senior Chemist at B&C, discussed Sustainable Chemistry (i.e., Green Chemistry) under new TSCA. Dr. Engler stated “new TSCA is largely silent on sustainability” and indicated that the “primary benefit” to Sustainable Chemistry under new TSCA is the abbreviated review period when EPA determines that a new chemical is “not likely to present” an unreasonable risk (i.e., 90-day period waived and manufacturers can commence manufacturing immediately). Dr. Engler addressed chemicals that EPA considers to present low hazard for health and ecotoxicity (“low/low” chemicals) and stated that new TSCA could be “more of a driver for Sustainable Chemistry,” if only low/low chemicals escape regulation.
Dr. Engler addressed “Relative Risk under New TSCA” and EPA’s “Safer Choice Program” (SCP). Dr. Engler discussed the Senate Report on S. 697, which suggested that EPA should consider “private sector voluntary consensus standards as an alternative” to SCP. Dr. Engler indicated that as the relevant section of the Senate report concerns Section 23, the Sustainable Chemistry Section that was not included in the enacted new TSCA, it is unclear how it applies to new TSCA as enacted. Dr. Engler stated that EPA is proceeding with SCP and hosting a summit in November on this topic.
The webinar concluded with a Questions and Discussion (Q&D) session, and B&C’s expert panel provided useful answers and analyses in response to attendees’ questions. Ms. Bergeson moderated the Q&D session, which was organized by topic.
In the Q&D session, Ms. Bergeson stated and asked Ms. Dolan: “Fees are super important … [small businesses and startups] might have a hard time mustering any type of financial liquidity to get their notifications through the gauntlet of EPA -- so how would you expect EPA to be defining lower fees for purposes of small business provision?”
Ms. Dolan responded by stating “[currently, the ratio is $2,500 and $100 for small businesses. I would imagine there will be some kind of comparable proportionality and currently there are other submissions (e.g., Low Volume Exemptions) that don’t require any fees. EPA has got to raise the money somewhere -- the more they put it on something else or the more they try to avoid charging fees for things, the more it’s going to jack up the cost and other things. I would imagine that they are going to charge something for everything. Whether they maintain that proportionality of 100:2500 remains to be seen. Another consideration is what constitutes a small business. There is a lot of conversation about that and the fact that definition hasn’t been updated in quite a while … This might be something that is the focus of a lot of attention in the proposed rule.]”
Ms. Bergeson drew on Mr. Auer’s extensive experience with EPA on several occasions during the Q&D session, starting questions with “If you were back at EPA,” and Mr. Auer’s responses were comprehensive. Dr. Engler responded to questions regarding Green Chemistry and discussed Persistent, Bioaccumulative, and Toxic (PBT) substances under new TSCA, and Ms. Burchi answered questions on California’s Safer Consumer Products Regulation (SCPR) and preemption under new TSCA.
More information on TSCA reform and B&C’s “The New TSCA: What You Need to Know” webinar series is available online.
By Lynn L. Bergeson, Kathleen M. Roberts, and Margaret R. Graham
Section 6(h) of new TSCA addresses persistent, bioaccumulative, and toxic (PBT) chemical substances listed in the 2014 TSCA Work Plan. For such chemicals, Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.” As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as will other high-priority chemicals. Instead, EPA will proceed immediately to assess and identify appropriate risk management actions for these chemicals that EPA believes achieves the goal of reduced exposure to the “extent practicable.” EPA is required under new TSCA to issue the proposed risk management rules by June 2019, or three years from enactment of new TSCA, and issue the final rules six months thereafter.
Importantly, manufacturers or other stakeholders of potential Section 6(h) chemicals can request that EPA conduct a risk evaluation prior to risk management decisions. Section 6(h)(5) expressly allows entities to request such risk evaluations, effectively blunting expedited action. The cost of the risk evaluation is borne by the entity requesting the evaluation. Such requests must be received prior to September 22, 2016, a fast-approaching deadline.
This deadline plainly poses ups and downs. On the one hand, absent a risk evaluation, fast tracking the process necessarily invites worst-case assumptions and a high degree of probability regulation actions will be extensive. On the other hand, in the absence of a defined risk evaluation process and a yet-to be-defined fee assessment process or schedule, volunteers may be few and far between. Understandably, a potential requester can be expected to want to know what the risk evaluation cost will be before making a commitment to pay that amount. Nonetheless, even with these uncertainties, under some circumstances the election may be worth considering and stakeholders are urged to consider the risks and benefits quickly as September 22 is less than a month away. Reportedly, EPA is preparing interim guidance for companies that wish to nominate a PBT for risk evaluation, and expects to issue it soon.
By Lynn L. Bergeson and Margaret R. Graham
On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA). Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance, and offer the following highlights.
On August 9, many speakers across different stakeholder groups flagged issues in terms of how EPA should conduct the chemical risk evaluation process:
- EPA must determine compatibility of information from third parties, e.g., assessment documents from other groups including within EPA, with TSCA Section 26 standards;
- EPA needs to improve its exposure methodologies, and develop new ones; EPA needs to modify its exposure ranking to acknowledge that chemical intermediates are typically consumed in the manufacture of a product and do not represent a primary source of exposure, especially outside of the production facility;
- Transparency throughout the risk evaluation process is critical;
- EPA is required to use best available science and weight-of-evidence;
- Potentially exposed and susceptible subpopulations should include workers, pregnant women, infants, fence-line populations, and consider the lifestyles (especially diets) of native populations as appropriate under the conditions of use; and
- EPA should undertake a tiered approach to testing, to minimize vertebrate testing and cost, as new TSCA requires.
As for the content of the actual chemical risk evaluation rule, stakeholders made the following comments:
- The rule should include more content beyond procedures by incorporating definitions for key items such as “weight of scientific evidence” and other scientific standards, and codifying criteria for evidence evaluation;
- The final reports should explicitly identify low exposure/low risk uses considered in the development of the Risk Evaluation; and
- Whether legal scientific requirements under TSCA Sections 6 and 26 need to be reflected in the procedural rule, and not be relegated to guidance documents – there was some disagreement on the best course of action on this issue.
A link to the agenda for the August 9, 2016, public meeting is available here. EPA’s risk evaluation meeting presentation is available here.
On August 10, comments made during the prioritization procedural rule meeting sessions were similar to those made at the August 9 meeting, with an emphasis on the application of Section 26 scientific standards. A few speakers expressed reservations about the prioritization methodology that EPA currently uses and suggested some alternative approaches.
A link to the agenda for the August 10, 2016, public meeting is available here. EPA’s prioritization procedural rule meeting presentation is available here.
If you are having trouble understanding basic process flows under the new Toxic Substances Control Act (TSCA), please reference Dr. Richard A. Denison’s flow charts that depict the basic processes applicable to existing chemicals already in commerce, and applicable to new chemicals prior to market entry. Comparisons are shown between the processes under the old and new TSCA. Dr. Denison is a Lead Senior Scientist at the Environmental Defense Fund (EDF). There are three flowcharts available:
- How the Lautenberg Act Works (Existing Chemicals);
- How the Original TSCA Worked (Existing Chemicals); and
- TSCA vs. Lautenberg Act (New Chemicals).
You can access the flow charts in Dr. Denison’s blog post on EDF’s Health webpage: Understanding basic process flows under the new TSCA.
For a deeper dive into how and when Toxic Substances Control Act (TSCA) programs will change and adapt to “New TSCA,” Chemical Watch and Bergeson & Campbell, P.C. (B&C®) are offering a series of complimentary webinars on “‘The New TSCA’ -- What You Need to Know,” featuring an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. Federal and State regulatory authorities. The second one in the series, Impacts on New and Existing Chemicals Programs (Sections 4, 5 and 6), is scheduled for July 14, 2016. The archived webcast for the first webinar, Major Changes: What to Expect and When to Expect It, is available online. The third and fourth webinars in the series, on Information and Reporting (Sections 8 and 14), and other provisions -- PBTs, Preemption, Green/Sustainable Chemistry, will be scheduled soon. The webinars are moderated by B&C Managing Partner Lynn L. Bergeson.