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 Sheryl L. Dolan, Kathleen M. Roberts, James V. Aidala, and Lynn L. Bergeson
On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA). Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016.
During the meeting, EPA solicited public comment in particular on the following five issues:
- To be able to defray 25 percent of costs of administering Sections 4, 5 and 6, and Confidential Business Information (CBI), does industry have considerations of weight amongst the three areas of fee collection?
- Does industry have thoughts on the types of factors (types of submissions, numbers of submissions, level of difficulty, etc.) that EPA should consider when structuring the fees?
- Has industry considered how to distribute payment amongst multiple manufacturers and/or processors?
- Does industry have thoughts on how to identify the whole universe of manufacturers, including importers and processors affected?
- Does industry have thoughts on how to arrive at an appropriate balance between manufacturers and processors?
In its presentation, EPA stated that it intends to publish a proposed rule by mid-December 2016, and a final rule in time for its statutory June 22, 2017, deadline.
Four industry trade associations gave prepared remarks during the meeting: the American Chemistry Council; the American Petroleum Institute; the Society of Chemical Manufacturers and Affiliates; and the American Fuel & Petrochemical Manufacturers. Their comments reflected several common but competing themes, including:
- EPA needs to share its expectations of internal costs as a starting point for discussions of the fee structure.
- The fee system should be straightforward to implement.
- EPA should be mindful in developing a fee structure so as not to stifle innovation; for example, placing too high of fees for review of new chemistries under Section 5 or confidentiality claims under Section 14.
- Not all sections should be given equal weight; in particular, as industry will pay for Section 4 data development, it should not be double-charged by assessing a fee for EPA’s review of these data.
- EPA must provide adequate consideration for the effect on small businesses.
- Consideration should be given to incremental fees, tied to EPA milestones.
- A business should have a way to exit from a Section 6 risk evaluation process if it elects to exit the market.
Congress recognized that the new TSCA tasks EPA with significant additional responsibilities, and included Section 26 as a venue to ensure adequate resources would be available to develop the infrastructure to meet these responsibilities according to the specified timelines and in conformity with sound science. Input from all affected stakeholders will be needed to devise a workable TSCA fee system, particularly in the compressed timeframe for rule development.
EPA and industry stakeholders are supportive of a simple framework, but the complexities and current unknowns of how new TSCA will operate will make this goal challenging. Many questions exist that will not be answered before next week’s comment deadline:
- Should a company have to pay fees for a Section 6 risk evaluation on uses that it does not support?
- Should there be fees associated with Section 6 prioritization actions? If not, does that mean that only high priority chemicals will have Section 6 fees assessed on them?
- Given the new threshold for affirmative findings under Section 5, will EPA complete the same number of new chemical notifications that it has in the past? If not, should that anticipated reduction in notification reviews be reflected in the fees proposal?
- Most industry stakeholders recognize that the current PMN fee of $2,500 will be increased, but how much is too much?
- As previously noted, is it appropriate to require industry to pay for testing under Section 4, and then charge for EPA review of that test data?
- To ensure that sufficient funds are raised, will we need to assess a fee for every “touch” that EPA has within Sections 4, 5, and 6? How can that cost be fairly allocated among all industry players, including small businesses?
While EPA did not offer to share information on budgets at the August 11, 2016, meeting, the Office of Pollution Prevention and Toxics (OPPT) presumably has pertinent information supporting its annual budgets that must be shared in the near term if it hopes to receive any meaningful ideas on a proposed fee structure. Although past program outputs done under old TSCA may bear little resemblance to the duties EPA now has under new TSCA, EPA’s new policies and responsibilities will be some scale of past program capabilities and budget.
Of more relevance will be the experience of OPPT’s sister program, the Office of Pesticide Programs (OPP). OPP has had a dedicated stream of user fees since the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and additional fees were imposed in 2004 with enactment of the Pesticide Registration Improvement Act (PRIA) fee-for-service program. While the FIFRA product licensing program is different in many respects from TSCA, there are relevant commonalities that OPPT should find helpful. OPP has a time accounting system, for example, that provides a principled basis on which to estimate the time required for study report review and risk evaluation.
With estimates derived from the time accounting system, OPP (and presumably OPPT) can estimate how much it costs EPA to review toxicity studies individually. For example, there is an estimate of how much it costs EPA to review a 90-day subchronic study, or how much to review a genotoxicity study. These calculations form the basis of the PRIA fee scheme, as PRIA is designed to generate one-third of the program costs involved. The “simple” general rule underlying a now elaborate fee schedule with almost 200 categories is that the more science review involved, the greater the required fee. The new law may not need or want to have so many different categories, but the operating principle can remain the same.
For OPPT, the dollar amounts could vary from OPP given the statutory limitation of the maximum amount to be generated, but the more difficult question will be how OPPT calculates its expected workload under the new law. Given the wealth of information available through OPP’s experience, sharing this information would further inform the public about what to expect in, or options for how to fashion, a fee scheme.
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.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA states that it is also proposing changes to regulations based on issues that it identified, as well as issues raised by public commenters, for significant new use rules (SNUR) previously proposed and issued under these regulations. Additionally, EPA claims to propose a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices. EPA states that it expects the changes “to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment.” Comments are due September 26, 2016.
The revisions include:
- Proposed Changes to 40 C.F.R. Section 721.63, Protection in the Workplace;
- Proposed Changes to 40 C.F.R. Section 721.72, Hazard Communication Program;
- Clarification of the Use of 40 C.F.R. Section 721.80, Industrial Commercial and Consumer Activities;
- Proposed Changes to 40 C.F.R. Section 721.91, Computation of Estimated Surface Water Concentrations: Instructions;
- Proposed Changes to 40 C.F.R. Section 721.11, Determining Whether a Chemical Substance or a Specific Use Is Subject to This Part When the Chemical Substance Identity or Significant New Use Is Confidential;
- Proposed Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVE), Low Release and Exposure Exemptions (LoREX), and Test Marketing Exemption (TME) Applications; and
- Fixing Typographical Errors and Other Non-Substantive Changes.
Although the notice downplays them, the proposal raises significant and complex issues. There may well be good reasons for several of the proposed changes. The minimal discussion provided in the notice and the lack of adequate public debate having occurred prior to its issuance raise troubling questions about the legal basis for, scope of, and complexity of the proposed changes, some of which may apply retroactively. The confusion the proposal can be expected to cause could have been avoided had adequate discussion preceded its publication, or at the least EPA could have raised these issues in the proposed rule’s preamble to focus stakeholders’ attention appropriately.
More information is available in our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.
By Lynn L. Bergeson
On July 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register soliciting a second round of comments on the burdens and value of information it periodically collects addressing significant new use rules (SNUR) for existing chemicals. Specifically, EPA submitted a request to renew the approval of an existing information collection request (ICR), Toxic Substances Control Act (TSCA) Section 5(a)(2) SNURs for Existing Chemicals, to the Office of Management and Budget (OMB). This notice provides chemical manufacturers and other interested parties a second opportunity to comment on certain questions, specifically: whether the agency accurately estimated the burden of responding to SNURs that it issues for chemicals in commerce; whether the agency could minimize the burden; and whether the information it collects is necessary.
The first ICR was issued on September 2, 2015, and comments were due November 2, 2015. Only two comments were filed in response to the initial ICR, by the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA), two trade associations. ACC and SOCMA stated in their comments that EPA underestimated the burdens its SNURs impose on chemical manufacturers and their customers.
This renewed ICR states that EPA estimated that six companies would be affected by its new use rules for existing chemicals, creating an estimated total burden of 1,025 hours per year and a cost of $100,595.
Comments are due August 25, 2016.
SNURs are deeply unpopular to some in the chemical community and welcomed outcomes of the premanufacture notice (PMN) or significant new use notification (SNUN) process to others. Most would agree that the cost of compliance with a SNUR can be difficult to estimate with any degree of precision. Some of us are also of the view that TSCA, as recently amended, may result in many more SNURs given the new “determination” requirements under TSCA Section 5(a). The comment period opened by today’s Federal Register notice provides an excellent opportunity to provide comment to EPA and thus help to ensure that EPA has an accurate and current basis upon which to estimate the cost.
By Lynn L. Bergeson and Margaret R. Graham
On July 25, 2016, the U.S. Environmental Protection Agency (EPA) announced its intention to hold two public meetings on August 9, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act:
- August 9, 2016: EPA states that this public meeting will inform its proposed rule on conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment; and
- August 10, 2016: EPA states that this public meeting will inform its proposed rule to establish a risk-based process for chemical prioritization.
The public meetings are scheduled for 9:30 a.m. to 4:30 p.m., and will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, D.C. EPA states that the input obtained during these meetings will be considered as the EPA develops its proposed procedural regulations for risk evaluation and chemical prioritization. EPA is recommending that any interested participants register in advance.
More information concerning EPA’s implementation of the amended TSCA is available in our memorandum EPA Publishes First Year Implementation Plan, as well as on the Bergeson & Campbell, P.C. (B&C®) website under Regulatory Developments: TSCA.
It is critically important that stakeholders attend and participate in these meetings. While the timing is regrettable in light of vacation schedules, EPA is under intense pressure to issue rules later this year and EPA has no choice other than to keep the process moving. EPA is to be commended for scheduling these opportunities as quickly as it has, and its efforts should be acknowledged by robust stakeholder engagement.
On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the "not likely to present an unreasonable risk" determination at Section 5(a)(3)(C). It is notable that all four determinations relied on structure activity relationship (SAR) analyses and data on analogs.
In all four cases, EPA found low potential for health hazards and low potential for environmental hazards (low/low). EPA estimated that each substance has some degree of persistence (from limited persistence to very persistent) and that all four have a low potential for bioaccumulation. Based on our experience with the new chemicals program under TSCA prior to new TSCA, when EPA made a low/low hazard call and either a low potential for persistence or a low potential for bioaccumulation, EPA "dropped" the submissions from further review, avoiding the time and expense of performing exposure assessments on substances of low potential hazard.
Under new TSCA, to make a Section 5(a)(3)(C) determination, EPA must identify potentially exposed or susceptible subpopulations (PESS) that are relevant under conditions of use. In these four Section 5(a)(3)(C) determinations, EPA identified known or reasonably foreseeable uses in addition to the uses identified in the PMNs. EPA identified the PESS under the intended use as workers for all four cases. We note that EPA identified consumers as a PESS if the substance notified in P-15-0281 was to be used as a lubricant or lubricant additive (the known or reasonably foreseen use that EPA identified). Even considering the PESS, EPA has concluded that a low hazard finding is sufficient to support a "not likely to present" finding under Section 5(a)(3)(C) and did not perform a formal exposure assessment. Since EPA has published the Section 5(a)(3)(C) findings, per Section 5(g), the submitters of these four PMNs may commence manufacturing without waiting for the remaining portion of the 90-day review period to expire.
||Fatty alcohols-dimers, trimers, polymers
Lubricant and lubricant additive
||Depolymerized waste plastics
||Intermediate for use in manufacture of polymers
Lubricant and lubricant additive
||Propyl silsesquioxanes, hydrogen-terminated
Lubricant and lubricant additive
||Organic modified propyl sisesquioxane
EPA determined that all four new chemicals satisfy the "not likely to present an unreasonable risk" determination under Section 5(a)(3)(C). The conditions of use for these chemicals indicate industrial scenarios that would point to workers as the PESS. The potential exposure to workers was not estimated. Instead, the determination of not likely to present an unreasonable risk hinges on the low hazard potential for these chemicals. Three of the four chemicals were estimated to be persistent with two categorized as very persistent. The chemicals were estimated to have low potential for bioaccumulation. No information was provided about potential releases to water.
It is reassuring that the SAR was used to reach determinations about persistence, bioaccumulation, and hazard potential, including mention of category analysis. This suggests that EPA intends to maintain SAR as a basic component in its evaluation of new chemicals consistent with the provisions at Section 4(h) to reduce vertebrate animal testing and to maximize the use of existing hazard information.
Bergeson & Campbell, P.C. (B&C®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation. We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees. The dates and topics will be confirmed when EPA makes announcements in the Federal Register.
By Lynn L. Bergeson and Margaret R. Graham
On July 14, 2016, the Environmental Law Institute (ELI) hosted an event in which the individuals and organizations critical to Toxic Substances Control Act (TSCA) reform, discussed the intricacies and challenges faced in drafting the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), the amended law, and its ultimate enactment.
The panelists included John Pendergrass, VP of Programs & Publications, ELI (moderator), Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, PC (B&C®), Sarah Brozena, Senior Director, Regulatory & Technical Affairs, American Chemistry Council, Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund, David Goldston, Director of Government Affairs, Natural Resources Defense Council, James J. Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, U.S. Environmental Protection Agency (EPA), David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce, and Senator Tom Udall, U.S. Senate (D-NM).
The overall consensus from the panelists was that the process undertaken in getting Lautenberg passed was challenging, but also inspiring and a true group effort on both sides of the aisle. Some of the key points from the discussion included:
- On June 23, 2015, when H.R. 2576 was passed by an overwhelming 398-1, there was a great spirit of bipartisanship in the House. McCarthy observed that this spirit of bipartisanship was especially acute on June 23, a rare event in Congress these days.
- Making a strong law that could be implemented by Jones and EPA was a high priority, and Jones’ role was “absolutely indispensable,” according to Udall who also stated, “[t]he one thing we wanted to make sure we did is not to produce a law that wasn’t going to work for [Jones] and his folks over at EPA.” In answer, Jones stated that EPA Staff were “excited about implementation,” and have “hit the ground running.” The law is strong, has great potential for serious reform and applicability, and is “an elegantly written, balanced and entirely implementable law that will make the world a better place,” according to Bergeson.
- In terms of cooperation and momentum, finding champions with endurance, and rewarding that support with some compromise on bill provisions created the recipe for success. As Udall stated “[y]ou need to find champions on your environmental bills that also have political will,” who are “will to do more than just introduce a bill. They need to deal with every stakeholder.” Denison followed with “to move the bill through the legislative process – to get people to engage, to make changes in exchange for their support, and broaden that” was the only way to get the bill passed, and these actions were “not only to build support, but to sustain momentum over more than one Congress to ultimately get it done.”
More information on the event can be found in the Environment & Energy Daily article “Architects of TSCA Compromise See Hope for Polarized Congress” available online, through paid subscription. A video recording of the event and other materials from the event are available to ELI Associates on ELI’s website. ELI Associates must login to see the materials. A full analysis of Lautenberg is available in the B&C memorandum An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.
The House’s Office of the Law Revision Counsel has posted the U.S. Code version of the Toxic Substances Control Act, as revised by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182. The U.S. Government Publishing Office (GPO) has not yet posted the official version of the public law, but is expected to soon. The GPO version of the public law will be available at https://www.gpo.gov/fdsys/.