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.
Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA):
The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed. The term is defined in TSCA Section 3 and also appears one or more times in the following Sections: 5, 6, 9, 14, 18, 21, and 26. The term is not used in Sections 4 and 8. B&C’s BNA article explores the use and application of conditions of use under Sections 5 and 6 and provides insights into the implications of what may be its unusual use in Section 5 in comparison to Section 6.
Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. Charles M. Auer and Lynn L. Bergeson’s September ABA article analyzes that question.
Other B&C articles on amended TSCA and other regulatory issues of interest are available on our website.
By Charles M. Auer and Oscar Hernandez, Ph.D.
On September 21, 2016, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its regulatory determinations for a batch of Microbial Commercial Activity Notices (MCAN) and premanufacture notices (PMN).
The announcement by EPA consisted of ten new microorganisms submitted as MCANs and seven new chemicals submitted as PMNs. All microorganisms and chemical substances were determined “not likely to present an unreasonable risk” (per Toxic Substances Control Act (TSCA) Section 5(a)(3)(C)). This determination was based in all cases on the low hazard of the microorganism or the chemical substance. The microorganisms and chemical substances are:
- J-16-0010: Generic: Saccharomyces cerevisiae modified;
- J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015, and J-16-0016: Generic: Biofuel Producing Organism;
- J-16-0017: Generic: Saccharomyces cerevisiae modified;
- J-16-0018: Generic: Saccharomyces cerevisiae modified; and
- J-16-0006: Generic: Trichoderma reesei modified.
- P-16-0343 and P-16-0344: Generic: Modified urethane polymer;
- P-16-0391: Generic: Polyester polyol polymer with aliphatic isocyanate and phenol derivates;
- P-16-0366: Generic: Blocked polyisocyanate;
- P-16-0373: Generic: Tris(alkyloxyphenyl)triazine compounds;
- P-16-0466: Generic: 2,5-Furandione, telomer with ethenylbenzene and (alkylethyl)benzene, amides with polyethylene-polypropylene glycol aminoalkyl Me ether, alkali salts; and
- P-16-0348: Generic: Polypentaerythritol, mixed esters with linear and branched monoacids.
In both types of submissions, the EPA reports are facilitated by the use of templates. The footnotes in the template describe the approach and methodology followed to identify uses and to determine persistence, bioaccumulation, human health hazard, and environmental hazard.
The MCAN template includes three footnotes that describe: (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for human health hazard; and (3) criteria for ecological hazard.
The PMN template includes seven footnotes that describe: (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for persistence; (3) criteria for bioaccumulation; (4) criteria for human health hazard ranking; (5) criteria for ecological hazard ranking; (6) link to the TSCA New Chemicals Program Chemical Categories; and (7) link to the Organization for Economic Cooperation and Development’s (OECD) 2014 Guidance on Grouping of Chemicals. The OECD link and a link to the Sustainable Futures Manual within footnote 5 are obsolete.
The ecological hazard ranking criteria are consistent with OPPT’s past practice. The human health ranking criteria departs from practice by using a single descriptor for all endpoints. Other approaches that EPA has used for several years utilize criteria that address specific end points. Examples include the ChAMP (Chemical Assessment and Management Program) Methodology and the section 8(e) program.
For the MCANs, the “unlikely to present” determination is based on the human health hazard criteria identified in the template for human health hazard: “a microorganism is considered to have low human health hazard if it is not known to be a frank human pathogen that causes disease in healthy adults, and/or animal studies have demonstrated a lack of pathogenicity or toxicity”; and “a microorganism is considered to be of low ecological hazard if it is not known to be an animal or plant pathogen, and the genetic modifications do not impart pathogenic or toxigenic traits, and the introduced genetic material does not provide a selective growth advantage in outcompeting indigenous microbial communities in the environment.”
For the chemical substances, estimates indicated that the majority of these chemicals were persistent or very persistent and bioaccumulation potential was low for all chemicals. Human health hazard was determined by using a combination of physicochemical properties and structural analogs. Ecological hazard determinations utilized analog information and, as appropriate, estimates made by the Ecological Structure Activity Relationships (ECOSAR) Class Program. Exposure estimates were not conducted based of the low hazard concern from which followed the “not likely to present an unreasonable risk” determination.
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
On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg). EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section 5(a)(C)(3). The PMN Case Numbers, Chemical Identities, a summary of the determination, the decision dates, as well as the links to the determinations themselves are below. The review start date for all of these determinations was the date of Lautenberg’s enactment, June 22, 2016. Bergeson & Campbell, P.C. (B&C®) is reviewing these determinations and will provide an analysis.
- P-16-0281: Generic: Fatty Alcohols-Dimers, Trimers, Polymers. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity.” The decision was issued on July 15, 2016.
- P-16-0292: Generic: Depolymerized Waste Plastics. EPA determined that “[t] he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.” The decision was issued on July 20, 2016.
- P-16-0301: Generic: Propyl Silsesquioxanes, Hydrogen-Terminated. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.” The decision was issued on July 20, 2016.
- P-16-0302: Generic: Organic Modified Propyl Silsesquioxane. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.” The decision was issued on July 20, 2016.
On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our May 26, 2016, memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well as in proposing/promulgating future regulations.
One important change in this regard is the way that Lautenberg changes the requirements on the U.S. Environmental Protection Agency (EPA) when it includes articles within the scope of Section 5(a)(2) Significant New Use Rules (SNUR). Several relatively recent SNURs, as proposed, included imported/processed articles within their scope and would be affected by this amendment if the article provisions are retained in a final rule. Examples include proposed SNURs on certain polybrominated diphenylethers (PBDE), toluene diisocyanates (TDI), and long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemicals.
One interesting question to consider is the need for EPA to re-propose these SNURs if it intends to retain the requirements on imported/processed articles in the final rule. If these provisions are retained, it appears that EPA would need to re-propose the rule at a minimum to satisfy the requirement at Lautenberg Section 5(a)(5) that EPA make an affirmative finding that the reasonable potential for exposure to the chemical through the article or category of articles justifies notification.
In addition, EPA's Spring 2016 Regulatory agenda lists several SNURs under TSCA that are at the proposed rule stage, including SNURs for alkylpyrrolidone products and certain uses of trichloroethylene (TCE). These rulemakings would need to address the Lautenberg changes in the proposal.
The Spring 2016 Regulatory agenda also lists three proposed rulemakings under TSCA Section 6(a), and a TSCA Section 4 test rule. The former will be affected by Lautenberg while the latter may be affected depending on the approach taken as discussed in our memorandum.
Read the full memorandum, TSCA: What Effect Will the TSCA Amendments Have on Proposed and Future Rulemakings?, online.