Some 20 months have passed since the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) was signed into law, making wide and significant changes to the Toxic Substances Control Act (TSCA). During that time, EPA has been working to implement the extensive new provisions. At this point, EPA has issued final rules, proposed rules, and draft and final policy statements; held multiple public meetings; and provided opportunities for comment. Some of these actions have already been challenged in courts of appeals.
These efforts will continue in 2018. This alert provides background information about implementation of the LCSA and describes anticipated developments for the coming year concerning new chemical substances under section 5; prioritization, risk evaluation, and risk management rulemaking under section 6; Inventory Reset reporting under section 8(b); a TSCA fees rule under section 26(b); and an upcoming review of pre-LCSA policies, procedures, and guidelines.
TSCA Section 5 – New Chemical Substances
EPA is still implementing changes to its New Chemical Review Program under TSCA section 5 to expedite the process for reviewing premanufacture notices (PMNs) for new chemical substances. While amended TSCA section 5 largely retains the structure of the original section by requiring a prospective manufacturer to submit a PMN to EPA prior to manufacturing a “new” chemical substance (one that is not on the TSCA Inventory), it differs in a key respect: unless it restricts a PMN substance, EPA is now required to make an affirmative finding that the substance is not likely to present an unreasonable risk of injury to health or the environment before non-exempt commercial manufacture may commence.
EPA has changed its New Chemicals Review Program to reflect this new obligation. That resulted in a significant slowdown in the process and delays since enactment of the LCSA on June 22, 2016. EPA has made some improvements to the process since then, but it is still not consistently meeting the 90-day deadline for reviewing PMNs and making determinations. Industry has raised concerns that EPA’s review of PMNs is still failing to meet the 90-day deadline and is creating confusion, uncertainty, and ongoing delays in the production of new chemical substances.
EPA has taken additional steps more recently to reduce the delays. On December 6, 2017, it hosted a stakeholder
TSCA Section 6 – Existing Chemical Substancesmeeting on the New Chemicals Review Program. One purpose of the meeting was to solicit public input on a variety of working documents, including its New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA (New Chemicals Decision-Making Framework); a detailed outline of its New Chemicals Decision Guidelines Manual; and draft Points to Consider When Preparing TSCA New Chemical Notifications. EPA also accepted written comments on the New Chemicals Decision-Making Framework until January 20, 2018. It received over 60 comments from a range of stakeholders.
Under amended section 6(b), prioritization – EPA’s process for selecting which chemical substances to evaluate for possible regulation – is the gatekeeper. EPA issued its final rule in July 2017 for prioritizing high- and low-priority chemical substances. The rule sets forth a risk-based screening process and criteria for identifying and designating high-priority substances, which must undergo risk evaluations, and low-priority substances, which do not meet the high-priority screening criteria and will not receive a risk evaluation. EPA’s prioritization process will involve the following steps: initiation, screening, proposed designation, and final designation. EPA also published a timeline depicting the prioritization process. Section 6(b) requires EPA to have completed the prioritization process for 20 low-priority chemical substances and 20 high-priority chemical substances by December 22, 2019.
EPA will initiate the prioritization process for a chemical substance of interest once it is confident that all information required to prioritize the chemical substance has been made “reasonably available.” (The preamble indicates that a chemical substance may be of interest even if it is a recent PMN chemical substance or classified as inactive through the Inventory Reset process, although EPA does not expect this to be the case often.) EPA will then publish a notice of initiation in the Federal Register identifying the chemical substance and a general explanation for why it chose to initiate prioritization on that substance. This publication will trigger a 90-day public comment period for interested persons to submit relevant information, which may include information that assists EPA with its screening review of the chemical substance.
EPA noted in the preamble that it expects to select as high-priority substances those that present the “greatest hazard and exposure potential first.” The rule provides that EPA will aim to select as candidates for high-priority prioritization, among others, those chemical substances listed in the 2014 Update of the TSCA Work Plan for Chemical Assessments that:
- Have persistence and bioaccumulation scores of 3; and
- Are known human carcinogens and have high acute and chronic toxicity.
The entries on the list meeting those criteria not already designated for risk evaluations are the following:
- Arsenic and arsenic compounds;
- Cadmium and cadmium compounds;
- Chromium and chromium compounds;
- Cobalt and cobalt compounds;
- Lead and lead compounds;
- Long-chain chlorinated paraffins (C18-20);
- Medium-chain chlorinated paraffins (C14-17);
- Molybdenum and molybdenum compounds;
- Nickel and nickel compounds;
- Octamethylcyclotetrasiloxane; and
- Pigment Yellow 83
EPA aims to ensure that “at any given time” at least 50% of all high-priority chemical substances are drawn from the 2014 Update.
The rule sets forth seven screening criteria that EPA will consider to determine whether the chemical substance is high- or low-priority. The information that EPA will use to assess these criteria may include hazard and exposure data from sources listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document, as well as information received from the public during the initial 90-day public comment period. The rule further requires EPA to consider the chemical substance as a whole, and not to consider a chemical substance’s specific uses or “conditions of use,” as defined by section 3 of TSCA. The criteria are:
- Hazard and exposure potential of chemical substance;
- Persistence and bioaccumulation;
- Potentially exposed or susceptible subpopulations;
- Storage near significant sources of drinking water;
- Conditions of use or significant changes in the conditions of use of the chemical substance;
- Volume or significant changes in the volume of the chemical substances manufactured or processed; and
- Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance’s priority.
The first six criteria are drawn directly from section 6(b)(1)(A). The final one is a general catch-all for EPA to consider other, potentially unknown risks. EPA must prioritize a chemical substance without considering costs or other non-risk factors. EPA’s designation of a high- or low-priority substance turns on whether the substance “may present an unreasonable risk of injury to health or the environment” based on hazard and exposure risks.
The final rule does not include any provision addressing what the proposal had described as pre-prioritization activities. Instead, EPA will generally expect to obtain sufficient information before beginning the prioritization process by using voluntary methods and its authority under section 4 (requiring testing on environmental and health effects); section 8 (requiring submission of health and safety studies); and section 11 (subpoenas), for which there is no time deadline. This provision suggests that EPA hopes to avoid the situation where at the end of the 12-month period for prioritization it still has insufficient information, because section 6(b)(1)(C)(iii) requires EPA in that situation to designate the chemical substance being prioritized as a high-priority substance.
Upon determination that a chemical substance meets one or more criteria, EPA will propose to designate the chemical substance either high- or low-priority. It will publish the proposed designation in the Federal Register. A proposed designation triggers a second 90-day public review period.
Following that 90-day review period, EPA will make a final designation of a chemical substance as either a high-priority or low-priority chemical substance. This designation will be published in the Federal Register. A high-priority designation requires EPA to immediately begin a risk evaluation on the chemical substance. The final rule states that “designation as a High-Priority Substance is not a finding that the chemical substance presents an unreasonable risk.” Commenters on the proposed rule expressed concerns that a high-priority designation could stigmatize chemicals before they undergo risk evaluation. EPA responded by amending the proposed rule to provide that it will generally aim to publish information and grounds on which the final designation is supported. For high-priority substances, EPA will further identify which specific conditions of use were the basis for the designation. Under section 6(b)(2)(B), EPA must designate 20 chemical substances as high-priority by December 22, 2019.
Conversely, EPA will designate a chemical substance as low-priority where none of the chemical substance’s conditions of use meets the criteria for health or environmental risks of a high-priority substance. Section 6(b)(2)(B) requires that EPA designate 20 chemical substances as low-priority by December 22, 2019. The preamble explains that the determination that a chemical substance is low-priority is considered a final agency action, and as such it is subject to judicial review. EPA may revisit a low-priority designation should information become available that demonstrates that the chemical substance could meet the high-priority criteria.
In November 2017, EPA published a Discussion Document describing possible approaches and tools for identifying potential candidate chemical substances for prioritization (i.e., pre-prioritization). The document described several approaches EPA is considering to help guide prioritization. The approaches included:
- Incorporating TSCA Work Plan Methodology;
- An approach modeled from Canada’s Chemical Management Plan;
- The Safer Chemicals Ingredients List (for low-priority substances);
- A functional category approach, based on use and exposure potential;
- A functional category approach, based on chemical structure and function; and
- Integration of traditional and new approach methods.
EPA held a public meeting to discuss the document and take stakeholder input on December 11, 2017. Written comments were accepted until January 25, 2018.
Risk Evaluation: Framework Rule
Section 6(b)(4)(B) also required EPA to draft a framework rule outlining the procedure for evaluating risks of existing chemical substances. EPA issued the final rule on July 20, 2017.
Procedure for Risk Evaluation
The final rule closely follows the statutory mandates in section 6(b). It provides that risk evaluations will consist of the following steps:
- As part of this step, EPA will determine which uses of a chemical substance will be considered as part of the risk evaluation. It will also identify potentially exposed or susceptible subpopulations, ecological receptors, and hazards to human health and the environment that the agency anticipates considering. EPA will describe the reasonably available information and science approaches it plans to use, as well as a plan for peer review. The final risk evaluation framework rule requires EPA to publish a draft scope for a risk evaluation and allow at least 45 days for public comment. The final scoping document must be published in the Federal Register within six months of initiation of the risk evaluation. EPA indicated that it expects most decisionmaking about proposed scope to be made during the prioritization process.
- Hazard assessment. Following the scoping phase, EPA will conduct a hazard assessment that identifies the types of adverse health or environmental effects or hazards that can be caused by exposure to the substance. This will include a dose-response assessment. It may also include evaluation of the potential activity of the substance with respect to cancer, mutation, reproductive, developmental, respiratory, immune, cardiovascular, and neurological impacts.
- Exposure assessment. EPA must also conduct an exposure assessment, which will include information on physical-chemical properties, and environmental fate and transport parameters. It will also include a discussion of the individuals or populations expected to be exposed. In the preamble to the final rule, EPA stated that exposure assessments will typically be quantitative and will be estimated for each identified condition of use.
- Risk characterization. EPA must also conduct a risk characterization, which will convey the agency’s judgment as to the nature and presence or absence of risks. This will include an explanation of how the risk was assessed, what assumptions were used, what uncertainties remain, and what policy choices will need to be made in the risk determination.
- Peer review. Each risk assessment will undergo independent peer review. This review will include the hazard assessment, exposure assessment, and risk characterization. EPA will seek public comment on the questions that will be posed to peer reviewers. The peer review will not include any determination on whether the identified risks are unreasonable, which EPA views as an agency policy determination.
- Unreasonable risk determination. The final step of a risk evaluation will be EPA’s determination whether the substance, under the conditions of use, presents an unreasonable risk of injury to health or the environment. A separate determination will be made for each condition of use in scope of the inquiry. If EPA determines, for any relevant conditions of use, that the substance presents an unreasonable risk, EPA must initiate a separate rulemaking that will impose requirements to manage that risk. Any risk management rule would only apply to the conditions of use EPA identified as presenting unreasonable risk. EPA noted in the preamble that it will have the discretion to revisit any unreasonable risk determinations, although it did not include language into this rule about how and when this might happen.
The rule states that EPA may make and announce the results of a risk evaluation in stages. EPA may make early risk determinations that a substance does or does not present an unreasonable risk under certain conditions of use. Such expedited determinations may be made at any point after the final scope is published and would become part of the final, complete risk evaluation.
Under TSCA section 6(b)(4)(G), risk evaluations must be complete within three years, with the possibility of a six-month extension. The three-year window begins when a chemical substance is designated as a high-priority substance or upon completion of the manufacturer request process. The window closes when the final risk evaluation is published.
Manufacturer-Requested Risk Evaluations
Section 6(b)(4)(C)(ii) allows a manufacturer, or a group of manufacturers, to request risk evaluations for substances they manufacture. The risk evaluation framework rule fulfills EPA’s mandate to establish, by rule, the “form and manner” and “criteria” that govern such requests. Section 6(b)(4)(E) requires EPA to grant any such requests that meet the criteria, until the statutory minimum of 25% of the total EPA-initiated risk evaluations is met. Once this minimum threshold has been met, EPA has discretion to grant or deny further requests, up to the statutory maximum of 50%. In this circumstance, TSCA requires EPA to give preference to chemicals regulated by states in a manner that may significantly impact interstate commerce. When promulgating the final rule, EPA announced that it plans to give further preference to requests in the order they are received. It expects to receive about five requests per year.
The final rule gives a manufacturer the option of requesting risk evaluations only for uses relevant to that manufacturer. If the risk evaluation goes forward, however, EPA will determine the scope in the same manner as any other risk evaluation. A manufacturer request must include information on the substance’s hazard and exposure potential; the substance’s persistence and bioaccumulation; any relevant or potentially exposed or susceptible subpopulations; whether there is any storage of the substance near significant sources of drinking water; the substance’s production volume or significant changes in production volume; and any other information relevant to the risks potentially presented by the substance.
Within 15 days of receiving a valid request, EPA will give public notice of its receipt, either on its website or by email announcement. Within 60 days from receipt, EPA will publically announce the request in the Federal Register, and will open a docket for public comment. The comment period will last at least 45 days. The Federal Register notice will also announce EPA’s determination about whether the uses identified by the manufacturer warrant risk evaluation, and whether EPA has identified other uses that warrant review. Within 60 days of closure of the comment period, EPA will notify the manufacturer whether it will grant or deny the request. If EPA indicates the request will be granted, the manufacturer will have 30 days to withdraw the request for a risk evaluation.
Under section 6(b)(4)(E)(ii), manufacturers whose requests are granted must pay a fee. Under section 26(b)(4)(D), the fee will be 50% of EPA’s cost of conducting the risk evaluation for chemical substances listed in the 2014 update to the TSCA Work Plan and 100% of the cost for other chemical substances. The risk evaluation rulemaking did not identify what that cost would be, since it will be the subject of a separate rulemaking. However, the proposed fees rule proposed a fee of $1,300,000 for a manufacturer-requested risk evaluation for a chemical substance on the 2014 update to the TSCA Work Plan and $2,600,000 for one that is not.
Risk Evaluations for First Ten Chemical Substances
Section 6(b)(2)(A) required EPA to select ten chemical substances from the 2014 TSCA Work Plan for a risk evaluation. EPA selected the following chemical substances in December 2016:
On June 22, 2017, EPA posted, and began public comment on, the scope documents for the substances (available in the dockets linked above). The risk evaluations for these chemical substances must be complete by December 22, 2019. Additionally, on January 19, 2017, EPA proposed risk management rules for N-methylpyrrolidone (NMP), methylene chloride, and trichloroethylene (TCE). Moving forward with these proposed rules was listed as a long-term action item on EPA’s most recent regulatory agenda.
PBTs under TSCA Section 6(h)
Congress also designed a separate “expedited action” track within amended section 6 for risk management of persistent, bioaccumulative, and toxic chemical substances (PBTs). Under section 6(h), by June 22, 2019, EPA must propose risk management rules for TSCA Work Plan chemical substances that score high for persistence or bioaccumulation and high or moderate for the other criteria (using the TSCA Work Plan Chemicals Methods Document (2012) or successor scoring system), so long as EPA determines that exposure to such chemical substances under the conditions of use is likely to impact either the general population, a potentially exposed or susceptible subpopulation, or the environment. Unlike for other chemical substances assessed under section 6(b), EPA does not have to conduct a risk evaluation of section 6(h) chemical substances. It must, however, conduct an exposure and use assessment.
The final PBT risk management rule must be published within 18 months after publishing the proposal. In selecting restrictions, EPA is directed to reduce exposure to the extent practicable. Excluded from this provision are metals and metal compounds; chemical substances for which EPA has completed a TSCA Work Plan problem formulation; chemical substances for which EPA has initiated a review under section 5; and chemical substances for which EPA has entered into a testing consent agreement under section 4.
EPA announced in October 2016 that it regarded five chemical substances as PBTs under section 6(h):
- Decabromodiphenyl ethers (decaBDE), CAS No. 1163-19-5
- Decabromodiphenyl ethers (decaBDE), CAS No. 1163-19-5
- Pentachlorothiophenol (PCTP), CAS No. 133-49-3
- Phenol, isopropylated, phosphate (3:1) (according to EPA, this name describes multiple chemicals)
- 2,4,6-Tris(tert-butyl) phenol, CAS No. 732-26-3
Background documents for the exposure and use assessments mandated by section 6(h) for the five chemical substances were published in August 2017. EPA hosted a public webinar on the use information on September 7, 2017. Public comments were accepted until January 12, 2018. EPA is currently considering these comments.
TSCA Section 8 – Inventory Reset
The TSCA Inventory Reset – a key feature of the LCSA – is underway. EPA is required by amended section 6(b) to “reset” the TSCA Inventory by determining which of the 85,000 chemical substances on the TSCA Inventory have been manufactured, imported, or processed in commerce in recent years. To achieve this end, EPA promulgated the Inventory Reset rule on August 11, 2017, which set forth the regulatory process for designating chemical substances on the TSCA Inventory as either “active” or “inactive” based on notifications from manufacturers, importers, and processors.
The rule required manufacturers and importers to notify EPA by February 7, 2018 regarding the manufacture or import of chemical substances for non-exempt commercial purposes during the 10 years prior to enactment of the LCSA, i.e., from June 21, 2006 to June 21, 2016. Now that this initial reporting phase has ended, EPA will release an updated draft list identifying chemical substances on the Inventory that are active based on the notifications already received from manufacturers and importers. For chemical substances on the confidential portion of the Inventory, the draft will identify those accession numbers and corresponding generic names which are considered to be active chemical substances.
Processors of chemical substances still have the opportunity, and incentive, to report the chemical substances they process to EPA unless already designated as active or exempt. The rule allows, but does not require, processors to notify EPA regarding chemical substances that they processed for non-exempt commercial purposes during the 10-year lookback period by October 5, 2018 (i.e., within 420 days of publication of the final Inventory Reset rule). Processors who choose to report must submit a Notice of Activity Form A providing the chemical identity of each chemical substance being reported. For chemical substances that are on the confidential portion of the Inventory, they must also indicate whether they seek to maintain an existing confidential business information (CBI) claim to protect the chemical identity from disclosure.
After the final reporting period has closed on October 5, 2018, EPA will formally designate all chemical substances on the TSCA Inventory as either active or inactive. Once EPA has completed its final designations and the TSCA Inventory has been formally “reset,” no one will be permitted to manufacture, import, or process an inactive chemical substance without first submitting a notification to EPA. Anyone who intends to manufacture or process an inactive substance must first submit a Notice of Activity Form B that includes the chemical identity and anticipated date of manufacture or processing to EPA within the 90-day period before the anticipated date of manufacturing or processing. Upon receiving such a notice, EPA will change the designation of the chemical substance from inactive to active, and manufacturing or processing may commence.
TSCA Section 8 – Mercury Reporting Rule
TSCA section 8(b)(10) requires EPA to establish and maintain an inventory of mercury supply, use, and trade in the United States. To assist EPA with this task, Congress directed EPA to promulgate a mercury reporting rule to collect information by June 22, 2018.
EPA released the initial mercury inventory report on March 29, 2017, and proposed a reporting rule on October 26, 2017. EPA accepted public comments on the proposed rule until January 11, 2018. As proposed, the first reporting submission under the rule would cover the data from January 1 to December 31, 2018. Companies that may be subject to this reporting rule should review the final rule and plan for data collection and submission.
TSCA Section 26 – Update of Policies, Procedures, and Guidance Documents
Section 26(l) requires EPA, by June 22, 2018, to “develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments” to TSCA. Three years later, by June 22, 2021, and every five years thereafter, EPA must review and, if necessary, revise TSCA policies, procedures, and guidance documents. Stakeholders may wish to consider suggesting documents for EPA to develop or revise.
TSCA Section 26 – Fee Rule
Under section 26(b)(1) of TSCA, EPA “may, by rule, require” fee payments to support administrative activities under sections 4 (testing), 5 (new chemical substances), 6 (existing chemical substances), and 14 (confidential business information) of TSCA. The collected fees would be deposited into a TSCA Service Fee Fund. TSCA authorizes EPA to initially collect fees to defray 25% of the administrative costs for the activities under these four sections or $25 million per year (whichever is lower). EPA may charge fees to defray up to 50% or the full amount of the costs for conducted manufacturer-requested risk evaluations under section 6. EPA has no statutory deadline to promulgate the initial fee rule, but it must review the fee amount every three years starting in 2019.
EPA released a proposed TSCA section 26 user fee rule on February 26, 2018. In the proposed rule, EPA estimated that it would collect approximately $20.05 million in fees from eight fee categories arising from sections 4 and 5 activities, as well as EPA-initiated section 6 activities. EPA would also separately charge fees for manufacturer-requested risk evaluations under TSCA section 6. Section 14 claims would not incur additional fees. Under the proposed rule, EPA envisioned two fee schedules, one for small business entities and another for other entities, and would revise the qualification criterion for small businesses.
Comments on the proposed rule are due by April 27, 2018. EPA currently expects the rule to be finalized by September 2018. As currently proposed, the fee regulation would take effect one day after it is finalized.
Pending Legal Challenges
Challenges to the Prioritization and Risk Evaluation Rules
In August 2017, three sets of petitioners filed challenges to the prioritization framework rule in the United States Courts of Appeal for the Second, Fourth and Ninth Circuits. The same three sets of petitioners, primarily environmental organizations, filed petitions challenging the risk evaluation framework rule in the same three Circuits. Several trade associations have intervened on these cases. The six matters, now consolidated, are pending before the Ninth Circuit with opening briefs due on March 20, 2018.
The issues cited by the petitioners are expected to relate in large part to how the rules interpret the “conditions of use” of a substance being evaluated. In the proposed rules, the prioritization framework rule and risk evaluation framework rule would have required EPA to consider all known, intended, and reasonably foreseen activities associated with a chemical substance. In the final versions of the rules, EPA may use its discretion to focus only on circumstances of use likely to present the greatest concern. The subsequent risk evaluation would focus on the specific “conditions of use” designated by EPA.
Challenge to the Inventory Reset Rule
On September 1, 2017, the Environmental Defense Fund filed a petition against EPA challenging the Inventory Reset Rule. A number of entities have moved to intervene. The issues presented include whether EPA lawfully exempted chemicals produced solely for export from the Inventory Reset rule (the “export only” exclusion in section 12(a)(1) excludes section 8 requirements). The petitioner also challenges the rule’s treatment of CBI. The rule allows manufacturers and processors to rely on another company’s prior CBI claim to protect the identity of a chemical substance when notifying EPA that a chemical substance should be on the active list. The petitioner objects to this, asserting that this reliance on a prior CBI claim has the effect of allowing a notifying company to make new CBI claims for a chemical identity using a process only designed to maintain CBI claims that it had previously asserted.
Challenge to the New Chemicals Decision-Making Framework
The Natural Resources Defense Council filed a petition for review of EPA’s working document, the New Chemicals Decision-Making Framework, on January 5, 2018. The petition characterizes that document as a final rule. Other entities have intervened. No briefing schedule has yet been established.
Looking Ahead to 2018 and Beyond
Stakeholders can expect EPA to continue its implementation of the amended TSCA, including the following:
- Strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing (due by June 22, 2018).
- Final rule requiring manufacturers of mercury or mercury-added products (or those who otherwise intentionally use mercury in a manufacturing process) to periodically provide reports to EPA (June 22, 2018).
- Develop any policies, procedures, and guidance EPA determines are necessary to carry out the TSCA amendments (June 22, 2018).
- Final TSCA fees rule (no deadline, but expected September 2018).
- Pre-prioritization for 20 high-priority substances and 20 low-priority substances (proposed designations due between December 22, 2018 and March 22, 2019).
- Use and exposure assessment for five chemical substances designated as PBTs (proposed risk management rules due by June 22, 2019).
- Designation of at least 20 chemical substances as high-priority substances and at least 20 chemical substances as low-priority substances (December 22, 2019).
- Following an unsuccessful negotiated rulemaking, publication of a proposed rule limiting the reporting requirements for manufacturers of inorganic byproducts when such byproducts are subsequently recycled, reused, or reprocessed (final rule by December 22, 2019).
- Consult with parties potentially subject to fees and increase or decrease fees as necessary to adjust for inflation and ensure the funds are sufficient to defray the costs of the TSCA program (September 30, 2020).
- Report to Congress on any exports of mercury compounds for disposal that occurred after June 22, 2016 (June 22, 2021).
- Review the adequacy of the policies, procedures, and guidance, including with respect to animal, non-animal, and epidemiological test methods and procedures for assessing and determining risk, and revise them as necessary (June 22, 2021).