Search results for: Toxic Substances Control Act

This week we are pleased to have a guest post from Emilee Mooney Scott, a member of Robinson+Cole’s Environment, Energy + Telecommunications practice group.  Emilee focuses her practice on environmental transactional and compliance matters, with a particular focus on the management of hazardous and toxic substances.

The Toxic Substances Control Act (TSCA) has long provided EPA with authority to review new chemical substances in a gatekeeper role as such substances enter U.S. commerce. Through amendments in 2016, EPA was also given the authority to evaluate selected existing chemical substances using a three-step framework (explained in further detail here). There are a few dozen substances in the pipeline now, with the first ten substances almost at the end of a long process that will culminate in substance-specific rules. Around the fifth anniversary of the TSCA amendments later this year, the first round of risk management rules should be proposed. These risk management rules could have significant impacts on manufacturers that use the substances in question, and will provide insight on EPA’s approach to such rules going forward. Continue Reading Chemical “Risk Management Rules” on the Horizon for 2021

Thank you to my colleague, Emilee Mooney Scott, for this post. Emilee focuses her practice on chemicals and hazardous materials regulation and is counsel in our Environmental & Utilities Practice Group.

As we previously outlined, the Toxic Substances Control Act (“TSCA”) was amended in 2016 to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in commerce).  While EPA has met its statutory deadlines thus far, several critical deadlines are looming in 2019.  EPA’s progress toward its 2019 deliverables has been delayed by the recent government shutdown and redeployment of resources.

Risk Evaluations and Prioritizations Expected in 2019

TSCA requires EPA to systematically review selected substances that are already active in commerce through a three-step process of prioritization, risk evaluation, and risk management.  The prioritization step identifies chemical substances that may pose an unreasonable risk of injury to health or the environment and designates them as “high priority” for further study.  Those high priority substances are then subjected to a risk evaluation step to determine whether they do indeed pose an unreasonable risk of injury to health or the environment.  Substances that do pose an unreasonable risk must then be subject to a risk management rule to mitigate such risks, though, for example labeling or work practices requirements.

The 2016 TSCA amendments directed EPA to identify a slate of ten substances that would skip the prioritization step and proceed directly to the risk evaluation step.  Those first ten substances were identified in late 2016, and risk evaluation problem formulations were released in the summer of 2017.  Since then, risk evaluations have been underway.  Final risk evaluations are due for the first ten substances by December 19, 2019 (subject to possible six-month extension), so draft risk evaluations must be published by October 20, 2019 to allow for the required sixty-day comment period.

EPA released its first draft risk evaluation under amended TSCA in November 2018, concluding that Pigment Violet 29 does not pose an unreasonable risk to human health or the environment.  EPA was expected to release the rest of the first ten draft risk evaluations this winter to allow ample time for public comment and agency reevaluation.  At a conference this week, Alexandra Dunn, assistant administrator for the Environmental Protection Agency’s Office of Chemical Safety and Pollution Prevention, said that the remaining draft risk evaluations are instead expected this summer.

Earlier this week, the U.S. Government Accountability Office (GAO) released a report detailing some of the factors that have led to EPA’s slower than anticipated progress.  Internal EPA discussions about priorities for the Integrated Risk Information System (IRIS) have led to delays, and amended TSCA places a significantly increased workload on the relevant office of EPA.  The fast timelines imposed by the TSCA amendments have also required EPA to begin implementing the law before internal guidance and procedures are fully in place.  According to GAO, EPA officials “likened it to building an airplane as they fly it.”  Several of EPA’s rules implementing TSCA amendments have been challenged in court, and depending on how the challenges are resolved, additional delays could result.  The government shutdown in late 2018 and early 2019 also delayed EPA’s efforts.

EPA has a significant amount of work ahead of it—dozens of TSCA-related deliverables are due at the end of 2019.  In addition to the final first ten risk evaluations being due by December 19, 2019, by December 22, 2019 EPA is required to ensure that at least twenty risk evaluations on high-priority substances are underway, and must designate an additional twenty substances as low-priority.

Update to TSCA Inventory

EPA has already achieved one of its most anticipated 2019 milestones: release of the revised TSCA Inventory.  The TSCA Inventory is a list, maintained by EPA, of all the existing chemicals in commerce.  If a substance is not listed on the TSCA Inventory it is considered “new” and subject to review before it is introduced into commerce.

In connection with the 2016 amendments to TSCA, EPA was required to revise the TSCA inventory and cull the substances that exist but are not active in commerce.  EPA’s review of the TSCA inventory was informed by reporting by manufacturers and importers in 2012 and 2016, and by “Notice of Activity” forms submitted by manufacturers, importers, and processors of chemical substances in 2018.

In February 2019, EPA released the revised TSCA inventory.  Of the 86,228 substances on the TSCA inventory, only 40,655 were identified as active in commerce.  If there are any substances marked inactive on the revised TSCA inventory, but which are still being manufactured, imported or processed, manufacturers/importers/processors have until May 20, 2019 (90 days from publication of the revised Inventory) to submit a Notice of Activity Form B (through the Central Data Exchange) to prevent the substance from being designated as inactive.  Once a substance is designated inactive, it may not be re-introduced into commerce until EPA receives a Notice of Activity form alerting it to the re-introduction.

 

Thank you to my colleague, Emilee Mooney Scott, for this post. Emilee is an associate in our Environmental & Utilities Practice Group.

TSCA Framework Rules Promulgated

As we outlined last year, the Toxic Substances Control Act (“TSCA”) was recently updated to provide EPA with much broader authority to regulate “existing” chemical substances (i.e., those that are already in use in commerce).  EPA’s review of existing chemical substances under its new TSCA authority will follow these three steps: 1) Prioritization; 2) Risk Evaluation; and 3) Risk Management (as we explained in further detail in December).

On July 20, 2017, EPA issued the final rules on the Prioritization and Risk Evaluation processes.  Notably, the final rule specifies that when EPA conducts a risk evaluation, it will not evaluate all possible conditions of use, but will instead focus on the conditions of use that raise the greatest potential for risks.  This will conserve agency (and industry) resources by limiting the need for data and analysis on conditions of use that are uncommon or risks that are remote.

Risk Evaluations Underway

The TSCA reform bill also directed EPA to identify a slate of ten substances that would skip the prioritization step and proceed directly to the risk evaluation step.  EPA recently published the risk evaluation scope for each of these first ten substances.  EPA has opened a docket for each substance, and will accept comments on risk evaluation scopes until September 19, 2017.  The table below provides links to the risk evaluation scopes (and any supporting documents), the use and exposure pathways and hazards identified by EPA, and the docket that interested parties may use to leave comments.

Substance Use and Exposure Pathways Hazards Docket
1,4-Dioxane Used in consumer products. Present in groundwater, ambient air and indoor environments.  High reported releases to the environment. Possible human carcinogen. EPA-HQ-OPPT-2016-0723
1-Bromopropane Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, soil. Estimated to have high releases to the environment. Possible human carcinogen. EPA-HQ-OPPT-2016-0741
Asbestos Used in chlor-alkali production, consumer products, coatings and compounds, plastics, roofing products, and other applications. Also found in certain imported products such as brakes, friction products, gaskets, packing materials and building materials. Known human carcinogen; Acute and chronic toxicity from inhalation exposures. EPA-HQ-OPPT-2016-0736
Carbon Tetrachloride Used in commercial/industrial products. Present in biomonitoring, drinking water, indoor environments, surface water, ambient air, groundwater, soil. High reported releases to the environment. Probable human carcinogen. EPA-HQ-OPPT-2016-0733
Cyclic Aliphatic Bromide Cluster (HBCD) Flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances Acute aquatic toxicity EPA-HQ-OPPT-2016-0735
Methylene Chloride Used in consumer products. Present in drinking water, indoor environments, ambient air, groundwater, and soil Probable human carcinogen EPA-HQ-OPPT-2016-0742
N-Methylpyrrolidone (NMP) Used in consumer products. Present in drinking water and indoor environments. High reported releases into the environment. Reproductive toxicity. EPA-HQ-OPPT-2016-0743
Pigment Violet 29 Used in consumer products. Estimated to have moderate releases to the environment. Aquatic toxicity. EPA-HQ-OPPT-2016-0725
Trichloroethylene (TCE) Used in consumer products. Present in drinking water, indoor environments, surface water, ambient air, groundwater, and soil. Probable human carcinogen. EPA-HQ-OPPT-2016-0737
Tetrachloroethylene (perchloroethylene) Used in consumer products and dry cleaning. Present in biomonitoring, drinking water, indoor environments, ambient air, groundwater, soil. High reported releases to the environment. Probable human carcinogen. EPA-HQ-OPPT-2016-0732

In December 2016 and January 2017 EPA also issued proposed rules that would 1) ban the use of TCE in aerosol degreasing and spot cleaning; 2) ban the use of TCE in vapor degreasing; and 3) ban the use of methylene chloride and NMP in consumer and most commercial coating removal products.  These rules have not yet been finalized, and the new administration has repeatedly extended the comment deadlines.

While the proposed TCE rules face an uncertain fate, they do potentially forecast how risk evaluations might proceed.  The proposed TCE rules do not include any restrictions on what is presently the most common use of TCE in the United States: as a precursor in refrigerant manufacturing.  When TCE is used in refrigerant manufacturing, the use occurs in a closed system with very limited potential for worker exposure or releases to the environment.  In other words, when a discrete use of a high-priority substance poses little risk, it may be allowed to continue even in the face of a total ban on other uses.  Manufacturers aware of such low-risk uses should take advantage of opportunities for public comment to make sure EPA is aware as well.

Thank you to my colleague, Emilee Mooney Scott, for her contributions to this post. Emilee is an associate in our Environmental & Utilities Practice Group.

In a rare bipartisan effort, Congress overwhelmingly passed a bill significantly reforming the chemical safety provisions of the Toxic Substances Control Act (“TSCA”) for the first time in its forty-year history.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) (“Lautenberg Bill”) represents the culmination of a years-long effort supported by environmental groups and the regulated community, and President Obama’s signature is expected in the coming days.

TSCA is the primary federal statutory scheme governing the safety of chemicals in commerce (it also contains provisions governing specific substances like asbestos and PCBs).  Under TSCA, EPA screens new chemical substances being introduced into commerce, requiring chemical manufacturers and importers to submit information and potential limitations on use.  By contrast, the EPA has had limited authority over existing chemical substances – until now.

Existing Substances: Greatly Expanded EPA Authority

The Lautenberg Bill sets forth a three-step process for EPA to evaluate, and potentially regulate, existing chemical substances:

  1. Prioritization:

EPA must conduct an initial risk-based screening process to identify substances that have a high priority for further study.  EPA must designate a substance as high-priority if it concludes that a particular substance may pose an “unreasonable risk of injury to health or the environment,” including impacts on sensitive populations like children and pregnant women under the “conditions of use,” i.e., the circumstances under which a “chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”  Substances not found to pose such a risk are to be designated low-priority substances and would not be subject to further evaluation or regulation.

EPA may not consider “costs or other nonrisk factors” in its prioritization process.  While the exact prioritization process will be laid out in an EPA rulemaking, by statute the prioritization process must take between 9 and 12 months per substance and must include opportunities for stakeholder participation and public comment.

  1. Risk Evaluation:

High-priority chemical substances are then subject to risk evaluations to determine whether the chemical substance in fact poses an unreasonable risk to human health or the environment.  Again, in conducting the risk evaluation, EPA may not consider costs or other nonrisk factors and must “take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance…”  EPA must clearly state the scope of the risk evaluation, and must complete the risk evaluation within 3 years of initiation.

  1. Risk Management:

For chemical substances determined to present an unreasonable risk to human health or the environment, EPA must develop a risk management rule.  EPA must  propose a risk management rule for the chemical substance within 1 year of the risk evaluation’s completion, and promulgate a final rule within 2 years of the risk evaluation’s completion (subject to the possibility of a 2-year extension).  Stakeholders will have an opportunity to weigh in on the proposed risk management rule as it is being finalized.

While EPA is not permitted to consider costs in the Prioritization and Risk Evaluation phases, EPA is directed to consider economic and practical factors in developing restrictions on a chemical substance, including “the reasonably ascertainable economic consequences of the rule” and the beneficial uses of the chemical substance.  In notable contrast to current TSCA, EPA is no longer required to use the “least burdensome” means of regulating a chemical substance.

The Lautenberg Bill provides timelines for EPA action on existing chemical substances:

  • Within the first six months after enactment, EPA must have at least 10 risk evaluations underway, on chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments.
  • Within the first year after enactment, EPA must develop rules for the prioritization of chemical substances (e., designation as either high or low priority for further evaluation), and for the risk evaluation process.
  • Within three years after enactment, risk management rules must be in place for certain high-priority chemical substances.

Other Notable Features of the Lautenberg Bill

While the regulation of existing chemical substances is the highlight, the Lautenberg Bill includes several other changes that manufacturers should be aware of, including:

  • The pre-manufacture notice process for initiating review of new chemical substances entering commerce is similar to current TSCA, but EPA will be required to more formally and rigorously evaluate the safety of such new chemical substances.
  • EPA will have enhanced authority to order testing of both new and existing chemical substances.
  • EPA will catalog the chemical substances presently in active commerce and re-set the inventory.
  • State programs in existence as of April 22, 2016 are not preempted, but new state regulation of chemical substances may be preempted depending on EPA’s actions with respect to the substance. Preemption was a major sticking point that had to be overcome to achieve the compromise Lautenberg Bill, and there will likely be further controversy (and perhaps litigation) as the states adapt to the new TSCA regime.

To round out our series on industry and legal outlooks for 2016, I have compiled some of the many things for manufacturers to be aware of in the Environmental Health & Safety world for 2016.

1. Expansion of CERCLA Liability

The Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”) is always a concern for manufacturers who handle hazardous substances because of its broad imposition of liability. Every year brings with it a number of new developments under CERCLA, but one case that stands to shake up the CERCLA legal landscape is Pakootas, et al. v. Teck Cominco Metals Ltd. This case involves the question of whether air emissions that ultimately settle on land or water can be considered a disposal subject to CERCLA liability. A district court in Washington held that they could, but the issue is now before the Ninth Circuit on appeal. The case is set to be argued in April 2016, and, if the district court holding is upheld, it will widen the net of potentially responsible parties under CERCLA to anyone who emits hazardous substances into the air.

2. Revisions to RCRA Generator Rules

EPA published a proposed rule in the Fall of 2015 that would overhaul regulations applicable to hazardous waste generators under the Resource Conservation and Recovery Act (“RCRA”). Public comment on the proposed rule closed at the end of 2015, so we can expect to see a final rule in 2016. If the final rule looks like the proposed rule, hazardous waste generators can expect to see some benefits as well as drawbacks. For example, starting with good news, Conditionally Exempt Small Quantity Generators, which would now be called Very Small Quantity Generators, would be permitted to send waste to Large Quantity Generators under the control of the same person. This move will allow for waste consolidation and efficiencies in managing wastes across properties. The proposed rule also potentially increases the burden on generators, however, particularly with regard to documentation and reporting requirements, directing more specificity in recording the date and materials accumulated and increased reporting for Large Quantity Generators. All hazardous waste generators need to be aware of and tracking the EPA’s ultimate issuance of the final rule.

3. TSCA Reform

2016 may bring a whole new era in toxic substances regulation. The Toxic Substances Control Act (“TSCA”) has not seen reform in almost 40 years , but in 2015, both the House and Senate passed historic bills to reform TSCA. The two bills, which had a number of differences, must be reconciled, but the stage is set for a major overhaul TSCA. Stay tuned.

4. Increased Penalties and Enforcement to Protect Worker Safety

The Occupational Safety and Health Administration (“OSHA”) is doing its best to put more bite in its bark in 2016. With the end of 2015 came legislation that will increase OSHA’s civil penalties by about 80 percent in 2016. In addition, the Department of Labor and the Department of Justice recently announced that they are teaming up to increase criminal prosecution for worker safety violations. These prosecutions are likely to rely on a combination of worker safety and environmental violations, and resources are being deployed to make sure the initiative is carried forward. Employers need to be vigilant in addressing workplace safety, but also in identifying other potential violations as well as behaviors (witness tampering, obstruction of justice) that could allow for criminal penalties.

5. NextGen Compliance

It is 2016, and time to move into the digital age. The Environmental Protection Agency (“EPA”) is in the process of rolling out Next Generation Compliance, or NextGen, in an effort to make its programs more effective and facilitate compliance in the regulated community. We can expect to see increased electronic reporting, but along with that will likely come increased public availability of the data and reporting submitted to EPA. We can also expect EPA to use that data to evaluate industry compliance and ultimately drive enforcement priorities. NextGen brings with it new monitoring techniques, such as fence-line and drive-by monitoring, which will allow EPA (and others) to conduct monitoring more frequently and less conspicuously. And, perhaps most importantly, NextGen is focused on creative enforcement strategies that attempt to expand an alleged offender’s response to a violation. It is important to keep on top of NextGen as EPA continues to formalize and solidify its goals.

On March 13, the California Department of Toxic Substances Control (DTSC) announced the initial draft list of “priority products” under the state’s Safer Consumer Products program.  Once the list is finalized, the program will requires companies to determine if there are less toxic alternatives to the chemicals in these consumer products.

The three “priority products” are:

  • spray polyurethane foam systems used in building insulation containing unreacted diisocyanates in;
  • children’s foam padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) found; and,
  • paint and varnish strippers and surface cleaners containing methylene chloride (DCM).

The Safer Consumer Product regulations, sometimes referred to as “green chemistry regulations”, went into effect on October 1, 2013.  The program’s purpose is to seek to reduce toxic chemicals in consumer products, create new business opportunities in the emerging safer consumer products economy, and make it easier for consumers and businesses to identify the components of products they buy.

The program created a four-step continuous, science-based process to identify safer consumer product alternatives.

  1. Establish an immediate list of “candidate chemicals” and specify a process for the DTSC to identify additional chemicals.  This has already been started.
  2. Evaluate and prioritize product and candidate chemicals, called chemicals of concern, combinations to develop a list of “priority products” for which alternatives analyses must be conducted.  The products above are the first draft of that list. The DTSC will begin the public comment on the list in the summer of 2014
  3. Responsible entities—manufacturers, importers, assemblers, and retailers— will be required to notify DTSC if their product-chemical combination is a Priority Product.  Manufacturers must then perform an “alternatives analysis” for the product and the chemicals of concern in the product to determine how best to limit exposures to the chemicals of concern in the product.  The alternatives analysis requires manufacturers to ask three questions: (1) if the chemical ingredient is necessary, (2) if there is a safer alternative, and (3) if the alternative is feasible.
  4. DTSC must identify and implement possible regulatory responses, ranging from product labeling to a sales ban,.

For the more visual among us, DTSC put together a great flow chart explaining the process.

The chemicals in these products are not new to regulatory scrutiny.  The EPA previously targeted certain diisocyanates in a 2011 Action Plan that calls for relevant health and safety data to be submitted.  The EPA noted that diisocyanates are well known dermal and inhalation sensitizers and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions.  The concern with unreacted diisocyanates is that their increased consumer availability means that they are increasingly used in and around buildings, including homes and schools, by workers and self-employed workers, which can lead to an increased number of incidental exposures.  The EPA also conducted a draft risk assessment in 2012 of DCM and the use of DCM-based paint strippers as part of its comprehensive approach to enhance the Agency’s existing chemicals management program under the Toxic Substances Control Act (TSCA).

 

Last week, we discussed the new OSHA “Annotated Permissible Exposure Limits,” which OSHA announced in a press release dated Thursday, Oct. 24.  In the same press release, OSHA announced its new “Safer Chemical Tool Kit” for employers.

The idea is to go beyond compliance, and substitute, reduce, or even eliminate chemical hazards.  This is not a new idea – use of safer chemicals is sometimes referred to as “green chemistry,” and EPA has been advocating this for years.  A related concept is pollution prevention, and on this blog, we wrote earlier this year about changing practices to limit the need for permits and the attendant obligations.  For all of these, the goal is go to the source – whether it’s chemical use or waste generation or just facility operations – and think about how to do things differently to avoid the hazard, and therefore the potential liability and costs, at the end.

Change is hard.  But the benefits can be great.  OSHA points out three possible benefits to chemical substitution:

  • Cost Savings — Reduce expenses and future risks.
  • Efficiency — Improve performance.
  • Industry Leadership — Invest in innovation to stay competitive.
  • Corporate Stewardship — Advance socially responsible practices.

Besides the OSHA toolkit, some other resources for eliminating or reducing chemical hazards are: