Tag: EPA

EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in their coordinated regulation of biotechnology products. Consistent with a directive issued by President Biden in September 2022, the agencies’ plan identifies specific issues that each has either recently addressed or will work to address to promote such products’ safe use.

Key Takeaways

  • What Happened: EPA, USDA, and FDA issued a joint plan for regulatory reform under their Coordinated Framework for the Regulation of Biotechnology.
  • Who’s Impacted: Developers of PIPs, modified mosquitos, biopesticides, and other biotechnology products under EPA’s jurisdiction.
  • What Should They Consider Doing in Response: Watch the three agencies’ regulatory dockets closely and consider submitting comments once new rules or draft guidance are published that may affect their products.

Background

President Biden’s executive order defined “biotechnology” as “technology that applies to or is enabled by life sciences innovation or product development.” Biotechnology products thus may include organisms (plants, animals, fungi, or microbes) developed through genetic engineering or manipulation, products derived from such organisms, and products produced via cell-free synthesis. These products may, in turn, be regulated under the overlapping statutory frameworks of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Federal Food, Drugs and Cosmetics Act (FFDCA), Plant Pest Act (PPA), Federal Meat Inspection Act, Poultry Products Inspection Act, and more. Therefore, close coordination between EPA, USDA, and FDA is essential to ensure effective and efficient regulation of biotechnology products.

EPA Sets Sights on PIPs, Mosquitos, and Biopesticide Products

The agencies’ newly released plan identifies five biotechnology product categories where regulatory clarification or simplification are warranted: (1) modified plants; (2) modified animals; (3) modified microorganisms; (4) human drugs, biologics, and medical devices; and (5) cross-cutting issues. Under the new plan, EPA is engaged in all but the fourth category above.

For example, EPA has already taken steps to clarify its regulation of modified plant products, such as exempting from regulation under FIFRA and FFDCA certain plant-incorporated protectants (PIPs) created in plants using newer technologies. EPA next plans to address the scope of plant regulator PIPs and update its 2007 guidance on small-scale field testing of PIPs to reflect technological developments and harmonize with USDA containment measures.

Regarding modified animal products, EPA intends to work with USDA and FDA to coordinate and provide updated information on the regulation of modified insect and invertebrate pests. Specifically, EPA intends to provide efficacy testing guidance on genetically modified mosquitos intended for population control. As outlined in guidance published by FDA in October 2017, products intended to reduce the population of mosquitoes by killing them or interfering with their growth or development are considered “pesticides” subject to regulation by EPA, while products intended to reduce the virus/pathogen load within mosquitoes or prevent mosquito-borne disease in humans or animals are considered “new animal drugs” subject to regulation by FDA.

EPA also now intends to prioritize its review of biopesticide applications, provide technical assistance to biopesticide developers, and collaborate with state pesticide regulators to help bring new biopesticide products to market more quickly.

Further, the three agencies are making efforts to collaborate with each other and with the regulated community. The agencies jointly released plain-language information on regulatory roles, responsibilities, and processes for biotechnology products in November 2023 and now intend to explore the development of a web portal that would direct developers to the appropriate agency or office overseeing their product’s development or regulatory status. The agencies also intend to develop a mechanism for a product developer to meet with all agencies at once early in a product’s development process to clarify the agencies’ respective jurisdictions and provide initial regulatory guidance; to update their joint information-sharing memorandum of understanding; and to formally update the Coordinated Framework for the Regulation of Biotechnology by the end of the year.

Biotechnology product developers should closely monitor EPA, USDA, and FDA’s progress on the actions described above, as well as other USDA- and FDA-specific regulatory moves. Developers should assess the regulatory barriers to their products’ entry to market, consider potential fixes, and be prepared to submit feedback as the agencies propose new rules or issue draft guidance for comment.

© 2024 Beveridge & Diamond PC
For more news on EPA, USDA, and FDA guidance, visit the NLR Administrative & Regulatory section.

House and Senate Hold Hearings on EPA’s FY 2025 Budget Request

On April 30, 2024, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2025 budget request for the U.S. Environmental Protection Agency (EPA). The Senate Appropriations Subcommittee for the Interior, Environment, and Related Agencies held a separate hearing on EPA’s FY 2025 budget request on May 1, 2024, and the Senate Committee on Environment and Public Works held its own hearing on May 8, 2024. On May 15, 2024, the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials held a hearing. EPA Administrator Michael S. Regan testified before both of the House Subcommittees, the Senate Subcommittee, and the Senate Committee (written testimony is hyperlinked).

April 30, 2024, House Subcommittee Hearing

During the April 30, 2024, House Subcommittee hearing, Ranking Member Chellie Pingree (D-ME) asked for an update on EPA’s risk assessment of per- and polyfluoroalkyl substances (PFAS) in biosolids. Regan stated that EPA is working on issuing it in final in 2024, and it will include a focus on certain PFAS to help EPA understand better the specific risks posed to farmers and the uptake in crops and livestock. Regan noted that EPA is working with the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) to research the risk from biosolids application. EPA intends to hold the polluters responsible for the PFAS accountable and does not want farmers, water systems, or taxpayers in affected communities to bear the burden of the contamination.

As reported in our November 3, 2023, blog item, on November 2, 2023, EPA announced that it granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) to address the use of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires. Representative Derek Kilmer (D-WA) asked whether EPA still planned to issue an advance notice of proposed rulemaking (ANPRM) under TSCA Section 6 by the end of 2024 to obtain more information to inform a subsequent regulatory action. Regan stated that EPA expects to issue the ANPRM by fall 2024.

May 1, 2024, Senate Subcommittee Hearing

During the May 1, 2024, Senate Subcommittee hearing, Senator Martin Heinrich (D-NM) asked Regan to explain how EPA will address PFAS contamination under the FY 2025 budget request. Regan noted that EPA recently issued its first-ever National Primary Drinking Water Regulation (NPDWR), which will reduce PFAS exposure to over 100 million people. EPA also announced grants available to help smaller communities comply with the NPDWR. According to Regan, EPA needs the resources and staff to have a comprehensive approach to protect water quality from PFAS. Regan stated that EPA would use the funding to continue to collect scientific evidence and to study how to design technology and health-based standards to protect as many people as possible from different forms of PFAS.

Senator Gary Peters (D-MI) noted that during a 2023 Senate hearing, Regan testified that EPA had an additional 29 PFAS on its radar for a similar drinking water update and asked Regan about the status of the rulemaking. Regan stated that through the Unregulated Contaminant Monitoring Rule, EPA is monitoring drinking water in communities across the United Sates for these 29 PFAS and that EPA intends to pursue regulation for these PFAS.

Senator Patty Murray (D-WA), Chair of the Senate Appropriations Committee, asked Regan about the key funding increases included in the FY 2025 budget request for some of EPA’s core programs. Regan stated that the increases are intended to allow EPA to keep up with recent progress that it has made. While EPA recently issued the NPDWR for six PFAS, there are an additional 29 PFAS being monitored, and thousands more. EPA wants to ensure the safety of chemicals before they hit the market, and that is one of the places where EPA has a deficit in terms of staffing. According to Regan, EPA is getting more requests from agricultural communities about herbicides and pesticides.

Senator Katie Britt (R-AL) stated that EPA’s recent Endangered Species Act (ESA) proposals, such as the Herbicide Strategy, could impose hundreds of millions of dollars in new restrictions on farmers. Britt asked Regan how EPA would implement Congress’s bipartisan instructions in the FY 2024 appropriations report to consider best available data on pesticide usage, conservation practices, and real-world studies on spray drift and water concentrations. Regan testified that previous EPA decisions spanning decades and court rulings have put EPA in a precarious position. According to Regan, EPA is speaking with the farming and agricultural community and has come up with strategies that have received positive feedback. Britt asked whether EPA would consider appointing designated non-federal representatives to help EPA meet its ESA responsibilities. Regan responded that EPA needs more staff and resources to respond to court decisions and that the particular EPA office is down to levels from the early 2000s. Regan stated that he would need to talk through the use of non-federal representatives and agreed to discuss the issue with Britt.

Subcommittee Chair Jeff Merkley (D-OR) asked Regan what Congress can do to accelerate a solution to replace 6PPD with something that works as well without harming salmon. Regan stated that EPA intends to publish an ANPRM by fall 2024 and that EPA is also researching mitigation efforts to fill in the gap until it can take regulatory action.

Ranking Member Lisa Murkowski (R-AK) noted that in its FY 2024 budget request, EPA proposed a significant decrease in discretionary funding because of new revenues coming in from the Superfund tax, while the FY 2025 request includes additional funding for the program. Murkowski asked Regan for his view of the long-term funding outlook for the Superfund program. Regan testified that the tax collections for the first two years were lower than forecasted by the U.S. Department of the Treasury. Because of the gap, for FY 2025, EPA has requested additional funding.

May 8, 2024, Senate Committee Hearing

Senator Cynthia Lummis (R-WY) described EPA’s designation of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) as flawed, stating that this would place the financial burden on passive receivers such as water utilities. More information on the designation and on EPA’s PFAS Enforcement Discretion and Settlement Policy Under CERCLA is available in our April 23, 2024, memorandum.

Committee Chair Thomas R. Carper (D-DE) asked Regan to describe the impact that the FY 2024 funding levels had on the TSCA program and what EPA could accomplish if it received the full amount requested in the FY 2025 budget request and maximized revenue collection through the recently updated TSCA fees rule. Regan stated that EPA received a small increase for TSCA in the FY 2022 and 2023 budgets, and it more than doubled the number of chemical reviews that it did each month. Without the funding in the FY 2025 budget request, EPA will see slower approval of new chemistries, especially for those companies in the semi-conductor, automotive, and battery sectors.

May 15, 2024, House Subcommittee Hearing

During the hearing held by the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials, Subcommittee Ranking Member Paul Tonko (D-NY) asked Regan what EPA is doing to address the backlog of new chemical reviews and what Congress can do to support EPA. Regan stated that with the budget increases that EPA received in 2022 and 2023, it more than doubled the number of new chemicals reviewed each month. According to Regan, EPA has reduced the backlog by half and prioritized new chemistries for the semi-conductor, automotive, and battery manufacturing sectors. According to Regan, without the funding in the FY 2025 budget request, EPA will see slower approval of new chemicals.

Representative Frank Pallone (D-NJ), Ranking Member of the Energy and Commerce Committee, noted that the reinstated Superfund tax has brought in lower receipts than projected by the Treasury and asked how EPA is adapting to the difference between the Treasury’s forecast and the actual funds collected. Regan testified that EPA is working with the Treasury Department to refine its estimates. According to Regan, the $300 million in the FY 2025 budget request will fill in the gap between the projected and actual tax receipts. Without the additional funding, Regan stated that there would be a slowdown in EPA’s ability to clean up Superfund sites. Pallone then asked Regan what the designation of PFOA and PFOS as CERCLA hazardous substances and EPA’s enforcement policy mean for different sectors. Regan responded that EPA is focused on the manufacturers responsible for the PFAS and will not pursue enforcement actions against sectors such as farmers or water systems.

Representative Randy Weber (R-TX) asked about EPA’s final rule amending the TSCA risk evaluation framework and its removal of the definition of “best available science.” Regan stated that he would have to get more context to respond to Weber. More information on EPA’s final rule is available in our May 14, 2024, memorandum.

Representative Dan Crenshaw (R-TX) asked Regan to comment on the almost 400 premanufacture notifications (PMN) awaiting a risk determination and the more than 90 percent that have passed the statutory deadline of 90 days. According to Regan, the issue predates the Biden-Harris Administration. Regan repeated that with the additional resources from Congress in 2022 and 2023, EPA has more than doubled the reviews completed each month.

Representative John Curtis (R-UT) noted that applications in EPA’s New Chemicals Program have dropped from 600 annually to just over 200 and that in the last two calendar years, EPA made 95 and 101 determinations, respectively. According to Curtis, although EPA is required by law to return fees if it misses deadlines, it has never returned the fee to an applicant when EPA has missed the deadline because applicants coincidentally suspend or withdraw their applications before the deadline. Curtis asked Regan to explain the coincidence of PMNs being suspended or withdrawn just in time to allow EPA to keep the money. Regan stated that he was unaware that applications were being withdrawn from EPA and committed to looking into it. Curtis stated that he has been told that EPA has effectively threatened applicants by phone to suspend or withdraw their applications and stated he would like Regan to look into this and report back. Regan committed to doing so. Curtis followed up by asking about EPA’s assumption that it can charge user fees covering 25 percent of the TSCA program’s budget, regardless of the cost. Regan responded that he is not sure that he agrees with the premise and that he needs to look at EPA’s performance with the budget that it did receive. Regan agreed to have a deeper conversation with Curtis on the topic.

Commentary

The hearings for EPA’s FY 2025 budget request were similar to the hearings for EPA’s FY 2024 budget request. Republicans pressed EPA on why it needs additional funding, criticizing the cost and reach of its current rulemakings, while Regan highlighted EPA’s obligations under federal statutes, including the Clean Water Act, the Safe Drinking Water Act, TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act, and the ESA, as well as recent court decisions. On balance, no new information emerged.

©2024 Bergeson & Campbell, P.C.
For more news on EPA’s 2025 Budget Request, visit the Environmental, Energy & Resources section.

U.S. EPA Finalizes Designation of Two PFAS Chemicals as Hazardous Substances Under CERCLA

On April 19, the U.S. Environmental Protection Agency (EPA) released its long-awaited final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as “hazardous substances” under Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”) (the “Final Rule”). The designation, which takes effect 60 days after the final rule is published in the Federal Register, will provide expanded investigation and remediation authority to EPA, will provide a powerful tool for private actions under CERCLA, and will trigger additional release reporting requirements. It will also expand enforcement authority in states that regulate CERCLA-designated hazardous substances.

Hazardous Substance Designation of PFOA and PFOS Has Broad Implications for Cleanups and CERCLA Liability

PFOA and PFOS are two specific chemical compounds within a broad group of thousands of manmade chemicals known as per- and polyfluoroalkyl substances (PFAS). EPA focused its regulatory efforts on these two PFAS; however, the vast majority of PFAS remain unregulated under CERCLA even after issuance of the Final Rule.

Designating PFOA and PFOS as hazardous substances triggers numerous requirements. The primary impact of the Final Rule is that it incorporates PFOS and PFOA into CERCLA’s strict, joint and several liability framework. This change grants EPA the power to investigate releases of PFOA and PFOS and compel potentially responsible parties (PRPs), including owners and operators of a property or facility, to remediate releases of PFOA and PFOS through the specific CERCLA enforcement provisions. PRPs also now have a clear private right of action under CERCLA to pursue cost recovery and contribution actions. Additionally, when the Final Rule becomes effective, facilities will be required to immediately report releases of PFOA and PFOS above their designated “reportable quantities,” (currently one pound within a 24-hour period), to the National Response Center and relevant state or tribal authorities.

Furthermore, many states include CERCLA hazardous substances under their cleanup statutes, meaning these states will now be able to require remediation of PFOA and PFOS under state law.

Listing PFOA and PFOS as “hazardous substances” under CERCLA does not make PFOA or PFOS contaminated waste a “hazardous waste” or a “hazardous constituent” under the Resource Conservation and Recovery Act. However, this designation does require the U.S. Department of Transportation to designate PFOA and PFOS as “hazardous materials” for purposes of transport under the Hazardous Materials Regulations.

While the PFOA and PFOS CERCLA Listing is Final, Questions Remain

As noted in our prior article on the proposed rule, EPA’s designation of PFOA and PFOS as “hazardous substances” leaves several questions unanswered.

  • How will EPA’s CERCLA enforcement discretion policy really play out in practice? 

    Concurrently with the publication of the Final Rule, EPA also released a PFAS Enforcement Discretion and Settlement Policy under CERCLA. This enforcement policy captures EPA’s current position that it does not intend to pursue PRPs under circumstances where “equitable factors” do not support doing so. Enumerated circumstances in the policy include so-called “passive receivers” of PFAS, including community water systems and publicly-owned treatment works, publicly-owned municipal solid waste landfills, publicly-owned airports and local fire departments, and farms where PFAS-containing biosolids are applied to the land. However, EPA’s enforcement policy—which is not binding upon the agency and is subject to change at any time—should be viewed with a healthy dose of skepticism among regulated industries, considering the sheer breadth of potential CERCLA liability for these substances, as well as continued Congressional proposals to codify exemptions for passive receivers within the CERCLA statute itself. Notably, the agency’s enforcement position does not in any way prevent private parties from initiating cost recovery or contribution actions under CERCLA.

  • How will regulated industries manage the costs of PFOA and PFOS cleanup?PFAS contamination can be wide-ranging due to several factors unique to the chemicals themselves. Further, unlike remediation technologies for other well-studied contaminants, existing remediation technologies for PFOA and PFOS are nascent at best and are expensive at a large scale. It is therefore often difficult to even estimate accurate cost ranges for PFOA and PFOS cleanups, but costs can easily run into the millions of dollars at complex sites. Although EPA has published interim guidance on PFOA and PFOS disposal methods, and the recently passed Infrastructure Investment and Jobs Act provides $3.5 billion over five years for Superfund cleanups, the methods and money may not go as far as planned if cleanup costs for PFOA and PFOS sites end up exponentially higher.
  • How will EPA handle potential PFOA and PFOS contamination at closed Superfund sites?In response to comments seeking clarification on whether designating PFOA and PFOS will lead to the reopening of closed Superfund sites, EPA stated that the final rule “has no impact” on EPA’s authority to list PFOA and PFOS sites as Superfund sites. EPA’s question-and-answers page—which we note is not a binding statement from the agency—also states that “[d]esignation will not change EPA’s process for listing and/or deleting [National Priorities List (NPL)] sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.” While the final rule does not require PFOA and PFOS sampling at closed sites, it does not prevent EPA from ordering sampling at these sites. PRPs who may have long ago stopped budgeting for remedial costs at existing or legacy locations that were remediated years and even decades ago, may find that they are required to revisit these sites where PFOA and PFOS may be present.
  • What cleanup standards will govern PFOA and PFOS remediation?There is a current patchwork of state regulatory standards relating to PFAS, ranging from binding cleanup levels, advisory guidance, or no PFAS standards at all, which may lead to similarly patchwork cleanup standards depending on which standards are applied as an appropriate “applicable or relevant and appropriate requirement” (ARAR) at a specific site. In addition, on April 10, 2024, EPA issued a final rule setting Maximum Contaminant Levels (MCL) for PFOA and PFOS in drinking water at 4.0 parts per trillion (ppt), individually. While these drinking water standards are separate from EPA’s final rule listing PFOA and PFOS as “hazardous substances” under CERCLA, the “hazardous substances” rule notes that the MCL may be an appropriate ARAR for cleanup efforts under CERCLA.
  • What other PFAS will EPA next target under CERCLA?As noted above, PFOA and PFOS are two specific PFAS among thousands of others currently and historically used. Much of the science on the potential health effects of PFAS (both individual chemical compounds and as a class) continues to evolve. In the meantime, EPA has moved to regulate additional types of PFAS under other statutes. For example, as we noted in a previous client alert, EPA recently published a proposed rule listing seven other PFAS compounds as hazardous constituents under RCRA. Some or all of these PFAS may eventually be targets of future CERCLA rulemaking efforts.

Next Steps

The Final Rule will take effect 60 days after it is published in the Federal Register. Affected parties should consider their portfolio of planned, active, and in some cases, closed remediation sites for potential implications, and companies may consider reviewing and updating their hazardous substance reporting and transportation protocols to address PFOA and PFOS as applicable.

© 2024 Foley & Lardner LLP
For more on PFAS, visit the NLR Environmental, Energy & Resources section.

EPA Designates Two PFAS as Hazardous Substances

On April 19, 2024, the U.S. Environmental Protection Agency (EPA) announced that it was designating two common per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund. As expected, EPA is issuing a final rule to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances. The pre-publication version of the rule is available here.

Once the rule is effective, entities will be required to report releases of PFOA and PFOS into the environment that meet or exceed the reportable quantity. Reporting past releases is not required if the releases have ceased as of the effective date of the rule. EPA will have the authority to order potentially responsible parties to test, remediate, or pay for the cleanup of sites contaminated with PFOA or PFOS under CERCLA.

Massachusetts established reportable concentrations for six PFAS, including PFOA and PFOS, in 2019. The Massachusetts regulations also contain cleanup standards for PFAS contamination in soil and groundwater.

Under Maine law, these substances also are automatically deemed a Maine hazardous substance regulated under the Maine Uncontrolled Hazardous Substance Sites Law. Maine’s PFAS screening levels are available here.

Solid waste facility operators had expressed serious concerns about the prospect of PFOA and PFOS being listed as hazardous substances under CERCLA and have advocated for a narrow exemption. Landfills can be recipients of PFAS-containing waste without knowing it. Similarly, wastewater treatment plant operators feared liability and increased costs if the rule designating PFOA and PFOS as hazardous substances became final.

EPA’s announcement of the final rule came with a CERCLA enforcement discretion policy [PFAS Enforcement Discretion and Settlement Policy Under CERCLA] that makes clear that EPA will focus enforcement on parties that significantly contributed to the release of PFAS into the environment.

The policy states that the EPA does not intend to pursue certain publicly‑owned facilities such as solid waste landfills, wastewater treatment plants, airports, and local fire departments, as well as farms where biosolids are applied to the land. Firefighting foam (aqueous film-forming foam, or AFFF) is known to contain PFAS, and runoff from the use of AFFF has been known to migrate into soil and groundwater.

©2024 Pierce Atwood LLP. All rights reserved.
For more news on EPA PFAS regulations, visit the NLR Environmental, Energy & Resources section.

Global Regulatory Update for April 2024

WEBINAR – Registration Is Open For “Harmonizing TSCA Consent Orders with OSHA HCS 2012”: Register now to join The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) for “Harmonizing TSCA Consent Orders with OSHA HCS 2012,” a complimentary webinar covering case studies and practical applications of merging the requirements for consent order language on the Safety Data Sheet (SDS). In this webinar, Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, Acta, will explore two hypothetical examples and provide guidance on practical approaches to compliance. An industry perspective will be presented by Sara Glazier Frojen, Senior Product Steward, Hexion Inc., who will discuss the realities of managing this process day-to-day.

SAVE THE DATE – “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Acta affiliate B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the Toxic Substances Control Act (TSCA) stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).

AUSTRALIA

Changes To Categorization, Reporting, And Recordkeeping Requirements For Industrial Chemicals Will Take Effect April 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced regulatory changes to categorization, reporting, and recordkeeping requirements will start April 24, 2024. For the changes to take effect, the Industrial Chemicals (General) Rules 2019 (Rules) and Industrial Chemicals Categorisation Guidelines will be amended. According to AICIS, key changes to the Rules include:

  • Written undertakings replaced with records that will make compliance easier;
  • Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
  • Changes to the categorization criteria to benefit:
    • Local soap makers;
    • Introducers of chemicals in flavor and fragrance blends; and
    • Introducers of hazardous chemicals where introduction and use are controlled; and
  • Strengthening criteria and/or reporting requirements for health and environmental protection.

AICIS announced final changes to the Industrial Chemicals Categorisation Guidelines that will take effect April 24, 2024. According to AICIS, the changes include:

  • Refinement of the requirement to check for hazardous esters and salts of chemicals on the “List of chemicals with high hazards for categorisation” (the List);
  • Provision to include highly hazardous chemicals to the List based on an AICIS assessment or evaluation;
  • Expanded options for introducers to demonstrate the absence of skin irritation and skin sensitization; and
  • More models for in silico predictions and an added test guideline for ready biodegradability.

AICIS states that it will publish a second update to the Guidelines in September 2024 due to industry stakeholders’ feedback that they need more time to prepare for some of the changes. It will include:

  • For the List: add chemicals based on current sources and add the European Commission (EC) Endocrine Disruptor List (List I) as a source; and
  • Refined requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential.

CANADA

Canada Provides Updates On Its Implementation Of The Modernized CEPA: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. Canada is working to implement the bill through initiatives that include the development of various instruments, policies, strategies, regulations, and processes. In April 2024, Canada updated its list of public consultation opportunities:

  • Discussion document on the implementation framework for a right to a healthy environment under the Canadian Environmental Protection Act, 1999 (CEPA) (winter 2024);
  • Proposed Watch List approach (spring/summer 2024);
  • Proposed plan of chemicals management priorities (summer 2024);
  • Draft strategy to replace, reduce or refine vertebrate animal testing (summer/fall 2024);
  • Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);
  • Discussion document for toxic substances of highest risk regulations (winter 2025); and
  • Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).

EUROPEAN UNION (EU)

ECHA Checks More Than 20 Percent Of REACH Registration Dossiers For Compliance: The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per year, it has checked compliance for around 30 percent of the dossiers.

According to ECHA, in 2023, it conducted 301 compliance checks, covering more than 1,750 registrations and addressing 274 individual substances. ECHA “focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances.” ECHA sent 251 adopted decisions to companies, “requesting additional data to clarify long-term effects of chemicals on human health or the environment.” ECHA states that during the follow-up evaluation process, it will assess the incoming information for compliance. ECHA will share the outcome of the incoming data with the EU member states and the EC to enable prioritization of substances. ECHA will work closely with the member states for enforcement of non-compliant dossiers. Compliance of registration dossiers will remain a priority for ECHA. In 2024, ECHA will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registration compliance, and, together with stakeholders, develop new priority areas on which to focus. More information is available in our March 29, 2024, blog item.

Council Of The EU And EP Reach Provisional Agreement On Proposed Regulation On Packaging And Packaging Waste: The Council of the EU announced on March 4, 2024, that its presidency and the European Parliament’s (EP) representatives reached a provisional political agreement on a proposal for a regulation on packaging and packaging waste. The press release states that the proposal considers the full life-cycle of packaging and establishes requirements to ensure that packaging is safe and sustainable by requiring that all packaging is recyclable and that the presence of substances of concern is minimized. It also includes labeling harmonization requirements to improve consumer information. In line with the waste hierarchy, the proposal aims to reduce significantly the generation of packaging waste by setting binding re-use targets, restricting certain types of single-use packaging, and requiring economic operators to minimize the packaging used. The proposal would introduce a restriction on the placing on the market of food contact packaging containing per- and polyfluoroalkyl substances (PFAS) above certain thresholds. The press release notes that to avoid any overlap with other pieces of legislation, the co-legislators tasked the EC to assess the need to amend that restriction within four years of the date of application of the regulation.

EP Adopts Position On Establishing System To Verify And Pre-Approve Environmental Marketing Claims: The EP announced on March 12, 2024, that it adopted its first reading position on establishing a verification and pre-approval system for environmental marketing claims to protect citizens from misleading ads. According to the EP’s press release, the green claims directive would require companies to submit evidence about their environmental marketing claims before advertising products as “biodegradable,” “less polluting,” “water saving,” or having “biobased content.” Micro enterprises would be exempt from the new rules, and small and medium-sized enterprises (SME) would have an extra year to comply compared to larger businesses. The press release notes that the EP also decided that green claims about products containing hazardous substances should remain possible for now, but that the EC “should assess in the near future whether they should be banned entirely.” The new EP will follow up on the file after the European elections that will take place in June 2024.

On April 3, 2024, a coalition of industry associations issued a “Joint statement in reference to ‘the ban of green claims for products containing hazardous substances’ in the Green Claims Substantiation Directive (GCD).” The associations “fully support the principle that consumers should not be misled by false or unsubstantiated environmental claims and share the EU’s objective to establish a clear, robust and credible framework to enable consumers to make an informed choice.” The associations express concern that the proposed prohibition of environmental claims for products containing certain hazardous substances “will run contrary to the objective of the Directive to enable consumers to make sustainable purchase decisions and ensure proper substantiation of claims.” According to the associations, for a number of consumer products, “the reference to ‘products containing’ would encompass substances that would have intrinsic hazardous properties,” implying that there would be a ban of making any environmental claim(s), “even if such trace amounts of unavoidable and unintentional impurities and contaminants are present in these products.” The signatories include the International Association for Soaps, Detergents and Maintenance Products; the European Brands Association; APPLiA; the Association of Manufacturers and Formulators of Enzyme Products; CosmeticsEurope; the European Power Tool Association; the Federation of the European Sporting Goods Industry; the International Fragrance Association; LightingEurope; the International Natural and Organic Cosmetics Association; Toy Industries of Europe; Verband der Elektro- und Digitalindustrie; and the World Federation of Advertisers.

ECHA Clarifies Next Steps For PFAS Restriction Proposal: ECHA issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict PFAS in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under REACH. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. Following the screening of thousands of comments received during the consultation, ECHA states that it is clarifying the next steps for the proposal. According to ECHA, RAC and SEAC will evaluate the proposed restriction together with the comments from the consultation in batches, focusing on the different sectors that may be affected.

In tandem, the five national authorities who prepared the proposal are updating their initial report to address the consultation comments. This updated report will be assessed by the committees and will serve as the foundation for their opinions. The sectors and elements that will be discussed in the next three committee meetings are:

March 2024 Meetings

  • Consumer mixtures, cosmetics, and ski wax;
  • Hazards of PFAS (only by RAC); and
  • General approach (only by SEAC).

June 2024 Meetings

  • Metal plating and manufacture of metal products; and
  • Additional discussion on hazards (only by RAC).

September 2024 Meetings

  • Textiles, upholstery, leather, apparel, carpets (TULAC);
  • Food contact materials and packaging; and
  • Petroleum and mining.

More information is available in our March 18, 2024, blog item.

ECHA Adopts And Publishes CoRAP For 2024-2026: On March 19, 2024, ECHA adopted and published the Community rolling action plan (CoRAP) for 2024-2026. The CoRAP lists 28 substances suspected of posing a risk to human health or the environment for evaluation by 11 Member State Competent Authorities. The CoRAP includes 11 newly allocated substances and 17 substances already included in the previous CoRAP 2023-2025 update, published on March 21, 2023. For 11 out of these 17 substances, ECHA notes that the evaluation year has been postponed, mainly to await submission of new information requested under dossier evaluation. Of the 28 substances to be evaluated, ten are to be evaluated in 2024, 13 in 2025, and five in 2026. The remaining substance of the 24 substances listed in the previous CoRAP was withdrawn as its evaluation is currently considered to be a low priority. According to ECHA, for this substance, a compliance check is needed first. ECHA states that the substance can be placed in the CoRAP list again, if after the conclusion of the dossier evaluation process, concerns remain beyond what can be clarified through dossier evaluation. ECHA has posted a guide for registrants that need to update their dossiers with new relevant information such as hazard, tonnages, use, and exposure.

Comments On Proposals To Identify New SVHCs Due April 15, 2025: A public consultation on proposals to identify two new substances of very high concern (SVHC) will close on April 15, 2024. The substances and examples of their uses are:

  • Bis(α,α-dimethylbenzyl) peroxide: This substance is used in products such as pH-regulators, flocculants, precipitants, and neutralization agents; and
  • Triphenyl phosphate: This substance is used as a flame retardant and plasticizer in polymer formulations, adhesives, and sealants.

UNITED KINGDOM (UK)

HSE Publishes UK REACH Work Programme For 2023/24: In February 2024, the Health and Safety Executive (HSE) published its UK REACH Work Programme 2023/24. The Work Programme sets out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. Alongside these activities, HSE and the Environment Agency will engage with stakeholders. The Work Programme includes the following deliverables and target deadlines:

Topic Deliverable Target
Substance evaluation Evaluate substances in the Rolling Action Plan (RAP) Evaluate one
Authorization Complete the processing of received applications within the statutory deadline (this includes comments from public consultation and REACH Independent Scientific Expert Pool (RISEP) input) 100 percent
SVHC identification Undertake an initial assessment of substances submitted for SVHC identification under EU REACH during 2022/23 and consider if they are appropriate for SVHC identification under UK REACH Assess up to five
Regulatory management options analysis (RMOA) Complete RMOAs initiated in 22/23 

Initiate RMOAs for substances identified as priorities

 Up to ten 

Up to five
Restriction Complete ongoing restriction opinions 

Begin Annex 15 restriction dossiers

Initiate scoping work for restrictions

 Two

One 

Two

HSE Opens Call For Evidence On PFAS In FFFs: HSE is working with the Environment Agency to prepare a restriction dossier that will assess the risks of PFAS in firefighting foams (FFF). HSE will propose restrictions, if necessary, to manage any significant risks identified. To help compile the dossier, HSE opened a call for evidence. HSE states that it would like stakeholders to identify themselves as willing to engage in further dialogue throughout the restrictions process. In particular, it would like to hear from stakeholders with relevant information on PFAS (or alternatives) in FFFs, especially information specific to Great Britain (GB). Regarding relevant information, HSE is interested in all aspects of FFFs, including:

  • Manufacture of FFFs: Substances used, process, quantities;
  • Import of FFF products of all types: Quantities, suppliers;
  • Use: Quantities, sector of use, frequency, storage on site, products used;
  • Alternatives to PFAS in FFF: Availability, cost, performance in comparison to PFAS-containing foams, barriers to switching;
  • Hazardous properties: SDSs, new studies on intrinsic properties and exposure, recommended risk management measures;
  • Environmental fate: What happens to the FFF after it is used, where does it go;
  • Waste: Disposal requirements, recycling opportunities, remediation; and
  • Standards: Including product-specific legislation, performance, certification.

HSE states that the call for evidence targets companies (manufacturers, importers, distributors, and retailers) and professional users of FFFs, trade associations, environmental organizations, consumer organizations, and any other organizations and members of the public holding relevant information. HSE intends to publish the final dossier, including any restriction proposals, on its website in March 2025. Interested parties will also then be able to submit comments on any proposed restriction.

New GB BPR Data Requirements Will Apply To Applications Submitted In October 2025: The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of the GB Biocidal Products Regulation (BPR), were laid in Parliament on March 13, 2024, and came into force on April 6, 2024. The legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties that previously relied on animal testing. HSE held a public consultation on the proposed changes in 2023 and has posted a report on the outcome of the consultation. The new data requirements will apply to applications received 18 months after the legislation came into force (October 6, 2025) and do not apply to existing applications. HSE will provide further guidance on the changes in the future.

© 2016 The Acta Group All Rights Reserved.
For more on Global Regulation, visit the NLR Environmental, Energy & Resources section.

Curb Your Pollution: EPA Issues Final Rule to Reduce Toxic Air Pollution

EPA Issues Final Rule to Reduce Toxic Air Pollution from the Synthetic Organic Chemical Manufacturing Industry and the Polymers and Resins Industries

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule that is touted to provide critical health protections to hundreds of thousands of people living near chemical plants. The final rule, signed March 28, 2024, will reduce emissions of hazardous air pollutants, including the toxic chemicals chloroprene and ethylene oxide (EtO). The rule implements sections 111 and 112 of the Clean Air Act.

When fully implemented, the final rule will reduce more than 6,200 tons a year of over 100 air toxics – including EtO and chloroprene – from covered equipment and processes at plants in Texas and Louisiana, along with plants in other parts of the country including Delaware, New Jersey, and the Ohio River Valley.

As part of the final rule, the EPA is also issuing new emissions limits for dioxins and furans. This will reduce more than 23,000 tons of smog-forming volatile organic compounds (VOCs) each year.

EPA’s final rule will also require plants to conduct fenceline monitoring if any of the equipment or processes covered by the rule use, produce, store, or emit EtO, chloroprene, benzene, 1,3- butadiene, ethylene dichloride or vinyl chloride. Fenceline monitoring is used to measure levels of pollution in the air around the perimeter of a facility. The fenceline monitoring provisions of the rule require owners and operators to ensure that levels of these six pollutants remain below a specified “action level.” Fenceline monitoring provides owners and operators the flexibility to determine what measures to take to remain below the action level, while ensuring that they are effectively controlling toxic air pollution.

The final rule will significantly reduce emissions of air toxins, especially those that are potentially harmful for surrounding communities. According to the EPA, these emission reductions will yield significant reductions in lifetime cancer risk attributable to these air pollutants, in addition to other health benefits.

©2024 Norris McLaughlin P.A., All Rights Reserved
For more on Air Pollution, visit the NLR Environmental, Energy & Resources section.

EPA Issues Final Rulemaking on Clean Water Act Hazardous Substance Facility Response Plans

Key Takeaways

  • What Is Happening? On March 14, 2024, The U.S. Environmental Protection Agency (EPA) signed a final rule requiring certain facilities to develop Facility Response Plans (FRPs) for a potential worst-case discharge of Clean Water Act (CWA) hazardous substances, including planning for the threat of a worst-case discharge. Existing EPA regulations require FRPs where certain thresholds of oil are exceeded; the new rule extends the FRP requirement to cover CWA hazardous substances, among other changes. The rule takes effect on May 28, 2024, and has a 36-month implementation period. We anticipate challenges to the rule, but unless a court issues a stay, affected facilities should plan to implement the rule’s new requirements in this timeframe.
  • Who Is Impacted? Affected industries include many industrial and commercial sectors and facilities that handle hazardous substances at or above current reportable quantity thresholds. These may include manufacturing and chemical plants and storage operations located near navigable waters that have an inventory of CWA-listed hazardous substances at or above threshold amounts. Facilities associated with oil and gas extraction, mining, construction, utilities, crop production, animal production and aquaculture, and support activities for agriculture and forestry, among others, could also be affected.
  • What Should I Do? Facility owners and operators potentially affected by the rule should assess whether they are subject to the rule and then begin developing their facility response plans.

The rule requires Facility Response Plans for worst-case discharges of CWA hazardous substances from onshore non-transportation-related facilities that, because of their location, could reasonably be expected to cause substantial harm to the environment by discharging into or on the navigable waters, adjoining shorelines, or exclusive economic zone. Facilities already subject to requirements for Spill Prevention, Control Countermeasure Plans, or FRPs for oil under 40 CFR Part 112 should anticipate that they will fall within the scope of the new rule and plan for compliance.

Background

The final rule is EPA’s response to the settlement of a 2019 lawsuit brought by the Natural Resources Defense Council and others. The lawsuit asserted that EPA failed to meet its statutory duty to issue regulations “requiring non-transportation-related substantial-harm facilities to plan, prevent, mitigate and respond to worst-case spills of hazardous substances.”

The Consent Decree required EPA to take final action on a rule addressing worst-case discharge plans for hazardous substances by September 2022. This final action represents EPA’s final action under the consent decree.

Applicability Criteria

EPA set forth a two-step process to determine whether the new rule applies to a facility. See 40 CFR 118.3. Specifically, the owner or operator of a covered facility must assess two screening criteria and, if both criteria are met, then assess the ability of the facility to cause substantial harm to the environment through the application of the substantial harm criteria. If an owner or operator determines that the covered facility meets one of the substantial harm criteria, the owner or operator must prepare a hazardous substance FRP in accordance with the new regulations.

  • Initial Screening. These screening criteria are to be assessed concurrently, with no implied order of priority:
    1. Facility has a maximum quantity onsite of 1,000x the Reportable Quantity of CWA Hazardous Substances. The RQs published in 40 CFR Part 117 are based on a level of release of a hazardous substance that could potentially cause harm to waters. EPA’s decision to set the threshold criteria at 1000x rather than the initially proposed 10,000x the RQ represents a potentially significant expansion of the scope of the new rule.
    2. Facility is within 0.5 miles of navigable water or conveyance to navigable water.

If a facility meets the two screening criteria, it must undergo an evaluation to determine whether it meets the substantial harm criteria.

  • Substantial Harm Criteria. If the two screening criteria are met, the next step is a substantial harm evaluation, which includes determining whether the facility meets one of the following four substantial harm criteria:
    1. Ability to adversely impact public water system.
    2. Ability to cause injury to fish, wildlife, and sensitive environments.
    3. Ability to cause injury to public receptors.
    4. Has experienced a reportable discharge of CWA hazardous substances that reached navigable water within the last five years.

These criteria are easily triggered under the FRP process for oil, which preexisted the new rule. For instance, an “injury” means any measurable adverse change, either long- or short-term, in the chemical or physical quality or the viability of a natural resource resulting either directly or indirectly from exposure to a discharge or exposure to a product of reactions resulting from a discharge. 40 CFR 112.2.

If both screening criteria and one or more substantial harm criteria apply, the facility must prepare and submit an FRP to EPA that includes information on each CWA hazardous substance above the threshold quantity onsite. The owner or operator must assess all substantial harm criteria.

Amendments from the Proposed Rule

  • In the final rule, the Agency determined that a 1,000x RQ multiplier, instead of the proposed 10,000x, will more appropriately screen for covered facilities that could cause substantial harm to the environment from a worst-case discharge. In response to comments, EPA indicated that the screening criteria, in conjunction with the substantial harm criteria, will appropriately target covered facilities that could cause substantial harm to the environment from a worst-case discharge of a CWA hazardous substance into or on the navigable waters. This change in scope from the proposed rule will likely significantly broaden the number of locations that must now complete the new assessment process for CWA hazardous substances.
  • As the basis for assessing risk to the environment, the new rule requires the use of the volume by the maximum quantity onsite inventory of hazardous substances above RQs, rather than the maximum onsite container capacity. EPA made this change in the final rule based on its view that this approach will more accurately reflect the hazard posed and is consistent with how oil is measured and regulated.
  • Once a facility determines it meets one of the substantial harm criteria, the owner or operator must now develop an FRP for all, not just one, of the CWA hazardous substances onsite above the threshold quantity. EPA made this adjustment by recognizing that the response and/or recovery actions may vary widely depending on which substance is released. Thus, the FRP must include information on each hazardous substance onsite that is above the threshold quantity.
  • EPA added § 118.4(a)(6) to the final rule, which requires a covered facility owner or operator to review and recertify their plan Agency every five years. EPA decided that this will ensure the FRPs remain up-to-date and owners or operators remain informed of their responsibilities. This requirement is consistent with oil FRP requirements.
  • EPA also added § 118.4(a)(7), requiring a facility owner or operator to evaluate or re-evaluate operations whenever EPA adds or removes a CWA hazardous substance from the list at 40 CFR 116.4 or adjusts relevant RQs as found in 40 CFR 117.3. EPA reasoned that such adjustments are made through a formal notice and comment rulemaking procedure; thus, regulated entities will have notice of these changes prior to them becoming final and effective.

Implementation and Enforcement

Facility Response Plan preparation, submission, and implementation timelines are subject to the effective date and an initial 36-month implementation period. EPA included this implementation period to allow covered facilities time to familiarize themselves with the rule requirements and prepare their plans.

  • Initially-regulated covered facilities. The owner or operator of a non-transportation-related onshore facility in operation on November 30, 2026, that satisfies the applicability criteria must implement the requirements of the new regulations by June 1, 2027.
  • Newly-regulated covered facilities. The owner or operator of a non-transportation-related onshore facility in operation after November 30, 2026, that satisfies the applicability criteria must comply within six months.
  • Newly-constructed covered facilities. Covered facilities starting operations after June 1, 2027, must comply prior to the start of operations, including a 60-day start-up period adjustment phase.

Appeals

Similar to current regulations for Oil FRPs, a facility that believes it is not subject to the new rule may appeal a decision by the EPA Regional Administrator determining the potential or threat of substantial harm or significant and substantial harm from a facility or, in the case of an FRP that has been prepared, the Regional Administrator’s disapproval of a CWA hazardous substance FRP. If warranted, that decision can then be appealed to the EPA Administrator.

Petitions

The public and other government agencies may also petition EPA to determine whether a CWA hazardous substance-covered facility should be required to submit an FRP to EPA. Given the breadth of the new rule relative to the long list of hazardous substances and the 1000x RQ threshold, this public participation opportunity is a significant consideration for facilities that may already be under community scrutiny for other reasons.

© 2024 Beveridge & Diamond PC
For more news on Clean Water Act Regulations, visit the NLR Environmental, Energy & Resources section.

OECD Tour de Table Includes Information on U.S. Developments on the Safety of Manufactured Nanomaterials

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 23rd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2023. The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. Risk assessment decisions, including the type of nanomaterials assessed, testing recommended, and outcomes of the assessment include:

  • The U.S. Environmental Protection Agency (EPA) completed review of four low volume exemptions (LVE) that included a graphene material, a titanium dioxide material, and two graphene oxide materials, one of which was a modification to an existing exemption. EPA denied two of the LVEs and granted two under conditions that limited human and environmental exposures to prevent unreasonable risks.
  • According to the Tour de Table, EPA has under review 17 premanufacture notices (PMN), 16 of which are for multi-walled carbon nanotube chemical substances and one of which is for a graphene material. The Tour de Table states that EPA is still reviewing these 17 chemical substances for potential risks to human health and the environment. EPA completed its review of one significant new use notice (SNUN) for a single-walled carbon nanotube, regulating it with a consent order due to limited available data on nanomaterials. The consent order limits uses and human and environmental exposures to prevent unreasonable risks.

The Tour de Table includes the following information regarding risk management approaches in the United States:

  • Between June 2022 and June 2023, EPA received notification of two nanoscale substances based on metal oxides that met reporting criteria pursuant to its authority under the Toxic Substances Control Act (TSCA) Section 8(a), bringing the total number of notifications to 87. Reporting criteria exempted nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that did not have unique or novel properties. According to the Tour de Table, most reporting was for metals or metal oxides.
  • Since January 2005, EPA has received and reviewed more than 275 new chemical notices for nanoscale materials under TSCA, including fullerenes and carbon nano-onions, quantum dots, semiconducting nanoparticles, and carbon nanotubes. EPA has issued consent orders and significant new use rules (SNUR) permitting manufacture under limited conditions. A manufacturer or processor wishing to engage in a designated significant new use identified in a SNUR must submit a SNUN to EPA at least 90 days before engaging in the new use. The Tour de Table notes that because of confidential business information (CBI) claims by submitters, EPA may not be allowed to reveal to the public the chemical substance as a nanoscale material in every new chemical SNUR it issues for nanoscale materials. EPA will continue to issue SNURs and consent orders for new chemical nanoscale materials in the coming year.
  • Because of limited data to assess nanomaterials, the consent orders and SNURS contain requirements to limit exposure to workers through the use of personal protective equipment (PPE), limit environmental exposure by not allowing releases to surface waters or direct releases to air, and limit the specific applications/uses to those described in the new chemical notification.

Regarding updates, including proposals, or modifications to previous regulatory decisions, the Tour de Table states that “[t]he approaches used, given the level of available information, are consistent with previous regulatory decisions. EPA’s assessments now assume that the environmental hazard of a nanomaterial is unknown unless acceptable hazard data is submitted with nanomaterial submission.”

The Tour de Table lists the following new regulatory challenge(s) with respect to any action for nanomaterials:

  • Standards/methods for differentiating between different forms of the same chemical substance that is a nanomaterial;
  • Standardized testing for the physical properties that could be used to characterize/identify nanomaterials; and
  • Differentiation between genuinely new nanoscale materials introduced in commerce and existing products that have been in commerce for decades or centuries.
©2024 Bergeson & Campbell, P.C.
Fore more on Nanomaterials, visit the NLR Environmental, Energy & Resources section.

Oil Pollution Act: Tips for Spill Response, Compliance, and Enforcement

Oil spills commonly occur when least expected and, even in smaller quantities can significantly disrupt business operations and create risks for enforcement and/or litigation. It’s important that companies are prepared and know the environmental requirements for when the least expected happens, including understanding what actually is “oil” (hint: it’s broader than you might think!), who to notify, legal authorities at play, and best practices to ensure compliance and minimize exposure to regulators and/or private parties.

What is “Oil” Anyway?

Section 311 of the Clean Water Act (CWA) and the Oil Pollution Act (OPA) make up the federal statutory framework for oil spills. However, many companies may not realize that both petroleum-based and non-petroleum-based substances are regulated as “oil” under the CWA and OPA. As a result, many companies may not realize that they are subject to these laws and, therefore, fail to adequately prepare for compliance and/or response both pre- and post-spill.

Specifically, Section 311(a)(1) of the CWA defines oil as “oil of any kind or in any form, including, but not limited to, petroleum, fuel oil, sludge, oil refuse, and oil mixed with wastes other than dredged spoil.” 40 CFR § 112.2 further defines oil as “oil of any kind or in any form, including, but not limited to: fats, oils, or greases of animal, fish, or marine mammal origin; vegetable oils, including oils from seeds, nuts, fruits, or kernels; and, other oils and greases, including petroleum, fuel oil, sludge, synthetic oils, mineral oils, oil refuse, or oil mixed with wastes other than dredged spoil.” This definition is notably broader than what many may consider “oil” (i.e., crude oil and refined petroleum products) and encompasses animal fats, vegetable oils, and non-petroleum oils.

When to Notify?

The CWA and OPA require companies to notify the National Response Center (NRC) of oil spills as soon as they are discovered (i.e., within 15 minutes). This applies to all discharges that reach navigable waters of the U.S. (WOTUS) or adjoining shorelines and (1) cause a sheen; (2) violate applicable water quality standards; or (3) cause a sludge or emulsion beneath the surface of the water or upon adjoining shorelines. In practice, this typically results from a sheen, which 40 C.F.R. § 110.1 defines as an “iridescent appearance on the surface of water.” The Oil Pollution Prevention regulations (discussed further below) also identify discharges from regulated facilities that require reporting, though there are exceptions—for example, when the discharge is in compliance with a permit under Section 402 of the CWA.

Under state and local laws, notification may be much more stringent. For example, California requires immediate reporting of “any significant release or threatened release” of a hazardous material, which includes oil. This can be subjective and requires a fact- and legal-specific evaluation of whether the release qualifies as “threatened” and/or “significant.” In Georgia, immediate notification is required either when the oil creates a “significant sheen on top of state waters” or when the amount discharged is unknown—further creating different criteria for when reporting is required. Regardless of what triggers notification, it is important that companies understand that different agencies—federal, state, and local—may each have different reporting requirements, and accurate and timely reporting is absolutely crucial. Often, failure to timely report is the first violation sought by agencies and can result in increased penalties and additional scrutiny.

What Authorities Are at Play?

At the federal level, two agencies primarily exercise authority over oil spills—the U.S. Environmental Protection Agency (EPA) and U.S. Coast Guard (CG). Depending on the location of the spill, the EPA or CG may lead federal oversight with the EPA overseeing inland spills and CG overseeing offshore spills. The Pipeline and Hazardous Materials Safety Administration and Federal Railroad Administration may also exercise authority for pipeline or railroad releases, respectively.

As mentioned above, Section 311 of the CWA and OPA—enacted in 1990 in response to the Exxon Valdez oil spill—make up the federal statutory framework for oil spills. In practice, these authorities are best categorized into two areas: (1) oil spill response; and (2) oil spill prevention and preparedness. It is important for companies to understand the expectations for both (discussed in more detail below), and the National Oil and Hazardous Substances Pollution Contingency Plan (often referred to as the National Contingency Plan or NCP), which outlines the federal government’s cleanup strategy for responding to oil spills, including other cleanups under CERCLA. The goal of the NCP is to ensure that resources are available and responses are consistent. Thus, when the federal government oversees a cleanup, the federal On-Scene Coordinator will expect that all response efforts, including those conducted by the responsible party, are consistent with the NCP.

At the state level, most utilize their respective water laws to address oil spills, though some states, like Louisiana, have laws comparable to OPA. At the local level, municipalities have notification and emergency response authorities that will be applicable. In the end, it’s very important that companies understand that several layers of government may have some form of oversight depending on the size, impact, and location of an oil spill.

OPA v. CWA

While the CWA and OPA are complimentary, including OPA amending the CWA, companies should understand the goals and implications of both. Generally, the CWA focuses on oil spill enforcement for cleanups and penalties, and the OPA broadens national and regional capability for preventing, responding to, and paying for oil spills.

For the CWA, Section 311(b)(3) expressly prohibits the discharge of oil (or hazardous substances) into or upon WOTUS and adjoining shorelines in quantities that may be harmful.1 For oil, this generally means discharges to WOTUS that cause sheening or violate applicable water quality standards. Sections 311(c) and (e) of the CWA provide extensive authority to the federal government to respond to these discharges, including threatened discharges, by issuing orders—either unilaterally or by consent—to owners, operators, or persons in charge of the facility from which the discharge occurs.

Sections 311(b)(6) and (7) of the CWA further empower the federal government to pursue significant penalties—both administrative and civil—for spills that reach WOTUS and/or when responsible parties fail to comply with an order. If gross negligence or willful misconduct is involved, you can expect even greater penalties—commonly more than three-fold—not to mention possible criminal liability. Internally, the EPA utilizes the Civil Penalty Policy for Sections 311(b)(3) and (j) of the CWA and factors outlined in Section 311(b)(8) of the CWA, including the seriousness of the violation, economic benefit to the responsible party, history of prior violations, and efforts to minimize or mitigate the discharge, to evaluate enforcement and penalty calculations.

Akin to the CWA, Section 2702(a) of OPA also makes responsible parties liable for removal costs and natural resource damages resulting from any discharge of oil, including a substantial threat of discharge, to WOTUS and adjoining shorelines. Notably, this includes not only costs incurred by the federal government, but also costs or damages to private parties, including damages for the loss of personal property, loss of revenues/profits due to injury, and cost of additional services during or after a spill. OPA further aims to strengthen national and regional response strategies, amend the National Oil and Hazardous Substances Pollution Contingency Plan, require facilities to develop prevention and response plans, and establish a fund for damages and cleanup costs—each discussed below.

While it is typically always the priority of the federal government to have responsible parties pay for and conduct their own spill cleanups, when a responsible party is unknown, unable, or refuses to pay, funds from the Oil Spill Liability Trust Fund (OSLTF) can be utilized to pay for the response. The OSLTF is managed by the CG’s National Pollution Funds Center (NPFC) and the NPFC thereby manages any oversight or cleanup costs incurred by the federal government. Thus, if an oil spill occurs at your facility and the federal government incurs costs responding or overseeing, the NPFC will be the entity that seeks recovery of those costs—even if the EPA later pursues penalties for the same discharge pursuant to Sections 311(b)(6) and (7) of the CWA. In addition, when a non-liable party performs a cleanup or incurs damages as a result of an oil spill, that party may file a claim for reimbursement directly against the responsible party and/or seek reimbursement from the NPFC.

Lastly, regarding liability, both the CWA and OPA are strict liability and provide limited liability defenses for acts of God, acts of war, or acts/omissions of third parties—comparable to CERCLA. Even so, it’s important to note that Section 309(g)(6) of the CWA states that the federal government may not seek enforcement, including penalties, if the state “has commenced and is diligently prosecuting an action” under a comparable state law. This includes issuing a final order or directing a responsible party to pay a penalty. As mentioned above, states typically pursue oil spill violations via their respective water laws, which may be considered comparable. State penalties may often be substantially less than those sought by the federal government—thus, early engagement with the state can be advantageous depending on the circumstances.

Oil Pollution Prevention Regulations

Section 311(j) of the CWA and OPA, as outlined in 40 C.F.R. Part 112, require facilities that store oil in significant quantities to prepare Spill Prevention, Control, and Countermeasure (SPCC) Plans to prevent accidental releases from reaching WOTUS or adjoining shorelines. Facilities with a greater risk of release and impact to WOTUS may also be required to develop a Facility Response Plan (FRP) to prepare for “worst-case spills.” At the outset, companies should confirm whether these regulations are applicable to their operations and facilities.

SPCC plans are required for facilities that are: (1) non-transportation-related (i.e., they store, process, or consume oil rather than simply move it from one facility to another); and (2) collectively store more than 1,320 gallons of oil above ground or 42,000 gallons below ground that could reasonably be expected to discharge oil to a WOTUS or adjoining shorelines. This can include oil drilling and production facilities, oil refineries, industrial, commercial, and agricultural facilities storing/using oil, facilities that transfer oil via pipelines or tank trucks (including airports), and facilities that sell or distribute oil, like marinas. Practically, these regulations require facilities to have a written plan certified by a professional engineer (apart from qualified facilities), maintain adequate secondary containment for oil storage, maintain updated lists of the federal, state, and local agencies that must be contacted in case of a spill, and follow regular inspection requirements, among other requirements.

In addition to SPCC, FRP plans are required for facilities that could reasonably expect to cause “substantial harm” to the environment by discharging oil into or upon WOTUS. They either have: (1) total oil storage capacity greater than or equal to 42,000 gallons and transfer oil over water to/from vessels; or (2) total oil storage capacity greater than or equal to 1 million gallons and either do not have sufficient secondary containment, are located at a distance such that a discharge could cause “injury” to habitat or shut down a drinking water intake, or within the past five years, have had a reportable discharge greater than or equal to 10,000 gallons. If so, given that FRP is self-identifiable, the facility must prepare and submit its FRP plan to its applicable EPA regional office. Among other things, these plans include evaluating , medium, and worst-case discharge scenarios, descriptions and records of self-inspections, drills, and response training, and diagrams of the facility site plan, drainage, and evacuation plan.

EPA commonly conducts inspections at subject facilities to ensure that SPCC and FRP plans are effectively implemented. Should your facility have an oil spill, plan on an inspection very soon to evaluate compliance and mitigation efforts with your respective requirements.

Suggested Actions

Beyond being aware of the above implications and requirements, below are several actions to consider to ensure compliance and minimize possible enforcement and/or litigation when the least expected occurs.

  • Act Fast: Should an oil spill occur, regardless of size, act fast to respond, mitigate, and determine if notification is required. This includes immediate internal coordination with those responsible for responding, as well as outreach to your environment counsel and/or consultant. If the determination for reporting is close, it is recommended that you report (with a qualified caveat) rather than withhold.
  • Education and Training: Ensure your staff is trained to effectively respond to, report, and prevent oil spills. Oil spills happen despite best attempts otherwise. When the inevitable happens, make sure facility staff are prepared to respond and mitigate the potential impacts of the spill, including having spill reporting hotlines and other contact numbers easily accessible and staff trained on where all information is located. Also, learn from past spills and/or near spills by conducting evaluations and identifying lessons learned to be utilized to prevent future spills.
  • Prepare for Outside Communication: If the spill is significant or causes public impacts, be prepared for outreach by the public, including local news and community groups. Notifications to the NRC are available online and impacts to public or private property often lead to alerts to local news and organizations. Ensure your public affairs contact(s) are aware and develop necessary communication, including desk statements, should the spill create public attention.
  • Review Compliance: Evaluate your current compliance with federal, state, or local requirements, including the development, assessment, and update (if needed) of SPCC and/or FRP response plans. This includes determining if either or both are required at your facility. Should a spill occur, it is important to make sure your response plans are up-to-date and ready for implementation.
  • Regular Audits and Updates: Periodically audit your spill response and prevention measures (SPCC and FRP plans), including any changes to facility operations, secondary containment features, or volumes of oil stored, to identify and correct inaccuracies and ensure that your plans are up-to-date. For FRP, this includes submitting updates to the appropriate EPA regional office within 60 days of each change that may materially affect the response to a worst-case discharge.
  • Insurance: Though not always necessary, consider appropriate insurance coverage to mitigate potential financial liabilities.
  • Consultation: If you have any doubts about your obligations during an oil spill or need assistance with compliance, please do not hesitate to contact your environment counsel or consultants for guidance and support.

1 While this discussion focuses on the impacts of oil spills, it’s important to remember that Section 311 of the CWA (though not OPA) also applies to hazardous substances—discharges to a WOTUS that exceed a reportable quantity pursuant to 40 C.F.R. § 117.3—though the federal government may typically utilize the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund), or combination thereof, to pursue such releases.

© 2024 Beveridge & Diamond PC
For more news on Oil Spills, visit the NLR Environmental, Energy & Resources section.

Multistate Coalition Supports EPA’s Proposed Revisions to the Safer Choice Standard

As reported in our December 5, 2023, memorandum, the U.S. Environmental Protection Agency (EPA) proposed updates to the Safer Choice Standard on November 14, 2023, that include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. On January 16, 2024, California Attorney General Rob Bonta announced that, alongside a coalition of 12 attorneys general, he submitted a comment letter that:

  • Supports EPA’s proposed revisions to its Safer Choice Standard;
  • Recommends that EPA not allow products with plastic primary packaging to use the Safer Choice label or DfE logo;
  • Recommends that if EPA does allow products with plastic primary packaging to use the label and logo, EPA should prohibit the use of chemical recycling in meeting the proposed standard’s plastic packaging recycled content requirements; and
  • Calls on EPA to exclude any products or packaging that contain any per- and polyfluoroalkyl substances (PFAS), “whether intentionally introduced or not.”
©2024 Bergeson & Campbell, P.C.
For more news on EPA’s Safer Choice Standard, visit the NLR Environmental, Energy & Resources section.