Environmental Law Archives - Page 2 of 43

EPA Announces Strengthening the Safer Choice and Design for the Environment Standard for Commercial and Household Cleaning Products

According to EPA, the Safer Choice program was implemented so consumers and purchasers for facilities like schools and office buildings could find cleaners, detergents, and other products made with safer chemical ingredients. It encourages use of chemicals that meet EPA’s stringent criteria for human health and the environment and provides opportunities for companies to differentiate their products in the marketplace with the Safer Choice label.

Similarly, the DfE program assists consumers to find antimicrobial products that meet high standards for public health and the environment. It assists consumers to identify antimicrobial products like disinfectants that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as meeting the Safer Choice and DfE Standard.

In addition to updated clarifying language, the final updated Standard includes:

A new certification program for cleaning service providers that use Safer Choice- and DfE-certified products. The Cleaning Service Certification logo is available for organizations and businesses that use cleaners, detergents, disinfectants, and related products as part of their primary operations. The logo distinguishes cleaning service providers who use Safer Choice-certified products for cleaning and DfE-certified products for disinfection either exclusively or to the maximum extent practicable.
Strengthened criteria that pet care products must meet to ensure they use only the safest possible ingredients for humans, pets, and the environment.
Updated safer packaging criteria, ensuring primary packaging does not include any unintentionally added per- and polyfluoroalkyl substances (PFAS) or other chemicals of concern.
Strengthened sustainable packaging requirements for all Safer Choice-certified products to use post-consumer recycled content and be recyclable or reusable.
Updated criteria for wipe products to ensure certified wipes contain “Do Not Flush” language to help reduce damage to wastewater treatment systems.
New, optional energy efficiency or use reduction criteria to encourage companies to use less water, use renewable energy, and improve energy efficiency.

This update follows a November 2023 request for public comment on EPA’s proposed updates to the Standard. This is EPA’s fourth update of the Standard since its inception in 2009 and the first since 2015. EPA states it periodically updates the Standard to keep current with the state of scientific and technological innovation, increase transparency and reduce redundancy, and expand the scope of the program as appropriate.

The updated Standard is available here.

EPA Announces Initial Recipients for Historic Community Change Grants Program

The United States Environmental Protection Agency (EPA) has announced more than $325 million in funding for 21 projects aimed at addressing environmental and climate justice issues in disadvantaged communities. This funding is the first round of nearly $2 billion from the new Community Change Grants Program, the largest environmental justice investment in history.

The program has two tracks:

Track I, Community-Driven Investments for Change, will distribute around $1.96 billion for 150 community-scale projects, each receiving $10-20 million. Recipients include organizations and municipalities across the U.S. Nelson Mullins pro bono clients, Dillard University and United Way of Southeast Louisiana, are Track I applicants who are implementing community-scale projects to address environmental and climate justice challenges.

Track II, Meaningful Engagement for Equitable Governance, will allocate approximately $40 million for 20 projects focused on enhancing community involvement in governance, with grants ranging from $1-3 million.

“The EPA’s selection of Dillard University’s Community Change Grant submission, in partnership with the United Way of Southeast Louisiana, is a testament to the value we place on collaboration with our array of stakeholders to transform our community,” said Dillard University’s Interim President Dr. Monique Guillory. “As a native New Orleanian, I am distinctly familiar with the environmental injustices that have plagued this region. It is that understanding that makes this award a special honor as I am called to serve the Bleu Devil family as interim president. This is not just an award for Dillard University, but for our entire New Orleans community. I extend a special note of appreciation to our partners at Nelson Mullins and the Louisiana congressional delegation for their leadership and support of this effort. We look forward to leveraging this award for substantive impact to the Dillard University community and beyond.”

Nelson Mullins helped Dillard University and United Way of Southeast Louisiana identify and obtain this grant funding opportunity by drafting a legislative background briefing, facilitating meetings with EPA senior staff, reviewing the Notice of Funding Opportunity (NOFO) with the clients, and conducting strategy sessions with the clients and grant writing team. Nelson Mullins also engaged in congressional outreach for application support and prepared the clients in advance of their oral presentation before the EPA.

“Today’s announcement of funding to support disadvantaged communities in addressing environmental and climate justice challenges marks a significant step forward,” said the president and CEO of United Way of Southeast Louisiana, Michael Williamson.

Community Change Grants Program applications are open until Nov. 21 and will be reviewed on a rolling basis. The program encourages early applications and offers technical assistance until Aug. 16.

Read the EPA press release here.

NJDEP Publishes New Climate Change Rule Proposal

Substantial changes to NJDEP’s use Coastal, Flood Hazard, Wetland and Stormwater regulatory programs are coming that will severely impact proposed and existing development. NJDEP published its Protecting Against Climate Threats (PACT) Resilient Environments and Landscapes (REAL) rule in the August 5, 2024 New Jersey Register and has up to a year to adopt the proposed amendments.

The proposal is extensive and will implement sweeping regulatory changes across various regulatory permitting programs, affecting new development and redevelopment, and substantial improvements to existing development. The proposal relies on several reports and studies commissioned or prepared by NJDEP, including the NJ Scientific Report on Climate Change (NJ Climate Science Report), the New Jersey Climate Change Alliance Science and Technical Advisory Panel (STAP) “Rising Seas and Changing Coastal Storms” report prepared by Rutgers University, and two rainfall studies in 2021, which predict a less than 17% chance that sea level rise (“SLR”) will exceed 5.1 feet by Year 2100, and that the State’s precipitation rates and intensity are expected to increase through the Year 2100. DEP is using this very conservative less than 17% chance as the basis for these proposed rules.

NJDEP will establish a regulatory Inundation Risk Zone (IRZ) largely in coastal areas along tidal waters that are predicted to be at risk of daily inundation or standing flood waters of up to 5.1 feet (by Year 2100). The extent of the IRZ is determined by adding 5 feet to the calculated mean higher high water (MHHW) line elevation. Projects in the IRZ involving new residential development, critical buildings and substantial improvements to existing structures will need to meet onerous enhanced risk assessment criteria including an alternatives analysis designed to avoid the risk (a/k/a discourage building). The rule will also establish a new Climate Adjusted Flood Elevation (CAFE) in tidal flood hazard areas, which represents a 5-foot addition to FEMA’s 100-year flood elevation based on NJDEP’s very conservative SLR predictions.

Numerous other proscriptive measures are proposed. Some of the more noteworthy provisions are listed below.

General

New burdens will be imposed regarding pre-commencement work notices, including that such notices be made no more than 14 days in advance of the start of work in addition to reporting requirements for completion of work. In our experience, notices similar to these are simply filed and are merely a regulatory burden.

Coastal

Non-mainland (barrier island) coastal centers will be extinguished and, in many cases, strict new impervious cover limitations (3%) and vegetative preserve/plantings requirements will become applicable. This makes development or redevelopment in most of the barrier islands improbable, if not impossible.
A 3% cover limit will be applicable even in designated centers for lands identified as a Coastal Environmentally Sensitive Area, even if these areas can be otherwise developed with permits from discrete programs such as wetlands or flood hazard areas.
Construction continuation rights beyond the permit expiration date in the CAFRA Individual Permit context will be curtailed based on new requirements to justify the continuation based on the reasonable financial investment of the permittee “in proportion to the project as a whole”.
The CAFRA infill exception for a single-family house or duplex in a coastal high hazard area and erosion hazard area will be removed for parcels in the IRZ.

Wetlands

Limitations and mitigation requirements will be enhanced with respect to wetland buffers and permitting.
New conditions will be imposed for wetland general permits requiring stormwater compliance for projects that are a major development, in contrast to the current rules which only require stormwater compliance if the wetland and/or buffer impacts are considered major development thresholds.
The rules will require General Permit applicants to demonstrate “no other practicable configuration” that would avoid or reduce the impacts to wetlands, effectively holding General Permit applicants to standards similar to the alternatives analysis required for an Individual Permit, contrary to the purpose of the General Permit program as a streamlined approval process.
Wetland buffer averaging plan approvals will impose onerous conditions requiring placement of conservation restrictions on the entire wetland and buffer complex, whether or not a project has only limited impacts and additional future regulated activities would otherwise be allowed under NJDEP’s rules, but for the conservation restriction.

Flood Hazard

Permittees will need to recertify that flood hazard areas remain unchanged if work is not commenced within 180 days after a permit is issued, and the work must involve elements of permanent construction of a habitable structure and not only site clearing/preparation, excavation, roadwork or construction of accessory structures (garages). If flood hazard conditions have changed, the project may need to be revised to address the changed conditions, and NJDEP approval obtained before the approved work may occur.
A FEMA Letter of Map Revision approval will be required for certain projects involving minimal flood elevation increases before NJDEP will take action on the permit application. This will add a substantial period of time to the review since FEMA is not required to make a decision within a specified time period, unlike DEP which must adhere to the 90-day law time periods for decision making.
Single-family home subdivisions with more than two units will be held to the same access road elevation requirements currently applicable only to muti-residential and critical buildings, and NJDEP is removing the minimal flexibility currently afforded to redevelopment projects that allows for access roads to be up to a foot below the applicable flood elevation where it is not feasible to elevate. This will make many developments and redevelopments infeasible. There is no clarity on the issue of how far dry access must extend for it to be approvable by DEP.
New criteria will be imposed for access roads including that they must accommodate two-way traffic of motor vehicles providing access to and from each building for the duration of the flood.
The current restriction on construction of a single-family home on a lot created after 2007 in a fluvial flood hazard area if there is already an existing habitable building or authorization for same from NJDEP will be extended to multi-residence buildings.
Critical and multi-residence buildings will be required to grade pedestrian areas outside of the building footprint to 1 foot above CAFE subject to certain non-feasibility conditions.
Limitations and mitigation requirements will be enhanced with respect to riparian buffers and permitting, including removal of the current exemptions for disturbance in truncated riparian zones and along manmade channels conveying stormwater.
The land area subject to 150-foot riparian zone buffers associated with threatened or endangered species habitat is being expanded. Activities within 25 of top of bank will be curtailed.
A permit will be required to conduct horizontal directional drilling below riparian zones (or wetlands), and enhanced permitting requirements will be imposed for solar panels in a flood hazard area.
A Verification will need to be obtained for projects impacting riparian zones.

Stormwater

Stormwater requirements will be enhanced including new requirements on redevelopment of 80% TSS removal for stormwater runoff for new and redeveloped motor vehicle surface (increased from 50% for redeveloped impervious surfaces).

The proposed amendments do nothing meaningful to incentivize development opportunities in areas outside of the IRZ or CAFE. The FHA hardship provisions do not provide meaningful opportunities for relief, and in fact, the proposal imposes new conditions making it even less likely that hardship relief may be obtained.

Legacy (previously, grandfathering) provisions remain consistent with current NJDEP rules and depend largely on securing relevant approvals or the filing of a complete application before the rules become effective. Applications submitted before the effective date and declared technically complete will qualify for legacy status.

Three public hearing dates are scheduled (September 5, 12 and 19, 2024) and comments on the rule proposal must be submitted by November 3, 2024. If you have questions regarding qualification for legacy status or how the forthcoming rules may affect your project, please contact one of the attorneys in our Environmental Department. A courtesy copy of the draft proposal can be found here.

DOE Ramping Up General Service Lamp Enforcement

Largely out of public view, the U.S. Department of Energy (DOE) has been ramping up enforcement of its “backstop” efficiency standard and sales prohibition regarding general service lamps, including incandescent bulbs. After a period of enforcement discretion (previewed in published guidance) that has now passed, we expect at least some of DOE’s efforts to become public in the coming months as the Department begins to settle enforcement actions and assess civil penalties against non-compliant lamp manufacturers, importers, distributors, and retailers.

The Final Rule

Following a rulemaking process that took many twists and turns over the past decade (as summarized in a prior alert), as of July 25, 2022, the sale of any general service lamp that does not meet a minimum efficacy standard of 45 lumens per watt hour (lm/W) is prohibited. 10 C.F.R. § 430.32(dd).

A “general service lamp” (GSL) is a lamp that:

Has an ANSI base;
For an integrated lamp, is able to operate at a voltage or in a voltage range of 12 or 24 volts, 100–130 volts, 220–240 volts, or 277 volts;
For a non-integrated lamp, is able to operate at any voltage;
Has an initial lumen output of greater than or equal to 310 lumens (or 232 lumens for modified spectrum general service incandescent lamps) and less than or equal to 3,300 lumens;
Is not a light fixture;
Is not an LED downlight retrofit kit; and
Is used in general lighting applications.

10 C.F.R. § 430.2. GSLs include, but are not limited to, general service incandescent lamps, compact fluorescent lamps, general service light-emitting diode lamps, and general service organic light-emitting diode lamps. GSLs consist of pear-shaped A-type bulbs, but also five categories of specialty incandescent lamps (rough service lamps, shatter-resistant lamps, 3-way incandescent lamps, high lumen incandescent lamps, and vibration service lamps), incandescent reflector lamps, and a variety of decorative lamps (T-Shape, B, BA, CA, F, G16-1/2, G25, G30, S, M-14 of 40W or less, and candelabra base lamps). DOE maintains exclusions for twenty-six categories of lamps, including appliance lamps and colored lamps, among others. Id.

Approximately 30 percent of light bulbs sold across the United States in 2020 were incandescent or halogen incandescent lamps. Almost all such lamps would fail to meet the statutory 45 lm/W backstop standard. Because many LED lamps, in contrast, can meet the 45 lm/W standard, DOE’s actions are accelerating a transition to LEDs.

Federal and State Enforcement

During this transition, DOE enforcement is likely to most aggressively target manufacturers and importers continuing to distribute non-compliant lamps, and will include the assessment of civil penalties. DOE is authorized to assess penalties of as much as $560 for each non-compliant lamp sold. While enforcement actions typically settle for tens or hundreds of thousands of dollars, DOE has obtained seven-figure settlements for more significant violations or where a business has repeatedly failed to comply.

Specifically with respect to general service lamps (but not for other covered products), the Department is also authorized to enforce against distributors and retailers who sell non-compliant lamps, and early indications are that DOE is beginning to act on that authority. Because the federal backstop standard is enforced at the time of sale, lamps imported into the United States before July 25, 2022, are not exempt from enforcement if sold after the deadline.

Separately, some states—including California—also enforce their own efficiency standards for products not subject to federal standards. The California Energy Commission recently settled an enforcement action for over $120,000 against a company that was selling state-regulated LEDs that were not certified in California’s compliance database prior to sale, and which did not meet state standards.

Next Steps

Businesses operating at any stage in the lamp supply chain should, therefore, take immediate steps to ensure they are not making, importing, distributing, or selling to consumers any lamps that do not meet applicable federal or state requirements. To determine whether a particular general service lamp meets the backstop standard, one can take the total lumens produced by the lamp and divide it by its wattage. If the calculated number is below 45, and the product does not qualify for any of the listed exclusions, then it is non-compliant, and its continued sale could prompt federal enforcement.

Environmental Compliance in 2024: What Does it Take to Avoid Triggering EPA Scrutiny?

As environmental concerns continue to take center stage, more and more companies are finding themselves facing scrutiny from the U.S. Environmental Protection Agency (EPA). As a result, from a risk management perspective, environmental compliance is more important than ever in 2024—and this is likely to remain the case for the foreseeable future.

What does this mean for companies whose operations have (or have the potential to have) environmental impacts? The short answer is that they need to make EPA compliance a priority. They must proactively address all areas of concern, and they must be prepared to demonstrate their proactive efforts to the EPA if necessary.

The EPA’s enforcement arm is extremely active, and several offices within the agency are tasked with uncovering and addressing environmental regulations violations. As discussed below, many federal environmental laws include criminal enforcement provisions as well, and the EPA regularly works with the U.S. Department of Justice (DOJ) to pursue criminal charges when warranted.

7 Keys to Avoiding EPA Scrutiny in 2024 (and Beyond)

With all of this in mind, what do company owners and executives need to know in order to avoid triggering EPA scrutiny in 2024 (and beyond)? Here are seven tips for effectively manage environmental compliance in today’s world:

1. Thoroughly Assess the Company’s Environmental Compliance Obligations

The EPA enforces numerous federal environmental statutes, and it has promulgated an extraordinarily long, dense, and complicated set of regulations under these statutes. The EPA enforces a number of environmentally focused Executive Orders (EOs) as well. As a result, for all companies, the first step toward implementing an effective EPA compliance program is determining which laws, regulations, and EOs apply. Here are just some of the most common examples:

Clean Air Act (CAA) compliance
Clean Water Act (CWA) compliance
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance
Endangered Species Act (ESA) compliance
Energy Independence and Security Act (EISA) compliance
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) compliance
Food Quality Protection Act (FQPA) compliance
Marine Protection, Research, and Sanctuaries Act (MPRSA) compliance
Resource Conservation Recovery Act (RCRA) compliance
Safe Drinking Water Act (SDWA) compliance
Toxic Substances Control Act (TSCA) compliance
Environmental Executive Order (EO) compliance

Determining applicability requires an in-depth understanding of each source of authority’s focus and scope. As a result, assessing a company’s environmental compliance obligations generally involves engaging experienced outside EPA counsel.

2. Develop Custom-Tailored Environmental Compliance Policies, Procedures, and Protocols

Of course, simply understanding a company’s compliance obligations is not enough. To effectively manage environmental compliance, companies must develop environmental compliance policies, procedures, and protocols that are custom-tailored to their operations and facilities. These should be sustainable practices that will increase operational efficiency and reduce costs and waste.

This, too, involves working with experienced EPA counsel. To establish and maintain EPA compliance, companies may need to take a variety of different steps. Depending on the specific environmental risks a company’s operations present (or may present), these steps may include:

Applying for a license, permit, or registration with the EPA
Passing EPA inspections
Restricting or preventing the discharge of contaminants or pollutants
Issuing notifications to consumers and/or the EPA
Promptly remediating spills and other exposure events

These are just a handful of numerous possibilities. While managing EPA compliance will be relatively straightforward for some companies, for others it can be a substantial undertaking. In both cases, developing custom-tailored policies, procedures, and protocols is a critical step toward effective regulatory compliance management.

3. Prioritize Environmental Compliance as an Element of Corporate Culture and Responsibility

Managing EPA compliance is not a one-time event. In other words, while developing custom-tailored policies, procedures, and protocols is a critical step toward effective compliance management, it is ultimately just one step in an ongoing process.

To effectively manage EPA compliance, companies need to take a top-down approach. They need to prioritize environmental compliance as an element of corporate culture and responsibility, and they need to make clear that personnel at all levels of the organization play an important role in protecting both the environment and the company. Lack of understanding and commitment at the executive level is a red flag for the EPA, and ineffective implementation of a company’s EPA compliance program can significantly increase its risk of both committing violations and facing enforcement.

4. Monitor and Audit Environmental Compliance

Another critical aspect of effectively managing a company’s environmental compliance-related risk is internally assessing compliance on an ongoing basis. Once a company has implemented its custom-tailored policies, procedures, and protocols, it must determine whether these are functioning as intended. While they should be, companies cannot afford to assume that this is the case. Ineffective training, oversights during implementation, changes in a company’s operational procedures, and various other issues can lead to compliance failures despite the implementation of an otherwise well-suited EPA compliance program.

Internally assessing compliance has two main components: (i) continuous monitoring, and (ii) periodic auditing. Companies should have safeguards in place that are designed to detect material violations when they occur. Companies must also conduct compliance audits at least annually to perform a deep-dive analysis of the efficacy of their compliance efforts. Crucially, if a company’s monitoring or auditing efforts uncover a violation of environmental rules, the company must then respond appropriately—and it must do so as efficiently as possible.

5. Generate and Store Environmental Compliance Documentation as a Matter of Course

When facing scrutiny from the EPA, being prepared to affirmatively demonstrate a company’s good-faith environmental compliance efforts is essential. In almost all cases, this is both the most effective and the most efficient way to resolve an EPA inquiry. Doing so requires clear and comprehensive documentation of the company’s ongoing compliance efforts, including its efforts to monitor, audit, and enforce compliance.

This means that companies need to generate and store environmental compliance documentation as a matter of course. By building documentation into their procedures and protocols, companies can do this efficiently and in a manner that facilitates demonstrating compliance to the EPA when necessary.

6. Respond Promptly (and Appropriately) to Information Requests and Other Inquiries

Companies can hear from the EPA under a variety of different circumstances. While different types of inquiries call for different types of responses, in all cases, a prompt and informed response is critical.

Once the EPA initiates an inquiry, it isn’t simply going to go away. Delay tactics will raise red flags; and, in the meantime, the EPA will be continuing its investigative and enforcement efforts. As part of their EPA compliance policies and procedures, companies should establish a step-by-step process for responding to the EPA in various scenarios. In most scenarios, the first step in this process will be engaging the company’s outside EPA counsel to provide guidance.

7. Update the Company’s Environmental Compliance Program as Necessary

Just as companies need to monitor their EPA compliance efforts on an ongoing basis, they must also monitor for any changes that necessitate updates to their environmental compliance programs. These changes could involve either: (i) changes in the environmental legislation; or, (ii) changes in the company’s operations that present new environmental compliance risks. In both cases, prompt action is key, as the EPA expects companies to consistently maintain comprehensive compliance.

Failing to Effectively Address Environmental Compliance: What Are the Risks?

Ideally, companies will maintain effective EPA compliance programs, and this means that they won’t have to worry about the risks of noncompliance. But, let’s say a company doesn’t do everything that is required. If the EPA has grounds to pursue enforcement, what are the risks involved?

Depending on the circumstances, the risks of environmental noncompliance can include:

Loss of License, Permit, or Registration – Companies may need to obtain a license, permit, or registration from the EPA in various scenarios. Failure to comply with the terms of licensure, permitting, or registration can lead to temporary suspension or permanent revocation.
“No Sale” Orders, Injunctions, and Other Administrative Remedies – The EPA also has the authority to impose “no sale” orders, injunctions, and other administrative remedies as necessary. If a company’s products or operations pose immediate environmental risks, the EPA can—and will—step in to intervene.
Civil Monetary Penalties – Environmental noncompliance can also trigger civil monetary penalties in many cases. Under several statutes, these penalties accrue on a daily or per-violation basis, which can lead to substantial financial liability for companies of all sizes.
Criminal Fines – As noted above, many of the statutes within the EPA’s enforcement jurisdiction include provisions for criminal enforcement. In criminal enforcement cases, companies can face substantial fines—and, in the aggregate, these fines can easily total millions, if not tens or hundreds of millions, of dollars.
Federal Imprisonment for Owners, Executives, and Others – Criminal enforcement cases can also expose companies’ owners, executives, and others to the risk of federal imprisonment. While relatively rare, the EPA and DOJ do not hesitate to pursue incarceration of implicated individuals when warranted.

PFAS CERCLA Expansion Now On Hold

We have regularly reported on the EPA‘s long-anticipated rule to designate PFOA and PFOS as “hazardous substances” under CERCLA. In April 2024, the EPA also issued an Advanced Notice of Proposed Rulemaking (ANPRM), which aimed to have seven additional PFAS added to the CERCLA list of “hazardous substances.” EPA originally set a deadline of April 2025 to finalize the rule to add seven additional PFAS to CERCLA; however, EPA’s July 2024 Unified Agenda now indicates that the deadline to finalize the rule for the additional seven PFAS is “to be determined.”

The shift in priorities away from an expanded PFAS CERCLA designation is a significant development that anyone follows PFAS regulatory or litigation news.

CERCLA PFAS Scope Designation To Date

On January 10, 2022, the EPA submitted a plan for a PFAS Superfund designation to the White House Office of Management and Budget (OMB) when it indicated an intent to designate two legacy PFAS – PFOA and PFOS – as “hazardous substances” under the Comprehensive Environmental Response, Compensation & Liability Act (CERCLA, also known as the Superfund law). The EPA previously stated its intent to make the proposed designation by March 2022 when it introduced its PFAS Roadmap in October 2021. Under the Roadmap, the EPA planned to issue its proposed CERCLA designation in the spring of 2022. On August 12, 2022, a CERCLA PFAS designation took a significant step forward when the OMB approved the EPA’s plan for PFOA and PFOS designation. This step opened the door for the EPA to put forth its proposed designation of PFOA and PFOS under CERCLA and engage in the required public comment period.

When OMB initially contemplated approving the EPA’s proposed rule, it designated the rule as “other significant”, which meant that the rule was predicted to have costs or benefits less than $100 million annually. However, the OMB received several pieces of feedback expressing concern that such an estimate fa undervalued the impact that such a designation will have. More specifically, the Chamber of Commerce provided its own estimate that the CERCLA designation would have a cost impact of over $700 million annually. As a result, the OMB changed its designation of the EPA’s propose rule to “economically significant”, which triggered the EPA to have to conduct a RIA prior to proposing the PFAS CERCLA designation. Under the RIA, the EPA will have to provide support for its position that a CERCLA designation is justified to achieve EPA goals and to provide support for the contention that such a designation is the least burdensome and most cost-effective way to achieve the EPA’s goals.

Despite the call for a RIA by the OMB, the EPA nevertheless released its final CERCLA designation in May 2024, the significance of which, if it survives legal challenges, will be felt for some time.

Additional CERCLA Designation

In February 2023, the EPA sent a proposed rule to the OMB that states the following:

“EPA plans to publish in the Federal Register an advance notice of proposed rulemaking requesting public input on whether the agency should consider designating as hazardous substances precursors to PFOA and PFOS, whether the agency should consider designating other PFAS as CERCLA hazardous substances and whether there is information that would allow the agency to designate PFAS as a class or subclass.”

The OMB reviewed the proposal and on March 24, 2023, approved the proposal so as to permit the EPA to proceed with publishing the Advanced Notice of Proposed Rulemaking (ANPRM).

On April 13, 2023, the EPA published in the Federal Register an ANPRM that seeks public comment on a proposal to list as “hazardous substances” the following additional PFAS: PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and PFDA. The EPA indicated that the seven PFAS were chosen based on available toxicity data for the chemicals.

CERCLA PFAS Designation: Impact On Businesses

Once a substance is classified as a “hazardous substance” under CERCLA, the EPA can force parties that it deems to be polluters to either cleanup the polluted site or reimburse the EPA for the full remediation of the contaminated site. Without a PFAS Superfund designation, the EPA can merely attribute blame to parties that it feels contributed to the pollution, but it has no authority to force the parties to remediate or pay costs. The designation also triggers considerable reporting requirements for companies. Currently, those reporting requirements with respect to PFAS do not exist, but they would apply to industries well beyond just PFAS manufacturers. The CERCLA PFAS scope in any final regulation is therefore critical to numerous industries that were or are downstream users of PFAS.

The downstream effects of a PFOA and PFOS designation would be massive, but a designation of the entire class of PFAS or even various subclasses of PFAS would be potentially unquantifiable in financial magnitude. With over 15,000 PFAS in existence according to the EPA and many of them in continued use to this day, the potential environmental pollution ramifications touch on countless industry types. Companies that utilized PFAS in their industrial or manufacturing processes and sent the PFAS waste to landfills or otherwise discharged the chemicals into the environment will be at immediate risk for enforcement action by the EPA given the EPA’s stated intent to hold all PFAS polluters of any kind accountable. Waste management companies should be especially concerned given the large swaths of land that are utilized for landfills and the likely PFAS pollution that can be found in most landfills due to the chemicals’ prevalence in consumer goods. These site owners may be the first targeted when the PFOA/PFOS designation is made, which will lead to lawsuits filed against any company that sent waste to the landfills for contribution to the cost of cleanup that the waste management company or its insured will bear. However, with a broader PFAS designation a possibility now, there should naturally be concern regarding re-openers in the future for these same sites.

Of course, all of the above are subject now to legal challenges of the final CERCLA designation, which will play out over the next several months. In addition, EPA (and the rest of the country) are now living in a post-Chevron world, which is sure to have significant impacts on challenges to EPA’s intentions with respect to PFAS under CERCLA. It is perhaps for these reasons that EPA recently adjusted its deadline to finalize the expended PFAS CERCLA designation to a status of “to be determined.” This is quite significant and shows to me that EPA is adjusting its resources to prepare for the legal challenges to come, as well as focusing more earnestly on initiatives that it can pass prior to a potential shift in party power in the November 2024 elections.

Conclusion

While it is likely fair to say that almost all significant PFAS initiatives that EPA wishes to undertake will not be pushed forward until after the November election cycle, it is nevertheless of great importance for companies, insurers, and financial world specialists to continue to monitor PFAS developments. Even with a party shift in November, PFAS is unlikely to be wiped off of the map, so to speak, in terms of an environmental issue. The awareness of PFAS issues among media, politicians and citizens is simply too great at this point. In addition, developments that will be critical to monitor because of the impact that they may have on PFAS litigation, which will surely subsume PFAS regulatory impacts if November brings a party power shift.

Washington Shake-Up: Vice President Harris to Lead Democratic Nomination for 2024 Presidency

Following President Biden’s withdrawal from the 2024 presidential race on Sunday, the nation’s capital has experienced another political shock, leading to swift mobilization within the Democratic Party. President Biden quickly endorsed Vice President (VP) Kamala Harris as the Democratic nominee, triggering a rapid wave of support from Congressional leaders, governors, stakeholders, and party donors including former Speaker Nancy Pelosi (D-CA), Senate Majority Leader Chuck Schumer (D-NY), House Democratic Leader Hakeem Jeffries (D-NY), all 24 Democratic governors, EMILYs List, and the United Auto Workers.

VP Harris has secured enough backing from Democratic delegates to clinch her party’s nomination to challenge former president Donald Trump in November. With the election a little over 100 days away, we have highlighted VP Harris’ stance on key issues during her tenure in Congress and her 2020 Presidential bid.

Technology

VP Harris is very familiar with the tech industry due to her roots in Silicon Valley as San Francisco’s district attorney, and her subsequent roles as Attorney General and US Senator from California. Although she hasn’t called for the breakup of big tech like some of her former colleagues in the Senate, she has criticized tech CEOs for the data privacy practices and targeted advertising tactics that their companies deploy, and voiced support for general regulation of big tech firms. In the White House, she serves as President Biden’s lead on AI initiatives and has actively promoted policies aimed at mitigating AI risks such as algorithmic bias, disinformation, and privacy concerns, while maximizing its benefits for Americans.

Climate Change

VP Harris has a long history of challenging the oil industry for its role in pollution and is likely to take it a step further than President Biden in tackling climate change. In the 2020 Presidential race, Harris proposed a $10 trillion climate plan aimed at achieving a carbon-neutral US economy by 2045, featuring initiatives such as a climate pollution fee and the elimination of fossil fuel subsidies.

In the Senate, Harris authored legislation that would have authorized grants to fund projects that address the specific climate-related challenges faced by vulnerable communities and invest in critical upgrades to the nation’s water infrastructure.

As California’s attorney general, VP Harris brought lawsuits against major oil companies, including British Petroleum (BP) for failing to stop underground storage tanks from leaking gasoline at 800 sites across the state, and also filed an investigation into ExxonMobil over its climate change disclosures.

Health Care

Maternal health was at the forefront of Harris’ health care priorities during her tenure in the Senate and has continued in her current role as Vice President. She sponsored landmark legislation such as the Black Maternal Health Momnibus Act, aimed at tackling the crisis facing Black maternal health care. This legislation enhances data collection, expands access to prenatal, postpartum, and doula care in underserved communities, promotes implicit bias training for health care professionals, and funds research and innovation to improve health outcomes and reduce disparities for Black women. Although the bill was not enacted, it remained a priority in both chambers of Congress after Harris’ departure from the Senate. It is also the centerpiece bill of the Congressional Black Maternal Health Caucus. Harris also championed legislation aimed at addressing the impact of uterine fibroids on women’s health through initiatives such as research funding, patient support tactics, and health care provider training. Additionally, she supported legislation to establish a loan repayment program for mental health professionals working in areas with critical workforce shortages.

In her 2020 presidential campaign, Harris introduced a health care plan that proposed a gradual transition toward Medicare-for-All over a decade. Her plan allowed individuals and employers to initially buy into Medicare while maintaining strict regulations for private insurance options. She also consistently opposed efforts to restrict access to reproductive health care services.

Tax

With numerous tax provisions under former President Trump’s Tax Cuts and Jobs Act set to expire in 2025, all eyes are on VP Harris’ anticipated tax policy proposals. During her tenure in Congress, she championed a significant tax reform bill that would have introduced the LIFT credit—a refundable tax credit of $3,000 for single filers and $6,000 for married couples—benefiting a large portion of middle- and working-class Americans. Unlike the Earned Income Tax Credit (EITC), this credit’s amount would not depend on the number of children reported on a taxpayer’s return but would phase out as income increased. Harris emphasized that this credit aimed to boost families’ after-tax income to help them cope with rising living costs.

Additionally, she sponsored legislation in Congress aimed at protecting workers from harassment and discrimination, funding earthquake mitigation efforts, and providing housing assistance to low-income families. During her 2020 presidential campaign, Harris advocated strongly for repealing Trump’s tax law. She proposed implementing a financial transaction tax to expand Medicare coverage and advocated for taxing capital gains as part of her broader economic platform.

A Look Ahead

With midterm elections looming in the House and 33 Senate seats up for election, the impact of VP Harris’ nomination on Congressional races will be watched closely. As the first woman of color and the highest-ranking woman in US history to hold the office of Vice President, Harris’ nomination marks a pivotal moment in American politics. It may influence voter behavior, candidate strategies across the aisle, and the broader political landscape leading up to the November elections.

The Democratic National Convention (DNC) is scheduled to be held in Chicago, Illinois, from August 19 to August 22. However, due to upcoming state ballot deadlines which precede the convention date, a virtual roll call where delegates formally select Kamala Harris as the nominee will conclude by August 7. Harris is expected to choose her running mate in the coming days, as her campaign team has sent vetting materials to Arizona Sen. Mark Kelly, Michigan Gov. Gretchen Whitmer, Minnesota Gov. Tim Walz, North Carolina Gov. Roy Cooper, and Pennsylvania Gov. Josh Shapiro.

Recent Federal Developments, July 2024

TSCA/FIFRA/TRI

EPA’s Proposed NMP Risk Management Rule Includes Requirements To Protect Workers And Consumers: On June 15, 2024, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would protect workers and consumers from exposure to N-methylpyrrolidone (NMP). 89 Fed. Reg. 51134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP in several occupational conditions of use (COU); require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational COUs; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements. Comments are due July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before July 15, 2024. According to EPA’s June 5, 2024, press release, NMP is used to manufacture and produce many electronics, polymers, agricultural chemicals, and petrochemical products. EPA states that NMP is used in the production of specialized electronics, such as semiconductors and magnet wire, as well as lithium-ion batteries used in a wide variety of applications, including aerospace vehicles and electronic devices. EPA notes that NMP “also has numerous other industrial, commercial and consumer applications, including adhesives and sealants, paints and coatings, paint removers, lubricants, automotive care products, degreasers, cleaning and furniture care products.” For more information, please read the full memorandum.

EPA Announces Final Cancellation Order And Updates To Existing Stocks Provisions For Several Chlorpyrifos Products: On June 25, 2024, EPA announced the issuance of a final cancellation order for Corteva’s chlorpyrifos product “Dursban 50W in Water Soluble Packets” and three Gharda chlorpyrifos products, and an amendment to the existing stocks provisions for two Liberty and three Winfield chlorpyrifos end-use products. EPA also states that it has updated its frequently asked questions about chlorpyrifos. More information is available in our July 2, 2024, blog.

EPA Announces New Initiatives To Improve Efficiency, Worker Protections, And Transparency In New Chemical Reviews: During the June 26, 2024, “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C^®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA, provided the keynote address. During her remarks, Freedhoff announced four new initiatives in EPA’s review of new chemicals under TSCA. As later announced by EPA, these initiatives are:

Engineering checklist: In May 2024, EPA began implementing an internal engineering checklist to review systematically new chemical submissions and identify potential data gaps at the beginning of the review process.
Worker protections: According to EPA, most TSCA Section 5(e) orders are consent orders negotiated between EPA and the notice submitter that use standard “boilerplate” text. In June 2024, EPA updated the boilerplate language to strengthen worker protections and provide further clarity to the text.
Updated statistics for new chemical review timelines: On June 26, 2024, EPA began including completed “rework” risk assessments when reporting monthly statistics on new chemical reviews. EPA has updated its Statistics for the New Chemicals Program under TSCA web page to include a category listing all completed rework risk assessments since the beginning of 2024.
Reference Library: On June 26, 2024, EPA launched the New Chemicals Division Reference Library, an index of EPA documents related to the work of the New Chemicals Division. It currently contains over 90 entries, and EPA will update it as it develops new materials.

More information is available in our June 26, 2024, blog item. A summary of the conference is available in our July 9, 2024, memorandum.

EPA Postpones Proposed Expansion Of The Safer Choice And DfE Programs: As reported in our July 27, 2023, memorandum, in July 2023, EPA proposed an expansion of the Safer Choice and Design for the Environment (DfE) programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding, however, EPA is not able to pursue expansion at this time. EPA plans to reconsider the expansion in the future as resources allow.” On June 28, 2024, a summary of comments received on EPA’s proposed expansion was posted in the online docket. More information is available in our July 5, 2024, blog item.

EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review: On July 1, 2024, EPA announced the release of the draft risk evaluation for 1,1-dichloroethane and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (also known as ethylene dichloride) prepared under TSCA. EPA states that it “preliminarily determined 1,1-dichloroethane poses unreasonable risk to human health (of workers) and the environment.” According to EPA, the effects to people from exposure to 1,1-dichloroethane and 1,2-dichlorethane are “kidney and other cancers, as well as harmful non-cancer renal, nasal, immune system, and reproductive effects.” Publication of a notice of availability in the Federal Register will begin a 60-day comment period. More information will be available in a forthcoming memorandum.

Court Vacates TSCA Section 4 Test Order, Grant’s Vinyl Institute’s Petition For Review: On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against EPA, seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under TSCA Section 4(a)(2). The court states that “EPA’s non-public part of the administrative record is not part of ‘the record taken as a whole’ subject to our heightened substantial evidence review of TSCA test orders.” According to the court, to the extent EPA relies on non-public portions of the administrative record, it “has failed to provide substantial evidence that meets its statutory mandate.” The court vacated the test order, remanding to EPA to satisfy that mandate with “substantial evidence in the record taken as a whole.” The court also denied VI’s motion to supplement the record “with scientific information it could have — and should have — submitted earlier.” More information is available in our July 10, 2024, blog item.

EPA Publishes Compliance Guide For Final Methylene Chloride Risk Management Rule: On July 10, 2024, EPA published a compliance guide for its final methylene chloride risk management rule issued under TSCA. According to EPA, the compliance guide will help industry, workers, and other interested stakeholders understand and comply with the new regulations to prevent injuries, long-term illnesses, and deaths. EPA also announced that in June 2024, it released a fact sheet on the rule containing information on who is subject to the rule along with a summary of compliance timelines. More information will be available in a forthcoming memorandum.

EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found In Fluorinated Plastic Containers: EPA announced on July 11, 2024, that it granted a petition filed a petition under TSCA Section 21 requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly commence an appropriate proceeding under TSCA Section 6.” According to EPA’s announcement, EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA); and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. More information will be available in a forthcoming memorandum.

EPA’s Spring 2024 Unified Agenda Includes Proposed And Final TSCA, TRI, And PFAS Rules: EPA’s Spring 2024 Unified Agenda, published on July 5, 2024, includes a number of proposed and final TSCA, Toxics Release Inventory (TRI), and PFAS rulemakings. More information on the rulemakings, including links to our memoranda, will be available in an upcoming blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Publishes 2024-2027 Climate Adaptation Plan: EPA announced on June 20, 2024, the release of its 2024-2027 Climate Adaptation Plan, which describes Agency actions to address the impacts of climate change and help build a more climate-resilient nation. Highlights include:

Fostering a climate-ready workforce;
Building facility resilience;
Developing climate-resilient supply chains;
Integrating climate resilience into external funding opportunities;
Applying climate data and tools to decision making; and
Integrating climate adaptation into rulemaking processes.

EPA Amends Standards And Practices For All Appropriate Inquiries: EPA issued a final rule on June 24, 2024, amending the “Standards and Practices for All Appropriate Inquiries” to reference a standard practice recently made available by ASTM International, “a widely recognized standards development organization.” 89 Fed. Reg. 52386. EPA states that it is amending the All Appropriate Inquiries Rule to reference ASTM International’s E2247-23 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process for Forestland or Rural Property” and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In addition, after one year, EPA will remove recognition of the previous version of that standard, ASTM E2247-16, as compliant with the All Appropriate Inquiries Rule. The final rule will be effective August 23, 2024.

EPA Proposes To Remove Affirmative Defense Provisions From Specified NSPS And NESHAP: On June 24, 2024, EPA proposed amendments to several New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA). 89 Fed. Reg. 52425. Specifically, EPA proposes to remove the affirmative defense provisions associated with violation of emission standards due to malfunctions. According to EPA, it proposes to remove these provisions because they are inconsistent with a D.C. Circuit Court decision that vacated affirmative defense provisions in one of EPA’s CAA regulations, and because EPA finds that the reasoning in the decision applies equally to other CAA rules. Since the court decision, EPA has been removing affirmative defense provisions from CAA rules when they were otherwise revised or amended. EPA states that this action “proposes to remove the remaining affirmative defense provisions more efficiently.” Comments are due August 8, 2024.

PHMSA Amends HMR To Require Real-Time Train Consistent Information In Electronic Form: The Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on June 24, 2024, amending the Hazardous Materials Regulations (HMR) to require railroads that carry hazardous materials to generate in electronic form, maintain, and provide to first responders, emergency response officials, and law enforcement personnel certain information regarding hazardous materials in rail transportation to enhance emergency response and investigative efforts. 89 Fed. Reg. 52956. According to PHMSA, the amendments address a safety recommendation of the National Transportation Safety Board and statutory mandates in The Fixing America’s Surface Transportation Act, as amended by the Infrastructure, Investment, and Jobs Act, and complement existing regulatory requirements pertaining to the generation, maintenance, and provision of similar information in hard copy form, as well as other hazard communication requirements. The effective date of the final rule is July 24, 2024. The voluntary compliance date was June 24, 2024. The delayed compliance date for Class I Railroads is June 24, 2025, and for Class II and III Railroads is June 24, 2026.

EPA Proposes To Extend Compliance Date For Installation Of Certain Variable Refrigerant Flow Systems: On June 26, 2024, EPA proposed to amend a provision of the Technology Transitions regulations promulgated under the American Innovation and Manufacturing Act. 89 Fed. Reg. 53373. The proposed amendment would allow one additional year, until January 1, 2027, solely for the installation of new residential and light commercial air conditioning and heat pump variable refrigerant flow systems that are 65,000 British thermal units per hour or greater using components manufactured in the United States or imported prior to January 1, 2026. According to EPA, the existing January 1, 2026, compliance date for the installation of certain variable refrigerant flow systems “may result in significant stranded inventory that was intended for new construction. EPA is promulgating this action to mitigate the potential for significant stranded inventory in this subsector.” Comments are due July 26, 2024.

PHMSA Requests Feedback On De Minimis Quantities Of Explosives: PHMSA published a request for information (RFI) on June 28, 2024, to solicit information from hazardous materials (HAZMAT) shippers pertaining to what small quantities or low concentrations of explosives they offer for transport appear to present a low risk to life, property, and the environment. 89 Fed. Reg. 54157. PHMSA seeks to determine what small quantities or low concentrations of explosives HAZMAT shippers offer for transport that appear to present a low risk (e.g., negligible severity, remote probability) to life, property, and the environment. PHMSA will use the information to define the focus of a research project investigating the risk of small and/or de minimis quantities of explosive substances and in selecting test samples for PHMSA research and development Contract# 693JK322C00003. Comments are due September 26, 2024. PHMSA states that it will consider comments received after that date to the extent possible.

EPA Determines Current NESHAP For PQBS Source Category Provides “Ample Margin Of Safety”: On July 5, 2024, EPA published a final rule regarding the residual risk and technology review conducted for the NESHAP for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and the periodic technology review for the Coke Oven Batteries (COB) source category NESHAP. 89 Fed. Reg. 55684. EPA states that it is issuing a final determination that risks due to emissions of hazardous air pollutants (HAP) from the PQBS source category are acceptable and that “the current NESHAP provides an ample margin of safety to protect public health.” The final rule was effective July 5, 2024, except for amendatory instruction 3, which was effective July 15, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register beginning July 5, 2024. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register as of July 13, 2005.

EPA Releases Science-Based Recommendations To Help Reduce Exposure To Contaminants, Including PFAS, In Fish: EPA announced on July 11, 2024, that it issued updated recommendations under the Clean Water Act (CWA) for contaminants that states, Tribes, and territories should consider monitoring in locally caught, freshwater fish. According to EPA, for the first time, it has added several PFAS to the contaminant list alongside lead, three cyanotoxins, a flame retardant, and amphetamine. With this announcement, EPA suggests that states, Tribes, and territories monitor for these contaminants. EPA notes that this update comes after reviewing scientific literature, analyzing data, and seeking external peer review of the Agency’s analysis, and it will help ensure that state and Tribal fish advisories consider the latest science.

FDA

FDA Updates Resources For FSMA Rule: On June 27, 2024, the U.S. Food and Drug Administration (FDA) released additional resources to help industry comply with the Food Traceability Rule, a component of the Food Safety Modernization Act (FSMA). Resources include a template spreadsheet to help fulfill data submission requests and minor revisions to the Food Traceability List. Additional information is available at the link here.

FDA Releases Update For Priority Guidance Topic List: On June 28, 2024, FDA provided an update for its priority guidance topic list, which was released in January. Since January, FDA has issued the following guidance documents:

FDA notes that its “intent is to publish all draft and final guidance topics on the list” but that “modifications in plans may be needed to support emerging issues and Administration priorities.”

FDA Revokes Authorization For Brominated Vegetable Oil: On July 3, 2024, FDA amended its regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. 89 Fed. Reg. 55040. The final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. FDA notes that there are no other FDA authorized uses. The rule is effective on August 2, 2024.

NANOTECHNOLOGY

ECHA Evaluating Function Of EUON; Survey Closed July 3, 2024: The European Chemicals Agency (ECHA) is evaluating the function of the European Union (EU) Observatory for Nanomaterials (EUON). As part of its evaluation, ECHA conducted a survey to collect responses from EUON website visitors and stakeholders. The survey closed July 3, 2024. More information is available in our June 24, 2024, blog item.

ECHA Updates Report On Key Areas Of Regulatory Challenge, Addresses Micro- And Nano-Sized Materials: On June 12, 2024, ECHA announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas where scientific research is needed to protect human health and the environment from hazardous chemicals. The report addresses micro- and nano-size materials. More information is available in our June 17, 2024, blog item.

NIOSH Highlights NTRC’s Work On Engineering Controls And PPE: On July 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item entitled “Celebrating 20 Years of the Nanotechnology Research Center: Highlights from Engineering Controls and Personal Protective Equipment,” part of a series commemorating the 20th anniversary of the Nanotechnology Research Center (NTRC). NIOSH researchers plan to develop a new reliable aerosol testing method that can accurately evaluate the respirator penetration against workplace nanomaterials; evaluate the effectiveness of NIOSH-approved^® respirators to determine whether existing respirator guidelines apply to workers exposed to nanomaterials; and compare nanomaterial penetrations determined by direct-reading and elemental carbon analysis methods. More information is available in our July 5, 2024, blog item.

NNI And NNCO Will Hold July 24 Workshop On “Responsible Development, Social Science, And The National Nanotechnology Initiative”: The National Nanotechnology Initiative (NNI) and the National Nanotechnology Coordination Office (NNCO) are convening a July 24, 2024, workshop, “Responsible Development, Social Science, and the National Nanotechnology Initiative: A Workshop to Explore Past and Future Intersections.” The agenda includes a presentation about the recently released “Blueprint for the Use of Social and Behavioral Science to Advance Evidence-Based Policymaking,” introductions to key nanotechnology case studies by federal experts, and flash talks by social scientists. More information is available in our July 3, 2024, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C^® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

House Appropriations Committee Approves FY 2025 Interior, Environment, And Related Agencies Appropriations Act: The House Appropriations Committee announced on July 9, 2024, that it approved the Fiscal Year (FY) 2025 Interior, Environment, and Related Agencies Appropriations Act by a vote of 29 to 25. According to the press release, the bill:

Ensures chemical and pesticide manufacturers are not overburdened with requirements that would drive business overseas and threaten American competitiveness;
Blocks EPA’s car regulations on light, medium, and heavy-duty vehicles;
Prohibits EPA from allowing California to require that new small off-road engines, such as lawn care equipment, be zero-emission;
Prohibits funds for EPA’s Clean Power Plan 2.0 and regulatory overreach regarding ozone emissions and steam electric power plants;
Reduces funding for EPA by 20 percent;
Reduces funding for the Council on Environmental Quality to the authorized level of $1 million;
Rejects eight of the Administration’s climate change executive orders; and
Prohibits agencies from using the Social Cost of Carbon (SCC) in cost-benefit analyses and blocks the Interagency Working Group on Social Cost of Greenhouse Gases.

House Committee Holds EPA Oversight Hearing On July 10, 2024: The House Committee on Oversight and Accountability held a full committee hearing on July 10, 2024, on “Oversight of the U.S. Environmental Protection Agency.” The Committee’s July 3, 2024, press release quotes Committee Chair James Comer (R-KY) as stating: “We know the Biden Administration is overreaching its environmental protection authorities extensively, flouting the limits the Supreme Court set upon them two years ago in West Virginia v. EPA and adopting statutory interpretations that surely will not pass muster under the Court’s recent decision in Loper Bright Enterprises v. Raimondo. The Committee looks forward to holding the agency accountable next week for its efforts to cement Green New Deal and other misguided priorities that have hurt both American businesses and consumers across the country.” More information will be available in a forthcoming memorandum.

MISCELLANEOUS

California Court Grants Injunction To Stop Prop 65 Warnings For Titanium Dioxide In Cosmetic And Personal Care Products: On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No. 2:23-cv-01006-TLN-JDP (E.D. Cal. 2024). In its Order, the District Court enjoined the California Attorney General and any private citizen enforcers from enforcing Prop 65’s warning requirement for “cancer as applied to Listed Titanium Dioxide (i.e., titanium dioxide that consists of airborne, unbound particles of respirable size) in cosmetic and personal care products.” The District Court also denied a motion to intervene by Environmental Health Advocates, Inc. (EHA), who had argued it was “an interested party because it is the primary enforcer of Prop 65.” For more information, please read the full memorandum.

Proposition 65: OEHHA Proposes Additional Changes To “Short-Form” Warning Option: On June 14, 2024, the California OEHHA issued a notice proposing additional changes to its Prop 65 Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes proposed now are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memorandum available here. Written comments on the proposed changes were due no later than June 28, 2024. More information is available in our July 5, 2024, memorandum.

June 2024 IRIS Program Outlook Released: EPA’s Health and Environmental Risk Assessment (HERA) Program announced on June 27, 2024, the release of the June 2024 Integrated Risk Information System (IRIS) Program Outlook. To maintain transparency, the IRIS Program provides an updated outlook of program activities. The IRIS Program Outlook describes assessments that are in development and projected public milestone dates.

Registration Opens For July Webinars On Minnesota’s PFAS In Products Law; MPCA Publishes Summary Of Comments On CUUs: The Minnesota Pollution Control Agency (MPCA) will hold two public webinars in July to provide updates and answer questions on Minnesota’s PFAS in products law (Amara’s Law), which takes effect in stages between 2025 and 2032:

Progress on rule development, July 18, 2024, 10:00 a.m. – 11:30 a.m. (CDT): Join MPCA staff for a presentation on preliminary rule writing for the PFAS in products reporting, fees, and currently unavoidable use (CUU) rules. Registration is open.
Information on 2025 prohibitions for retailers and manufacturers, July 25, 2024, 11:00 a.m. – 12:00 p.m. (CDT): This webinar will discuss how the 2025 PFAS in products prohibitions will affect retailers and manufacturers starting January 1, 2025, when 11 categories of consumer products must be free of intentionally added PFAS. Registration is open.

As reported in our January 12, 2024, blog item, MPCA published a request for comments (RFC) on planned new rules governing CUU determinations for products containing PFAS. According to the RFC, the main purpose of the rulemaking is to establish criteria and processes through which MPCA will make decisions on what uses of intentionally added PFAS will qualify as CUUs in products sold, offered for sale, or distributed in Minnesota. Any such determinations must be published by rule by MPCA by January 1, 2032. MPCA has posted a summary of the comments received on the RFC. More information is available in our June 24, 2024, blog item.

Minnesota Department Of Health Highlights Recent Publications On PFAS Bioaccumulation And PFAS In Infant Formula: The Minnesota Department of Health (MDH) recently noted that Health Risk Assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to PFAS:

OIRA Will Offer Training Sessions On Effective Participation In The Public Comment Process: As part of its efforts to strengthen public engagement in the federal regulatory process, the Office of Information and Regulatory Affairs (OIRA) in OMB announced on July 10, 2024, that it will offer training sessions on effective public participation in the public comment process. 89 Fed. Reg. 56777. In response to feedback received from the public and as part of its ongoing efforts to strengthen public participation in the regulatory process, OIRA will hold two training sessions on effective participation in the public comment process. During the training sessions, OIRA will describe opportunities to provide comment in the federal regulatory process; how to submit public comments; and how to draft effective public comments. The training sessions will be held on July 18, 2024, from 3:00 p.m. to 3:45 p.m. (EDT) and July 24, 2024, from 5:30 p.m. to 6:15 p.m. (EDT).

CISA Hosts 2024 Chemical Security Seminars On July 11 And 18, 2024: The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is hosting the fully virtual 2024 Chemical Security Seminars on July 11 and July 18, 2024, from 10:00 a.m. – 3:00 p.m. (EDT). The sessions will cover a range of topics related to the security of dangerous chemicals. More information is available in our July 8, 2024, blog item.

Comments On Canada’s Updated Draft State Of PFAS Report And Revised Risk Management Scope Are Due September 11, 2024: The July 13, 2024, Canada Gazette includes a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of PFAS, excluding fluoropolymers, be added to Part 2 of Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the Revised Risk Management Scope, Canada is considering:

As a first step, a regulatory instrument under CEPA to restrict PFAS not currently regulated in firefighting foams; and
Additional regulatory instrument(s) under CEPA to prohibit other uses or sectors in relation to PFAS. Prioritization for prohibition may be based on factors such as socioeconomic considerations, the availability of feasible alternatives, and the potential for human and environmental exposure.

The Revised Risk Management Scope states that “[v]oluntary risk management actions are also being considered to achieve early results to reduce releases of PFAS, as a complement to the proposed regulatory instruments.” Comments are due September 11, 2024. More information is available in our July 12, 2024, blog item.

Firework Safety Tips: Enjoying Independence Day Without the Risks

Independence Day celebrations are not complete without some fireworks displays. The only problem is that some of the people participating in creating the displays fail to exercise due diligence, increasing the risk of personal injury to themselves and other parties.

There is a history of explosives used for fun, resulting in untold losses and, in some cases, death. A good example is the 2017 case in Oregon, where a fire was started by a firecracker flung by a 15-year-old. What followed was a fire that burned for three months straight, charring 50,000 acres, and reports of pockets of fire nine months later.

Economic losses aside, there have been quite a number of deaths reported as a result of fun-related explosives and thousands of personal injuries suffered every year, with children and young adults being most at risk. There is no problem with enjoying some fireworks as a part of the Independence Day celebration. However, you will want to exercise extra caution to reduce the risks; below are some tips you may want to borrow.

Leave It to Professionals

The beautiful fireworks display you see during Independence Day celebrations are the work of professionals who have received specialized training on safety. But still, there has been an occasion where the displays have gone wrong, resulting in revelers suffering personal injuries.

These incidents are quite rare compared to the many times individuals have suffered injuries in fireworks displays handled by untrained individuals. If you must enjoy a fireworks display and are not sure of your ability to handle explosives safely, it is best to attend a public display.

Handle With Care

Some people will not be content with a public fireworks display, and there is the thrill that comes with setting off your own fireworks. If this feels like you, and not setting off fireworks is out of the question, you must tread carefully. Most fireworks come with a how-to-use guide, and it’s best to follow manufacturer guidelines for safety.

Basic preventive measures like maintaining a safe distance between you and the fireworks after lighting, not pointing it at someone else, and using it in an open area can help avoid accidents. You may want to have water or a fire extinguisher on standby in case of an accidental fire. Lighting multiple fireworks at a time greatly increases the risks of an accident, so you may want to ensure that you light one at a time in your group.

Have the Right Person Handle It

The risk posed by fireworks is too great to entrust the responsibility of lighting to anyone, especially not children. If they must ignite fireworks, ensure there is an adult to supervise and guide them.

Alcohol, a big part of Independence Day celebrations, does not go well with tasks that require caution and sobriety, like igniting and supervising fireworks displays. If you must drink, wait until after the display to drink to avoid the chance of alcohol getting into your decision-making and, ultimately, accidents.

Clean Up

After a display, there will always be pieces of fireworks that fail to go off or burn up completely. If reignited, these pieces still pose a significant risk, and children may be tempted to reignite them out of curiosity.

So, ensure you clean up all the pieces after the display by soaking them in water before disposing of them. Remember, mistakes that result in an accident can lead to you facing legal consequences in the event they cause personal injuries or property damage to other parties.

SCOTUS Freezes States’ Efforts to Resolve Water Conflict

What Happened?

On June 21, 2024, the Supreme Court narrowly held that three states could not enter a consent decree to settle their interstate water dispute without the support of the intervening federal government. The ruling halts the agreement between Texas, New Mexico, and Colorado to settle Texas’s claims and reconfigure water allocation under the Rio Grande Compact going forward. The decision frustrates multi-year efforts by the states to fairly apportion shrinking water supplies and continues uncertainty for water users dependent on flows from the Rio Grande. More generally, the decision highlights the federal government’s power in cases arising under interstate compacts where federal interests are “inextricably intertwined” with the outcome.

Background

In 2013, Texas sued New Mexico and Colorado, claiming that New Mexico’s increased groundwater pumping was diminishing flows from the Rio Grande, unfairly shorting water allocated to the Lonestar state. This claim arose under the Rio Grande Compact, a 1938 allocation agreement between the three states that depend on the Rio Grande’s waters. The Supreme Court allowed the federal government, although not a party to the Compact, to intervene in the dispute in 2014, based on the federal interests in delivering water to Mexico under a 1906 treaty, in operating a Bureau of Reclamation reservoir and irrigation project closely connected to Compact compliance, and in fulfilling potential federal obligations to Indian tribes. The Supreme Court held that the federal government’s interests were “inextricably intertwined” with the case.

Since that decision, the states sought a compromise, recognizing that the 1938 Compact failed to predict severe droughts and dwindling water supplies, new circumstances that require adaptation. Despite this negotiated solution, the federal government refused to sign the agreement. The federal government claimed that the settlement undermines the Compact’s plain language, which cannot be modified without congressional approval, and that the negotiated agreement would impose new obligations on the federal reservoir and irrigation project. Based on its intervenor status, the federal government asked the Supreme Court to reject the deal in the absence of its consent.

Writing for the 5-4 majority, Justice Jackson explained that the Court’s 2018 decision to allow federal claims in the case to proceed “leads inexorably” to the federal government’s approval being necessary before a valid resolution. Justice Gorsuch, writing for the dissent, cautioned that this deference to the intervenor risks federalizing interstate water disputes and limiting the necessary discretion for states to independently manage their waters. Despite previously authoring a unanimous 2018 decision that green-lighted the federal claims, his dissent pointed back to “a century’s worth” of precedent, holding that the Reclamation Act requires the federal government to comply with state control of water resources and not to assert incompatible federal interests. The majority reasoned, by contrast, that the federal government’s interest was particular to the Compact, where compliance depends on federal action.

Analysis

The Court’s acknowledgment of the federal interest in the three states aligning Rio Grande Compact compliance with contemporary water realities is expressly tailored to the unique federal role in this situation. The problem the Court focused on was the proposed resolution’s failure to include the federal government, given its intervenor status and its integral role in managing a reservoir and irrigation project essential to the Compact. This does not authorize federal interference in all interstate water compacts, as the dissent fears, but others may be “inextricably intertwined” with federal interests. Still, the pointed dissent may signal that a significant court minority stands ready to guard state control of water resources when the federal government overreaches. The decision’s immediate impact will perpetuate uncertainty for water users in all three states as the parties are forced back to trial or the negotiating table.

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The Final Rule

Federal and State Enforcement

Next Steps

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7 Keys to Avoiding EPA Scrutiny in 2024 (and Beyond)

1. Thoroughly Assess the Company’s Environmental Compliance Obligations

2. Develop Custom-Tailored Environmental Compliance Policies, Procedures, and Protocols

3. Prioritize Environmental Compliance as an Element of Corporate Culture and Responsibility

4. Monitor and Audit Environmental Compliance

5. Generate and Store Environmental Compliance Documentation as a Matter of Course

6. Respond Promptly (and Appropriately) to Information Requests and Other Inquiries

7. Update the Company’s Environmental Compliance Program as Necessary

Failing to Effectively Address Environmental Compliance: What Are the Risks?

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Technology

Climate Change

Health Care

Tax

A Look Ahead

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Leave It to Professionals

Handle With Care

Have the Right Person Handle It

Clean Up

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Background

Analysis

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