Driven by the entry of renewable generation resources locating far from load centers and the new demands placed on the grid by their differing characteristics, the Federal Energy Regulatory Commission (FERC) launched a comprehensive review of its policies regarding regional transmission planning, interconnection and cost-allocation. In an Advance Notice of Proposed Rulemaking (ANOPR), the agency requested public comments on its current policies and offered potential areas for reform with a view toward anticipated future generation. According to FERC Chairman Richard Glick, “(a) piecemeal approach to expanding the transmission system is not going to get the job done. We must take steps today to build the transmission that tomorrow’s new generation resources will require.” Continue Reading FERC Reviewing Rules for Grid of the Future
The easing of the coronavirus pandemic in the United States, with 67.7% of adults having at least one vaccine shot, provides the Biden Administration’s EPA with a unique opportunity to take stock of its pandemic response and consider any potential policy improvements that could be made. This post focuses on two particular issues: (1) EPA’s regulation of pesticide devices, including in particular indoor air quality-related devices, and (2) treated articles.
The Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) regulates both pesticide devices and pesticides. Pesticide devices operate by physical or mechanical means, and EPA has concluded that ultraviolet (“UV”) lights and various types of air cleaning machines are pesticide devices, if claims to kill microbes or other pests within FIFRA’s jurisdiction are made. Under FIFRA, devices are subject to fewer requirements than pesticides—for example, unlike pesticides, devices are not subject to pre-sale review and approval by EPA. Instead, EPA’s principal substantive regulation of devices is premised on its authority to take action regarding “misbranded” devices. 7 U.S.C. § 136j. EPA interprets the misbranding requirement as mandating that a device be safe and effective for its claimed use and that devices not bear any false or misleading labeling—including efficacy claims that are not adequately substantiated.
While EPA requires sellers of devices to not make false or misleading efficacy claims, EPA has provided little guidance to industry regarding what efficacy data or other substantiation is adequate to support such efficacy claims. Indeed, in an April 12, 2021 letter addressing UV lights, EPA declined to provide detail regarding the type of substantiation it believes is appropriate for UV lights, other than to note that “[i]f claims are made against specific pathogens, EPA maintains that testing of the device against those pathogens on the specific substrate (e.g., E.coli on cloth) is necessary to substantiate those claims.” Likewise, EPA has cautioned consumers about devices claiming to be effective against SARS-CoV-2, but has not provided guidance on what efficacy substantiation is required for such products.
This lack of guidance is in tension with recommendations by public health authorities that such devices may be important tools to combat the pandemic. For example, the CDC has indicated that upper-room UV light systems “can be used to control SARS-CoV-2 as a useful ventilation tool to consider in reducing the spread of infectious pathogens.” Yet an entity marketing such a system would have little guidance as to what type of efficacy data might satisfy EPA, or what data EPA considers necessary to substantiate any given claim.
With the easing of the pandemic, EPA now has an opportunity to consider, in a non-emergency context, whether and how it can provide guidance to both regulated parties and consumers regarding appropriate efficacy claims and substantiation. There may well be significant challenges associated with such guidance, given the different types of devices and the fact that their effectiveness could potentially change depending on the environment in which they are used. Nevertheless, EPA plainly could develop some guidance (e.g., safe harbor specifications, generalized guidance regarding certain efficacy claims and data requirements, efficacy claims it views as impermissible or data it views as unreliable), and nothing prohibits the Agency from doing so after soliciting input from stakeholders via a public notice and comment process.
Treated articles are products that are treated with an EPA-approved antimicrobial pesticide to kill microbes (e.g., a shower curtain treated to resist mildew). Under longstanding EPA regulations and guidance, claims for such treated articles are limited to claims to protect the article itself. 40 C.F.R. § 152.25(a), PR Notice 2000-1. Thus, claims to kill disease-causing bacteria or viruses may not be made in connection with treated articles. Instead, to make such claims, an entity must “register the article as a pesticide product,” which is a lengthy, complex, and costly process. PR Notice 2000-1. Unlike pesticide devices, this class of products is subject to full-blown regulation under FIFRA.
Based on publicly-available information, EPA has registered few, if any, articles with claims to kill disease-causing bacteria or viruses. One of the few examples emerged earlier this year, when EPA announced that certain copper alloys used in hard surfaces (e.g., a doorknob) was the first such product registered to make antiviral claims. EPA has also provided draft guidance for hard-surface antimicrobial coatings. But for many other types of products, EPA has not developed test protocols or other guidance indicating what sort of data (efficacy, safety etc.) would be adequate.
It is not difficult to imagine the potential utility of such products, both now and in any future pandemic—especially a pandemic where surface transmission is a significant disease vector. For example, treatment of high-contact surfaces (e.g., public transit seats, light switches) could potentially provide significant public-health benefits, assuming efficacy, safety, and durability can be ensured.
To be sure, there may be significant challenges and questions associated with developing such products. But that is all the more reason for EPA to implement a process to work through these issues sooner rather than later.
EPA has played a key role in regulating antimicrobial products throughout the SARS-CoV-2 pandemic, and in expediting a variety of approval processes to provide immediate assistance in combatting the pandemic. Now that the pandemic appears to have abated, EPA could consider giving thought to lessons learned from this pandemic, including how to provide a broader suite of antimicrobial tools to combat the next pandemic, while ensuring that those products are in fact safe and effective for use.
This is the twenty-fifth in our series on the “ABCs of the AJP.”
The American Jobs Plan aims to electrify 20% of the country’s iconic yellow school bus fleet through a new “Clean Buses for Kids” program, alongside a broader effort to replace 50,000 diesel transit vehicles. The move will have important health benefits and assist in the electrification of the heavy duty transportation and freight sectors, which face additional challenges as they seek to decarbonize. Continue Reading Yellow School Buses and Diesel Electrification
This is the twenty-fourth in our series, “The ABCs of the AJP.”
In 2020 alone, the United States suffered 22 separate extreme weather and climate-related disasters that each caused at least $1 billion in damages, for a total of more than $100 billion in losses. That staggering statistic is not an anomaly, as climate change continues to result in more and more extreme weather events every year. For example, the Texas freeze that rocked the state earlier this year and killed more than one hundred people, also shut down the state’s significant petrochemical industry, disrupting supply chains nationwide, and caused an estimated $80 billion to $130 billion in direct and indirect economic losses. Hundreds of deaths are attributed to the unprecedented and record-breaking heat wave of the Pacific Northwest, and a British Columbia village where the highest temperature ever recorded in Canada was devastated by wildfire. Taking into account these and other weather-related tragedies, the losses become inestimable on a human scale. Continue Reading X-Treme Weather and the Need for Climate Resiliency
This is the twenty-third in our series, “The ABCs of the AJP.”
President Biden’s American Jobs Plan (AJP) proposed $111 billion of investments into improvements in drinking water and wastewater management systems across the United States. The Bipartisan Infrastructure Framework that the President endorsed last week would provide just about half of that amount – $55 billion – which the President nevertheless described as “the largest investment in clean drinking water and waste water infrastructure in American history.” Continue Reading Win-Win Solutions for Clean Water, from Wisconsin to Washington, D.C.
On June 22, the U.S. Court of Appeals for the D.C. Circuit issued a decision in Environmental Defense Fund v. FERC vacating and remanding FERC’s order issuing a certificate of public convenience and necessity to Spire STL Pipeline LLC (“Spire STL”) under Section 7 of the Natural Gas Act. The decision is a rare instance of the D.C. Circuit vacating a FERC certificate order upon finding that FERC’s determination regarding the market need for the proposed pipeline was arbitrary and capricious, and was not supported by the Commission’s Certificate Policy Statement. Thus, there is no clear precedent for how FERC may approach Spire STL’s application moving forward. The D.C. Circuit’s decision also comes as FERC considers revising its Certificate Policy Statement, including the framework for determining need for a proposed project, after receiving over 100 comment filings from interested stakeholders in response to FERC’s February 18 Notice of Inquiry on certificate policy. Continue Reading D.C. Circuit Vacates FERC’s Spire STL Pipeline Certificate Order
This is the twenty-second in our series on “the ABCs of the AJP”
The single largest expenditure in President Biden’s original proposal for his American Jobs Plan is a $174 billion investment to promote electric vehicles (EVs). This considerable sum reflects the fact that increasing the number of EVs on the road in the United States would advance a number of key administration priorities, as described below. Continue Reading Vying for America’s Future through Electric Vehicles
This is the twenty-first in our series, “The ABCs of the AJP.”
President Biden’s American Jobs Plan (AJP) sets an ambitious goal of “achieving 100 percent carbon-free electricity by 2035.” To accomplish this, the AJP proposes significant investments in grid modernization, transmission infrastructure, offshore wind, and energy storage, as detailed by our prior posts. Whether these investments – carrots, if you will – will be sufficient to drive down emissions in all states and achieve the 2035 target, in the absence of an enforceable clean electricity standard (CES), remains uncertain. Equally uncertain is the pathway for Congress to enact a CES. Continue Reading Using Carrots and Sticks to Unleash the Potential for Clean Utilities
On June 17, FERC took two actions intended to facilitate greater coordination with and between state regulators on electric transmission policy and development. First, FERC issued an order establishing a Joint Federal-State Task Force on Electric Transmission (Task Force), and soliciting nominations for state commission representation on the Task Force from the National Association of Regulatory Utility Commissioners (NARUC). According to FERC’s order, the Task Force will focus on topics related to efficiently and fairly planning and paying for transmission, including generator interconnection, that provide benefits from a federal and state perspective. If successful, the Task Force could play a critical role in re-designing FERC’s interstate transmission policy to better accommodate the state-policy-driven development of renewable energy generation facilities across the country. Continue Reading FERC Establishes Unprecedented Joint Federal-State Task Force on Electric Transmission, Issues Policy Statement on State Voluntary Agreements
In a recent order, FERC pulled back, for now, its decision to sharply limit the ability of retail regulators to prohibit distributed energy resource (DER) aggregators from bidding retail customer demand response (DR) into wholesale markets. Instead, the issue will be considered in an ongoing inquiry that is addressing whether to totally eliminate the ability of retail regulators to keep retail DR resource offers out of FERC-jurisdictional wholesale markets. Continue Reading FERC Reconsidering Limits On Retail Regulator Control Over Aggregating Demand Response