Tag: EPA

EPA Can Help You Keep It Clean in a World with COVID-19

Virus-killing myths, like gargling salt water, are floating around as fast as toilet paper has flown off the grocery store shelves.

When those shelves are restocked, what is effective for cleaning surfaces in residential, commercial, and industrial environments?  The U.S. Environmental Protection Agency (“EPA”) has released a list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Along with hand washing and social distancing, cleaning and disinfecting with effective products are an important part of slowing the spread of the virus.  The EPA published the list with other important information on disinfectant products and links to the Centers for Disease Control (CDC) to inform the public and help reduce the spread of COVID-19.  According to the EPA’s accompanying press release, coronaviruses are “enveloped viruses, meaning they are one of the easiest types of viruses to kill with the appropriate disinfectant product. Consumers using these disinfectants on an enveloped emerging virus should follow the directions for use on the product’s master label, paying close attention to the contact time for the product on the treated surface (i.e., how long the disinfectant should remain on the surface).”

How do we know the listed products are effective and not a scam?  The EPA developed its Emerging Viral Pathogen program in 2016 to allow manufacturers to voluntarily provide EPA with data to show their products are effective against viruses. The purpose of the program was to gather the information through a pre-approval process so that if an outbreak occurs, companies with pre-approved products can make off-label claims for the use of the products against the outbreak virus. That planning proved fruitful: the use of the program was triggered for the first time for SARS-CoV-2 on January 29, 2020.

The EPA’s list includes recognizable products such as Clorox Multi-Surface Cleaner + Bleach and Lysol Brand Bleach Mold and Mildew Remover but is not meant to serve as an agency endorsement of any particular product as there may be additional disinfectants it has not reviewed that do meet the program’s criteria.  The EPA recommends to consumers to check if the EPA registration number that is on the product’s label (“EPA Reg. No.”) is included on the program list of disinfectants for use against SARS-CoV-2 to ensure the product can be used effectively.  Products can be marketed and sold under different brand names, but if they have the same EPA registration number, they are the same underlying product and can be used.

© 2020 Ward and Smith, P.A. All Rights Reserved.

EPA Registers New Uses for Existing Products to Help Reduce the Spread of Candida auris

On February 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of 11 products that have been approved for use to disinfect surfaces against the emerging multidrug-resistant fungus Candida auris (C. auris).  C. auris can cause severe infections and spreads easily among hospitalized patients and nursing home residents.  The 11 products are approved for use against C. auris to disinfect surfaces in hospitals, nursing homes, and other healthcare facilities, to help reduce patient infections.  There were no antimicrobial pesticide products registered specifically for use against C. auris prior these new use registrations.

EPA worked in collaboration with the Centers for Disease Control and Prevention (CDC) and other federal partners to ensure that the products would be effective against C. auris.  Previously, on October 16, 2019, EPA had granted public health exemptions under the provisions of section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, to the CDC, for uses of antimicrobial products, on hard, nonporous surfaces in healthcare settings for disinfection from C. auris.

The 11 products that are now registered for use against C. auris are:

  •  Avert Sporicidal Disinfectant Cleaner (EPA Reg. No. 70627-72);
  •  Blondie (EPA Reg. No. 67619-24);
  •  Dagwood (EPA Reg. No. 67619-25);
  •  Micro-Kill Bleach Germicidal Bleach Wipes (EPA Reg. No. 37549-1);
  •  Oxivir 1 (EPA Reg. No. 70627-74);
  •  Oxivir 1 Wipes (EPA Reg. No. 70627-77);
  •  Oxivir Wipes (EPA Reg. No. 70627-60);
  •  Oxycide™ Daily Disinfectant Cleaner (EPA Reg. No. 1677-237);
  •  Virasept (EPA Reg. No. 1677-226);
  • Wonder Woman Formula B Germicidal Wipes (EPA Reg. No. 9480-12); and
  •  Wonder Woman Formula B Spray (EPA Reg. No. 9480-10).

Because there are few products with C. auris claims at this time, CDC and EPA have identified additional products that are effective against C. auris. Although these products do not yet have formal EPA-registered claims for C. auris, testing at CDC has confirmed they are effective against C. auris.  The label on the product will not include instructions for C. auris.  CDC guidance states to “follow the instructions provided for C. albicans, if included, or else follow those for fungicidal activity.” These products include:

  •  Oxivir TB Spray (EPA Reg. No. 70627-56); and
  •  PDI Super Sani-Cloth (EPA Reg. No. 9480-4).

The CDC Guidance further states that, if none of the above-listed products are available, or any of the EPA-registered products that are newly approved for the specific claims against C. auris, CDC recommends use of an EPA-registered hospital-grade disinfectant effective against Clostridioides difficile spores, because CDC believes these products have been used effectively against C. auris (List K).

Additional information on C. auris is available on EPA’s website and CDC’s website.

©2020 Bergeson & Campbell, P.C.

For more on EPA disinfectant registrations, see the National Law Review Environmental, Energy & Resources section.

New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.

©2020 Bergeson & Campbell, P.C.

For more on biotech, see the National Law Review Biotech, Food & Drug lawpage.

PFAS Rolling into Regulation

Introduction

Per- and polyfluoroalkyl substances, abbreviated as PFAS, are a class of widely dispersed chemicals quickly gaining notoriety in the public health and environmental remediation space. In 2019, rapid developments toward regulation to govern the investigation and cleanup of PFAS contamination to protect human health are occurring in a wide variety of arenas, including federal regulation and congressional action as well as at the state level through both regulation and enacted legislation. This article examines the current state of regulatory developments for PFAS and projects where things are heading in the remainder of 2019, with particular focus on how those developments will incentivize and accelerate the pace of site cleanups and cost recovery, and pose significant challenges to existing sites where other contaminants are already being addressed.

What are PFAS?

PFAS are a class of more than 4,000 synthetic chemicals comprised of carbon-fluorine chains of varying lengths. PFAS have been in use since the late 1940s, due to their unique resistant physical and chemical properties. For example, PFAS have been used in non-stick applications such as cookware, paper packaging, and textiles, as well as in certain types of firefighting foam.[1] The two most widely studied PFAS are perfluorooctane sulfonate or PFOS and perfluorooctanoic acid or PFOA.

Over the past decade, understanding of PFAS and their potential toxicity to humans and the environment has increased. Of particular concern is their stability in the environment. The properties that made PFAS so desirable for commercial and industrial use keep these compounds from degrading in the environment and allow them to pose a long-term threat if not removed from the environment and/or from drinking water supplies. Common exposure to these compounds can come through their product use as well as drinking from contaminated water supplies impacted by their release. Also notable are the very low levels at which these compounds exhibit their toxicity, and the very stringent levels under consideration by the regulatory agencies for controlling these compounds. For example, EPA has set interim screening levels of 70 nanograms per liter (parts per trillion or ppt), and several states have proposed guidance levels of 15 ppt or less. For context, 15 ppt is equivalent to a few droplets in an Olympic-sized swimming pool.

Federal Regulatory Developments

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) authorizes cleanup at sites where hazardous substances have been released, and enables parties conducting cleanups to seek cost recovery from other potentially responsible parties. The ability to potentially recover costs under CERCLA can be an important driver in encouraging impacted parties to investigate and remediate contaminated sites. However, as an emerging contaminant class, PFAS are not currently regulated as hazardous substances under CERCLA.

In February 2019, EPA issued an Action Plan outlining its steps to address PFAS and protect public health.[2] Among its listed priority actions was to propose a national drinking water regulatory determination for the two most widely studied PFAS, PFOA and PFOS, by the end of 2019. This proposed determination would begin the process towards establishment of a maximum contaminant level, or MCL, for these compounds. Another priority action was to initiate the process to list PFOA and PFOS as CERCLA hazardous substances; in April of 2019 at a meeting of state regulators, EPA committed to proposing this hazardous substance designation by the end of 2019.[3] Such a designation will have a multitude of impacts, including 1) PFOA and/or PFOS-contaminated sites will be eligible for listing as Superfund sites; 2) Federal and State authorities will have mechanisms through which they can seek damages or cleanup costs from responsible parties; and 3) Superfund monies will be eligible for use in cleaning up sites contaminated with PFOA and/or PFOS.

This commitment to regulate PFOA and PFOS under CERCLA was reaffirmed in a keynote speech of EPA’s General Counsel on September 12th at the American Bar Association, Section Environment, Energy, and Resources Fall Conference in Boston, Massachusetts. In his speech, the Honorable Matthew Leopold indicated that EPA was actively looking at designating PFOA and PFOS as CERCLA hazardous substances by year’s end. This would represent one of the few times in which new contaminants such as these were regulated under CERCLA.

Concurrent with these EPA actions, congressional legislators have called for increased and expedited federal action to regulate PFOA and PFOS, and in some cases the entire PFAS class of 4000 plus chemicals. There have been several bills proposed in 2019 which would commit EPA to taking expedited action with regards to PFAS, including listing some or all PFAS as hazardous substances, and establishing federal MCLs.[4] Perhaps most notably are two bills regarding appropriations for the Fiscal Year 2020 National Defense Authorization Act. S.1790 (passed by the Senate on June 27, 2019) would require EPA to promulgate drinking water MCLs for PFOA and PFOS within two years of enactment, and H.R.2500 (passed by the House on July 12, 2019) would require EPA to designate all PFAS as hazardous substances within one year of enactment.

State officials have also actively petitioned for more expedited federal action on PFAS. On July 30, 2019, 22 state and territory attorneys general issued a letter to Congress requesting that certain PFAS be designated hazardous substances, in particular, PFOA, PFOS, and a PFOA-replacement chemical known as GenX. In their letter, the attorneys general specifically note that such a designation would promote cleanup efforts, including federal facilities formerly owned or operated by the US Department of Defense.[5]

Based on these developments from multiple agencies and levels of government, it appears likely that in the relatively short term PFOA and PFOS will be designated as hazardous substances under CERCLA. This in turn will open the door for CERCLA regulation of PFAS-contaminated sites. Once designated, the next question will be one of appropriate cleanup levels. Typically, EPA would take the lead with establishment of MCLs that can be used to develop risk-based cleanup levels, and from which states could either adopt or modify. However, the process for proposing and finalizing a federal MCL can take years. Thus, faced with increasing public pressure to respond to PFAS contamination, the states have stepped in to fill this gap.

State Regulatory Developments

In November 2018, New Jersey became the first state to issue an MCL for any individual PFAS, specifically for the chemical perfluorononanoic acid (PFNA).[6] For PFOA and PFOS, there are currently no state MCLs that have been finalized. However, many states have established PFOA and PFOS advisory or screening levels, and several states have begun the MCL rule-making process, with some anticipating finalization this year.

In 2019, three states have proposed MCLs of varying concentrations for PFOA and PFOS:

  • In April, New Jersey proposed an MCL of 14 ppt for PFOA and 13 ppt for PFOS; the public comment period has since closed, and the standard is in the process of finalization;[7]
  • In June, New Hampshire proposed an MCL of 12 ppt for PFOA and 15 ppt for PFOS (they also proposed MCLs for two other PFAS chemicals);[8] those MCLs were approved on July 18,[9] and will become effective on October 1; and
  • In July, New York proposed an MCL of 10 ppt for PFOA and PFOS making them the most protective standards in the nation; the proposal is currently out for public comment, which closes on September 24.[10]

In addition, several other states have provided commitments to establishing MCLs in the near future. These include Massachusetts with an MCL rule proposal anticipated by the end of 2019;[11] Michigan with an MCL rule proposal expected by October with finalization in 2020;[12] and Vermont with a commitment to establishing and adopting MCLs by February 1, 2020.[13] Other states are also moving forward with efforts to regulate PFAS. For example, in August 2019 California established notification levels for PFOS and PFOA in drinking water of 6.5 ppt and 5.1 ppt, respectively, that go into effect January 1, 2020. [14],[15]

Conclusion

With federal and state regulatory action underway, and mounting public pressure to expedite a response, it is clear that regulation of some PFAS under CERCLA is imminent. By the end of the year, it is likely that 1) EPA will have designated, or be close to designating, PFOA and PFOS as hazardous substances; and 2) several states will have finalized MCLs to regulate their remedial response. These two developments will open the door for parties to investigate, cleanup, and ultimately recover the costs associated with PFAS-contaminated sites. In addition, these developments will likely complicate existing sites in terms of both their required remedial response as well as their cost recovery strategy. New PFAS regulation at existing sites will unlock a myriad of cost implications not the least of which involve cost allocation among potentially responsible parties. In the face of these complications and uncertainties, what is clear is that PFAS regulation has rolled off the horizon and directly in front of those involved with protecting public health and the environment.

The opinions expressed are those of the authors and do not necessarily reflect the views of the firm or its clients. This article is for general information purposes and is not intended to be and should not be taken as legal or accounting advice.

[1]  For a more thorough background on the history and usage of PFAS, see the Interstate Technology Regulatory Council fact sheets at https://pfas-1.itrcweb.org/

[2] https://www.epa.gov/newsreleases/epa-acting-administrator-announces-first-ever-comprehensive-nationwide-pfas-action-1

https://www.epa.gov/pfas/epas-pfas-action-plan

[3] https://www.asdwa.org/2019/04/11/cooperative-federalism-pfas-are-top-issues-at-ecos-spring-meeting/

[4]  https://fas.org/sgp/crs/misc/R45793.pdf

[5]  https://portal.ct.gov/-/media/AG/Press_Releases/2019/Multistate-PFAS-Legislative-Letter73019FINAL.pdf

[6]  New Jersey regulated PFNA largely in response to a regional issue relating to specific historic discharges from a chemical manufacturing facility.

[7]  https://www.nj.gov/dep/rules/notices/20190401a.html

[8]  https://www.des.nh.gov/media/pr/2019/20190628-pfas-standards.htm

[9]  https://www.gencourt.state.nh.us/rules/jlcar/minutes/AM7-18-19.pdf

[10]  https://www.governor.ny.gov/news/governor-cuomo-announces-availability-350-million-water-system-upgrades-statewide-and-directs

[11]  https://www.mass.gov/files/documents/2019/06/20/pfas-stakeholder-presentation-20190620.pdf

At the American Bar Association, Section Environment, Energy, and Resources Fall Conference in Boston, Massachusetts, the Commissioner of the Massachusetts Department of Environmental Protection participated in a panel discussion titled “The State of CERCLA Following EPA Reform: More of the Same or Something Super?” In this discussion, Mr. Suuberg indicated that Massachusetts will finalize its PFAS standards by the end of the year, and in an accompanying paper noted that the comment period on the proposed cleanup standard of 20 ppt (for a sum of six PFAS) had closed in July and was currently under review.

[12]       https://www.michigan.gov/egle/0,9429,7-135-3308_3323-494077–rss,00.html

[13]       https://dec.vermont.gov/sites/dec/files/PFAS/Docs/Act21-2019-VT-PFAS-Law-Factsheet.pdf

[14]            https://www.waterboards.ca.gov/drinking_water/certlic/drinkingwater/PFOA_PFOS.html

[15]      California already had notification levels of 14 ppt for PFOA and 13 ppt for PFOS and will continue to have a response level for those drinking water systems exceeding 70 ppt for the total combined concentration of both compounds, consistent with EPA’s advisory level. 

© Copyright Nathan 2019

ARTICLE BY Brian Henthorn and Christopher Loos of Nathan.
For more PFAS Regulation developments, see the National Law Review Environmental, Energy & Resources law page.

EPA Repeals Obama Rule Defining Waters of the U.S.

On Thursday, September 12, EPA General Counsel Matt Leopold announced EPA’s final rule repealing the 2015 Waters of the United States (“WOTUS”) Rule. Significantly, General Counsel Leopold did not announce the final replacement WOTUS Rule, which was proposed in February of this year; the replacement rule remains at the final rule stage as EPA revises the rule in light of public comment. A recent interview with Administrator Wheeler indicates that it will be a few months before the replacement rule is finalized.

The 2015 WOTUS Rule, also called the Clean Water Rule, significantly extended the Clean Water Act’s jurisdiction over streams and wetlands on the basis of significant hydrological or ecological connections to traditional navigable waters, interstate waters, and territorial seas. The 2015 Rule was successfully challenged by a number of states in federal district courts on the grounds that the 2015 Rule departed from both the statutory text of the Clean Water Act and major Supreme Court decisions guiding how “waters of the United States” is to be interpreted. As a result, the 2015 Rule was effective only in 22 states, creating a patchwork of applicability that frustrated government officials and the regulated community alike.

The repeal of the rule will be effective 60 days from the official notice in the Federal Register. When the repeal rule goes into effect, the entire country will be governed by the pre-2015 status quo. The 1986 WOTUS Rule will be the basis for determining which waterbodies are WOTUS until the replacement rule is effective, and the SWANCC and Rapanos guidance documents remain in effect as well.

© 2019 Bracewell LLP

Federal Judge Limits the Reach of the WOTUS Rule

Introduction

During the Obama Administration, the Environmental Protection Agency (“EPA”) and the United States Army Corps of Engineers (collectively, “the Agencies”) adopted a rule amending the regulatory definition of “waters of the United States” (the “WOTUS Rule” or “Rule”).  As explained in a previous alert, the WOTUS Rule has far-reaching implications for project development and landowners across the energy, water, agricultural, construction, and transportation sectors, and it has been the subject of extensive litigation, as well as rulemaking by the Trump Administration.

On Wednesday, August 21, 2019, the United States District Court for the Southern District of Georgia ruled in Georgia v. Wheeler that the WOTUS Rule impermissibly extended the Agencies’ authority beyond the scope of the Clean Water Act (“CWA”) and failed to comply with the Administrative Procedure Act (“APA”). The Court remanded the WOTUS Rule back to the Agencies and extended its preliminary injunction of the Rule.

Background

Since its enactment, the WOTUS Rule has been the subject of many legal challenges, and it was enjoined in numerous states. Additionally, under the Trump Administration, the Agencies proposed a new rule that would have delayed the effectiveness date of the WOTUS Rule for two years (the “Suspension Rule”). As previously discussed, the Suspension Rule was the subject of a nationwide injunction in South Caroline Coastal Conservation League v. Pruitt.  A federal judge in the Western District of Washington then vacated the Suspension Rule in Puget Soundkeeper Alliance v. Wheeler.

After the vacatur of the Suspension Rule, the WOTUS Rule continued to provide fodder for litigation. To date, the WOTUS rule is enjoined in 27 states: Alaska, Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, Nevada, North Carolina, North Dakota, South Carolina, Oregon, South Dakota, Texas, Utah, West Virginia, Wyoming, and Wisconsin.  The Rule remains effective in 22 other states and the District of Columbia.

The Opinion

In Georgia v. Wheeler, the Court—relying primarily on Justice Kennedy’s concurrence in Rapanos v. United States—held that the WOTUS Rule impermissibly extended the Agencies’ jurisdiction beyond their delegated authority under the CWA.

The Court also held that the Agencies’ definitions of interstate waters, tributaries, adjacent waters, and case-by-case waters violated the CWA, and that the Rule significantly interfered with lands and waters that were traditionally under state authority without clear congressional intent.

Additionally, the Court determined that the Rule failed to comply with the APA both procedurally and substantively. These topics are further discussed below.

Definition of Interstate Waters

The Court found that the definition of interstate waters, which considers all interstate waters to be a “water of the United States” irrespective of navigability, disregarded the Supreme Court’s ruling in Rapanos. In particular, the Court found that WOTUS reads the term “navigability” out of the CWA. As such, under the WOTUS Rule, a non-navigable interstate water with no significant nexus to a “water of the United States” would still be regulated. According to the Court, that result extends beyond the Agencies’ authority under the CWA.

Definition of Tributaries

The Court also concluded that the Rule’s definition of “tributaries” was over-inclusive because it used the presence of an ordinary high water mark (“OHWM”) and bed and banks as physical indicators of volume sufficient to create a regulated “tributary.”  The Court took particular issue with provisions in the WOTUS Rule discussing situations in which these physical indicators are “absent in the field,” but are nevertheless determined to be present by “other appropriate means,” such as “lake and stream gage data, elevation data, spillway height, historic water flow records, flood predictions, statistical evidence, the use of reference conditions, or through . . . remote sensing and desktop tools.”  The Court found this approach inconsistent with Justice Kennedy’s concurrence, noting that “the physical indicators that the Agencies assert provide evidence of sufficient volume and flow to adhere to Justice Kennedy’s significant-nexus test need not actually be physically present in a geographic area so long as computer programs can decipher that they exist and need not presently exist so long as those programs can conclude that they have existed at sometime in the past.”

The Court was also troubled by the application of the “tributaries” definition in the Arid West, citing evidence that the physical indicators of a tributary often appear around water bodies in the Arid West, even when they are wholly isolated from navigable waters. The Court found that the definition of tributaries could inadvertently regulate dry areas that may contain attributes of an OWHM and a bed and bank due to an extreme weather event—a result that Justice Kennedy’s concurrence in Rapanos sought to avoid. Accordingly, Court concluded that the “tributaries” definition extended too far.

Definition of Adjacent Waters

According to the Court, the definition of “adjacent waters” clearly conflicted with Justice Kennedy’s opinion in Rapanos by erroneously including waters adjacent to non-navigable tributaries. The Court recognized that, while adjacency is a permissible factor to consider when determining jurisdiction under the CWA, that factor must still be subject to Kennedy’s significant-nexus test.  The Court reasoned that the definition impermissibly extended jurisdiction over isolated and inconsequential waters.

Case-by-Case Waters

The Court presumed that the case-by-case category was the Agencies’ attempt to implement Justice Kennedy’s significant-nexus test. Because the Agencies relied on impermissible definitions of “interstate waters” and “tributaries” in formulating their criteria for the case-by-case category of waters, the criteria were also invalid to the extent they were the logical outgrowth of these definitions. Because the definitions of “interstate waters” and “tributaries” were already overbroad, the Agencies could not base case-by-case category waters of those definitions, as they too would impermissibly expand federal jurisdiction. Notably, the Court concluded that the Agencies’ reliance on erroneous definitions of “tributaries” and “interstate waters” was the only error in the WOTUS Rule’s case-by-case category under the CWA.

The WOTUS Rule Substantially Interferes with Traditional State Power

The Court also found that the Rule substantially encroached on traditional state power. Recognizing that the CWA permits the federal government to regulate waters in order to protect the biological and physical integrity of the Nation’s waters, the Court also emphasized the Congressional policy in the CWA stating that states should retain primary responsibility over land and water resources. The Court found that the WOTUS Rule as written would result in the federal government regulating immense stretches of intrastate land not contemplated by that CWA.  To support this finding, the Court cited statements made by the Agencies under the Trump Administration in a recently-proposed rule to rescind the WOTUS Rule that the WOTUS Rule “may have altered the balance of authorities between the federal and State governments, contrary to the agencies’ [prior] statements,” and to statistics suggesting the WOTUS rule was estimated to increase the scope of federal jurisdiction over waters by at least two percent — an increase the Court characterized as “a substantial intrusion into lands and waters traditionally left to state authority.” According to the Court, this significant increase in jurisdiction improperly stripped states of their traditional authority to regulate these types of lands and waters.

The Rule failed to comply with APA and was arbitrary and capricious

The Court found that the rule violated the APA in two ways: (1) the final Rule was not the logical outgrowth of the Agencies’ previously-proposed version of the Rule; and, (2) there were parts of the Rule that were arbitrary and capricious. The Rule failed to be the logical outgrowth of the Agencies’ proposed rule for three reasons. First, while the proposed Rule did not include distance limitations when defining “neighboring waters,” the final Rule did. Second, the proposed Rule similarly did not include distance limitations for adjacent waters in the case-by-case categories, while the final Rule did. Lastly, the proposed Rule did not contain any explicit farming exemption, but the final Rule contained a farming exemption for adjacent waters. The Court agreed with Plaintiffs’ argument that, had they known that there was going to be a farming exemption for adjacent waters, they would have also commented that there should be a farming exemption for tributaries.

The Court also determined that portions of the Rule were arbitrary and capricious. The Court found that the Agencies’ inclusion of a farming exemption for adjacent waters but not tributaries was arbitrary and capricious because it failed to treat similar cases in a similar manner without justification. The Court also found that the Agencies’ decision to use FEMA 100-year floodplain maps to define adjacent and case-by-case waters was arbitrary because of the inaccuracies of outdated flood maps, and because the Agencies failed to sufficiently explain why the 100-year floodplain was the proper limit. Lastly, the Agencies’ use of a distance limitation for adjacent waters was arbitrary because the Agencies only gave broad, conclusory reasons why the limit was selected and failed to explain their decision.

Practical Implications

Georgia v. Wheeler represents yet another federal court to examine the merits of the WOTUS Rule and to find it exceeding the Agencies’ statutory authority under the CWA and violating provisions of the APA.  The Court did not vacate the rule, but simply remanded it back to the Agencies, and therefore the Rule remains effective where not enjoined. This case continues the patchwork implementation of the WOTUS Rule, which is now enjoined in 27 states, but is still effective in 22 other states and the District of Columbia.

This patchwork situation may not last long, as appeals will likely be filed challenging the Georgia v. Wheeler decision and other decisions enjoining or declining to enjoin the WOTUS Rule. Additionally, the Agencies under the Trump Administration are expected in the near future to publish a final version of their proposed new WOTUS Rule, which is also very likely to face legal challenges.

As a result on the ongoing litigation and rulemaking processes, the regulated community is unlikely to see true certainty on the question of the geographic scope of the CWA until Congress takes action to clarify its scope or the Supreme Court issues a new substantive decision addressing this issue.

© 2019 Van Ness Feldman LLP

Asbestos Receiving Renewed Attention in Light of Additional US EPA Assessments under TSCA and Potential Ban by Congress

Asbestos is in the hot seat these days and is receiving significant attention from both US EPA and Congress.  In particular, US EPA continues to evaluate asbestos risks under the Toxic Substances Control Act (TSCA) and has imposed additional regulations, while Congress is currently considering an outright ban on the substance.

On April 25, 2019, US EPA issued a final Significant New Use Rule (SNUR) under Section 5 of TSCA to prevent certain discontinued uses of asbestos from re-entering the marketplace without a review by EPA.  The rule essentially restricts manufacturing, importing or processing of asbestos for certain target uses that are neither ongoing, nor already prohibited under TSCA.

The SNUR covers a number of target uses for which US EPA “has found no information” indicating that they are ongoing: adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; certain friction materials; high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and “any other use of asbestos that is neither ongoing nor already prohibited under TSCA.”  While the SNUR does not actually prohibit these uses, none of the uses may return to the marketplace without EPA review of their potential risks to health and the environment.   A party must submit a “significant new use notice” to US EPA at least 90 days prior to commencing manufacturing, importing or processing of asbestos for such uses.

While the Rule effectively expands the number of restricted uses, the SNUR has raised concerns as it essentially removes the uses from US EPA’s pending TSCA risk evaluation of asbestos, which is being performed pursuant to EPA’s December 2016 listing of substances under Section 6(b) of TSCA for which a final risk assessment is due in December 2019.

Meanwhile, Congress is considering a ban on all uses of asbestos (which is already banned in more than 60 countries).  Most recently on May 8, 2019, the House Energy and Commerce Committee’s environmental panel held a hearing on H.R. 1603 (the “Alan Reinstein Ban Asbestos Now Act of 2019” introduced on March 7, 2019).  The Bill seeks to amend TSCA to require US EPA to ban importation and use of asbestos in the US within one year of enactment, broaden EPA’s definition of asbestos to include additional fiber types, and also require that EPA and the Departments of Health and Human Services and Labor assess and report to Congress regarding existing “legacy” asbestos in residential, commercial, industrial, public, and school buildings to determine quantity and risk.

Although there is reportedly openness to a bipartisan compromise on the Democratic-sponsored bill, concerns have been raised as to its application, including the effect upon the chlorine industry and that it may hamper the industry’s ability to manufacture chlorine for public water supply use and healthcare facility sanitization.  For instance, on May 8, 2019, the American Water Works Association submitted comments to the Committee noting that “more than forty percent of the chlorine supply in the United States is dependent on production methods that rely on asbestos.” Further, the relatively short 12-month transition period has been cited as another concern, as well as the associated costs.

While US EPA’s TSCA risk evaluation remains ongoing through the end of 2019 (and possibly beyond) and Congress considers the ban proposed in H.R. 1603 in committee and markup, asbestos will continue to received increased attention.  Industries that deal with asbestos-containing materials would be advised to consult with technical and legal experts to consider the implications of these measures, as well as look for additional opportunities to advocate its position to decision makers as these measures are considered and finalized.

 

© Copyright 2019 Squire Patton Boggs (US) LLP
Read more on Environmental & EPA issues on the National Law Review Environmental, Energy & Resources page.

EPA Issues New Emergency Response Requirements for Community Water Systems

On March 27, 2019,  The Environmental Protection Agency (EPA) published the Federal Register Notice for New Risk Assessments and Emergency Response Plans for Community Water Systems describing the requirements and deadlines for community (drinking) water systems to develop or update risk and resilience assessments (RRAs) and emergency response plans (ERPs) under  America’s Water Infrastructure Act (AWIA) which was signed into law on October 23, 2018 and amends the Safe Drinking Water Act (SDWA).   Additionally, as described below, preparation of an ERP will enable owners or operators of community water systems to apply for grants from EPA for fiscal years 2020 and 2021.

Covered water systems.  Community water systems that serve more than 3,300 people are covered by these requirements. EPA interprets the population served to mean all persons served by the system directly or indirectly, including the population served by consecutive water systems, such as wholesalers.

Deadlines.  Each covered Community Water System completing an RRA and ERP must send certifications of completion by the dates listed below, and then review for necessary updates every 5 years thereafter:

Population Served by the Community Water System

Risk and Resilience Assessment (RRA) Certification

Emergency Response Plan (ERP)

The dates below are 6 months from the date of the RRA certification, based on a utility submitting a risk assessment on the final due date. Depending on actual RRA certification, ERP due dates could be sooner.

≥100,000

March 31, 2020

September 30, 2020

50,000-99,999

December 31, 2020

June 30, 2021

3,301-49,999

June 30, 2021

December 30, 2021

Risk and Resilience Assessment Requirements.  Each covered community water system must assess the risks to, and resilience of, its system including:

  • risk to the system from malevolent acts and natural hazards
  • resilience of the pipes and constructed conveyances, physical barriers, source water, water collection and intake, pretreatment, treatment, storage and distribution facilities;
  • electronic, computer, or other automated systems (including the security of such systems) which are utilized by the system;
  • monitoring practices of the system;
  • financial infrastructure of the system;
  • use, storage, or handling of various chemicals by the system; and
  • operation and maintenance of the system.

Emergency Response Plan Requirements (ERP). No later than six months after certifying completion of its risk and resilience assessment, each system must prepare or revise, where necessary, an emergency response plan that incorporates the findings of the assessment.  The ERP must include:

  • strategies and resources to improve the resilience of the system, including the physical security and cybersecurity of the system;
  • plans and procedures that can be implemented, and identification of equipment that can be utilized, in the event of a malevolent act or natural hazard that threatens the ability of the community water system to deliver safe drinking water;
  • actions, procedures, and equipment which can obviate or significantly lessen the impact of a malevolent act or natural hazard on the public health,  safety, and supply of drinking water provided to communities and individuals, including the development of alternative source water options, relocation of water intakes, and construction of flood protection barriers; and
  • strategies that can be used to aid in the detection of malevolent acts or natural hazards that threaten the security or resilience of the system.

The Federal Register Notice indicates that EPA is not requiring water systems to use any designated standards or methods to complete RRAs or ERPs, provided all of the requirements of the SDWA and AWIA are met.  AWIA already defines resilience and natural hazards. EPA will provide additional tools to foster compliance with its provisions and baseline information regarding malevolent acts no later than August 1, 2019.  With respect to the latter, it is anticipated that the agency will include consideration of acts that may (1) substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water; or (2) otherwise present significant public health or economic concerns to the community served by the system.

Potential Impacts & Next Steps.  Preparation of an ERP will enable the owners or operators of community water systems to apply for grants under the Drinking Water Infrastructure Risk and Resilience Program, under which EPA may award grants in fiscal years 2020 and 2021.  If consistent with its ERP, a community water system may apply for grant funding for projects that increase resilience, such as:

  • Purchase and installation of equipment for detection of drinking water contaminants or malevolent acts;
  • Purchase and installation of fencing, gating, lighting, or security cameras;
  • Tamper-proofing of manhole covers, fire hydrants, and valve boxes;
  • Purchase and installation of improved treatment technologies and equipment to improve the resilience of the system;
  • Improvements to electronic, computer, financial, or other automated systems and remote systems;
  • Participation in training programs, and the purchase of training manuals and guidance materials relating to security and resilience;
  • Improvements in the use, storage, or handling of chemicals by the community water system;
  • Security screening of employees or contractor support services;
  • Equipment necessary to support emergency power or water supply, including standby and mobile sources; and
  • Development of alternative source water options, relocation of water intakes, and construction of flood protection barriers.

The EPA is currently developing a comprehensive training schedule, which will include both classroom and webinar options.

 

© 2019 Van Ness Feldman LLP.
Read more water infrastructure news on our environmental type of law page.

Three Strategies to Develop Renewable Energy Projects on Potentially Contaminated Lands

Developing renewable energy on contaminated lands has proven to be both effective and cost-effective for companies pursuing a new solar or wind energy project. The utility-scale solar farm constructed on the 120-acre Reilly Tar & Chemical Corporation Superfund site is a great example, and there are thousands more that are ripe for redevelopment.

Renewable energy continues to grow in volume and importance in the U.S. as corporations drive demand for sustainable energy, with 166 companies to date committing to go 100 percent renewable as part of a global initiative called RE100. At the same time, states and local governments are driving policy that prioritizes sustainable energy development. Two recent Illinois bills, the Path to 100 Act (HB 2966/SB1781) and Clean Energy Jobs Act (HB3624/SB2132), seek to incentivize the development of new renewable energy and move the state to 100 percent renewable energy by 2050. Other states, including California, New Jersey, New York, and Wisconsin, have called for or passed similar laws.

Using Superfund sites, brownfields, retired power plants, and landfills offers potential benefits to developers and community stakeholders:

  • Preserve Open Space: Large-scale renewable energy facilities – often called “utility scale” projects – can require a lot of land that may displace or impact agricultural lands, open space, or other “greenspace.” Developing renewable energy on potentially contaminated properties can help to preserve the “greenspace” while returning blighted lands to sustainable and productive use.

  • Lower Costs and Shorter Timeline: Developers can significantly lower costs and timelines because contaminated sites are usually already served by existing infrastructure, like substations, power lines, and roads, which would otherwise need to be constructed. Streamlined permitting and zoning can also reduce costs and timelines because potentially contaminated property is often already zoned for industrial or commercial use, which likely poses fewer obstacles to constructing renewable energy structures. Decreased land costs, programs for the procurement of renewable energy credits generated from developing renewable energy projects on brownfields or potentially contaminated properties, and federal and state brownfield tax incentives can drive costs down even further.

  • Greater Community Support: Communities may be quicker to get behind renewable energy projects that are sited on potentially contaminated lands because, rather than taking agricultural land out of production, the projects can clean up the otherwise abandoned sites, boost surrounding property values, increase tax revenues, and provide low-cost clean power.

Despite these benefits, developers often build renewable energy facilities on greenspaces rather than brownfields because of concerns related to potential liabilities or contamination. Below are three strategies that developers can use to move past those concerns and develop a successful renewable energy project on potentially contaminated lands.

  1. Screen Sites for Renewable Energy Potential

Screen potentially contaminated properties to see whether they’d be a good fit for your renewable energy project. For example, confirm that a property has enough usable space and is close enough to transmission or distribution lines to support development. Determine whether a site is free from land-use restrictions that would preclude the use of your chosen renewable energy. Ensure the community doesn’t already have a plan in mind to redevelop the property you’re assessing. And inspect the property for evidence of potential contamination, like soil surface staining or debris stockpiles. If a site has not yet been assessed, you will need to investigate the site to determine whether redevelopment is appropriate. To help, the EPA has published guidance to assist prospective developers in screening prospective sites for solar and wind projects on potentially contaminated lands.

  1. Coordinate the Cleanup and Renewable Energy Development

Developing renewable energy can occur at any stage of a property cleanup, from site inspection and preliminary assessment to post-construction completion. However, identifying and coming to a site at the beginning of or early on in the cleanup process has its advantages. It allows you to engage the community and other stakeholders, including potentially responsible parties, from the start of the redevelopment. It also allows you to coordinate and integrate the cleanup and renewable energy development decisions. For example, you can work with the governmental agency overseeing the site to fold renewable energy design requirements into the remedial design, rather than having to construct renewable energy structures on top of and around the completed remedy. Getting in early will ensure that the renewable energy project is compatible with the remedial design, institutional controls, monitoring activities, and engineering controls.

  1. Protect Yourself from Liability Exposure

Many prospective developers, purchasers, and lenders stay away from or tread cautiously around building on contaminated properties for fear of liability under federal or state cleanup laws. However, many state cleanup programs provide liability protections for new owners or lessees, like a developer, who are not responsible for prior contamination at a site. The federal Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) also generally limits EPA enforcement at certain qualifying brownfield sites, known as “eligible response sites”, where a party is conducting a response action in compliance with a state cleanup response program. Contact a lawyer and work with state government early on in the process to see what liability protections are available to you and how to qualify.

Other contaminated properties may be addressed under the CERCLA cleanup program. CERCLA has several self-implementing liability protections for developers and the like who acquire contaminated property but did not cause the contamination, including a protection for “bona fide prospective purchasers.” Ensure that you take the required steps to qualify for the BFPP protection, which will include, among other things, working with an environmental consultant to conduct “all appropriate inquiries” through a Phase I environmental site assessment. CERCLA can also offer liability protections for people who lease contaminated properties.

 

© 2019 Schiff Hardin LLP
This post was written by Alex Garel-Frantzen and Amy Antoniolli of Schiff Hardin LLP.

Municipal utilities need to be concerned with PFAS

Municipalities face increasing challenges under the growing regulatory focus of the United States Environmental Protection Agency (EPA) and state environmental agencies on the emerging contaminants Per-and Polyfluoroalkyl Substances, known by the acronym “PFAS.” This newsletter will describe some of those challenges for municipalities and the announcement  and the importance of following good protocol when sampling and analyzing for these compounds.

What are PFASs and why are they considered harmful?

PFASs are a group of chemicals that have been used since the middle of the 20th century in many industrial applications and consumer products including stain proofing for water proof carpeting, clothing, upholstery, leather treatment, food paper wrappings, firefighting foams (commonly used at military bases, airports, fire stations and refineries), car washing cleaners, metal plating and non-stick cookware (such as Teflon). Some research has suggested probable links between exposure to PFAS and diagnosed high cholesterol, ulcerative colitis, thyroid disease, testicular and kidney cancers and pregnancy induced hypertension. As a result, the family of PFAS chemicals have been classified by EPA as an “emerging contaminant.”

EPA has set a lifetime health advisory (LTHA) level (the level below which no harm is expected) for two PFASs in drinking water: perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). The PFOA/PFOS LTHA level is 70 parts/trillion, which is equivalent to about 3 ½ drops of water in an Olympic swimming pool. The low threshold is a signal of the risk potential for this emerging contaminant as well as the difficulty in confidently determining the concentrations of PFOA/PFOS in water samples and the challenges in undertaking cost effective remediation when PFASs are discovered.

PFAS concerns for municipal utilities

In November 2018, President Trump signed the America’s Water Infrastructure Act of 2018 (AWIA). This legislation will require smaller communities to test their water systems for chemicals like PFOA and PFOS. Prior to the signing of this AWIA legislation, only water systems with more than 10,000 community customers were required to test for PFAS chemicals. Under this new legislation, smaller water utility communities who serve between 3,000 – 10,000 customers must also begin testing for these emerging contaminants.

In addition, on Feb. 4, 2019, the EPA announced its PFAS Action Plan. See here. In particular, EPA has announced its intention to develop a maximum contaminant level for PFOS and PFOA, including the LTHA reference point of 70 parts/trillion as a federally enforceable drinking water standard, under the Safe Drinking Water Act.

In a memorandum dated Feb. 20, 2018, the state of Michigan announced a monitoring proposal for waste water treatment plants that accept potential sources of PFAS to begin testing their facilities for PFAS containing chemicals. Michigan also has begun testing leachate from landfill facilities that accept municipal solid waste. The results of these preliminary tests have recorded the presence of PFAS in leachate generated by many of these landfills. Since leachate is commonly sent to wastewater treatment facilities for treatment, this discovery of PFAS in leachate could raise additional concerns for municipal treatment facilities, particularly since PFAS compounds are not specifically addressed in municipal wastewater treatment. The concern is that the PFAS is eluding treatment and is present in the effluent or other waste streams, or is adsorbing to the biosolids and sludges generated by the WWTP, which are thereafter frequently land spread with uncertain impacts.

An additional concern for municipalities, separate from wastewater, relates to historic (and potentially closed) waste landfills owned and operated by municipalities. Certain studies suggest that discarded carpet (such as Stainmaster products) and clothing (such as products treated with Scotchgard) are leading sources of PFAS contamination, including the leachate, in landfills.

Finally, the Wisconsin Department of Natural Resources (WDNR) has convened a PFAS Technical Advisory Group to discuss a broad range of PFAS concerns in Wisconsin. The first quarterly meeting of the Advisory Group occurred on Feb. 22, 2019. More information on the PFAS Technical Advisory Group can be found here.

All of these developments suggest that municipal utilities should be concerned about the legal implications of detections of PFAS. Given the extraordinarily low health advisory standards that apply to this class of chemicals (parts per trillion), these municipal utilities must take great care in deciding when to test for these materials and, if a decision is made to test, the quality assurance and quality control measures that should be taken to ensure reliable results.

Copyright © 2019 Godfrey & Kahn S.C.

 

This post was written by Arthur J. Harrington Daniel C.W. Narvey and Edward (Ned) B. Witte of Godfrey & Kahn S.C.

Read more on PFAS regulation on the Environmental type of law page.