Author: Brook Duer

As of mid-June 2025, agricultural stakeholders are increasingly aware of claims by clean water advocates and regulatory concerns that land-applying municipal sewage waste (biosolids) may contaminate soil and groundwater with per- and polyfluoroalkyl substances (PFAS). In 2023, approximately 60% of U.S. biosolids were land-applied, according to the U.S. Environmental Protection Agency (EPA).  Also,  according to the EPA, PFAS exposure may pose health risks, though ongoing research continues to assess the impacts of low-level, long-term exposure, especially in children.

Federal and state regulators are working to eliminate PFAS compounds considered the most dangerous to our environment and our health, perfluorooctanoic acid (PFOA) or perfluorooctane sulfonic acid (PFOS), from consumer products.  However, reducing environmental PFAS loads will also require alterations to current practices which may simply be recycling existing environmental loads, including agricultural uses of biosolids. Legal changes are expected.  Farmers, who own or rent most of the land involved in applications of biosolids, will be a central focus.  

What we have seen over the last few years has been a smattering of individual state government actions restricting and limiting the practice of land application of biosolids in various ways.  In some extreme instances, these have included quarantine orders of entire tracts of farmland preventing or limiting further agricultural production.  

A compilation of those individual state actions has been assembled by a national environmental consulting firm, ALL4 , and it is publicly available at this link: State-by-State Regulatory Update (March 2025 Revision)(see Table 2 – State Water Regulation Highlights).  This documents the patchwork in regulatory landscape faced across the country.  

Complicating enforcement, biosolids are increasingly transported across state lines, undermining the consistency of state-level regulation and calling for a more unified approach. This regulatory inconsistency challenges both land-applicators and regulators tracking PFAS from production to final disposal.

While the Clean Water Act (CWA), via the National Pollutant Discharge Elimination System (NPDES), governs the permitting of biosolid land applications, PFAS-specific regulation under this system remains limited. EPA has issued only non-binding guidance to states for performing their CWA duties. 

Adding a new pollutant to those already identified and regulated in biosolids is ultimately controlled by the text of 33 U.S.C. §1345(d) of the CWA (“Disposal or Use of Sewage Sludge”), and regulations at 40 CFR Part 503. These require EPA to establish numeric limits and mandatory management practices to protect public health and the environment from the reasonably anticipated adverse effects of designated pollutants during the use or disposal of biosolids. EPA is also required to review these regulations at least every two years and develop standards where evidence warrants.  To date, EPA has not established numeric PFAS limits for biosolids, but a draft risk assessment released on January 15, 2025, marks a first step in that direction. 

Historically, EPA’s “PFAS Strategic Roadmap” progress reports have stated it would complete by winter 2024 a risk assessment for PFAS in biosolids for use in determining whether to regulate these particular substances in biosolids.  

On January 15, 2025, EPA commenced that process by publishing in the Federal Register the following document, “Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS).  After multiple extensions, the public comment period is now scheduled to close on August 14, 2025.  The public comments so far are available at the following regulatory docket: EPA-HQ-OW-2024-0504.  

The upshot of EPA’s draft risk assessment states the following: 

The draft risk assessment indicates that there are potential risks to human health to those living on or near impacted properties or primarily relying on their products from land application. . .  

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After the public comment period has closed, the EPA will. . . prepare a final risk assessment. . . If the final risk assessment indicates that there are risks above acceptable thresholds when using or disposing of sewage sludge, the EPA expects to propose a regulation under CWA section 405 to manage PFOA and/or PFOS in sewage sludge to protect public health and the environment. 

Last year, on June 6, 2024, a federal lawsuit was commenced seeking to compel EPA to establish regulatory standards for PFAS in land-applied biosolids. Farmer, et al. v. EPA, No. 24-cv-1654.  The plaintiffs in that case allege the EPA’s inaction has allowed PFAS-laden biosolids to contaminate millions of acres, harming farmers and the public.  This lawsuit is currently moving slowly with preliminary matters and no resolution is expected for at least another year.

One thing is certain in the coming months and years.  Those farmers and agricultural stakeholders across the country involved in the common practice of land-applying biosolids will see significant change mandated in their practices and operations by the emergence of PFAS regulation in biosolids. 

Duer, Brook, and Paul Goeringer. “Why aren’t PFAS compounds in land applied biosolids prohibited by EPA?” Southern Ag Today 5(26.5). June 27, 2025. Permalink

While the current outbreak of highly pathogenic avian influenza (HPAI) began in 2022 primarily infecting wild birds and domestic poultry, 2024 produced evidence of a mutated virus infecting dairy cattle in large numbers, as well as evidence of human infections thankfully limited in both case numbers and virulence.   

In human and animal health circles, the concepts underlying the terminology “One Health” (i.e. an integrated, collaborative approach by the medical and veterinary professions to the control of zoonotic disease) have been discussed for years.  However, during this past year, the reality of the general public itself following a multi-disciplinary and multi-state epidemiological investigation of the HPAI strain in dairy cattle has thus far produced a complex set of still-evolving answers. 

To some, in particular those who feel they are now armed with relevant recent knowledge gained from the COVID-19 pandemic, USDA and CDC disease control efforts have been perceived as not aggressive nor collaborative enough. In the end, perhaps only the history books will be able to render a judgment on that score.

But in the meantime, one fairly recent development in an unrelated legal dispute may address questions at the core of any One Health effort to control this zoonotic disease.  What are the statutory limits of the federal government’s attempts to control a potential animal disease?  

The federal government’s legal authority in this regard arises from a law known as the Animal Health Protection Act. This law vests broad and sweeping powers in USDA’s Animal and Plant Health Inspection Service (USDA APHIS) over the import, export and interstate movement of livestock and “articles or means of conveyance,” by regulations and orders “necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock.”  7 U.S.C. § 8305(1). The primary statutory tools have and likely will continue to be orders designed to control interstate movement of dairy cattle, as well as other means of disease conveyance—including milk itself. 

By fortunate historical circumstances and decades of regulatory precedent, mandatory pasteurization of milk in interstate commerce fits the bill as the most effective and efficient control measure for this zoonotic disease.  

Nevertheless, re-examination and a fundamental questioning of the Animal Health Protection Act’s parameters of authority has been raised by the October 30, 2024, commencement by beef cattle producers of a lawsuit seeking to invalidate USDA’s final rule on electronic identification eartag (“EID”) requirements for certain cattle and bison. The final rule was promulgated, effective November 5, 2024, pursuant to Animal Health Protection Act authority, specifically animal disease traceability as a subset of the broad authority over any and all means of disease conveyance. 

In Ranchers-Cattlemen Action Legal Fund United Stockgrowers of America v. United States Department of Agriculture, No. 5:24-cv-05085, multiple beef cattle producers (hereinafter collectively referred to simply as “R-CALF USA”) commenced a lawsuit by complaint in the U.S. District Court for the District of South Dakota seeking to invalidate the USDA APHIS final rule titled “Use of Electronic Identification Eartags as Official Identification in Cattle and Bison” (89 FR 39540). For the purposes of this article, the portion of the final rule at issue is the new text at 9 CFR §86.4(a)(1)(i) stating that all official eartags sold for and applied to cattle and bison that are required to be officially identified for interstate movement must be readable both visually and electronically. 

The producers allege, among multiple claims, that the final rule exceeds the authority granted by the Animal Health Protection Act to take actions “necessary to prevent the introduction or dissemination” of a pest or disease of livestock because “participants within the production chain [of affected animals] may continue to use EID eartags in the exact same way that they use visual-only eartags,” and as such, the rule is not necessary because it “does not actually fix the problems it is supposedly addressing.”  In other words, the determination of “necessity” is lacking for the new requirement of electronic readability. 

By way of further explanation, according to the complaint, “USDA has previously ‘stated that a participation rate of 70 percent of the nation’s cattle herd would be necessary for a [animal disease traceability, or “ADT”] program to be effective’ . . . but the Rule only applies to 11 percent of the nation’s cattle herd.”  R-CALF USA goes on to state: “APHIS provides only a conclusory statement that the ADT program helps prevent the dissemination of disease by helping minimize the effect of outbreaks through restrictions, such as the EID eartag requirement, that the agency has determined are necessary for efficient livestock tracing. . . But this bold statement does not reasonably explain how the EID Final Rule achieves any efficiency gains or why hypothetical efficiency gains are significant enough to be deemed ‘necessary’ under the Animal Health Protection Act.”

This litigation’s outcome could have broad and negative implications for all USDA APHIS actions taken pursuant to Animal Health Protection Act authority. The case essentially argues that every aspect of each regulatory requirement justified as serving animal disease control objectives must be subjected to the type of rigorous and individualized proof of “necessity” suggested by the R-CALF USA plaintiffs, taken out of the context of its role and place in the cumulative impact of the regulatory scheme on disease control and regulation. If this position is a correct interpretation of the law, the toolbox of measures available to USDA APHIS may shrink to only a handful of measures—perhaps only those which are proven to have a direct and independent causal relationship to ending the disease’s biological functioning. 

While such a restrictive view of executive branch regulatory authority under the Animal Health Protection Act may not be inconsistent with some recent U.S. Supreme Court decisions reigning in administrative rulemaking, it would be a sea change in zoonotic disease control.

Duer, Brook, and Paul Goeringer. “2024 Brings Unprecedented Zoonotic Disease Control Challenge As Well As Far-Reaching Questions of Legal Authority.” Southern Ag Today 5(2.5). January 10, 2025. Permalink

Postscript:  After this article was completed and while waiting to be published, the Ninth Circuit Court of Appeals rendered a decision on October 2, 2024, upholding the EPA’s decision to deny the plaintiff environmental groups’ petition to compel revised CAFO regulations. A request for the granting of an appeal to the U.S. Supreme Court must be filed within 90 days of October 2, 2024.

Note: This article is a continuation of a topic first discussed in an article published on March 15, 2024, titled, “EPA Made Commitment to CAFO Permitting Reform But No Action Evident to Date.” 

There have been significant developments in the last six months since Southern Ag Today first published an article outlining: 

1. the United States Environmental Protection Agency’s (“EPA”) announcement of an internal “comprehensive evaluation” of its Clean Water Act (“CWA”) NPDES permit regulations for confined animal feeding operations (“CAFO”) for potential agency initiation of reforms; and 
2. a lawsuit captioned, Food & Water Watch, et al. v. EPA, No. 23-2146, pending in the U.S. Court of Appeals for the Ninth Circuit, seeking NPDES CAFO permit reform through court intervention and order. 

At issue is EPA’s continued use and implementation of a regulatory scheme defining NPDES permit obligations by reference to species-specific animal equivalency units (“AEU”) housed on site—resulting in the now familiar CAFO classifications as Large, Medium and Small, each carrying varying obligations, or none at all. Notably, the CWA contains no definition of a CAFO, which statutorily must be regulated as a point source discharge under the NPDES permit system. EPA uses those classifications to implement and enforce the law in substitution for measurement or monitoring of discharges. EPA’s regulatory scheme is based entirely upon an agency interpretation, not one found in the law. 

1. EPA internal CAFO Permitting Reform Process

EPA has begun its internal assessment of NPDES CAFO permitting reform in earnest with:

• April 30, 2024: EPA appointments to the advisory Animal Agriculture and Water Quality Subcommittee “(AAWQ”), charged with making reform recommendations to EPA; 
• May 30-31, 2024: First AAWQ meeting (Washington, D.C.) 
• August 8-9, 2024: Second AAWQ meeting (Lancaster, PA)

It has been slightly more than one year since EPA announced its internal CAFO Reform effort, and its parameters. EPA included its plan within two August 15, 2023, agency adjudications denying administrative petitions filed by Food & Water Watch and others challenging the continued legal efficacy of the current NPDES CAFO permit regulations. Despite fifteen years of use (last revised in 2008) the petitioners argue that the regulations fail to conform to CWA statutory authority and purposes. It is a relatively safe assumption that this process will likely continue at a slow pace. 

1. Litigation on its way to the U.S. Supreme Court?  

Meanwhile, Food & Water Watch, and the other petitioners, appealed the August 15, 2023, denial of those two petitions to the Ninth Circuit Court of Appeals in Food & Water Watch, et al. v. EPA, No. 23-2146.  That case has now completed:

• All Briefs have been filed by the parties. 
• September 12, 2024: Oral argument conducted (view recording). 

Oral argument is a difficult predictor of an outcome, but questioning during oral argument by the Ninth Circuit panel of 3 judges appeared to be more sympathetic to EPA’s arguments. That is not surprising based upon the heretofore poor track record of success of administrative petitions seeking to force regulation changes.  

Nevertheless, the most important thing about the pending appeal is that the U.S. Supreme Court is the next available appeal. Whichever party receives an adverse ruling, in whole or in part, the outcome at the Ninth Circuit will almost certainly result in a request to the U.S. Supreme Court to grant an appeal and review the legal issue of whether current EPA NPDES CAFO permit regulations should stand as-is, be declared invalid and remanded to EPA for further action, or some permutation of those outcomes as applied to individual provisions.  

The current U.S. Supreme Court has illustrated its interest in becoming involved in cases where it perceives an administrative agency has overstepped its statutory bounds in promulgating regulations and/or has made interpretations not directly supported by the statute on how to fulfill its statutory duties to implement and enforce a statute.

That willingness has been illustrated in full flower in the well-known recent decisions in both Sackett et ux. v. EPA et al., No. 21-454 (reversing EPA’s regulatory scheme for interpreting the statutory term “waters of the United States” (“WOTUS”) under the Clean Water Act) and Loper Bright, et al., v. Raimondo, et.al, No. 22-451 (no longer granting any deference to administrative agency interpretation of how to implement and enforce a regulation when faced with a statute containing an ambiguity).    

Before the U.S. Supreme Court granted an appeal of the Circuit Court of Appeals outcome in the Sackett case in 2022, few, if any, legal observers would have pegged that relatively obscure litigation as the future vehicle for a monumental overhaul of the WOTUS definition in federal law. 

Will this case be the next unlikely vehicle for groundbreaking U.S. Supreme Court intervention in administrative agency regulatory practice?  

Duer, Brook, and Paul Goeringer. “Will the U.S. Supreme Court Be Asked to Send EPA Back to the Drawing Board on CAFO Permits?” Southern Ag Today 4(41.5). October 11, 2024. Permalink

In August 2023, the United States Environmental Protection Agency (EPA) publicly disclosed an ambitious and extensive internal plan to conduct a potentially transformative reform process of NPDES permitting confined animal feeding operations (“CAFO”) under the Clean Water Act. The commencement of this process can best be described as a “soft launch” in that it was first revealed in a relatively obscure agency decision denying an administrative petition pending since 2017.  National attention to this undertaking will certainly grow as it progresses due to its potential, at least on paper, to be the seeds of significant changes to the CAFO permitting and regulatory scheme which has become an integral part of the national agricultural lexicon. 

On March 8, 2017, a group of environmental groups led by Food & Water Watch filed a petition with EPA seeking a complete re-write of the Clean Water Act CAFO permitting system embodied in federal regulations. Petitions seeking changes to federal executive agency regulations are quite common. While very rarely producing the requested relief, they create an agency decision-making process the results of which can be appealed to federal court. This serves to place a particular objective of the petitioners in play with an agency and, most importantly, provides a chance to appeal the results to a federal court which may be more sympathetic than the agency to some portion of the petitioners’ arguments. Generally, those arguments are that a regulation, on its face or as applied, fails to comply with the authorizing legislation’s text. Such was the case in this instance. 

The 2017 Food and Water Watch petition’s first paragraph summarized its contents as follows: “[T]he agricultural sector, including CAFOs, remains largely unregulated and is now the nation’s leading source of water quality impairments. The Agency’s current CAFO regulations are plainly not up to the task of protecting our waterways from industrial livestock operations.” On August 15, 2023, after six years pending and a subsequent October 2022 petition seeking similar relief, the EPA denied both the 2017 and 2022 petitions.   

Within the agency denials, the EPA announced it reform undertaking, which its website currently describes as “a comprehensive evaluation of the CAFO program” which will include “a detailed study of the CAFO effluent limitations guidelines [ELGs] as well as establishing a Federal Advisory Committee, the [Animal Agriculture and Water Quality Subcommittee (AAWQ)], . . . through which a diverse array of stakeholders will help inform EPA’s efforts to improve its CAFO program.” 

Noteworthy text within the EPA decisions included the following:

• “EPA also shares your concern that CAFOs can be a significant source of pollutants into waters of the United States. The Agency recognizes that there may be opportunities to do more to address these pollutants.”

• “Federal and state agency staff, have experienced challenges effectively implementing and assuring compliance with the current CWA CAFO regulatory requirements.”

The EPA’s statements do not read like an agency entirely confident that all is well with the status quo of its enforcement efforts of the Clean Water Act concerning CAFOs. 

Following the August 2023 decisions, the EPA published a Federal Register Notice on November 16, 2023, soliciting nominations to the AAWQ subcommittee by a deadline of January 24, 2024.  Thus far, there has been no further word on appointments.  EPA’s “detailed study” of the CAFO ELGs was in fact previously announced in January 2023.  However, there has been no public evidence of that undertaking being conducted over one year later.   

Meanwhile, the federal courts are now also involved. On September 8, 2023, the EPA’s denials were appealed through the filing of a petition for review with the U.S. Court of Appeals for the Ninth Circuit, docketed at Food & Water Watch, et al. v. EPA, No. 23-2146. American Farm Bureau Federation, National Pork Producers’ Council, U.S. Poultry & Egg Association and United Egg Producers have become intervening parties to that case. Presently, briefing by the parties is slated to conclude by June 1, 2024. A decision could take anywhere from a few months to a few years, and the outcome at the Ninth Circuit (perceived as potentially more sympathetic to the petitioners than the other eleven Circuit Courts of Appeals) remains uncertain. The same could be said about the prospects of any attempt by a dissatisfied party to appeal an adverse outcome to the U.S. Supreme Court (perceived as not sympathetic to the petitioners).  

The coming months or years will tell us how diligently EPA pursues unilateral changes of its own accord in its Clean Water Act enforcement regarding CAFOs, either as presently defined or under a new regulatory design. Over that time, we will also learn whether decisions about the future of EPA’s CAFO regulatory and permitting scheme will be dictated by the federal courts. This effort could alter not only the federal definition of a CAFO itself and how potential surface water discharges of animal production operations are regulated and permitted, but also may include new tools like monitoring or drastically overhauled effluent standards. Any changes at the federal level will assuredly impact each states’ undertakings, where applicable, of NPDES and non-NDPES water quality programs and, most importantly, state budgeting for the same.  

Duer, Brook, and Paul Goeringer. “EPA Made 2023 Commitment To CAFO Permitting Reform But No Action Evident to Date.” Southern Ag Today 4(10.5). March 8, 2024. Permalink