Susan Goldhaber, MPH, of the American Council on Science and Health does an excellent job in her column describing the Administrative Procedures Act, the law that requires federal agencies to consider public comments on proposed new rules. 

She also explains why it is so important to make significant comments that warrant a response from the agency. 

In May, the Center submitted public comments to the Environmental Protection Agency (EPA) on two issues important to our mission, giving us the opportunity to let the EPA know directly how some of the independent scientific work we have funded can help inform its decisions: 

  1. Our public comment on levels of PFAS in drinking water
  2. Our public comment on ethylene oxide emissions standards for sterilization facilities

We hope EPA will take our comments under consideration before finalizing the rule, and consult the rigorous reviews performed by these talented independent researchers, which assess the quality of studies most often cited in rulemaking on PFAS and ethylene oxide

Agency rules should always be made using the strongest available science. When they aren’t, the public comment process is an important window of opportunity for members of the scientific community to speak up about it. 

Below, reprinted with permission, is Ms. Goldhaber’s recent piece:

The Power Of Public Comments

By Susan Goldhaber MPH — Originally published on June 27, 2023, on the ACSH blog

In March 2023, the EPA proposed controversial drinking water regulations for two “forever chemicals,” PFOA and PFOS – setting extremely low allowable levels for both. On May 30, the public comment period ended. How EPA responds to public comments could significantly shape the final rule. This article examines the Administrative Procedures Act (APA) requiring agencies to consider public comment and a few of the significant comments received on the proposed rule.

The APA, enacted in 1946, governs how federal agencies issue regulations. It requires agencies to issue rulemaking notices in the Federal Register and provide a public review period to submit comments on proposed rules.

Kenneth Culp, an administrative law scholar, has described the “notice and comment” rulemaking process as “one of the greatest inventions of modern government.”

This is because not only is the agency required to review and consider the submitted comments, regardless of who they are from and the form in which they are submitted, they must respond to significant comments submitted during the review period before the rule can be finalized and become effective. 

This provides a significant check on agency power, forcing agencies to think through their proposed actions, serving as a form of “quality control” mechanism. It also forces agencies to take comments seriously because if they do not, the Court can invalidate the rule, finding that the agency acted in an “arbitrary and capricious manner” and the rule it produced did not reflect reasoned deliberation. 

The Controversial Rule

PFOA and PFOS are part of a large group of chemicals containing linked carbon and fluorine chains. They were used in many consumer products, including furniture, carpets, fabrics, and fire-fighting foams. They are no longer manufactured in the U.S., and agreements between the government and corporations in the early 2000s have greatly reduced exposure to PFOA/PFOS. However, they are still detected at very low levels in drinking water.

The EPA’s newly proposed drinking water regulations use problematic science to justify the proposed rule, including the very limited data that was the basis for declaring PFOA/PFOS carcinogens. I participated in the public comment process by filing my statement outlining these issues.

Public Comments

121,991 comments were received, with 1,522 comments posted and available for viewing. Before the number of comments blows your mind, it is essential to understand that this does not mean that 121,991 individuals or organizations submitted comments on the rule. It is based on the number of individual documents submitted, which includes attachments, supplementary material, mass-mailing campaigns, and individual submissions. Regardless, this is a tremendous response. 

EPA is required to respond to all significant comments and typically prepares a “comment-response” document summarizing the comments submitted, along with the EPA responses. If EPA disagrees with the commenter, they must explain their reasoning and show they have seriously considered the comment.

What is significant?

“In determining what points are significant, the “the arbitrary and capricious” standard of review must be kept in mind. Thus, only comments which, if true, raise points relevant to the agency’s decision and which, if adopted, would require a change in an agency’s proposed rule cast doubt on the reasonableness of a position taken by the agency. Moreover, comments which themselves are purely speculative and do not disclose the factual or policy basis on which they rest require no response. There must be some basis for thinking a position taken in opposition to the agency is true.” 

Parker S. Kennedy Professor in Law, Chapman University School of Law.

The public commenters represent a wide range of organizations and individuals, representing water utilities, individual water districts or water suppliers, trade associations, public interest groups, corporations, and private citizens. 

Consider these significant comments:

The American Water Works Association (AWWA): The largest organization of water supply professionals in the world, representing more than 4,500 water utilities, will bear the brunt of the regulation’s economic impact. In a detailed toxicological assessment and cost analysis, they recommended that the EPA consider rewriting the drinking water standards for PFOA and PFOS, given that the underlying analyses lack transparency, are inconsistent with the best available science, and are unclear.

The Natural Resources Defense Council (NRDC), A large environmental advocacy organization that focuses on legal action, filed jointly with 38 other public interest groups. They were very satisfied with the proposed rule and urged the EPA to resist calls to weaken or withdraw the proposed standards based on concerns about water affordability. They focused on strategies to reduce regulation costs, including maximizing federal funds’ use, especially for disadvantaged communities, holding PFAS manufacturers accountable for treatment costs, and adapting rate structures and other programs to increase utility revenue without burdening low-income customers.

US Poultry and Egg Industry: The world’s largest poultry organization representing poultry farmers and growers whose members primarily live and operate in small rural communities. They felt the proposed rule is flawed because it does not consider the technical expertise and costs associated with collecting and interpreting the laboratory results for PFOA/PFOS, resulting in a lack of accredited commercial laboratories capable of these tests (only seven certified laboratories in the southern US). They also noted the unintended consequences of very different messaging on the hazards of PFOA/PFOS within EPA offices, the EPA and other agencies, such as the FDA, and different countries.

The core value of the public comment process is that it focuses the Agency’s attention on practical issues, as seen by critical stakeholders, such as the high cost and difficulties of implementation. It also works as a check against agency power, as it is often the basis for future litigation where a court has invalidated rules because an agency did not respond sufficiently to public comments. For example, in 2015, a court characterized the EPA response to the comments of the NRDC as “wan responses,” concluding that

“EPA cannot get away so easily from its obligations under the APA to respond to its relevant and significant comments.”

In the past, EPA often counted on the courts giving deference to the Agency’s positions when rules were litigated. However, several recent Supreme Court rulings have shown increasing skepticism by the Court of Agency interpretations of statutes.

It remains to be seen whether EPA will use the public comment process as intended in the PFOA/PFOS drinking water regulation, i.e., to seriously assess the issues raised by the commenters and make appropriate changes to the rule. The EPA would be wise to consider the public comments at this rule-making stage before the almost inevitable litigation.