Regulatory Writing That Protects You (And Proves It)

The Administrative Procedure Act (5 U.S.C. §§ 551–559) governs how federal agencies make rules and how those rules can be challenged. Its notice-and-comment rulemaking process — in which agencies publish proposed rules in the Federal Register, solicit public comments, and must respond to significant comments in the final rule — is designed to create a participatory record. The quality of that record, and the effectiveness of participation in it, depends almost entirely on the quality of the written comments submitted.

An agency that does not respond to a significant, well-supported comment in its final rule has created grounds for judicial review under the APA's arbitrary-and-capricious standard. But "significant" is determined by the content and clarity of the comment, not by the identity of the commenter. A well-structured, technically precise comment from a small company can create a stronger administrative record than a long, scattered comment from a large trade association. The comment that creates a record does so through the quality of its argumentation and the specificity of its evidence — not through the prestige of its author.

How Regulatory Staff Read Submissions

Federal agency staff who process regulatory comments — policy analysts, attorneys, subject matter experts — typically work through comment volumes in condensed timeframes during the post-comment review period. The Federal Register's guidance on comment submissions notes that agencies receive thousands of comments on significant rulemakings; for major rules, comment volumes routinely exceed 100,000.

The reading methodology that emerges from this volume constraint is predictable. Staff reviewers are typically categorizing comments by issue and by commenter type simultaneously. A comment that states its central argument in the first two paragraphs, provides specific regulatory or statutory references, and places technical detail in clearly labeled sections allows a reviewer to categorize it quickly and accurately. A comment that presents its argument in narrative form without clear structure requires the reviewer to read the full document to categorize it — which introduces the risk of miscategorization and reduces the probability that the specific technical arguments receive the focused attention they deserve.

The Office of the Federal Register's Document Drafting Handbook, which governs the format of federal regulatory documents, provides guidance on plain language requirements that apply to agency-authored documents. These same principles apply — as a matter of effective advocacy rather than regulatory requirement — to documents addressed to agencies. A comment written in the same plain language conventions that agencies use in their own documents is a comment that reads naturally to agency staff rather than requiring stylistic adjustment.

Writing Comments That Create a Record vs. Comments That Get Filed

In APA rulemaking, not all comments are created equal for purposes of administrative record review. Courts evaluating whether an agency's final rule was arbitrary and capricious examine the administrative record to determine whether the agency engaged with significant opposing views. A "significant" comment for this purpose is one that raises a specific, substantive argument that the agency must address to justify its final rule.

Comments that get filed — that are received, logged, summarized in aggregate, and addressed only in a general response — are comments that failed to create an individually significant record. This happens when a comment:

• States a general opposition to the rule without specific technical grounds
• Raises arguments already addressed in the preamble to the proposed rule without engaging with the agency's stated rationale
• Presents technical arguments without citing the relevant statutory or regulatory authority that requires the agency to consider them
• Requests relief that the agency lacks statutory authority to provide
• Combines unrelated issues in a single comment in a way that prevents focused response to any of them

Comments that create a record share different characteristics. They engage with the specific regulatory text being proposed, citing specific sections and subsections. They raise technical arguments that are outside the expertise of agency staff who wrote the rule and that require agency response. They cite specific data, studies, or industry experience that the agency's rulemaking record does not address. And they request specific modifications to the regulatory text — not just general reconsideration — in language the agency could plausibly adopt.

Agency-Specific Submission Standards

Major regulatory agencies have developed submission standards and guidance documents that reflect decades of experience with the types of documentation that support regulatory decisions. Understanding these standards — which differ meaningfully across agencies — is essential for effective regulatory communication.

FDA regulatory submissions — including Investigational New Drug applications, New Drug Applications, 510(k) premarket notifications, and de novo requests — are governed by the FDA's Common Technical Document (CTD) format and specific guidance documents for each submission type. The FDA's Center for Drug Evaluation and Research (CDER) has published guidance on the content and format of INDs, NDAs, and supplemental applications that specifies what information each section must contain, in what format, and with what level of technical detail. Submissions that do not follow this format receive Refuse to File letters before any substantive review occurs.

SEC disclosure submissions — including registration statements, annual reports, and proxy materials — must comply with the specific line-item requirements of the applicable form. The SEC's plain language guidance for prospectuses, adopted in 1998 and updated since, requires that disclosure documents be written in plain English: short sentences, everyday language, active voice, tables and lists for complex information, and no legal or business jargon that is not explained. SEC staff comment letters — which request clarification or additional disclosure — often cite specific plain language failures in proposed submissions.

EPA permit applications and environmental impact statements require documentation of environmental impacts in sufficient detail to support agency decision-making under the National Environmental Policy Act. The Council on Environmental Quality's NEPA implementing regulations at 40 CFR Part 1502 specify that environmental impact statements "shall be written in plain language and may use appropriate graphics so that decision-makers and the public can readily understand them."

Plain Language in Regulatory Context: What It Actually Requires

The Plain Writing Act of 2010 (5 U.S.C. § 301) requires federal agencies to use plain writing in covered documents. OMB's plain language guidance, and the Federal Plain Language Guidelines published by the Plain Language Action and Information Network (PLAIN), define plain writing as language "that the intended audience can read, understand, and use."

For regulatory communications, plain language does not mean simple language — it means language matched to the reading level and expertise of the intended audience. A technical comment to the FDA on pharmacokinetic data should use pharmacokinetic terminology, because that is the vocabulary appropriate to the audience. But it should state its argument directly, use active voice, organize information for the reviewer's workflow, and not bury its key technical points in paragraphs of background.

The specific plain language requirements that apply most directly to regulatory filings:

• Active voice — "We request that the agency modify Section 3(a) to read..." rather than "It is requested that Section 3(a) be modified..."
• Short sentences — the recommended maximum is 20 words for regulatory documents, compared to the 35-plus word sentences common in legal writing
• Defined terms used consistently — technical terms defined on first use and used consistently throughout, without variation
• Parallel structure in lists — items in a list that begin with the same grammatical form and maintain it throughout
• Tables for complex information — comparison data, multiple-variable data, and alternative scenarios presented in tables rather than in prose

Technical Precision vs. Accessibility in Multi-Audience Filings

Regulatory filings are frequently reviewed by multiple audiences with different levels of technical expertise: the subject matter expert who evaluates the technical claims, the policy analyst who evaluates the regulatory implications, the attorney who evaluates the legal arguments, and the senior official who makes the final decision. A filing that satisfies the technical reviewer while failing the policy analyst — or vice versa — has reached only part of its audience.

The document structure that serves multiple audiences simultaneously is consistent across effective regulatory communications: the executive summary (one to two pages) states the commenter's position, requested action, and primary grounds in plain language accessible to a non-specialist; the body addresses each regulatory issue in technical depth appropriate to the subject matter expert; the legal argument sections address statutory authority and procedural requirements in the language appropriate to attorneys; and appendices provide the underlying data, studies, and technical documentation that support the body's claims.

This structure allows each reader to focus on the sections relevant to their role without reading the full document. It ensures that the decision-maker who reads only the executive summary has an accurate, complete picture of the filing's core argument. And it provides the agency with the structured, issue-keyed documentation needed to respond to each argument specifically in the final rule — which is the purpose of the regulatory comment.