Jay Mitchell, USDA APHIS Bogotá, Colombia April 12, 2018 Domestic Public Consultation and Notice and Comment Procedures for More Effective Technical Regulations The Administrative Procedures Act provides the overarching legal framework and requirements for rulemaking by US agencies. Each agency has its own statutory authority with respect to mandate, mission and objectives, so internal rulemaking practices across agencies can vary somewhat. This presentation is based on a sampling of agency practices. Contributors to this presentation Animal & Plant Health Inspection Service (USDA/APHIS) Bureau of Industry and Security (DOC/BIS) Environmental Protection Agency (EPA) Food and Drug Administration (HHS/FDA) Food Safety & Inspection Service (USDA/FSIS) National Highway Traffic Safety Administration (DOT/NHTSA) National Oceanic & Atmospheric Administration (DOC/NOAA) Jay Mitchell, USDA APHIS Bogotá, Colombia April 12, 2018

What is Rulemaking The process by which USDA APHIS and other US Government agencies promulgate new regulations. It is a thorough process that provides the public with a “meaningful opportunity to comment” on regulations before they are finalized. The process includes various steps to ensure that regulations are sound and consistent with applicable laws and policies. Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

APHIS Rulemaking Process Step 1: Publication of a Proposed Rule Step 2: The Comment Period 60 day comment period is typical; it is sometimes extended Step 3: Publication of a Final Rule Step 3: Entry into Effect of a Final Rule Usually 30 days after publication of Final Rule Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

“Meaningful opportunity to comment” – agency duties At time of proposed rule: disclose, in sufficient detail, the thinking underlying its proposal and supporting data enables public to criticize proposal, formulate alternatives At time of final rule: respond in a reasoned manner to “significant comments” explain how agency resolved those comments and show how this resolution led agency to final rule it issued Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

“Significant comments” Agencies not required to respond to every comment; only significant ones “Significant comments” are those which raise relevant points, and which, if adopted by the agency, would require a change in the agency’s proposed rule Examples of non-significant “Relevant” - a broad concept Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

Good Governance Role Requirement for agency to explain its decision to issue a final rule in light of comments: gives agency the opportunity to confront its planned actions in detail, including all steps in its reasoning process serves as an internal check on arbitrary agency action by ensuring that an agency can clearly articulate the reasons for its decision (before taking any final action) Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

Benefits of taking comments into account Supports accountability Sustains confidence in the legal environment Makes regulations more secure and accessible, and less influenced by special interests Thus, they are more open to competition, trade and investment Why take comments into account? Gain insights of outside experts and any market participants that would be required to comply with, or might otherwise be affected by, the proposal thereby improving both the effectiveness and the efficiency of the rule in meeting its objective.

Steps in processing of comments “Significant”? Categorizing, based on type of issue Grouping with similar comments Analyzing merits/evaluation Developing recommended responses to comments Including any needed changes to rule 6) Obtaining policy guidance on key responses 7) Drafting final rule 8) Reviewing draft final rule Ensuring that responses to comments and rationales for those responses are sound

Staff responsible for evaluating and responding to comments Team of agency program officials, economists, and lawyers Typically the same ones who were responsible for developing the proposal, and will be responsible for recommending acceptance or rejection of comments to management/changes to proposal Categorizing and grouping comments: use of contractor for complex rulemaking (some agencies)

Categorizing & Grouping Comments Determine whether any aspect of each comment is “significant” If so, categorize the comment E.g., feasibility, compliance period, costs, etc. Group that portion of the comment together with portions of other comments addressing that issue Use of spreadsheets (e.g., Excel) to aid work as a team

Evaluating & Analyzing Comments Merits/value of each significant comment Merit/value is measured by persuasiveness of supporting arguments and quality of supporting data, not the identity of the commenter Any changes requested by commenters in the rule, including whether suggested changes would be feasible, enforceable and acceptable in view of program goals and the law

Recommendations to management on responses to comments Staff then prepares recommendations regarding the disposition of each comment May include: an explanation of the reasons that a comment is inaccurate or mistaken, and so no change to the proposed rule is necessary an explanation of the reasons that the agency agrees with the comment, and a revision of the proposed rule as suggested an explanation agreeing with the comment, but addressing the concern in a fashion different from that suggested by the commenter  

Obtaining management guidance on responses to key comments Senior management provides guidance on analyses and recommendations regarding important comments Head of the agency may review proposed disposition of especially important comments  

Reviewing draft final rule, including comment responses Agency Review by senior agency officials for technical matters, economics and law, and by agency head Department (Ministry) For significant final rules to be issued by non-independent agencies, review by the Secretary OMB and interagency For all significant final rules, review by OMB

Final Rule: Response to Comments Contained in preamble or separate “response to comments” document Includes reasons for agreeing or disagreeing with comments and changes to address comments Similar comments are grouped and discussed together (to avoid needless repetition and ensure coherent, substance-based approach) Many agencies do not identify commenters Focus is on substance of comments

“and take the comments and the results of the discussions into account” Agencies provide, in sufficient detail, the underlying rationale and supporting data/analysis in the proposal Agencies consider comments through an organized, deliberative process and show how they responded to comments in the final rule Overarching legal frameworks governing agencies’ administrative procedures provide transparency, predictability and accountability US experience with these 12 words – these practices provide “quality assurance” in rulemaking, including with respect to “minimizing their negative effects on trade”

Benefits of Taking Comments Into Account Through Public Forum Country soliciting comments learns about potential downfalls (e.g., not consistent with WTO obligations, not workable in real life) and/or better alternatives that achieve the same goal Countries providing comments on the measure have input to development of regulations that could impact their trade ALL countries have equal access to the same information Transparency helps to even the playing field

Good Regulatory Practices (GRPs) Key Elements in the US System A regulatory agency in the United States not only must be transparent in how it seeks input (or comments) from the public on draft regulatory measures… …but it must also be accountable by demonstrating precisely how they took the input and public comments into account in finalizing that regulatory measure.

Good Regulatory Practices (GRPs) Key Elements in the US System Any tool for public consultation must have predictability to be effective, which means: The public must have sufficient knowledge about a draft measures and its goals when providing input The regulatory process must be sufficiently advanced to be able to provide adequate detail on a proposed measure The regulatory authority should be clear that it will only take input into account that is relevant to the draft measures and its intended result

Good Regulatory Practices (GRPs) Key Elements in the US System Effective rulemaking must be evidence-based: The scientific justification or evidence underlying the proposed measure needs to be made public to a sufficient extent for the public to take it into account when giving input This may mean the underlying risk analyses or other types of scientific justification may also need to be submitted for public comment in order to obtain the full range of comment needed from the public to move forward with finalizing a draft measure

OECD Document from 2012: RECOMMENDATION OF THE COUNCIL ON REGULATORY POLICY AND GOVERNANCE OECD recommends that Members: Adhere to principles of open government, including transparency and participation in the regulatory process to ensure that regulation serves the public interest and is informed by the legitimate needs of those interested in and affected by regulation. This includes providing meaningful opportunities (including online) for the public to contribute to the process of preparing draft regulatory proposals and to the quality of the supporting analysis. Governments should ensure that regulations are comprehensible and clear and that parties can easily understand their rights and obligations.

Thank you Any Questions?