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Spotlight On: Regulatory Development Support

Regulatory Development Support

Developing effective regulations requires exacting data, insightful analysis, a transparent process, stakeholder engagement, and the tools and know-how to provide all of the above. For more than 35 years, Abt has delivered extensive regulatory support services to state and federal clients, including the Environmental Protection Agency, Department of Transportation, Department of Health and Human Services, Department of the Interior, Coast Guard, and Occupational Safety and Health Administration. Our experts work collaboratively with clients to make informed decisions and design and implement effective regulatory frameworks that address challenges in public health and safety, natural resource management, and environmental quality.

Want to know more about regulatory development? Here are some questions we often receive from clients and partners.

What is regulatory development?

Regulatory development refers to the process for developing and implementing regulatory actions (also referred to as “rules”). This may include publishing a new rule, amending an existing rule, or repealing existing rule.

The Administrative Procedure Act (APA) sets forth the overall process by which federal agencies develop and issue regulations. It includes requirements for publishing notices of proposed and final rulemaking in the Federal Register, and for providing opportunities for the public to comment to ensure a transparent process. In addition, there are numerous other statutes, executive orders, or agency policies that may require special analyses under particular circumstances.

What types of analyses support regulatory development?

Preparing a Regulatory Impact Analysis (RIA) is a core requirement of the regulatory development process. An RIA integrates various regulatory analysis components to enable agencies to understand regulatory options and make the best decision. The RIA typically includes a benefit-cost analysis quantifying the tradeoffs between the achievement of a regulatory objective and the costs of compliance. Analyses also consider factors such as whether benefits and costs can be monetized fully, whether there are unique or cultural values at stake, the distribution of impacts across society, and the uncertainties associated with benefit-cost calculations.

In addition, agencies may need to undertake analyses to meet the requirements of applicable statutes and Executive Orders. These analyses include, but are not limited to, analysis of impacts on small businesses, environmental justice in minority and low-income populations, children’s health, energy supply and use, and employment.

How can Abt help?

Good public policy requires thoughtful analysis, which is why our clients and stakeholders rely on Abt’s rigorous regulatory support. We’re a recognized powerhouse in regulatory, economic, health, and environmental analyses, building on decades of institutional experience and the individual expertise of our personnel.

We’re known for our ability to develop analytical methods that withstand scientific and public scrutiny, and provide complete rulemaking support within tight timelines. Our deep understanding of the issues, combined with our technical expertise, enables us to provide our clients with proven solutions throughout the full regulatory development process.

Abt’s commitment to maximizing project efficiency and engagement often includes bringing expertise from one project to another. For example, Abt supported EPA’s Office of Emergency Management (OEM) in finalizing requirements to amend the National Contingency Plan regulations that apply to the use of any chemical or biological agents that may be used in response to an oil discharge. To support EPA in preparing more accurate analyses, Abt estimated testing unit costs by leveraging its experience working with commercial laboratories to obtain cost information. 

abt services

We work at all stages of the rulemaking process—from initiation to implementation—to help clients achieve their desired outcomes.

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Abt’s Expertise

Abt has built a strong reputation with our federal government clients as a leader in applying science and economics to support sound public policy decisions. In the past five years alone, we have provided regulatory support for more than 50 major regulatory and deregulatory actions.

Abt  is regularly ranked as one of the top 20 global research firms and one of the top 40 international development innovators, with multiple offices in the U.S. and program offices in nearly 40 countries. 

Services Offered
We provide proven and cost-effective support services across all phases of the regulatory development process.

Strategy and Planning

From the start of the process, we work with clients to identify and better understand issues/priorities that may be best addressed through regulation rather than a non-regulatory program. This includes developing industry profiles; analyzing statutory requirements, existing regulations, agency policies, and industry standards that may be relevant; drafting white papers and issue papers on baseline and policy options; and identifying key stakeholders. This early work helps clients better understand potential options and challenges as a regulation is initiated.

The breadth of our expertise allows us to be at the forefront of understanding key policy issues and pivot in response to changing priorities, while also ensuring that day-to-day program work is unimpeded. For example, we bring expertise and novel approaches in areas such as climate, environmental justice, PFAS, and marine litter to address current challenges, such as Justice40. Working strategically with our clients, we also identify whether and how to bring other regional, state, tribal, and international perspectives to regulatory challenges, to help bridge understanding between multiple vested stakeholders.

Regulatory Process Management

Regulatory development requires adherence to established processes, providing appropriate documentation, and providing transparent analyses. We work hand-in-hand with our clients to support the regulatory development process, including participating in workgroups, engaging stakeholders, developing technical background documents, and maintaining the administrative record. We also develop regulatory tracking systems, document templates, and other tools to help agencies track workflow, develop consistent documentation, and report to management and the public.

Economic and Regulatory Analysis

Abt is a leading provider of economic and regulatory analysis support, including:

  • Background study development to support the development of a regulation, including data collection and analyses for robust market profiles of regulated entities.
  • Baseline and post-regulation policy analysis, considering effects on key policy objectives, such as human health or environmental quality endpoints.
  • Costs and economic impact analysis, including compliance costs, indirect and opportunity costs, and employment and household income effects.
  • Cost effectiveness analysis for regulatory options with timely support in defining and analyzing alternative options during the options review and selection process.
  • Benefits analysis, including quantifying and monetizing human health, environmental, and economic benefits using leading market and nonmarket methods.
  • Methodology and model development, with particular expertise in designing spatial social-environmental-economic modeling frameworks to support integrated benefit-cost analysis.
  • Uncertainty analysis to better state the range of potential impacts for decisionmakers’ evaluation of alternative regulatory options.
  • Environmental justice, small business, and other distributional analyses, examining the impacts on specific subpopulations.
Information Collection
  • Survey design and implementation. Abt’s survey department conducts approximately 500 survey projects each year for government agencies and other clients, and is a leading provider of state-of-the-art surveys and focus group services. We provide survey instrument design, instrument testing, sample design, and survey administration for web, mail, telephone, and in-person interview surveys.
  • Information Collection Requests (ICR). Our support for ICRs includes estimating changes in the respondent burden associated with changes in regulatory requirements, preparing the ICR supporting statements for one-time or recurring programmatic data collection, updating renewal ICRs, and developing and conducting one-time industry surveys. Our agile approach is based on our experience preparing many ICRs every year.
Public Comment Management

Timely and efficient management of public comments and agency responses is critical to demonstrating that all public comments are reviewed and considered in the final rule. With CommentCounts™,  Abt provides our clients with an intuitive, web-based tool for efficiently organizing, summarizing, and responding to public comments. Abt also supplements our conventional comment management work using Natural Language Processing. Learn more about CommentCounts™.

Public Hearings

Agencies rely on public hearings to facilitate the effective exchange of information, input, and feedback on potential regulations. Abt provides comprehensive logistical support for public hearings, including identifying and contracting for meeting space, court reporters/transcripts, language translators, teleconference lines, audiovisual equipment, and technicians. We provide onsite (or virtual) support for public hearings attended by thousands of industry and environmental representatives, concerned citizens, and the media. We also coordinate technical site visits for our clients. For example, we arranged site visits to industrial waste facilities to observe best practices for methane emissions reductions or capture.

Regulatory Guidance and Manuals

Guidance documents help the regulated community and others involved in implementing a regulation to understand legal requirements. Abt helps develop technical guidance documents that describe applicability, explain examples, provide templates, and clarify instructions. For example, we developed and later updated more than 900 pages of technical guidance on the oil pollution prevention regulation that was downloaded more than 19,000 times the first month it was published. We also provide an annual update to reporting forms and instructions that are used by more than 20,000 reporters to the EPA Toxics Release Inventory (TRI) program. To help streamline access to guidance on TRI materials, we developed a user friendly GuideMe tool.

Outreach and Training

Effective communication, outreach, and training are critical steps to ensure the goals of a regulation are realized. We take a tailored approach to supporting outreach and training on regulations where we focus on the needs of the target audience. Often the stakeholder engagement during the regulatory process, particularly insights learned during public comment and hearings, inform our understanding of needs and tactics to consider in communication planning. For example, for the Lead Renovation, Repair and Painting Rule, in one year we attended more than 20 technical conferences to educate thousands of attendees about the rule’s requirements. We maintained a database with more than 27,000 industry contacts that we used to send 76,644 emails to targeted subgroups. We have also developed training for the regulated community – including facilities that report to TRI – as well as EPA inspectors and regional staff on a number of regulatory programs.

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Relevant Expertise 

National Contingency Plan Regulations for Oil Spill Response 
Client: U.S. Environmental Protection Agency (EPA), Office of Emergency Management (OEM) 

Abt provided OEM with technical, analytical, and regulatory development support for OEM’s mission of preventing, preparing for, and responding to health and environmental emergencies. This effort included support for a final regulation implementing a new dispersant monitoring requirement. Abt developed cost-benefit analysis of the final regulation, which was approved by the Office of Management and Budget (OMB). This included modeling a range of potential future oil spill incidents, with different sizes and other characteristics, to estimate the potential costs of compliance with the final rule. Abt also provided public comment summary and response-to-comment support, drafted preamble sections, drafted working-group papers, and related assessments. These new monitoring requirements are anticipated to better target dispersant use, thus reducing the risks to the environment.

Clean Water Act Hazardous Substance Worst Case Discharge Planning Regulation 
Client: U.S. Environmental Protection Agency (EPA), Office of Emergency Management (OEM) 

Abt provided OEM with comprehensive regulatory development support across the full regulatory life cycle for a regulation that establishes a program for worst-case discharge planning for facilities storing CWA hazardous substances that cause substantial harm or significant and substantial harm to the environment. This support included developing the proposed rule technical supporting materials, managing the public comment process, developing the final rule technical support materials, and creating the federal docket, or record, for the regulation.

Lead and Copper Rulemaking Support 
Client: U.S. Environmental Protection Agency (EPA), Office of Groundwater and Drinking Water (OGWDW) 

Abt has been assisting with the Lead and Copper Rule Revisions (LCRR) since 2015. Our support has included modeling exposure to lead from drinking water to estimate the risk to human health, and developing a digital tool to estimate the benefits and costs of the LCRR under different options. We developed and implemented several approaches to evaluate how blood lead levels change with increasing exposures to lead in drinking water, while also considering non-drinking water sources of lead exposure.

Formaldehyde Emissions for Wood Products Rulemaking Support 
Client: EPA, Office of Pollution Prevention and Toxics (OPPT) 

Abt helped EPA’s Office of Pollution Prevention and Toxics promulgate a regulation managing formaldehyde emissions for wood products under the Toxic Substances Control Act (TSCA). We developed and pre-tested a survey instrument and an Information Collection Request (ICR) package for wood product manufacturers. Our successful collaboration with independent industry experts ensured that our survey instrument accurately assessed the industry’s potential challenges. When the Office of Management and Budget (OMB)-approved survey was implemented, we achieved 100 percent response rates from medium-density fiberboard, and particleboard manufacturers, and an 82 percent response from plywood manufacturers.

Safety of Natural Gas Transmission Pipelines Rulemaking Support 
Client: U.S. Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration, Office of Pipeline Safety (OPS) 

We provided comprehensive rulemaking support for OPS’s promulgation of the 2019 Safety of Natural Gas Transmission final rule. This work included summarizing and responding to public comments using Abt’s CommentCounts™ tool, and developing the economic analysis and technical support documents. We also engaged subject matter experts to collect engineering unit cost data for pipeline safety compliance measures, and conducted a detailed empirical analysis of historical incident data to establish baseline risk. To overcome limitations in the data available, we developed an innovative spatial analysis that integrated pipeline system, transportation system, housing density, land-use, and other data. This improvement in the regulatory analysis, along with Abt’s expert support during intra- and inter-agency review of the final regulation, helped OPS successfully meet its aggressive regulatory schedule.

Contact Us

Frank Divita

Frank Divita, Ph.D.

Principal Associate, Health & Environment

Health & Environment
Rockville, MD

Debra Fleischer

Debra Fleischer

Senior Associate, Environment & Health

Health & Environment
Rockville, MD

Jon Hecht, Ph.D.

Jon Hecht, Ph.D.

Principal Associate, Environmental Economics

Health & Environment
Cambridge, MA

meghan lynch

Meghan Lynch

Principal Associate

Health & Environment
Cambridge, MA

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