Public Comments & Testimonies

Scholarly analysis of the potential effects of particular rulemakings from federal agencies, and advice to Congress on how to improve the rulemaking process by GW Regulatory Studies Center scholars.


Photo of Senators James Lankford and Kyrsten Sinema during a hearing.

Joint Statement

Senator Kyrsten Sinema (D-AZ)
Senator James Lankford (R-OK)

"Your input and expertise during the drafting of the Early Participation in Regulations Act of 2019 and SMART Act of 2019 was invaluable."



DEA's Mobile Narcotic Treatment Program

April 27, 2020

By: Laura Stanley
This public interest comment assesses the Drug Enforcement Administration's proposed rule and offers four sets of recommendations: a) DEA should immediately begin approving mobile components in response to the coronavirus crisis, while the agency works towards finalizing the proposed rule, b) DEA should revise or remove conditions in the proposed rule that do not decrease the risk of diversion but do increase the burden of expanding mobile components, c) DEA should issue an updated economic analysis, and d) DEA should commit to conducting an evaluation of the mobile NTP program.


DOT's Proposed Rule for Air Travel with Service Animals

April 7, 2020

By: John Bertino & Mark Febrizio
The Department of Transportation (DOT) is proposing amendments to its Air Carrier Access Act regulation on the transportation of service animals by air, which would change DOT’s definition of a service animal. This public interest comment summarizes the rulemaking, evaluates the proposal’s key provisions and analysis, and makes recommendations for improving DOT’s analysis of its proposed action. We specifically emphasize the need for DOT to explicitly evaluate alternatives to its preferred option and highlight the importance of distinguishing transfers from social welfare effects.


FDA & USDA Food Identity Standards

April 2, 2020

By: Laura Stanley
This public interest comment assesses the proposed rule in four main sections: a) FDA should include additional principles aimed at improving the efficacy of food identity standards, b) FDA should alter its proposed approach, which is not to review any existing standards, and instead devote agency resources to conducting retrospective review, c) FDA should alter its existing temporary permit program for food identity standards, and d) FDA should issue a revised economic analysis and rely on that evidence in setting final standards.

Reply Comment on Benefit-Cost Analysis at the STB

March 18, 2020

By: Jerry Ellig
This reply comment is on the Surface Transportation Board's solicitation of information regarding the Association of American Railroads' petition for a rule on benefit-cost analysis, and it addresses several concerns about the suitability of benefit-cost analysis for STB proceedings that stakeholders raised in earlier comments.


CEQ's Proposed Update to NEPA

March 11, 2020

By: Mark Febrizio
The Council on Environmental Quality is proposing an update to its regulations for implementing the procedural provisions of the National Environmental Policy Act of 1969. Although the fundamental understanding of NEPA would remain the same under the revised implementing regulations, CEQ’s proposed rule implies both substantive and procedural changes that affect the extent to which environmental review informs agency decision-making processes. This public interest comment offers comments on CEQ’s NPRM by focusing on aligning NEPA with regulatory best practices, encouraging systematic regulatory analysis of the proposed rule, and addressing specific topics where CEQ invites comment.


OMB's Request for Comment on Marginal Excess Tax Burden and EO 13771

February 20, 2020

By: Brian F. Mannix
This public interest comment begins by making some general observations about the use of Marginal Excess Tax Burden in the context of budgetary, tax, and regulatory policy. It then offers responses to the eight specific questions listed in the OMB notice.


OMB's Request for Comment on Marginal Excess Tax Burden and EO 13771

February 18, 2020

By: Mark Febrizio
This public interest comment responds to the Office of Management and Budget’s request for comment in two ways. First, the author focuses on the general implementation of EO 13771 accounting because it has significant implications for properly addressing the Marginal Excess Tax Burden issue. Second, the author offer comments on three of the topics specifically outlined by OMB.


Fake It Till They Make It: How Bad Actors Use Astroturfing to Manipulate Regulators, Disenfranchise Consumers and Subvert the Rulemaking Process

February 6, 2020

By: Steven J. Balla
The House Committee on Financial Services Subcommittee on Oversight and Investigations held a hearing on the effect of mass and fake comment campaigns on the rulemaking process. Senior scholar Steven J. Balla presented the findings of his research into thousands of mass comment campaigns to the Subcommittee.


STB Petition to Consider Benefit-Cost Analysis

January 31, 2020

By: Jerry Ellig
On July 8, 2019, the STB decided to delay consideration of a petition asking the board to adopt a procedural rule that would require benefit-cost analysis in certain board rulemakings. On November 4, 2019, the STB solicited further information from the public about specific methods that could be used for benefit-cost analysis of rules related to economic regulation of freight railroads. The STB is prudent to explore methods for improving its economic analysis of regulatory proposals—as several other independent agencies have done in recent years.


GSA's Mass and Fake Comments Meeting

January 30, 2020

By: Steven J. Balla
The General Services Administration held a public meeting in their Auditorium at 1800 F Street NW to discuss the effect mass and fake comments in the rulemaking process. Senior scholar Steven J. Balla presented the findings of his research into thousands of mass comment campaigns to the agency.


FDIC's Framework for Analyzing the Effects of Regulatory Actions

January 29, 2020

By: Jerry Ellig
The FDIC is wise to use Circular A-4 as a template for economic analysis. The analytical approaches in Circular A-4 are critical for determining whether a regulation under consideration is likely to produce more good than harm. The principles in Circular A-4 are also general enough that they can be applied to banking and financial regulation. The Securities and Exchange Commission’s (SEC’s) experience with an analytical framework based on Circular A-4 demonstrates that the framework is practicable and can produce a noticeable improvement in the quality of economic analysis.


STB's Rate Review and Market Dominance -- Reply Comment

January 13, 2020

By: Jerry Ellig
This reply comment addresses issues raised during two recent proceedings where the Surface Transportation Board proposed a streamlined approach to assessing whether a railroad has market dominance and a final offer process for small rate disputes.


STB's Railroad Revenue Adequacy

December 02, 2019

By: Jerry Ellig
The Surface Transportation Board will hold a hearing on December 12 to discuss recommendations from the STB's Rate Reform Task Force. This comment addresses several of the task force's proposals, and provides additional recommendations for the STB to improve its revenue adequacy regulations.


STB's Market Dominance and Final Offer Rate Review

November 06, 2019

By: Jerry Ellig
The two rulemakings this comment addresses are the Surface Transportation Board’s (STB’s) latest efforts to develop simpler and less costly rate complaint processes. These two proceedings provide an excellent opportunity for the STB to “test drive” the framework for benefit-cost analysis that is most commonly employed by federal agencies: the analytical principles and requirements articulated in President Clinton’s Executive Order 12866 and OMB Circular A-4. The most common and accurate term for this type of analysis is “Regulatory Impact Analysis” (RIA), because a full RIA involves more than just estimation of benefits and costs. This comment briefly explains the RIA framework and demonstrates how it could be used to answer key factual questions the STB must answer in order to accomplish its statutory goals.



Agricultural Research and 2018 Farm Bill Implementation

July 31, 2019

By: Joseph J. Cordes
On June 13, 2019, the U.S. Department of Agriculture (USDA) released what it describes as a “Cost-Benefit Analysis” of the proposed relocation of NIFA and ERS from Washington DC to Kansas City. Based on its analysis the USDA concludes that relocation of these two agencies would save $19 million per year which could be reinvested in other USDA programs. This written testimony accesses the agency's benefit cost analysis under Circular A-94 standards.


IRS's Safe Harbor Notice on State and Local Tax Credits

July 10, 2019

By: Jerry Ellig
The IRS seeks comment on a guidance notice that allows taxpayers to count contributions for which they received a state or local tax credit as a payment of state or local taxes, subject to the $10,000 SALT cap. This notice corrects a problem created by a regulation issued on June 11, 2019, which prohibits taxpayers from taking a charitable deduction if they received a state or local tax credit in exchange for the contribution. Without this notice, the regulation is overly broad, because it takes away the deduction for taxpayers below the SALT cap even though they are not a cause of the tax avoidance problem the regulation seeks to solve.


FDA's Proposed Rule on Mammography Standards

June 24, 2019

By: Bridget C.E. Dooling
Early detection of breast cancer can save lives, and mammography is one of the screening tools that has contributed to reductions in breast cancer mortality. The FDA has a unique role in mammography and should be commended for proposing to update its rules, however, the proposed rule’s breast density notification raises issues of state preemption; lessons that can be learned from testing, evaluation, and assessment of prior state action; and analysis of distributional and equity effects.


From Beginning to End: An Examination of Agencies’ Early Public Engagement and Retrospective Review

May 07, 2019

By: Susan E. Dudley
Susan Dudley testified before the U.S. Homeland Security and Governmental Affairs Regulatory Affairs and Financial Management Subcommittee on May 7, 2019, commending the Subcommittee’s bipartisan regulatory reform legislation. By 1) engaging public input earlier in the regulatory development process and 2) providing for retrospective review of regulations to evaluate whether they are achieving their objectives, the two bills can help ensure that regulations are based on the best evidence available and that they are working as intended for the American people.


DOE's Energy Conservation Program for Appliance Standards

May 07, 2019

By: Mark Febrizio
The Department of Energy is proposing to update and modernize its current rulemaking methodology for establishing new or revised energy conservation standards and test procedures, called the “Process Rule.” While the agency has adhered to internal procedures for years, the notice of proposed rulemaking seeks to make those procedures binding on the agency. The proposed rule includes many important provisions and is largely a step in the right direction. This public comment focuses on eight areas of interest in the revised Process Rule, highlighting both beneficial changes and additional areas for improvement.


Revising WOTUS

April 16, 2019

By: Jonathan H. Adler
In this public interest comment, Jonathan Adler finds that the EPA and the Army Corps of Engineers proposed revision of the definition of “waters of the United States” is a substantial improvement over prior definitions, not least because it acknowledges the statutory and constitutional limits on federal regulatory jurisdiction under the CWA and takes seriously the need for greater clarity and certainty about the scope of federal regulatory jurisdiction.


IRS Qualified Business Income Deduction

April 08, 2019

By Jerry Ellig & Jeffery Kaufman
The 2017 tax reform allowed investors in real estate investment trusts (REITS) and publicly-traded partnerships (PTPs) to take a tax deduction equal to 20 percent of qualifying distributions from REITs and PTPs. The Internal Revenue Service seeks comment on whether investors should also be allowed to take this deduction if they own REITs or PTPs through a regulated investment company, such as a mutual fund. Unfortunately, the IRS did not conduct an economic analysis sufficient to determine which choice is economically efficient. A complete analysis would first assess whether the deduction is economically efficient; building on that analysis, the IRS could then determine whether extending the deduction is efficient. We provide some illustrative calculations that point the way toward a more complete analysis.


Wasted Energy: DOE’s Inaction on Efficiency Standards and Its Impact on Consumers and the Climate

March 07, 2019

By: Brian Mannix
The House Committee on Energy and Commerce, Subcommittee on Energy held a hearing titled, "Wasted Energy: DOE's Inaction on Efficiency Standards and Its Impact on Consumers and the Climate." Research Professor Brian Mannix submitted a written statement on the 40 year history of appliance efficiency standards, and why analysis dating back to the Carter administration is still relevant today.


NTIA's Approach to Consumer Privacy

November 12, 2018

By Daniel R. Pérez
The National Telecommunications and Information Administration issued a request for public comments on developing the administration's approach to consumer privacy. This public interest comment provides an overview of the agency's proposed approach to guide federal policymaking, and provides three core recommendations (1) Privacy regulation should be based on consumers' value, (2) the benefits of regulation should exceed social costs, and (3) future research should be focused on improving benefit-cost analysis of privacy regulations.


EPA's Proposed “Affordable Clean Energy” (ACE) Rule

October 31, 2018

By Brian F. Mannix
The proposed “Affordable Clean Energy” (ACE) rule rests on a stronger legal foundation and a sounder economic analysis than the stayed Clean Power Plan (CPP). In particular, the choice of a “best system of emissions reduction” (BSER) based on heat-rate efficiency, a measure of CO2 intensity, is much more consistent with the Clean Air Act than was the CPP’s statewide budget approach, as is the decision to use domestic benefits to justify the rule. The proposed reforms to section 111(d) procedures and to the New Source Review criteria are both important and stand on their own right.


SAFE Vehicles Rule

October 25, 2018

By Julian Morris
Executive Director of the International Center for Law & Economics and a Senior Fellow at the Reason Foundation - provides insights on the effects of the Safer Affordable Fuel-Efficient Rule and the preliminary regulatory impact analysis thoroughly completed by the EPA and NHTSA. This public interest comment discusses the likely effects of the rule on vehicle fuel economy, fuel consumption, the cost of new and used vehicles, safety, and the environment. The author's findings suggest that the new rule will save billions of dollars in economic costs, potentially decrease traffic fatalities, and is unlikely to have a significant negative effect on the environment.


IRS's Proposed Rule on SALT Credits

October 12, 2018

By Jerry Ellig
The Internal Revenue Service (IRS) has proposed a regulation that would prevent all individual taxpayers from claiming a federal charitable deduction if the taxpayer received a state tax credit equivalent to more than 15 percent of the donation. This comment explains why the proposed regulation is much broader than necessary to address the real problem the IRS seeks to solve: state tax credit programs designed explicitly to aid taxpayers in avoiding the cap on deductibility of state and local taxes.


Dept. of Education's Student Assistance & Loan Programs

September 07, 2018

By: Daniel R. Pérez
This comment argues that the Dept. of Education's proposal to rescind its 2016 change to the definition of misrepresentation and to change its 2016 approach making a priori assumptions about the quality of non-profit and for-profit schools better complies with existing regulatory requirements. The Department should retain borrowers’ ability to file affirmative claims, collect additional data to inform future rulemaking, and more thoroughly consider the net impact of its proposed rules on processing borrower claims on a case-by-case basis.


Council on Environmental Quality - Implementing NEPA

August 20, 2018

By: Mark Febrizio
This comment makes recommendations for how the Council on Environmental Quality could improve its data collection methods, how to use those data to enhance retrospective review of National Environmental Policy Act regulations and their effect on industry and the environment, and where to increase transparency in its decision-making process.


Increasing Transparency in Considering Costs and Benefits in the Rulemaking Process -- Update

August 20, 2018

By: Brian F. Mannix
In this comment, Mannix explores the reasons why the Council on Environmental Quality might choose to conduct a rulemaking on the general topic of how it considers benefits and costs, reviews some of the legal considerations that should be brought to bear on that effort, and recommends that the administration consider encouraging this type of activity in other agencies.


EPA's Benefit-Cost Analysis in the Rulemaking Process

August 13, 2018

By: Joseph J. Cordes

In this comment, Cordes discusses the value-added of using benefit-cost analysis in the regulatory process, the extent to which guidance is presently available on the application of benefit-cost analysis to regulatory analysis, the specific issue of which stakeholders should receive standing in benefit-cost analysis, and the inclusion of indirect effects, also referred to as co-benefits, in benefit-cost calculations.


EPA's ANPRM on Increasing Transparency in Benefit-Cost Analysis

August 13, 2018

By: Brian F. Mannix

This comment begins by exploring the reasons why EPA might choose to conduct a rulemaking on the general topic of how it considers benefits and costs, and then discusses some of the legal considerations that should be brought to bear on the effort.


Increasing Consistency and Transparency in EPA's Benefit Cost Analysis

July 17, 2018

By Susan E. Dudley

In this comment, Dudley supports EPA’s efforts to improve the transparency and consistency of the analysis supporting its significant regulations and, referring to the Consumer’s Guide to Regulatory Impact Analysis, reviews ten tips for achieving this objective. She encourages EPA, as a first step, to review all its statutory authority and, to the maximum extent possible, interpret its statutory standards through a lens of standard benefit-cost analysis principles.


DHS's Proposed Rule: Removal of International Entrepreneur Parole Program

June 29, 2018

By: Daniel R. Pérez & Lisa Zimmer

The Department of Homeland Security is proposing to eliminate its international entrepreneur program, which was created in 2017, despite the agency's previous findings that the program will increase economic growth, job creation, and U.S. based innovation. The proposal also runs contrary to the administration's declared policy of shifting towards a more merit-based immigration system, decreasing regulatory costs, and demonstrated early success from the program.


FDA’s Advanced Notice of Proposed Rulemaking: Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

June 15, 2018

By: David Zorn, Ph.D.

In a comment filed on the "Advance Notice of Proposed Rulemaking, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes," Zorn observes that the FDA's plan to develop a maximum nicotine level for cigarettes is a novel and creative approach to promote public health. He also examines some drawbacks of the FDA's plan, including the speculative and unproven nature of the underlying hypothesis, as well as the limitations of removing access to only combustible sources of nicotine.


FSIS's Egg Products Inspection Regulations

June 12, 2018

By: Richard B. Belzer, Independent Consultant

This public interest comment provides an overview of the Food Safety Inspection Service’s (FSIS) proposed rule requiring official plants that process egg products to develop and implement Hazard Analysis and Critical Control Point Systems and Sanitation Standard Operating Procedures. FSIS would eliminate certain existing requirements, and add new labeling requirements. The comment reviews the justifications for the rulemaking change, and provides answers to how it would affect previous rules, industry growth, and foodborne illness rates.


EPA’s Proposed Rule Strengthening Transparency in Regulatory Science

May 18, 2018

By: Susan E. Dudley

The EPA’s “Strengthening Transparency in Regulatory Science” proposed rule seeks to improve the data and models that underlie the rulemaking process by making them publicly available for further analysis and validation. This public interest comment examines the merits of the proposed rule and how it relates to existing practices. These remarks conclude with a case for why clearer explanations of rulemaking rationale would encourage more openness and constructive discussion, ultimately improve policy decisions, and engender greater acceptance of policy choices.


EPA's Repeal of Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units

April 27, 2018

By: Brian F. Mannix

The EPA has proposed to repeal the greenhouse gas (GHG) emissions guidelines for electric generating units issued on October 23, 2015—better known as the Clean Power Plan (CPP). The Agency has also sought comment separately on what, if anything, ought to replace it. This comment, often drawing on earlier comments, will focus on the Regulatory Impact Analysis (RIA) that supported EPA’s 2015 CPP final rule, and outlines those areas where the agency made major errors in the 2015 RIA, and where it could go further to improve the analysis.


OMB's 2017 Draft Report to Congress on the Benefits and Costs of Federal Regulations

April 09, 2018

By: Brian F. Mannix, Sofie E. Miller, & Susan E. Dudley

The George Washington University Regulatory Studies Center improves regulatory policy through research, education, and outreach. As part of its mission, the GW Regulatory Studies Center conducts careful and independent analyses to assess rulemaking proposals from the perspective of the public interest. This comment on the Office of Management and Budget’s 2017 Draft Report to Congress offers suggestions for improving the information value of the Report, as well as the evidence on which regulatory policies depend, and does not represent the views of any particular affected party or special interest.


DOE's "Process Rule" for Energy Efficiency Standards

March 02, 2018

By Sofie E. Miller

In response to the Department of Energy request for public comment on the proposed modifications to its "Process Rule," Sofie E. Miller filed recommendations regarding improvements to direct final rulemaking, retrospective review, and the analysis that supports the Department's rules.


EPA's State Guidelines for Greenhouse Gas Emissions from Existing Electric Utility Generating Units

February 27, 2018

By: Brian F. Mannix

Mannix recommends four features that the agency should incorporate into a possible replacement for the agency’s Clean Power Plan. First, the agency should set standards for CO2 intensity, rather than a mass-based cap on CO2 emissions. Second, the standards should be tiered by technology. Third, the agency should allow trading of CO2 credits, both within and across technology categories. Fourth, the agency should incorporate a safety valve mechanism that keeps the price of CO2 credits commensurate with the domestic social cost of carbon. Such a rule could function as a “last-ton tax,” with many of the economic efficiencies of a carbon tax, but without exceeding the boundaries of EPA’s regulatory authority.


CPSC Hearing on Safety Standard Addressing Blade-Contact Injuries on Table Saws

August 14, 2017

By Sofie E. Miller & Jacob Yarborough
In a testimony before the Consumer Product Safety Commission, Miller and Yarborough discuss three components of the Commission's proposed performance standard for table saws: 1) there is not a clear market failure to justify the rulemaking, 2) the rule will have negative effects on competition by creating a legal monopoly, and 3) the benefits that the Commission expects to result from its standard are uncertain.


CPSC’s Proposed Rule: Safety Standard Addressing Blade-Contact Injuries on Table Saws

July 27, 2017

By: Sofie E. Miller & Jacob Yarborough
The CPSC’s proposed rule mandates that all table saws sold in the U.S. be equipped with Active Injury Mitigation (AIM) technology. Miller and Yarborough argue that this rule would lead to a monopoly of the table saw market. This monopoly would reduce consumer choice, dramatically raise costs, and stifle innovation. In addition, they question the underlying assumptions and models that the CPSC uses to conduct their benefit-cost analysis and argue that the benefits may be overstated and the costs understated.


FCC’s Proposed Rule: Restoring Internet Freedom

July 11, 2017

By Gerald Brock, Ph.D, Co-Director
As an independent regulatory agency, the Federal Communications Commission (FCC) is not required to perform a Regulatory Impact Analysis (RIA) of major regulations. In this public interest comment on the FCC’s “net neutrality” rule, Brock argues that it is desirable to conduct RIA voluntarily because they have become the standard method of ensuring careful analysis of proposed regulations in the U.S. and other major countries.


DOE’s Request for Information on Reducing Regulation and Controlling Regulatory Costs

July 07, 2017

By Sofie E. Miller
This comment provides the Department of Energy with recommendations on how to reduce regulatory burdens pursuant to Executive Orders 13771 and 13777. Miller recommends that DOE establish consistent internal standards for determining whether a rule is "economically justified," including using a threshold to limit the proportion of consumers who bear net costs. DOE should also review each rule before increasing the stringency of its standards, and consider surveys or other measures of actual consumer behavior to ensure that its assumptions about household appliance energy use are accurate.


How to Regulate Genome-Edited Animals? A Comment on FDA’s Proposed Guidance

June 19, 2017

By Randall Lutter, Ph.D, Visiting Scholar, and Lena Lewis
The FDA is considering an approach to oversight of genome-edited animals that closely follows its current policy regarding genetically engineered animals. Unfortunately, the proposed approach is unwise because the existing policy regarding genetically engineered animals, which it mimics, has itself simply failed. In this public comment, Lutter and Lewis argue that FDA’s draft guidance for genome edited animals lacks a cogent scientific basis, is inconsistent with FDA’s policies regarding genome edited plants, and is unlikely to advance FDA’s mission to protect and promote public health.


DOE's Energy Conservation Standards for Residential Central Air Conditioners and Heat Pumps

April 25, 2017

By Sofie E. Miller
The Department of Energy’s direct final rule amends the energy efficiency standards for residential central air conditioners and split-system heat pumps. However, DOE’s own analysis suggests that up to 45% of households in some regions will bear net costs as a result of these standards, and that consumers would experience greater savings under less stringent energy efficiency standards. Due to the lack of consumer input in the negotiated rulemaking process—and the significant burdens that consumers are likely to bear from this standard—DOE should not pursue this standard via direct final rule.


Examining How Small Businesses Confront and Shape Regulations

March 29, 2017

By Sofie E. Miller & Daniel R. Pérez
On March 29th, the U.S. Senate Committee on Small Business & Entrepreneurship met to consider legislative reforms that would affect how small businesses confront and shape regulations. This prepared statement for the record focuses on S. 584: Small Business Regulatory Flexibility Improvements Act. The analysis suggests that the Committee should: be careful to avoid the problem of double-counting indirect costs, use an evidence-based regulation framework to strengthen retrospective review, and safeguard against unintentionally reducing the efficacy of the existing Small Business Advocacy Review process.


Agency Use of Science in the Rulemaking Process: Proposals for Improving Transparency and Accountability

March 14, 2017

By Susan E. Dudley
As the Senate subcommittee on Regulatory Affairs and Federal Management considers proposals for improving transparency and accountability in agencies’ use of science in the rulemaking process, it should recognize two problems. “Hidden policy judgments” occur when scientists, intentionally or unintentionally, insert, but do not disclose, their own policy preferences in the scientific advice they provide government decision-makers. The “science charade” occurs when scientists and/or policymakers conflate scientific information and nonscientific judgments to make a policy choice, but then present that decision as being solely based on science.


OMB's Interim Guidance Implementing Section 2 of the Executive Order Titled "Reducing Regulation and Controlling Regulatory Costs"

February 13, 2017

By Susan E. Dudley, Brian F. Mannix, Sofie E. Miller, & Daniel R. Pérez
In this comment on the Office of Information and Regulatory Affairs’ (OIRA) interim guidance on Executive Order 13771, GW Regulatory Studies Center scholars acknowledge that the Order represents a significant departure from past practice, however, they emphasize that the additional budgeting constraints it imposes need not supplant longstanding requirements to examine regulatory benefits as well as costs and to achieve regulatory objectives as cost-effectively as possible. The comment reinforces OIRA’s draft questions and answers, and offers some suggestions for clarification and improvement.


NHTSA’s Federal Automated Vehicles Policy: Accelerating the Next Revolution In Roadway Safety

November 16, 2016

By Sofie E. Miller, Howard Beales and Daniel R. Pérez
This comment on the National Highway Traffic Safety Administration’s (NHTSA) recent Federal Automated Vehicles Policy considers the impact of regulating driverless car technology on innovation and social welfare. NHTSA is correct to be cautious of the effects that a federal policy could have on innovation, particularly because the safety gains from highly automated vehicles (HAV) could be significant. As a result, the agency should avoid any type of premarket approval authority for HAV technology, which could potentially delay the adoption of life-saving innovations and result in thousands of traffic fatalities.


Public Comment to the Commission on Evidence-Based Policymaking

November 08, 2016

By Marcus Peacock, Sofie E. Miller and Daniel R. Pérez
Scholars at the GW Regulatory Studies Center show how the U.S. could make regulations more evidence-based in a comment to the Commission on Evidence-Based Policymaking. Evidence-based regulations plan for, collect, and use evidence to predict, evaluate and improve societal outcomes throughout the rule’s life. This comment lays out a process for producing such rules and provides over a dozen specific recommendations on how the U.S. could better adopt and implement such a system.


DHS’s Proposed International Entrepreneur Rule

October 18, 2016

By Daniel R. Pérez
The Department of Homeland Security’s proposed rule would expand the use of its discretionary authority to parole individuals into the United States for reasons of “significant public benefit” to include foreign entrepreneurs looking to start a business in the U.S. DHS recognizes that “the full potential of foreign entrepreneurs to benefit the U.S. economy is presently limited since many…do not qualify under existing nonimmigrant and immigrant classifications.” The rule proposes several criteria for approving applicants on a case-by-case basis. This comment proposes several changes that DHS could make to its proposed rule to maximize its potential benefits.


DOE's Energy Conservation Standards for Manufactured Housing

August 16, 2016

By Sofie E. Miller
The Department of Energy’s proposed rule would establish new energy efficiency standards for manufactured housing (formerly known as mobile homes). Due to anticipated price increases, the rule would have a regressive effect on low-income and elderly households, who are the primary occupants of manufactured homes. DOE’s analysis doesn’t take into account resale market obstacles that could prevent homeowners from recouping the higher upfront costs of efficient units, especially in Southern states with high poverty rates that bear the highest costs from the rule.


ED’s Proposed Rule on Student Assistance General Provisions, Federal Student Loans Programs and Teacher Education Assistance for College and Higher Education Grant Program

August 02, 2016

By Daniel R. Pérez
The total outstanding balance of student loans is currently estimated to be $1.35 trillion, and default rates among borrowers have reached their highest levels in 20 years. The rule proposed by The Department of Education (ED) would make several amendments to regulations governing its Federal Direct Loan Program, including: 1) an expansion of the conditions wherein ED forgives borrowers’ loan balances, 2) additional provisions that broaden its ability to recover losses from institutions, and 3) expanded financial requirements for postsecondary schools. ED estimates this rule could have annual federal budget impacts of up to$4.23 billion.


EPA’s Proposed Renewable Fuel Standards for 2017 and Biomass-Based Diesel Volume for 2018

July 12, 2016

By Sofie E. Miller
EPA’s latest Renewable Fuel Standard proposal would increase the mandated total renewable fuel production to 18.8 billion gallons in 2017. Although it was intended to improve the environment, availability of new scientific, technical, and economic information shows that the RFS program is likely causing significant environmental harm through increased greenhouse gas emissions and damage to waterbodies and ecosystems. Given the environmental damage and the large economic impact of the standards, EPA should update its benefits analysis and consider using its waiver authority to further reduce the standards.


DOE’s Regulatory Burden Request for Information "Reducing Regulatory Burden"

July 11, 2016

By Sofie E. Miller
To improve its ongoing retrospective review efforts, this public comment recommends that the Department of Energy incorporate plans for retrospective review into its economically significant or major rules, and provide enough time between energy efficiency standards to allow for an effective review of each rule before increasing the stringency of its standards. DOE should also consider surveys or other measures of actual consumer behavior to ensure that its assumptions about household appliance energy use are accurate. Finally, DOE should commit to measuring whether its standards negatively affect competition in regulated industries.


An Introduction to a Regulatory Budget

July 07, 2016

By Richard J. Pierce
When you combine the effects of the Executive Orders that forbid an agency from issuing a rule with costs that exceed its benefits to society with the effects of the Executive Orders that require agencies to identify and to rescind or amend any existing rule with costs that exceed its social benefits, you get a regulatory budget that maximizes the net social benefits created by rules issued by federal agencies by ensuring that the aggregate social benefits of those rules exceed the aggregate costs of those rules. That is a sensible version of a regulatory budget. Any version of a regulatory budget that considers only the cost of rules and ignores the benefits of rules will reduce social welfare by costing society hundreds of billions of dollars in the forms of loss of lives, increased injuries and illnesses, and damage to property.


Home Appliance Energy Efficiency Standards under the Department of Energy – Stakeholder Perspectives

June 10, 2016

By Sofie E. Miller
In testimony before the House Energy and Commerce Subcommittee on Energy and Power, Senior Policy Analyst Sofie E. Miller explains that one-size-fits-all energy efficiency standards can deprive consumers of the ability purchase the appliances that best suit their unique circumstances and constraints. As a result, these regulations cost consumers rather than benefiting them, as the Department of Energy posits. In addition, these standards disparately impact low- and median-income households, and current analyses of their effects suggest that these populations bear significant costs as a result.


FCC's Protecting the Privacy of Customers of Broadband and Other Telecommunications Services

May 27, 2016

By J. Howard Beales III
The FCC has proposed detailed rules governing privacy practices of broadband Internet access service (“BIAS”) providers. The rule would establish new, and different, privacy standards, beyond those that apply to other Internet companies. This comment argues that the FCC’s rationales for treating BIAS providers differently are flawed and the proposed separate regulatory regime for broadband providers would inhibit innovation, reduce competition, and harm consumers. If it feels it must regulate, the FCC should adopt a functionality based approach to privacy regulation to maximize consumer welfare.


The Federal Government on Autopilot: Delegation of Regulatory Authority to an Unaccountable Bureaucracy

May 24, 2016

By Sofie E. Miller
In testimony before the House Task Force on Executive Overreach, Senior Policy Analyst Sofie E. Miller explains that retrospective review is a key component of an effective regulatory process because it allows agencies to review whether existing rules are accomplishing their intended goals and to determine what effect they have on the regulated public. Miller argues that writing rules at the outset to facilitate this measurement can improve outcomes and enable policymakers to learn from what has worked and what hasn’t.


FDA’s Public Availability of: Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes

May 13, 2016

By Daniel R. Pérez
Genetically-modified mosquitoes hold great promise for addressing mosquito-borne diseases that threaten South Florida. Yet, the Florida Keys Mosquito Control District has been waiting since 2011 for approval from FDA to allow the biotechnology company Oxitec to conduct field trials for this promising technology. This public interest comment points out that the trial poses no appreciable risk to human or animal health or the environment. The unusually lengthy timeframe for approval has unnecessarily limited our ability to combat the spread of life-threatening diseases, like Zika and Dengue.


Public Interest Comment to the National Economic Council on The President's Executive Order 13725: Steps to Increase Competition and Better Inform Consumers and Workers to Support Continued Growth of the American Economy

May 12, 2016

By Sofie E. Miller, Daniel R. Pérez, Susan E. Dudley & Brian Mannix
This public comment suggests several areas of regulatory policy where federal regulations have hindered, rather than helped, competition, and recommends that agencies take this opportunity to reduce these regulatory barriers to competition.


Are Future Lives Worth More, Today, Than Our Own – Simply Because of Income Growth?

March 07, 2016

By Brian Mannix
The EPA has presented its Environmental Economics Advisory Committee a series of questions that relate to an analytical procedure for estimating the value of statistical lives saved in the future – possibly the distant future – as a result of regulations imposed today. Intertwined with the detailed analytical questions, however, is a fundamental ethical and methodological question: Is it right to force a relatively poor population to pay an inflated price – higher than they are willing to pay to save their own lives – to save the lives of a richer population, on the theory that rich people’s lives are more valuable?


Oversight of the Renewable Fuel Standard

March 02, 2016

By Sofie E. Miller
Since Congress created the Renewable Fuel Standard (RFS) program, new information has become available about the effects of mandated biofuel production indicating that the environmental effects are significant and negative. This invited testimony for the record examines evidence from the existing literature, which finds that biofuel production produces criteria pollutants, damages water systems from crop fertilizer runoff, and may not reduce greenhouse gas emissions relative to gasoline. Given this evidence, Congress should reevaluate the goals of the program and put the program on a sustainable trajectory.


Should Federal Regulatory Agencies Report Benefits to Americans from Mandated Reductions in Greenhouse Gas Emissions?

February 09, 2016

By Art Fraas, Randall Lutter, Susan E. Dudley, Ted Gayer, John Graham, Jason F. Shogren, W. Kip Viscusi
In a letter to the National Academy of Sciences on its project, "Assessing Approaches to Updating the Social Cost of Carbon," a group of prominent regulatory economists argues that federal regulatory analysis should compare domestic regulatory benefits to domestic costs. The current government approach of reporting only the global benefits of reducing carbon emissions neglects that duty. The letter recommends that the panel adopt a dual approach that refocuses regulatory impact analysis of climate regulations on domestic benefits, while providing for separate reporting of estimated global benefits.


EPA's Proposed Supplemental Finding that it is Appropriate and Necessary to Regulate Hazardous Air Pollutants from Coal- and Oil-Fired EGUs

January 11, 2016

By Susan E. Dudley
EPA fails to show that its MATS is appropriate and necessary to address risks to public health and the environment from hazardous air pollutants. Its preferred approach has methodological problems and does not address the Supreme Court’s direction to balance the harm of the regulation against the good. Its benefit-cost analysis is dominated by co-benefits that are not subject to the statutory authority on which it relies, and that could be addressed more cost-effectively elsewhere. EPA also ignores the fact that the $9.6 billion cost will have large detrimental effects on public health.


OMB's 2015 Draft Report to Congress on the Benefits and Costs of Federal Regulations

December 15, 2015

The Office of Management and Budget’s 2015 Draft Report to Congress provides information on costs and benefits for certain final rules issued between FY 2004 and FY 2014. The Report provides the public valuable information both on estimates of the effects of major executive branch regulations, and also on OMB’s focus and priorities. This comment offers recommendations for improving regulatory impact assessments, writing rules to encourage retrospective review of regulations, and the use of “private benefits” to justify energy efficiency standards.


EPA's Proposed Rule: Federal Plan Requirements for Greenhouse Gas Emissions From Electric Utility Generating Units

November 19, 2015

By Brian Mannix
This Public Interest Comment, filed last year in response to EPA’s proposed Clean Power Plan, addresses the relative merits of a “mass-based” or “rate-based” emissions trading program in state plans required by EPA’s rule. This same question has arisen again in the context of EPA’s development of Federal Implementation Plans (FIPs) that might be imposed on noncomplying states. The comment (which has now been filed in the FIP rulemaking) concludes that a rate-based trading program, similar to the EPA’s successful program for trading lead in gasoline in the 1980s, has compelling advantages over a mass-based program.


EPA and NHTSA's Proposed Rule: Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium and Heavy-Duty Engines and Vehicles – Phase 2

October 02, 2015

By Brian Mannix
Contrary to claims, EPA and NHTSA’s proposed standards to regulate greenhouse gas emissions and fuel efficiency for medium and heavy-duty engines and vehicles is not “a win-win-win.” The agencies’ RIA forecasts large benefits, mostly in the form of private fuel savings but, fails to recognize that competitive markets are far better informed, and far better motivated, to pursue these fuel savings efficiently. The net effect will be higher costs, not savings. Other external benefits might be used to justify the standards, but an honest RIA would acknowledge that these come at a price.


A Review of Regulatory Reform Proposals

September 17, 2015

By Susan E. Dudley
The Senate Homeland Security & Government Affairs Committee held a hearing on Thursday September 16, at which they asked Susan Dudley to provide expert input on six regulatory reform proposals scheduled for markup. Her testimony complimented the Committee on the constructive, bipartisan reforms, which if passed, could bring about real improvements in regulatory procedures and outcomes. She offered detailed comments on each bill, of which three focus on evaluating the effects of existing regulations and modifying them as appropriate, and three focus on enhancing analytical procedures conducted before new regulations are issued.

NRC's Financial Qualifications for Reactor Licensing

July 30, 2015

By Gerald W. Brock
The Nuclear Regulatory Commission published a draft regulatory basis for a proposed rulemaking that would amend the financial qualifications standard for new reactor licensing from the current "reasonable assurance" to the proposed "appears to be financially qualified." However, the proposed standard is unnecessary because there is a market test of financial qualifications that is more accurate than regulatory review. While the proposed new financial qualification standard is better than the current financial qualification standard, simply abolishing the financial qualifications requirement for licensing would be an improvement over the proposed new standard.


EPA's Proposed Renewable Fuel Standards for 2014, 2015, and 2016

July 24, 2015

By Sofie E. Miller
The Renewable Fuel Standard program is mandated by Congress to increase the production and use of renewable fuels, such as corn ethanol, in gasoline and diesel. However, the availability of new scientific, technical, and economic information shows that the RFS program does not work as it was intended to, and is likely causing significant environmental harm through increased greenhouse gas emissions and damage to waterbodies and ecosystems. In this proposed rule, EPA appropriately uses its waiver authority to set renewable fuel standards below those prescribed by statute. Given the environmental damage and the large economic impact of the standards, EPA should update its benefits analysis and consider using its waiver authority to further reduce the standards. Responsibility rests with Congress to reevaluate the effects of the statutes it authorized, which are now causing economic and environmental harm.


Accounting for the True Cost of Regulation: Exploring the Possibility of a Regulatory Budget

June 23, 2015

By Susan E. Dudley
On June 23, RSC scholars Susan Dudley and Richard Pierce and President of the Canadian Treasury Board, Tony Clement, testified during a joint hearing before the U.S. Senate Committee on the Budget and Committee on Homeland Security and Government Affairs. Dudley testified in support of a regulatory budget and cited the potential for constructive debate on the real impacts of regulations, greater transparency, more efficient allocation of resources, and ultimately the potential for more cost-effective achievement of public priorities.


Accounting for the True Cost of Regulation: Exploring the Possibility of a Regulatory Budget

June 23, 2015

Richard J. Pierce, Jr.
On June 23, RSC scholar and GW Professor of Law Richard Pierce, RSC Director Susan Dudley, and President of the Canadian Treasury Board, Tony Clement, testified during a joint hearing before the U.S. Senate Committee on the Budget and Committee on Homeland Security and Government Affairs. Pierce testified in strong support of a regulatory budget but urged the dire importance of using benefit-cost analysis when considering any recommendations. He explains that there are two versions of a regulatory budget that would harm the nation.


Examining Practical Solutions to Improve the Federal Regulatory Process

June 03, 2015

Susan E. Dudley
Though regulation affects every aspect of our lives, as a policy tool it rarely reaches the attention of voters (and consequently of elected officials) because, unlike the federal budget, its effects are often not visible. This testimony offers recommendations in four areas that may meet the Subcommittee's request for "common sense ideas that could garner bipartisan support and provide immediate improvement to the federal regulatory process." These are 1) codifying regulatory impact analysis requirements, 2) providing for earlier analysis and public input on new regulations, 3) increasing resources for regulatory oversight, and 4) being mindful of regulatory consequences when passing new legislation.


Recommendations for Improving the Regulatory Process

May 04, 2015

Response to the Senate Homeland Security and Governmental Affairs Committee's Letter Requesting Input on its Regulatory Improvement Effort
Regulation is one of the primary vehicles by which federal policy is formulated, and it affects every household, employee, and business in the United States. This document summarizes the key regulatory reform insights from some of our research on regulatory impact analysis, judicial review, congressional oversight, retrospective review, public input, and risk assessment. This research will provide the members of the Senate Homeland Security and Government Affairs Committee with relevant context for their ongoing Regulatory Improvement Effort.


FAA's Proposed Rule: Operation and Certification of Small Unmanned Aircraft Systems

April 24, 2015

By Blake Taylor
The FAA suggests that this rule will be the first step in a long, complex path of integrating unmanned aircraft systems (UAS) into the National Airspace System. However, it will be a challenge for the Administration to ensure that this incremental approach occurs at a pace that closely mirrors market and technological changes. Because UAS are nascent technologies, the FAA has very little information on the potential benefits and risks. Retrospective review involving ambitious data collection is essential to structuring the future steps in the integration framework. In order for UAS to be truly integrated into the NAS, the FAA must commit now to ensure the rulemaking process going forward is more dynamic, and respectful of the societal gains innovation can bring.


DOL's Proposed Rule: Discrimination on the Basis of Sex

April 16, 2015

By Lynn White, Esq.
In this proposed rule, the Office of Federal Contract Compliance Programs (OFCCP) attempts to clarify the requirements that contractors must fulfill to ensure nondiscrimination on the basis of sex. The OFCCP understated the total costs of the proposed rule, limiting the regulatory analysis to rule familiarization and new costs associated with providing pregnancy accommodations to a limited number of contractor employees. However, actual costs could reach an estimated $130 million or more per year, according to the author's analysis.


CFPB's Prepaid Accounts Under the Electronic Fund Transfer Act (Regulation E) and the Truth in Lending Act (Regulation Z)

March 23, 2015

By Blake Taylor
This Consumer Financial Protection Bureau (CFPB or “Bureau”) proposed rule would extend various consumer protections to prepaid account products. Protections for traditional bank account and credit products now exist through Regulation E, which governs electronic funds transfers, and Regulation Z, which governs the use of consumer credit. However, prepaid accounts such as debit cards that can be pre-loaded with funds are currently unregulated. CFPB proposes to amend Regulation E and Regulation Z to apply existing and new protections to these relatively new financial products by imposing various information disclosure, limited liability, error resolution, and consumer credit requirements. Before proceeding, CFPB should gather more updated information on the prepaid debit card market about sellers and buyers of prepaid cards, as required by statute. As this proposal stands, it is likely to increase costs and may reduce access with little or no discernible benefits for card users.


EPA's National Ambient Air Quality Standards for Ozone

March 17, 2015

By Louis Anthony (Tony) Cox, Jr., Affiliated Scholar
EPA’s quantitative risk estimate (QRA) provides no legitimate reason to believe that the proposed action is “requisite to protect public health” or that reducing the ozone standard further will cause any public health benefits. Given EPA’s information and the unquantified model uncertainty that remains, there is no sound technical basis for asserting with confidence, based on the models and analyses in EPA’s ozone risk assessment, that an ozone standard of 65 ppb would be any more protective than 70 ppb, or that 80 ppb is less protective than 60 ppb. To the contrary, available data suggest that further reductions in ozone levels will make no difference to public health, just as recent past reductions in ozone have had no detectable causal impact on improving public health.


EPA's CO2 Emission Guidelines for Existing Stationary Sources – Electric Utility Generating Units

December 02, 2014

By Brian Mannix
EPA has proposed state-by-state carbon-intensity targets for electricity generation. Several states and other parties have asked EPA to convert these intensity targets into "mass-based" targets – i.e., carbon caps that could be used in cap-and-trade programs. RSC Visiting Scholar Brian Mannix argues that this would be a mistake; emissions trading can work well under an intensity constraint, and would be far more resistant to rent-seeking than would a cap-and-trade program.


DOE's Proposed Efficiency Standards for Commercial Heating and Cooling Equipment

December 01, 2014

by Sofie E. Miller
The Department of Energy's proposed rule amends the existing energy efficiency standards for commercial unitary air conditioners (CUAC) and commercial unitary heat pumps (CUHP), which are used for space conditioning of commercial and industrial buildings. The standards will increase appliance prices for commercial customers such as grocery stores, restaurants, universities, and hospitals by between $2,167 and $5,043 per unit. As DOE explains in its proposed rule, two types of market failure could potentially be addressed by setting energy efficiency standards for CUAC and CUHP: externalities related to greenhouse gas emissions and asymmetric information (and related misaligned incentives) regarding high-efficiency commercial appliances. However, neither of the potential market failures cited by DOE is solved by its proposed energy efficiency standards, leaving the proposal economically unjustifiable.


NHTSA’s Advance Notice of Proposed Rulemaking: Federal Motor Vehicle Safety Standards: Vehicle-to-Vehicle (V2V) Communications

October 21, 2014

By Gerald W. Brock & Lindsay M. Abate (Scherber)
Seeking to address the high number of motor vehicle crashes in the United States, the National Highway Traffic Safety Administration (NHTSA) recently issued an ANPRM that preliminarily proposes to mandate vehicle-to-vehicle (V2V) communication capabilities in new passenger cars and light trucks beginning in 2020. While NHTSA argues that a mandate is necessary to induce collective action because "no single manufacturer will have the incentive to build vehicles able to 'talk' to other vehicles if there are no other vehicles to talk to," we argue that the agency has not clearly demonstrated a market failure that requires regulation. Second, we contend, based on previous government attempts at anticipatory standardization, that it is impossible to predict the future course of technology with enough confidence to prescribe a specific detailed standard that will remain in effect for many years. Finally, we argue that NHTSA's cost-benefit analysis, though necessarily uncertain at this time, appears to underestimate some costs and overestimate some benefits.


FDA's Sanitary Transportation of Human and Animal Food

June 16, 2014

By: Philip J. Austin
The proposed regulation would establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads, properly protecting food during transportation, and strengthening record-keeping standards. This rule would build upon current requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.


FMCSA Hours of Service for Trucking Industry

The Department of Transportation Federal Motor Carrier Safety Administration has established federal hours of service regulations that limit on-duty driving time of drivers of commercial motor vehicles in order to ensure they have adequate time for rest. This proposal would supplement and reinforce those requirements in several ways.

EPA's GHG Emissions from Electric Utility Generating Units

May 9, 2014

By: Sofie E. Miller
The proposed rule would establish new standards of performance for carbon dioxide emissions from coal- and natural gas-fired power plants, or electric generating units. Pursuant to Section 111 of the Clean Air Act, EPA must establish federal standards of performance for new sources which, in the judgment of the Administrator, “cause, or contribute significantly to, air pollution which may reasonably be anticipated to endanger public health or welfare.” The standards should “reflect the degree of emission limitation achievable through the application of the best system of emission reduction which (taking into account the cost of achieving such reduction and any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated.” EPA refers to this as the best system of emission reduction.


EPA's Standards of Performance for Heaters

May 5, 2014

By: Susan E. Dudley
This comment suggests ways to improve EPA’s ex ante analysis, and also recommends steps EPA should commit to now so that it can evaluate whether the rule achieves the projected outcomes once implemented.


NHTSA's Safety Standards for Child Restraint Systems-Side Impact Protection

April 23, 2014

By: Sofie E. Miller
This comment on the National Highway Traffic Safety Administration’s proposed rule setting side-impact requirements for child restraint systems is part of a new project to evaluate how well agencies are preparing for retrospective review and analysis of regulations, pursuant to Executive Order 13563.


NLRB's Representation Case Procedures

April 7, 2014

By: Sofie E. Miller
The proposed regulations govern how notice of an election may be served to an employer, when to determine which employees constitute a “unit” for purposes of representation, how union organizers obtain employee data, the types of issues that can be raised during a pre-election hearing, and in which cases it may be appropriate to appeal election results.


Public Interest Comment on The Interagency Technical Support Document: Technical Update of the Social Cost of Carbon for Regulatory Impact Analysis under Executive Order No. 12866

February 26, 2014

By Susan E. Dudley & Brian Mannix
This comment endorses the administration’s effort to arrive at a uniform SCC, to help ensure internal consistency across a portfolio of policies directed at reducing carbon emissions. However, it raises concerns that the task of estimating the SCC was undertaken with an apparent bias that needs to be corrected before it can be taken as objective.


FDA’s Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

August 12, 2013

By Sofie E. Miller & Cassidy B. West
The Food and Drug Administration’s (FDA) proposed rule establishing standards for growing, harvesting, packing and holding raw produce does not fully meet its statutory obligations and fails to satisfy the regulatory analysis requirements in Executive Orders 12866 and 13563. The rule’s authorizing statue, the Food Safety Modernization Act (FSMA), requires science-based standards and provision of flexibility to all businesses, especially small businesses. However, the proposed rule relies on highly uncertain data to calculate its benefits, and the current formulation of the rule is likely to have a disproportionately negative impact on the small and very small farms covered by the rule. Furthermore, according to FDA’s Preliminary Regulatory Impact Analysis, the regulatory option chosen in the proposed rule does not maximize net benefits. The comment recommends exempting farms with less than $100,000 in annual sales, removing expensive and relatively ineffective standards from the rule, using more realistic statistical representation to calculate the benefits, and explicitly providing for biannual retrospective review to facilitate future improvements to the rule.