Week in Review

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President Biden issues executive order on regulatory review, EPA proposes new standards for drinking water reports, and more…

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  • President Joseph R. Biden signed an executive order seeking to modernize the U.S. federal government’s regulatory processes. The order updates the threshold for the comprehensive economic analysis of new regulations, and it calls for federal agencies to increase public participation and include affected communities in regulatory activities. The Office of Information and Regulatory Affairs (OIRA) also proposed revisions to its guidance on regulatory analysis. Those revisions call for the office’s benefit-cost analysis of regulatory proposals to include a fuller range of impacts, including by offering new standards for calculating the present value of future costs and benefits of a proposed rule. OIRA Administrator Richard L. Revesz stated that these changes aim to “produce a more efficient, effective regulatory review process that will help improve peoples’ lives.”
  • The U.S. Environmental Protection Agency (EPA) proposed revisions to the consumer confidence report rule, which requires community drinking water providers, such as a municipality’s water department, to deliver an annual report to their customers about water quality. The revised rule would require providers to include more information on lead levels, corrosion, and their actions to address lead contamination. The revised rule would also require providers serving over 10,000 customers to submit biannual quality reports to EPA. The agency stated that the revised rule would help identify public health threats. 
  • The U.S. Department of Justice issued a final rule granting the Director of the Federal Bureau of Prisons the discretion to allow individuals who were released from prison to home confinement during the coronavirus pandemic to remain under home confinement after the public health emergency expires. The rule also allows the Bureau of Prisons to move individuals under home confinement into a residential reentry center if that individual’s home is no longer a secure option. U.S. Attorney General Merrick B. Garland noted that the rule will ensure that individuals are “not unnecessarily returned to prison.”
  • EPA also proposed updates to the Mercury and Air Toxics Standards that would reduce the amount of mercury, arsenic, nickel, and lead emissions allowed by coal-fired power plants. EPA noted that these updates fulfill its responsibility under the Clean Air Act to review emissions standards. The proposed updates would protect the health of communities that live near power plants and anyone affected by hazardous air pollution. EPA Administrator Michael S. Regan stated that the proposal leverages proven methods to reduce emissions at reasonable costs. 
  • The Kansas legislature voted to override Governor Laura Kelly’s veto of a bill that bars transgender scholastic athletes from competing in girls’ and women’s sports. The law, which Kelly had previously vetoed on two other occasions, is now set to take effect on July 1. In her latest veto message, Kelly contended that the law will “harm the mental health of our students.” On the other hand, Kansas House Majority Leader Dan Hawkins argued that the bill’s passage reflected the legislature’s desire to “proudly stand with female athletes.”
  • The U.S. Food and Drug Administration (FDA) issued a draft guidance recommending that manufacturers of machine learning-based medical devices include particular information when they submit those devices for approval from the agency. Current regulations require makers of these devices to describe expected algorithmic modifications to their products and those modifications’ safety and effectiveness. FDA stated that this guidance reflects the agency’s interest in promoting innovation in and taking a “least burdensome approach” to developing these types of machine learning models.
  • EPA also granted California two waivers approving recent California Air Resource Board regulations aimed at reducing transportation emissions. The approved regulations include a requirement that manufacturers transition to producing vehicles with zero emission technology. EPA Administrator Michael S. Regan stated that these regulations are a part of California’s “long standing authority” to set its own standards for vehicle emissions.
  • New Jersey Governor Philip D. Murphy signed legislation that doubles the state’s campaign contribution limits from $2,600 to $5,200 per election cycle. The legislation also authorized the governor to appoint commissioners to the state’s Election Law Enforcement Commission without approval from the state senate and reduced the statute of limitations on campaign finance investigations from 10 years to 2 years. Opponents of the legislation argued that it rolls back campaign finance reforms and eliminates the commission’s impartiality.
  • Australian Attorney-General Mark Dreyfus announced a ban of the app TikTok from all government-owned devices. Australia’s ban, which Dreyfus announced would be implemented “as soon as practicable,” makes it the last country in the “5 Eyes” intelligence-sharing alliance to ban the app on federal devices. New Zealand, Canada, the United Kingdom, and the United States had already banned the app. Although the ban is intended to eliminate the app’s presence on all government devices, Dreyfus noted that the government would grant limited exemptions to the ban with proper security measures.



  • In an essay in The Regulatory Review, Patricia J. Zettler, professor at the Ohio State University Moritz College of Law, Jacob S. Sherkow, professor at the University of Illinois College of Law, and Christi Guerrini, professor at the Baylor College of Medicine, discussed the lack of regulations governing genetic self-experimentation and encouraged the government to reconsider its current approach. Zettler, Sherkow, and Guerrini explained that genetic self-experimentation is a part of a movement called genetic biohacking, where individuals subject themselves to genetic scientific experimentation, such as injecting themselves with a potential HIV therapy. Zettler, Sherkow, and Guerrini observed that traditional research regulations that protect human research participants do not apply to self-experimentation. Zettler, Sherkow, and Guerrini suggested that, although FDA regulates genetic self-biohacking kits, the potential for genetic biohacking to affect other individuals—such as through CRISPR’s genetic editing of embryos—means that regulators should scrutinize these tools more closely.