Latest Regulatory News

May 22, 2019 - - 0
We Have the Technology to Customize Our Babies. It Needs Regulation.

When Chinese scientist He Jiankui announced last November his experiments making heritable genetic changes in human embryos followed by live births of twins, alarms went off. What shocked many scientists and others was how Mr. He used new technology for gene editing without serious oversight or transparency, amid grave questions about the medical rationale and potential future damage. One good thing came out of this: Mr. He spurred a more deliberate, international effort to answer the hard questions. Now that effort must lead to stricter regulation. The world is at an inflection point not unlike that which gave rise to the Asimolar Conference on Recombinant DNA in February 1975. That conference considered biohazards and published guidelines on what was then an emerging biotechnology field; these guidelines helped steer significant research for decades. Something of similar scope and power is needed for germline editing of genes in human embryos, sperm and eggs that can create changes to be passed through future generations. The technology of the method CRISPR-Cas9, in which genetic material can be edited quickly and cheaply, was used by Mr. He to manipulate an embryo to edit a gene. Ultimately, the amazing CRISPR technology may help conquer certain diseases and alleviate suffering, but it could be used recklessly and immorally. A commentary in the journal Nature has called for a global, temporary moratorium on clinical uses of human germline editing, defined as “changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children.” The moratorium could be hard to enforce, but it would offer a breather to sort out scientific and ethical issues. Among the authors of the essay is Nobel laureate Paul Berg, an emeritus professor of biochemistry at Stanford University, who helped organize Asimolar. The authors suggest that a goal might be some kind of international research framework. Genome editing ultimately can affect all humankind, but any regulation must be sensitive to individual nations and societies — not an easy task.

May 22, 2019 - - 0
Don't Look to Texas on Energy Deregulation

If President Trump wants to know what a deregulated energy future looks like, he doesn’t have to look any further than Texas. The president believes ending protections for workers and the environment will help big business thrive. Not surprisingly, this view looks pretty good to the billionaires he surrounds himself with. But in the Houston area this spring, our own view has been obscured by plumes of dark smoke rising from three major industrial fires. We’re seeing up close how a lack of industrial regulation damages communities and ecosystems. It is short-sighted and, in the long run, hurts everyone.

May 22, 2019 - - 0
EPA’s Magic Disappearance Trick

Trump EPA’s argument is really nothing more than a play on words. It takes the terms “public health” and “margin of safety” and twists them into meaning something quite different: a guarantee of absolutely zero risk. But there are no such guarantees, as Congress knew full well. Trump’s EPA wants to use a sleight of hand to magically make hundreds of annual deaths disappear from sight. Like most disappearing acts, this requires distracting the audience with something flashy while the magician hides something right beneath the audience’s eyes.

May 22, 2019 - - 0
Sea Levels Could Rise Faster Than Expected, Swamping Coastal Cities: Study

A study published Monday warned sea levels could rise by more than two meters (about 6.6 feet) by the end of the century due to climate change, which would swamp coastal cities. The authors of a study published in the Proceedings of the National Academy of Sciences concluded it was "plausible" that sea level rising could exceed two meters, potentially resulting in the displacement of up to 187 million people and significant land loss in "critical regions of food production." "A SLR [sea level rise] of this magnitude would clearly have profound consequences for humanity," the team concluded.

May 22, 2019 - - 0
What the FERC? How One Federal Agency Is Quietly Shaping Climate Policy.

Some of the most consequential decisions about how the US government deals with climate change are being made by the Federal Energy Regulatory Commission (FERC), an agency few people are aware exists and even fewer people track closely. But FERC sits at the heart of the clean energy transition, overseeing two key areas of frequent conflict. The first is bulk electricity — interstate transmission lines and regional wholesale power markets. The second is natural gas infrastructure; the agency licenses the siting and building of all new pipelines. FERC is composed of five commissioners; by law, no more than three may be from one party. In a series of 3-2 decisions, the Trump-appointed Republican commissioners have effectively refused to take climate into account at all in pipeline decisions. This has prompted a series of scathing dissents from Commissioner Richard Glick, a former Democratic Senate aide whom President Trump appointed to the commission in 2017. Now Glick has taken a step back and, along with his adviser Matthew Christiansen, gathered his thoughts into an academic article, just published in the Energy Law Review. It’s called “FERC and climate change.” Their conclusion, in a nutshell, is that FERC doesn’t need to reinvent the wheel to address climate change. It doesn’t need a new regulatory regime or new authorities. It just needs to diligently obey its current mandates.

This Week at OIRA

Updated Fridays. Abbreviations: IFR = Interim Final Rule | PR = Proposed Rule | FR = Final Rule | RIN = Regulation Identifier Number


CPBSD, Significant Revisions of Part 51, Committee for Purchase From People Who Are Blind or Severely Disabled, PR, RIN: 3037-AA12received 5/13/19
DOC-PTO, Requirement of U.S. Licensed Attorney for Foreign Trademark Applicants and Registrants, FR, RIN: 0651-AD30received 5/13/19
DOI-BLM, Non-Energy Solid Leasable Mineral Royalty Rate Reduction, PR, RIN: 1004-AE58received 5/14/19
DOL-ETA, Trade Adjustment Assistance for Workers, PR, RIN: 1205-AB78received 5/14/19
HHS-CMS, Request for Information: Patients over Paperwork, Notice, RIN: 0938-ZB54 – received 5/10/19
IRS, MEPs and the Unified Plan Rule, PR, RIN: 1545-BO97received 5/13/19
IRS, Regulations Under Sections 91 and 245A, IFR, RIN: 1545-BO64received 5/14/19
IRS, Guidance Related to Section 951A (Global Intangible Low-Taxed Income Regulations), FR, RIN: 1545-BO54received 5/16/19
IRS, Guidance Under Sections 951(b) and 951A, PR, RIN: 1545-BP15 – received 5/16/19
IRS, Guidance on Section 4968 Excise Tax on College Net Investment Income, PR, RIN: 1545-BO75received 5/16/19
VA, Service Mbrs Grp Life Insurance – Definition of Stillborn Child for Purposes of Coverage, PR, RIN: 2900-AQ49 – received 5/16/19
VA, Center for Innovation for Care and Payment, PR, RIN: 2900-AQ56 – received 5/16/19
Received Week of 5/13/19 – 5/17/19


DOC, Revision to a Country Group Designation to Better Protect U.S. National Security Interests and to Better Align with Other EAR National Security Provisions, FR, RIN: 0694-AH78 – completed 5/14/19 (received last week)
DOJ, Board of Immigration Appeals: Affirmance Without Opinion, Referral for Three-Board-Member Review, and Publication of Decisions as Precedents, FR, RIN: 1125-AA58completed 5/10/19
HHS-CMS, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses, FR, RIN: 0938-AT92 – completed 5/16/19
VA, Removing Net Worth Requirement From Health Care Enrollment, FR, RIN: 2900-AP37completed 5/14/19
Completed Week of 5/13/19 – 5/17/19
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