April 20, 2018
Capitol Update

In this issue:

Please note, due to the 2018 Engineering Public Policy Symposium, there will not be a new edition of Capitol Update next Friday, April 27.


NEW REPORT TACKLES HURDLES FACING NEXT GENERATION OF BIOMEDICAL RESEARCHERS

The National Academies of Science, Engineering and Medicine recently released a report detailing necessary changes to “strengthen the U.S. biomedical research system for the next generation of scientists.” The report was drafted at the request of Congress, with suggestions on how to open up science careers to make them more accessible and encourage those already in careers to explore opportunities. It also explores the challenges that have led to industry reforms in the past, with propositions on how to be successful going forward.

Biomedical engineering in the U.S. has stagnated to the extent that younger generations of scientists are encountering major hurdles to break into the field. Young, qualified scientists interested in pursuing a career in academic biomedical research currently face a dearth of tenure-track opportunities. Those fortunate enough to obtain one of these coveted positions will spend years in a position that requires long hours, with little training and opportunity for independent research, for even lower pay. The report explains that as of 2016, researchers who were able to transition to independent research received their first National Institute of Health (NIH) grant at an average age of 43, 13 years older than the average age in 1980.

The report provides recommendations to help combat this problem, and ameliorate the opportunities for future bioengineers, which are broken down by intended audience. There are policy and milestone considerations listed for Congress, the NIH, and research institutions.

To view the full report, click here: https://www.nap.edu/catalog/25008/the-next-generation-of-biomedical-and-behavioral-sciences-researchers-breaking


PRESIDENT TRUMP ORDERS TIMELY PROCESSING OF EPA AIR QUALITY REVIEWS

In a new presidential memorandum to Environmental Protection Agency (EPA) Administrator Scott Pruitt, President Trump has asked that the agency speed up its decision making process on company and state air quality compliance with the NAAQS. This is a move intended to bolster the manufacturing industry by making it easier to open new plants. 

In the memorandum Trump stated, “These actions are intended to ensure that EPA carries out its core missions of protecting the environment and improving air quality in accord with statutory requirements, while reducing unnecessary impediments to new manufacturing and business expansion essential for a growing economy.”

The memo instructs the EPA to work with the states as much as possible to ensure they are aware of all the factors affecting their air quality. This includes exploring ways to combat and reduce major pollutants, and improving pollution monitoring and modeling that could benefit both states and their resident industries.

To view the full memorandum, click here: https://www.whitehouse.gov/presidential-actions/presidential-memorandum-administrator-environmental-protection-agency/


REPORT HIGHLIGHTS DIGITAL MANUFACTURING

Globally, the manufacturing landscape is changing as it pushes towards a more digitalized scene to stay on par with the latest technological developments. But what does this mean for an industry traditionally rooted in manual labor? A new report from the Information Technology and Innovation Foundation (ITIF) explores the digitalization of manufacturing, including definition of “smart” manufacturing, also known as “Industry 4.0”.

The report also provides a deeper dive into the promised results of digital manufacturing compared to more traditional manufacturing. “The digitalization of manufacturing is changing how products are designed, fabricated, used, and serviced, just as its transforming the operations, processes and energy footprint of factories and supply chains.”

These analyses are done with a global focus examining the different operating procedures of several countries with strong manufacturing industries, through five case studies. The report provides suggestions of how these states can best support their manufacturing industries transition to a more digitalized mode of operation with the support of standards development.

To view the full report, click here: http://www2.itif.org/2018-manufacturing-digitalization.pdf?_ga=2.127894596.854649056.1523972649-793708545.1523972649


FOOD AND DRUG ADMINISTRATION RELEASES FINAL GUIDANCE ON NEXT-GENERATION SEQUENCING

The Food and Drug Administration (FDA) recently finalized two guidance documents on next-generation sequencing (NGS). The goal of both documents is to aid and expedite developers in bringing their product to market.

The finalized guidance provides recommendations on creating and developing accurate tests, as well as using genetic variant databases to support the trials. Director Jeffrey Shuren, Director of FDA Center for Devices and Radiological Health explained, “The rapid adoption of NGS technologies in research and clinical settings is helping to identify countless new genetic variants. However, information about genetic variants is generally stored in a manner that is not publicly accessible…[the] release of the FDA’s final guidance on genetic variant databases will help change this paradigm by encouraging data sharing and the accumulation in public databases of evidence supporting the clinical validity of genomic tests to help provide an event more efficient path the market.”

One of the documents provides insight into what the agency is looking for in a successful premarket submission, including how validity of tests and trials was determined. The other document details how product developers can better use current resources, including FDA databases, to support the clinical validation of the tests and products they are developing.  FDA will be holding a webinar on these two final guidance documents on May 24, 2018.

For more information on the May 24 webinar, click here: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm603766.htm  

To view the final guidance documents, click here:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509837.pdf

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509838.pdf


TRUMP ADMINISTRATION HINTS AT EXPANDING E15 FUEL USE

President Trump recently announced that he is considering reforms to allow use of E15 fuel all year round. E15 fuel is a gasoline mixture that contains 15 percent ethanol; normal gasoline contains approximately 10 percent ethanol. The Environmental Protection Agency (EPA) currently bans the use of E15 fuel during the summer months due to the risk that the higher percentage of ethanol leads to an increase in ground-level ozone emissions.

The biofuel industry was quick to laud the president’s announcement. Growth Energy CEO Emily Skor said in a statement, “The White House clearly understands that Reod Vapor Pressure (RVP) relief will expand a growing market for America’s farmers while letting consumers pick their fuel of choice. This simple fix allows retailers to offer better options alongside traditional blends all year long.”

The announcement was made as discussions on reforming the Renewable Fuel Standard (RFS) continue. The RFS currently stipulates that refiners incorporate specific amounts of ethanol and other renewable fuels into their fossil fuels, or buy renewable fuel credits. Many in the fossil fuel refining industries are concerned that these stipulations may be harmful to their sectors, prompting discussions on amending the necessary levels of biofuels that need to be incorporated. Earlier this year, President Trump held a meeting with legislators representing both sides, these discussions failed to reach a decision.

For more information on the RFS program, visit: https://www.epa.gov/renewable-fuel-standard-program

The articles contained in Capitol Update are not positions of ASME or any of its sub-entities, unless specifically noted as such. This publication is designed to inform ASME members about issues of concern being debated and discussed in the halls of congress, in the states and in the federal agencies.

ASME Government Relations
1828 L Street, NW, Suite 810
Washington, DC 20036
Website: http://www.asme.org/about-asme/advocacy-government-relations

Paul Fakes is the Regulatory and Government Relations Manager, Technology Policy. He covers Standards and Energy and Environment.

Samantha Fijacko is the Senior Government Relations Representative. She covers Advanced Manufacturing, Robotics and R&D.

Anne Nadler is the Government Relations Representative. She covers Bioengineering, STEM Education and R&D.