By Sunny Lewis

WASHINGTON, DC, March 14, 2017 (ENS) – So many biotechnology products are expected to come to market over the next five to 10 years, that their number and diversity could “overwhelm the U.S. regulatory system,” advises a new report from the National Academies of Sciences, Engineering, and Medicine.

The U.S. biotechnology economy is growing rapidly, with the scale, scope, and complexity of products increasing. More types of organisms will likely be engineered, the report says, and the kinds of traits introduced with biotechnology will increase.

mouse

Transgenic mouse at the University of Wisconsin, Madison’s Biotechnology Center (Photo courtesy UW Madison)

Engineered animals, plants, insects and microbes designed to live in the environment with little or no human management are likely to be more common, finds the report.

Animals revived from extinction, landmine-detecting mice, bioluminescent trees, ever-blooming plants, and microbes designed for bioremediation, as well as synthetic organisms such as DNA barcodes to track products, are just a few of the bioengineered products of the future designed for open release into the environment listed in the report.

The federal agencies involved in regulating biotech products should increase their scientific capabilities, tools, and expertise in key areas of expected growth, advised the 12-member committee of scientists and attorneys who conducted the study and wrote the report.

Agencies will need an approach that balances assessing potential risks while allowing technological advances, the committee says.

“The rate at which biotechnology products are introduced – and the types of products – are expected to significantly increase in the next five to 10 years, and federal agencies need to prepare for this growth,” said committee chair Richard Murray, a bioengineering professor at the California Institute of Technology.

These federal agencies are headed by the U.S. Environmental Protection Agency, the Food and Drug Administration and the Department of Agriculture, the three agencies that sponsored the report.

During a March 9 webinar announcing the report, Murray said an explosion in new biotech products over the next decade could overwhelm federal regulators.

Some future biotechnology products are likely to use genome-editing techniques such as CRISPR for familiar applications, such as modifying agricultural crops.

Other future products are expected to be entirely new – plants that can serve as sentinels of environmental contamination, for example, and collections of microorganisms that can efficiently produce chemical compounds.

“We hope this report will support agency efforts to effectively evaluate these future products in ways that ensure public safety, protect the environment, build public confidence, and support innovation,” Murray said.

Some of the bioengineered products of the future listed in the report as “designed for containment” include:

  • Cowless leather and cowless meat derived from animal cell culture – both under development
  • Implantable biosensors
  • Metal recycling organisms
  • Plastics produced by plants for industrial use
  • Synthetic silk
  • Antimicrobials derived from bacteria
  • Bacterial strains for fermentation-based products
  • Algae-derived products to substitute for shark fins, shrimp, biofuels, ethylene
  • Probiotics

There are many bioengineered products designed for containment already on the market.

Existing products include:

  • Transgenic lab animals such as mice, rats, dogs, mini-swine
  • Genetically engineered salmon grown in land-based facilities
  • Industrial enzymes
  • Biobased chemicals to replace fossil fuel feedstocks
  • Bioluminescent microbes for home and landscape uses
  • Yeast-drived molecules to create food products: vanillin, stevia, saffron, eggwhites, milk protein, gelatin

One bioengineered product line that could revolutionize drug development, disease modeling and personalized medicine are
microchips lined by living human cells called “organs-on-chips.”

Wyss Institute researchers at Harvard University, and their collaborators, report that they have engineered microchips that “recapitulate the microarchitecture and functions of living human organs, including the lung, intestine, kidney, skin, bone marrow and blood-brain barrier.”

These microchips, called “organs-on-chips,” offer a potential alternative to traditional animal testing.

Each individual organ-on-chip is composed of a clear flexible polymer about the size of a computer memory stick that contains hollow microfluidic channels.

These channels are lined by living human cells interfaced with a human endothelial cell-lined artificial vasculature, the researchers explain.

Mechanical forces can be applied to mimic the physical microenvironment of living organs, including breathing motions in lung and peristalsis-like deformations in the intestine.

Because the microdevices are translucent, they provide a window into the inner workings of human organs.

Current staffing levels, expertise, and resources available at EPA, FDA, USDA and other agencies may not be able to address the expected scope and scale of future biotechnology products, the report says.

Interests and concerns articulated by the Executive Office of the President in requesting the report include: supporting innovation, protection of human health, preserving biodiversity, reducing negative environmental effects, promoting public confidence in the regulatory process, increasing transparency and predictability in the regulatory process, reducing unnecessary costs and burdens, making use of new tools from many disciplines and interacting with the global economy.

“Our conclusion was that staffing levels may not be sufficient,” Murray said on the webinar. He suggested that agencies could add staff and also build more public-private partnerships and improve efficiency.

It is critical that the regulatory agencies develop and maintain scientific capabilities, tools, and expertise in key evolving areas such as understanding the unintended effects of genetic changes on both target and non-target organisms, predicting and monitoring ecosystem responses, and predicting the economic and social costs and benefits of biotechnologies.

The report predicts, “The pipeline of biotechnology products likely to emerge over the next decade probably will result in disruptive innovations and significant societal impacts.”

The report says, “The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion.”

At times, FDA, EPA, and USDA may need to make use of the flexibility under their statutes to minimize gaps in jurisdiction, the committee writes.

Even when statutes do allow agencies to regulate products, the current statutes may not adequately equip regulators with the tools to regulate the products effectively, the panel said.

For example, the statutes may not empower regulators to require product sponsors to share in the burden of generating information about product safety, and may place the burden of proof on regulators to demonstrate that a product is unsafe before they can take action to protect the public.

“This implies that adequate federal support for research will be crucial to protect consumer and occupational safety and the environment,” the panel advises.

Biotechnology products on the horizon are likely to generate substantial public debate, the report notes. Many members of society have concerns over the safety and ethics of various biotechnologies, while others see prospects for biotechnology addressing social or environmental problems.

The U.S. regulatory system will need to achieve a balance among competing interests, risks, and benefits when considering how to manage development and use of new biotech products.

The panel calls for more research to develop methods for governance systems that integrate ethical, cultural, and social implications into risk assessments in ways that are meaningful.

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