New plants like corn and mushrooms altered with CRISPR gene editing are falling outside the purview of US regulators

The first article below contains the usual false claims of accuracy and precision for "gene editing" GMO techniques, and of a supposed scientific consensus on the safety of GM crops in general.

But the take-home message is that with regard to GMOs developed using the CRISPR gene editing technique, the US is not even applying the abysmally weak regulations it normally applies to old-style GMOs.

The USDA has stated that the new corn and mushrooms will be unregulated by the agency.

1. The next generation of GMO food is here, and it's technically not a GMO
2. Here come the unregulated GMOs
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1. The next generation of GMO food is here, and it's technically not a GMO

Erin Brodwin
Business Insider, 18 Apr 2016
http://uk.businessinsider.com/dupont-crispr-corn-in-stores-in-5-years?r=US&IR=T

In a letter released to the public on Monday, chemical giant DuPont Pioneer announced plans to market the first crop that uses a type of precise genetic modification called CRISPR-Cas9.

DuPont is the fourth-largest chemical corporation in the world, and it wants to see the product — a hybrid type of corn — in farmers' fields as early as 2021.

"We're applying our 90 years of knowledge of corn biology to develop the next generation of high-quality waxy corn hybrids for the benefit of the entire value chain from growers to processors and end users," Neal Gutterson, DuPont Pioneer's vice president of research and development, said in a statement.

The US Department of Agriculture has said that it will not subject the CRISPR corn to the same rules as traditional GMOs.

In response to Pioneer's "Regulated Article Letter of Inquiry," about the new product, the USDA said that it does not consider the CRISPR corn "as regulated by USDA Biotechnology Regulatory Services."

This comes on the heels of a letter released last week in which the USDA said that it wouldn't regulate a mushroom that had been gene-edited with the same type of CRISPR technology. In its case, the genetic tweaks helped keep the mushroom from turning brown.

Like with the corn, this approach is widely different from the one the USDA has previously taken with traditional GMOs, which are regulated by the agency's Animal and Plant Health Inspection Service. APHIS keeps an eye on new genetically modified organisms that "may pose a risk to plant health".

But unlike the mushroom, which was created by researchers at Penn State with no plans to bring the product to market, the corn would ideally be on grocery-store shelves in the next few years.

"The next generation of waxy hybrids developed with CRISPR-Cas will represent a step-change in how efficiently we bring elite genetic platforms of high-yielding waxy corn to our customers," said Gutterson.

Essentially, CRISPR is a far more accurate method of modifying genes than scientists have had access to before.

At the center of the agency's decision not to subject the new crop to its rules is the fact that the CRISPR-edited crops don't contain any "introduced genetic material" or foreign DNA, and so would not be a threat to other plants.

This is the focus of a lot of the policy surrounding GMOs, or genetically modified organisms. Because GMO crops are tweaked in a lab to contain harmless DNA from other organisms, like bacteria, which help make them more resistant to things like drought or pests, they are regulated by the USDA.

In its letter, the agency says firmly that the CRISPR-edited mushroom doesn't pose a risk to plant health, so it doesn't need to be regulated:

APHIS has no reason to believe that CRISPR/Cas-9-edited white button mushrooms are plant pests. Therefore, consistent with previous responses to similar letters of inquiry, APHIS does not consider CRISPR/Cas-9-edited white button mushrooms ... to be regulated.

A world of CRISPR crops?

This could be the shape of things to come.

"If USDA decides the first product does not require regulation, that would definitely be encouraging for the many people already using CRISPR," Joyce Van Eck, an assistant professor at the Boyce Thompson Institute, told the Genetic Expert News Service last week.

Many researchers are currently looking into developing CRISPR food products.

DuPont Pioneer has been collaborating on research and intellectual property with Caribou Biosciences, the biotech company cofounded by Jennifer Doudna, one of the discoverers of CRISPR, for sometime now.

Maywa Montenegro wrote for environmental-news site Ensia in January:

“Since its 2013 demonstration as a genome editing tool in Arabidopsis and tobacco — two widely used laboratory plants — CRISPR has been road-tested in crops, including wheat, rice, soybeans, potatoes, sorghum, oranges and tomatoes. By the end of 2014, a flood of research into agricultural uses for CRISPR included a spectrum of applications, from boosting crop resistance to pests to reducing the toll of livestock disease.”

This could be good news given Americans' hefty — though scientifically unfounded — opposition to GMOs. The National Academy of Sciences, the American Association for the Advancement of Science, and the European Commission have all said that traditional GMO foods are safe to eat.

A large scientific study from 2013 found no "significant hazards directly connected with the use of genetically engineered crops". But CRISPR crops won't be traditional GMOs. And perhaps they'll start to change people's minds about the future of food.

2. Here come the unregulated GMOs

by Antonio Regalado
MIT Technology Review, April 15, 2016
https://www.technologyreview.com/s/601285/here-come-the-unregulated-gmos/

* New plants like a mushroom altered with CRISPR gene editing are falling outside the purview of regulators

People are arguing about whether genetically modified foods should carry labels. But the next generation of GMOs might not only be unlabeled — they might be unregulated.

Over at Scientific American you can read a 6,000-word story about how one such plant, a GM mushroom, was created. The short version is that a plant scientist named Yinong Yang used the gene-editing technique called CRISPR to snip out a few DNA letters in the genome of “Agaricus bisporus, the most popular dinner-table mushroom in the Western world”.

The result: he turned off an enzyme that turns mushrooms brown.

Why wouldn’t a modified mushroom be regulated, you ask? Because regulation of GMOs is a big mess that doesn’t make too much sense. Back in the 1900s, when Monsanto and the like were first coming out with biotech crops, the U.S. cobbled together a way to regulate them from existing rules.

Those early GMOs (and most since) had genes from bacteria in them, like the gene that makes Monsanto’s Roundup Ready soybeans survive a dousing of weed killer. What the U.S. Department of Agriculture decided is, since the plants had DNA from germs, it could regulate these crops under its authority to control plant pests.

But Yang’s mushroom doesn’t have any bacterial DNA in its genome. He didn’t add any DNA at all, he told the U.S. Department of Agriculture. Instead, he just used gene-editing to blow a few teeny little holes in one gene and shut it off.

As a result, the USDA’s APHIS division told Yang his GMO plant isn’t going to be regulated because it sidesteps the regulation:

“APHIS has concluded that your CRISPR/Cas9-edited white button mushrooms as described in your letter do not contain any introduced genetic material. APHIS has no reason to believe that CRISPR/Cas9-edited white button mushrooms are plant pests.”

It’s not the first product to get cleared in this way. Last summer we wrote about a potato with a similar modification, also to stop browning, and there have been a handful of others.

Biotech plant companies are excited. They’re going to be able to innovate fast now that they don’t have to spend a decade doing field trials.

Regulators are scrambling to catch up with the science. Right now, the U.S. is revisiting its rules governing how GMOs should be handled and crop developers are also “anxiously waiting” to find out if gene-edited plants will be treated any differently in Europe, according to Jennifer Kuzma, a professor and policy researcher at North Carolina State University.

Kuzma’s recent analysis of GMO regulations will interest anyone who wants the details. Her takeaway is that “oversight of [genetic-engineering] has never seemed so much like a powder keg waiting to explode”. She thinks the rise of gene editing is “a chance to start over” with regulations that make more sense scientifically but that also find a way to reflect the “values” of people who oppose GMOs and just don’t like messing with nature.

Don’t hold your breath for this mushroom to hit store shelves. Yang, a professor at Pennsylvania State University, told me that the company that helped pay for the research, Giorgio Mushroom Co. of Pennsylvania, isn’t convinced they’d want to sell it. “[The] marketing people at Giorgio are more interested in organic mushrooms and are afraid of negative response regarding GMO from consumers,” Yang says.