Monday, July 30, 2018

Guest Blog: European Union Issues Crucial Ruling on Regulating Gene-edited Organisms as GMOs

Guest Blog by Greg Jaffe, Center for Science in the Public Interest
Click here to access the original blog

The long wait is over. The decision by the European Court of Justice (ECJ) on whether certain gene-edited organisms are included in the European Union’s (EU) GMO regulation was released July 25, 2018. The court’s unambiguous conclusion is that organisms made by any mutagenesis method are GMOs under the European GMO regulations [1].  However, the Court stated that a small subset of mutagenesis techniques “which have been conventionally used in a number of applications and have a long safety record” are exempt from the substantive requirements of those regulations. Newer mutagenetic techniques developed after 2001, including gene-edited techniques such as CRISPR that permit more precise gene editing than previous techniques, do not qualify for the mutagenesis exemption and must meet the same regulatory requirements that more traditional GMOs must abide by, such as an environmental risk assessment and government authorization.

The Court's Decision

In making its decision, the ECJ applied a strict interpretation of EU Directive 2001/18 (Directive)—the EU regulation for the deliberative release into the environment of a GMO—and heavily relied on its understanding of the objectives of that Directive, as set forth in the EU Parliament’s stated reasons for enacting it (the “whereas” or recital statements preceding the Directive [2]).

Under EU Directive 2001/18, a GMO is “an organism…in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” The Directive then lists some techniques that are considered genetic modification, such as recombinant DNA and cell fusion, and it also includes an exhaustive list of techniques that are not considered genetic modification, such as in vitro fertilization and conjugation. The Directive also asserts that certain GMO techniques should be exempt from its substantive requirements, meaning that the product is a GMO but no risk assessment or approval is required. Mutagenesis is included in that exempt category but only if it “does not involve the use of recombinant DNA molecules or GMOs.” Based on those provisions in the Directive, the ECJ found straightforwardly that organisms produced with any mutagenesis techniques, which alter the genetic material of organisms, qualify as GMOs under the Directive. The EU Parliament clearly meant for mutagenetic organisms to be GMOs the court reasoned, because it then exempted some of them from the substantive obligations of the Directive.

The ECJ’s opinion then discusses whether the mutagenesis exemption is frozen in time or can incorporate newer methods of mutagenesis, such as certain gene-editing techniques that do not introduce foreign DNA. Here, the elephant in the room was CRISPR. To decide this question, the ECJ relied heavily on Recital 17 of the GMO Directive, which states that it does not apply to techniques “which have conventionally been used in a number of applications and have a long safety record.” The ECJ also relied on the EU Parliament’s reference to the precautionary principle (Recital 8) and the Directive’s objective “to follow closely the development and use of GMOs” (Recital 55). The ECJ also found persuasive the statement from the referring French court that “the risks linked to the use of those new techniques/methods of mutagenesis might prove to be similar to those which result from the production and release of a GMO through transgenesis” and that gene editing could produce the same product as when a foreign gene is introduced.

Based on all those provisions, the ECJ stated that for mutagenesis techniques developed after 2001, such as CRISPR, “the risks for the environment or for human health have not thus far been established with certainty.” Therefore, the ECJ determined that only conventional mutagenetic techniques with a long safety record are excluded from the scope of the directive, and so CRISPR and other new mutagenesis techniques are to be treated like GMOs.

Implications of the Court Decision

The first impact of the ECJ decision is that the mutagenesis exemption is frozen in time. Only conventional mutagenesis techniques with a proven safety record that were used before the regulation was enacted in 2001 qualify for the exemption. Any new agricultural breeding techniques that are developed after 2001 that alter genetic material in a way that does not occur “naturally by mating and/or natural recombination” will not only meet the definition of a GMO but will also need to comply with the regulation’s substantive provisions. This means that the length of time that a technique has been used is the primary consideration determining whether a product gets a safety assessment, not the potential risk of the technique or the product itself. By not basing regulatory oversight on potential risk, the result is that some techniques and products that pose little or no risk will be overregulated. Instead, it would be better policy if safety oversight were based on the potential risk of the technique and the product produced, not whether a breeding technique qualifies under a 17-year-old definition of a GMO. The regulatory system should use its scarce resources to review and ensure the safety of products that pose potential risks, rather than wasting time on products that don’t raise any safety concerns, which could be the case for some gene-edited products.

The second impact of the ECJ decision will be that the EU regulatory system could be inundated with applications to release gene-edited crops and cause significant trade disruptions. Many gene-edited crops are under development in the United States, Europe, and throughout the world. Under the ECJ decision, all of those will need to undergo the rigorous approval process that the EU currently performs for GMOs. By contrast, the United States Department of Agriculture has stated that gene-edited crops that mimic crops that could be produced with conventional mutagenesis need no regulatory oversight.  So, if the EU’s regulatory system does not adopt different procedures for gene-edited products than it has for GMOs and does not review those products in a timely fashion, compliance with Directive 2001/18 could become a barrier that prevents gene editing from being utilized in Europe. In addition, as farmers start producing gene-edited products in the United States and other countries around the world, products that have not been deemed safe under the European GMO regulations will not be allowed to enter the EU, creating trade disputes. The world already has experienced the economic impact of asynchronous approvals for GMOs, when China and Europe rejected U.S. grain imports because a GMO crop was not approved in that country. However, the impact could be several times greater this time because there are so many gene-edited crops in the commercial development pipeline. The trade issue also will be compounded by the fact that biological tests can identify traditional GMOs, while it will be extremely difficult, if not impossible, to identify gene-edited crops.  Many of the genetic alterations will mimic, and be indistinguishable from, changes that could be produced with conventional mutagenesis techniques.

Final Thoughts

It will take some time for the different stakeholders in Europe to determine all the ramifications of today’s ECJ decision and for the regulatory system to decide how it will implement that decision. Legislators could also become involved and draft a new directive to clarify whether to continue to include these newer mutagenesis techniques under the existing GMO Directive. While the ECJ decision continues the overall precautionary approach that Europe takes to new biotechnology, one can hope that this ECJ decision will spark for Europe to establish a new regulatory system for gene-editing techniques that is proportionate and risk based, and that treats those products on their own merit, instead of relegating them to a GMO regulatory system that was not designed for them, and one with a track record that has a lot to be desired.

[1] “Mutagenesis” is defined as changing the genetic material of an organism in a stable manner, resulting in a mutation.

[2] A “Recital” or “Whereas” clause is the preamble to a law or regulation in which the legislators identify the reasons for the law or regulation.  It is not part of the law but explains to the public, regulators, and judges some of the facts or circumstances that the legislators considered when they passed the law.

Wednesday, July 25, 2018

County Fair Season: Through the Evolving Eyes of an Exhibitor

Ever since I was a little girl, not yet old enough to exhibit animals of my own, the county fair was a highly anticipated time of year. Although I still look forward to this season every summer, my involvement and experiences have changed tremendously throughout the past 23 years.

As I look back on the days of my six-year-old self at the Monroe County Fair, my memories are fairly vague. Remembering the faint smell of kettle corn makes my mouth water; the crash and bang of demolished cars sits me down on the wooden benches in the grandstand; the feelings of sticky, red fingers reminds me of that delicious snow cone that quenched my thirst on a hot summer day; and the faint sound of pigs, cows, horses, and chickens provides background noise as Dad and I walk through a sea of green John Deere tractors.

Reminiscing on the Memories 

As the years passed by, I became more involved and the fair quickly developed a different meaning. What was once just a fun day at the fair became the event of the summer, in my eyes. After working hard throughout the year, the fair was the ultimate reward. I was proud of what my family did for a living and the fair was always a way to showcase our passion and hard work. It was a chance to grow, and grow up.

I remember the sense of pride I felt after looking up at my family in the bleachers as they watched me show my first calf. The nervous butterflies that twisted and turned in my stomach return when I reminisce on the day the announcer called my horse, Thunder, and I to the arena for our turn at completing the trail-riding course we had been training for all summer. A smile forms on my face when I look back on the countless water balloon wars that took place in the wash racks. Excitement overwhelms me as I recall winning the 2013 Monroe County Fair Queen contest--a goal I had set for myself during my first few years of joining 4-H. Happiness fills my heart as I relive those "congratulations, kid" and "I'm so proud of you" hugs I received from my parents at the backdrop while holding new hardware for the trophy case.

Throughout the Years

Regardless of your involvement, I'm sure you have memories filed away from your time at the fair. Now that I am a 4-H has-been, I spend a great deal of time thinking back on the memories made, friendships created, and lessons learned. I now live vicariously through my youngest sister and celebrate in her successes. It's gratifying to see individuals display the fruits of their labor and watch the agriculturalists of tomorrow prosper and grow through their experiences at the fair. That feeling of accomplishment, passed down from one generation to the next, instills confidence in the future of agriculture. During this year's local and state fair season, I encourage all of you to step outside the grandstands or midway and instead open your eyes to the best American agriculture has to offer. Ask questions, learn something new, or find ways to get involved.

By: Kylie Peterson

Friday, July 20, 2018

Free-range Poultry Paper Adds Credible Info to the Debate

CAST EVP Kent Schescke welcomed audiences at three sessions in the nation's capital on July 18 to roll out the organization's latest issue paper: Impact of Free-range Poultry Production Systems on Animal Health, Human Health, Productivity, Environment, Food Safety, and Animal Welfare Issues.
The events included a morning panel discussion cohosted by the Food Marketing Institute, a lunch program at the Longworth House Office Building, and an afternoon program at the Senate's Capitol Visitor Center. 

Above: Anthony Pescatore presents at a CAST rollout on the Hill. He and cochair Jacqueline Jacob (both of the University of Kentucky) led three sessions. Click here to access a video/PowerPoint presentation of the key findings.

As farmers in the United States try to develop new poultry operations that meet consumer demand and continue to make sustainability strides, they often deal with confusing definitions and confounding research related to this field. Led by Task Force Cochairs Jacqueline P. Jacob and Anthony J. Pescatore, the authors of this issue paper bring attention and clarification to the topic as they assess various aspects of multiple poultry production systems.

A Feedstuffs article says the paper shows that "while many perceive free-range poultry production systems to be more animal-welfare friendly, the research comparing the different production systems is inconclusive and often contradictory." An analysis in AgriPulse agreed and noted the research shows that "The safety of poultry meat and eggs is determined more by management than by whether the birds are in confined facilities or outdoors."

The full text of IP 61 is here, and its companion Ag quickCAST is here.  

Monday, July 16, 2018

New Research about Free-range Chickens--and Poultry Insights about Backyards and Sexing

CAST Research Paper Rollout 

The Council for Agricultural Science and Technology is hosting three presentations regarding the new research paper Impact of Free-range Poultry Production Systems on Animal Health, Human Health, Productivity, Environment, Food Safety, and Animal Welfare Issues

The rollout will occur at three venues in Washington, D.C., on Wednesday, July 18. 

8:30 - 10:30 AM EDT
Breakfast Presentation and Panel Discussion
FMI, 2345 Crystal Drive, Suite 800, Arlington, VA
~ cohosted by Food Marketing Institute (FMI)

12:15 to 1:15 PM Lunch Presentation
1302 Longworth House Office Building

2:30 to 3:30 PM Presentation
Capitol Visitor Center, Room 202 (Senate side)
CAST will post a video on its website and provide a free download of the issue paper. 

Raising Backyard Chickens--Better than Television 

With the boom in backyard chicken entities, observers note plenty of benefits along with some specific concerns. This blog entry is about a farm couple who took on chicken raising with the right attitude and for the right reasons.

The Problem with Sexing--and Science to the Rescue

When prospective chicken farmers order their birds, they sometimes receive a certain amount of roosters with the shipment. As you might expect, the males generally make a lot of noise and bother the productive females. They don’t even taste very good. Apparently, sexual misidentification is hurting this backyard chicken movement
Two breakthroughs might help with this problem:  (1) A new gene technology to differentiate between male and female chicks pre-hatch could improve animal production, reduce costs, and eliminate ethical dilemmas for the egg and poultry industries. (2) The race to bring egg sexing tech to market is extremely close, and different technologies are being developed in Germany, Israel, Canada, and the Netherlands.
by dan gogerty (bottom pic from dailygreen.jpg)