What will your Christmas gifts be placed under this year? A Fraser fir? A Douglas fir? An artificial tree?

While some individuals love the look and smell of a real Christmas tree, others prefer the low upkeep and longevity of an artificial tree.

But what if we could use genetics to improve the Christmas tree? Would you trade in the fake tree for a fir that loses less needles and requires less upkeep?

Here are four facts about using genetics in pursuit of a more perfect Christmas tree:

1) Very little has been known about the genomes of Christmas trees. Megan Molteni of Wired reported last year:

“…the conifer genome is not just enormous-20 billion base pairs compared to your 3 billion-but also pretty weird. At some point in their deep past, spruces, pines, firs, and their relatives acquired a complete second set of genes. Scientists think this genome-wide duplication likely helped shape these species into the tallest, hardiest plants in the world. But it’s also made sequencing them an incredibly daunting challenge. And unlike corn and soybean, there hasn’t been much money available to even try. So far scientists have managed to put together partial DNA blueprints for only a handful of conifers, not including the most popular Christmas tree species.”

2) Scientists and researchers are studying genetic data taken from Christmas trees around the world to better understand the DNA of these trees and increase the potential for genetic improvement. For example, North Carolina State University’s Christmas Tree Genetics Program has been working since 1996 to advance the state’s Christmas tree industry through the application of genetic principles.

“We are doing DNA sequencing to understand the DNA of Christmas trees, and in the long term, this may lead in the future to genetic engineering.” – John Frampton, professor in the department of Forestry and Environmental Resources at North Carolina State University

3) Genetics research could lead to the development of Fraser firs that are resistant to pests like Phytophthora root rot and the balsam woolly adelgid. A Christmas tree spends six to 10 years growing before it is cut to be sold, and such pests can kill a tree before that time.

Phytophthora is a fungus-like organism that can infect a Fraser fir and cause yellow-green needles, wilting, dead branches, and eventually tree death.

Balsam woolly adelgid is a small insect that feeds on Fraser firs and kills the trees after several years of infestation.

4) Genetics research is also exploring what separates the best needle-holders from the worst. Using branches from different trees, Gary Chastenger, a plant pathologist at Washington State University, has been researching the genetic variations of trees and needle retention. Via Wired:

Today, Chastagner’s team hangs the branches on racks or wire clotheslines strung across a temperature-controlled concrete cistern, where they rest without water for seven to 10 days. Then, a few well-trained technicians gently rub each branch and rate the needle retention on a scale of one (1 percent of needles fall off) to seven (91 to 100 percent loss).

Chastagner is only interested in the extremes on both sides of the spectrum. Over the years, he’s taken any cuttings that rate zero to one, or six to seven and grafted little bits of them onto rootstocks his lab manages on 15 acres in Puyallup. This process converts each outlying specimen into an isolated stand of genetically identical trees, preserving their unique DNA in what’s called a clonal holding block.

Now, those trees are part of a massive effort to pinpoint the tiny genetic variations that determine why some trees turn out better than others.

Six years ago, Chastagner and researchers at Washington State University, North Carolina State University and University of California, Davis jointly secured $1.3 million in funding from the U.S. Department of Agriculture to find genetic markers for Phytophthora root rot resistance and needle retention.

Chastagner’s graduate student, Katie McKeever, is collecting isolates of Phytophthora in various growing areas. By sequencing these samples and conducting pathogenicity trials, McKeever will contribute critical information to the team’s search for mechanisms of resistance in trees. Once the researchers find the relevant genetic markers, they can screen adult trees and select the most promising as seed sources for viable Christmas tree plantations.

The team will use similar techniques to resolve the matter of needle shedding. Chastagner’s multi-decade cataloging of Christmas trees with varying degrees of postharvest needle retention will give this part of the project a jump-start. By using these and other trees, scientists will be able to quickly identify needle-retentive gene sources so growers can produce desirable Christmas trees.

Through genetics research we can improve firs that are used for Christmas trees and ensure the genetic conservation of firs. There is much more to learn about conifer genetics, but as Chastagner said in the interview with Wired, “the potential for genetic improvement in these species is huge.”

What will your Christmas gifts be placed under this year? A Fraser fir? A Douglas fir? An artificial tree?

While some individuals love the look and smell of a real Christmas tree, others prefer the low upkeep and longevity of an artificial tree.

But what if we could use genetics to improve the Christmas tree? Would you trade in the fake tree for a fir that loses less needles and requires less upkeep?

Here are four facts about using genetics in pursuit of a more perfect Christmas tree:

1) Very little has been known about the genomes of Christmas trees. Megan Molteni of Wired reported last year:

“…the conifer genome is not just enormous-20 billion base pairs compared to your 3 billion-but also pretty weird. At some point in their deep past, spruces, pines, firs, and their relatives acquired a complete second set of genes. Scientists think this genome-wide duplication likely helped shape these species into the tallest, hardiest plants in the world. But it’s also made sequencing them an incredibly daunting challenge. And unlike corn and soybean, there hasn’t been much money available to even try. So far scientists have managed to put together partial DNA blueprints for only a handful of conifers, not including the most popular Christmas tree species.”

2) Scientists and researchers are studying genetic data taken from Christmas trees around the world to better understand the DNA of these trees and increase the potential for genetic improvement. For example, North Carolina State University’s Christmas Tree Genetics Program has been working since 1996 to advance the state’s Christmas tree industry through the application of genetic principles.

“We are doing DNA sequencing to understand the DNA of Christmas trees, and in the long term, this may lead in the future to genetic engineering.” – John Frampton, professor in the department of Forestry and Environmental Resources at North Carolina State University

3) Genetics research could lead to the development of Fraser firs that are resistant to pests like Phytophthora root rot and the balsam woolly adelgid. A Christmas tree spends six to 10 years growing before it is cut to be sold, and such pests can kill a tree before that time.

Phytophthora is a fungus-like organism that can infect a Fraser fir and cause yellow-green needles, wilting, dead branches, and eventually tree death.

Balsam woolly adelgid is a small insect that feeds on Fraser firs and kills the trees after several years of infestation.

4) Genetics research is also exploring what separates the best needle-holders from the worst. Using branches from different trees, Gary Chastenger, a plant pathologist at Washington State University, has been researching the genetic variations of trees and needle retention. Via Wired:

Today, Chastagner’s team hangs the branches on racks or wire clotheslines strung across a temperature-controlled concrete cistern, where they rest without water for seven to 10 days. Then, a few well-trained technicians gently rub each branch and rate the needle retention on a scale of one (1 percent of needles fall off) to seven (91 to 100 percent loss).

Chastagner is only interested in the extremes on both sides of the spectrum. Over the years, he’s taken any cuttings that rate zero to one, or six to seven and grafted little bits of them onto rootstocks his lab manages on 15 acres in Puyallup. This process converts each outlying specimen into an isolated stand of genetically identical trees, preserving their unique DNA in what’s called a clonal holding block.

Now, those trees are part of a massive effort to pinpoint the tiny genetic variations that determine why some trees turn out better than others.

Six years ago, Chastagner and researchers at Washington State University, North Carolina State University and University of California, Davis jointly secured $1.3 million in funding from the U.S. Department of Agriculture to find genetic markers for Phytophthora root rot resistance and needle retention.

Chastagner’s graduate student, Katie McKeever, is collecting isolates of Phytophthora in various growing areas. By sequencing these samples and conducting pathogenicity trials, McKeever will contribute critical information to the team’s search for mechanisms of resistance in trees. Once the researchers find the relevant genetic markers, they can screen adult trees and select the most promising as seed sources for viable Christmas tree plantations.

The team will use similar techniques to resolve the matter of needle shedding. Chastagner’s multi-decade cataloging of Christmas trees with varying degrees of postharvest needle retention will give this part of the project a jump-start. By using these and other trees, scientists will be able to quickly identify needle-retentive gene sources so growers can produce desirable Christmas trees.

Through genetics research we can improve firs that are used for Christmas trees and ensure the genetic conservation of firs. There is much more to learn about conifer genetics, but as Chastagner said in the interview with Wired, “the potential for genetic improvement in these species is huge.”

Starting in 2019, shoppers will be able to buy products such as salad dressings and granola bars that are healthier thanks to gene-editing.

In an article for the Associated Press, reporter Lauren Neergaard dives into the promising potential of gene-editing as it is used in both plants and animals to make better products for human consumption.

“By early next year, the first foods from plants or animals that had their DNA ‘edited’ are expected to begin selling. It’s a different technology than today’s controversial ‘genetically modified’ foods, more like faster breeding that promises to boost nutrition, spur crop growth, and make farm animals hardier and fruits and vegetables last longer.”

As Neergaard also notes (and as we’ve covered here and here), gene-editing also holds the potential to save industries that have been ravaged by plant diseases, such as the orange industry in Florida.

The fate of gene-editing to solve these type of challenges, however, will ultimately be decided by consumers’ acceptance of the technology. It’s important to note though, that the products set to hit grocery stores next year are the result of making edits to an organism’s own DNA.

One such product comes from biotech firm Calyxt, led by chief science officer Dan Voytas, who has edited the genes of soybeans so that the versatile crop contains higher levels of healthier oils.

“Those new Calyxt soybeans? [Dan] Voytas’ team inactivated two genes so the beans produce oil with no heart-damaging trans fat and that shares the famed health profile of olive oil without its distinct taste.”

Another food category that could hit stores soon as a result of enhancements made through gene-editing is milk that has been produced by cows without horns.

The hornless calves? Most dairy Holsteins grow horns that are removed for the safety of farmers and other cows. Recombinetics Inc. swapped part of the gene that makes dairy cows grow horns with the DNA instructions from naturally hornless Angus beef cattle.

“Precision breeding,” is how animal geneticist Alison Van Eenennaam of the University of California, Davis, explains it. “This isn’t going to replace traditional breeding,” but make it easier to add one more trait.

How these products are then traded with other countries, or regulated here in the U.S., is a work in progress, however.

The Agriculture Department says extra rules aren’t needed for “plants that could otherwise have been developed through traditional breeding,” clearing the way for development of about two dozen gene-edited crops so far.

In contrast, the Food and Drug Administration in 2017 proposed tighter, drug-like restrictions on gene-edited animals. It promises guidance sometime next year on exactly how it will proceed.

Because of trade, international regulations are “the most important factor in whether genome editing technologies are commercialized,” USDA’s Paul Spencer told a meeting of agriculture economists.

Europe’s highest court ruled last summer that existing European curbs on the sale of transgenic GMOs should apply to gene-edited foods, too.

But at the World Trade Organization this month, the U.S. joined 12 nations including Australia, Canada, Argentina and Brazil in urging other countries to adopt internationally consistent, science-based rules for gene-edited agriculture.

BIO has noted its support for the U.S. in joining the 12 other nations to encourage science-based regulations for gene-edited agriculture – which includes both plants and animals. Currently, the U.S. Department of Agriculture is the lead agency in following this guidance as it has stated it will not regulate gene-edited plants that could otherwise be created through conventional breeding. Though USDA still retains the authority to regulate many of these products once in the market if any problems should arise.

BIO knows that consumers may still have concerns about gene-edited products even if proper oversight exists. After all, new technologies are inherently met with skepticism. Just ask the creator of the microwave. But we also know that researchers working with this burgeoning technology are taken every precaution possible. As Van Eenennaam attests to when speaking with the Associated Press:

Scientists are looking for any signs of problems. Take the hornless calves munching in a UC-Davis field. One is female and once it begins producing milk, Van Eenennaam will test how similar that milk’s fat and protein composition is to milk from unaltered cows.

“We’re kind of being overly cautious,” she said, noting that if eating beef from naturally hornless Angus cattle is fine, milk from edited Holsteins should be, too.

Gene-edited products should not be met with skepticism but instead with optimism. Aside from the handful of products that will hit stores in 2019, researchers are determined to enhance other crops for the greater good. This includes enhancements to critical crops in poor countries, such as cassava (potato). As Jennifer Kuzman of the Genetic Engineering and Society Center at North Carolina State University sums it up best, “We think it’s [gene-editing] going to really revolutionize the industry.”

Starting in 2019, shoppers will be able to buy products such as salad dressings and granola bars that are healthier thanks to gene-editing.

In an article for the Associated Press, reporter Lauren Neergaard dives into the promising potential of gene-editing as it is used in both plants and animals to make better products for human consumption.

“By early next year, the first foods from plants or animals that had their DNA ‘edited’ are expected to begin selling. It’s a different technology than today’s controversial ‘genetically modified’ foods, more like faster breeding that promises to boost nutrition, spur crop growth, and make farm animals hardier and fruits and vegetables last longer.”

As Neergaard also notes (and as we’ve covered here and here), gene-editing also holds the potential to save industries that have been ravaged by plant diseases, such as the orange industry in Florida.

The fate of gene-editing to solve these type of challenges, however, will ultimately be decided by consumers’ acceptance of the technology. It’s important to note though, that the products set to hit grocery stores next year are the result of making edits to an organism’s own DNA.

One such product comes from biotech firm Calyxt, led by chief science officer Dan Voytas, who has edited the genes of soybeans so that the versatile crop contains higher levels of healthier oils.

“Those new Calyxt soybeans? [Dan] Voytas’ team inactivated two genes so the beans produce oil with no heart-damaging trans fat and that shares the famed health profile of olive oil without its distinct taste.”

Another food category that could hit stores soon as a result of enhancements made through gene-editing is milk that has been produced by cows without horns.

The hornless calves? Most dairy Holsteins grow horns that are removed for the safety of farmers and other cows. Recombinetics Inc. swapped part of the gene that makes dairy cows grow horns with the DNA instructions from naturally hornless Angus beef cattle.

“Precision breeding,” is how animal geneticist Alison Van Eenennaam of the University of California, Davis, explains it. “This isn’t going to replace traditional breeding,” but make it easier to add one more trait.

How these products are then traded with other countries, or regulated here in the U.S., is a work in progress, however.

The Agriculture Department says extra rules aren’t needed for “plants that could otherwise have been developed through traditional breeding,” clearing the way for development of about two dozen gene-edited crops so far.

In contrast, the Food and Drug Administration in 2017 proposed tighter, drug-like restrictions on gene-edited animals. It promises guidance sometime next year on exactly how it will proceed.

Because of trade, international regulations are “the most important factor in whether genome editing technologies are commercialized,” USDA’s Paul Spencer told a meeting of agriculture economists.

Europe’s highest court ruled last summer that existing European curbs on the sale of transgenic GMOs should apply to gene-edited foods, too.

But at the World Trade Organization this month, the U.S. joined 12 nations including Australia, Canada, Argentina and Brazil in urging other countries to adopt internationally consistent, science-based rules for gene-edited agriculture.

BIO has noted its support for the U.S. in joining the 12 other nations to encourage science-based regulations for gene-edited agriculture – which includes both plants and animals. Currently, the U.S. Department of Agriculture is the lead agency in following this guidance as it has stated it will not regulate gene-edited plants that could otherwise be created through conventional breeding. Though USDA still retains the authority to regulate many of these products once in the market if any problems should arise.

BIO knows that consumers may still have concerns about gene-edited products even if proper oversight exists. After all, new technologies are inherently met with skepticism. Just ask the creator of the microwave. But we also know that researchers working with this burgeoning technology are taken every precaution possible. As Van Eenennaam attests to when speaking with the Associated Press:

Scientists are looking for any signs of problems. Take the hornless calves munching in a UC-Davis field. One is female and once it begins producing milk, Van Eenennaam will test how similar that milk’s fat and protein composition is to milk from unaltered cows.

“We’re kind of being overly cautious,” she said, noting that if eating beef from naturally hornless Angus cattle is fine, milk from edited Holsteins should be, too.

Gene-edited products should not be met with skepticism but instead with optimism. Aside from the handful of products that will hit stores in 2019, researchers are determined to enhance other crops for the greater good. This includes enhancements to critical crops in poor countries, such as cassava (potato). As Jennifer Kuzman of the Genetic Engineering and Society Center at North Carolina State University sums it up best, “We think it’s [gene-editing] going to really revolutionize the industry.”

Once again, Blue Cross Blue Shield is out with a report attempting to stoke fear and confusion about prescription drug costs. And once again (because we’ve chronicled it before) what the major insurance company has to say is contradicted by its own pharmacy benefits manager.

These drug cost middlemen, also known as PBMs, manage prescription drug benefits on behalf of health plans. It just so happens that Blue Cross Blue Shield plans own one of the largest PBMs in the country – Prime Therapeutics. One should expect that the report released by Blue Cross Blue Shield would be reflected in the data put forward by its own PBM. But it’s not.

Here is what Prime Therapeutics has said this year about the trend of prescription drug costs:

• In February, Prime announced “the second consecutive year of outstanding trend results.” What made them so outstanding? Prime’s “numerous management tools” led to a 0.2 percent drop in the drug trend for commercial health plans.
• Prime also noted a drop a -0.8 percent and -5.4 percent drop for Medicare and Medicaid, respectively.
• Prime’s chief clinical officer said they were “thrilled drug expenditures for our clients declined in 2017.”

It’s always important to note that what PBMs report reflects what health plans are actually paying. The same can’t be said for the Blue Cross Blue Shield report. As even they have to admit – in a note buried on page 11 of its report – the prices they point to “do not include the impact of drug rebates.” That’s unfortunate because the impact is significant. Drugmakers negotiate rebates to help lower costs and expand access. In 2017, these rebates totaled more than $150 billion. Is there any wonder why Blue Cross Blue Shield failed to include them?

As Dr. Adam Fein – one of the nation’s top experts on pharmaceutical economics – has noted before:

“Clearly, drug spending is not spinning out of control. Pharmacy benefit costs are growing much more slowly than is growth in other part of the U.S. healthcare system, such as hospital spending and physician salaries.”

That’s the reality reflected in most of the data put out by a wide range of health care stakeholders. Of course, that’s never the reality insurance companies want the public to see. Prime’s President’s and CEO Jim DuCharme noted earlier this year:

“Our close alignment with 22 Blue plan clients – 18 of whom are owners – allows us to see the complete pharmacy and medical drug picture to help us drive total cost of care outcomes.”

Such a close alignment should ensure both Blue Cross Blue Shield and its PBM are singing from the same song sheet when it comes to the facts about prescription drug costs. But apparently not.

Writing for The Hill, Dr. Cynthia Sears, president of the Infectious Diseases Society of America (IDSA), discussed the looming threat of antimicrobial resistance (AMR) and highlighted new survey data revealing that Americans are counting on Congress to step in and support efforts to combat against it.

The survey, commissioned by Research!America in collaboration with the IDSA and supported in part by Pfizer, shows that nearly two-thirds of Americans (65%) say antibiotic resistance is a threat to public health. What’s more, a strong majority (81%) are concerned that antibiotic resistance will make more infections difficult, or even impossible, to treat.

As Dr. Sears writes:

“Americans are right to be concerned that the antibiotic treatments that ushered in the era of modern medicine are losing their power to stop infections. These life-saving medications are essential, for example, to allow patients to get through cancer treatments and transplants that were not possible before.”

The survey also indicates that efforts to educate the general public about appropriate antibiotic usage is needed. For example, more than a third (37%) of survey respondents wrongly identify antibiotics as effective for treating viral infections.

“The survey answers demonstrate substantial gaps in public knowledge. Thus, the survey answers should be taken as a call-to-action to strengthen public health efforts countering antibiotic resistance,” Sears noted.

As of 2017, the pipeline to tackle priority pathogens like AMR included roughly 50 products. That number pales in comparison to the more than 1,100 medicines and vaccines for cancer are currently in development. But as the survey finds, nearly three quarters (73%) agree that the federal government should provide incentives to encourage increased private sector investment in the development of new antibiotics, which is a big step in the right direction

“I’m encouraged that more than three-quarters of respondents agreed the federal government should increase funding for research as well as public health initiatives to address antibiotic resistance, while nearly three-quarters agreed that the federal government should provide incentives to encourage increased private sector investment in the development of new antibiotics,” Dr. Sears added.

For more, read the full op-ed here.

California Public Employees Retirement System decreased its holdings in shares of Puma Biotechnology Inc (NASDAQ:PBYI) by 33.2% in the second …

The biotech industry recently realized its 300^th IPO since the Jumpstart Our Business Startups (JOBS) Act was enacted in 2012. This marks an important milestone for our young and quickly growing industry, culminating in $25 billion raised by promising companies developing potentially life-saving medical advances. Over 18 percent of these companies have a lead drug candidate that targets a rare disease, and companies developing novel therapeutics to address cancer, neurology disorders, and infectious diseases make up almost half (46 percent) of these newly public companies. In that sense, the JOBS Act did more than spearhead capital formation for innovative startups-it channeled historic investment volumes into some of the most promising companies developing treatments for some of the most daunting health challenges of our time.

In just six years, the JOBS Act has left a significant imprint on the biotechnology industry by significantly accelerating the pace of biotech IPOs, which is up 270 percent since the same period before its enactment. For emerging growth companies (EGCs), the JOBS Act strikes an important balance between easing the ability of early-stage biotechs to access public capital markets while keeping important investor protections in place.

And I’m happy to say that 2018 so far has been a banner year for EGCs, with 53 companies going public year-to-date – the second-best year for issuances since the law’s passage.

While the JOBS Act has helped pave the path for an unprecedented number of innovative biotechnology companies to go public, additional reforms are necessary to allow these companies to stay public.

One of the most important provisions of the JOBS Act is a temporary five-year exemption for qualifying companies from Sarbanes-Oxley section 404(b) requirements for an auditor attestation of a company’s internal controls over financial reporting. As helpful as the five-year exemption is, the fact remains that the biotech development timeline is a decades-long affair.  Many of the biotech companies that have gone public as EGCs under the JOBS Act remain in the lab and clinic when their five-year exemption expires, and they are forced to divert hundreds of thousands of dollars away from research and development toward superfluous financial disclosures that do not benefit their investors.  In just two short months, at the dawn of 2019, over 80 emerging biotech companies will lose their EGC status and be forced to siphon off funds from clinical trials and research and development towards an additional audit that often doubles their financial reporting costs without improving investor confidence in their companies.

BIO calls on the Senate to build on this success by passing the bipartisan Fostering Innovation Act (S. 2126/488), which would extend important regulatory relief to JOBS Act companies that maintain a public float below $700 million and average annual revenues below $50 million. Extending this regulatory relief provision would allow growing companies to focus their capital on groundbreaking R&D, rather than one-size-fits-all disclosure requirements.

The road to 300 wasn’t easy, but America’s small business innovators have fought tirelessly to bring medical breakthroughs like gene therapy, immunotherapy and RNAi therapy to the market. By continuing to adopt sensible capital markets reforms like the Fostering Innovation Act, Congress can support the innovation economy, helping patients to benefit from America’s unparalleled biopharmaceutical research ecosystem.

On Friday, November 2, the U.S. government joined 12 other nations in supporting policies that enable agricultural innovation, including gene editing.

This support was reflected in a statement titled “The International Statement on Agricultural Applications of Precision Biotechnology,” which was led by Argentina and released at a meeting in Geneva at the World Trade Organization Committee on the Application of Sanitary and Phytosanitary Measures. Both the U.S. Department of State and Agriculture issued statements, welcoming the U.S.’s sign-on.

The non-binding statement presents several principles that each country agrees to follow in order to create an international system that is harmonized on how to regulate products of precision biotechnology, including gene editing.

The statement is in response to frequent regulatory roadblocks that companies can face when developing agricultural applications of precision biotechnology – whether for plants or animals.

Gene editing can create highly beneficial products to more quickly meet consumer and societal needs by using the natural potential within an organism, without introducing any foreign DNA.  Examples include healthier cooking oils from gene edited crops and disease resistant, enhanced welfare animals.  In many instances, identical products could be achieved using traditional breeding and brought straight to market, but if the same product was made through a gene edit it may be met with increased regulatory process simply because of the difference in method to achieve the same result.

By aligning regulatory approaches across the globe, the U.S. hopes to create an international regulatory environment that does not hinder agricultural products just because they were developed through gene editing as opposed to conventional breeding.

Here in the U.S., USDA has taken a science-based regulatory approach to gene edited plants because the agency understands that many of these products are the same as those developed through conventionally breeding – just using a modern and more precise method.

In a statement published in March, USDA stated with respect to pre-market regulatory approval processes “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional [conventional] breeding techniques…”.  USDA still retains the authority to regulate many of these products once in the market if any problems should arise.

But USDA isn’t the only U.S. agency with some oversight of products of agricultural innovation.  The Environmental Protection Agency and the Food and Drug Administration may have a role to play, too, and the picture at USDA’s sister agencies isn’t very clear.

The Environmental Protection Agency takes responsibility in regulating plants that have been developed to carry pesticide-like traits (plant incorporated protectants) – but not if achieved through conventional breeding.

Recently, EPA noted they are evaluating gene editing technology and whether such products should fall within their oversight. So, the question becomes: Will they regulate gene edited plants that are identical to those made through conventional breeding? We don’t know, but if they do it would conflict with the international statement that the U.S. has signed on to.

As the International Statement states, “In either case [whether through conventional breeding, transgenic mutation or gene editing], the food, animal, and environmental safety of such products can be adequately addressed by existing regulatory frameworks for agricultural products and existing safety standards based on the characteristics of the product or organism.”

Translation: plants with pesticide-like characteristics developed through gene editing should be judged on what they are as a product and not on the method to achieve them.  And since the product in many cases will be the same as ones that already exist or that could be created through traditional methods, they should be treated the same way from a regulatory perspective.

Therefore, EPA should not be regulating plants just because they were made through gene editing. If they were to follow the international statement, they would be more aligned with USDA’s approach: they would not require a pre-market approval process for products identical to those that could be created through traditional methods but would retain the authority to regulate if a problem arose.

The U.S. Food and Drug Administration may also have role to play in oversight of products of agricultural innovation.  For plants, FDA has not yet publicly stated how it intends to oversee products developed using gene editing.  Regarding gene edited animals, the FDA has carved out a regulatory position that treats these products as “new animal drugs,” a stance that is arguably inconsistent with the recent international statement.

However, the FDA recently announced a “Plant and Animal Biotechnology Innovation Action Plan,” which the agency says, “aims to implement and clarify risk-based policies with the goals of ensuring that developers know what they need to do to efficiently bring a product to market.” Through this program, BIO hopes the agency will establish a right-sized regulatory approach for gene editing, similar to that of USDA and consistent with the broader international statement

The international statement was drafted because gene editing is so new, and the international community has yet to get on the same page as to how to establish appropriate oversight.  BIO strongly supports the principles articulated in the international statement and encourages the adoption of these principles by governments around the world-including our own.

In a new blog post at the GMO Answers Medium page, GMO Answers volunteer expert Dr. Elizabeth Hood details the benefits of GMOs for growers, consumers and the environment. She explains how genetically engineered crops help not just farmers and consumers, but the planet, too.

She writes

The first GE plants had new characteristics that made them resistant to environmental conditions. One of the very first improved crops through genetic engineering saved the papaya industry in Hawaii.

Anyone who has ever been to Hawaii has been introduced to this wonderful, orange, creamy-fleshed fruit. However, if not for genetic engineering, this fruit would not be available.

and

Another example of how GE can help the environment (and farmers and consumers) is through control of insects.

Organic farmers use a bacterium to combat insects by sprinkling the bacterium on the leaves of their plants. Genetic Engineers took this a few steps further by taking the bacterium’s genes (called Bt genes) that kill insects and putting them directly into the plant. The bacterium has more than 50 genes that kill insects.

By learning which ones kill which insects, scientists can make the plant resistant to their most damaging predators. Bt genes in corn, cotton, soybeans and eggplant (as well as other traits) have removed 6 million tons of pesticides from the environment.

To learn more about how GMOs help the environment, please visit the GMO Answers Medium page, and the GMOs and the Environment section on the GMO Answers website.