In May 2024, the FDA released guidance stating in effect that the agency will primarily be responsible for regulating genetically engineered animals. Heres what to know about gene-edited animals, labeling of GMO products, and what this means for consumers.

Humans have been shaping the genetics of plants and animals for millennia. Through selective breeding, humans choose to mate plants or animals possessing certain favorable traits to promote those traits in the population. While this technique only incrementally changes a populations traits, over many generations it can lead to drastic changes.

However, modern genetic engineering technologies allow scientists to directly induce targeted changes in an organisms DNA, allowing for much quicker and more precise changes in population-level traits. In recent decades, scientists have used genetic engineering to insert genes (i.e., portions of DNA) from one organism into another. And with newer gene-editing technologies such as CRISPR, scientists can even make narrowly targeted edits in a plant or animals DNA.

Food products derived from genetically modified plants have been sold in the US for decades. For example, the great majority of corn, soybeans, and cotton currently grown in the US are genetically modified. However, it is only within the last few years that genetically modified animals have been approved for commercial use. These animals are bioengineered to possess some desirable quality, such as faster growth or increased durability in response to environmental hazards.

In 2015, the FDA approved the first genetically engineered animal for commercial use in the US: AquAdvantage Salmon, which is a salmon modified to reach maturity more quickly than standard salmon. Since then, the FDA has approved other gene-edited animals for commercial purposes, including pigs that are less likely to induce allergic reactions that some humans have as a result of tick-borne illness. Other gene-edited animals are still in development, such as shorter-haired cows that are better able to withstand rising temperatures due to climate change.

But until recently, there was some controversy over which federal agency would be responsible for regulating genetically engineered animals.

The FDA announced in May 2024 that the agency will lead the charge on regulation of animals with intentional genomic alterations (IGAs). In its guidance, the FDA stated that the agency will consult with the USDA, but that the FDA will primarily be in charge of regulating these animals. Newly developed gene-edited animals will need to go through an oversight process, in which the agency will assess potential risks, before they can enter the market. Products that represent limited risk will receive proportionately less oversight.

For the past several years, it was unclear which agency, the FDA or the USDA, would regulate genetically engineered animals. CSPI argued in two op-eds, appearing in The Hill and STAT, that the FDA should be the agency to regulate these animals. For one, the FDAs mandate includes public health and animal health, while the USDAs mandate includes promoting the US agricultural industry and does not center human health. Additionally, while the USDA has oversight over some agricultural animalspoultry, cattle, horses, swine, and goatsthe FDA has authority over all others, so a system not centered on the FDA would be inefficient. Finally, the FDA has pre-existing experience in regulating genetically engineered animals, as well as the scientific resources and regulatory framework needed to effectively tackle regulation of these animals.

As CSPI President Dr. Peter G. Lurie stated, The FDAs scientific expertise and human and animal health mandates make it the appropriate agency to maximize the benefits and minimize the risks of the next generation of genetically altered animals.

Statement: Final guidance on regulation of genetically altered animals rightfully awards regulatory authority to FDA

Under federal law, manufacturers must disclose when their food products contain certain genetically modified ingredients. In July 2016, President Obama signed the National Bioengineered Food Disclosure Law (NBFDL), requiring food manufacturers to disclose the presence of bioengineered foods and ingredients.

Federal rules now require most foods and ingredients that have modified DNA to make a disclosure. The disclosure may be on the package or may require consumers to go to a website or make a telephone call. However, there are several exemptions to these disclosure rules, including for restaurant foods, small-scale manufacturers, and animals fed bioengineered crops. In addition, the disclosure will tell you that there are bioengineered ingredients but will not necessarily tell you which ingredients are bioengineered.

Moreover, not all animal-derived products are covered under the NBFDL. The rules do not apply to products that list meat, poultry, or eggs as their first ingredient (or their second ingredient after water, stock, or broth) because those product labels are regulated by other USDA statutes.

CSPI will continue to educate policymakers and the public about the benefits and risks associated with genetically engineered crops and animals. We will also continue to advocate for strong federal regulation of genetically engineered food products and press the biotechnology industry and farmers to use genetically engineered crops and animals in a sustainable manner.

Support CSPIs efforts to protect consumers

See the article here:
Genetically engineered animals to be regulated by FDA - CSPI Newsroom

Chris Oyakhilome, founder of LoveWorld Incorporated better known as Christ Embassy, has claimed that genetically modified corns cause hypertension.

In a live broadcast during a church programme, Oyakhilome warned the people to avoid genetically modified corn.

The clergyman claimed that most countries no longer produce local corn and that much of the corn sold in the markets has been genetically modified.

Im sure many of you who dont have an idea of organic corn. What it is. Dont think of the one youve been buying in the market, in your local market I mean. Dont think that one is really organic. Oyakhilome said.

Most countries dont have the original corn anymore. Its one of the earliest genetically modified crops, so most of what youve been eating is modified a long time ago.

Thats why you have to do something; you have to think again. The earlier you stop it, the better because no one is giving you this information. They are not telling you that the unexplained hypertension that your grandfather suffered with, that your father and granduncle suffered with, and that youre probably suffering with have something to do with corn.

Almost all the people Ive known that have high blood pressure all love corn and corn products but nobody ever told them that had anything to do with their problems.

The video has been shared by several posts on YouTube. It can be found here and here.

WHAT ARE GMOS?

Genetically Modified Organisms (GMO) are plants, animals, or microbes in which one or more changes have been made to the genome (DNA) through genetic engineering, in an attempt to alter its characteristics.

Genes can be introduced, enhanced, or deleted within a species, across species, or non-related species. Some examples of GM crops include Bt corn, soybeans, Bt potatoes, peanuts, Bt-sweet corn, Roundup Ready soybeans, Roundup Ready Corn, and Liberty Link corn.

Some of the objectives of developing genetically modified plants are to produce crops with enhanced characteristics which could be to improve crop protection by making them resistant to a particular disease and create higher-yield crops.

PROCESS OF GENETIC MODIFICATION OF CROPS

To transform a plant into a GMO plant, the gene that produces a genetic trait of interest is identified and separated from the other genetic material in a donor organism. It is then transferred into a plant cell. A donor organism may be a bacterium, fungus, or another plant. In the case of Bt corn, the donor organism is a naturally occurring soil bacterium Bacillus thuringiensis (Bt).

The maize variant has Bt genes that provide protection against some insects and help the maize plant tolerate moderate drought. Bt corn prevents crop damage by reducing the need for spraying insecticides.

One of the methods used to transfer DNA is to coat the surface of small metal particles with the relevant DNA fragment and bombard the particles into the plant cells using the gene gun method.

The gene gun introduces the DNA directly into plant cells containing cell walls. The gene gun is used to bombard the plant cell wall with many DNA-coated metal particles by using compressed helium as the propellant.

The metal particles commonly used for gene gun bombardment include gold, tungsten, palladium, rhodium, platinum, and iridium. They are coated with DNA, accelerated by helium gas, and bombard the plant cells.

The metal particles punch holes in, pass through the cell wall, and enter the plant cells, leaving the DNA cargo inside the cells.

An alternative method is through the use of a bacterium or virus. The bacterium most frequently used for genetically modified crops is the Agrobacterium Tumefaciens. The gene of interest is transferred into the bacterium and the bacterial cells then transfer the new DNA to the genome of the plant cells. The plant cells that take up the DNA are then grown to create a new plant with new characteristics.

In January, the federal government approved the commercial release and open cultivation of four Tela Maize varieties a high-yielding maize variety, developed by the Institute of Agricultural Research (IAR) in partnership with the African Agricultural Technology Foundation (AATF).

The maize variety has been genetically engineered for improved insect resistance and drought tolerance to boost farmers yield and also ensure food security. GM corn is used for foods, drinks, and livestock feed.

DOES GENETICALLY MODIFIED CORN CAUSE HYPERTENSION?

Discussions and concerns have been raised over the effects of genetically modified crops on health. While some studies suggest that genetically modified crops may have health implications for humans, other researches argue that these crops are unharmful to human health and provide some nutrients like their conventional counterparts.

However, the US Food and Drug Administration (FDA) said GMO foods are as healthy and safe to eat as their non-GMO counterparts.

According to the World Health Organisation (WHO), genetically modified foods currently available on the international market have passed safety assessments and are not likely to present risks to human health.

The health organisation also said no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved.

According to WHO, Hypertension (also known as high blood pressure) is when the pressure in the blood vessels is higher than normal.

The risk factors of hypertension include unhealthy diets (high salt consumption, a diet high in saturated fat and trans fats), physical inactivity, being overweight, and excess alcohol intake. Other factors include genetics/family history of hypertension and aging.

It is recommended that hypertension be diagnosed when a persons systolic blood pressure (SBP) is greater than 140 mm Hg and/or their diastolic blood pressure (DBP) is greater than 90 mm Hg following repeated examination ((140/90 mmHg or higher).

TheCable spoke with Jerome Mafeni, technical director at the Network for Health Equity and Development (NHED), to confirm if there are studies that suggest genetically modified corn causes hypertension.

Mafeni said at the moment, there is no scientific study that says GM corn causes hypertension, but noted that there might be the likelihood of reactions to such food items over time.

There is no scientific study that suggests such. Because they (TELA maize) are just coming into the country, it will take a much longer time to conduct a study to be able to prove any linkage between GMO foods and health conditions, Mafeni said.

That said, the fact that they are genetically modified means that there might be the possibility that people who consume GMO foods may have reactions to those foods without knowing. But that is yet to be verified.

TheCable also reached out to Bukola Odele, a food and nutrition scientist. Odele noted that corn is made up of carbohydrates, adding that hypertension is caused by excessive salt intake.

Before now, I dont think we consume GM corn in Nigeria and the one we know about was approved in January as a test run. If you even check that, saying that our grandfathers died as a result of that through hypertension is false, Odele said.

I think they even had better blood pressure than that of our current generation and that is because they often ate more fresh meals from the farm, while in this generation, people are consuming a whole lot of processed foods.

Industries are flooding the market with convenience, easy-to-make foods that have very low nutritional value and adverse effects on health. A lot of these processed foods contain a lot of salt, sugar, or fat. And when you have these in excess, they always have health implications.

About corn, naturally occurring foods contain sodium but in low quantities. These low quantities are also in healthy quantities. The moment the sodium we consume is from processed food items, thats when it becomes an issue. If youre thinking of what genetically modified corn would cause, the first thing you would look at is not even hypertension but diabetes. So far, I havent found any evidence that links GM corn to hypertension. I know that the largest cause of hypertension is high sodium intake from most of the processed food we consume.

Agnes Asagbra, the director-general of the National Biosafety Management Agency (NBMA), told TheCable that the approved TELA maize went through a thorough assessment before it was recommended for commercialisation.

We regulate the activities of modern biotechnology. In the course of our work, we ensure due diligence before any permit is granted. We have granted three permits so far for commercialisation of cowpea, BT cotton for textiles, and Tela maize, she said.

Before those approvals were granted, they went through a series of rigorous risk assessments.

We do our risk assessments, we dont do it independently but with sister agencies like the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria Agricultural Quarantine Service (NAQS), and other relevant agencies including the academia, NGOs, and research institutes. We bring them all together to review these permutations thoroughly.

So far, the Tela maize that has been approved is not even in the market and has not been launched. This is the first GM corn that will be commercially released in Nigeria.

The risk assessment that we have carried out declared the crop safe and there is no scientific evidence that links GM corn to hypertension. We have done our due diligence and it is safe, as safe as its conventional counterpart.

Also speaking, Olusina Ajidahun, an internal medicine physician, said: There are no studies to show that GM corn increases your risk of hypertension. This particular claim is not backed scientifically.

We are having an increase in the rise of genetically modified foods and we know for sure that some genetically modified foods can increase the risk of toxic effects on organs like the liver, heart, pancreas, and kidney. Studies are still trying to correlate the linkage of GM foods to cancer.

Theres no scientific evidence that taking GM corn increases the risk of having hypertension. One thing about hypertension is that it is multifactorial, it could be a result of genetics, lifestyle, or a lot of things. Coincidentally, it might be the case where these people are hypertensive and for some reason, they just like corn.

VERDICT

Theres no scientific evidence to support the claim that genetically modified corn causes hypertension as claimed by Oyakhilome.

More here:
FACT CHECK: Does genetically modified corn cause hypertension as Oyakhilome claims? - TheCable