Regulation in the genetic engineering process

Grace Troupe, Presenter Author

10/12/2018 Added

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Are GMOs regulated? Who determines if they are safe? The EPA, USDA-APHIS, and FDA are all involved in the process of determining if a genetically engineered food is safe before it ever reaches the consumer. You can watch this video to learn about how and when these agencies are involved and how it compares to traditional breeding methods.

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[00:00:06.220]This presentation will help you get an idea
[00:00:08.630]of how regulation and safety testing fit in
[00:00:12.620]with the overall picture of genetic engineering
[00:00:14.870]as you've seen in the four steps
[00:00:17.140]in solving the problem in this app.
[00:00:21.250]So what I want you to see here is that up top,
[00:00:25.630]this is the process of making a genetically engineered crop.
[00:00:29.950]So you can see this red part, this is identifying
[00:00:32.970]and isolating the gene and modifying it,
[00:00:35.060]so this red is the transgene designer, step one.
[00:00:38.490]And here we have the orange.
[00:00:39.690]This is the plant transformation specialist,
[00:00:43.360]so this is getting the gene into the plant.
[00:00:45.400]And we move into the backcrossing,
[00:00:48.260]and that's the breeder.
[00:00:50.650]And so then finally the DNA analysis is done
[00:00:55.000]at more than one step here,
[00:00:56.530]but it's also done at the end here for step four.
[00:00:58.930]And so this whole process of making a genetically
[00:01:01.150]engineered crop takes about a decade.
[00:01:03.950]As you can see below here, this is how the regulation
[00:01:08.700]sort of roughly lines up with the process.
[00:01:11.090]And through the whole process, there is regulation.
[00:01:15.570]Before, you can see here, as soon as they
[00:01:18.040]identify the gene, there's already regulation
[00:01:20.950]before you even moved it anywhere.
[00:01:24.985]One of the first things that happens is
[00:01:27.750]the researcher wants to be sure
[00:01:29.800]that the gene they want to transfer
[00:01:33.150]isn't already known to be a risk,
[00:01:36.040]because they'll waste a lot of time and money
[00:01:38.170]if they start this process, spending a lot of money
[00:01:41.130]putting it into a new plant,
[00:01:42.810]if it's going to be found to be unsafe,
[00:01:45.850]and they have to ditch the process anyway.
[00:01:48.720]And so what they'll be able to do is compare
[00:01:50.830]the history of the gene, so has the source that it's from,
[00:01:55.080]is it known to be an allergen?
[00:01:58.320]Or maybe even a toxin?
[00:01:59.500]And then also they look, and they compare the sequence
[00:02:03.040]to other known allergens and toxins.
[00:02:05.750]And so that's done before you move the gene anywhere,
[00:02:08.210]before you modify it at all.
[00:02:10.590]And then later on as you start to get into the actual
[00:02:15.410]moving of the gene, there's different regulatory
[00:02:18.580]agencies that really wanna be sure that this is safe,
[00:02:21.440]before you really get anywhere with it.
[00:02:24.220]So the USDA and APHIS, this regulatory agency
[00:02:28.850]wants to be sure that this is safe in the environment,
[00:02:32.740]and safe in the food system, so you can see here,
[00:02:37.210]that they determine it's safe, and won't have any
[00:02:40.970]negative impacts on the environment.
[00:02:43.030]And so before you can even plant a transgenic crop
[00:02:46.800]outside, you have to clear it with this regulatory agency.
[00:02:53.550]The EPA, this regulatory agency is just really concerned
[00:02:58.160]about how it'll be, this trait.
[00:03:02.720]The new trait will interact in the environment,
[00:03:05.780]and if there'll be any negative impacts.
[00:03:07.890]And so they look out for us on that aspect.
[00:03:11.070]And then the FDA wants to be sure
[00:03:13.430]that this could be safe in our food system,
[00:03:17.920]for both people and animals.
[00:03:21.500]And so finally, if a project makes it through all of these,
[00:03:27.220]and it's determined that the level of risk is so low
[00:03:30.830]that it's acceptable, eventually what every
[00:03:33.870]genetic engineering project is aiming for,
[00:03:36.290]is what's called deregulation.
[00:03:39.250]deregulation is when the crop is found to be
[00:03:45.260]safe enough that it can be grown without any
[00:03:49.320]extra consideration, it can be grown like a normal crop.
[00:03:52.920]So that's when it can be grown in fields,
[00:03:55.510]and incorporated into our food system.
[00:03:58.480]So in this whole process, we've got
[00:04:01.880]all sorts of regulation that's going on
[00:04:03.920]to help ensure our safety.
[00:04:05.990]And if at any point it's determined
[00:04:07.690]that the risk is unacceptable,
[00:04:09.300]if there's really any known risk at all
[00:04:11.820]the project will be scrapped.
[00:04:13.960]And so what we're able to do then is,
[00:04:17.370]compare the process and the regulation
[00:04:20.080]to regular crossbreeding that we've been
[00:04:22.800]doing for thousands of years.
[00:04:25.190]So up here you can see this is genetic engineering,
[00:04:29.810]and below, down here this is the process of breeding.
[00:04:34.690]So in breeding, what you do is you make crosses,
[00:04:37.600]and you grow out the generation and you select
[00:04:40.430]the plants that have the desired traits.
[00:04:44.090]You screen and test them, and you continue making
[00:04:46.390]crosses and looking at their offspring and selecting
[00:04:49.830]until you get a product that you consider
[00:04:53.020]to be significantly improved.
[00:04:59.247]In breeding you are swapping thousands of genes at a time,
[00:05:05.380]in genetic engineering you're moving over
[00:05:08.750]one gene of known function.
[00:05:11.470]In traditional breeding many of the genes
[00:05:14.770]are unknown that you're moving over.
[00:05:17.270]And so this page, it makes it seem like
[00:05:19.850]maybe genetic engineering is faster,
[00:05:22.390]and I wanna debunk that idea, that actually
[00:05:27.690]what's shown here, this distance between
[00:05:30.360]the time it takes for breeding and
[00:05:31.590]the time it takes for genetic engineering,
[00:05:33.310]the gap is actually smaller,
[00:05:35.390]enough that it's pretty insignificant.
[00:05:37.590]It could take about the same time for each
[00:05:40.080]of these to be developed.
[00:05:41.340]The main advantage of genetic engineering though,
[00:05:43.780]is that we can get a broader range of traits,
[00:05:46.940]than we can necessarily with breeding,.
[00:05:50.030]And so what's most interesting right here,
[00:05:52.410]is comparing the regulation of the two processes.
[00:05:56.410]On top we have the regulation for genetic engineering
[00:05:58.920]that I walked you through before,
[00:06:00.980]and on the bottom we have the regulation
[00:06:02.780]for traditional crossbreeding,
[00:06:06.200]and we have this FDA asterisk.
[00:06:08.910]And the reason it has an asterisk,
[00:06:10.710]is because if you're doing breeding
[00:06:13.130]and there isn't any traits that are considered to be
[00:06:16.570]all that novel, then you don't even have
[00:06:20.410]to go through regulatory processes.
[00:06:24.210]It's considered to be generally safe,
[00:06:29.080]and it can just reach the market.
[00:06:31.610]And so with genetic engineering,
[00:06:36.500]there's about a decade of regulation
[00:06:39.100]before it ever could reach the market.
[00:06:41.660]Whereas with traditional breeding
[00:06:43.690]we just assume it's safe,
[00:06:45.250]and it can go straight to the market.
[00:06:50.280]What I want to communicate,
[00:06:52.450]is that the change in genetic engineering
[00:06:57.200]is very heavily scrutinized, and it's only
[00:06:59.450]a one gene difference in a crop
[00:07:01.980]that we would otherwise regard as safe,
[00:07:05.130]as you can see down here.
[00:07:06.570]And so just comparing those two,
[00:07:08.680]I really encourage you to get on this website
[00:07:10.640]and look deeper into this, and explore
[00:07:14.060]what these different regulatory agencies do
[00:07:16.890]to ensure our safety in the food system.

Regulation in the genetic engineering process

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