Ragini Gupta, CLB Student Fellow—LLM (Environmental Law and Policy, ’23)

This post will discuss some legal issues related to genetically engineered trees. While raising some questions, the post does not answer any of these – this is an attempt to start a discussion.

Earlier this year, A San Francisco based company  released a whitepaper announcing that its genetically enhanced poplars could capture 27% more carbon dioxide as they can grow 1.5 times faster and accumulate 53% more biomass. According to Living Carbon, their results provide a proof-of concept for engineering treesto help combat climate change. The company plans to plant about 4 million trees by 2023. It estimates that if the existing acreage of planted trees is doubled each year, this will have removed 604 million metric tons of carbon by 2030. Living Carbon’s researchers used a bacterium to insert genes from pumpkin and green algaeinto poplar trees. The result: more efficient photosynthesis, making the trees absorb more carbon dioxide.

In January 2023, Living Carbon raised USD 21 million in Series A funding bringing the total investment to USD 36 million. It says it specializes in planting on abandoned mine lands, degraded agricultural land and unproductive soils and plans to partner with landowners, who it will pay to plant the trees. It plans to generate revenue from carbon offsets, which it is already offering through monthly subscriptions.

Though Living Carbon initially published its results before a peer review process, its results have now been peer reviewed and published in Forests, a forestry journal. It remains to be seen however, how well these trees will grow in field trials, outside a controlled laboratory setting. Dr. Steven Strauss, a forest biotechnology expert who has earlier served on Living Carbon’s advisory board and is collaborating with the company on research also says that it is too early to tell whether the enhanced trees will outpace unmodified trees.

There are other concerns.  The Campaign to Stop GE Trees, an alliance of organizations that opposes the release of genetically engineered trees (“GE trees”) into the environment argues that GE trees could “exacerbate the climate crisis by threatening forest ecosystems.” They further argue that the long term risks of GE trees on forests, wildlife and human health are unknown. Living Carbon says that all its trees are female,do not produce pollen, hence the possibility of them reproducing is very low.  Further, the company says it selects sites so that surrounding trees with which the GE trees are planted, are not closely related enough to fertilize them.

Applicable law

GE trees, like other biotechnology products are regulated under the Coordinated Framework for Regulation of Biotechnology (“Coordinated Framework”), which was first published in 1986. Under the Coordinated Framework, the three federal agencies that regulate products of biotechnology, including GE trees are the Environment Protection Agency (“EPA”), the US Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The FDA regulates GE trees where they produce food for humans or animals. The EPA regulates certain GE plants under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) and the Federal Food, Drug and Cosmetics Act (“FFDCA”). FIFRA and FFDCA apply to pesticides and the amount of pesticide residue that may be present in food. FIFRA regulates “plant-incorporated protectants” (“PIPs”), or pesticidal traits of certain plants. Where a GE tree does not produce a pesticide, EPA would not exercise oversight.

Under the Plant Protection Act (“PPA”), the USDA is authorized to “prohibit or restrict the importation, entry, exportation or movement in interstate commerce of any plant, plant product, biological control mechanism, noxious weed, article or means of conveyance” if it determines that “the prohibition or restriction is necessary to prevent the introduction into the  United States or the dissemination of a plant pest or noxious weed within the United States.” The USDA’s authority to regulate genetically engineered organisms is delegated to The Animal and Plant Health Inspection Service (“APHIS”). APHIS oversees the environmental release of genetically engineered organisms, including genetically engineered plants through its Biotechnology Regulations, 7 Code of Federal Regulations [CFR] part 340 (“the Regulations”).

The Regulations apply to plants that[1] (i) have a plant-trait-mechanism of action combination that has not been evaluated by APHIS in its Regulatory Status Review process; (ii) meets the definition of “plant pest”[2](iii) encode a product intended for pharmaceutical or industrial use. Such plants cannot be “moved” (an expansive definition which includes release into the environment) without a permit from APHIS.[3] There are also exemptions[4] from the Regulations – they do not apply to plants that have been modified through certain processes. These include changes resulting from cellular repair of targeted DNA break in the absence of an externally provided repair template, targeted single base pair substitution and introduction of a gene known to occur in a plant’s gene pool. Importantly, the regulations will not apply to plants earlier determined by APHIS to not require regulation under its ‘Am I Regulated’ process and such plants will retain their non-regulated status under the regulations. (The Am I Regulated Process, a part of APHIS’s old regulations is now obsolete). Importantly, the Regulations allow developers to self-determine whether their products qualify for exemptions.

According to Living Carbon, the USDA, under the Am-I-Regulated process, ruled that its trees did not need to be regulated. This is because the regulations at the time applied to plants or trees if (i) they had pests that are on USDA’s list of plant pests (ii) the process of introducing the change in their genome involved an organism on the list of plant pests or (iii) any of the introduced DNA came from an organism on the list of plant pests. Since Living Carbon’s GE trees were not created in this manner, they were exempted and will likely retain this status as per the present Regulations.

The Regulations have a Regulatory Status Review[5] (“RSR”) process. Any person can request a request for RSR[6] and APHIS can also initiate[7] a RSR of a GE plant to identify whether it is subject to review under the Regulations. Re-review can also be requested provided the request is supported by “new, scientifically valid evidence” bearing on the plant pest risk associated with movement of the plant.[8] In a RSR, APHIS will consider whether there is a “plausible pathway by which the GE plant, or any sexually compatible relatives that can acquire the engineered trait from the GE plant would pose an increased plant pest risk” relative to the non-GE comparator.[9] For determining whether there will be an increased plant pest risk, APHIS considers factors including the trait and mechanism-of-action of the modification[10]. It also considers effects of the trait and mechanism-of-action on[11]:

1. Distribution, density or development of the plant and its sexually compatible relatives;
2. Production or enhancement of a plant pest or a plant pest reservoir;
3. Harm to non-target organisms beneficial to agriculture;
4. Weedy impacts of the plant and its sexually compatible relatives.

If APHIS identifies such a “plausible pathway”, the developer of the GE plant may apply for a permit, otherwise the plant in question will not be subject to the Regulations. Submitting a product to APHIS to determine whether it is subject to the Regulations is not compulsory under the RSR – it is voluntary if the developer wishes to confirm its status[12]. However, since APHIS also has the power to initiate RSR or re-review[13], developers might decide seek confirmation anyway, for certainty. Since APHIS can initiate an RSR process, would it have considered whether Living Carbon’s trees have the “plausible pathway” to increased plant pest risk? The answer might not matter since they were exempted under the Am-I-Regulated process and will retain this status.

Questions

With the threat of climate change looming, the possibilities presented by carbon-sucking trees are exciting. However, there are several questions as regards these trees, and GE trees generally:

Is it justifiable to claim offsets for these trees when it is presently unclear whether they can absorb any more carbon than unmodified trees? [The description on the company’s website says that their biotech seedlings are “unique in their ability to capture more carbon on less land”]

The Regulations permit “any person” to request RSR, or re-review of a GE plant. Does this mean that any member of the public (other than the developer) can request RSR? An example could be a person on whose land a GE tree is being planted, or an owner of adjoining land apprehending risks from the GE trees. Of course, a request for RSR has to include considerably technical information including the genotype of the modified plant, including a detailed description of the differences in genotype between the modified and unmodified plant. Not all parties will have access to such information, hence there might be limitations in who has the ability to initiate the RSR.

Once APHIS determines under 7 CFR 340.4(b)(2) that no “plausible pathway” for plant pest risk exists, the GE plant falls outside APHIS’s jurisdiction and APHIS’s oversight ends there. However, APHIS could initiate a re-review. Is such an approach justified for trees, which live much longer than crops, making it more difficult to predict their long-term impact? Whether long-term impacts are monitored would depend on APHIS’s proactiveness in considering whether a re-review is required.

Under the Regulations, plants found to be exempt under the Am-I-regulated process will continue to retain their exempt status. How prudent is such a blanket exception, since the regulatory trigger under the earlier regulations was whether a GE tree was engineered using a DNA from a plant pest?  What if there was indeed a plausible pathway for plant pest risk from a GE tree, and the plant retained unregulated status? As mentioned earlier, GE trees have a longer life span, meaning we will continue to learn about their effects over the years. A blanket exemption that was granted based on old assumptions might not be suitable in such cases.

APHIS’s regulatory focus is centered around “plant pest risk.” As explained earlier, this includes considerations as to distribution and density of the plant, weedy impacts and effects on non-target organisms beneficial to agriculture. The “plant pest” might exclude some apprehended impacts on ecosystems and forest health generally. For instance, one of the fears with GE trees is that they might impact soil-dwelling fungi and microbes, on which the terrestrial food chain is dependent. These might not qualify as “agriculturally beneficial” even though they are nevertheless important to ecosystems. Is there a need to expand oversight to consider impacts of GE trees on ecosystems? For PIPs, the EPA, under FIFRA, considers whether a GE plant would cause “unreasonable adverse effects on the environment[14]”, but EPA’s oversight would not extend to a GE tree that does not produce a pesticide.

It has been argued that we do not have the luxury to wait for 30 years to ensure that nothing can go wrong with GE trees, because of the urgency of the climate crisis. Still, these questions should be debated so that the climate crisis is not exacerbated due to unintended consequences.

[1] 7 CFR 340.2

[2] As per 7 CFR 340.3 a “Plant pest” is “any living stage of a protozoan, nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the foregoing that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product.

[3] 7 CFR 340.5(a)

[4] 7 CFR 340.1(a)

[5] 7 CFR 340.4

[6] 7 CFR 340.4(a)(1)

[7] 7 CFR 340.4(a)(3)

[8] 7 CFR 340.4(a)(2)

[9] 7 CFR 340.4(b)(1)

[10] 7 CFR 340.4(b)(1)(ii)

[11] 7 CFR 340.4(b)(1)(iii)

[12] 7 CFR 340.4(a)(1)

[13]

[14] 7 USC 136a