President-elect Trump has promised his second administration will move aggressively to deliver relief from regulatory burdens in a number of areas. Though not widely noted in the current media coverage, some of the lowest-hanging fruit in this orchard involves the regulations impacting innovative agricultural technologies, commonly referred to as “GMOs.” Reducing unwarranted regulatory burdens would deliver a lasting boost to the U.S. agricultural economy and strengthen American competitiveness.
It is difficult to quantify the opportunity costs ineffective regulations have imposed on agricultural productivity, but they are widely recognized to be substantial. No calculus has been produced that justifies these costs, which are widely out of alignment with the safety benefits if there are any.
ITIF has commented extensively on these issues over the years, as previous administrations of both parties have (usually) pushed policies to advance innovation and ensure regulation is science-based by matching the degree of scrutiny and risk management to the actual level of product risk. Trump’s first administration made arguably the most important and scientifically defensible advances in this area in many years, though, as we noted then, they still did not go as far as data and experience justified.
We offered detailed recommendations for the first Trump administration, and while there was subsequent progress in some areas, there is more work to be done in other areas. The table below provides an overview.
Table 1: ITIF recommendations to boost America’s agricultural economy
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Initial Recommendation |
Status |
Still To Do |
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Enforce the mandate from the Office of Science and Technology Policy that agencies update their regulations and policies for innovative agricultural-biotechnology products, and that the revised regulations must be effective in preventing unreasonable risks while encouraging and enabling innovation. |
Significant progress was made in this area, particularly by USDA. Notably: ▪The Animal and Plant Health Inspection Service (APHIS) in May 2020 published revisions to its biotechnology regulations (previously called the SECURE Rule) to exempt modified plants that could have been developed with conventional breeding, and to give developers the option of requesting regulatory status reviews. |
Much remains to be done, especially at [the] FDA. Specifically: ▪Withdraw and revise the proposed rule for gene-edited animals to avoid undue scrutiny in the absence of unreasonable risk by requiring regulators to exercise discretion. ▪Revise the proposed rule for gene-edited plants to match the degree of scrutiny to the level of risk. ▪Establish categorical exclusions for classes of objects currently presumed to demonstrate unreasonable risks despite the absence of data. ▪Align the degree of regulatory scrutiny with the level of hazard and risk of exposure. |
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APHIS should set aside its proposal for process-based regulations. |
USDA made significant progress in this direction, marking arguably the greatest success of Trump’s first administration in this area. Notably: ▪APHIS revised the SECURE Rule to eliminate process-based regulatory triggers. |
Ample room for greater progress at low cost remains. For example: ▪Align the degree of regulatory review with [a] level of hazard and risk of exposure. |
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The Food and Drug Administration (FDA) should enforce the federal law prohibiting misleading food labels. |
ITIF filed a citizen petition to the Commissioner of Food and Drugs calling on the FDA to issue a regulation prohibiting the use of the term “Non-GMO” on consumer foods and goods and requiring distributors to omit any “Non-GMO” term or claims on their labeling. But no further action has been taken. |
This remains to be done. |
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The FDA should revise its current proposal for regulating gene-edited animals, withdraw its proposal for gene-edited plants, and develop new proposals to exercise its discretion in preventing unreasonable risks. |
The FDA issued requests for public comment on the use of “intentionally altered genomic DNA in animals,” and “genome editing techniques to produce new plant varieties,” respectively. |
This issue remains to be resolved, as ITIF explained in [the] comments we submitted for the proceedings on animals and plants, respectively. |
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The Environmental Protection Agency (EPA) should not prematurely obstruct gene-silencing technologies. |
EPA continues to regulate innovative products using gene-silencing techniques as pesticides, despite no plausible hazards being identified. |
Replace the current regime with a requirement to demonstrate there is a plausible hazard scenario before regulation can be imposed. |
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The Fish and Wildlife Service (FWS) should withdraw its prohibition on planting biotech-improved seeds on national refuge lands. |
The FWS withdrew its rule in August 2018. |
No further action is necessary. |
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Pursue efforts through the World Trade Organization to hold China and the European Union accountable for continuing to discriminate against crops improved through biotechnology, despite their treaty obligations that prohibit such discrimination. |
No progress has been made here. |
Numerous opportunities to bring trading partners to task for failing to uphold their obligations under international treaties continue to languish. For example: ▪China continues to impose regulatory measures that are arbitrary and far [more than] its obligations to implement science-based regulations under the International Plant Protection Convention. ▪The EU continues to impose regulatory measures arbitrarily discriminating against some products of modern biotechnology. |
The single most important thing that should be done to unshackle innovation in agricultural biotechnology would be to restore proportionality between the degree of regulatory scrutiny and risk management applied to innovation and the actual level of risk it entails (i.e., exposure to a hazard).
The ostensible purpose of these regulations is to protect against threats to human or environmental safety. [However,] the risk-management and mitigation measures currently in place are heavily weighted towards hypothetical risks, largely ignoring whether or not the risks are credible, which is unacceptable. Nearly four decades of practical experience [confirm] that the hypothetical harms adduced to justify regulating GMOs have so far failed to substantiate the existence of significant risks, which is to say, risks of exposure to unreasonable hazards. Most GMO regulations are thus not fit for purpose, as [has] been pointed out repeatedly by authoritative bodies.
It is, in fact, not difficult to envision an approach to risk management that would remove much of the scientifically indefensible over-regulation while preserving protections against the emergence of any unreasonable risks.
Five Principles for Successful Regulations
We have previously described how regulators can design regulations to focus scrutiny on areas where genuine, real-life hazards require practical risk assessment and management. As we noted, the past half-century of experience has provided five simple principles that make successful regulations without unduly impeding innovation.
1. The primary purpose of regulation is to advance safety. Policymakers should resist temptations to use regulation to advance other objectives. Regulation loses efficacy and credibility when other interests—such as protecting a trade advantage or shaping national land use patterns—creep into the equation. Effective regulations avoid this.
2. The first requirement for credible and effective regulations is to focus on products with genuine hazards. Millennia of experience has given humans deep familiarity with hazards associated with new crop varieties, such as ingesting toxins, allergens, or microbial disease from poor food preparation. Unfamiliar and novel hazards in this space are vanishingly rare, reflecting that humans and our ancestors have always been opportunistic omnivores.
3. Risk is created by exposure to a hazard (R = H x E). If a product does not have a trait or characteristic hazardous to humans, it presents no risk; its use provides no opportunity [for] exposure to a hazard, and no excuse for regulation. The fact that a law provides authority to regulate products in a certain category does not mean that it makes sense, [and] produces a safety benefit return on the investment, to do so. Most regulations applied to innovations derived through genetic technologies presume some risk exists without taking the prerequisite step of identifying a hazard or articulating a credible exposure scenario. Such regulations do nothing to protect against real risks. They erode respect for regulation generally, are not fit for purpose, and should be set aside.
4. Successful regulations seek to avoid unreasonable risk, not achieve zero risk. Reasonable people may disagree about where to draw the line between acceptable and unacceptable levels of risk, but no reasonable person seeks zero risk—which is unachievable.
5. Successful regulations evaluate relative risk, not absolute risk. Establishing the absolute risk associated with a product can be very difficult. But it is much easier to determine its relative risk—in effect, comparing the potential dangers of a new product with those of the old one it would supplant. Regulations that presume to establish the level of absolute risk have needlessly obstructed R&D on many innovations with no credible hazards. Such regulations undermine the public good.
A regulatory framework grounded in these solid lessons from experience would (and should) reduce or eliminate the vast majority of regulations for crops, microbes, and livestock improved through genetic technologies in the United States and worldwide. This would dramatically improve human welfare.
Moving Forward
What concrete steps can regulators take to modernize regulations for crops, livestock, and microbes improved through biotechnology?
▪ The first step should be to discard regulatory triggers based on the use of a specific production technology. These should be replaced with triggers based on demonstrated or plausible hazards of a product to humans, livestock, wildlife, or ecosystems.
▪ The second step would reorient risk assessment to focus on potential exposure to hazards that would produce an unacceptable level of risk. This should take place in a bureaucratic culture with a predisposition to accelerate [the] approval and adoption of novel products with a lower potential for unacceptable levels of risk compared to existing products. This means regulators must resist the temptation to demand answers to questions that may be nice to know but have little or no utility for mitigating unreasonable risks—for example, requiring animal feeding safety trials to duplicate those already performed in other jurisdictions. To date, very few regulators have been able to resist this temptation. This must change.
Regulations rooted in these lessons would deliver science-based, innovation-friendly rules to provide a high level of safety while promoting innovation.
Val Giddings received his Ph.D. in genetics and evolutionary biology from the University of Hawaii. Val is also president/CEO of PrometheusAB, Inc., and a senior fellow at the Information Technology and Innovation Foundation. You can follow Val on X @prometheusgreen
A version of this article was posted at the Information Technology and Innovation Foundation and is used here with permission. Check out the Information Technology and Innovation Foundation on X @ITIFdc
