The US agriculture industry has responded to requests for comments about a relaxation in the regulation of genetically engineered (GE) organisms.
The proposed change to GE regulations, put forward by the USDA’s Plant Health Inspection Service (APHIS), is referred to as Part 340, and is leftover from the Obama administration. It would exempt biotech products that present no risk to the environment or human health from the arduous and costly USDA approval process, using early stage USDA review to rule in or out new technologies.
“APHIS is proposing to revise its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by genetically engineered (GE) organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks. This would be the first comprehensive revision of the regulations since they were established in 1987.”
According to Politico, there was an attempt to update the same rule on GE regulations in 2008, but it was scrapped after a strong negative reaction from the industry. Though a few comments this time around recommended scrapping this change as well, most industry and stakeholder comments offered constructive changes.
The rule would represent a shift in how GE is regulated, focusing more on products resulting from GE, as opposed to the methods used.
A common theme, though nowhere near unanimous, was that moving toward regulating products and not methods is a positive step. But since it will shift the USDA’s review to earlier points in the product development process, critics say that this will slow innovation. Organizations representing or on the side of organic agriculture practices argue that direct harm is not a sufficient measure of risk when organic farms are indirectly affected by contamination. Generally, most commenters agreed that the proposal needed a lot more clarification and work before it could become a rule.
The next step in this process will be the release of an environmental impact statement for further comment from the industry although there is no clear timeline on this.
The USDA received 207 comments on the proposed rule change to GE regulations from citizens and industry. Many of the industry voices are below, drastically truncated to reflect their general statement of opinion. (To see the detailed reasoning behind each statement, click the link for each organization.)
Here is a look at the industry responses in their own words.
We are concerned that these flaws will have a significant negative impact on innovation, particularly for small companies and universities hoping to develop agricultural products for specific regional or environmental needs or to develop minor use crops that could be important domestically and internationally. Ultimately, we believe that problems with USDA’s proposed regulatory system are significant enough that USDA will need to substantially revise the proposed rule in order to address them.
Despite positive aspects of the proposal, the regulatory system proposed by USDA has significant shortcomings that could have unintended effects and adversely affect the ability of USDA to meet its goals for the proposal. ASTA believes these shortcomings are significant enough that substantial changes need to be made to the proposal, and we, therefore, do not support moving from this proposal to a final rule.
The Societies applaud APHIS for modifying its definition of a genetically modified organism and for undertaking the development of a regulatory system that is risk-based instead of method-based. However, certain requirements in this proposed plan need more clarity, and others may be overly burdensome to academic scientists running smaller-scale experiments with plants not intended for market.
ASA appreciates USDA’s goals to update the regulations and reduce regulatory burdens. However, in order to meet that goal, ASA believes USDA needs to make significant changes so that any final rule does not expand the regulatory reach of Part 340 to include noxious weed authority and instead creates regulatory certainty without stifling research and innovation. In addition, we believe USDA needs to make a clear statement on the direction of US policy on pre-market regulatory processes for biotechnology, including the exclusion of certain genome-editing tools.
By exempting most GE crops from regulation, USDA’s proposal would greatly exacerbate, rather than reduce, GE contamination and its costs, increase pesticides and superweeds and other harms of GE crops to farmers, health, and the environment. The government must fix these failings, not make them worse.
While CSPI supports some of the proposed changes, CSPI is concerned that the proposal eliminates USDA oversight of some “traditional” GE crops, which could result in harm to the environment or agricultural interests. The gaps in regulation resulting from the proposed rule changes, which are set forth below, need to be addressed by USDA before any changes to 7 CFR part 340 are finalized.
For years, APHIS’ approval process for the products of biotechnology has failed to protect the environment, public health and the livelihoods of farmers. As it is currently conceived, APHIS’ process is not capable of assessing or managing all of the risks associated with genetically engineered plants, animals or organisms. The current regulations do not adequately protect the safety of humans or the environment and they do not ensure farmer choice, fair practices in input markets or the ability of those who do not use this technology to operate without bearing unfair economic burdens. Since the introduction of patented GE organisms, a lack of oversight has led to the unwanted presence of unapproved GE crops, contamination of organic and non-GE crops with GE content and the decision to allow certain GE crops to be sold and planted with zero regulatory scrutiny. Any new regulatory framework must provide for the active monitoring, detection, assessment, mitigation and prevention of harmful impacts of GE crop production systems on farmers’ livelihoods, rural communities’ health and the environment, including non-target organisms. Unfortunately, this proposed rule does not meet any of these goals.
These changes have the potential to reduce the time, cost and uncertainty currently present in the existing regulatory process. It would allow smaller companies, start-ups, non-profits and universities to create new products through biotechnology and be
able to participate in their commercialization. This should result in a preponderance of new technologies reaching the farmer faster. But, for this to become reality, APHIS needs to clarify certain steps in their process to remove ambiguity, especially as it relates to determination of a noxious weediness and how more specifically the agency will deal with gene editing.
NASDA applauds USDA’s efforts to modernize these regulations to ensure they reflect and incorporate the best-available science and utilize the more than 30 years of experience USDA has in reviewing the safety of these crops. NASDA stands ready to assist our federal partners and the regulated community to revise and improve the proposed rule and to ensure any final rule-making reflects and incorporates the best available science, provides a consistent regulatory framework, facilitates innovation, and enables our producers, growers, and other agricultural stakeholders to continue to produce our nation’s food, fiber, and fuel in a collaborative and productive manner.
USDA must develop and execute an international engagement strategy that explains USDA’s latest thinking on pre-market regulatory approaches, including its approach to oversight of products developed with genome editing tools. U.S. government agencies should be encouraged to actively engage with our trading partners around these policies as soon as possible to work toward consistent, science-based, policies across countries to avoid trade disruptions.
NCFC recommends the Department reconsider the regulatory implications of this proposal and address these concerns by significantly revising the proposed rule.
It is time for the US Department of Agriculture’s Animal and Plant Health Inspection Service to take the roles of importation, interstate movement and release of genetically modified organisms much, much more seriously, not less. The safety of our food supply, the health of our environment and the wellbeing of our rural communities – where most GMOs are grown and harvested – depend on careful and stringent assessment and oversight.
The proposed regulatory updates will require significant modification if they are to encourage innovation and improved crop traits for all segments of agriculture, while protecting plant health. Unfortunately, as written, the proposal would instead increase uncertainty and regulatory burdens especially for smaller acreage crops, which are most in need of advances to remain competitive in the global marketplace.
NSAC strongly believes the direct and indirect economic, social, and environmental impacts associated with biotechnology regulation should be broadly assessed, with the goal of developing a robust and meaningful regulatory framework that ensures all American farmers can thrive. Such a framework must include: Sound, science-based information that empowers farmers to make good decisions regarding their production systems and to implement stewardship practices that enhance coexistence; Effective measures to prevent contamination of organic and other non-GE farm products and crop seed with unintended GE content; fair and workable system of compensation in the event that GE contamination leads to economic losses for organic and non-GE producers; and Mechanisms for preventing and responding to problems associated with drift of agricultural chemicals associated with GE crops onto neighboring farms, including concerns for not damaging crops and natural resources such as pollinator habitat.
NOFA-NY believes that USDA has the authority provided by the Plant Protection Act to implement regulations to protect farmers, the environment, and our communities from unwanted harm and impacts from GE organisms. This proposal would significantly weaken existing regulations and provide loopholes that would deceive the public into believing that GE organisms are indeed being regulated adequately. We urge the Department to withdraw this proposal and use your authority to develop and implement stronger regulations to protect the citizens and the environment of the United States.
GE organisms pose unique risks to farmers and the environment, and in particular to farmers growing certified organic or non-GE crops. In revising its Part 340 regulations, we urge USDA to improve coordination with EPA and FDA, and to take into account the true environmental and economic impacts of GE crops.
While we appreciate USDA utilizing the noxious weed authority granted in the Plant Protection Act (PPA), the proposed rule exemplifies the one step forward two steps back approach to the regulation of biotechnology. OEFFA is concerned the USDA has not developed any means to prevent or mitigate the unintended presence of GE material in organic and non-GE seeds and products. Organic agriculture is the only segment of agriculture seeing double-digit growth for more than a decade. In order for this vital and vibrant agricultural sector to continue to grow, we must protect our ability to grow products without contamination from biotechnology.
The proposed revisions to USDA biotechnology regulations, published at the end of the previous administration, take some positive steps in the right direction. Despite the positive aspects of the proposal, however, the regulatory system proposed by USDA has shortcomings that could unintentionally make it harder for USDA to meet its goals. The American Farm Bureau Federation has enumerated those shortcomings in their comments. Those shortcomings are significant enough that OKFB is unable to support the regulatory revisions as proposed.
The new rule is an invitation for China to conduct risky new genetic experiments in the US. The new rule exempts most bio-factories from US oversight, making the US the ideal place for China to grow crops that produce pharmaceuticals or industrial compounds. American farmers and the American public deserve greater protection from US regulators. The proposal to further deregulate genetically modified organisms must be rejected.
The proposed revisions to USDA biotechnology regulations are helpful in some respects. For example, the proposed regulations convey a strong message that regulatory oversight should be proportional to actual risk. In addition, USDA’s proposed position that pre-market review of products of newer breeding methods such as gene editing, and the similarity of many products developed using these methods to those developed using more traditional plant breeding methods is particularly encouraging. While we are encouraged by these positive aspects of the proposed regulations, we join our counterparts and fellow stakeholders in the production agriculture community to highlight our shared concerns.