First rewrite of USDA’s biotechnology rules set in 1987
The Bloomberg story (see item 1 below) announces that "The Trump administration would exempt many new genetically engineered crops from regulation by the US Department of Agriculture under a broad overhaul of biotechnology rules announced on Wednesday."
The proposed new rule (see item 2 below), ironically called by the acronym "SECURE", would exempt many gene-edited organisms from regulation.
Moreover, the USDA proposes that GMO developer companies can "self-determine" whether new traits qualify for exemption.
The US's regulation of GMOs is already extremely weak. Thus far the USDA has "regulated" GMOs only if they pose a plant pest risk or are a noxious weed. In practice, though, the agency has not done anything to restrict herbicide-tolerant GMOs that have led to the spread of herbicide-resistant superweeds, which surely qualify as noxious weeds.
Also GM bentgrass has long behaved like a noxious weed but the USDA has done nothing about it apart from offload responsibility onto farmers and states.
GMOs that express a pesticide, like Bt crops, are regulated by the EPA under the pesticide regulations.
The US Food and Drug Administration, the FDA, has only conducted a voluntary review process that if successful for the industry applicant, culminates not in the FDA's approval of the GMO as safe, but in the FDA sending a letter to the applicant reminding the applicant that it is their responsibility to only put safe foods on the market.
For more information about this system, see GMO Myths and Truths.
You can view the proposed new rule here – public comments are invited.
1. Trump Administration proposes easing rules on genetically engineered crops
2. USDA proposes new SECURE biotechnology regulations to protect plant health and promote agricultural innovation
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1. Trump Administration proposes easing rules on genetically engineered crops
By Mike Dorning
Bloomberg, 5 June 2019
https://www.bloomberg.com/news/articles/2019-06-05/trump-team-proposes-easing-rules-on-genetically-engineered-crops
* USDA plans to exempt many new modified plants from regulation
* First rewrite of department’s biotechnology rules set in 1987
The Trump administration would exempt many new genetically engineered crops from regulation by the U.S. Department of Agriculture under a broad overhaul of biotechnology rules announced on Wednesday.
The overhaul, which the department said would cut the cost of developing genetically engineered plants, would exempt crops with traits “similar in kind” to modifications that could be produced through traditional breeding techniques. Developers would be allowed to make a “self-determination” that their products are exempt from regulation.
The administration argues the approach will allow regulators to focus on "increasingly complex products which, in turn, may pose new types of risks.”
The USDA estimates the proposal would save developers an average of $3.6 million for each new genetically engineered crop, if the product isn’t also regulated by the Food & Drug Administration or Environmental Protection Agency. If another government agency also regulates the plant, the average savings would drop to $730,000.
“This common sense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store,” Greg Ibach, Under Secretary of Agriculture for Marketing and Regulatory Programs, said in a statement.
The proposal replaces regulations the Obama administration proposed in January 2017 but the Trump administration later withdrew. The Agriculture Department said in the new regulatory proposal that comments on the Obama regulations indicated the requirements “would be too burdensome and had the potential to stifle innovation.”
The proposal would be the first significant revision of its biotechnology regulations since they were issued in 1987, the USDA said in a statement. The proposed rule will be open for public comment through Aug. 5 before the department issues a final regulation.
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2. USDA proposes new SECURE biotechnology regulations to protect plant health and promote agricultural innovation
USDA, 6 June 2019
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/brs-news-and-information/2019_brs_news/340_secure_proposed_rule_pr
The U.S. Department of Agriculture (USDA) today announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.” In preparing this proposal, we were guided by the following principles: Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, or SECURE for short. The SECURE rule will modernize the Department’s biotechnology regulations with a balanced approach that continues to protect plant health while allowing agricultural innovation to thrive.
“As the name SECURE implies, this proposed rule incorporates the need for efficient and sustainable agricultural production to help feed and clothe the world combined with responsible and predictable regulatory oversight to safeguard America’s ecology and plant health,” said USDA Under Secretary for Marketing and Regulatory Programs Greg Ibach.
SECURE would mark the first significant revision of USDA’s biotechnology regulations since they were established in 1987. For several years, USDA has worked to engage stakeholders about potential changes to these regulations, with the goal of fostering public confidence while providing industry with an efficient and transparent review process that doesn’t restrict innovation.
USDA’s Animal and Plant Health Inspection Service (APHIS) oversees the importation, interstate movement and environmental release of genetically engineered organisms to ensure they do not pose a plant pest risk. SECURE is designed to have sufficient regulatory flexibility for advances in genetic engineering and our understanding of the plant pest risk posed by them. SECURE also incorporates certain provisions of the 2008 Farm Bill and recommendations from the 2015 USDA Office of Inspector General report on GE organisms.
“SECURE would enable APHIS to evaluate GE organisms for plant pest risk with greater precision than the current rule allows, ensuring oversight and risk are based on the best available science,” said Ibach. “This common sense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store.”
USDA’s proposed rule will be available for public review and comments will be accepted for 60 days beginning June 6, 2019, through August 5, 2019. After the public comment period closes, we will decide next steps based on our evaluation of public comments. Additionally, USDA plans to publish a draft programmatic Environmental Impact Statement (EIS) soon, and we look forward to stakeholder input on that document.
This notice may be viewed in the Federal Register. Members of the public can submit comments through August 5, 2019 at the link below.