USDA Releases Proposed Exemptions for Plant Modified Through Genetic Engineering

On November 15, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published an Exemption Proposal in the Federal Register, introducing five new types of genetic modifications that plants can possess. These modifications would be exempted from 7 CFR part 340 Movement of Organisms Modified or Produced Through Genetic Engineering (hereinafter "7 CFR part 340"), as they can be achieved through conventional breeding methods. Any comments can be submitted online by December 15, 2023.

Five New Types of Genetic Modifications Enjoying Exemptions:

Combination of function modifications loss. Any diploid or autopolyploid plant qualifies for exemption if it has a combination of modifications that result in the loss of gene function in one or all alleles of a single genetic locus. It is important to note that these modifications should occur without the insertion of external DNA.
A single contiguous deletion of any size. Diploid or autopolyploid plants with a single contiguous deletion of any size on one or more chromosomes.
Modification extension. The modifications covered by specific existing exemptions in the regulations are to be extended, including all alleles of a genetic locus on the homologous chromosomes of an autopolyploid plant.
Multi-modification: a) up to four modifications; b) each of which qualifies for exemption individually; c) modifications are made either simultaneously or sequentially. Importantly, each modification should occur at a different genetic locus.
Successive modification. Plants which have undergone a voluntary review confirming exempt status, and have been grown and observed using traditional breeding methods, can undergo additional modifications following the same exemptions. This would reduce regulations for plants modified through genetic engineering, as long as they do not pose greater risks than conventionally bred plants.

APHIS regulates organisms created through genetic engineering to ensure their safety for agriculture and important agricultural resources. According to existing regulations, enterprises have the option to review the existing exemptions outlined in 7 CFR part 340 to assess if their modified plant qualifies for exemption from regulation. Otherwise, enterprises can choose to voluntarily request confirmation from APHIS to verify if their modified plant meets the criteria for regulatory exemption.

Voluntarily Request Confirmation from APHIS

On the same day, APHIS issued an announcement regarding the regulatory status review of genetically engineered plants. The findings of the review indicate that 12 modified plants do not pose a significantly higher risk of plant pests compared to other cultivated plants. Consequently, they are not subject to regulation under 7 CFR part 340.

Here are the details of these modified plants:

No.	Plant (Common Name)	Scientific Name	Traits	Phenotypes	Regulatory status
1	Pennycress	Thlaspi arvense	Altered product quality	1) Lowered erucic acid in seeds 2) Lowered fiber in seeds	Approved
2	Brown mustard	Brassica juncea	1) Altered flavor 2) Altered texture	1) Reduced pungency 2) Reduced trichome production	Approved
3	Camelina	Camelina sativa	Herbicide resistance	Resistance to glufosinate	Approved
4	Soybean	Glycine max	Herbicide resistance	1) Resistance to glufosinate 2) Resistance to dicamba 3) Resistance to 2,4-D 4) Resistance to mesotrione	Approved
5	Banana	Musa acuminata	1) Altered fruit quality 2) Marker gene	1) Reduced browning 2) Resistance to a compound	Approved
6	Corn	Zea mays	Altered appearance	Color change induced by pathogen attack	Approved
7	Camelina	Camelina sativa	Herbicide resistance	1) Resistance to glufosinate 2) Resistance to ALS/AHAS inhibitor herbicides	Approved (1) Approved (2) Approved (3)
8	Corn	Zea mays	Altered plant architecture	Altered plant height	Approved
9	Corn	Zea mays	1) Altered enzyme levels 2) Herbicide resistance	1) β-mannanase production 2) Resistance to glufosinate	Approved
10	Soybean	Glycine max	Herbicide resistance	Resistance to auxin mimic herbicides	Approved

Enterprises seeking exemption for plants developed with additional modifications through conventional breeding must provide written documentation, which includes a clear description of the modifications, supporting evidence of feasibility through conventional plant breeding, relevant scientific literature or data, and full disclosure of any unfavorable information. It is important to note that although exempted from biotechnology regulations, products may still be subject to APHIS Plant Protection and Quarantine (PPQ) permit and/or quarantine requirements.

ChemLinked suggestion：

According to data released by the USDA's National Agricultural Statistics Service, in 2023, the adoption rates of genetically modified soybeans, corn, and cotton in the United States reached 95%, 93%, and 97%, respectively. These crops are the mainstay of genetically modified crops in the United States and are extensively cultivated for commercial purposes.

While genetically modified crops are widely accepted in the States, the cultivation amount and restrictions can vary depending on the specific crop and where it's grown. Influenced by factors like local laws, environmental concerns, market demands, and consumer preferences, some states or regions may have rules that limit or even ban the cultivation of certain genetically modified crops. Therefore, it's important for enterprises to be aware of these laws and regulations and ensure that their products meet the required standards.