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SECURE Rule Regulatory Changes

APHIS’ SECURE rule revises the regulations regarding the importation, interstate movement, and environmental release of certain organisms to account for advances in genetic engineering and in our understanding of the plant pest risks posed by organisms developed using genetic engineering.

The SECURE rule differs from the previous regulatory framework by focusing on an organism’s properties and not on the method used to produce it. This approach enables us to regulate organisms developed using genetic engineering for plant pest risk with greater precision than the previous approach. This will reduce regulatory burden for developers of organisms that are unlikely to pose plant pest risks, and continue to provide oversight of organisms developed using genetic engineering that pose a plant pest risk.

WHAT IS A PLANT PEST?
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.


LEARN ABOUT THESE CHANGES IN MORE DETAIL BELOW

EXEMPTION PROCESS OVERVIEW
The exemption and confirmation process will take effect on August 17, 2020

Under the SECURE rule, certain categories of modified plants would be exempted from the regulations because they could otherwise have been developed through conventional breeding techniques and thus are unlikely to pose an increased plant pest risk compared to conventionally bred plants. APHIS has historically not regulated conventionally bred plants under 7 CFR part 340. These exemptions apply only to plants because the long history of plant breeding gives us extensive experience in safely managing associated plant pest risks.  

The revised regulations also exempts plants developed using genetic engineering that contain a plant-trait-mechanism of action (MOA) combination that APHIS has already evaluated under the previous or new regulations and found to be unlikely to pose a plant pest risk. The results of all completed regulatory reviews will be publicly accessible on the APHIS website. 

CLAIMING REGULATORY EXEMPTION
A developer may review the exemptions to assess whether a plant belongs to one of the categories exempt from the regulations. A developer has the option to request written confirmation from APHIS that the plant is exempt. 

A plant that contains a single modification of a type in one of the following three categories is exempt from regulation:

  1. A change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or
  2. A targeted single base pair substitution; or
  3. Introduction of a gene known to occur in the plant’s gene pool, or a change in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.    

A plant that contains a plant-trait-mechanism of action (MOA) combination that APHIS has already evaluated under the previous or new regulations and found to be unlikely to pose a plant pest risk is also exempt from regulation. 

EXPANSION OF EXEMPTIONS
APHIS can expand the exemptions to ensure the regulations remain current with technology and science. Stakeholders can request expansion through a process that provides public notice and comment. 

CONFIRMATION OF EXEMPTIONS
Developers may seek confirmation from APHIS that the product meets an exemption and is not subject to the regulations in 7 CFR part 340. APHIS will provide a written response (“confirmation letter”) within 120 days of receiving a sufficiently detailed confirmation request. APHIS will post issued confirmation letters on its website, with redactions to protect Confidential Business Information and Personal Identifying Information, as appropriate. This confirmation process takes the place of the preexisting “Am I Regulated?” process and “extension” process.

Learn More About Exemptions in APHIS Biotechnology Regulations 340.1

REGULATORY STATUS REVIEW PROCESS
Will be implemented for certain crops on April 5, 2021 and fully implemented on October 1, 2021 

Under the previous regulations, APHIS assessed the plant pest risk of each plant transformation event (also sometimes referred to as the individual transformed line, transgenic line, or genetically-engineered (GE) line) separately, even though the inserted genetic material may have been identical or very similar to transformation events already assessed. This has sometimes been referred to as an “event-by-event” approach.  

Under the revised regulations, developers have the option of requesting a permit or a regulatory status review of a plant developed using genetic engineering that has not been previously evaluated and determined to be nonregulated. This process replaces the petition process in the previous regulations. The revised regulations evaluate whether a plant requires oversight based on the characteristics of the plant itself and not on the method by which the plant was genetically engineered. Once APHIS determines that the plant is not regulated, subsequent transformation events using the same plant-trait-mechanism of action combination would not be regulated. 

Decisions on regulatory status are based on our assessment of plant pest risk. If movement or release of a plant developed using genetic engineering is found to be unlikely to pose a plant pest risk, APHIS would not require regulation under 7 CFR part 340. If we were unable to reach such a finding, APHIS would regulate the plant and it would be allowed to move only under permit. 

RSR EVALUTATIONS 

RSR evaluates plant pest risk based on

  •  
  • the biological properties of the plant; and
  • the trait (or new characteristic); and
  • the mechanism of action (or how the genetic modification causes the new trait to occur) 

RSR will include one or two steps, depending upon the plant 

STEP 1 (APHIS will complete Step 1 in 180 days)

Evaluate the characteristics of the plant developed using genetic engineering relative to an appropriate comparator plant to identify whether a plausible pathway to increased plant pest risk exists and the corresponding factors of concern. 

    •  
  • If APHIS does not identify a plausible pathway to increased plant pest risk, the plant is not subject to regulation.
  • If APHIS does identify a plausible pathway to increased plant pest risk, the developer may:
    • elect to take no further action   
    • request a permit to move the plant and/or perform field trials
    • request that APHIS complete the second step in the process 

NOTE:  A developer can request both a permit and that APHIS complete the second step in the process. 

STEP 2 (APHIS will complete its entire evaluation within 15 months)

Evaluate the identified factors of concern involving the plant developed using genetic engineering to determine the likelihood and consequence of the plausible increased plant pest risk.

    •  
  • Publish the results of the evaluation in the Federal Register
  • Solicit and review comments from the public
  • If APHIS finds the plant is unlikely to pose an increased plant pest risk, the plant is not subject to the regulations
  • If APHIS does not make such a finding, the plant will remain regulated

Learn More About the RSR Process in APHIS Biotechnology Regulations 340.4

Will take effect on April 5, 2021

Permits are required for the importation, interstate movement, or environmental release of any plant or organism developed using genetic engineering that may post a plant pest risk to plant health. For plants, developers must apply for a permit if the plant does not qualify for an exemption or if the regulatory status review (RSR) process determines that the plant poses a plausible plant pest risk. APHIS will approve or deny an application for an importation or movement permit within 45 days, and an application for a permit for an environmental release in 120 days. Developers may also choose to request a permit rather than request an RSR, or they may elect to obtain a permit and request an RSR.  Applicants still apply for a permit using the same methods as before – a paper application, ePermits, or APHIS eFile. 

In the previous regulations, APHIS also offered an option for Notifications for certain plants an administratively streamlined alternative to a permit. Under the revised regulations, the notification process has been eliminated and replaced by the RSR and permitting process.

Learn More About the Permitting Process in Aphis Regulations 340.5

Apply for a Permit

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