The White House is issuing new legislation that impacts how federal agencies select life-sciences vendors.

Your screening certification is now a core requirement for working with academic institutions, federal contractors, and government partners.

Providers like IDT, Thermo Fisher, and Twist Biosciences are already using screening to get ahead of the curve. Start your certification now to avoid disruptions with your customer contracts and workflows.

What are the new standards?

By October 24, 2024, all federal agencies are mandating compliance and certification with screening requirements.

This new requirement applies to funding from federal grants to universities and foundations and federal contracts to prime contractors and subcontractors. Providers working with these partners need to be compliant and certified months before the requirements take effect.

Providers are defined as manufacturers, bench-top synthesizers, resellers, distributors, biofoundries, cloud labs, core facilities, and CROs for all DNA and RNA, including oligonucleotides, genes, plasmids, and viral vectors.

How we got here

We’ve had more than a decade of escalating policy moving our industry from elective to mandatory screening standards.

Protein design and synthetic biology experts are also signing on to support mandatory screening, including Nobel Laureate Frances Arnold and Professors George Church and David Baker.

What are the implications and opportunities?

There are critical advantages to maintaining screening compliance:

1. Accelerate growth
Screening certification is required to sell to government and institutions receiving federal funding, like universities, foundations, and federal contractors. On average, federal grants and contracts make up more than 20% of the market.

2. Trust and buy-in from researchers
Many leading researchers are already committing to purchasing only from providers that perform screening, highlighting a shift toward responsible sourcing.

3. Mitigate risk
Adhering to regulatory protocols significantly reduces reputational risks and the liability of noncompliance or negligence, which can lead to severe penalties, fines, and loss of client trust.

How to get started

An automated screening tool is essential. Even with a small number of orders, nucleic acid sequences can have hundreds of hits that are time-consuming to review and prone to error. Many of the automated tools developed by the biosecurity community took years to build to ensure the right compliance decision based on the available biological data and the complex regulatory decision tree.

If you’re impacted by the new screening requirements, you can start with an automated tool like Aclid, which puts your security compliance on autopilot. In addition to sequence and customer screening that meets the ASPR Screening Framework Guidance, we are the leading solution for biosafety compliance and continue to evolve with changing industry and regulatory standards.

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