The Centers for Disease Control and Prevention (CDC), in collaboration with the Animal and Plant Health Inspection Service (APHIS), has initiated a public comment period for proposed changes to how federal agencies track and regulate potentially dangerous biological agents and toxins. Published in the Federal Register on September 8, 2026, this action primarily introduces a new standardized form for reporting the discovery of previously unregistered select agents or toxins, aiming to close a critical gap in national biosecurity protocols and ensure more robust oversight of these hazardous materials. This move comes as part of a continuing effort to refine regulations under the Paperwork Reduction Act of 1995 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Background of Federal Select Agent Regulations
The regulatory framework governing select agents and toxins stems from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This landmark legislation established a dual mandate: Subtitle A (42 U.S.C. 262a) tasks the Department of Health and Human Services (HHS) with regulating agents posing a severe threat to public health and safety. Concurrently, Subtitle B, known as the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401), requires the Department of Agriculture (USDA) to oversee agents that could severely threaten animal or plant health.
To streamline compliance and minimize administrative burden, the CDC's Division of Select Agents and Toxins (DSAT) and APHIS's Division of Agricultural Select Agents and Toxins (DASAT) collaborate to form the Federal Select Agent Program (FSAP). This program administers unified regulations (42 CFR part 73, 7 CFR part 331, and 9 CFR part 121), compelling individuals and entities handling these materials to register with either the CDC or APHIS, unless specific exemptions apply. Failure to register for regulated material constitutes a regulatory violation, potentially leading to civil, criminal, or administrative penalties.
The Challenge of Undiscovered and Unregistered Pathogens
Since the implementation of the select agent and toxin regulations in 2003, federal authorities have encountered a recurring issue: the "discovery" of select agents or toxins in facilities that were not registered to possess them. The Federal Register notice highlights at least 100 such instances. These discoveries often arise from various circumstances, including:
- Studies associated with personnel who have departed an entity, leading to samples lacking reassigned custodianship.
- Materials labeled with obsolete pathogen names, making their regulatory status unclear.
- Pathogens found in laboratories where their active use had long ceased, sometimes decades before the regulations were even established.
These scenarios underscore a significant challenge in maintaining comprehensive oversight of biological materials that, even inadvertently, could pose severe threats. The absence of a dedicated reporting mechanism for such discoveries has meant that these incidents were not consistently tracked or understood, hindering the ability of regulatory bodies to assess the scope of the problem and ensure proper remediation.
Proposed Amendments and the New Reporting Mechanism
To address this vulnerability, HHS/CDC proposes to amend section 73.2 of the select agent regulations. This amendment will clearly mandate that any individual or entity in possession of a select agent or toxin for which an exclusion or exemption does not apply, and which is not covered by an existing certificate of registration, must immediately report such possession to the HHS Secretary or USDA Administrator. This ensures that all discoveries of unregistered select agents or toxins are reported, regardless of whether the discovering entity is otherwise registered with the program.
Crucially, the CDC and APHIS are introducing a new standardized form, APHIS/CDC Form 6, titled "Report of Discovery of Select Agent or Toxin form" (42 CFR 73.19(c)). This new form will replace the previous practice of reporting discoveries via Form 3, which was primarily designed for incident notifications like theft, loss, or release, not for the specific context of an unexpected discovery. By establishing Form 6, the agencies aim to standardize the information collected during such reports, allowing for a more thorough understanding of the circumstances surrounding discoveries and a more consistent assessment of potential regulatory violations.
The overall information collection associated with the Federal Select Agent Program is also being revised, encompassing five existing forms (Application for Registration, Request to Transfer, Incident Notification, Reporting Identification, Request for Exemption) and the newly added Form 6. Additionally, various other documentation requirements, such as self-inspections, security plans, biosafety plans, and training records, continue to be integral parts of the regulatory framework.
Implications for Regulated Entities and Biosecurity
The proposed changes carry several implications for entities that handle or might inadvertently come across select agents and toxins. The most immediate is an increased administrative burden. The CDC estimates the annualized burden for all data collection will rise by 5,416 hours from the previous approval, totaling an estimated 8,919 hours. This increase is attributed to changes in the number of respondents, shifts in average burden per response across forms, the introduction of Form 6, and corrections to previous underestimations.
Entities, including those already registered, must now be acutely aware of the immediate reporting requirement for any newly discovered, unregistered select agent or toxin. This emphasizes the need for rigorous inventory management, historical record-keeping, and internal audit procedures to prevent such discoveries. Registered entities that knowingly come into possession of material prior to amending their registration will also utilize the new form, and the CDC is seeking comments on whether this dual reporting (discovery and subsequent amendment) poses an undue burden.
From a broader perspective, these revisions underscore the federal government's commitment to continuously strengthening biosecurity measures. By closing the reporting loophole for discovered pathogens, the FSAP aims to enhance its ability to track, assess, and mitigate risks associated with these dangerous materials, ultimately bolstering national defense against accidental release or intentional misuse.
The public comment period for these proposed changes concludes on November 9, 2026. Interested parties are encouraged to submit feedback, particularly regarding the necessity and utility of the proposed collection, the accuracy of burden estimates, and ways to improve the quality and minimize the burden of information collection, including through electronic submission methods. This public input is crucial for refining the regulatory approach and ensuring its effectiveness while minimizing unintended consequences for the scientific and research communities.
