FR 2021-00774

The recent document titled "Notice of Availability of a Draft Federal Select Agent Program Policy Statement for Biosafety for Large Animal Study-Related Activities With Brucella abortus and Brucella suis Using Outdoor Containment Spaces" is a significant release by the Animal and Plant Health Inspection Service (APHIS) of the USDA. This draft policy statement is aimed at guiding the development of biosafety plans for outdoor research studies involving specific livestock, with the goal of advancing research on brucellosis.

General Summary

Brucellosis is a disease primarily affecting animals like cattle, bison, and swine, and can also impact human health. Ensuring proper containment and safety when studying this disease is crucial, which is why APHIS has made this policy statement available for public comment. The document outlines how researchers can create and submit biosafety plans to comply with federal regulations concerning select agents and toxins. Public feedback on this draft is encouraged until February 16, 2021, through various submission methods.

Significant Issues and Concerns

The document presents a comprehensive guideline; however, it includes technical jargon that may not be easily understood by those without a background in scientific research or regulatory compliance. Moreover, the policy does not delve into the specific financial impacts of implementing these biosafety measures, which could be a crucial concern for stakeholders.

Another notable absence is information on oversight and auditing mechanisms to ensure adherence to these biosafety plans. Without clear compliance monitoring, the effectiveness of the regulations may be compromised. Furthermore, although the document is open for public comment, it would benefit from examples of useful feedback, which might facilitate more constructive input.

Additionally, ethical considerations about conducting large animal studies outdoors are not addressed in this draft, leaving potential ethical implications unexplored. Lastly, the availability of the policy statement in various locations could create confusion as to which version serves as the most authoritative.

Public Impact

For the general public, understanding the complexity and necessity of biosafety in agricultural studies might pose challenges, but it is critical for safeguarding public health. By offering the opportunity to participate in the feedback process, the public can engage with and influence scientific research and regulatory practices that may affect millions.

Stakeholder Impact

For researchers and institutions conducting studies on brucellosis, this document is highly relevant. It outlines the requirements to meet federal safety standards and offers a pathway to legally and safely conduct necessary research. This could facilitate advancements in diagnostics and vaccine development, ultimately benefiting both livestock and human populations by curbing the spread of this disease.

On the other hand, organizations may face increased costs and administrative burdens due to compliance with these biosafety plans. The lack of clarity on oversight might also lead to uncertainties in .implementing the necessary measures effectively.

In conclusion, while the draft policy statement represents progress in managing brucellosis risk, addressing the identified issues will be crucial for its successful implementation and public acceptance.

In the Federal Register document titled "Notice of Availability of a Draft Federal Select Agent Program Policy Statement for Biosafety for Large Animal Study-Related Activities With Brucella abortus and Brucella suis Using Outdoor Containment Spaces," there is a single financial reference mentioned in relation to agricultural production losses. This reference provides a historical perspective on the economic impact of the disease being addressed in the policy statement.

Summary of Financial Reference

The document cites that in 1952, agriculture production losses due to brucellosis exceeded $400 million. This figure illustrates the significant economic burden that brucellosis has historically imposed on agricultural output. The financial impact highlights the importance of regulatory efforts and research to control and mitigate the disease, emphasizing why policies and measures for managing brucella and related studies are critical.

Relation to Identified Issues

While the document acknowledges past financial impacts, it does not delve into the current or projected costs associated with implementing the proposed biosafety measures. This lack of current financial data is relevant to one of the identified issues: the document does not provide detailed explanations on the specific financial implications, such as potential costs for implementing biosafety measures. By not addressing these costs, the document may not fully equip individuals and entities with the financial information needed to plan adequately for compliance.

Furthermore, the document does not touch upon the allocation of financial resources to oversee or audit compliance with the proposed biosafety plans, another concern noted among the issues. This omission could be significant because understanding the potential financial resources required for oversight is crucial for comprehensive regulatory planning and enforcement.

There is also an absence of information about potential funding or financial support for entities that might struggle to implement these biosafety measures, a factor that could be beneficial in alleviating some of the financial burdens related to compliance.

In conclusion, while the document provides a historical monetary context that underscores the importance of addressing brucellosis, it lacks contemporary financial analysis or discussion about the economic implications of implementing and complying with the proposed biosafety policy. This gap could potentially affect stakeholders' ability to plan and manage the financial aspects of these regulatory changes effectively.