FR 2021-00877

The document from the Federal Register, issued by the Centers for Disease Control and Prevention (CDC), announces the availability of a draft policy statement. This document aims to gather public comments to refine safety protocols for conducting outdoor large animal studies with two specific bacteria, Brucella abortus and Brucella suis. These bacteria pose significant risks to both animal and human health. The proposal seeks to ensure any such research complies with existing federal safety regulations established by both the CDC and the U.S. Department of Agriculture (USDA).

Summary and Purpose

The CDC has proposed a new policy to guide researchers in developing biosafety plans for studying certain bacteria outdoors. These studies are crucial as they involve Brucella bacteria known to cause brucellosis, a disease impacting various animals including cattle, bison, swine, and even humans. The draft policy outlines the need for stringent safety measures during such research projects to protect public and animal health, maintaining compliance with federal regulations on select agents.

The proposal is open for public feedback until March 16, 2021, with submissions possible via mail or the online portal regulations.gov. This participatory approach underscores the CDC's commitment to transparency and community involvement in shaping biosafety standards.

Significant Issues and Concerns

Several potential issues arise from this draft policy statement. Firstly, the document lacks specific budgetary information, leaving questions about the financial implications of implementing the proposed safety measures. Without a clear financial outline, stakeholders may worry about unplanned expenses or ineffective allocation of resources.

Secondly, the document is largely silent on whether any specific organizations or experts have been consulted during its formulation. This absence may raise concerns about the transparency and inclusiveness of the policy-making process, especially if there are existing public-private partnerships.

Additionally, the document's reliance on complex legal references might limit accessibility for the general public. Referring to statutes like 42 U.S.C. 262a and 7 U.S.C. 8401 without sufficient explanation could be confusing for individuals unfamiliar with legal jargon.

Lastly, while the document opens the floor for public commentary, it does not adequately guide people on how to effectively engage in the process. Citizens unfamiliar with regulatory procedures might find it challenging to participate in the consultation without further instructions.

Public and Stakeholder Impact

From a broader perspective, this draft policy has implications for public health safety by striving to ensure that research into infectious diseases is conducted responsibly. If successfully implemented, these measures could prevent potential biohazard conditions, ultimately safeguarding both humans and animals from the spread of diseases.

For specific stakeholders, including agricultural producers and researchers, the policy could have varied impacts. Agricultural stakeholders may experience both relief and concern: relief from the potential eradication of a costly animal disease but concern regarding possible increased regulation burdens.

For scientists and research entities, the policy may open up more research opportunities with clear guidelines for conducting important studies, though it may also imply an increase in regulatory compliance efforts. Nonetheless, by involving the USDA as a joint regulator, the policy recognizes the overlapping concerns of both human and animal health risks, striving to create a more coherent regulatory framework.

In conclusion, the document presents a vital step in enhancing biosafety practices in agricultural and scientific research while balancing the interests of various stakeholders. However, it would benefit from added clarity in funding details, partnerships, and public engagement instructions, thereby fostering a more inclusive and transparent decision-making process.

The Federal Register document discusses a draft policy concerning the biosafety of large animal studies related to Brucella abortus and Brucella suis using outdoor containment spaces. While the document touches upon various aspects of policy and regulation, financial references within the document are limited and provide historical rather than contemporary financial data.

In the context of financial references, the document highlights a historical figure related to agricultural losses due to brucellosis. Specifically, it states that in 1952, the agricultural production losses from brucellosis exceeded $400 million. This figure underscores the severe economic impact the disease has had on agriculture, justifying the need for ongoing research and biosafety measures. However, it does not reflect current or projected financial allocations or appropriations for implementing the proposed policy.

Given this financial reference, it's important to consider how these historical losses relate to current and future spending. The document does not outline any specific budget, spending plans, or financial commitments for the implementation of the policy, which could raise concerns about how resources will be allocated or whether sufficient funding is in place to support the research and biosafety measures the policy aims to promote. The absence of clear financial plans could lead to questions regarding transparency and accountability in using federal funds.

Moreover, the document does not detail partnerships or collaborations with specific organizations that might involve financial transactions or funding allocations. The lack of such details may raise concerns about potential transparency issues if any financial partnerships exist but are not disclosed.

The document encourages public involvement through commentary on the draft policy, but the financial aspect of participation, such as costs associated with public meetings or further actions arising from the feedback, is not addressed or estimated. This omission may contribute to uncertainty regarding the financial implications of bringing the policy to fruition following public commentary.

In summary, while the document provides a historical perspective on economic losses due to brucellosis, it lacks clarity on current and future financial plans and necessary appropriations for implementing the proposed biosafety measures. This absence necessitates further transparency and detail to ensure stakeholders understand the financial framework supporting the policy’s development and execution.