Overview
Title
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
Agencies
ELI5 AI
The government is updating a list of dangerous germs and viruses to say that some of them, like certain types of germs that affect animals and plants, are no longer considered big threats. This change is expected to help scientists do more research and save money.
Summary AI
The Animal and Plant Health Inspection Service (APHIS) of the Department of Agriculture is amending the list of biological agents and toxins under the Bioterrorism Preparedness and Response Act of 2002. This change involves removing pathogens like Brucella abortus, Brucella suis, Brucella melitensis, Peronosclerospora philippinensis, and African horse sickness virus from the list of select agents. These changes are due to the evaluation that these agents are unlikely to serve as bioterrorism threats and are expected to reduce costs and enhance research opportunities, benefiting producers and research institutions.
Abstract
In accordance with Title II, Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which is cited as the "Agricultural Bioterrorism Protection Act of 2002" and referred to as the Act), we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins (the list) and the revision of the list as necessary. This action implements the findings from the biennial review of the list. The biennial review was initiated within 2 years of the completion of the previous biennial review. This final rule will focus solely on removing from the select agent list the following pathogens: Peronosclerospora philippinensis (Peronosclerospora sacchari) (Plant Protection and Quarantine select agent), African horse sickness virus (Veterinary Services select agent), and Brucella abortus, Brucella suis, and Brucella melitensis (overlap select agents).
Keywords AI
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AnalysisAI
Overview of the Rule
The Animal and Plant Health Inspection Service (APHIS) under the Department of Agriculture has made amendments to the selection of agents and toxins listed under the Bioterrorism Preparedness and Response Act of 2002. These changes are aimed at adjusting which biological agents and toxins—those with potential threats to animal or plant health—are deemed a security concern. Specifically, the rule is removing several pathogens, including Brucella abortus, Brucella suis, Brucella melitensis, Peronosclerospora philippinensis, and the African horse sickness virus from this list. This decision follows assessments suggesting these agents are unlikely to be employed as tools of bioterrorism. The intent behind this adjustment is to minimize regulatory costs and expand research opportunities, thereby benefiting producers and research outfits.
Concerns and Recommendations
While aimed at facilitating certain benefits, the document raises several significant concerns:
Transparency and Decision-Making: The delisting process relies heavily on insights from interagency working groups, as well as public input. However, the criteria or processes used by these bodies to formulate their recommendations lack transparency, making it challenging to fully understand their conclusions.
Economic Analysis and Impact: Even though the document mentions economic impacts, it falls short of providing detailed quantitative data, especially concerning how small businesses might be affected. Currently, it seems the narrative is more qualitative than it is backed with numbers that could provide a thorough view of economic implications.
Technical Language: The document encompasses scientific terminology—such as "intradermal pathogenicity index" and "monovalent vaccine"—that may overwhelm or confuse readers not well-versed in such specifics. This could stand as a barrier to understanding for a general audience.
Risk Considerations: While public comments favoring the delisting were included, opposing views—especially those concerning the potential risks of removing certain agents from the list—are briefly handled. As a result, these perspectives might not be adequately addressed in terms of identifying how delisting could present challenges.
Guidelines for Vaccine Usage: One comment highlighted the lack of clear domestic guidelines for vaccine application in the case of an African horse sickness outbreak. This issue appears inadequately addressed, leaving ambiguity around preparedness and response strategies.
Impacts on the Public and Stakeholders
From a broader perspective, this rule could carry various implications:
General Public: The removal of specific agents from the select list could indirectly influence public health and safety by possibly altering the nature of bioterrorism preparedness within certain contexts. There might be a question over balance between facilitating advanced research and ensuring security.
Research Entities and Producers: The rule is expected to be largely beneficial for research bodies and agricultural producers. By easing regulations, these entities are likely to witness reduced costs associated with compliance, as well as greater feasibility of conducting extensive research and development, particularly in vaccine creation.
Regulatory Landscape: By aligning regulation more closely with current scientific assessments of risk, the agricultural and research sectors might find improved operational flexibility. This could pave the way for enhanced innovation and less bureaucratic inertia in response to evolving scientific data.
In conclusion, while the amendments apparently pursue a constructive agenda—encouraging scientific progress and cost-effectiveness—the issues of transparency and potential risks warrant careful consideration. Balancing these needs with the overarching goal of public safety remains crucial.
Financial Assessment
The document outlines several key financial aspects related to the delisting of certain select agents and toxins under the Agricultural Bioterrorism Protection Act of 2002. These financial references primarily revolve around the economic implications of delisting specific agents, the cost of movement permits, and potential savings for entities involved in research and handling of these agents.
Permit Costs and Economic Benefits
One of the significant financial points in the document is the cost associated with the movement of the delisted Brucella species. If these species are delisted, APHIS regulations will require permits for their movement, costing $150 per permit. This cost is significantly lower compared to the prior expenses, which included paying numerous thousands of dollars on shipping costs due to heightened security measures for moving select agents interstate. This reduction in cost is expected to economically benefit entities by making research and courier services for these agents more accessible and affordable.
The document further highlights that this reduction addresses a major overhead for research institutions and laboratories that had previously been hindered by the high cost of shipping these agents for research purposes. By reducing the shipping costs from a magnitude of several thousand dollars to $150 per permit, the rule facilitates increased research activities and sharing of isolates among laboratories.
Economic Impacts on Entities
The analysis acknowledges that entities involved with the delisted agents will have the option to purchase a permit for movement only if they decide the benefits of the permit outweigh the cost of $150 per permit. The financial requirement for movement is deemed insignificant, particularly when entities report receipts in the millions to billions of dollars, indicating that this minor cost reduction enhances their operational capabilities without being a financial burden.
This aspect directly links to one of the issues identified in the document concerning the economic impacts on small entities. Despite the reduction in costs for permit purchases, the document does not provide a detailed quantitative analysis of these economic impacts, particularly how significant these benefits are for smaller entities. Although there is mention of a reduced financial burden, a deeper quantitative understanding would clarify whether the benefits markedly influence the smaller, financially constrained entities within applicable industries.
Costs of Continued Regulation
In contrast, the document also outlines the financial consequence of continuing to regulate the Brucella species as select agents. For entities wishing to register with the Federal Select Agent Program (FSAP) for work with these agents, continued regulation incurs a one-time cost of approximately $29,000. This substantial cost has been presented as a deterrent to ongoing and prospective research. By eliminating such financial barriers through delisting, entities may save significant amounts, thus promoting more extensive research endeavors and advancements in the field.
Challenges and Insufficiencies
While the document explores the financial benefits and implications of delisting, it could be criticized for briefly addressing the potential negative financial outcomes of delisting these select agents. Tangible risks, such as possible increased exposure or spread of the agents due to delisting, and associated unforeseen costs, are not thoroughly discussed. The brief acknowledgment of costs related to potential regulatory gaps or additional research safety measures might be understated, thus limiting the full financial impact assessment.
Moreover, there is an observed dependency on previous census data (2017 and 2021) which may not accurately depict the current financial state of industries affected by the rule. This reliance on potentially outdated information also raises the issue of whether economic projections and the purported benefits can be realistically quantified or deemed current and actionable.
In summary, the document illustrates a clear financial shift stemming from the delisting of specific agents, primarily focused on significant reductions in associated costs for research and movement permits. This aligns with the intent to alleviate financial burdens and enhance operational efficiencies for entities dealing with these agents, although the full breadth of economic analysis, particularly in terms of quantitative impacts and potential risks or costs, remains somewhat lacking.
Issues
• The document largely depends on the recommendations of interagency working groups and the public comments for delisting certain agents. However, the process or specific criteria used by these groups in reaching their decisions is not fully transparent.
• The economic analysis provides an overview of costs and benefits but lacks detailed quantitative data showing the specific economic impacts, especially on small entities.
• The document includes technical and scientific terms (e.g., intradermal pathogenicity index, monovalent vaccine) which might be difficult for laypersons to understand without sufficient background information or context.
• The consideration of opposing comments, especially regarding the potential risks associated with delisting agents, appears to be brief and may not fully address these concerns.
• Concerns raised by one commenter regarding inadequate domestic guidelines for vaccine use in the event of an outbreak of African horse sickness virus have not been sufficiently addressed in the document.
• While the removal of agents from the list is set to economically benefit certain entities, potential risks or negative outcomes of delisting these select agents are minimally discussed.
• The section on small-entity prevalence uses outdated census data (2017 and 2021) that may not accurately represent the current state of industries affected by the rule.