Health infrastructure evaluations of trading partners for equivalence: Why they are important and current hurdles for One Health collaboration

Abstract

The history of trade has numerous examples of movement of diseases and pests. Nations institute barriers to protect human, animal, and plant populations from incursions; sometimes successfully, sometimes not. The World Trade Organization and international standard-setting bodies (ISSB) are multilateral organizations that promote equitable treatment and safe trade. Equivalence of outcome is a concept that crosses animal, human, and environmental health standards. Loosely defined, it is taken to mean achieving a similar reduction in risk by different methods. Countries conduct assessments known as health infrastructure evaluations (HIE) to allow safe trade in commodities of food, plant, and animal origin. This review analyzes the use of HIE for trade purposes, with an added focus on their One Health context. The goal is to identify areas of HIE in which a One Health approach could assist in achieving the goal of “treating like partners alike,” thereby fostering transparent decision-making in trade negotiations, a key obligation under World Trade Organization rules.

HAZARD AND RISK: TWO DIFFERENT THINGS

The starting point of any health infrastructure evaluation (HIE) for trade is a review of the hazard “table” of the commodity. “Hazards” are pathogens or pests that occur naturally within a commodity or via contamination from other sources. Most HIE for trade in food, plant, and animal (FPA) are focused on hazards that fall explicitly under the mandate of the importing oversight body. Although overlapping hazards (humans ↔ animals ↔ plants ↔ environment) are well recognized, coordination and collaboration for HIE that cross FPA health disciplines are often ad hoc, if done at all (Figure 1). Invasive species that may be introduced via trade or travel into a new environment are of particular concern from a One Health perspective when they become established in the new location. Invasive species can fall between mandates of competent authorities when dealing with HIE for trade (1). Given the cross-health discipline impact that hazards in FPA can carry, HIE should be transdisciplinary by default.

FIGURE 1.

Types of hazards and their profiles. Overlap among humans, animals, plants, and the environment.

AMR — Antimicrobial resistance.

Another way of describing this concept is through a specific commodity and the health disciplines they impact (due to overlapping hazards). For example, manure-based fertilizer can pose risks to environmental health, animal health (both wild and domestic animals) and human health, via runoff.

Risk associated with trade of FPA commodities is assessed by evaluating the likelihood of introduction and spread of a hazard via an imported commodity. The trust one has in the origins of that commodity and the certifying organization issuing trade documents has a role in quantifying that risk.

HISTORY OF SANITARY AND PHYTOSANITARY (SPS) BARRIERS TO TRADE

Sanitary and phytosanitary (SPS) barriers have existed since the beginnings of commercial trade (Appendix 1, available online from: www.canadianveterinarians.net, for summary of SPS barriers from the 1400s to the late 20th century). Import conditions facilitate safer trade of a commodity from a country with a different SPS status to that of the destination country. Exporting nations with developed economies view incursion of hazards as having a huge economic impact and go to great lengths to mitigate risks and respond to FPA “health events.”

“Health events” resulting from trade can be defined as in incursion or outbreak of a disease or pest for which the importing country has declared “official freedom” or for which they have a control program meant to limit its spread. The 2001 Foot and Mouth Disease outbreak in the United Kingdom, which was limited in time and did not become endemic, is estimated by the National Audit Office to have cost £8 billion (pounds sterling) in 2007 (not adjusted for inflation) (2). In some instances, control programs are meant to eradicate the hazard of concern, should it appear. International standards that are the basis for SPS barriers can be “too costly” to benefit emerging economies (3–5). To quote Chien (6) on overcoming silos and fostering collaboration,

“In the age of globalisation, a framework like OWOH (One World One Health) with a … sophisticated understanding of disease causality and management is certainly welcomed by many actors. Undoubtedly, improved cross-sectoral surveillance platforms such as the GLEWS (Global Early Warning System) have facilitated quick detection and contingency responses to disease outbreaks. Despite these improvements in technical cooperation and strategies, whether the WHO, FAO and OIE [now known as World Organization for Animal Health, WOAH] will overcome barriers of bureaucratic divisions, professional specialisation, and international politics to realise One Health is still up in the air.”

The 3 principal international trade standard-setting bodies for FPA are the World Organization for Animal Health (WOAH), founded in 1924; the International Plant Protection Convention (IPPC), founded in 1952; and the Codex Alimentarius Commission (CAC), founded in 1961. These organizations provide science-based, consensus-trade conditions with the aim of facilitating safer trade in their respective commodities (7). The WOAH became a World Trade Organization (WTO)-recognized standard-setting body for trade in 1998 (8). The CAC and IPPC were included as official standard-setting bodies in the Sanitary Phytosanitary (SPS) Agreement from its inception in 1995.

Article 2.3 of the WTO SPS Agreement outlines that countries with similar health statuses should be treated in a like manner (9) and that any restriction on trade be the least necessary to achieve the importing country’s appropriate level of protection (ALOP). There is flexibility built into the SPS Agreement as to what an ALOP is and how to achieve it; the principal requirement is that the ALOP must be science-based. Each country establishes what the baseline ALOP is for hazards of concern; this can vary from zero tolerance to a hazard to mitigation measures. The international standard-setting body (ISSB) guidance for safer trade in FPA allows for outright prohibition of import and sanitary barriers to trade if a country views the risk as unacceptable. They allow for differences in treatment between 2 similar countries (10) based on ALOP. Furthermore, HIE is 1 instrument used for establishing import conditions.

BUILDING TRUST

An individual country’s import conditions will vary by country of origin of a commodity. Import requirements are dependent on knowledge the importing country has on the system of oversight for FPA that is present in the country seeking access. Knowledge of commodity-specific FPA health infrastructure is required to assess for equivalence of outcome and if the exporting country can meet the importing country’s ALOP. This builds confidence in certification and decreases risk to the importing country. Health infrastructure evaluations are, by nature, complex; they often assess for equivalence of outcome of the trading partner’s oversight system. The process of an HIE can be quite lengthy and labor-intensive for both countries. An HIE results in a detailed analysis of the system of oversight, usually focused on a specific commodity/health status. However, the information collected may have implications for other commodities/health disciplines.

Countries often have an explicit legal duty to conduct HIE and cannot simply delegate to outside parties (11). They have a duty of care to domestic producers/consumers and other internal stakeholders. Furthermore, they must balance limiting risk with SPS requirements to use the least restrictive method to achieve their ALOP (12). Import conditions must be no stricter than those applied domestically for the same hazard under the SPS Agreement (9). Whereas importing countries assess exporting nations, they are in turn assessed for compliance with that philosophy. Importing countries must have scientific rationales that support their decisions on import conditions and be prepared to defend them. Furthermore, there is the risk of formal WTO complaints (13) if the importing country’s restrictions are seen as a disguised barrier to trade.

INTERNATIONAL STANDARD-SETTING BODY (ISSB) STANDARDS ON TRADE AND APPROPRIATE LEVEL OF PROTECTION (ALOP)

Member states of the WTO generally want to be seen as principled and following science-based rules and promoting reciprocity. There is sometimes tension with that desire and a country’s perception of risk, leading to a higher ALOP that is an important driver of SPS barriers to trade. Resolving barriers may require additional information from the exporting country on what can be done to mitigate perceived risk.

SANITARY AND PHYTOSANITARY (SPS) BARRIERS AND HEALTH INFRASTRUCTURE EVALUATIONS (HIE) FOR EQUIVALENCE

Both the WTO and ISSB refer to risk assessment for equivalence and health assessments that can be captured under the definition of HIE; the HIE considers a wide range of activities overseen by a central, competent authority wishing to export. A trade oversight system can be represented by broad categories (rows) and functions within the system (columns) in the conceptualization of the oversight system for trade-related HIE (Figure 2); these 2 planes intersect to create the focus of HIE for trade.

FIGURE 2.

Conceptualization of the oversight system for trade-related health infrastructure evaluations (HIE) using 3 categories and 4 trade functions. (Created by the authors, 2022.)

The “enabling environment” is defined as the statutes, regulations, and overarching policies that give an oversight body its authority and responsibility to deliver its mandate(s); e.g., what gives the power to an oversight body to carry out the mandate.

“Capabilities” are defined as the people tasked with developing programs to deliver the mandate(s), and the qualifications, training, and experience required for the roles. “Capacity” refers to the physical, human, and financial resources that are at the disposal of the oversight body to carry out its mandate(s) and what level of gaps are permitted (e.g., what percentage of positions are unfilled?). Alternatively, this can be defined as what tools and people exert the power of the mandate.

An HIE that is focused on “implementation” reviews the published programs to verify that they are carried out as written. “Performance” is interested in whether reviews of programs are carried out to seek areas for improvement and detect noncompliance with the mandate/programs. In other words, is the power delivered as described in the mandate?

ROLE OF INTERNATIONAL STANDARD-SETTING BODIES (ISSB) AND GOVERNMENTS IN HEALTH INFRASTRUCTURE EVALUATIONS (HIE) AND TRADE

Examples of template questionnaires and frameworks for health status, equivalence assessments, and HIE are listed in Appendix 2 (available online from: www.canadianveterinarians.net). Other methods of evaluation for trade include commodity-specific or sole-import risk assessment; these often quantify risk for specific commodities. Lists are created of commodities “generally regarded as safe” (GRAS) by both governments and ISSB, for which no or minimal import conditions are applicable. Other commodities require quarantine and test post-import, the most onerous import conditions. These are of a higher risk to the importing country as there is the chance of hazard spread within its jurisdiction. Furthermore, ISSB template questionnaires are often used or adapted by various governments to conduct their HIE for trade (by discipline). If an HIE has a positive outcome, it allows for fewer restrictions; e.g., import based on certification without post-import conditions. This is advantageous to the exporting country. The general process flow for HIE for equivalence or health status is represented in Figure 3 (11,12,14).

FIGURE 3.

Generic process flow for health infrastructure evaluations (HIE) for equivalence or health status [food or animal systems, based on personal knowledge of the first author and others (11,12,14)].

ALOP — Appropriate level of protection; GRAS — Generally regarded as safe.

CONSEQUENCES OF HEALTH INFRASTRUCTURE EVALUATIONS (HIE) AND EQUIVALENCE

An HIE is often the basis of SPS barriers to trade. Given uncertainty around the reliability of certification, importing countries exercise caution. An HIE must be scientifically sound, as the reports are reviewed by the country under assessment. Determination of equivalence or ALOP has effects on investment for export and the domestic sector in the exporting country. This affects the work of the oversight body. Trade is known to facilitate economic growth for a country. Equivalence between countries affects control processes for transboundary diseases/pests if they are identified in an exporting nation. Import restrictions during FPA health events are often regionalized and resolved quickly with an exporting country whose oversight system is known, as there is trust in the ability of the country to regain control and limit or eliminate the hazard. Impacts on an importing country of equivalence/ALOP errors can be serious, both from a health standpoint and economically (for exports).

THE PROBLEM WITH LACK OF ONE HEALTH COLLABORATION ON HEALTH INFRASTRUCTURE EVALUATIONS (HIE) AND UNSTANDARDIZED HIE REPORTS

The issues around One Health collaboration and lack of standardization go back to their foundations. Authors such as Thomson et al (15) detailed how standardization of HIE within a food system, specifically those based on Hazard Analysis Critical Control Point, would go a long way toward levelling trade playing fields with the Global South. It is recognized that One Health collaboration in response to FPA health events or natural disasters is beneficial, but the lack of a common language, framework, or methodology across disciplines creates barriers to implementation (16). An example of this type of transdisciplinary collaboration is the Netherlands’ Room for the River program, an integrated water management program in response to flooding in the 1990s (17).

This recognition of the utility of One Health collaboration is scarce in HIE for trade, despite the goal of safer trade that minimizes or prevents health events. In describing how One Health works in Africa, Cunningham et al (18) stated that there should be “…a focus on community engagement, where social difference, politics and interests and diverse perspectives and knowledges are put centre-stage.” The authors share the view that bringing together experts from different disciplines will spur innovation. There will likely be conflict and differences of opinion; but without tension, there can be no improvements.

ONE HEALTH IN OPERATION AND MISSED OPPORTUNITIES

Some countries have consolidated their departments of oversight of trade where the authority rests within 1 organization and multiple legal instruments. There are persisting FPA silos within such organizations, and HIE are mostly discipline-specific. Reports using different methods are difficult to interpret by other disciplines. The useful information from FPA HIE is thus underutilized. Examples of countries with joint delivery of some level of oversight of trade functions in FPA health include Canada, with the Canadian Food Inspection Agency; the United Kingdom, with the Animal and Plant Health Agency; and the United States, with the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. Despite these working relationships, FPA HIE are still not uniformly transdisciplinary, nor are conclusions presented in a standardized format. This makes judgments on reproducibility of the conclusions difficult, and comparison of systems and the import conditions for multiple trading partners less transparent.

MOVING TOWARD ONE HEALTH IN HEALTH INFRASTRUCTURE EVALUATIONS (HIE)

The HIE reports are written in a narrative fashion; they have a wealth of information within them, which allows authors to present conclusions in their preferred style of writing. However, terms such as “effective” or “satisfactory” are not consistently defined across FPA disciplines. Furthermore, the linkage to the evidence is not always clear, nor is how the conclusions were reached. When a subsequent evaluation is undertaken for a different commodity in the same country, the HIE report may not be useful due to the lack of understanding of a different discipline’s lexicon. This leaves a wealth of information in HIE underutilized and a duplication of efforts to recapture information from the same organizations. The lack of a common reporting template may inhibit assessing if the evaluating nation has used equitable treatment of trading partners, even within a health discipline.

There have been many calls (19–23) for closer working relationships among competent authorities responsible for public health, FPA, and environmental health, under a One Health context. However, the view persists that One Health is a perspective, and so difficult to operationalize, especially for trade negotiations and HIE. One way to implement One Health is by linking multiple experts within disciplines that carry out HIE, allowing each to analyze the hazards/risks within their mandate while being cognizant of the focus of the other discipline (first author’s personal experience, 2006 to 2020).

STANDARD METHOD OF REPORTING CONCLUSIONS TO PROMOTE COLLABORATION AND GREATER USE OF HEALTH INFRASTRUCTURE EVALUATION (HIE) REPORTS (WITHIN AND ACROSS DISCIPLINES)

There is a need for research in HIE with a One Health lens to identify factors behind the lack of collaboration within departments and across One Health disciplines. This is important given the overlap of hazards in traded commodities.

Generic processes of conducting HIE often touch on the same topics, functions, and categories, regardless of discipline (Figure 2).

The format of reporting conclusions is discipline-specific; however, collaboration across FPA disciplines is not routine. To avoid losing the depth of knowledge within an HIE, rather than imposing a universal checklist or simplified process, we can explore common formats for reporting conclusions. In addition, a standard operating procedure (SOP) within a country, mandating a 360-degree hazard profile at a minimum, for any HIE for an import commodity with transdisciplinary hazard profile, and collaboration across FPA authorities, is envisioned in Appendix 3 (available online from: www.canadianveterinarians.net). A “360-degree hazard profile“ is defined for this purpose as one that reviews the hazards for FPA that could be reasonably expected to be in a particular commodity; e.g., human or animal viruses in organic, animal-based manures, as well as plant pests and other hazards such as heavy metals. Sharing results in a searchable platform is potentially beneficial for efficiency of reviewing past work done on a particular country.

These tools may increase the utility of HIE reports for future evaluations (within a system) and different health disciplines (within a country). Standardization on conclusion format would increase transparency of an equivalence determination. A standardized reporting method would assist evaluators to determine if there is reproducibility between evaluators. Reproducibility between evaluators would make HIE more transparent and equitable. As well, these tools would lend themselves to a more systems-based approach for HIE by stressing the interconnectedness of human, animal, and environmental health.

A potential template for reporting conclusions, adapted from a framework developed in 2016 to 2017 by a government oversight body (unpublished data co-developed by the first author), is shown in the suggested standardized conclusion card of an HIE (Figure 4). This lays out a focus for the HIE, by the category and nonoverlapping conclusion levels that range from a focus that is absent to one that is implemented and subject to continuous improvement.

FIGURE 4.

Suggested template for standardized conclusion card of a health infrastructure evaluation (HIE). (Created by the first author, 2022.)

The concept of a 5-level conclusion card, with each level being distinct, was inspired by species- and breed-specific body condition score cards in veterinary medicine [Zielke et al (24)].

The Definition of One Health published by the 2021 One Health High Level Expert Panel, made up of the Food and Agriculture Organization of the World Health Organization, World Health Organization, WOAH, and United Nations Environment Programme, states,

“One Health is an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems. It recognizes the health of humans, domestic and wild animals, plants, and the wider environment (including ecosystems) are closely linked and inter-dependent.

The approach mobilizes multiple sectors, disciplines and communities at varying levels of society to work together to foster well-being and tackle threats to health and ecosystems, while addressing the collective need for clean water, energy and air, safe and nutritious food, taking action on climate changes and contributing to sustainable development” (25).

Using the proposed SOP and reporting template would concretely apply One Health transdisciplinarily to HIE for trade purposes. This aligns with the 6 interdependent One Health Joint Plan of Action action tracks (26). The SOP and reporting tool are most obviously related to action track numbers 4 and 6; however, as all the tracks are interdependent, there are impacts for all of them. Action track 4 deals with strengthening the assessment, management, and communication of food safety risks; this would be enhanced by linking HIE for plant, animal, and environmental risks and food safety. Action track 6, integrating the environment into One Health, would be supported by the mandatory transdisciplinarity of the proposed SOP. As well, the standard reporting card could act as a “Rosetta stone” across health disciplines, bridging the differences in each discipline’s professional language.

Further evaluation was carried out on a proposed SOP (Appendix 3, available online from: www.canadianveterinarians.net) and this reporting schema, and strengths and weaknesses of current practices in HIE were reviewed. The utility of the suggested innovations was presented to a panel of experts in 2022. Results of that evaluation will be discussed in a follow-up publication. CVJ