Produce Safety Summit: Implications of Mandatory Safety Standards

As a result of stringent, mandatory standards presented as part of the simulation scenario, participants were forced to confront a very challenging and complex compliance and enforcement environment. The focus of the simulation was not on the standards themselves. Rather, the standards were developed to drive participants to learn from analyzing what attempting to implement and enforce them could reveal.

As each team presented its responses (e.g., actions and concerns) to the simulation scenario to the larger group, common themes consistently emerged. The following sections summarize key insights articulated by participants during the course of the Summit.

Standards should be universal and ensure a “level playing field.”

Standards for produce, including those covering imports and produce sold only within a state, must be universally applied and enforced to the extent feasible.

Different standards, such as standards affecting only domestic produce, will create inequities, as there will be advantages for those not subject to the standards and disadvantages for those who must expend resources to adhere to them. The inequities of standards may cause a perceived lack of legitimacy within the industry and serve as a disincentive to comply with the regulations.

The interconnectedness of the produce industry makes it difficult to successfully incorporate standards at only one stage of production (e.g., harvest or packaging). Standards developed in isolation from one another for different stages of production or segments of the supply chain may be inconsistent, likely making it impossible to ensure the safety of produce.  Consequently, standards should not only be applied horizontally but also vertically to the supply chain from produce growing through distribution.

Standards must take into account differences between specific commodities and growing regions.

Although standards should be uniformly applied and enforced, they must reflect differences from one commodity to another, and from one growing region to another. Different commodities have different growing characteristics and, consequently, have different associated risks, concerns, and responses. Different regions also have unique considerations. For example, irrigation practices are different in California, Arizona, and Florida. These differences must be taken into account to create standards that can be successfully implemented by producers.

A scarcity of resources complicates effective implementation and enforcement of mandatory standards.

Given the current scarcity of resources available to address food safety in general, significantly greater investments would be required to meet the requirements of standards like the ones described in the simulation. Resources are needed at every level, from the creation of infrastructure to support standards to the development of technical capabilities.

Infrastructure: Equipment, laboratory facilities, information technology, and records/data processing capabilities are examples of just a few of the areas in which infrastructure capacity would need to be significantly expanded, if mandatory standards are adopted. An enhanced infrastructure would enable more effective data sharing across multiple parties.

All parties may be willing to share data provided that several items are well defined and communicated, including the requirements and/or justifications for the usage, transmission and proprietary protection, and appropriate access authorization. 

Technical Capabilities: Enforcement of mandatory standards requires a cadre of specialists specifically trained in the complexities and nuances of produce safety. For example, these trained personnel would be required to conduct inspections, review data, maintain records, ensure overall compliance with the standards, and conduct educational and outreach activities to encourage compliance with the standards. Detailed knowledge of specific commodities bolsters their enforcement and compliance capabilities. This highly specialized cadre does not exist today in sufficient numbers, and will only be more difficult to obtain as the complexities and specialization within commodity-specific standards increase.

The issue of produce safety requires a science- and risk-based approach. 

Scientific research and risk analysis can be lengthy processes, and situations may arise, such as out-breaks, in which interim measures may need to be adopted quickly. However, a careful, methodical, overall approach, based on science and analysis of current risks, should be adopted with regards to produce safety to the fullest extent possible.

Science and risk analysis should determine the setting of specific requirements and guide how standards should be appropriately implemented and enforced. Standards created using this approach will better ensure that the standards will be effective in protecting public health. This is an area in need of immediate investment, as there are gaps in scientific knowledge.

Standards must be nimble and continuously updated.

Agricultural and manufacturing practices, as well as scientific knowledge of health risks, continually advance. Once mandatory standards are in place, a slow and cumbersome regulatory system could impede continuous improvements and even discourage research and development.

Standards should instead be crafted to be nimble and flexible, providing an overall framework for implementation and reflective of evolving science. The standards should also be supplemented with a rich set of commodity-specific guidelines for compliance and enforcement. For the standard-setting process to occur in a timely manner, built-in processes to refine/ revise/re-publish the guidelines periodically based on feedback and developments are needed. There is also a need for particular caution when including numeric measures in standards, as they are the most rigid type of requirements.

Standards need to be implemented using a phased approach.

A carefully designed phasing-in of mandatory standards will be important if they are to succeed. Introducing standards in phases allows for differences in capacities in different sectors. For example, phasing might require larger businesses to implement stan¬dards at a certain point and provide additional time for smaller businesses with limited resources. Additionally, a phased approach will allow for feedback to be received from all stakeholders at each stage of implementation. Course corrections will occur during the process, building a solid foundation for each standard that will subsequently be introduced. Voluntary demonstrations and pilot programs could also be considered.

The standards development process must be transparent and engage all stakeholders.

Because all stakeholders in the standards environment have unique perspectives, they each need to have an active voice and participate in the formulation of standards from the beginning of the process. A productive, multi-stakeholder dialogue to help define an implementable plan to resolve conflicts and competing priorities will lead to the creation of optimal standards that are ultimately more likely to succeed. Involving all stakeholders in the process will also create transparency and is more likely to generate support from stakeholders from the onset.