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Enhancing Food Safety: The Role of the Food and Drug Administration (2010)

Chapter: 9 Improving Food Safety and Risk Communication

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Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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9
Improving Food Safety and Risk Communication

According to the National Research Council (NRC) (NRC, 1989), risk communication is “an interactive process of exchange of information and opinion among individuals, groups, and institutions. It involves multiple messages about the nature of risk and other messages, not strictly about risk, that express concerns, opinions, or reactions to risk messages or to legal and institutional arrangements for risk management.” Communication with stakeholders is an essential activity of any regulatory agency. In a food safety regulatory agency, the various stakeholders provide different perspectives on factors that enter into the decision-making process of a risk-based food safety management system. Indeed, this type of communication with stakeholders is integral to a risk-based approach and is an important aspect of many of the steps in such an approach as delineated in Chapter 3.

Risk communication can also be viewed more broadly as a policy tool available to the U.S. Food and Drug Administration (FDA) to achieve its food safety–related public health objectives. As such, risk communication encompasses a range of activities, from consulting with the public or professional organizations, to meeting with governmental partners, to designing and delivering recalls or warnings. Preceding chapters have addressed several aspects of risk communication in various contexts, focusing on such topics as identifying the roles of different partners (Chapter 4), sharing data (Chapter 5), and integrating federal activities with those of state and local governments (Chapter 7). This chapter complements those discussions by focusing on risk communication activities at the FDA across contexts, but with emphasis on those contexts in which the FDA provides

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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messages or training to inform and support food safety–related decisions and behaviors.

The Food Protection Plan (FPP) explicitly includes communication as one key step in responding to food safety problems, but it also mentions other FDA actions that entail communication (e.g., risk assessments for prevention, compliance guides, technical advice, training programs or materials for food safety workers and industry) (FDA, 2007). This responsibility is also implied in legislation that directs the FDA to enhance various specific communication functions.1,2 Accordingly, the agency’s website states that: “[t]he FDA is also responsible for helping the public get the accurate, science-based information they need to use medicines and foods to improve their health” (FDA, 2009a).

The FDA’s food risk communication activities range from issuing recalls and outbreak notifications, to sharing information about food defense with other countries, to providing guidance and training materials for food safety organizations and individuals. The FDA communicates risks both indirectly, by regulating the labeling and advertising of some products, and directly, by developing and sharing information with all parties in the food system. While the agency’s ultimate goal is to protect the public health, the specific objectives, audiences, and methods of its communications differ across tasks and contexts (FDA, 2009a). Communications during crises are a major FDA responsibility3; during a recall, for example, the agency is required to ensure efficient and effective communications, reaching people throughout the food system rapidly with actionable messages. In contrast, training and guidance about food safety involve long-term partnerships and collaborations with, for example, professional associations and educational institutions.

Dramatic changes in food production and distribution systems (see Chapter 2) and additional knowledge about the epidemiology and determinants of foodborne illness have resulted in a food safety enterprise that is increasingly complex. For example, worldwide feed production has nearly doubled since 1980—from 370 million tons in 1980 to 614 million tons in 2004 (IFIF, 2009), and the number of food facilities increased by 10 percent from 2003 to 2007 (GAO, 2008a). This complexity adds to the challenges of communicating food safety information to food suppliers, preparers, consumers, and other stakeholders. As populations grow, as food sources globalize, and as production increases in scale, the potential for rapidly

1

Food and Drug Administration Amendments Act of 2007, Public Law 110-85, 110th Cong. (September 27, 2007).

2

FDA Food Safety Modernization Act of 2009, 111th Cong., 1st sess., Congressional Record 510 IS. (March 3, 2009).

3

Food and Drug Administration Amendments Act of 2007, Public Law 110-85, 110th Cong. (September 27, 2007).

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

evolving crises—and the need for effective crisis communication—escalates (GAO, 2004a, 2008b).

Food safety and risk communications are critical at numerous points in the food system, from training field workers and restaurant or institutional food service employees to alerting consumers who may have contaminated products in their kitchens (Taylor and David, 2009). This chapter begins with a general overview of the FDA’s risk communication and education activities. In particular, it highlights the FDA’s most recent progress in this area, such as the establishment of the Transparency Task Force and the Risk Communication Advisory Committee (RCAC). It examines the communication efforts that are needed during crisis situations, such as recalls. Communication with the food industry is emphasized as an area that warrants increased attention. The chapter also offers recommendations for enhancing food safety and risk communication activities with regard to consumers, public health officials, and other health professionals. Finally, the chapter underscores the importance of conducting social research to design messages and to evaluate risk communication efforts as an essential element of a risk-based approach.

FOOD RISK COMMUNICATION AND EDUCATION AT THE FDA

Risk communication and education is one way the FDA can help ensure food safety. To be effective, risk communication requires an understanding of the needs of those involved, two-way communication, and evaluation (NRC, 1989). As with other interventions, the use of communication and education as policy tools needs to be part of strategic planning in a risk-based approach (see Chapter 3). In addition, decisions to adopt specific communication or education interventions should be based on empirical evidence of effectiveness. In essence, developing a risk-based approach such as that recommended in Chapter 3 is the first step in developing effective risk communication and education activities as policy interventions. An appropriate approach to assessing the level of risk and identifying the possible prevention and mitigation points in food production, processing, distribution, and preparation will also identify the points at which risk communication can reduce risk. This knowledge will enable the FDA to respond consistently and appropriately to stakeholders’ needs for information. In addition, such an approach should serve to identify those stakeholders that can collaborate most effectively with the FDA to reduce risk at different points in the system. As discussed in Chapter 3, the strategic planning process should identify the various stakeholders and how they will be consulted and engaged for their contributions. Included in the stakeholder list should be the subgroup of consumers, industry workers, and health professionals that is the focus of this chapter. The committee agrees with the general risk

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

communication steps and actions in the FPP, but it concludes that the necessary details of implementation are lacking. The committee was unable to obtain detailed information about the FDA’s communication and education programs specifically related to foods; therefore, the information in this chapter was obtained from public meetings and the FDA website.

As noted, the FDA’s risk communication responsibilities are specified in the Food and Drug Administration Amendments Act of 2007 (FDAAA). The act also directs the agency to establish and consult with the RCAC, which is composed of risk communication experts from academia and industry as well as representatives of consumer advocacy groups (FDA, 2009b).

One recent positive development has been the introduction of foodsafety.gov, a website managed by the U.S. Department of Health and Human Services (HHS) as a collaborative effort of the White House, HHS, the U.S. Department of Agriculture (USDA), the FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health. Its purpose is to consolidate food safety information produced by various federal agencies that have a role in the regulation of the U.S. food supply and to provide the public with current information about food safety. Containing very little technical jargon, the website is designed for consumers and food safety educators and also for vulnerable populations. Much of the website contains information about food safety alerts, prevention, food preparation, causes of food poisoning, and how state and federal governments respond to foodborne illness outbreaks. The website also links to the official websites of the FDA, USDA, and CDC. Written content is supplemented by simple charts, videos, audio podcasts, and social media tools that allow for two-way communication.

Numerous entities within the FDA are engaged in communication (see Table 9-1). The agency’s risk communication activities are coordinated by an internal Communication Council. A risk communication director in the Immediate Office of the Assistant Commissioner for Planning leads the agency’s strategic planning process and is in charge of coordinating both the internal Communication Council and the external RCAC.4 The lack of past strategic planning for risk communication and education suggests that prior to these initiatives, risk communication and education efforts at the FDA lacked a cohesive strategy.

Work of the RCAC

The RCAC was established specifically as an FDA advisory body on communications with patients and consumers, recognizing that the agency

4

Personal communication, Nancy M. Ostrove, FDA RCAC, Washington, DC/North Gaithersburg Hilton, February 28, 2008.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

TABLE 9-1 Description of Communication-Related Activities at the U.S. Food and Drug Administration (FDA)

Office of the Commissioner

Office of Foods

  • Directs a program of public outreach and communication on food safety, nutrition, and other food-related issues to advance the FDA’s public health and consumer protection goals.

Office of Legislation

  • Works with members of Congress and staff on legislative proposals that grant new agency authority.

  • Provides Congress with requested information on FDA programs and policies.

Office of Chief of Staff, Office of Executive Secretariat

  • Serves as the FDA’s liaison to the U.S. Government Accountability Office and the U.S. Department of Health and Human Services (HHS) Office of the Inspector General on several highly visible studies.

  • Coordinates numerous high-level briefings for the commissioner and manages the FDA’s review and clearance process for executive correspondence, memorandums of understanding, reports to Congress, consumer correspondence, and other items.

Office of External Affairs, Office of External Relations

  • Arranges briefings between the commissioner and outside stakeholders on crucial FDA issues.

  • Manages high-level outreach to various stakeholder groups on all major FDA announcements. Develops a series of innovative “listening sessions” between the commissioner and major stakeholders.

  • Continues to refine and strengthen the FDA’s newly designed home page and its web-based consumer information program, producing articles to support the FDA’s public health mission and establishing new distribution channels for this material.

Office of External Affairs, Office of Public Affairs (OPA)

  • Provides numerous announcements of agency actions, including food recalls and implementation of requirements under the Food and Drug Administration Amendments Act of 2007.

  • Conducts crisis communication activities, such as the response to the outbreak of Salmonella Saintpaul.

  • Provides public affairs presence at FDA public meetings, congressional hearings, and advisory committee meetings and responds to inquiries from members of the media.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

Office of External Affairs, Office of Special Health Issues

  • Is responsible for engaging, collaborating, and communicating with health professionals, patients, patient advocates, and other special-interest populations about FDA regulatory decisions and policies.

  • The “FDA Updates for Health Care Professionals” e-list provides recent announcements related in particular to human medical product safety, human medical product approvals, opportunities to comment on proposed rules, upcoming public meetings, and other information of interest to health professionals.

  • Has a new health professional webpage—MedWatch—to serve as a portal for FDA information, particularly safety-related information of interest to health professionals.

Office of Policy, Planning, and Budget, Office of Policy

  • Handles high-priority, cross-cutting, and novel regulatory issues, and coordinates the issuance and publication of all FDA regulations, notices, and guidance documents.

Office of Policy, Planning, and Budget, Office of Planning

  • Analyzes risk communication activities and assists agency components in planning to improve the effectiveness of those activities.

  • Coordinates the Risk Communication Advisory Committee (RCAC).

  • Sets up internal pilot projects for testing messages prior to issuance. Completed a national survey of physicians concerning their perceptions about emerging and uncertain risks of medical products, the results of which will guide communications directed toward that audience.

  • Leads the process to develop the FDA’s Strategic Plan for Risk Communication, as well as a prioritized research agenda.

  • Coordinates the presentation of the strategic plan and research agenda to the RCAC for feedback.

Office of the Counselor to the Commissioner, Office of Crisis Management

  • Provides coordination and strategic management of the FDA’s response to numerous incidents concerning FDA-regulated commodities, including outbreaks, natural disasters, and actual or potential product defects that pose a risk to human or animal health (e.g., melamine-contaminated infant formula, salmonella in imported produce, flooding in the midwest).

  • Charged with meeting the HHS goal to improve the FDA’s ability to respond quickly and efficiently to crises and emergencies that involve FDA-regulated products.

Advisory Committee Oversight and Management Staff

  • Works to maintain and improve the transparency, integrity, and consistency of the FDA’s advisory committee program.

  • Published important new draft guidance on when the FDA convenes advisory committee meetings.

  • Helped improve the FDA webpage on advisory committees, increasing the program’s transparency and improving public access to important information.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

FDA Centers and Office of Regulatory Affairs (ORA)

Center for Food Safety and Applied Nutrition

  • Manages the 1-800-SAFEFOOD information line and e-mail inquiries from consumers, industry, and other constituents; this information line averages around 2,100 inquiries monthly.

  • Develops and implements comprehensive risk communication roll-out strategies to reach all stakeholder groups, domestic and international, including industry, consumers, state and local public health and regulatory agencies, the clinical community, and media, with FDA messages related to emergencies as well as new regulations and guidance and other initiatives.

  • Directs the development of long-term consumer education campaigns for multiple targeted audiences and messages related to food safety and nutrition best practices.

  • Maintains a comprehensive stakeholder directory.

  • Coordinates with other FDA entities and develops major media news releases and social media (Web 2.0) tools related to emergency response communications for foodborne outbreaks and major recalls.

  • Conducts social research to support communication efforts.

Center for Veterinary Medicine

  • Protects human and animal health by regulating animal drugs and feeds for millions of companion animals, poultry, cattle, swine, and other animal species.

  • Communicates frequently with veterinarians, industry, the public, and other stakeholders about product recalls, new animal drug approvals, guidance for industry, and other animal health issues.

Office of Regulatory Affairs (ORA), Division of Federal State Relations

  • Uses a number of mechanisms to provide accurate and timely information to state, local, and tribal partners.

  • Serves an advisory role to field public affairs specialists.

ORA, Public Affairs Specialists

  • Located in ORA field offices, work within their local communities around the country to promote and protect the public health and work closely with OPA to deliver FDA messages.

  • In addition to serving the general public, work with traditionally underserved populations, such as women, seniors, and ethnic minority communities.

  • Reach a variety of audiences—including health professionals and students, government and industry representatives, and members of community groups and faith-based organizations—through outreach and educational programs, workshops, conferences, exhibits, and speeches.

  • Take the pulse of the public, reporting consumer concerns to agency management. This feedback guides future FDA programs so that messages are better targeted to consumer concerns, and agency decisions are responsive to developing public health policy.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

needs to communicate more effectively with the public and based on recommendations in the Institute of Medicine (IOM)/NRC report The Future of Drug Safety: Promoting and Protecting the Health of the Public (IOM/NRC, 2007). As noted, the FDAAA of 2007 chartered the RCAC, establishing a mandate for the committee to advise the FDA on its risk communication activities in general and on crisis communications during recalls. The RCAC consists of a core of 15 voting members selected by the commissioner for their expertise in such fields as social marketing and health literacy, and for their experience in risk communication and work with patients, consumers, and health professional organizations (FDA, 2009b). Since its inception, the RCAC has held nine public meetings, some of which have addressed food risk communication issues. Meeting agendas have included the review of a draft strategic plan for risk communication at the FDA, research on risk communication, and communication strategies during food recalls and outbreaks (FDA, 2009c,d).

As an example of its advisory role, the RCAC was consulted with regard to communication with the public during food recalls, which remains problematic. Specifically, the RCAC was asked about the appropriateness of a draft press release template for communicating with consumers during Class 1 recalls.5

The FDA receives formal and informal recommendations during the RCAC meetings. Informally, for example, the committee chair proposed the different types of expertise needed for effective risk communication. In addition, the chair suggested considering a model recommended by the Canadian Standards Association, and adopted by some government agencies, that requires two-way communication between risk managers and stakeholder representatives throughout the development and implementation of a program (CSA, 1997). Following a more formal process, the RCAC adopted the resolutions in Box 9-1 at its August 2008 meeting. After receiving RCAC recommendations, the FDA reports back to the committee in subsequent meetings on its progress, for example, with regard to risk communication funding in the FDA supplemental budget.6

One of the first actions of the RCAC in 2008 was to advise the FDA to engage in strategic planning of its risk communication activities (FDA, 2009d). With this impetus and with attention to aligning its specific strategies with the risk communication–related goals of the FPP (improve risk communications to the public, industry, and other stakeholders [FDA, 2007]), the FDA developed a draft Risk Communication Strategic Plan

5

A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

6

Personal communication, Nancy M. Ostrove, FDA RCAC, Washington, DC/North Gaithersburg Hilton, February 28, 2008.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

BOX 9-1

Risk Communication Advisory Committee Resolutions, August 2008

  • The U.S. Food and Drug Administration (FDA) should consider risk communication as a strategic function.

  • The FDA should engage in strategic planning of its risk communication activities.

  • The FDA should find ways to do risk communication research efficiently, ensuring that communications are designed in a timely fashion to a scientific standard.

  • The FDA should routinely present quantitative risk and benefit information, in formats consistent with its regulatory constraints.

  • The FDA should develop a participatory design and testing process for FDA consumer communication. The process should include vulnerable groups with barriers to understanding and access.

SOURCE: FDA, 2009d.

(FDA, 2009e). The plan, which was aligned with the goals of the HHS Strategic Plan, presents the FDA’s strategies for risk communication and proposes ways to improve the agency’s science base, its capacity for action, and its policy processes (see Box 9-2). Also, communication is included in the FPP explicitly as one key step in responding to food safety problems. The three primary goals in the draft Risk Communication Strategic Plan are

  1. expand FDA capacity to generate, disseminate, and oversee risk communication;

  2. optimize FDA policies on communicating risks and benefits; and

  3. strengthen the science that supports effective risk communication (FDA, 2009e).

In this plan, the FDA states its view that risk communication is a two-way process integral to carrying out its mission effectively, that such communication must be adaptable to the various needs of the parties involved, and that it should be evaluated to ensure optimal effectiveness (FDA, 2009e).

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

BOX 9-2

Summary of U.S. Food and Drug Administration (FDA) Risk Communication Strategic Plan

Expand the FDA’s capacity to generate, disseminate, and oversee effective risk communication.

Capacity Strategy 1:

Streamline and more effectively coordinate the development of communication messages and activities.

Capacity Strategy 2:

Plan for crisis communications.

Capacity Strategy 3:

Streamline processes for conducting communication research and testing, including evaluation.

Capacity Strategy 4:

Clarify roles and responsibilities of staff involved in drafting, reviewing, testing, and clearing messages.

Capacity Strategy 5:

Increase staff with decision and behavioral science expertise and involve them in communication design and message development.

Capacity Strategy 6:

Improve the effectiveness of the FDA’s website and Web tools as primary mechanisms for communicating with different stakeholders.

Capacity Strategy 7:

Improve two-way communication and dissemination through enhanced partnering with government and nongovernment organizations.

The FDA’s Transparency Task Force

On January 21, 2009, President Obama issued two memorandums to the heads of executive departments and agencies expressing a commitment to promoting transparency and openness in government (FDA, 2009f; GPO, 2009). These memorandums were followed by the Open Government Directive in December 2009 (OMB, 2009). Executive departments and agencies have been charged with harnessing new technologies to disclose information about operations and decisions online and to make this information readily available to the public. In addition, executive departments and agencies have been instructed to solicit public input and feedback to identify information of greatest use to the public (GPO, 2009).

Accordingly, the FDA has formed a Transparency Task Force (see

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

Optimize the FDA’s policies on communicating risks and benefits.

Policy Strategy 1:

Develop principles to guide consistent and easily understood FDA communications.

Policy Strategy 2:

Identify consistent criteria for when and how to communicate emerging risk information.

Policy Strategy 3:

Re-evaluate and optimize policies for engaging with partners to facilitate effective communication about regulated products.

Policy Strategy 4:

Assess and improve FDA communication policies in areas of high public health impact.

Strengthen the science that supports effective risk communication

Science Strategy 1:

Identify gaps in key areas of risk communication knowledge and implementation, and work toward filling those gaps.

Science Strategy 2:

Evaluate the effectiveness of FDA’s risk communication and related activities, and monitor those of other stakeholders.

Science Strategy 3:

Translate and integrate knowledge gained through research/evaluation into practice.

SOURCE: FDA, 2009e.

Box 9-3), which includes the agency’s principal deputy commissioner, center directors, associate commissioner for regulatory affairs, chief counsel, and chief scientist (FDA, 2009g). The task force is soliciting public opinion on various communication and transparency matters and has held two public meetings. The first public meeting, held on June 24, 2009 (FDA, 2009h), was meant to solicit input on how the agency can make useful and understandable information about its activities and decision making more transparent and readily available to the public. The second public meeting, on November 3, 2009, was held to receive comments on three specific issues: (1) early communication about emerging safety issues, (2) disclosure of information about product applications that are abandoned or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications (FDA, 2009i). In addi-

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

BOX 9-3

Transparency Task Force Action Items

  • Seek public input on issues related to transparency.

  • Recommend ways that the agency can better explain its operations, activities, processes, and decision making, compatible with the agency’s goal of appropriately protecting confidential information.

  • Identify information the U.S. Food and Drug Administration (FDA) should provide about specific agency operations, activities, processes, and decision making, including enforcement actions, recalls, and product approvals.

  • Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision making to the public, taking into consideration health literacy and the needs of special populations.

  • Identify appropriate tools and new technologies for informing the public.

  • Recommend changes to FDA’s current operations (e.g., internal policies and procedures, standards, information formats, guidance) to improve the agency’s ability to provide such information to the public in a timely and effective manner.

  • Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide such information to the public.

  • Submit a written report to the Commissioner on the Task Force’s findings and recommendations.

SOURCE: FDA, 2009g.

tion to these meetings, the FDA has established a Transparency Blog, which also provides opportunities to learn about, and provide feedback on, what the agency is doing, specific topics prompted by the FDA, the basis for its decisions, and the processes used to make those decisions (FDA, 2009j). In response to comments and requests in these forums, the FDA has created a website explaining the basics of its activities.7

The task force was to submit a written report to the FDA commissioner approximately 6 months after being convened, and the commissioner was to report back and confer with the Secretary of HHS on the recommendations in the report. The FDA envisions that implementation of the task force’s

7

See http://www.fda.gov/AboutFDA/Basics (accessed October 8, 2010).

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

recommendations will make agency actions, decisions, and underlying processes more transparent to the public while still meeting the agency’s goal of appropriately protecting confidential information. Further, implementation of the recommendations should reduce the need for public requests for agency information under the Freedom of Information Act (FDA, 2009g). To date, this transparency initiative has resulted in recommendations that the FDA plans to implement in three different phases: (1) development of a web-based resource that will provide information about commonly misunderstood agency activities; (2) formulation of an approach to making information and decision making more transparent; and (3) transparency specifically to regulated industry. As planned, in December 2009 the task force submitted a written report to the HHS Secretary detailing progress in implementing phase 1, the launching of the FDA basics website.8

Although the task force is an admirable effort and intuitively valuable, an evaluation of its activities would be premature since it has been in place for only a few months. The committee encourages its continuation and future evaluation of this new activity.

COMMUNICATING AT A TIME OF CRISIS: FOOD RECALLS AND OUTBREAKS

The number of food recalls issued annually has increased by an order of magnitude in the last two decades and is expected to continue increasing with improved detection technologies (GAO, 2004b). The most common tool the FDA now uses to mitigate emerging outbreaks is public warning.9 During these recalls, the FDA currently sends an e-mail to all state public health departments and key stakeholders (e.g., the Food Allergy and Anaphylaxis Network in the case of allergens) to post on their websites, and it posts the same information on its own website and on foodsafety.gov. The FDA has also begun using social media and provides Twitter feed about recalls on request.10 Section 1003 of the FDAAA contains provisions concerning enhancing the quality and speed of the FDA’s communication with the public in recall situations.11,12

In its 6-month and 1-year FPP progress reports, the FDA reported the development of templates for recalls that it presented to the RCAC in 2008 (FDA, 2008a,b). These templates were tested within the agency’s

8

See http://www.fda.gov/AboutFDA/Basics (accessed October 8, 2010).

9

Personal communication, Nancy M. Ostrove, FDA RCAC, Washington, DC/North Gaithersburg Hilton, February 28, 2008.

10

Personal communication, Nancy M. Ostrove, FDA RCAC, Washington, DC/North Gaithersburg Hilton, February 28, 2008.

11

FDAAA, Public Law 110-85, 110th Cong. (September 27, 2007).

12

Code of Federal Regulations Food and Drugs § 7.42 Recall strategy (2003).

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

own heterogeneous workforce and used as surrogate groups representing public responses. The RCAC provided specific advice on the development of these templates during one of its meetings with the FDA, as noted above. The FDA has also considered partnerships with other organizations as a way of carrying out formative evaluations of communication strategies.

For food recalls, the FDA recognizes that people must be given answers to three key questions: (1) What is the product? (2) What is the concern? and (3) What do I need to do? In a national survey on awareness of and behavioral responses to food recalls, Hallman and colleagues (2009) found that the messaging used during the most recent food recalls had been ineffective in leading consumers to take action. Messages must be delivered quickly with clear criteria for identifying a recalled product and the symptoms caused by consumption of the product. They also need to provide motivational information on the appropriate course of action without frightening consumers, which the survey results suggest is lacking since few respondents had ever looked for recalled food products in their homes. The survey revealed that, while most Americans hear or read about food recalls, they fail to recognize recalled products and feel that food recalls are more relevant to other consumers. Consumers are unaware of the frequency of food recalls and exhibit widespread misconceptions about the division of responsibilities between federal agencies in such situations. Nearly 75 percent named the FDA as responsible for meat and poultry recalls (which are the responsibility of USDA); 48 percent failed to identify any agency as responsible for fruit and vegetable recalls, and just 32 percent identified the FDA as the responsible agency. Thus, despite awareness of recent food recalls, an illusion of invulnerability and a lack of knowledge about the food recall process appear to be widespread among American consumers. These findings signify the need for a clear, coordinated, and centralized communication strategy for food recalls.

This need for information applies to feed as well. Failures in communication during the melamine-associated pet food recall of 2007 spurred the passage of special sections (1002 and 1003) of the FDAAA directed at ensuring the safety of pet food and animal feed. These improvements to the feed safety system include “posting information about a recall in a single location on FDA’s Web site” and establishing a Reportable Food Registry for feed in addition to food (Covington and Burling, LLP, 2007; FDA, 2008b,c).

Further, the FDA has been criticized for damaging the food industry by issuing overly general messages (e.g., do not eat raw spinach). It is important to recognize that during the course of a recall, government officials are challenged to be expeditious about communicating with the public while also being accurate and specific about the contaminated product. Protecting

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

the public health without inhibiting sales of safe food requires a delicate balance when the information needs to be provided quickly.

Another challenge in managing recalls is communicating their termination. FDA regulations provide that a recall will be terminated only when “it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.”13 The regulations require the FDA to provide written notification of termination to the recalling firm, but they do not address the communication of such information to the public. Risk perception research shows that consumers generally do not know when recalls end and tend to play it safe by avoiding the general category of the recalled product for months thereafter (Cuite et al., 2007). The FDA’s procedures regarding recall termination need to be reviewed so that economic losses can be minimized to the extent possible consistent with protecting the public health.

The FDA is working on a set of goals for understanding how to better use food distribution and communication networks to reach consumers. The agency is concerned about being able to reach consumers with timely updates as recall situations evolve.14 If consumers receive a behavioral cue at an opportune moment—for example, when they are purchasing or preparing food—they can reduce their risk of foodborne illness (e.g., Nauta et al., 2008). Grocery store receipts (Hallman et al., 2009), televised and online recipe and cooking information (Powell, 2000; Mathiasen et al., 2004), newspaper recipe and menu sections, and vending machines are examples of contact points at which recall information could be communicated.

A cursory analysis of online government portals for food recall information shows that the new foodsafety.gov website is prominent, but so, too, are other federal government sites, such as the Joint Institute for Food Safety and Applied Nutrition’s foodrisk.org and the USDA National Agricultural Library site foodsafety.nal.usda.gov. These latter sites may confuse consumers, however, because either they do not link to foodsafety.gov for food recalls, or they link to more than one site with information about recalls. The current design of foodsafety.gov includes an immediately visible recall window, as required in Section 1003 of the FDAAA, but other parts of the website link to other websites for core food safety information. The more that linking steps are required, the greater is the potential for communication failures. Consumers, educators, and state and local governments cannot at present find food recall information and report food safety prob-

13

21 C.F.R. 7.55(a).

14

Personal communication, Nancy M. Ostrove, FDA Risk Communication Advisory Committee, National Transportation Safety Board Conference Center, Washington, DC, August 13, 2009.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

lems and foodborne illnesses on a single authoritative website. Section 1003 states that the FDA website and recall database shall be easily accessed and understood by the public; without an empirical evaluation, it is difficult to demonstrate that these goals have been achieved.15

EDUCATING THE FOOD INDUSTRY

As stated above, risk and safety communications are critical at numerous points in the food system. Food producers, processors, and retailers play a vital part in the prevention of foodborne illness and require education tailored to their role in the food safety system. For example, effective training of industry personnel is a critical component of a preventive, risk-based food safety system and is necessary for successful implementation of Hazard Analysis and Critical Control Points (HACCP) (NACMCF, 1997). As the leading food safety oversight agency, the FDA must incorporate the risk and safety communication needs of the food industry and regulators into its risk communication strategy.

Food service workers at institutions, such as schools or nursing homes, that purchase and prepare food for large numbers of potentially sensitive subpopulations are an important control point for risk communication in the food safety system. In fact, the majority of foodborne illnesses in confirmed outbreaks in OutbreakNet for 200716 were associated with exposures outside the home, with 30 percent of illnesses attributed to restaurants or delis. Rising trends in eating out, food preparation and service employment, and a high proportion of young (Bureau of Labor Statistics, 2009), foreignborn (ROC-United, 2009; Bureau of Labor Statistics, 2010a), and Hispanic or Latino workers in food service (Bureau of Labor Statistics, 2010a; ROC-United, 2009, 2010) underscore the importance of targeting this sector for food safety training. Food preparation and service workers rely primarily on short-term on-the-job training to prepare for the work (Bureau of Labor Statistics, 2010b). While a lack of health care benefits and illness policies contribute to workers showing up for work when ill (ROC-United, 2009),

15

Section 1003 reads: “(1) work with companies, relevant professional associations, and other organizations to collect and aggregate information pertaining to the recall; (2) use existing networks of communication, including electronic forms of information dissemination, to enhance the quality and speed of communication with the public; and (3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable database of recalled human foods and a searchable database of recalled pet foods, that is easily accessed and understood by the public” (FDAAA, Section 1003, Public Law 110-85. 110th Cong. [September 27, 2007]).

16

OutbreakNet. Foodborne Outbreak Online Database. See http://wwwn.cdc.gov/foodborneoutbreaks/Default.aspx (accessed October 8, 2010).

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

studies of food service employees suggest that targeted training in the positive outcomes of specific behaviors (e.g., hand washing making it less likely that people will get sick), in combination with reducing barriers to such behaviors (e.g., convenient facilities, available time), can contribute to needed improvements in food safety behaviors (Howells et al., 2008; Pilling et al., 2008, 2009; see also Green and Selman, 2005).

Numerous sources of information and training materials currently exist for the food industry. The Center for Food Safety and Applied Nutrition (CFSAN) posts training materials and notices on its website under the Retail Food Protection’s Industry and Regulatory Assistance and Training Resources page, as well as under Food Defense (FDA, 2009k,l). In addition, industry associations provide comprehensive and standardized training materials for the food industry. For example, ServSafe is well recognized as the leading training program for food retailers (ServSafe, 2009). Grocery Manufacturers of America has developed a HACCP guide for the food industry that is frequently modified by others to suit their needs (GMA, 2009). Other groups, such as the National Environmental Health Association, also provide training materials for the food industry (NEHA, 2008).

The feed industry relies heavily on trade associations such as the American Feed Industry Association, the National Grain and Feed Association, and specific food animal associations (e.g., the National Pork Producers Council, National Turkey Federation, U.S. Poultry and Egg Association) for information and training. Further, many land grant universities have developed feed safety bulletins and other educational materials and have those materials available on their websites. Not unlike conferences addressing specialty crops, nearly every conference targeting livestock production includes topics on safe feed/safe food. While all of these mechanisms are excellent sources for the industry, however, some may be expensive for small processors and retailers (Behnke, 2009).

The Cooperative Extension System provides a broad range of educational programs and serves as a resource for food safety training and information for the food industry. Regulatory agencies frequently refer food producers, particularly small establishments, to Cooperative Extension Services for training and information on food safety and the implementation of new regulations. Cooperative Extension Services often advertise their programs through their websites and by mailing risk communication and training notifications to the food industry. They frequently set their training schedules months in advance but get little, if any, advance notice of the implementation of new regulations. As a result, they can be overwhelmed when new regulations are issued. In addition, funding shortfalls compound the problem as state and federal agencies cut their budgets. Therefore, while Cooperative Extension Services are a good resource for meeting the food industry’s educational needs, their ability to serve the large number of food

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

processors and retailers in the United States is limited. Also, few Land Grant institutions have spent the time and effort to develop significant expertise in feed production and safety, although, based on the experience of committee members, this situation is slowly beginning to change (Behnke, 2009).

One particular subgroup of the food industry that may not have the resources to update its workforce on the latest policy developments and may need more targeted attention is small producers, processors, and retailers. Hirsch and Cutter (2006) used several methods to examine the training and support available to small and very small meat and poultry establishments. They also conducted a mail survey and later organized a workshop to learn from small and very small meat and poultry producers in the Northeast about their sources of information and the value and quality of training available to them. The results point to the inadequacies of, and barriers to, training and the need for standardization (Hirsch and Cutter, 2006).

The committee is unaware of similar studies for the portion of the food industry regulated by the FDA. Yet while the study by Hirsch and Cutter focuses on USDA-regulated establishments, it clearly demonstrates the need for a comprehensive, standardized education and training program for the food industry, and the industry training needs it identifies could impact producers of FDA-regulated products as well. The committee concluded that a similar study should be conducted to identify training needs in the FDA-regulated portion of the food industry.

OTHER TARGETED POPULATIONS

In addition to information for industry, the FDA creates and collates on its website important information for targeted populations, such as consumers, industry, and health professionals. This section addresses the importance of enhancing communications with these populations.

Consumers

While the food industry—from the farm to the retailer—plays an essential part in mitigating the risks from foods, consumers also play a role in reducing their risks from food through appropriate food purchases and handling (Nauta et al., 2008). Understanding what consumers know, value, and do is an essential first step in providing them with relevant information in a form they can understand and use; risk communication research can bridge the gap between what experts say and consumers hear, or need to hear, about handling food safely (Fischhoff and Downs, 1997; Morgan et al., 2001; Bruhn, 2005; Fischhoff, 2009). If consumers are to make informed food consumption decisions, they also need information with which to weigh benefits and risks—for example, to understand when the

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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nutritional benefits of foods may outweigh the risks from potential trace contaminants (IOM, 2007).

While in some cases consumers may be unaware of food risks, in others they may be unnecessarily worried because they lack specifics on what they can do to protect themselves effectively. Although estimates of the percentage of Americans that have confidence in the safety of the food supply vary considerably because of methodological differences across surveys, in general confidence appears lower today than it has been since 2001 (Gallup, 2010). Public opinions about, and confidence in, food safety are highly responsive to specific food safety incidents (Cuite et al., 2007; Blendon et al., 2009), although, as with other risks (Weinstein, 1989; Rothman et al., 1996), consumers generally tend to be optimistic and, as noted above, to believe that foodborne illnesses and food recalls are more relevant to the general public than to themselves (Miles and Scaife, 2003; Hallman et al., 2009). Kinsey and colleagues (2009) analyzed the influence of media attention on consumer confidence and concluded that media coverage has a significantly negative effect on consumer confidence in the safety of the food system. Overall, favorable attitudes toward the FDA declined from 1997/1998 to 2010 (from 75 percent to 58 percent) (The Pew Research Center, 2010). This general trend toward lower confidence in the FDA, however, may be due not only to food safety incidents and coverage by the media but also to increasing general distrust in the U.S. government (and in the FDA in particular) since the late 1990s (The Pew Research Center, 2010). Kinsey and collaborators’ most recent data17 show that confidence in food safety has neither decreased further nor increased much in the last year.

According to FDA research (Levy et al., 2008), several safe food practices have increased in the United States over the last decade. Consumer knowledge about foodborne pathogens, high-risk foods, vulnerable populations, and safe food-handling practices has also increased in recent years, although this knowledge is sometimes incomplete or wrong (FSIS, 2002). On the other hand, despite increased self-reported use of safe food-handling practices, food preparers do not always follow these practices (Redmond and Griffith, 2003; Anderson et al., 2004; Howells et al., 2008; Abbot et al., 2009). The International Food Information Council found that for some practices, such as washing hands, the majority of those surveyed reported using them as a precaution. For other practices, the percentages of use reported were lower—for example, 50 and 25 percent, respectively, for using a different or freshly cleaned cutting board for each type of food and for using a food thermometer to check the doneness of meat and poultry

17

Personal communication, Jean Kinsey, Director, The Food Industry Center, University of Minnesota, May 21, 2010.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

items (IFIC, 2009). Other research shows that younger people in particular are increasingly ignorant of safe food-handling practices and foodborne illness (Byrd-Bredbenner et al., 2007a,b); young adults (aged 18–25) are the age group most likely to engage in risky food handling (Byrd-Bredbenner et al., 2007a,b).

Although these findings about precautionary behaviors are disappointing, they may reflect consumers’ difficulty in understanding what to do. Once consumers become aware of the risk associated with particular food-handling and consumption behaviors (e.g., consuming certain raw foods), they may become concerned; however, they are unlikely to take protective action unless they see the risk as personal, know what to do to reduce the risk, and are confident that they can do it (Prochaska and Velicer, 1997; Prochaska et al., 2002; Brewer et al., 2004, 2007; Weinstein et al., 2007; Cuite et al., 2008). Social pressures and practices can also influence consumer behaviors (Cialdini and Goldstein, 2004; Cialdini, 2005, 2007; Abroms and Maibach, 2008).

Risk communications that build on empirical evidence of, and interactive exchanges about, consumer understanding and food risks and benefits can help consumers make informed decisions (Morgan et al., 2001; Bruhn, 2005; Fischhoff, 2009). In the United States, people currently learn about food safety from a variety of sources, ranging from social networks and television to specific government programs (Cuite et al., 2008; Hallman et al., 2009). Use of these sources varies by consumer circumstances. For example, in a 2008 study (Kwon et al., 2008), Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) recipients surveyed reported receiving food safety information from WIC (78.7 percent), family (63.1 percent), and television (60.7 percent). In a 2003 survey conducted in Lubbock, Texas (Whatley et al., 2005), family and friends were cited overwhelmingly as sources of food safety information. With respect to young adults, home economics classes are becoming increasingly rare (Beard, 1991); instead, young adults learn about food safety primarily from their parents, with very few (5 percent) reporting never learning about it (Byrd-Bredbenner et al., 2007a,b).

Certain groups—infants and children, pregnant women, and older persons—are deemed biologically and clinically more susceptible to food safety risks. This susceptibility stems in part from altered or adversely affected immune systems or chemical kinetics, the sensitivity of developing organ systems to toxicological insult, or the effects of age-related diseases, treatments, and declining physiological function (Kendall et al., 2006; Hayashi, 2009).

In addition, the United States is becoming increasingly diverse both culturally and ethnically, adding complexity to the food safety messages provided to the public. This increased diversity will likely have an impor-

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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tant impact on the risk of food safety incidents for several reasons. First, ethnic and cultural food preferences may affect the distribution of domestic food consumption, altering risks to consumers. For example, diets high or low in processed meats or raw vegetables may affect the general risks of foodborne illness associated with these food categories. Second, various groups may differ in socioeconomic status or access to different types of foods (French, 2003; Zenk et al., 2009), again altering food safety risks. Also, various ethnic groups may have special dietary traditions and recipes associated with altered risk because of either food content or special methods of preparation. For example, Yersiniosis infections associated with unsafe preparation of chitterlings in Georgia have been documented and addressed through communications (Georgia Division of Public Health, 1998). Likewise, the consumption of Mexican-style soft cheese resulted in Listeriosis infections among pregnant Hispanic women (MMWR, 2001). There have also been documented problems with contaminated food products in retail ethnic food establishments (Rudder, 2006). The special food safety issues associated with diverse ethnic and cultural food acquisition, preparation, and dietary practices have been only partially evaluated and deserve additional attention.

Health Professionals

From the FDA’s perspective, both the public and clinical health professional communities are important audiences for food safety education and risk communication. This is especially true for specific subgroups, such as doctors, educators, media specialists, and others who either work with food safety or mediate risk communications with the public or other stakeholders. In addition to guidance for producers to minimize food contamination,18,19 the FDA’s website includes information for health professionals and educators on the latest advisories regarding pathogens and diagnoses of foodborne illness.20 It also offers information designed to assist the states in laboratory analysis and inspectional procedures.21 While state and local public health agencies conduct important food safety–related work, such as surveillance and testing, they often require information from other states

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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and the federal government to carry out this work, generating an important set of multidirectional communication needs (see Chapter 5). In addition, food safety–related programs and surveillance findings from state and local public health agencies—as well as those from federal agencies such as the FDA, USDA, and CDC—must be communicated clearly to the public.

Communicating with the clinical health community is also critical to maintaining food safety. Severe food-related adverse clinical events are almost always detected in the clinical care system. Such patients need to be identified, treated, and reported to public health agencies, again necessitating effective communication channels. In addition to this detection and surveillance role, the clinical care system plays a critical preventive role in food safety. Health professionals manage many patients with conditions that place them at increased risk of harm from tainted or contaminated foods, as well as patients who use special diets to control various chronic illnesses. In both of these cases, the FDA and other federal agencies have an important role in communicating about food-related risks to primary care, specialty, and dietetic professionals who specify diets for such patients.

MECHANISMS FOR EFFECTIVE INFORMATION EXCHANGE AND TRANSPARENCY

The FDA has available a number of mechanisms to enhance its food risk communication and education efforts. They include stakeholder involvement through formal partnerships, ad hoc public forums and consultations, and innovative interactive web tools.

An example of a formal partnership is the Partnership for Food Safety Education (PFSE), a nonprofit collaboration of industry, government, and consumer groups. PFSE launched its food safety initiative, Fight BAC!, under the Clinton Administration, but is no longer funded solely by the government. Its goal is to educate consumers about safe food-handling practices (PFSE, 2006). Another example of such a partnership is the International Food Protection Training Institute, which has the FDA as a partner and was established to deliver career-spanning training for state and local food protection professionals.

The FDA also has many partnerships with academic, domestic, and international organizations and governments through formal agreements (FDA, 2009m). As of 2004, there were more than 50 interagency agreements governing food safety (GAO, 2004a); in 2005, 71 such agreements were identified (GAO, 2005). The U.S. Government Accountability Office recommends that the FDA use these agreements to reduce spending on duplicate efforts and to share resources so as to stretch limited funds. Memorandums of understanding (MOUs) also exist between the FDA and universities for collaboration in the areas of education, research, and out-

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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reach. There are currently 12 such MOUs in effect, most of them between the FDA and one university.

In addition to those formal partnerships to facilitate communication, other means of collaborating would enhance the FDA’s risk communication activities. Tabletop discussions,22 public forums, and consultations with scientists and advocacy groups on critical decisions would enable the agency to anticipate new needs and reactions to new activities and adapt appropriately. The media, advocacy groups, and scientists should be essential partners in the agency’s efforts to communicate with the public. However, the FDA’s activities have been less than transparent to many parties over the last decade. Advocacy groups and others have been surprised by FDA actions that have at times been taken without consultation or communication with stakeholders, nor have they been full participants at media briefings.23 One concern raised during an RCAC public meeting was the difficulty of obtaining timely information from the FDA. During the same meeting, according to journalist Kathryn Foxhall, the FDA was identified as among the most stringent agencies in applying permission-to-speak systems, which were implemented across the federal government more than a dozen years ago. All communications with reporters go through a public relations officer and may be subject to additional clearances. This process has been characterized as effectively destroying the relationship between the media and the agency. In Ms. Foxhall’s words, “Agencies track, monitor, control, and chill our conversations with staff.”24 One way of learning about diverse needs is to talk to those in the mass media with special interests in food safety on a regular basis. Lacking good relationships with the press, the FDA is unlikely to gain the scientific and authoritative profile it needs to communicate effectively with the public.

As noted above, mechanisms for two-way communication with the public can lead to improved foodborne illness surveillance. Interactive websites can be used to collect information from the public as well as to present information, and they are increasingly used in government to gather both general and program- or product-specific feedback and suggestions. Communications with less conventional sources of information on food safety may be possible as part of an effective FDA-based communication program. For example, allowing members of the public to report putative outbreaks through a health professional (e.g., their primary physician) could serve as an early warning system for local, state, and federal agencies. Similar

22

A tabletop discussion is a focused practice activity that places the participants in a simulated situation requiring them to function in the capacity that would be expected of them in a real event.

23

Personal communication, Tony Corbo, Food and Water Watch, September 2009.

24

Personal communication, Katherine Foxhall, FDA RCAC, Washington, DC/North Gaithersburg Hilton, February 28, 2008.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

mechanisms, such as the Vaccine Adverse Event Reporting System (Chen et al., 1994) or the Consumer Complaint Monitoring System in USDA’s Food Safety and Inspection Service (Dubrawski et al., 2006), have already been implemented in other venues. Such data cannot be taken at face value, but methods are being developed to take advantage of the information they provide (Dubrawski et al., 2006). Mechanisms for ongoing surveillance in health systems can be built into electronic health records (EHRs) so that suspected foodborne illnesses are reported. For example, it may be possible for EHRs to generate surveillance messages automatically based on specific clinical text, as well as to generate educational messages relevant to food safety for patients and clinicians when certain clinical situations arise. Communications with drug manufacturers could be another important source of surveillance through automated monitoring of prescriptions or sales of medications, such as antidiarrheal drugs. All of these approaches would require thorough research and demonstration, and in some cases legislative change, but their potential for enhancing food risk communications warrants the effort.

RESEARCH, EVALUATION, AND CONTINUOUS IMPROVEMENT

Given the importance of communications with stakeholders as one of the interventions in the FDA’s tool kit of interventions, decisions about how to best provide these communications should be based on data collected (see also Chapters 3 and 5). Through research, the FDA estimates consumers’ awareness, understanding, and reported behaviors related to food contaminants, such as methyl mercury, Salmonella, pathogenic Escherichia coli, and Listeria monocytogenes. These results are used to inform and evaluate the FDA’s policies and rules as well as its public information and educational outreach on safe food handling and preparation. The FDA’s typical research methods are both quantitative (surveys, experiments) and qualitative (focus groups, interviews, mental modeling).

Research can also help target messages that are more effective at reaching different cultural and ethnic groups, people with varying levels of education or language skills, and other subpopulations. Media segmentation and multimodal strategies may help reach more people than conventional methods. New social media marketing and viral marketing approaches may enhance the value of the FDA’s communication efforts (Gosselin and Poitras, 2008). The Consumer Studies Team at CFSAN helps set program priorities and informs communications within CFSAN and across the FDA and other agencies (e.g., the Federal Trade Commission, the U.S. Environmental Protection Agency, USDA, and CDC). As of February 2008, the team included eight social scientists from a variety of disciplines conduct-

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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ing both survey and experimental research.25 The team members typically design all of their own research protocols, perform their own data analyses, and use an extramural contractor for field service.

Recognizing that the FDA is not a research institution, there is nevertheless a need to reorient its activities so that empirical evidence from research constitutes the basis for its interventions (see Chapter 6). While the deficiencies of the FDA’s risk communication research have been noted (e.g., IOM, 2007), the creation and recent activities of the RCAC and the internal Communications Committee are promising developments that may enhance the agency’s research efforts in this critical area. In its May 6–7, 2010, meeting with the RCAC, which focused on research, the FDA reported that a research priority list was being developed with previous input from the RCAC.

An effective food safety system requires dedicated funding for behavioral and social science research on food safety risk communication and education, as well as a capacity to conduct this research. As noted in Chapter 3, academic programs generally do not offer adequate training and education in risk analysis disciplines, including risk communication. In particular, there is value in evaluating the role of past communication techniques in crisis situations, such as during the outbreaks related to peppers and peanuts (Cuite et al., 2005). Retrospective review using both formative and summative approaches can make subsequent communication programs more effective. Moreover, social and behavioral science research on the food safety knowledge and patient advice practices of public health professions should drive the FDA’s educational activities targeted to those groups. Surveillance of food industry knowledge and practices can also identify the educational needs of those stakeholders. The committee did not receive sufficient information from the FDA to evaluate the research capacity in social and behavioral sciences pertaining to risk communication in the food safety area.

One potential avenue for educating consumers and promoting safe food handling, for which further research on effectiveness is needed, is labeling of food products with respect to safety. In the United States, some laws or regulations mandate safety information on food labels. For example, raw or partially cooked meat and poultry products must contain information on cooking, storage, and handling. Also, U.S. law requires that eight food allergens be identified in plain English on all food labels, although it does not require any advisories. Otherwise, food producers and retailers are under no obligation to use food labels that contain food safety advice, and they are often reluctant to do so. There are likely many reasons for this, including the large amount of information that might be placed in the lim-

25

Personal communication, Steven Bradbard, FDA RCAC, Washington DC/North Gaithersburg Hilton, February 28, 2008.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

ited space on labels (e.g., nutritional content, source content, traceability of sources, eco-friendly procedures, techniques of manufacture, suggested recipes) and the difficulty of communicating risk in such a small space, including warnings about special high-risk groups (e.g., Listeriosis among pregnant women) (Caswell, 2006). It is also likely that food manufacturers do not want to deter food purchasers by implying that their product is categorically unsafe.

Current food safety–related label messages that appear to be simple and straightforward are actually unregulated by the FDA and may be subject to varied interpretation; an example is “sell by” or “best if used by” on date labels. In focus groups, messages such as the product contains “antilisterial” agents were not well received (Lenhart et al., 2008) and perhaps not fully understood. Similar issues may exist in labeling for potential food allergens, where different messages (“may contain,” “shared equipment,” “same plant”) may be correct but do not convey information that is helpful in interpreting risk and promoting appropriate behavior (Pieretti et al., 2009). It is likely that underlying some of these problems of effective labeling is the challenge of communicating risk and appropriate responses in a way that effectively guides healthful attitudes and behaviors. The FDA should develop and sustain a label research program to inform the design of safety labels that effectively communicate and enhance safe food-handling behaviors among consumers. When a suitable body of evidence is available, regulations for mandatory safety messages on food products should be considered.

A Slow Process for Research Approval and Funding

Information sharing is a critical policy tool (OTA, 1995) that, to be effective, can require audience-based assessments and product evaluations (e.g., Schriver, 1989, 1996; Roth et al., 1990). Implementation of the FDA’s social science research agenda can be slowed by many factors, some of which are common to any research agenda, such as the sensitive nature of new research and emerging topics, collaboration with others, funding cycles and budgets, and standard operating procedures for review and clearance at the level of the center, agency, and department. Another factor recognized by the RCAC to be a barrier to the FDA’s ability to conduct communication-related research in a timely and scientifically sound manner is the current interpretation of the Paperwork Reduction Act (PRA) of 1990.26 The act stipulates that agencies must seek public comment (through 60-day notices in the Federal Register) on proposed research involving the

26

Paperwork Reduction and Federal Information Resources Management Act of 1990, 101st Cong.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

collection of information and receive clearance from the Office of Management and Budget (OMB) if ten or more subjects are involved in such research. The agency publishes its response to public comments in a 30-day Federal Register notice, which reopens the docket for an additional public comment period. When this comment period closes, the agency again reviews comments, provides OMB with written responses, and addresses any remaining OMB concerns. Negotiations between OMB and the FDA, possibly including changes in the research plan and/or the instruments, may take as long as 7 or 8 months before OMB approval. Exceptions to standard PRA requirements are made for focus groups and interviews, rapid response surveys, and 30-day emergency OMB approval. In an effort to find a solution to these delays, the RCAC recommended that the FDA identify the public welfare implications of not testing its communications. The RCAC also recommended that the FDA submit a proposal to OMB for a protocol for evaluating food safety communication research that would balance the public welfare needs associated with the FDA’s mandate and the requirements of PRA (FDA, 2009e).

Concurrently with this review by OMB, the Research Involving Human Subjects Committee (RIHSC) (the FDA’s Institutional Review Board [IRB]) is tasked with reviewing all studies using human subjects. Every FDA center has an RIHSC liaison who reviews materials submitted in support of such research. Most social science research involving adults is considered exempt from full review unless it uses high-risk populations and/or studies highly sensitive topics. Nevertheless, even partial reviews, required under 45 Code of Federal Regulations (CFR) 46.101, can delay research projects.

Nationally, social and behavioral research conducted in pursuit of better communication, education, or policies continues to be impeded, and in some cases discouraged, by unnecessarily restrictive and intrusive human subjects review procedures developed for biomedical research (Schrag, 2009). In a 2006 study of the effectiveness of IRBs, “removing or reducing scrutiny of many fields within the social sciences and humanities that pose minimal risk” is a key recommendation (Gunsalus et al., 2007, p. 3). While OMB review may be the more onerous of the reviews to which FDA consumer studies are subjected, there is evidence that IRB reviews hamper and discourage such research as well. As an example, the FDA often uses its own workforce as surrogate groups representing public responses, which is a less than ideal subject sample. Given that such research does not collect sensitive personal information, is not overly intrusive, and likely contributes to more effective communications and warnings and therefore to public protection, consideration should be given to reducing or eliminating human subjects–related review requirements under 45 CFR 46.101 for social science research—in particular, research on perceptions and communications that meets appropriate confidentiality standards. A

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
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recent study at the University of Michigan characterizes “the tenor of the national conversation regarding the system for protecting human subjects from harm” as follows: “Regulations and policies are often narrowly and conservatively interpreted; terms and definitions are not clearly defined; the system is burdened with documentation requirements; and there is a paucity of empirical evidence to guide ethical decision making” (Pennell et al., 2008, p. vii). The need for OMB and IRB reviews may also be discouraging the FDA from conducting surveys or other data collection efforts that are more representative than focus groups.

Risk Communication Capacity

Effective risk communication programs require understanding public responses to messages, targeting the correct audiences, developing technologies and partnerships to reach targeted groups, and being familiar with information networks (NIH, 2008). As is the case for any federal agency with a public health mandate, the FDA cannot communicate successfully without interaction and advice, and it needs to build its internal capacity to design and evaluate risk communications. Capacity for effective communication is a function of organizational structure as well as human and technological resources. While the Consumer Studies Team at the FDA focuses on consumer studies, its emphasis with regard to food-related research is primarily on nutrition labeling, and its ability to conduct research is currently limited.27

With a small social science research group, significant research clearance requirements, and resource barriers to conducting empirical evaluations and research studies, the FDA has faced an uphill battle in developing its food safety education and risk communication efforts. Recent regulatory and organizational changes have improved the prospects for addressing these barriers, but much remains to be done to make the FDA a trusted and authoritative resource for food safety information so it can meet its food safety communication responsibilities effectively.

KEY CONCLUSIONS AND RECOMMENDATIONS

The RCAC, established in 2008, and the 2009 risk communication strategic planning are positive initiatives that will help the FDA improve its risk communication efforts. Although the FDA is on a path toward developing critical risk communication capacity, effective implementation of its risk communication strategic plan will require integrating such communication

27

Personal communication, Donald Zink, Senior Science Advisor, FDA/CFSAN, September 25, 2009.

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

into an overarching risk-based management strategy. For example, elements of the strategic plan, such as determining criteria for communicating risk information in areas of high public health impact, require a clearly articulated approach that is embraced throughout the agency. In an era of instantaneous communications and multiple media, transparency in communications about food safety issues is essential.

Many partners, including regulatory agencies, provide food safety education to the public in various formats; that is, there is no single, authoritative voice on food safety in the United States. This is of concern especially for communications in times of crises, such as national outbreaks, which demand a coordinated and centrally controlled plan. While the FDA, with other federal agencies, has established foodsafety.gov, a website intended to better provide food safety information to the public, enhancements to this gateway are needed. Likewise, many partners (e.g., trade organizations, Cooperative Extension Services at universities) are engaged in training industry in food safety, but coordination, research, and evaluation of these efforts are essential and appear to be lacking. Standardized food safety training and education for public health officials in state and local (including territorial and tribal) governments do not exist and are currently not being investigated or evaluated. While the FDA has many communication-related partnering arrangements in place, there is room for creative progress to take advantage of new information and communication technologies.

For the FDA to improve its food safety messages, scientific evaluation of risk communication as part of an overall social science research portfolio is essential. The results of such research make it possible to understand consumers’ knowledge, perceptions, and behaviors, including those of populations with heightened vulnerability to food hazards. Whether the research is extramural or intramural, obtaining approval and funding for a human subjects study currently requires a long, stringent process. Because risk communication studies are often time sensitive, this lengthy approval process deters investigators from conducting valuable research on food safety messages. Surveillance of those who may contribute to providing protection from foodborne illness, such as public health professionals and industry personnel, can also help in the FDA’s selection of communication interventions.

The committee recommends that the FDA continue to respond to the advice of the RCAC and offers the following recommendations to enhance the FDA’s risk communication and education functions.

Recommendation 9-1: In its effort to integrate risk communication into the recommended risk-based food safety management system, the FDA should play a leadership role in coordinating the education of the food industry, the public, clinical health professionals, and public

Suggested Citation:"9 Improving Food Safety and Risk Communication." Institute of Medicine and National Research Council. 2010. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/12892.
×

health officials at all government levels. The FDA could carry out its leadership role in educating industry personnel, health professionals, and public health officials by seeking authority to mandate the setting of training standards, preparing training materials, certifying trainers, and providing technical support for the interpretation of policies and for the implementation of the risk-based approach.


Recommendation 9-2: In collaboration with other federal agencies, the FDA should continue efforts to develop a single source of authoritative information on food safety practices, foodborne illness and risks, and crisis communications. The FDA, with other federal agencies, should develop a coordinated plan for communicating in one voice with all affected parties during crises so that stakeholders receive timely, clear, and accurate information from a single recognizable source.

To enhance these communication efforts, reducing barriers to and conducting more consumer research will be essential. To this end, the committee makes the following recommendation.


Recommendation 9-3: The FDA should improve its understanding of the knowledge and behavior of industry, health professions personnel, and consumers with respect to food safety, paying specific attention to knowledge about demographic groups that are particularly susceptible to food risks.

In making critical decisions about risk communication to implement recommendations 9-1, 9-2, and 9-3, the FDA should explore new mechanisms (e.g., tabletop discussions, public forums, consultations) for expanding its use of strategic partnerships and collaborations.

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Next: 10 Modernizing Legislation to Enhance the U.S. Food Safety System »
Enhancing Food Safety: The Role of the Food and Drug Administration Get This Book
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Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems.

Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more.

Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

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