Cover Image

PAPERBACK
$71.00



View/Hide Left Panel

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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 257
9 Improving Food Safety and Risk Communication A ccording 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.” Communica- tion 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 pro- fessional organizations, to meeting with governmental partners, to design- ing 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), shar- ing data (Chapter 5), and integrating federal activities with those of state and local governments (Chapter 7). This chapter complements those dis- cussions by focusing on risk communication activities at the FDA across contexts, but with emphasis on those contexts in which the FDA provides 

OCR for page 257
 ENHANCING FOOD SAFETY 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 mate- rials for food safety workers and industry) (FDA, 2007). This responsibility is also implied in legislation that directs the FDA to enhance various spe- cific 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 determi- nants 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 00, Public Law 110-85, 110th Cong. (September 27, 2007). 2 FDA Food Safety Modernization Act of 00, 111th Cong., 1st sess., Congressional Record 510 IS. (March 3, 2009). 3 Food and Drug Administration Amendments Act of 00, Public Law 110-85, 110th Cong. (September 27, 2007).

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION 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 com- munication efforts that are needed during crisis situations, such as recalls. Communication with the food industry is emphasized as an area that war- rants 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 effec- tive 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 com- munication 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 pro- cess 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

OCR for page 257
0 ENHANCING FOOD SAFETY communication steps and actions in the FPP, but it concludes that the nec- essary 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 poison- ing, 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 Gaith- ersburg Hilton, February 28, 2008.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION 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 • Serves as the FDA’s liaison to the U.S. Government of Staff, Office of Accountability Office and the U.S. Department of Health and Executive Secretariat 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 • Arranges briefings between the commissioner and outside Affairs, Office of stakeholders on crucial FDA issues. External Relations • 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 • Provides numerous announcements of agency actions, including Affairs, Office of food recalls and implementation of requirements under the Food Public Affairs (OPA) 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. continued

OCR for page 257
 ENHANCING FOOD SAFETY TABLE 9-1 Continued Office of External • Is responsible for engaging, collaborating, and communicating Affairs, Office of with health professionals, patients, patient advocates, and other Special Health Issues 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, • Handles high-priority, cross-cutting, and novel regulatory Planning, and issues, and coordinates the issuance and publication of all FDA Budget, Office of regulations, notices, and guidance documents. Policy Office of Policy, • Analyzes risk communication activities and assists agency Planning, and components in planning to improve the effectiveness of those Budget, Office of activities. Planning • 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 • Provides coordination and strategic management of the FDA’s Counselor to the response to numerous incidents concerning FDA-regulated Commissioner, commodities, including outbreaks, natural disasters, and actual Office of Crisis or potential product defects that pose a risk to human or animal Management 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 • Works to maintain and improve the transparency, integrity, and Oversight and consistency of the FDA’s advisory committee program. Management Staff • 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.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION TABLE 9-1 Continued FDA Centers and Office of Regulatory Affairs (ORA) Center for Food • Manages the 1-800-SAFEFOOD information line and e-mail Safety and Applied inquiries from consumers, industry, and other constituents; this Nutrition 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 • Protects human and animal health by regulating animal drugs Medicine 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 • Uses a number of mechanisms to provide accurate and timely Affairs (ORA), information to state, local, and tribal partners. Division of Federal • Serves an advisory role to field public affairs specialists. State Relations ORA, Public Affairs • Located in ORA field offices, work within their local Specialists 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.

OCR for page 257
 ENHANCING FOOD SAFETY needs to communicate more effectively with the public and based on recom- mendations 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 agen- cies, that requires two-way communication between risk managers and stakeholder representatives throughout the development and implemen- tation 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 strate- gies 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 Gaith- ersburg Hilton, February 28, 2008.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION BOX 9-1 Risk Communication Advisory Committee Resolutions, August 2008 • he U.S. Food and Drug Administration (FDA) should consider risk T communication as a strategic function. • he FDA should engage in strategic planning of its risk communica- T tion activities. • he FDA should find ways to do risk communication research effi- T ciently, ensuring that communications are designed in a timely fashion to a scientific standard. • he FDA should routinely present quantitative risk and benefit infor- T mation, in formats consistent with its regulatory constraints. • he FDA should develop a participatory design and testing process T for FDA consumer communication. The process should include vulner- able 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 communi- cation must be adaptable to the various needs of the parties involved, and that it should be evaluated to ensure optimal effectiveness (FDA, 2009e).

OCR for page 257
 ENHANCING FOOD SAFETY 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: treamline and more effectively coordinate the S development of communication messages and activities. Capacity Strategy 2: Plan for crisis communications. Capacity Strategy 3: treamline processes for conducting communica- S tion research and testing, including evaluation. Capacity Strategy 4: larify roles and responsibilities of staff involved C in drafting, reviewing, testing, and clearing messages. Capacity Strategy 5: ncrease staff with decision and behavioral sci- I ence expertise and involve them in communica- tion design and message development. Capacity Strategy 6: mprove the effectiveness of the FDA’s website I and Web tools as primary mechanisms for com- municating with different stakeholders. Capacity Strategy 7: mprove two-way communication and dissemina- I tion through enhanced partnering with govern- ment 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 infor- mation 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

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION Optimize the FDA’s policies on communicating risks and benefits. Policy Strategy 1: evelop principles to guide consistent and easily D understood FDA communications. Policy Strategy 2: dentify consistent criteria for when and how to com- I municate emerging risk information. Policy Strategy 3: e-evaluate and optimize policies for engaging with R partners to facilitate effective communication about regulated products. Policy Strategy 4: ssess and improve FDA communication policies in A areas of high public health impact. Strengthen the science that supports effective risk communication Science Strategy 1: dentify gaps in key areas of risk communication I knowledge and implementation, and work toward filling those gaps. Science Strategy 2: Evaluate the effectiveness of FDA’s risk commu- nication and related activities, and monitor those of other stakeholders. Science Strategy 3: ranslate and integrate knowledge gained through T research/evaluation into practice. SOURCE: FDA, 2009e. Box 9-3), which includes the agency’s principal deputy commissioner, cen- ter 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-

OCR for page 257
 ENHANCING FOOD SAFETY 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 manufactur- ers 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 per- haps not fully understood. Similar issues may exist in labeling for potential food allergens, where different messages (“may contain,” “shared equip- ment,” “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 avail- able, 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 0, 101st Cong.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION collection of information and receive clearance from the Office of Man- agement 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 pub- lic 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 reduc- ing 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 ham- per 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

OCR for page 257
 ENHANCING FOOD SAFETY 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 pau- city 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 technolo- gies 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 communi- cation is a function of organizational structure as well as human and tech- nological 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 cur- rently limited.27 With a small social science research group, significant research clear- ance requirements, and resource barriers to conducting empirical evalua- tions 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 develop- ing 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, Septem- ber 25, 2009.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION into an overarching risk-based management strategy. For example, ele- ments 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 com- munications about food safety issues is essential. Many partners, including regulatory agencies, provide food safety edu- cation to the public in various formats; that is, there is no single, authorita- tive 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 (includ- ing 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 port- folio is essential. The results of such research make it possible to under- stand 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

OCR for page 257
 ENHANCING FOOD SAFETY 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 conduct- ing 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 recom- mendations 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. REFERENCES Abbot, J. M., C. Byrd-Bredbenner, D. Schaffner, C. M. Bruhn, and L. Blalock. 2009. Com- parison of food safety cognitions and self-reported food-handling behaviors with observed food safety behaviors of young adults. European Journal of Clinical Nutrition 63(4):572−579. Abroms, L. C., and E. W. Maibach. 2008. The effectiveness of mass communication to change public behavior. Annual Reiew of Public Health 29:219−234. Anderson, J. B., T. A. Shuster, K. E. Hansen, A. S. Levy, and A. Volk. 2004. A camera’s view of consumer food-handling behaviors. Journal of the American Dietetic Association 104(2):186−191. Beard, T. D. 1991. HACCP and the home: The need for consumer education. Food Technol­ ogy 45:123−124.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION Behnke, K. 2009. Feed Manufacturing and the Connection to Human Health. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 25, 2009. , Blendon, R. J., K. J. Weldon, J. M. Benson, and M. J. Herrmann. 2009. Peanut Product Recall Surey. Harvard Opinion Research Program. Harvard School of Public Health. http:// www.hsph.harvard.edu/news/press-releases/2009-releases/peanut-product-recall-survey- americans-reduce-risk-sick.html. (accessed May 23, 2010) Brewer, N. T., N. D. Weinstein, C. L. Cuite, and J. E. Herrington, Jr. 2004. Risk perceptions and their relation to risk behavior. Annals of Behaioral Medicine 27(2):125−130. Brewer, N. T., G. B. Chapman, F. X. Gibbons, M. Gerrard, K. D. McCaul, and N. D. Weinstein. 2007. Meta-analysis of the relationship between risk perception and health behavior: The example of vaccination. Health Psychology 26(2):136−145. Bruhn, C. M. 2005. Explaining the concept of health risk versus hazards to consumers. Food Control 16:487−490. Bureau of Labor Statistics, U.S. Department of Labor. 2009. Occupational Outlook Hand­ book, 00– Edition, Food and Beerage Sering and Related Workers. http://www. bls.gov/oco/ocos162.htm (accessed May 11, 2010). Bureau of Labor Statistics, U.S. Department of Labor. 2010a. Table : Employed Persons by Detailed Occupation, Sex, Race, and Hispanic or Latino Ethnicity. http://www.bls. gov/cps/cpsaat11.pdf (accessed May 11, 2010). Bureau of Labor Statistics, U.S. Department of Labor. 2010b. Table .: Occupations with the Largest Job Growth. http://www.bls.gov/emp/ep_table_104.htm (accessed May 11, 2010). Byrd-Bredbenner, C., J. Maurer, V. Wheatley, D. Schaffner, C. Bruhn, and L. Blalock. 2007a. Food safety self-reported behaviors and cognitions of young adults: Results of a national study. Journal of Food Protection 70(8):1917−1926. Byrd-Bredbenner, C., J. Maurer, V. Wheatley, E. Cottone, and M. Clancy. 2007b. Food safety hazards lurk in the kitchens of young adults. Journal of Food Protection 70(4):991−996. Caswell, J. 2006. Quality assurance, information tracking, and consumer labeling. Marine Pollution Bulletin 53:650–656. Chen, R. T., S. C. Rastogi, J. R. Mullen, S. W. Hayes, S. L. Cochi, J. A. Donlon, and S. G. Wassilak. 1994. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 12(6):542−550. Cialdini, R. B. 2005. Basic social influence is underestimated. Psychological Inquiry 16(4):158−161. −161. 161. Cialdini, R. B. 2007. Descriptive social norms as underappreciated sources of social control. Psychometrika 72(2):263−268. Cialdini, R. B., and N. J. Goldstein. 2004. Social influence: Compliance and conformity. Annual Reiew of Psychology 55:591−621. Covington and Burling, LLP. 2007. New legislation regulating pet food and other animal feed. In Food and Drug E­Alert. Washington, DC: Covington and Burling, LLP. CSA (Canadian Standards Association). 1997. Risk Management: Guidelines for Decision­ Makers. Toronto, Canada: CSA. Cuite, C. L., H. L. Aquino, and W. K. Hallman. 2005. An empirical investigation of the role of knowledge in public opinion about GM food. International Journal of Biotechnology 7(1-3):178−194. Cuite, C. L., S. C. Condry, M. L. Nucci, and W. K. Hallman. 2007. Public Response to the Contaminated Spinach Recall of 00. Rutgers University, NJ: Food Policy Institute. Cuite, C. L., N. D. Weinstein, K. Emmons, and G. Colditz. 2008. A test of numeric formats for communicating risk probabilities. Medical Decision Making 28(3):377−384.

OCR for page 257
 ENHANCING FOOD SAFETY Dubrawski, A., K. Elenberg, A. Moore, and M. Sabhnani. 2006. Monitoring Food Safety by Detecting Patterns in Consumer Complaints. Paper presented at Proceedings of the National Conference on Artificial Intelligence, American Association for Artificial Intel- ligence/Innovative Applications of Artificial Intelligence, Boston, MA. FDA (U.S. Food and Drug Administration). 2007. Food Protection Plan: An Integrated Strat­ egy for Protecting the Nation’s Food Supply. Rockville, MD: FDA. FDA. 2008a. FDA Food Protection Plan: Six­Month Progress Summary. Rockville, MD: FDA. FDA. 2008b. Food Protection Plan: One­Year Progress Summary. Rockville, MD: FDA. FDA. 2008c. Third Edition: Draft Framework of the FDA Animal Feed Safety System, FDA. Rockville, MD: FDA. FDA. 2009a. About FDA: What We Do. http://www.fda.gov/AboutFDA/WhatWeDo/default. htm (accessed December 10, 2009). FDA. 2009b. Risk Communication Adisory Committee 00. http://www.fda.gov/ohrms/ dockets/ac/oc08.html#RCAC (accessed December 10, 2009). FDA. 2009c. 00 Meeting Materials, Risk Communication Adisory Committee to the Food and Drug Administration. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ RiskCommunicationAdvisoryCommittee/ucm116558.htm (accessed December 10, 2009). FDA. 2009d. Risk Communication Adisory Committee 00. http://www.fda.gov/ohrms/ dockets/ac/oc08.html#RCAC (accessed December 10, 2009). FDA. 2009e. Strategic Plan for Risk Communication at the Food and Drug Administration (Draft April 15, 2009). Rockville, MD: FDA. FDA. 2009f. Memorandum of January , 00 Freedom of Information Act. http:// . fdatransparencyblog.fda.gov/ (accessed January 13, 2010). FDA. 2009g. Transparency Task Force Mission. http://www.fda.gov/AboutFDA/WhatWeDo/ FDATransparencyTaskForce/ucm163781.htm (accessed March 12, 2010). FDA. 2009h. June , 00 Public Meeting on Transparency: Meeting Materials. http://www. fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm170422.htm (accessed March 12, 2010). FDA. 2009i. FDA Transparency Task Force. http://www.fda.gov/AboutFDA/WhatWeDo/FDA- TransparencyTaskForce/default.htm (accessed December 10, 2009). FDA. 2009j. FDA Transparency Blog. http://fdatransparencyblog.fda.gov/ (accessed December 10, 2009). FDA. 2009k. Industry and Regulatory Assistance and Training Resources for Retail Food. h ttp://www.fda.gov/Food/FoodSafety/RetailFoodProtection/IndustryandRegulatory AssistanceandTrainingResources/default.htm (accessed December 10, 2009). FDA. 2009l. Food Defense & Emergency Response: Training. http://www.fda.gov/Food/Food- Defense/Training/default.htm (accessed December 10, 2009). FDA. 2009m. FDA Memoranda of Understanding. http://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/default.htm (accessed December 10, 2009). Fischhoff, B. 2009. Risk perception and communication. In Oxford Textbook of Public Health, 5th ed., edited by R. Detel, M. Beaglehole, M. A. Lansang, and M. Gulliford. Oxford, UK: Oxford University Press. Pp. 940–952. Fischhoff, B., and J. S. Downs. 1997. Communicating foodborne disease risk. Emerging Infec­ tious Diseases 3(4):489−495. French, S. A. 2003. Pricing effects on food choices. Journal of Nutrition 133(3):841S–843S. FSIS (Food Safety and Inspection Service). 2002. Changes in Consumer Knowledge, Behaior, and Confidence Since the  PR/HACCP Final Rule. PR/HACCP Rule Evaluation Report. Washington, DC: USDA.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION Gallup. 2010. Nutrition and Food. http://www.gallup.com/poll/6424/Nutrition-Food.aspx (accessed May 12, 2010). GAO (U.S. Government Accountability Office). 2004a. Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Oerlap. Washington, DC: GAO. GAO. 2004b. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food. Washington, DC: GAO. GAO. 2005. Oersight of Food Safety Actiities: Federal Agencies Should Pursue Opportuni­ ties to Reduce Oerlap and Better Leerage Resources. Washington, DC: GAO. GAO. 2008a. Federal Oersight of Food Safety: FDA Has Proided Few Details on the Resources and Strategies Needed to Implement Its Food Protection Plan. Washington, DC: GAO. GAO. 2008b. Federal Oersight of Food Safety: FDA’s Food Protection Plan Proposes Positie First Steps, but Capacity to Carry Them Out Is Critical. Washington, DC: GAO. Georgia Division of Public Health. 1998. Healthcare providers: Be alert for yersiniosis. Georgia Epidemiology Report 14(9). GMA (Grocery Manufacturers Association). 2009. Grocery Manufacturers Association Offers Online HACCP Training. http://www.gmatraining.com/ (accessed December 10, 2009). Gosselin, P., and P. Poitras. 2008. Use of an Internet “viral” marketing software platform in health promotion. Journal of Medical Internet Research 10(4):e47. GPO (U.S. Government Printing Office). 2009. Presidential documents. Federal Register 74(15):4683–4684. http://www.gpo.gov/fdsys/pkg/FR-2009-01-26/pdf/E9-1773.pdf (accessed January 13, 2010). Green, L. R., and Selman, C. 2005. Factors impacting food workers’ and managers’ safe food preparation practices: A qualitative study. Food Protection Trends 25(12):981–990. Gunsalus, C. K., E. Bruner, N. Burbules, L. D. Dash, M. W. Finkin, and J. Goldberg. 2007. Improving the system for protecting human subjects: Counteracting IRB Mission Creep. University of Illinois Law & Economics Research Paper No. LE06-016. Qualitatie Inquiry 13(5):617–649. Hallman, W. K., C. L. Cuite, and N. H. Hooker. 2009. Consumer Responses to Food Recalls: 00 National Surey Report. New Brunswick: Rutgers, The State University of New Jersey. Hayashi, Y. 2009. Scientific basis for risk analysis of food-related substances with par- ticular reference to health effects on children. Journal of Toxicological Sciences 34(2): SP201–SP207. Hirsch, D. W., and C. N. Cutter. 2006. Preparing Small and Very Small Meat and Poultry Establishments for the Future of HACCP: A Cooperatie Approach. Storrs, CT: The University of Connecticut and the Pennsylvania State University. Howells, A. D., K. R. Roberts, C. W. Shanklin, V. K. Pilling, L. A. Brannon, and B. B. Barrett. 2008. Restaurant employees’ perceptions of barriers to three food safety practices. Jour­ nal of the American Dietetic Association 108(8):1345–1349. IFIC (International Food Information Council Foundation). 2009. 00 Food & Health Surey. Washington, DC: IFIC. IFIF (International Feed Industry Federation). 2009. Welcome to the World of Feed! http:// www.ifif.org/global_stats1.php (accessed December 21, 2009). IOM (Institute of Medicine). 2007. Seafood Choices: Balancing Benefits and Risks. Washing- ton, DC: The National Academies Press. IOM/NRC (National Research Council). 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. Kendall, P. A., Hillers, V. V., and L. C. Medeiros. 2006. Food safety guidance for older adults. Clinical Infectious Diseases 42(9):1289–1304.

OCR for page 257
0 ENHANCING FOOD SAFETY Kinsey J., R.W. Harrison, D. Degeneffe, and G. Ferreira. 2009. Index of consumer confi- dence in the safety of the United States food system. American Journal of Agricultural Economics 91(5):1470–1476. Kwon, J., A. N. S. Wilson, C. Bednar, and L. Kennon. 2008. Food safety knowledge and behaviors of Women, Infant, and Children (WIC) program participants in the United States. Journal of Food Protection 71(8):1651–1658. Lenhart, J., P. Kendall, L. Medeiros, J. Doorn, M. Schroeder, and J. Sofos. 2008. Consumer assessment of safety and date labeling statements on ready-to-eat meat and poultry prod- ucts designed to minimize risk of listeriosis. Journal of Food Protection 71(1):70–76. Levy, A. S., C. J. Choiniere, and S. B. Fein. 2008. Practice-specific risk perceptions and self- reported food safety practices. Risk Analysis 28(3):749–761. Mathiasen, L. A., B. J. Chapman, B. J. Lacroix, and D. A. Powell. 2004. Spot the mistake: Television cooking shows as a source of food safety information. Food Protection Trends 24(5):328–334. Miles, S., and V. Scaife. 2003. Optimistic bias and food. Nutrition Research Reiews 16(1):3–19. MMWR (Morbidity and Mortality Weekly Report). 2001. Outbreak of Listeriosis associated with homemade Mexican-style cheese—North Carolina, October 2000–January 2001. Morbidity and Mortality Weekly Report 50(26):560–562. Morgan, M. G., B. Fischhoff, A. Bostrom, and C. Atman. 2001. Risk Communication: The Mental Models­Approach. New York: Cambridge University Press. NACMCF (National Advisory Committee on Microbiological Criteria for Foods). 1 997. H azard Analysis and Critical Control Point Principles and Application G uidelines . Washington, DC: NACMCF. http://www.fda.gov/Food/FoodSafety/ HazardAnalysisCriticalControlPointsHACCP/ucm114868.htm (accessed April 22, 2010). Nauta, M. J., A. R. H. Fischer, E. D. van Asselt, A. E. I. de Jong, L. J. Frewer, and R. de Jonge. 2008. Food safety in the domestic environment: The effect of consumer risk information on human disease risks. Risk Analysis 28(1):179–192. NEHA (National Environmental Health Association). 2008. NEHA Food Safety Training: Protecting Enironmental Health Through Education. http://www.nehatraining.org/ (accessed December 10, 2009). NIH (National Institutes of Health). 2008. Making Health Communication Programs Work. Bethesda, MD: U.S. Department of Health and Human Services. NRC (National Research Council). 1989. Improing Risk Communication. Washington, DC: National Academy Press. OMB (Office of Management and Budget). 2009. Open Goernment Directie. Presidential Memorandum M-10-06, December 8, 2009. http://www.whitehouse.gov/omb/assets/ memoranda_2010/m10-06.pdf (accessed January 13, 2010). OTA (Office of Technology Assessment). 1995. Enironmental Policy Tools. www.fas.org/ota/ reports/9517.pdf (accessed March 16, 2010). Pennell, S., S. Ziniel, and Z. Lepkowski. 2008. Surey of Inestigator Experiences in Human Research. The Institute for Social Research, Uniersity of Michigan. www.ohrcr.umich. edu/news/surveyexperiences.pdf (accessed January 13, 2010). The Pew Research Center. 2010. People and Their Goernment: Distrust, Discontent, Anger and Partisan Rancor. Washington, DC: The Pew Research Center. PFSE (Partnership for Food Safety Education). 2006. About PFSE. http://www.fightbac.org/ content/view/1/16/ (accessed December 10, 2009). Pieretti, M. M., D. Chung, R. Pacenza, T. Slotkin, and S. H. Sicherer. 2009. Audit of manufac - tured products: Use of allergen advisory labels and identification of labeling ambiguities. Journal of Allergy and Clinical Immunology 124(2):337–341.

OCR for page 257
 IMPROVING FOOD SAFETY AND RISK COMMUNICATION Pilling, V. K., L. A. Brannon, C. W. Shanklin, A. D. Howells, and K. R. Roberts. 2008. Identify- ing specific beliefs to target to improve restaurant employees’ intentions for performing three important food safety behaviors. Journal of the American Dietetic Association 108(6):991–997. Pilling, V. K., L. A. Brannon, C. W. Shanklin, W. Carol, K. R. Roberts, B. B. Barrett, and A. D. Howells. 2009. Intervention improves restaurant employees’ food safety compliance rates. International Journal of Contemporary Hospitality Management 21(4):459–478. Powell, D. A. 2000. Food safety and the consumer—perils of poor risk communication. Canadian Journal of Animal Science 80(3):393–404. Prochaska, J. O., and W. F. Velicer. 1997. The transtheoretical model of health behavior change. American Journal of Health Promotion 12(1):38–48. Prochaska, J. O., C. A. Redding, and K. E. Evers. 2002. The transtheoretical model and stages of change. In Health Behaior and Health Education: Theory, Research, and Practice, edited by K. Glanz, B. K. Rimer and F. M. Lewis. San Francisco, CA: Jossey-Bass. Pp. 99–120 Redmond, E. C., and C. J. Griffith. 2003. Consumer food handling in the home: A review of food safety studies. Journal of Food Protection 66(1):130–161 ROC-United (Restaurant Opportunities Centers United). 2009. Burned: High risks and low benefits for workers in the New York City restaurant industry. A joint publication of ROC-United and ROC-NY. http://www.rocunited.org/what-we-know (accessed May 11, 2010). ROC-United. 2010. Behind the Kitchen Door. The Hidden Cost of Low Road Jobs in Chicagoland’s Thriing Restaurant Industry. http://www.rocunited.org/what-we-know (accessed May 11, 2010). Roth, E., M. G. Morgan, B. Fischhoff, L. Lave, and A. Bostrom. 1990. What do we know about making risk comparisons? Risk Analysis 10(3):375–387. Rothman, A. J., W. M. Klein, , and N. D. Weinstein. 1996. Absolute and relative biases in estimations of personal risk. Journal of Applied Social Psychology 26(14):1213–1236. Rudder, A. 2006. Food safety and the risk assessment of ethnic minority food retail businesses. Food Control 17(3):189–196. Schrag, Z. M. 2009. How talking became human subjects research: The federal regulation of the social sciences, 1965–1991. Journal of Policy History 21(1):3–37. Schriver, K. A. 1989. Evaluating text quality: The continuum from text-focused to reader-fo- cused methods. IEEE Transactions in Professional Communication 32(4):238–255. Schriver, K. A. 1996. Dynamics in Document Design: Creating Text for Readers. New York: John Wiley & Sons. ServSafe. 2009. SerSafe. http://www.servsafe.com/ (accessed December 10, 2009). Taylor, M. R., and S. D. David. 2009. Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System: Final Report. San Francisco, CA: School of Public Health and Health Services, The George Washington University. Weinstein, N. D. 1989. Optimistic biases about personal risks. Science 4935:1232–1233. Weinstein, N. D., A. Kwitel, K. D. McCaul, R. E. Magnan, M. Gerrard, and F. X. Gibbons. 2007. Risk perceptions: Assessment and relationship to influenza vaccination. Health Psychology 26(2):146–151. Whatley, K. W., D. L. Doerfert, M. Kistler, and L. Thompson. 2005. An examination of the food safety information sources and channels utilized and trusted by residents of Lubbock, Texas. Journal of Agricultural Education 46(3):70–81. Zenk, S. N., L. L. Lachance, A. J. Schulz, G. Mentz, S. Kannan, and W. Ridella. 2009. Health promoting community design/nutrition: Neighborhood retail food environment and fruit and vegetable intake in a multiethnic urban population. American Journal of Health Promotion 23(4):255–264.

OCR for page 257