April 9, 2018
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: "Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types" (Docket No. FDA-2012-N-0547) and "Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types" (Docket No. FDA-2018-N-0270)
Dear Dr. Gottlieb,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) at the U.S. Department of Health and Human Services (HHS) related to its open information collections, "Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types" (Docket No. FDA-2012-N-0547) and "Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types" (Docket No. FDA-2018-N-0270)," published in the Federal Register on February 7, 2018. To the extent possible, please find these comments responsive to both information collections unless the FDA deems some portion relevant only to one or the other. Representing over 100,000 registered dietitian nutritionists (RDNs);1 nutrition and dietetic technicians, registered (NDTRs); and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition and to providing medical nutrition therapy (MNT) and nutrition research and counseling to enhance America's food safety.
The Academy strongly supports the proposed information collections for surveys on the occurrence of foodborne illness risk factors in various settings. Our members look forward to utilizing forthcoming research results to enhance members' ongoing efforts to work with clients, patients, and policymakers to improve and protect health through evidence-based food safety initiatives.
A. Academy of Nutrition and Dietetics' Commitment to Food Safety
Foodborne illness is preventable, yet the United States experiences significant economic costs, loss of productivity and reduced quality of life as a result of more than 56,000 people per year becoming ill in the U.S. from food safety concerns.2 It is the policy of the Academy that "[r]egistered dietitian nutritionists and dietetic technicians, registered, are encouraged to participate in policy decisions, program development, and implementation of a food safety culture."3 "Registered dietitian nutritionists and dietetic technicians, registered, have unique roles in promoting and establishing food safety cultures in foodservice settings, clinical practices, community settings, and in public venues because their training integrates food; science; and health, both preventive and therapeutic."4 In addition, "RDNs and DTRs have unique roles in promoting and establishing food safety cultures when practicing with high-risk populations, which include children younger than age 5 years, seniors aged 65 years or older, pregnant women, and individuals who have compromised immune systems due to health conditions or their treatment, such as diabetes, human immunodeficiency virus/acquired immune deficiency syndrome, kidney failure, and cancer."5
B. Enhancing the Quality, Utility, and Clarity of the Information to Be Collected
The proposed new information collections have the potential to expand the ongoing surveys on food safety behaviors conducted by the FDA and can be complemented and extended by the observational studies conducted by the USDA's Food Safety and Inspection Service. In addition, we note that CMS and accrediting agencies (The Joint Commission, the Healthcare Facilities Accreditation Program, and DNV) already regularly audit the institutional food service locations listed in FDA's proposal, and they may be able to gain insight into high risk issues and educational needs for foodborne illness by data mining those reports. Infection control and food regulations in healthcare drive many of the food practices in institutional settings and these reports could provide information for hundreds of facilities.
The Academy's position paper notes that "[t]ransport and retail marketing of foods include steps to prevent, reduce, or eliminate contamination of foods and to keep perishable foods safe. [For example,] appropriate time and food temperatures must be maintained throughout the food supply chain to reduce pathogen growth in perishable foods."6 Temperature monitoring while in transit can be a significant challenge. Package indicators that register temperatures outside of the desirable range are available but are not in routine use.7 We note that surveyors' review of time and temperature controls are important, but question whether the ninety minutes that surveyors may be on-site for is adequate for larger facilities. The FDA should evaluate the impact of survey times on the results and whether conducting the surveys at non-peak times may lead to a greater propensity for false results. If that is the case, surveyors should conduct visits at peak survey times.
We respectfully suggest that the use of gloves is not adequately addressed in survey, and we encourage the FDA to assess whether there is an effect leading to an excessive reliance on handwashing and whether glove use provides superior food safety effects than handwashing. We recognize the importance of noting the use of hand antiseptics as handwashing in areas outside kitchens in lieu of traditional soap and water handwashing and the extent to which this represents conformity with food safety standards in various facilities.
The Academy encourages the FDA to consider adding a food allergy component to its surveys. Although not a traditional food safety issue, similar policies and procedures can apply with regard to glove use, hand washing, securing and protecting food against cross-contact, and suitable equipment cleaning. For those with food allergies, this is a food safety issue.
Members report confusion and frustration arising from differences between manufacturer dates, use by dates, and other expiry dates. For example, one may have to denote three dates on thawed meat: received date from distributor, thaw date (date moved from freezer to refrigerator), and use by date. We look forward to continued efforts with industry and the FDA to simplify and standardize expiration dates.
1. Retail Settings
In retail settings, personnel are responsible for following food safety procedures,8 and public health inspections monitor this compliance. As in food production settings, personnel in foodservice and other retail operations can contaminate foods when they do not practice recommended hygiene behaviors. In addition to public monitoring, third-party audits are used by many retailers to check their food safety processes for continuous implementation and improvement. We support surveying to identify the effectiveness of these efforts. Facilities are inspected regularly by a variety of agencies, and depending upon the facility, may include inspectors at the local, state, and federal levels. We suggest the FDA consider conducting the survey by using local inspectors who already inspect facilities for other purposes. Observation of incorrect procedures should inform educational efforts, which should be culturally-guided, provided in multiple languages, and include photos or illustrations to facilitate remediation.
We also suggest that the FDA consider modifying the survey to account for new foods and new means of securing food access in the retail environment, including grab-n-go, meal delivery services and kits, salvage stores, department and discount stores, farms with on-site retail, and sales of new exotic produce.
2. Institutional Settings
Hospitals are now health systems, with complex permitting and a the need to often hold multiple licenses. Hospital food service works diligently to provide food to the most at-risk populations, with many patients or hospital food service "customers" far more sick than they used to be. This team is also on the front lines of infection risk, working to reduce hospital acquired infections like c. diff. Within hospitals, there are more than just patients and cafeterias, including many smaller venues, kiosks, and retail outlets in ambulatory clinics and staff support buildings. We seek clarification about how these different venues will be handled in the survey process, and whether the FDA might focus on the central facilities , because of their scope and higher potential reach, impact and risk.
The Academy agrees that the survey is both necessary and valuable, but note the need not to neglect operational oversight. Members note that it already takes an entire day and a director's time to accompany the health department inspector when hospitals are inspected in several sites. Given the considerable time commitment and impact of taking someone out of operations—particularly when unscheduled—we seek clarification whether this survey will be a part of that process or in addition to it, and whether the survey will be scheduled or unannounced.
We also seek clarification how the FDA will ensure that the collection of this data will achieve the FDA's intent. Specifically, we ask for greater clarity as to which data points will be tied to which outcomes. Many of our members report their facilities have gone decades without a known foodborne illness and hope the results of the survey will be helpful for other facilities, but upon review they have been unable to assess how the collected information will be analyzed and to what end.
The Academy appreciates the opportunity to comment on the data collection related to the information collections on foodborne illness, which will provide insight to help reduce food borne illness, and address concerns regarding food safety practices at various facilities. The Academy will continue to be at the forefront of food safety, both by encouraging research and by ensuring our members are proactive in implementing and ensuring safe food handling practices. Please contact either Jeanne Blankenship at 312/899-1730 or by email at email@example.com or Pepin Tuma at 202/775-8277, ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Byrd-Bredbenner C, Berning J, Martin-Biggers J, Quick V. Food safety in home kitchens: a synthesis of the literature. Int J Environ Res Public Health. 2013;10(9):4060-85.
3 Cody MM, Stretch T. Position of the Academy of Nutrition and Dietetics: food and water safety. J Acad Nutr Diet. 2014;114(11):1819-29.
4 Ibid (internal citations omitted).
5 Ibid (internal citations omitted).
6 Ibid, citing US Food and Drug Administration. FDA Food Code 2013. http://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/ucm374275.htm. Updated November 21, 2013. Accessed January 12, 2014.
7 US Food and Drug Administration. Food facts from the U.S. Food and Drug Administration. Fresh and frozen seafood: Selecting and serving it safely. http://www.fda.gov/food/resourcesforyou/consumers/ucm077331.htm. Updated November 15, 2017. Accessed April 8, 2018.
8 US Food and Drug Administration. FDA Food Code 2013. Available at http://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/ucm374275.htm. Updated February 2, 2018. Accessed April 8, 2018.