Introductory Letter

ICR Attachment D – Example Introductory Letter for Establishments Selected for the Study

[DATE]

Dear Owner/Manager:

Your facility has been randomly selected as part of a nationwide research project designed to assess food preparation procedures and practices specific to the various segments of the retail food industry. The U.S. Food and Drug Administration (FDA) will use this research for identifying best practices within the industry and directing limited resources to areas that will provide the most significant public health benefits.

This is not a regulatory visit. Your participation is voluntary. No inspection report will be left with your facility. This is a research project designed to focus on the implementation of food safety procedures and practices within the retail food industry that are designed to protect the public health. The expected length of the data collection will be 90-120 minutes. Approximately 30 minutes of the data collection will focus on obtaining information on the nature of your operation.

Should an observation be made of a food safety procedure or practice that poses a significant public health risk, every effort will be made to work with you to ensure that the appropriate corrective action is taken to alleviate the hazard. Should a situation arise where a significant public health risk cannot be resolved during the data collection, the regulatory authority that has issued your permit will be contacted to work with you to ensure corrective action is taken.

An exit briefing will be provided at the end of the visit to discuss significant findings that may assist you in enhancing the effectiveness of your food safety system. If significant food safety issues are identified, they will be brought to the attention of the person-in-charge or responsible employee to determine the appropriate corrective action based on the current FDA Food Code. Your questions regarding the data collection process or food safety issues in general are encouraged as part of the visit to your facility.

Your facility’s name will not appear on any reports or public documents. The research project is designed to protect the privacy of participating establishments to the extent the law permits. The data collected is tabulated using broad industry segments and is not associated with any specific establishment.

FDA is responsible for providing technical assistance to approximately 75 state and territorial agencies and more than 2,300 local departments that assume primary responsibility for working with the industry on preventing foodborne illnesses. Beginning in 1998, FDA began collecting data related to direct observations made of food safety practices within institutional foodservice, restaurant, and retail food segments of the industry. From the data collected, FDA provides guidance to regulatory and industry food safety professionals to assist them in addressing food safety issues that have the most significant impact on protecting the public health.

FDA’s previous research studies can be accessed and downloaded from the following web link:

http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/default.htm

Public Reporting burden of this collection of information is estimated to average 150 minutes per response for the person in charge of a Hospital foodservice facility and 30 minutes for the program director (or designated individual) of the regulatory authority. This includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: FDA PRA Staff, Office of Operations, Food and Drug Administration, 11601 Landsdown St., North Bethesda, MD 20852. PRAStaff@fda.hhs.gov. OMB Control #0910-0799. Expires December 31, 2016.

Thank you for your willingness to cooperate in this important endeavor. It is through this type of cooperative effort that government and the food service industry seek to provide safe and wholesome food to the consuming public.

In the future, should you have any questions regarding this study or other food safety issues, please do not hesitate to contact me at [Specialist’s phone number].

Sincerely

[Specialist’s contact information]