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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-N-0104]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled Measuring Progress on Food Safety: Current Status and Future Directions. The purpose of the public workshop is to inform the public about current and potential measurements for assessing progress in food safety and associated methodological issues and to discuss potential improvements.

*Date and Time*: The public workshop will be held on March 30, 2010, from 9 a.m. to 5 p.m.                

*Location*: The public workshop will be held in the Regency A Ballroom of the Hyatt Regency Washington, 400 New Jersey Ave., NW., Washington, DC 20001, 202-737-1234, FAX: 202-737-5773.                

*Contact Person*: For registration information and general questions regarding the workshop, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1731, e-mail:                     *juanita.yates@fda.hhs.gov*.                

*Registration*: There is no registration fee. However, due to limited seating, we encourage all persons who wish to attend the workshop to register in advance. Attendees may register in advance by March 24, 2010. There will be no onsite registration. We encourage attendees to register for the workshop electronically at:                     *http://www.fda.gov/​Food/​NewsEvents/​WorkshopsMeetingsConferences/​ucm201102.htm*.                

                    If you need special accommodations due to disability, please contact Juanita Yates (see                     *Contact Person*) by March 24, 2010.                 

# SUPPLEMENTARY INFORMATION:

The Federal Government and the food industry are pursuing major new efforts to reduce foodborne illness that include science-based preventive controls in food production and processing. As recommended by the President's Food Safety Working Group (Ref. 1), one element of the Federal Government's food safety initiatives includes regularly assessing performance metrics for measuring progress in reducing foodborne illness. FDA, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) are collaborating to address the methodologic and data challenges involved in the development of feasible and effective food safety metrics. The agencies will engage the food safety expert and stakeholder communities to discuss this subject through a series of public workshops.

## I. Background

                    FDA and FSIS base decisions about policies and other interventions related to food safety, in part, on CDC's analyses of data on foodborne illness. These analyses are powerful tools for assessing the safety of food, which, in turn, reflects the effectiveness of Government and industry policies and interventions. The President's Food Safety Working Group has noted the importance of assessing metrics (Ref. 1). Through its epidemiologic and laboratory data collection and analysis, CDC generates various types of measures and estimates of foodborne illness, via a number of mechanisms, which serve different purposes. For example, the Foodborne Diseases Active Surveillance Network (FoodNet) collects data on laboratory-confirmed cases of nine foodborne illnesses caused by bacteria and parasites commonly associated with foodborne human illness (e.g.,                     *Salmonella*                     and                     *Escherichia coli*                     O157:H7). The cases are reported to CDC by State health authorities in 10 States representing 15 percent of the U.S. population (i.e., all of Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, and Tennessee and selected counties in California, Colorado, and New York). Based on the FoodNet data, CDC writes an annual report on the incidence and trends of laboratory-confirmed cases of these nine illnesses. The FoodNet also conducts special studies to determine risk factors for acquiring those illnesses.                          ( print page 9233)    

Periodically, CDC estimates the overall burden of foodborne illness. CDC's estimate of the overall burden of foodborne illness has a much larger scope than CDC's annual reports and draws heavily from FoodNet data as well as from a much wider variety of data sources, both inside and outside of CDC. This estimate also includes norovirus, a major contributor to the overall burden of foodborne disease, which can be transmitted not only by foods, but also by environmental sources, and is not monitored by FoodNet. CDC's last estimate of the overall burden of foodborne illness was issued in 1999 and included unknown causes of foodborne illness (Ref. 2). Since then, advances in methodology and data sources have improved capabilities in developing disease burden estimates; these will be reflected in CDC's next estimate.

                    In addition to CDC estimates, FDA and USDA use other measures to gauge the success, or implied success (i.e., via proxy measures), of policies and interventions for reducing foodborne illness. For example, although measurements of the food industry's compliance with a given food safety regulation cannot be used to directly measure the regulation's impact on the rate of foodborne illness, improved compliance can be reasonably expected to improve the likelihood that the foods involved will be safer and, thus, the likelihood that fewer illnesses will result. Examples include the tracking of                     *E. coli*                     O157:H7 in ground beef and of                     *Salmonella*                     in meat, and surveys of both domestic and imported produce, such as surveys conducted by FDA and USDA's Microbiological Data Program, which have targeted                     *Salmonella*                     and                     *E. coli*                     O157:H7.                

## II. Purpose of the Workshop and Topics for Discussion

The purpose of this initial 1-day public workshop is to discuss current and potential measurements for assessing progress in food safety and to provide workshop participants an opportunity to learn about metrics and to consider and suggest metrics for assessing the effects that policies and interventions have on foodborne illness. The workshop will focus on the current status and challenges involved in measuring foodborne illness and trends over time, including incidence and trends in the overall burden of foodborne illness and illnesses associated with specific foodborne pathogens and specific pathogens that affect specific foods. The workshop will include a discussion of other measures that are, or could be, used to measure food safety progress that cannot be directly linked to health outcomes. These include measures of process control in food production, studies on the prevalence of specific pathogens in specific classes of food, and studies of compliance with recommended or required food safety practices in retail and food-service operations.

                    Specifically, topics to be discussed include CDC's data sources and methods, including methods for estimating the burden of foodborne illness, and their various limitations and utilities; and FDA's and USDA's ongoing measures to gauge the success, or implied success (i.e., via the kinds of proxy measures described in previously mentioned examples; e.g., surveys for                     *E. coli*                     O157:H7 and                     *Salmonella*                     in produce and tracking of specific pathogens in meat), of policies and interventions, including the level of compliance with food safety regulations.                

## III. Transcripts

                    Please be advised that as soon as a transcript is available, it will be accessible at                     *http://www.regulations.gov*. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.                

## IV. References

                    The following references are on display at the Division of Dockets Management (see                     *Transcripts*), between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the following Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the                     **Federal Register**                    .)                

                        1. President's Food Safety Working Group findings,                         *http://www.foodsafetyworkinggroup.gov/​ContentKeyFindings/​HomeKeyFindings.htm*.                    

                        2. Mead P.S., L. Slutsker, V. Dietz, et al.,                         *Food-Related Illness and Death in the United States*,                         *Emerging Infectious Diseases*, 5(5), 607-625, 1999.                    

Dated: February 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-4110 Filed 2-26-10; 8:45 am]

BILLING CODE 4160-01-S