FDA_Food_Defense_Comments1 doc

April 24, 2012

The Honorable Margaret Hamburg Commissioner, Food and Drug Administration Department of Health and Human Services Attention: FDA-2012-N-0145

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

RE: Comments on Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities

Dear Madam Commissioner:

The National Association of County and City Health Departments (NACCHO) is responding to the Food and Drug Administration’s request for comments regarding the proposed collection of data and information to improve food safety and defense capacity at state and local levels.

NACCHO represents 2,800 local health departments across the country of which approximately 2,200 have food safety programs. These city, county, metropolitan, district, and tribal health departments work every day to ensure the safety of the food we eat by conducting retail and food service licensing and inspections, providing food retail facility trainings and technical assistance, conducting frontline surveillance, participating in outbreak response and recall efforts, providing public education and outreach, and operating laboratories. As local health departments serve as the frontline defense, it is important that as we move toward a more integrated system that the FDA and Congress have a full understanding of the capacities of all levels of government that engage in food safety activities.

NACCHO’s comments are organized by the following key points:

 The proposed collection of information is necessary for the proper performance of FDA’s

^{functions. Information gathered in this survey will have practical utility.}

 To ease the burden of the assessment on local and state government employees, NACCHO recommends FDA builds on information gathered from existing food safety and food defense surveys and assessments.

 Instead of surveying 1,400 local and state employees, FDA should survey at minimum 1,400 agencies that are representative of the different size jurisdictions, geographic locations, and types of agencies with food safety and food defense programs.

 NACCHO supports FDA using an online survey assessment and specifically recommends that the assessment be set up to allow agencies to have multiple employees access the survey on multiple occasions to fully and accurately complete the survey.

 The assessment should be conducted on a routine basis so that the FDA and other agencies participating in the food system are well prepared to tackle emerging food safety and food defense concerns.

1.) The proposed collection of information is necessary for the proper performance of FDA’s functions. Information gathered in the survey will have practical utility.

NACCHO supports the proposed collection of information and firmly holds that the information is necessary for the proper performance of FDA’s functions and will have practical utility. Understanding the capacity of state and local health departments is especially crucial in light of the fact that local health departments continue to face shrinking budgets and diminished capacity due to ongoing budget cuts. Budget pressures on federal, state and local governments are undermining their present work and impeding innovation. Since 2008, nearly 52,000 state and local health department jobs have been eliminated. In the last year alone, 10 percent of local health departments have reduced or eliminated their food safety programs.

The cumulative effect of these cuts threatens the ability of local health departments to prepare for and respond to emergencies and to provide basic services that people rely on. In the area of food defense, this means there are fewer restaurant inspectors to protect the community from foodborne illnesses, fewer trained professionals to detect intentional or unintentional foodborne disease outbreaks, and less staff to respond to foodborne disease outbreaks and recall efforts. Ultimately, the reduction in local health department capacity compromises FDA’s ability to identify and respond to emerging outbreaks because local health departments are the first responders in the event of an outbreak. Without local health departments reporting illnesses to state and federal agencies, the ability for state and federal agencies to identify and respond to outbreaks diminishes.

The Food Safety Modernization Act (FSMA) tasks FDA with the responsibility of enhancing the current food safety system so that it is an integrated system that is well equipped to prevent, detect, and respond to emerging food safety and food defense concerns. It is therefore vital for the FDA to understand the capacities of state and local governments in order to identify areas for enhancing staffing levels, increasing laboratory capacities, and improving information technology systems. This information is ultimately valuable not only for FDA but also for local, state, other federal agencies, and Congress who make decisions affecting the ability of the U.S. food safety system to ensure safe and unadulterated food for everyone.

2.) To ease the burden of the assessment on local and state government employees, NACCHO recommends that FDA build on information gathered from existing food safety and defense surveys and assessments.

Without seeing the actual assessment and the full methodology, it is difficult to comment on the accuracy of the estimated burden of the proposed collection of information. While NACCHO supports a food defense capacity survey administered by FDA, some local health departments have reported experiencing survey fatigue. Both NACCHO and the Association of State and Territorial Health Officials routinely administer surveys on the capacity of state and local health departments which include information on food safety activities. NACCHO is currently evaluating a more detailed survey it administered in the Spring of 2012 on the capacity of environmental health services (including food safety capacities). Additionally, several other organizations have administered and continue to administer a variety of survey instruments to assess local and state capacities, including the National Environmental Health Association, Council of State and Territorial Epidemiologists, and Association of Food and Drug Officials. Therefore, FDA should assess the methodologies and instruments that have been administered by various organizations and ensure that the FDA’s assessment builds off of these other efforts and does not duplicate the information that has already been collected.

3.) Instead of surveying 1,400 local and state employees, the FDA should survey at minimum 1,400 agencies that are representative of the different size jurisdictions, geographic locations, and types of agencies with food safety and defense programs.

Because there are 3,000 agencies, including roughly 2,200 local health departments responsible for protecting our food supply and these agencies employ tens of thousands of employees, NACCHO recommends that FDA conduct a census of the agencies on their food safety capacities instead of surveying 1,400 employees. If FDA is unable to complete a census, then NACCHO recommends that FDA focus its survey on 1,400 agencies that are a representative sample of jurisdiction size, geographic location, and the types of agencies that have food defense related programs. To emphasize the need for a representative sample of the agencies that includes local agencies, other assessments which have only focused on state agencies and had the state agencies provide local data have had incomplete and

flawed data because the state does not always accurately or adequately track local agency activities and capacities.

4.) NACCHO supports FDA using an online survey assessment and specifically recommends that the assessment be set up to allow agencies to have multiple employees access the survey on multiple occasions to fully and accurately complete the survey.

An hour long survey can be very burdensome for local health department staff who have many competing priorities. If possible, NACCHO recommends reducing the amount of time it takes to complete the survey. Additionally, to ease the burden of the survey, since it may be difficult for one employee to answer all of the questions regarding their agency’s food defense capacities as these responsibilities may be distributed across more than one individual, team, or department, NACCHO recommends that FDA set up the survey instrument to allow multiple users to log into the same survey to enter in their specific data. Depending on the information being requested, staff may not have the

information readily accessible and may need to locate data to complete the assessment. This will extend the length of time required to complete the survey. Therefore, NACCHO also recommends that FDA allows survey users the option to login multiple times to complete the survey.

Furthermore, while NACCHO supports FDA’s administration of web based survey, NACCHO also recommends that survey participants have the option to complete the survey in paper form. While the vast majority of LHDs have access to internet, there remain a few LHDs with limited ready access to web services.

5.) The assessment should be conducted on a routine basis so that FDA and other agencies participating in the food system are well prepared to tackle emerging food safety and food defense concerns.

Lastly, FDA states that the assessment is intended to be a one-time assessment. This will only provide a one-time snapshot of the capacities of state and local agencies and will not provide insight into the fluctuations in capacities overtime. NACCHO recommends that FDA uses this capacity survey as the foundation for a routine assessment of state and local capacities. Local health departments’ capacities are subject to a range of factors such as the economy, political leadership, public health related events such as disasters or emerging infectious diseases, and public support at the local, state, and federal levels. For example, despite the economic challenges of the last few years, LHDs have been able to offset some of the epidemiological related losses with special one-time funding for H1N1 response and federal funding from emergency preparedness. However, as H1N1 funding disappears and federal

funding for preparedness shrinks, it is anticipated that the capacity of LHDs to respond to outbreaks will be further challenged. If FDA only administers one assessment and makes plans based on the one-time assessment, the FDA will not be prepared if a major event occurs and they are relying on outdated data to formulate a coordinated response.

NACCHO supports FDA’s efforts to assess the capacities of state and local agencies’ food safety and food defense programs. This information will inform how FDA and Congress should proceed to ensure an integrated system that is well equipped to prevent, detect, and respond swiftly to foodborne disease outbreaks and illnesses. NACCHO appreciates the opportunity to provide comments and would be willing to give specific feedback on the survey instrument that FDA plans on using to assess state and local food safety and food defense capacities. Please contact Jennifer Li, Director of Environmental Health, at 202-507-4242 or jli@naccho.org.

Sincerely,

Jennifer Li, MHS

Director, Environmental Health

National Association of County and City Health Officials

1100 17th St NW, Seventh Floor

Washington, DC 20036

202-507-4242 jli@naccho.org