Summary of changes

Resubmission of EHS-Net Kitchen Manager Certification Study: Summary of Changes

In the spring of 2010, the Environmental Health Specialists Network (EHS-Net) program, located in the National Center for Environmental Health at the Centers for Disease Control and Prevention, submitted an OMB package (0920-0792) entitled ‘EHS-Net Kitchen Manager Certification Study’ to the Office of Management and Budget (OMB). This study was submitted under the EHS-Net generic (i.e., umbrella) package.

OMB reviewed the package and scheduled a meeting with us to discuss it. During this meeting they raised several concerns, and asked us to withdraw the package, revise it to address their concerns and comments, and resubmit it. We have revised the package and believe that we have successfully addressed the concerns raised by the Office, and are therefore resubmitting the package. Below is a summary of the changes we have made to the package.

1. The OMB reviewer had concerns that the information gained from the study might not warrant the burden the study placed on the public. We respectfully disagree with this assessment. Food safety epidemiologists and environmental health specialists from the Environmental Health Specialists Network (EHS-Net), a collaborative forum of local, state, and federal (including FDA and USDA) food safety agencies, were involved in the development of this study. These experts believe that it is important to determine how kitchen manager certification is related to environmental antecedents and foodborne illness risk factors, which this study will allow us to do. In an attempt to better communicate the importance of the data gained from this study, we have revised the study justification, analysis plan, and statistical methods sections of the package.

Additionally, we have revised the study protocol to increase the generalizability of the data. Specifically, the data we collect will be generalizable to the restaurant population in the EHS-Net catchment area. The greater generalizability of the data collected in this study increases its importance.

2. The OMB reviewer had concerns about the burden posed to the public by the study. She believed the time needed for data collection was too long and that we had underestimated the burden. We have addressed these concerns in two ways. First, we revised the instruments in light of her concerns, modifying some items and deleting others. This revision led to more focused and shorter instruments. For example, the manager survey was reduced from 20 items to 11 items and the observation was reduced from 55 items to 50 items. Second, we reviewed our burden estimates in an effort to ensure their accuracy. The burden estimates are based on our pretesting of the instruments and our past experience conducting studies in similar environments using similar methods. The new burden estimate- an hour and a half per restaurant- is similar to the old one. It is important to note that the data collectors will spend most of this time (about 50 minutes) observing the kitchen. This activity does not require active engagement on the part of managers or workers. The active burden is approximately 30 minutes for kitchen managers and 10 minutes for workers. We have clarified this in the package. Additionally, we have conducted previous studies using similar methods (manager interview and kitchen observation) and with similar data collection durations. These studies have had 60%-70% participation rates, indicating that most restaurants do not feel that this burden is too great.

The OMB reviewer also questioned whether it was necessary to conduct all four portions of the data collection- manager interview, survey, kitchen observation, and worker interview. These multiple data collection methods are necessary to accurately assess all components of this study. The manager interview is necessary for collecting information about manager training and certification and environmental antecedents to foodborne illness risk factors, the manager survey is necessary to collect information about the environmental antecedent of manager food safety knowledge, the observation is necessary to collect data about foodborne illness risk factors, and the worker interview is necessary to collect data about an important environmental antecedent- worker food safety knowledge. We have clarified this in the package.

3. The OMB reviewer asked us to address several potential biases that are common with interview and observation data collection methods, such as the social desirability and reactivity biases. We have addressed these biases.

4. The OMB reviewer asked us to clarify how the interviewed managers and workers will be chosen for participation. We have clarified this and addressed potential biases associated with the selection method.

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