For the past couple of years, the food industry has focused on the promulgation, implementation and impact of the Food Safety Modernization Act (FSMA), with good reason. FSMA represents a fundamental change in the manner in which the U.S. government intends to police food safety. In that effort, FSMA has imposed—or will require—various and sometimes time-consuming and expensive changes to food company operations. The full scope and effect of FSMA remain to be seen; certain key implementing regulations remain forthcoming.

Although FSMA has received most of the attention and commentary of late, it is important for food companies to:

• take heed of other legislation that may affect operations
• help shape, where appropriate, the regulations that will implement those enactments

One such piece of legislation that has, so far, slipped under the radar provides the U.S. Food and Drug Administration (FDA) with the far-reaching ability to collect information about your company and its operations. At first blush, that legislation may seem relatively innocuous. However, information collected may influence the manner in which FDA interacts with your company for purposes of FSMA and other regulatory compliance.

Specifically, in 2002, the government enacted the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act) for the purpose of improving the United States’ ability to prevent, prepare for and respond to bioterrorism and other public health emergencies. In that vein, the Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with FDA. FSMA added a renewal clause, requiring that all food facilities renew their registrations between October 1 and December 31 of each even-numbered year.

Now, in light of FSMA, which among other endeavors, directs FDA to allocate resources to inspect a facility according to known safety risks of the facility, FDA proposes to collect additional facility profile information to assist them in determining whether the facility is high risk or low risk, and the frequency at which the FDA will inspect the facility. FDA indicates that a facility will benefit from submitting such information through interaction with better-informed investigators and potentially reduced inspection time.

You have the opportunity to play a part in ensuring that FDA’s representation is accurate. In promulgating the final rule regarding collection of facility profile information, FDA is to consider and comment on industry remarks on the information collection effort. Specifically, FDA seeks comments on:

• whether the FDA requires the proposed facility profile information to properly perform its functions
• the accuracy of the FDA’s estimate of the burden placed on facilities to comply
• ways to reduce the burden on respondents
• ways to enhance the quality, clarity and utility of the information collected

Comments are due on or before July 10, 2012; comment-submitting instructions can be found on FDA’s website,, and at As FDA may use the information collected to establish a baseline by which your company will be measured for purposes of FSMA and other regulatory compliance, it is important to voice any concerns you may have before the comment period expires. 

Jason R. Klinowski and John T. Shapiro are attorneys and members of the Food Industry Team at Freeborn & Peters LLP (Chicago).