3] It is a logical and more easily understandable approach to distinguishing products. We fully support the FSIS/FDA workgroup’s rationale for determining what agency shall be awarded jurisdiction. Food products that primarily contain meat and poultry ingredients should be covered by resident type of inspection under FSIS, while food products that contain meat and poultry ingredients for accentuating flavor only should be assigned to FDA. This rationale is best illustrated, in our opinion, with sandwiches which pose a potential Listeria monocytogenes hazard to consumers, whether or not the sandwich is closed- or open-faced.

While AFDO recognizes the need for and importance of the jurisdictional examination, we note that the changes being considered will have an impact on state and local food safety programs. We urge that these impacts be considered during the decision-making process.

1] It is likely that some establishments that would be affected by the change are currently licensed and inspected by state and/or local regulatory agencies.  Should these establishments become Federally-inspected plants under FSIS, would state laws be preempted and state programs lose licensing fees?  What might FSIS do to ameliorate this impact?

2] AFDO has long supported the use of HACCP by all food manufacturers and wonders what will happen to current FSIS establishments operating under a HACCP plan that are then transferred to FDA jurisdiction where this requirement does not exist. It would seem inappropriate that a HACCP system, which has been mandated to and put into effect by a firm, might no longer be required. AFDO requests clarification of this matter.

3] It would follow that rule changes for firms that are placed under a new Federal jurisdiction will be impacted as well. Establishments complying with state-required date coding, record-keeping or processing schedules different from those required by FSIS, would have to make substantial changes.

4] A number of affected firms may be currently inspected by state authorities under FDA contracts. Transferring these firms to FSIS jurisdiction will impact such contracts.

5] A number of states have taken major enforcement actions due to Listeria monocytogenes contamination against sandwich manufacturers currently under FDA’s jurisdiction. These state actions include food seizures or embargoes, recalls, and license revocations. State programs report that some of these actions have led to requirements for “hold and test” programs and environmental plant testing. The potential for Listeria contamination in sandwich manufacturing facilities is of great concern to state and local food safety programs, and we believe the more intensive, resident-type inspection program of FSIS is warranted for such products. AFDO does ask FSIS to review with state programs any sandwich manufacturer under current state or local government authority where Listeria monocytogenes problems have existed.

This initiative could be an opportunity to look at new cooperative approaches to regulating food establishments subject to multiple jurisdictions. Food establishments where meat or poultry and non-meat or poultry products are produced in the same plant have always presented an awkward situation for regulators. Many of these plants are high-risk types such as low-acid canned food manufacturers, acidified food plants, and processors that cure, salt, or smoke various types of food products. Goals might be to prevent duplication of efforts and minimize the number of government food safety agencies with which small businesses must contend. At a minimum, where the states are not preempted entirely and continue to have a role in regulating multiple-product manufacturing establishments, the Federal agencies should provide a mechanism for consulting with the states on the coordination of Federal and state regulatory activities, including compliance efforts with retail food establishments.

AFDO is pleased to offer these comments to our Federal partners and applaud any decision that will result in a better utilization, coordination, and integration of the limited, yet very critical resources devoted to food safety.

Marion Aller; President

Association of Food & Drug Officials