September 3, 2008
Dr. Richard Raymond
Under Secretary for Food Safety
U.S. Department of Agriculture
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Dear Dr. Raymond:
I am writing on behalf of the National Association of State Departments of Agriculture (NASDA) and our affiliate organization, the National Association of State Meat and Food Inspection Directors (NASMFID), to request your immediate attention and assistance on a serious situation regarding the cooperative partnership between state meat inspection programs and the Food Safety and Inspection Service (FSIS). NASDA and NASMFID strongly believe there is an urgent need to improve the working relationship and the lines of communication between FSIS and the state inspection programs, and reestablish an effective partnership.
The current situation involves the State Self Assessment Process and all issues related to these procedures. In July 2008, FSIS published “At Least Equal To Guidelines for State Meat and Poultry Cooperative Inspection Programs.” This document is the most recent part of ongoing activities to implement the “National Criteria for Meat and Poultry Inspection Programs” issued in 2001 and the “Manual for State Meat and Poultry Inspection Program Review” issued in 2003. In addition, FSIS has issued numerous directives and notices related to these documents, as well as several written variations of the state review process.
Throughout this long period, NASDA and NASMFID have raised concerns and questions about the timing, implementation, selection, evaluation, and audit procedures for these state reviews. We believe a majority of these documents place unrealistic demands on state inspection programs and actually exceed the agency’s statutory authority. We believe that the federal Meat and Poultry Acts require states to have laws that are “equal to” only in three well-defined areas: (1) inspection; (2) re-inspection; and (3) sanitation.
The states were initially invited to participate and provide input on the July 2008 “At Least Equal To Guidelines”. However, FSIS made numerous changes that were not discussed or explained with the states. One of the most significant changes is a provision that all FSIS directives, notices, and policies must be elements for meeting “equal to” requirements, even though FSIS is on the record stating that directive, notices and policies are the instructions for FSIS personnel only. Basically, this expands the “equal to” determinations to cover virtually all aspects of state program activities.
State directors believe the July 2008 Guidelines are just one more attempt to overwrite exiting statutes. The Federal Meat Inspection Act and Poultry Products Inspection Act established mandatory requirements for the state programs to meet “equal to” provisions. These congressional acts also established regulatory boundaries for FSIS. States are expecting that FSIS will act within these boundaries and align their “expectations” to the existing law.
The state directors feel the newly published guidelines are severely flawed in making “at least equal to” determinations for two additional reasons: (1) FSIS has no system in place to actually be in a position to measure “at least equal to” and; (2) FSIS is continuously changing its expectations of state programs.
State Program Directors have long questioned FSIS management on what the phrase “at least equal to” actually means. It would seem to mean that a state program and its’ affiliated state establishments are operating at a level that is equal to FSIS and their affiliated federal establishments. However, FSIS has not done an internal comprehensive review of their federal in-plant program or had a formal review system in place for over a decade. Because auditors have no established baseline or nothing to compare state plants to, they have unrealistically set the bar at perfection.
An example of this can be taken from the recent on site audit conducted in North Dakota. Auditors concluded that state establishments were deficient in their raw ground beef systems because they didn’t have specific documents in place to address E. coli 0157:H7. North Dakota establishments addressed E. coli 0157:H7 in their HACCP plans, had prerequisite plans in place, conducted verification testing and met regulatory requirements. However, FSIS auditors had specific expectations of documentation they thought should be in place, either Certificates of Analysis from their supplying plants or third party audits conducted at these plants. It came as a surprise to auditors when their own agency published the “Results of Checklist and Reassessment of Control for Escherichia coli O157:H7 in Beef Operations” and demonstrated that not only were North Dakota establishments on par with federal establishments but were ahead of the majority of them by conducting verification testing.
We certainly understand the need for and actually welcome reviews, audits, inspections, and other tools necessary to assure FSIS and the public of our role as guardians of the public’s trust. However, in order for states to defend and justify their inspection programs in favor of the Federal inspection system, the playing field must be level. Until the very small federally inspected establishments are reviewed using this same methodology, state programs will be at a regulatory disadvantage.
The second issue regarding FSIS making “equal to” determinations is that the agency continuously changes its expectations of state programs. Throughout the various drafts and publications of state review manuals, FSIS has continued to review states’ self assessments and conduct on-site audits. Because of these constant changes, and for other various reasons, FSIS auditors are keying into new and different issues each and every year. The issues are not something that has suddenly made the states “not equal to,” they are simply topics that FSIS management has decided to take up because they have changed their expectations/interpretations of existing rules. If a change is necessary and realistic, states do not have a problem with it but, we must have this information communicated to us in a timelier and realistic manner. It is impossible to hit a moving target and this is exactly what is happening.
We are simply asking FSIS to clearly communicate any changes that may affect state programs in advance, citing the specific law that in the agency’s opinion supports this change. States expect to be allotted a sufficient amount of time to implement these changes. We would rather see FSIS identify the final outcome and allow states to find their own way to achieve this rather than attempting to shape state programs as a mirror reflection of a federal agency. There is no need for micromanagement. “Equal to” status should be measured by the outcomes/results, not adherence to procedures. The state inspection agencies offer the following recommendations:
* FSIS will act within the legal boundaries set in the Federal Meat Inspection Act and Poultry Products Inspection Act and align their “expectations” to the existing law.
* Eliminate the recent publication “At Least Equal To Guidelines for State Meat and Poultry Cooperative Inspection Programs” and replace it with established mandatory requirements for the state programs to meet “equal to” provisions.
* FSIS will clearly communicate any changes that may affect State Programs in advance, citing the specific law that in FSIS’ opinion supports this change. We will expect to be allotted a sufficient amount of time to implement these changes.
* FSIS allow states to achieve “at least equal to” without being the “same as.” Equal to status should be measured by the outcomes/results not adherence to procedures.
* FSIS establish and maintain a system for reviewing federally inspected establishments using the same methodology used to review states.
In November 2003, NASDA and NASMFID met with then Under Secretary Dr. Elsa Murano and FSIS Administrator Garry McKee to discuss these same issues and concerns. Those discussions were productive, positive, and resulted in a renewed collaboration with states. Now—more than five years later—we are back to a situation where FSIS is arbitrarily implementing new review requirements without state consultation for no apparent reason.
We value our state-federal partnership. For this reason, NASDA and NASMFID urge you and FSIS to take a “continuous improvement” approach in working with the states to ensure that the review system achieves mutually agreed upon, outcome-driven, food safety objectives. Resuming this dialogue and collaboration will allow us to move forward in a spirit of partnership and cooperation as we work together to ensure a safe and wholesome food supply.
Commissioner, North Dakota Department of Agriculture