As the egg industry races to meet the requirements for the introduction of the FDA Final Rule on salmonella it is of interest to review the case of the A. Chau Sprouting Co. This enterprise, located in Gretna, La., was the subject of a complaint filed in mid-March of this year in the U.S. District Court for the Eastern District of Louisiana.
The defendants were charged with violating the Federal Food, Drug, and Cosmetic Act “by preparing, packing and holding sprouts under unsanitary conditions where they may have become contaminated with filth.” The company distributes ready-to-eat sprouts widely in the Gulf Coast where they are incorporated into salads served to health conscientious consumers.
The FDA is charged with maintaining a supply of wholesome food from domestic sources and imports. It has been disclosed in congressional testimony that the FDA has insufficient inspectors to ensure adherence to good manufacturing practices in our own plants and inspects in a cursory fashion less than 2% of imported food.
In the A. Chau Sprouting Co. case the complaint alleges violations that include equipment and facilities that were unclean, unsanitary employee practices and inadequate cleaning and maintenance. If allegations are true - and there is no reason to doubt the FDA complaint - the Agency was fully justified in taking action.
The problem however is that five inspections carried out over the past nine years and specifically in August and September of 2009 revealed gross violations of basic sanitation and improper practices. The question arises as to why this unsatisfactory situation was allowed to continue for nearly a decade?
Based on training in epidemiology and public health and experience in both academia and industry this commentator is less than impressed with the diligence, sense of urgency and basic commitment of the Agency to its charter. Although the wheels of justice move slowly, nine years is an inordinate time before positive action is taken against a gross violation.
The obvious question that comes to mind is that if the FDA is apparently incapable of responding to an overt case of unsanitary production and processing which can be adjudged by subjective evaluation, how can we expect that implementation of the regulations in terms of the Final Rule will be implemented fairly and equitably?
Although the Final Rule is to be implemented in June 2010 the promised “Guidance Document” has yet to be published. Training of inspectors to carry out the planned 100 farm and plant visit each year has yet to be completed. The FDA has still not addressed the multitude of potential and in some cases profound problems raised by industry which were not considered by officials in framing the regulations.
Political expediency and grandstanding aside, one might wish that the FDA would generate sufficient competency to carry out their activities and functions which have a critical bearing on public health and food safety without taking on additional commitments in fields were they are ill-prepared.
The UEP Legislative Liaison Representative is meeting with institutional resistance on aspects concerning both introduction and implementation of the Final Rule. Officials at the FDA would be well advised to step back, recognize their inadequacies, take advice from disinterested specialists in academia, delay inception of the program and ensure that their Guidance Document, training programs and procedures are appropriate to the challenges which they face. At the end of the day producers and consumers alike will pay for intransigence and incompetence.