Its evident that the FDA regulated food industry does not want to pay user fees. With the political climate being what it is, FDA may not get sufficient funding to carry out its mandates.


If this is the way government and industry decides on what is best for the public health, then the consequences need to be assessed and some sort of alternative developed. See:


The problem is that there is no united opinion on on how best to develop an industry led government-private sector initiative that is universally adopted. The the current system of competing private standards has shown its limitations and we need more than this.


The FSMA should become the universal standard for industry compliance and conformance, a radically new approach, but totally common sense.


Much of what the FDA says needs to be done can be done through cooperation, allowing FDA to take a less aggressive position in regulation, This can happen only if voluntary compliance will work and industry will accept FDA standards as the bible, and FDA as the leader.


The potential savings for everyone could be maximized by developing the key programs and criteria that could be used by industry to support the FDA mission. If industry wishes to keep the current model of self inspection and provate standards, in line with the new model of mandatory reporting of FDA compliance, all the better.


Furthermore, FDA should start discussions about interagency agreements and contracts with state and local health departments to provide manpower to see how much can be saved through this approach.


Beyond the current FDA guidance documents, I propose a system that relies on mandatory reporting by the private sector to government.


This measure is not as perfect as an FDA inspector in the field. but competent industry personnel, working under strict management and oversight of FDA is a good half way point.


The electronic reporting requirements can easily be developed. FDA manpower and technology could better be used in this approach.


As a minimum I would suggest:


  1. Establish the food safety criteria to be used by FDA regulated segments, starting with the highest risk operations and develop reporting formats, this should move ahead if the funding issues can be dealt with
  2. Establish the qualification for third party second party and first party inspection for each of the critical sectors newly under FDA, this has to be done anyway
  3. Develop the oversight standards of the agency, not limited to frequency of reporting, criteria for determining risk, and interventions
  4. Establish the reporting database and security measures for the data entry

The application of technology is a key benefit in moving forward, especially if funding is minimal as predicted. Industry already has the experience in electronic reporting, and government should work with industry to further develop the methods already in use to collect and disseminate food safety data and manage risk in the food supply.


Instead of fighting over money, I would suggest a new spirit of can do and a frank discussion of how we can help one another.