How Much Will the FDA's FSMA Cost?

Online, August 6, 2013 (Newswire.com) - The time upon us. The government has spoken, the laws have been passed the new FSMA has become law. The FDA is requiring facilities that produce or process food to have either an effective HARPC (Hazard Analysis Risk- Based Preventative Controls) plan or complete and current cGMP (Current Good Manufacturing Procedures) records or both. These two regulations are modifications and overall modernization of the HACCP (Hazard Analysis Critical Control Point) system and the older CFR 21 part 110 (now referred to CFR 21 Part 117).

Facilities affected by the new law might be asking "how much is this all going to cost?" The answer is a bit of a suprise.

Some people believe that these new regulations are, well, something new and they are an over reach of the government's enforcement policies. Some people believe the costs of implementing these measures far exceeds the benefits.

The truth is that for some industries like Beef, Fish and Juice, HACCP has been enforced for over 20 years, while cGMPs have been requirements for well over 60 years (rough estimates). In fact most businesses have had SOPs and GMPs for much longer than they have been required. The reasons for that is that it helped production identify waste, ensures a consistent product and reduction in risk to the consumer to perceived acceptable levels. These new set of regulations put more emphasis on consumer safety and are further refinements that have been long overdue.

Foodborne illness (in the United States of America) accounts 16,000 per 100,000 to become ill, it accounts for 1 death per 100,000. It accounts for 43 per 100,000 to be hospitalized. It costs the US economy over $150 billion in related health care costs. That number does not take all the collateral costs into account such as missed work, school, etc.

The facts are that there is inherent risk and good reason to worry about the safety and quality of the food you produce and process. The best way (and legally required) to reduce the worry and the risk is to put a food safety scheme into place. The good news is that most facilities probably already have the bulk of the work completed.

People trained on how to build, implement and monitor a HACCP plan will know that the core of the "hard work" is in the creation of the prerequisites i.e. SOPs, GMPS, SSOPS, GAPs, etc. Anyone who's put a plan together or who's taken some training will say that the prerequisite programs are the heart and soul of a successful plan.

That being said, if the owner or are a production manager of a food production or processing facility and considering the "cost" of implementing the FSMA's requirements ask yourself if you already have certain prerequisites in place. If you have some of these prerequisite programs in place, then a large and expensive part of the job has already been done. After the initial creation of prerequisite programs there remains the need to establish critical control points, monitoring procedures, corrective actions and a way of documenting the data for a period of no less than 2 years.

To get a better understanding of the cost and scope it is recommended to attend a HACCP course or workshop and learn how to develop a team and a plan. Proper training and understanding is a must.

HACCP courses are offered through certain universities and can cost around $800-$1200 per person. Some food consultants will charge $700 - $1500 offering courses at different times and in different cities. Online courses can cost $299 - $800. SGS's HACCP Principles for Food Processors and Manufacturers. It costs $299 and provides a certificate with a seal from the International HACCP Alliance.

In having a food safety plan facilities can rest assured that they are producing the highest quality and safest foods that clients will buy again and again.