FSMA Preventive Control Proposed Rule – Key Points for Food Processors

Official Title - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

 There has been a lot of press regarding the FDA’s proposed rule on preventive controls. It has been hailed by many as a needed step for a safer food supply. If anything, it certainly helps to bring most every processor up to the same level in terms of HACCP based preventive measures.

The rule requires that FDA registered firms have a written food safety plan which is based upon HACCP principles.

For the food processor who has a HACCP plan in place and has undergone third party audits, there is nothing overwhelming within this rule. The challenge will be for those companies that do not have a HACCP system in place yet, (or a good plan in place). All companies who have registered their facility with the FDA, including those that do not ship out of state, may be subject to the FSMA preventive control rule. However, there are exemptions from the requirements for a Food Safety Plan for firms based upon size and whether they can be considered ‘on-farm’.

For firms with an active, functioning HACCP plan, the biggest thing to revise will be in the hazard analysis and the need to identify preventive controls. Preventive controls, as defined, can be CCPs or certain prerequisite programs that are needed to control potential hazards. Also, in addition to biological, chemical and physical hazards, we now include radiological hazards.

In current HACCP, the focus is on hazards controlled within the process by CCPs. In this, we acknowledge that prerequisite programs as making certain ‘hazards not likely to occur’. In the FSMA rule, all potential hazards must be addressed, and then for any considered reasonably likely to occur, the preventive control must be identified that renders the product safe (non-adulterated), whether that be a CCP or other program. In doing the hazard analysis, it will be important to include an assessment the severity of the illness or injury associated with the hazards.

Similar to what is done with CCPs, all preventive controls must have documented procedures. There must be monitoring, verification, and record keeping. However, unlike a CCP, there may not be a measurable parameter (critical limit). Validation for the preventive controls may not be needed (for sanitation and allergen control).

For example, one would need to identify sanitation as a preventive control for Listeria with a RTE food item when there is exposure of that product to the environment before packaging. They would need procedures for cleaning, verification that cleaning was done, and documentation to show this.

Facilities are required to have a written Recall Plan. At this time, there are no requirements for an environmental monitoring program, finished product testing, or supplier verification, although there is this with regard to process control (Proposed § 117.80(a)(5) would require that chemical, microbial, or extraneous-material testing procedures be used where necessary to identify sanitation failures or possible cross-contact and food contamination). FDA does ask for comments regarding the need of these being addressed. 

Food defense / intentional contamination will not be addressed in this rule.

Overall, FDA takes a less prescriptive approach with regard to the preventive control rule. While this gives processors opportunity to use a number of different methods to meet standard, it can be an issue when being inspected when that inspector doesn’t agree with that method. (We see that now with USDA inspectors with regard to validation…..’how do you know that process works’).

It is important to remember that this is just the proposed rule. This is the comment period and this closes on May 16th. At that time FDA will review and then reissue the rule, which then becomes implemented 60 days after being issued. Large firms will have one year to implement, small firms will have 2 years, and very small firms will have 3 years.

For more detailed summaries (prepared by lawyers) see http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm or http://leavittpartners.com/wp-content/uploads/2013/01/Proposed-Rule-On-Preventive-Controls-Key-Provisions.pdf

Other points to note – (Items I found interesting):

Training will be important. The rule requires that one or more qualified individuals prepare the food safety plan, validate controls, review records, and perform revalidation/reanalysis. A person becomes qualified through training and/or practice. It is also required that supervisors and sanitation people receive training.  

“Personnel responsible for identifying sanitation failures or food contamination must have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors must receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices”

There is much more attention on allergen control, specifically preventing cross contact (that is the term used for allergens instead of cross contamination). This includes personnel as a source of cross contact.

Corrective actions will require a root cause analysis to determine and then eliminate the cause for a deviation.

“Proposed § 117.110(d) would specify that the mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food.:

“Containers and carriers of raw materials must be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.”

The current section of 21 CFR Part 110, the current CGMP regulation, will be revised with current terminology and moved to 21 CFR Part 117 along with hazard analysis and risk-based preventive controls.

There is a whole section defining ‘on-farm” and a “facility”, regarding who needs to comply.