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FSMA for Human Food

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Probably one of the most anticipated sections of FSMA for all food manufacturers as it heavily affects the daily procedures, functions of workers and relates to all facilities that manufacture, process, pack/hold food products. Section 103 requires that each stakeholder have documented preventive control programs in place. Below are the main constituents of this proposed rule in the human food industry.

 

Section 103: PREVENTIVE CONTROLS

cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Originally the FDA proposed rule was 680 pages with a 120 day comment period including public meetings. Ultimately the FDA facilitated three comment period extensions until January 2014. Succeeding the comment period the FDA drafted a revised issue and released September 2014.

HACCP or Hazard Analysis Critical Control Program is a 7 principle based system that has been a core component of manufacturer's food safety programs since its development in the 1960's. FDA has taken this school of thought a step further in this proposed rule by recognizing that although Preventive Controls should be determined using Principle 1 (Hazard Analysis) in developing a HACCP program the Preventive Controls should not be limited to just CCPs. Additional areas that will be required:

  • Pre-requisite Programs
  • Recall Program
  • Sanitation Programs
  • Environmental Pathogens and Controls
  • Allergens and Controls
  • Equipment Calibration

Why Preventive Controls?

FDA's support information for requiring companies to develop and implement Preventive Controls programs vs. HACCP plans states that companies with HACCP plans have not put the due diligence into implementing and monitoring their CPs.

Thoughts are here that industry has deferred to a CP instead of a CCP so as to avoid having to monitor, record and react to possible variances required of a CCP in a HACCP Plan and this has thus, continued to cause contaminated products to be distributed and hence cause subsequent recalls.

Industry has also deferred to their Suppliers controls of certain possible hazards to the extent that they trust their Suppliers but never verify their Suppliers can and do achieve this level of control of a "likely to occur" hazard.

General Approach to Preventive Controls

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Supplier Controls

In the original proposal these were referred to in the FSMA pre-amble but, were not covered in the proposed rules. FDA requested comments on whether these should be required under FSMA. Comment period is now closed and the final ruling was submitted August 31st, 2015

What the rule says:

  • Supplier Controls mandate that the facility have a risk-based supply chain program for all incoming raw material and ingredients that have been identified to require an applied control. Exception: Facilities that are utilizing preventive controls to control a hazard or who follow the regulations for customers to control hazards need not have a supply chain program for the particular hazard.

Product Testing

In the original proposal these were referred to in the FSMA pre-amble but, were not covered in the proposed rules. FDA requested comments on whether these should be required under FSMA. Comment period is now closed and its inclusion will be determined upon the final rule of Preventive controls due August 31, 2015.

What is currently proposed:

  • A facility, as appropriate to the facility, the food and the nature of the preventive control, to conduct Product Testing to verify implementation and effectiveness of preventive controls.

If these provisions were to be included, the facility would have flexibility to determine the appropriate verification activity such as; On-Site Audit, Sampling & Testing, unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans.

In that instance, an annual on-site audit of the supplier would be required unless the facility can show that other verification activities and/or less frequent on-site auditing of the supplier provide adequate assurance that the hazards are controlled.

Environmental Monitoring

In the original proposal these were referred to in the FSMA pre-amble but, were not covered in the proposed rules. FDA requested comments on whether these should be required under FSMA. Comment period is now closed and its inclusion will be determined upon the final rule of Preventive controls due August 31, 2015.

What is currently proposed:

  • A facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct Environmental Monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.

Qualified Individual

The FDA has indicated that they feel contributing factors to the production and distribution of contaminated foods are:

  • Lack of understanding of the hazards associated with a Company's food products.
  • Lack of training of employees in knowing "likely to occur" hazards and what to do when they are shown to be present.

 

Implementation Timeline

If you are wondering how long you have to comply with the rules and regulations laid out by FSMA, you're not alone. FSMA has taken a revenue based approach for enforcement. This method has allowed additional flexibility to smaller businesses due to its nature in causing capital expenditures and longer implementation timetables.

FSMA Compliance Dates for Preventive Controls (Final Rule August 30, 2015)

 Small Businesses A business with fewer than 500 full-time equivalent employees: Two years
Businesses Subject to the Pasteurized Milk Ordinance Compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule: Three years
 Very Small Businesses Averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured processed, packed, or held without sale: Three years except for records to support its status as a very small business (January 1, 2016)
 Other Businesses Business that is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.