Differences between HARPC (FSMA Preventive Controls) and HACCP
FSMA places a much stronger emphasis on science, research and prior experience with outbreaks than HACCP. For example, the FDA now uses whole genome sequencing to match the exact strain of pathogen isolated from hospital patients to DNA recovered from food manufacturing facilities.
FSMA requires that a "Preventive Controls Qualified Individual" (PCQI) with training and experience oversee the plan. HACCP assigned responsibilities to a team drawn from management.
FSMA requires that firms vet ("Verify") all their suppliers for the effectiveness of their food safety programs. This has the effect of drafting companies into the FSMA enforcement effort, since the Supplier Verification and Foreign Supplier Verification programs require that the suppliers provide written proof that they have Prerequisite Programs and Preventive Controls systems which includes their own supplier vetting program.
FSMA-compliant Food Safety Plans rely on Prerequisite Programs such as GMPs, allergen controls, Integrated Pest Management and vetting suppliers far more than HACCP plans, since these programs tend to be preventive.
FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems.
FSMA explicitly requires a Food Defense component, with both terrorism and Economically Motivated Adulteration addressed. Businesses with less than $10,000,000 a year in sales are exempt.
FSMA-compliant Food Safety Plans de-emphasize Critical Control Points in favor of Preventative Controls. Preventive Controls do not require specific Critical Limits.
FSMA-compliant Food Safety Plans allow “Corrections” in place of “Corrective Actions” when the public health is not threatened. Corrections are not as strict regarding paperwork as Corrective Actions. The FDA believes that companies might have been avoiding making minor improvements because they felt that the paper trail of a Corrective Action would open them to legal risk due to discovery during investigations or lawsuits.
FSMA-compliant Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.