FDA FSMA (Food Safety Modernization Act) enacted in 2011 sets the stage to new provisions, such as HARPC (Hazard Analysis and Risk Based Preventive Controls). While of impact to food producers within the USA, it does significantly affects your organizations food safety program as well as the way to do business with the USA in matters within the food supply chain. If you organization imports foods to the USA or plans to do so, it applies to your organization. Interestingly other countries are taking note to benchmark the FSMA and especially HARPC.

The contents within a HARPC Plan requires that FDA mandates be explicit in reference to regulations within  surrounding facilities, controls, hazards, et al for safe foods (adulteration).  HARPC sets the stage that each food facility explicitly convey its plan, be periodically review and sustain it, a detailed flow diagram is an expectation. Equally records may be in paper or electronic media, yet electronic media is preferably (see 21 CFR 11).

There are some exemptions within the provisions of the FSMA for micro businesses, regardless food will subject to HARPC fundamentals. Thereof, HARPC represents a new requirement that needs be implemented appropriately and adequately to assure food safety in the eyes of FSMA.  Organizations must define, document and implement HARPC Plan align to FSMA. Data and information needs be promptly produce upon FDA oral or written request or through an inspection.

FSMA establishes the FDA as a recognition - accreditation entity to qualify and accredit auditors and third-party providers. Unfortunately, as it seems, the costs in association to these third-party programs will need be transferred to the consumers by way of a limited number of participating organizations.

BRS maintains updates through its assessment programs and public trust accredited certification FSMS ISO 22000 based FSMA - HARPC.



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Last Modified 19 July, 2021

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