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Even though many of the sections that make up the new combined FSMA regulations are published and in a complete form, this year we will see two new sections being released as a final ruling.

Notably these are:

  1. The final ruling for the regulations related to Sanitary Transportation; due for the final version release on March 31st, 2016
  2. The final ruling release for the regulations related to Intentional Adulteration; due for the final version release on May 31st, 2016.

Even though FSMA will be a whole new set of regulations related to the food and produce industry, many of the sections are modified and adapted from previous FDA regulations, but combined into one consolidated ruling, with more emphasis on Risk Management and Assessment, plus increased authority provided to the FDA for enforcement of compliance.

So what should you do as someone that will be impacted by the FSMA regulations?

As many of you may already be following current FDA Good Distribution Practices and prior regulations like the SFTA 2005 food transportation regulations, you may be on track to get to FSMA compliance a lot quicker. The following is a list of what steps you should take to insure readiness:

  1. Read and thoroughly understand the new regulations and how they will impact you.
  2. Appoint a food safety team that should include as required under FSMA, a FSMA Responsible Person within your organization.
  3. Evaluate your gap as to what you do now and what you need to do in the future to be compliant.
  4. Establish a system or set of "need to do's" to close the gap.
  5. Implement the new system and/or controls.
  6. Organize a third party audit.
  7. Then once implemented - Ongoing, maintain and improve the system and/or procedures.
  8. Conduct regular maintenance audits.

And remember - temperature condition monitoring will now be a mandated part of the new regulations that will be strictly audited for compliance from farm, or processing center, to distribution centers, to restaurants and resale locations - in other words right throughout the supply chain.

DeltaTrak will always be there to help you to achieve and maintain compliance as your FSMA regulation compliance partner.

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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.

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