FSMA Subpart G Rule: The 33 New Sections You Need to Understand

Key: Receiving facilities must verify suppliers’ preventive activities

Thanks to the U.S. Food and Drug Administration’s new FSMA Subpart G rule for human/animal food, the receiver is liable for supplier preventive controls. And there are now 33 sections that outline exactly what receivers must do to comply with these new requirements.

The 33 sections are meant to minimize the risk of food safety hazards that can befall the food supply chain, explains food safety expert Dr. John M. Ryan in his AudioSolutionz webinar, “Receiver Liability for Supplier Preventative Controls Under FSMA Subpart G Rule.” But the great burden is on receivers—who must ensure they’re using approved suppliers who, in turn, are providing verified raw materials and other ingredients.

5 Must-Dos for Receivers

Subpart G has plenty of boilerplate language outlining general responsibilities, but the real meat of the rule set is the outlining of receiver responsibilities—that is, how to:

  • Approve suppliers,
  • Determine appropriate supplier verification activities,
  • Conduct supplier verification activities for materials/ingredients,
  • Conduct an on-site audit of a supplier, and
  • Document your supply-chain program.

Under these rules, a receiving facility is responsible for both establishing the verification process and gathering data on suppliers. For instance, you must establish written procedures for receiving raw materials and ingredients, as well as conduct annual audits of a supplier before using any raw material or ingredient from that supplier.

Food Manufacturers Are ‘Receivers,’ Farms Are ‘Suppliers’

Who do the rules apply to? According to an FDA data sheet, the preventive control rules for human food apply if you “manufacture, process, pack, or hold human food for consumption in the United States, whether your facility is domestic or foreign. The requirements apply to you if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act.”

Generally, both large businesses and small businesses (i.e., fewer than 500 employees) should already be complying with the rules.

Businesses with less than $1 million in annual sales of human food plus the market value of the food manufactured, processed, or held without sale must now also comply—as of September 2018. Also as of September 2018, facilities subject to the Pasteurized Milk Ordinance get a compliance reprieve until the preventive controls rule requirements can be incorporated into the ordinance.

Who don’t the rules apply to? Entities defined as “farms” are not subject to the supplier preventive controls. Neither are retail food establishments or restaurants.

Don’t Take The Suppliers’ Word For It

FSMA Subpart G rule offers a list detailing what the receiving facility may not accept as supplier verification activity, which mostly boils down to not accepting supplier-conducted determinations. For instance, you may not accept:

  • The supplier’s determination of its own appropriate verification activities.
  • The suppliers’ review of its own relevant food safety records.
  • An audit conducted by the supplier.

Appropriate supplier verification activities include: on-site audits, testing/sampling, and safety records reviews. But receivers don’t have to do all the legwork themselves. Subpart G allows an “entity other than the receiving facility” to perform preventive controls work provided that the receiving facility reviews and assesses the entity’s applicable documentation.

There’s plenty about Subpart G that receivers must understand and incorporate into their operations, says John Ryan. In his FDA compliance webinar, he walks attendees through the new supply-chain-applied control rule requirements (for both U.S. and imported foods) and explores your options for assuring that your documentation systems provide proof of rule compliance.

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