FDA Preventative Controls Rule Similar to HACCP; Importers Will Have to Verify Supplier Compliance per FSVP

The upcoming Foreign Supplier Verification Program, which FDA said will be proposed shortly, will require importers to verify their foreign suppliers’ compliance with HARPC.

Comments on the HARPC proposed rule are due by May 16.

HARPC Would Require Written Plan w/ Analysis, Controls, Monitoring & Corrective Action

Similar to HACCP regulations, HARPC would require all covered facilities to develop a plan; identify hazards, identify and implement preventive controls; and then monitor and verify that the controls work. FDA’s proposed rule would create new 21 CFR Part 117, which would require:

Written food safety plan. The proposal would require the owner, operator, or agent in charge of a facility to have and implement a written food safety plan that includes: a hazard analysis; preventive controls; monitoring procedures; corrective action procedures; verification procedures; and a recall plan.

Written hazard analysis. The written hazard analysis would have to identify and evaluate “known or reasonably foreseeable hazards” for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are “reasonably likely to occur,” including biological, chemical, physical, and radiological hazards.

Written preventive controls. The proposed rule would require that the owner, operator, or agent in charge of a facility identify and implement preventive controls to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. These may include tolerances for the hazard, process controls, sanitation controls, and a recall plan, among other things, FDA said.

Written recall plan. Covered facilities would be required to have a written recall plan for food with hazards that are reasonably likely to occur.

Monitoring. Monitoring of the preventive controls would be required, to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.

Corrective Action. FDA would require that facilities establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.

Verification. The proposal would require that facilities conduct verification of preventative controls, monitoring, corrective action decisions, and effectiveness. It would also require re-analysis of the food safety plan at least once every three years, and more often when circumstances warrant.

Qualified individual. FDA’s proposed rule would establish qualification requirements for a “qualified individual,” who would be required to do or oversee the preparation of the food safety plan, validation of preventive controls, review of records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and re-analysis of a food safety plan.

Recordkeeping. FDA would require food facilities maintain records, including their written HARPC plan and documentation of monitoring, corrective actions, verification, and training for the qualified individual.

Proposed Exceptions to Requirements Include Small Businesses & Farms, Facilities w/ HACCP,

FDA’s proposed rule sets out several exceptions to HARPC requirements for food facilities. Small businesses would receive modified treatment, for example, and facilities that already have to comply with HACCP requirements would be exempted. Activities at facilities that are subject to FDA’s concurrently-proposed produce safety rule would be exempted as well.

Modified requirements for small and very small businesses. Small businesses that meet certain requirements, as well as all very small businesses, would be designated as “qualified facilities.” Small businesses would be defined as having average annual sales of less than $500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles). FDA still hasn’t decided on its criteria for very small businesses, and is requesting comments on whether to define very small businesses as those with average annual sales under $1,000,000; $500,000; or $250,000. Rather than be required to comply with full HARPC requirements, “qualified entities” would only have to:

• Notify FDA about its status; and
• Either:
  • Notify FDA that it is addressing hazards through preventive controls and monitoring; or
  • Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed

On-farm activities for small and very small businesses. “Low risk,” on-farm activities performed by small businesses and very small businesses would be exempt from most HARPC requirements. Low risk activities may include, for example, re-packing intact fruits and vegetables and grinding, milling, cracking, or crushing grains.

HACCP-compliant facilities. Facilities already complying with HACCP regulations for seafood and juice would be exempt from HARPC requirements.

Facilities compliant with low-acid canned food regulations. Facilities already compliant with low-acid canned food regulations would be exempt; however, this exemption would only apply to microbiological hazards.

Activities subject to produce safety rule. Activities that are subject to the FDA’s produce safety requirements would not have to comply with HARPC requirements. The proposed produce safety rule would cover most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw.

Alcoholic beverages requiring permits. Alcoholic beverages at facilities that are required to obtain a permit from, register with, or obtain approval of a notice or application from the Treasury Department as a condition of doing business would be exempt. This exemption would also apply to food at such facilities, providing the food is prepackaged and not more than 5 percent of sales.

Storage of non-fruit and vegetable agricultural commodities. Facilities that only store raw agricultural commodities, other than fruits and vegetables, intended for further distribution or processing would be exempt. This exemption would not apply to storage of fruits and vegetables.

Storage of non-exposed packaged food. Facilities that only store packaged food that is not exposed to the environment would be exempt. Modified HARPC requirements would apply to storage of refrigerated packaged food.

Staggered Compliance Date Between One and Three Years, Based on Business Size

When FDA eventually issues the final rule, the timeframe for compliance with HARPC requirements will vary based on business size, it said. Although the final rule will be effective within 60 days of publication of the final HARPC rule, FDA will allow one year for businesses other than small and very small businesses to come into compliance. Small businesses will get a two year grace period, and very small businesses will have three years to comply, FDA said.

No Provisions on Domestic Supplier Verification, but May Come in Final Version

FDA said it will issue a proposal of its Foreign Supplier Verification Program “in the near future.” FSVP will require importers to verify that their foreign suppliers provide “the same level of public health protection as that required by FDA regulations such as HARPC, the produce safety rule, allergen labeling, and adulteration provisions.”

While the proposed rule does not have provisions on domestic supplier verification, FDA said it is considering inclusion of such requirements in its final rule on HARPC. If these requirements are included, FDA said it will align its regulations on supplier verification and FSVP “to the fullest extent so we do not impose duplicative or unjustified requirements under those two regulations.”