Monday 24 April 2017

FSVP HARPC Preventative Controls Supplier Verification FDA.fw

Supplier Verification – Proposed Foreign Supplier Verification Rule Points to Proposed Preventative Controls Rule Change

A principal aim of the proposed Foreign Supplier Verification Program rule is to create a level playing field for domestic and foreign foods. Prior to the release of the FSVP rule the US FDA announced the Produce Safety Rule and the Hazard Analysis and Preventative Control and GMP** Revisions rule. The rules apply to domestic growers of produce and food manufacturers/processors. The FSVP rule states clearly the drafter do intend to apply the HARPC or Produce Safety rule to foreign suppliers. If an importer is subject to the two rules it will be because of a qualification stated in either rule, not the FSVP rule. The FSVP rule instead states a broad aim of ensuring foreign food (including drinks and dietary supplements) are as safe as domestic foods. If the aim of the rule is parity between foreign and domestic food one glaring bias lies in the FSVP rule mandating supplier verification whereas the HARPC rule does not.

The crux of the both the FSVP and HARPC is to introduce a new hazard analysis approach to processing/manufacturing food. The FSVP rule achieves this aim by specifically mandating supplier verification. What type of verification varies as will be discussed as Food Court writes about verification activities under the new rule. The HARPC rule famously lost its supplier verification components when reviewed and revised by the US Office of Budget Management. The OMB struck out supplier verification and pushed it to merely a mention as a potential component of monitoring hazards. This left the HARPC or Preventative Controls rule requiring facilities to identify and monitor facilities, but not conduct supplier verification activities. Th FSVP rule, however, requires the same identification of hazards, but also supplier verification the hazards are adequately controlled.

The HARPC rule may soon regain its supplier verification requirements. The FDA addresses the disparity between a mandate on importers to conduct supplier verification but not domestic facilities sourcing domestically. The rule states, “Approval and verification of suppliers of raw materials and ingredients is widely accepted in the domestic and international food safety community, and, as stated in the Preventive Controls Proposed Rule, we believe that such programs are an important part of an effective preventive controls approach.” The rule goes on to request comment “when and how” approval and verification of suppliers of raw materials and ingredients are an appropriate part of preventive controls. This is a surprising place to find the FDA requesting comment on how to amend or modify a rule. Given its context, the request can be seen as an effort to demonstrate the impact on foreign suppliers is potentially equal to domestic suppliers which would address trade barrier claims. It can also be seen as a reflection on how to ensure supplier verification is not duplicative, namely by requiring a facility to verify a supplier under HARPC who has already complied with the FSVP. It can also be seen as an end-run by the Agency to regain the supplier verification activities it originally intended to be part of HARPC.

No matter the motives facilities should note supplier verification may soon be added to the HARPC rule. This is an important area to comment on and its not the only area where the FSVP and HARPC rules run parallel (see e.g. qualified individual). Make sure to take the time to carefully read the rules and understand where the two meet, diverge, and potentially overlap.

*It’s impotant to emphasize the HARPC rule is split into two parts. The first pertains to hazard analysis and preventative controls, which exempts many HACCP facilities. The second relates to GMP revisions and affects all facilities regardless of HACCP.

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