Update Nov Dec 2013 - (Page 17)

Enforcement technicalities of compliance and for the first time strategies to avoid litigation. More Rules, More Changes No rule better exemplifies the broad and sweeping changes of FSMA than the proposed FSVP rule. At its simplest the FSVP rule requires importers to identify and control risks of its foreign suppliers. The proposed rule outlines seven required activities under an importer's FSVP. Those are: compliance history review; hazards analysis; verification activities; review of complaints, investigation of adulteration or misbranding, and taking of corrective actions; reassessment of the FSVP; ensuring that required information is submitted at entry; and recordkeeping. Among the list two activities stand-out as the core activities required by the rule - hazard analysis and verification activities. Hazard analysis under the proposed FSVP rule is both old and new. Many larger importers already conduct a hazard analysis if they currently implement Hazard Analysis Critical Control Point (HACCP). As with HACCP the proposed rule requires an analysis of unintentional hazards reasonably likely to occur or commonly occurring. The proposed rule suggests going further than HACCP by looking at intentional hazards, in particular economic adulteration. Economic adulteration is the intentional addition of inexpensive ingredients to stretch or enhance a product. This type of adulteration was the impetus to passing the Pure Food and Drug Act. After a recent focus on microbial contamination it may not only be a nod to the past, but foreshadow the future phase of food safety, perhaps resulting in FSMA II. Foreign Onsite Audits The requirements for supplier verification in the proposed rule on FSVP are FDLI primarily based on two factors. The first is who controls the hazards that are reasonably likely to occur with a particular food and the second is the nature of the hazard. The rule provides three alternatives as to who may control the hazard: the foreign supplier, the importer, or the importer's customers. The most onerous of the requirements fall on verifying hazards controlled by the foreign supplier. In the proposed rule, FDA puts forth two options for verifying hazards controlled by the foreign supplier. The first option requires annual onsite audits for hazards controlled by foreign suppliers that could cause serious adverse consequences or death (SAHCODHA) and for microbiological hazards in produce. The second option provides more leeway. It allows importers to choose from among the list of verification activities for all types of hazards controlled by the foreign supplier. Both options require maintaining a written list of foreign suppliers and the performance of supplier compliance status review, hazard analysis, and other standard verification requirements. Parity with the Preventative Controls Rule If there is a twin aim of the proposed FSVP rule it is parity with the proposed Preventative Controls rule. The drafters of the FSVP rule make it clear the rule is not intended to apply provisions of either the Preventative Controls or Produce Safety rules to foreign facilities. Instead it broadly seeks to ensure foreign food is as safe as domestic food. The Preventative Controls rule and FSVP share some common features. Both utilize a HACCP-style hazard analysis approach to managing foreseeable risks. The FSVP, however, requires supplier verification to ensure the hazard is properly managed. The Office of Management and Budget (OMB) struck out supplier verification from the Preventative Controls rule. The drafters seem aware of how this difference could lead to trade disputes or claims of an unfair advantage. In an unusual move the FSVP rule seeks comment on introducing supplier verification back into the Preventative Controls rule. This cross-rule comment request makes it clear the FDA believes supplier verification belongs in both rules. Third-Party Auditors Foreign onsite audits would be more onerous if not for third-party auditors. Importers complying with the FSVP will likely rely on third-party auditors to conduct audits of foreign facilities. The proposed Accreditation rule establishes a system for accreditation of third-party auditors and certification bodies. The FDA would only recognize audits and certifications verifying food is safe for entry if certified by a group accredited under the rule. The aim of accreditation is to establish confidence, competence, and consistency to the organizations and individuals conducting foreign food audits. The rule begins by setting the eligibility requirements for third-party auditors and accrediting bodies. The proposed rule recognizes a third-party auditor or accrediting body could be a foreign government or private third-party. Eligibility for both is the same. Each must "meet standards for legal authority, competency and capacity, impartiality and objectivity, quality assurance, and records procedures." Accreditation bodies and third-party auditors also share a required duty to maintain and provide FDA access to records, protect against conflicts of interest, and assess and correct any problems in its own performance. Additional requirements specific to auditors and accrediting bodies are also provided in the rule. The rule also establishes an authority to revoke recognition of an accrediting November/December 2013 Update 17

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013