Update Nov Dec 2013 - (Page 18)

Enforcement body. The rule clearly states an intent for the FDA to exercise oversight. That oversight could extend to enforcement actions against accrediting bodies. The FDA reserves the right to revoke or withdraw the eligibility of any accreditation body or auditor "for good cause." What constitutes good cause is an area the FDA seeks comments, specifically examples of what does not constitute good cause. Flexibility and Conflicts of Interest Both rules will need refinement before implemented. In drafting the rules FDA struggled with how to write standards for a broad and diverse industry. The rule reflects a flexible approach. The flexible approach, however, may undermine compliance with the new rules. Too much flexibility creates a loophole. It also risks provisions becoming ineffective before ever going into effect. The FSVP rule raises a conflict of interest by allowing the importer to decide if a risk qualifies as SAHCODHA. The FSVP proposes two alternative options to determine when a foreign onsite audit is required. Option one raises the question of who must identify whether a hazard is SAHCODHA or non-SAHCODHA. The proposed rule provides the importer the discretion to determine if the foreign supplier has a SACOHDHA hazard that would be subject to onsite auditing. The rule does provide examples of SACOHDHA, such as hazards that would lead to a Class I recall. The list, however, is only illustrative introducing flexibility and subjectivity for the importer to identify SACOHDHA hazards. Option one places the importer in a difficult position. Most importers will want to avoid the damage that arises from serious adverse events - the damage to the brand, the cost of a recall, and the risk of litigation. Still the rule 18 Update November/December 2013 introduces a conflict of interest, which may undermine compliance with the proposed rule. An importer can make the determination to classify a hazard as non-SAHCODHA and avoid the cost and time of an onsite audit. The Accreditation rule raises a conflict of interest between the facility audited and the auditor. Among the required responsibilities of an auditor is a notification duty when an auditor discovers a "serious risk to the public health." In an effort to provide elasticity the proposed rule does not define the term, instead leaving it to the auditor to interpret. The Agency requests comment on whether the notification requirement should encompass both Class I recall risks, those that present a reasonable probability of serious adverse health events or death, and Class II recall risks, which may cause temporary or medically reversible adverse events or the probability of serious adverse health events is remote. A broader definition, which includes both Class I and II risks, offers more flexibility and could be more preventative, but may also be problematic. The proposed Accreditation rule creates distrust between the facility audited and the auditor if a broad definition is adopted. Currently it is the facility's decision whether to notify the FDA of a potential food safety concern through the Reportable Food Registry. The facility is only required to do so in a Class I scenario otherwise, such as in a Class II recall situation, notification is voluntary. Notification of Class I risks presents a smaller conflict of interest. Auditors' notifications would merely impact the timing or readiness of a facility to report and react to a Class I recall. At its worse it places pressure on a facility dragging its feet. If auditors, however, are required to notify the FDA of Class II risks there is conflict of interest that may lead to mistrust. This level of transparency may dissuade food and dietary supplement firms from using third-party auditors and certifying bodies accredited under the proposed rule. The proposed rule makes note of this conflict of interest, but states it is "duty bound" to implement FSMA. It goes on to argue, "To gain credibility with consumers and address industry views on sensitive information, this proposed rule seeks to balance disclosure and confidentiality concerns." In the FDA's view the rule strikes the right balance. The Risk of No Comment If there is one take-away from the new rules it is the need to comment. Right on cue, the D.C. Circuit Court of Appeals issued a ruling this year on the risk of no comment on new rules. The Court of Appeals dismissed a California farmer's challenge to USDA rules requiring pasteurization of almonds. The suit argued the rule provides an unfair advantage to almond importers, who are allowed to sell the untreated nuts in the U.S. The court dismissed the case on procedural grounds. It found the plaintiff's failure to object to USDA authority during the comment period meant the farmer waived the right to later challenge the rule. Failure to comment during the comment period wiped away any ability to challenge the rule. As FSMA violations enter 483s, warning letters, import detention notices, and other new enforcement tools under FSMA challenges to the rules will arise. The success of those challenges will first depend on whether a comment is submitted during the comment period. Litigation Risks FSMA presents an enormous risk of litigation to facilities. Specific standards, www.fdli.org http://www.fdli.org

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

Update Nov Dec 2013