Third party certification - a power grab by FDA?

What's the verdict on the FDA's guidance on third party certification? Does it make sense to use third parties to help shoulder some of the FDA's responsibility to oversee food safety? Is the FDA trying to gain access to data that it would not have otherwise?

Luis of the Fresh Produce Industry Discussion Group posts a link to some dissent about the FDA's Guidance.

Meanwhile, here is a comment below on the guidance from NSF that points to some of the concern about how the FDA would encroach on relationships between private businesses and third party certification bodies:


A fine line must be drawn here, however, as many companies participate in third party certification programs with the understanding that the information they submit to certifiers, and the findings of the audit, are confidential to the company. However, if NSF discovers a safety issue related to a certified product, it will work with the company to inform appropriate regulatory agencies regarding the product, as well as specify appropriate corrective action.



Meanwhile, from the the comment on the guidance by the Produce Marketing Association, a relevant comment:

Authority to Examine and Gather Records and Other Information – The guidance currently would permit the “certification body and inspectors to examine records and other information relevant to the safety and security of the products for which certification is sought. This should include access to relevant records relating to the producing, manufacturing, processing, packing and holding of products for which certification is sought, including, but not limited to receiving preventative control plans and records, laboratory results, records regarding the upkeep and use of equipment, consumer complaint files and distribution records.”

These general attributes are common to all third-party audits currently used in the produce industry, but it does represent an interesting conundrum in that FDA currently does not have statutory authority to some of these categories of records when performing a routine inspection of a facility unless FDA finds clear evidence that a product is adulterated. Given this apparent conflict, does FDA have a legislative plan that specifically remedies this situation?

It would also be valuable for FDA to expand upon this section to point out more specifically which types of records the agency or an approved third party would want access to and how they will be used in determining the food safety status of the operation. For instance, if a third party should find a violation in a HACCP plan, e.g. in routine hourly readings of free chlorine levels in a vegetable processing wash system where the specified level of free chlorine is documented to be 3-7 parts per million (ppm), and the verification log shows the actual reading for the hour was 2 ppm, how will FDA react to that information? Currently when third-party auditors find an instance such as the example above, their focus is largely on the corrective actions taken by the producer and the verification of those actions. Will FDA work with approved third parties in the same manner, or will the agency view a single HACCP infraction as cause for regulatory action? Will FDA require certified third-party auditors to submit this type of information to the agency as a routine or only when or if that company comes under investigation?