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?

PMA to FDA: Set standards for third party audits

In comments submitted May 19, the Produce Marketing Association urges the U.S. Food and Drug Administration to standardize standards for third-party produce safety audits. From the release:

Newark, Del. – Produce Marketing Association (PMA) this week urged the Food and Drug Administration (FDA) to standardize food safety audit criteria, to provide some much-needed consistency to industry third-party audit programs and to ensure they are science-based.
Writing for PMA, Chief Science Officer Dr. Robert Whitaker urged FDA to set audit standards in comments submitted to the agency May 19. PMA’s request was made as part of the association’s response to an agency request seeking information on U.S. and worldwide third-party food safety certification programs. The agency requested this information in a Federal Register notice published April 2; comments were due by May 19.
“We would hope FDA would move to establish, or partner to create, a globally recognized food safety standard that incorporates the effort the produce industry has invested in developing commodity-specific food safety programs, that are based on best current science, and that are grounded on the principles of risk assessment and risk management,” said Whitaker, summarizing PMA’s comments to the agency.
“We support the certification of third parties to perform audits, and we think it makes sense for FDA to become an accrediting body similar to USDA’s role with the National Organic Program or alternately to align itself with an existing global accreditor,” noted Whitaker. “But more importantly, right now we could use formal recognition that the body of work developed by the produce industry with the federal agencies and others over the last several years is the de facto standard,” he continued.
FDA requested comments on third-party certification, seeking information on programs in the United States and around the world. The agency also asked whether third-party certification programs ensure compliance with FDA food safety requirements, and what obstacles exist to private sector participation in these third-party certification programs. Finally FDA asked for input on what incentives would increase participation in these third-party certification programs. Whitaker provided a snapshot of produce-specific programs; he also urged the agency to proceed carefully and with ample input from industry experts from across the supply chain.
“There is value in FDA having a mechanism to certify third parties, and the agency can certainly take steps to encourage participation in third-party certification programs,” added PMA Vice President of Government Relations and Public Affairs Kathy Means. “If constructed correctly, a third-party certification program can meet the produce industry’s needs, while also addressing the over-arching objective of both the industry and FDA to improve produce food safety.”
PMA’s comments can be viewed at http://owar6exc.vancepublishing.com/exchweb/bin/redir.asp?URL=http://www.pma.com/issues/FDAComments51608.cfm.