EU Commission - comment on voluntary third party certification

Just saw this comment on the federal docket from the EU about the FDA draft guidance on voluntary third party certification program. It is telling when the uber-regulated European Commission worries that the FDA plan is overly prescriptive. The EU is also concerned the FDA guidance discriminates in favor of domestic facilities. I pulled a few excerpts from the document below:

Based on the view that the food safety provisions of the European Union and the United States both deliver a similarly high level of protection, the implementation of the Food Protection Plan provides an important opportunity to strengthen the collaboration between FDA and DG Health and Consumers (SANCO). We hope that the Plan will reduce administrative burdens for food businesses in transatlantic trade rather than creating additional red tape and cost in the absence of identified risks of EU food and feed products.

Accordingly, the European Commission stands prepared to actively support all reasonable measures which promote a high level of safety in a proportionate and non-discriminatory manner. However, the draft Guidance document falls regrettably short of this goal in several important ways. Would it be enforced in its current form and wording, very few European businesses - which are among the world’s best performing and most strongly controlled – would qualify for certification under the voluntary program as it is currently laid out in the draft Guidance document. This cannot be justified.

Non-discrimination – is there a level playing field?

First and foremost, the Guidance de facto applies to businesses in foreign countries rather than US domestic facilities, and it is, therefore, deeply discriminatory.

US domestic businesses, which decide not to voluntarily sign up to a third party certification program, would potentially face a higher frequency of FDA inspection – depending from resources. Given that all businesses have to comply with the US Food Law and assuming that most of these businesses indeed act lawfully, the incentive for US domestic facilities to seek third party certification is very limited.

In contrast, importers are confronted with the alternative of either seeking third party certification or accepting delays and detentions in entry clearance with each day costing thousands of dollars of cash value. Importers of regular shipments of high volumes of good will have little choice but to ‘voluntarily’ subscribe to the program and accept the higher cost of market entry. Likewise, importers of perishable goods will have to balance the cost of potential delays against the considerable cost of compliance – in contrast to US domestic producers. And many small businesses will find it impossible to shoulder the higher cost involved in either accepting lengthy detentions or signing up to certification procedures.

Nothing in the history of EU food exports to the United States justifies this discrimination and, given the extent of the financial and organizational interrelationships of transatlantic food industries, such a discrimination might have deleterious economical consequences for both sides.

Proportionality – what is the appropriate level of protection?

Second, the scope of the proposed, voluntary measures goes far beyond the legal requirements of basis provided by the Food Drugs and Cosmetics Act. Given that there is no legal basis to request, for example, HACCP-based self control systems from US domestic businesses (except fishery products and fruit juices), crisis management plans or traceability systems from the very source of each ingredient all the way to the customer, can it be justified that these requirements are imposed on EU exporters? If the appropriate level of protection of the United States is defined by the Food Drugs and Cosmetics Act, official, regulatory decisions (i.e. detention at the border) must be taken on this basis and not on conditions which go far beyond these legally defined levels of protection.

Later....

Implementation – what exactly should be certified?

In its current form, the draft guidance lists all possible food safety and food security requirements –employee training, suppliers management, security issues, HACCP-based self control systems, traceability, complaints, recall and crisis management – in the form of a general wish list, which may be applicable or desirable. But the draft guidance document gives no guidance, which measures would actually be warranted and justifiable for specific food business operations in specific regions on the basis of a rational and transparent risk analysis, taking into account inherent risk of the product and criteria of threat or vulnerability.

Without further third party certifiers will feel obliged to follow the very letter of the available, general guidance, rather than making rational and proportionate judgments based on risk. To enjoy the benefit of expedited border processing, businesses will tend to play along and implement measures with high incremental cost and very little safety or security gains.

The incremental benefits of such a ‘race to the top’ would be rather small. The disadvantages are clear: Consumers ultimately will have to compensate the cost in the form of higher prices; small businesses will be driven out of markets and reduce competition and innovation; the diversity of our food supply and our choices will diminish.

To allow businesses and certifiers to strive for optimal solutions, balancing safety, security and cost, and implementing official and third party controls, FDA has to define its appropriate level of protection for individual products. Only with a clearly defined target, businesses and certifiers will be able to identify the appropriate mix of measures to meet them.

Wolf Maier
Counselor Health, Food Safety, Consumer Affairs
Delegation of the European Commission
Washington, DC