Food safety regulation shoes keep dropping

January, 2013

Eric F. Greenberg | Attorney-at-Law

In the world of food safety, the other shoe dropped in January. One of them, anyway. Can you use the expression “waiting for the other shoe to drop” when there’s going to be more than two shoes?

When FDA finally burst forth in January with its months-overdue proposed regulations on food maker Good Manufacturing Practices, especially their ‘preventive controls,’ and a separate proposal on produce handling, the event was a mere way-station on a rule-making process that started with the passage of the Food Safety Modernization Act in early 2011. The process will continue with collection of public comments until May 16, publication of the final version of the rules, and finally, effectiveness of the rules in a series of steps over the years following the final rule’s publication.

Other sets of shoes are overdue too, such as FDA’s proposed regulations on foreign supplier verification systems, which aren’t yet out at presstime but might be by the time you read this.

If you are concerned about how these proposed regulations might affect your business, you should have someone look at the January 16 edition of the Federal Register and pick out the potentially problematic provisions. Key questions for most companies are whether their operation is covered by the regulation and what exactly it requires them to do.

The “preventive controls” proposal is getting most of the headlines, but FDA is describing it as only one of a number of changes to the required Good Manufacturing Practices for foods, and there are many of them, covering many aspects of a food manufacturing and storage operation. Even food facilities that are exempt from the new preventive controls requirements will still have to comply with requirements for Good Manufacturing Practices, which have been revised a bit, for example to add some protection against allergen contamination.

The preventive controls rule sets forth FDA’s proposed plan to extend such programs beyond those food producers who currently are required to have them (seafood and juice) to essentially all food producers. These plans have traditionally been called “Hazard Analysis and Critical Control Points” plans, but the new regulation would call for plans that differ in some ways from HACCP plans.

Makers of packaging as such are not required by the proposal to have these plans. Foods subject to the low-acid canned food regulation are also exempt, as are “small” and “very small” businesses, dietary supplements and alcoholic beverages, as well as farms that don’t process food (unless it’s consumed on that farm or another one under the same ownership).

Companies that are subject to the proposed rule will have to develop plans that evaluate the hazards presented by their foods, identify and implement preventive controls at the spots when those hazards present themselves, follow those controls every time the food is made, take corrective action when necessary, and keep documents demonstrating their compliance.

It’s already clear that some elements of the proposal will prove seriously challenging to some companies. One is the requirement to develop a recall plan. Another is, consistent with the way HACCP plans have been required in the past, that a “qualified individual” will have to be in charge of the food safety plan or actually do the steps to prepare it, and that qualified individual will have to successfully complete appropriate training.

Unlike HACCP, the proposed FSMA preventive controls plans call for controls at spots in the process other than those that are “critical” control points (places in the production process where a food hazard could be introduced, controlled or enhanced), and not all preventive controls will need critical limits.

The types of preventive controls would depend on the facility and the food it produces, although FDA says that most hazards would be addressed through process, food allergen, and sanitation controls.

FDA is asking for comments on many topics, including the ideas of a supplier approval and verification program as a preventive control. FDA says that, using a preventive approach that includes a supplier approval and verification program, the facility receiving raw materials/ingredients from a supplier can help to ensure that the supplier (or even further up the chain of supply) has implemented preventive controls.

Packaging makers should watch for more demands for controls of their own, and information, from their food company customers who begin to implement supplier approval and verification programs.

The new proposed regulation on handling raw produce was also required by a portion of the new FSMA, and directly attacks an area FDA has long recognized as a common source of foodborne illness. The proposed rules on produce add important new requirements related to worker training, water, soil, and animal handling, and they contain a specific set of requirements targeting sprouts.

Don’t like the sound of any of these proposed provisions? That’s fine-the whole point of this process is to give you until May 16 to submit your comments to FDA.

Good comments are always substantive and detailed, quantify the cost burden represented by a proposed requirement in terms of dollars or time, and suggest alternative approaches when possible. This comment period Is crucial for those who want to have input into this process.

Whether you do or not, you will have a slug of time before the last shoe drops. The new requirements won’t be effective until one year after publication of the final rule, or two or three years after publication for small and very small businesses. PW

Eric Greenberg can be reached at [email protected],
and visit his firm’s Web site at

This article is informational only and is not intended as, and should not be considered to be, legal advice.

Be sure to check for any updated information about the topics discussed in this article.

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The Long Reach of FDA Accusations

The Long Reach of FDA Accusations

By Eric F. Greenberg, Attorney-at-law

The Long Reach of FDA Accusations

For those of you who think that regulators only pick on the small companies, have I got a story for you. And this story is also eye-opening if you have wondered who the government is most likely to go after when a problem arises, in a world of complicated chains of commerce involving multiple actors making and moving and bringing packaged products to market.

The short version of the story is that the Food and Drug Administration took action against Amazon for products sold on its website. Yes, that Amazon, the one with the big website where you can buy essentially everything for handy delivery. And this wasn’t the first time FDA has warned Amazon about products available on its popular website.

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