The law has two major themes: prevention and accountability. Prevention means that food companies need to have controls in place during manufacturing to assure the safety of their products and to prevent problems (not just react to them after-the-fact). Accountability means that food companies are accountable to the Food and Drug Administration (FDA) to help ensure that their suppliers are making safe ingredients.
Although the law primarily has significant implications for food manufacturers, importers, and the fresh produce industry, it also affects the food packaging industry. Importantly, not all provisions in FSMA apply to food packaging in the same way. Some provisions of the new law make food packaging manufacturers accountable to FDA, while other provisions make food packaging manufacturers accountable to their customers. In order to help keep everything straight, I encourage you to think about a few key principles as you read on.
• First, who does the legal requirement apply to? Some requirements apply to “food” as defined in the Federal Food, Drug, and Cosmetic Act (FFDCA), and others apply to “registered” food facilities.
• Second, where is your business in the supply chain? Are you acting as a seller or as an importer/buyer?
• Third, who cares about your activities? Is it FDA or your customers (or both)?
There are two major provisions in FSMA that are particularly relevant to food packaging manufacturers and their relationships with their food-industry customers: Preventive Controls and the Foreign Supplier Verification Program. Third-party certification is a tool that may help ease compliance for food packaging companies.
The Preventive Controls provision is found in Section 103 of FSMA (FFDCA Section 418). It requires all registered food facilities to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility and to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that the food is not adulterated and does not contain any undeclared allergens.
As stated above, this requirement applies to all food facilities registered as required by Section 415 of the FFDCA. By regulation, FDA has exempted food packaging companies from the registration requirement (it defined “food” to exclude “food contact substances”). This means that these companies are exempt from the legal requirement to comply with the Preventive Controls provision—meaning such companies are not accountable to the FDA. But in practice, they are still accountable to their customers.
Although food packaging manufacturers are exempt from the Preventive Controls provision, in all likelihood their customers—food facilities that use packaging materials to package foods—are subject to it. And it is important to understand that one of the preventive controls that registered food facilities will need to have in place is a supplier verification program. Because food manufacturers will be required by FSMA (and FDA) to verify that their suppliers are making safe packaging materials, they may very likely require their packaging suppliers to have preventive controls in place so they can meet their legal obligations.
Remember two of our key principles from above: Where are you in the supply chain? Who cares? In this case, if you are selling food packaging materials to food manufacturers, FDA will not require you to have preventive controls. Nonetheless, because food manufacturers (your customers) are accountable to FDA, you will be subject to your customers’ oversight. And your customers may require you to comply with the Preventive Controls provision or otherwise assure them that your packaging materials are safe.
The Foreign Supplier Verification Program
The second major provision in FSMA is called the Foreign Supplier Verification Program (FSVP) (FSMA Section 301; FFDCA Section 805). This provision applies to all importers of “food,” and requires importers to perform risk-based verification activities to ensure that the food they import is produced in compliance with the Preventive Controls provision (if applicable) and is not adulterated or does not contain any undeclared food allergens. There are two definitions that are critical to understanding how this provision may affect your business:
• First, FSMA defines “importer” as “the United States owner or consignee of the article of food at the time of entry of such article into the United States” or the U.S. “agent or representative of a foreign owner or consignee of the article of food at the time
• Second, for purposes of this section, “food” includes food packaging materials.
Therefore, if you are an importer, and you import food packaging materials, you will need to have an FSVP. If this is confusing, let’s look at our principles again: Who does the legal requirement apply to? Unlike the Preventive Controls provision, which applies to registered facilities, the FSVP applies to all importers of food, whether they are registered or not. Under the FFDCA, the term “food” includes food packaging materials.
Although FDA exempted food packaging materials from the definition of “food” for purposes of facility registration, that exemption only is an exemption from registration—the basic definition of food in the statute remains.
It is possible FDA may grant an exemption from the FSVP for importers of food packaging materials in the regulations implementing the provision, as some members of the packaging industry have requested of the agency. As of this writing, FDA has written a proposed rule implementing the FSVP, but that proposed rule has not yet been published or made publicly available. Once FDA releases the proposed rule, the agency must provide time for public comment on its proposal. At that time, food packaging manufacturers can comment on the proposed rule to FDA expressing their support for an exemption. Even if FDA does not propose an exemption in the proposed rule, it is possible that FDA may grant an exemption in the final rule. So stay tuned.
Furthermore, there is a tool at your disposal that may help you comply with FDA’s requirement that you have an FSVP and/or your customer’s requirement that you have preventive controls in place. The tool is third-party certification.
If you are an importer, you can use third-party certification as a verification activity. That is, you can require your suppliers to get certified. Then, meeting the FSVP requirement is much easier. If you are a supplier, you can use third-party certification to show your customers you have rigorous programs in place to ensure safety and quality. You can show your customers you are certified, and then they can more easily satisfy their obligations under FSMA. (Please keep in mind that you are not legally required by FDA to use third-party certification. I am merely suggesting it as a potential tool for your consideration.)
In the end, the passage of FSMA means that big changes are coming for food companies everywhere, and that applies to makers of food packaging as well. As you think about preparing for compliance with the law, be sure you:
Understand which provisions apply to registered food facilities (Preventive Controls), and which apply to importers of food (FSVP).
Think about what activities you need to engage in to satisfy FDA (FSVP), and what you need to do to satisfy your customers (preventive controls).
Work with others in your industry to see if FDA will grant an exemption from the FSVP for food packaging materials, and think about whether third-party certification makes sense to satisfy both FDA (if applicable) and customer requirements.