The rule puts in place requirements, aimed at ensuring consistency between controls exercised on domestic suppliers of food additives and ingredients and those applicable to foreign suppliers of such materials.
For companies operating in food packaging, however, it has put in place foreign supplier requirements that have no domestic parallel, and that have the potential to create significant administrative burdens for US companies that purchase food packaging materials and components from sources outside of the US.
By way of background, the Food Safety and Modernization Act (FSMA) was signed into law in 2011, and was intended to provide FDA with additional authority to control the safety of food in the US.
FSMA was structured around ensuring food safety through the implementation of risk-based controls.
Two of the key rules in FDA’s implementation of FSMA are the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food rule [2] (HARPC) and the FSVP rule.
The HARPC rule implements risk-based preventive controls for US food facilities.
In particular, and with a few exceptions, the requirements under HARPC apply to facilities that manufacture, process, pack, or hold human food for consumption in the US, i.e., facilities that are otherwise required to register as food facilities under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
As most facilities that produce food packaging and related food contact substances (FCSs) are not required to register as food facilities under the FD&C Act, the provisions of HARPC are generally inapplicable to companies producing food packaging and FCSs.
The primary purpose of the FSVP rule is to extend HARPC-type requirements to all imported food.
One key distinction between the FSVP and HARPC rules, however, is that they differ in scope, resulting in vastly different treatment of FCSs under the FSVP rule versus the HARPC rule.
In contrast to the HARPC rule, which applies to facilities registered with FDA, the FSVP rule applies to imported food. ‘Food’ is defined under the FSVP rule by cross-reference to section 201(f) of the FD&C Act, which defines ‘food’ as including ‘food additives.’
Thus, FCSs which are food additives are included within the scope of the FSVP rule. FDA also confirmed in the final rule its specific intention to cover FCSs, stating, in response to an industry comment that had requested exclusion of FCSs from the rule, as follows:
"We do not agree that it is appropriate to exclude food contact substances (including food packaging), as defined in section 409(h)(6) of the FD&C Act...from the definition of “food” for FSVP purposes...[S]ection 805 applies to imports of “food.” The term “food” is defined in section 201(f)(3) of the FD&C Act to include articles used as components of food, and the case law interpreting the definition makes clear that many substances that meet the definition of food contact substances under section 409(h)(6) of the FD&C Act also meet the definition of food...Further, we do not believe there is any evidence that Congress intended to exclude food contact substances from being considered “food” for purposes of section 805 and the FSVP regulation."
Thus, it is clear that FDA intentionally included FCSs within the scope of the FSVP rule.
The requirements of the FSVP rule apply to the importer of the ‘food,’ or in this case, the importer of any FCS that meets the ‘food additive’ definition.
The FSVP rule has five key elements:
- Hazard identification and analysis, involving an analysis of the hazards that are reasonably likely to cause illness or injury with the imported food;
- Foreign supplier approval, involving the evaluation and approval of foreign suppliers based on that hazard analysis;
- Supplier verification, involving the identification and implementation of appropriate activities (e.g., audits, etc.) to verify that identified hazards are appropriately controlled by the supplier;
- Corrective actions, as appropriate, to control hazards; and
- Recordkeeping, involving the maintenance of records of FSVP activities
The FSVP rule goes on to specify that these required activities must be conducted by a “qualified individual,” defined as an individual who possesses the appropriate education, training, and/or experience to perform these tasks.
Of particular note for imported FCSs, the FSVP rule states that if the hazard identification step described above results in a determination that there are no hazards requiring a control, the importer is exempt from the need to proceed with the foreign supplier approval and verification activities.
In other words, if the importer of a particular FCS determines that there are no hazards associated with the FCS that are reasonably likely to cause illness or injury for the consumed food, the importer would merely need to document this conclusion – using a qualified individual – and to maintain relevant records.
Although this exemption may help to minimize the burden of the rule for importers of certain FCSs, it does not provide complete relief from the requirements. Importers of FCSs will necessarily face greater administrative burdens when sourcing FCSs from foreign suppliers versus domestic suppliers.
The FSVP rule becomes effective on January 26, 2016; compliance with the requirements will be mandatory 18 months thereafter.
[1] See 80 Fed. Reg. 55,908 (September 17, 2015).
[2] See 80 Fed. Reg. 74,226 (November 27, 2015).
- Pamela Langhorn is a partner in Keller and Heckman’s food packaging law practice. She assists companies with establishing food-contact regulatory clearances for products in the US, South America, and the European Union. She also works on issues involving all substrates and applications, but with a particular focus on the worldwide regulation of food-contact paper, including recycled paper and paper additives. In addition, she works on EU regulatory issues under the EU Plastics Regulation and EU Member State legislation.