FSMA & Food Contact Packaging

Up until January 2011, when the Food Safety Modernization Act was signed, recalls within the food industry had been voluntary. With the implementation of FSMA, the FDA now has the authority to mandate a recall if one is not initiated voluntarily.

Just as existing food regulations are sometimes inclusive of food-contact packaging and other times not, so too, is the Food Safety Modernization Act (FSMA) sometimes inclusive ... and other times not. The elements of FSMA that apply to food-contact packaging refer to food-contact substances.

The sections of the Act that apply to packaging are:

• Section 101 – Inspection of Records
• Section 111 – Sanitary Transport
• Section 206 – Mandatory Recall Authority
• Section 207– Administrative Detention
• Section 301 – Foreign Supplier Verification
• Section 402 – Employee (Whistleblower) Protection

Section 101
Inspection of Records
This provision allows FDA Inspectors to review all records relating to manufacturing, processing, distribution, storage, and importation of food-contact packaging. Inspectors are awarded access if there is a reasonable belief that the packaging will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

With this in mind, food-contact packaging manufacturers should be updating their policies for handling regulatory inspections. In addition, the potential consequences of poor recordkeeping have just been increased. Therefore, training and monitoring against good recordkeeping should be a top priority.

Section 111
Sanitary Transport
At the time of this publication, the Act allows for the final regulation to include food-contact packaging. Of course, we may find an exclusion at the time of roll-out of the final regulation. However, to best prepare and to be in alignment with industry best practices, food-contact packaging manufacturers should be evaluating their transportation program.

Elements of the program should include identification of non-compatible materials that should not be permitted on the same load with packaging materials. It should also include restrictions about prior loads that may and may not be permitted in the vehicle. This is especially important when dealing with bulk shipments, such as bulk resin loads. Finally, the expectation is that there is a vehicle inspection program that includes documentation of the evaluation for sanitary conditions. Sanitary condition evaluations often include the integrity of the vehicle floors, walls and ceiling, pest evidence, debris, broken light fixtures, off-odors, and moisture.

Section 206
Mandatory Recall
Up until January 2011, when the Act was signed, recalls within the food industry had been voluntary. With the implementation of FSMA, the FDA now has the authority to mandate a recall if one is not initiated voluntarily.

This means that food-contact packaging companies need to update their Recall Policies to reflect this new authority, keeping in mind that it is in the company’s best interest to voluntarily recall product if it is in violation of the law.

Section 207
Administrative Detention
FDA’s right to detain food and related products went into effect under the Bioterrorism Act of 2002. However, at that time, it only had the right to detain the food if there was credible evidence that the product would cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Under FSMA, the threshold for detention has been lowered. The FDA may detain any product where there is reason to believe that it is adulterated or misbranded.

Section 301
Foreign Supplier Verification
U.S. companies that import food are required to confirm that the foreign manufacturers from whom they are receiving their goods are complying with FDA regulations. The Act allows this provision to apply to food-contact packaging, but whether or not it does so will not be known for certain until the final regulation is published.

In the meantime, food-contact packaging manufacturers should establish a robust Supplier Approval Program that includes all domestic and any foreign suppliers. Elements of the approval program should include confirmation of sanitary conditions and compliance to food-grade requirements.

Section 402
Employee (Whistleblower) Protection
Under this section, employees cannot be discriminated against for reporting violations of the Food, Drug, and Cosmetic Act to regulators. The human resource department should be made aware of this provision. In addition, the company’s procedure for handling regulatory inspections should include specifications on how inspections related to an employee report will be handled. Such an inspection will likely be more targeted than a routine inspection.

Increasingly, food-contact packaging is being viewed as any other ingredient in the food industry, contributing to the overall safety of products that reach the consumer. With this in mind, food-contact packaging companies should be looking at bringing their programs up to par with the rest of the food industry; partially because it is included in regulation, partially because it required by customers, but moreover because it is the right thing to do.

The author is Vice President of Food Safety Education, AIB International.