The final rules for FDA’s Food Safety Modernization Act (FSMA) are expected to be issued later this year and into next year. Food-contact packaging manufacturers should prepare now for how the updated regulations will impact their facilities.

Prior to FSMA, the compliance regulations for packaging materials were outlined in the Code of Federal Regulations in the following sections:

• 21 CFR 174-179, component use is an appropriately regulated indirect additive• 21 CFR 181, component use has prior approval as safe or:

o Consult threshold regulations, oro Consult list of Food Contact Substance Notifications, oro Follow FDA Food Contact Substance Notification process for exemption or satisfy GRAS criteria

• 21 CFR 182-186, component use is generally recognized as safe (GRAS)

New FSMA requirements for food-contact packaging (also food-contact substances) that affect packaging materials are found in these sections:

• 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 RecordsThis provision allows for 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, employee training for these new administrative powers and internal monitoring for good recordkeeping should be a top priority.

Section 111: Sanitary TransportAt the time of this publication, the Act allows for the final regulation to include food-contact packaging. There may be an exclusion when the final regulation is issued, but it is advised that food-contact packaging manufacturers prepare now and align with industry best practices for 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 of food-grade and non food-grade materials. 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.

How Does FSMA How Does FSMA Impact Your Food-Impact Your Food-Contact Packaging Contact Packaging Manufacturing Manufacturing Facility?Facility?

Section 206: Mandatory RecallUp until January 2011, when the Act was signed, recalls within the food industry have 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 violative product is suspected or confirmed.

Section 207: Administrative DetentionFDA’s right to detain food and related products went into effect under the Bioterrorism Act of 2002. However, at that time, they 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 VerificationUS companies that are importing food are required to confirm that the foreign manufacturers from whom they are receiving their goods are complying with FDA regulations. The Act allows for this provision to apply to food-contact packaging, but it 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 of primary and secondary components used to make packaging materials. Elements of the approval program should include confirmation of sanitary conditions and compliance to food-grade requirements previously cited in the beginning of this update.

Section 402: Employee (Whistleblower) ProtectionUnder this section, employees cannot be discriminated against for reporting violations of the Food, Drug, and Cosmetic Act to regulators. The Human Resource policies should include this potential situation. In addition, the company’s procedure for handling regulatory inspections should include specifically how inspections related to an employee report will be handled. Such an inspection will likely be more targeted than a routine inspection (i.e., based on the complaint).

Increasingly food-contact packaging is 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 update their product safety programs as appropriate per the impact of FSMA for food product manufacturing, transportation, and storage.

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