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FSMA and Food Contact Packaging
FSMA and Food Contact Packaging

It’s been a few years since the elements of FSMA have rolled out. And just like any new policy, there have been changes, revisions, and in some cases, enforcement discretion. Here is an updated look at the sections of the Act that apply to Food Contact Packaging.

Just like existing food regulations that are sometimes inclusive of food-contact packaging. and other times not, so is the Food Safety Modernization Act. 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 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 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, training and monitoring against good recordkeeping should be a top priority.

Section 111: Sanitary Transport

Exempt items from the Sanitary Transport Rule include transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances. Chances are, your facility already has a program in place for inspecting vehicles for unsanitary transportation practices and maybe even keeping bulk vessel wash tickets on file.

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 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 is 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, 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 Verification

This is one section that the FDA will exercise enforcement discretion. The compliance date for importation of food contact substances has been extended for at least two (2) years to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. In other words, the FDA does not intend to require importers of food contact substances to comply with the FSVP requirements.

US 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.

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 specifically 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 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.








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Avatar  Bakery Packaging 3 years agoReply

Nice blog good work thanks for sharing this amazing blog keep posting about <a href="https://qdunt.com/bakery/">bakery packaging</a> bakery packaging topics

Avatar  Vincent Hatty 3 years agoReply

Food contact packaging which requires Coatings for substrates requiring grease barrier properties heat resistance freeze and thaw capabilities Etc the manufacturers of the direct food contact inks and Coatings also must be registered with the FDA and aib certified because it is the coating which will actually come in contact with the food item not the packaging



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