FSMA Compliance for 2022: What The Pandemic Taught Us for Food Safety Compliance

Posted on August 4, 2022 by Eric Edmunds
Eric Edmunds

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Quality and safety standards for the food and beverage manufacturing industry have been shifting as the world experienced unprecedented supply chain disruptions through the pandemic. From this disruption, the FDA and other regulatory bodies have adapted some compliance requirements to ensure a steady supply of safe and quality food while developing new regulations. It is crucial that manufacturers understand, prepare for, and implement policies to comply with these changing standards.

As we enter the second half of the year, there are some new FSMA regulations and guidance documents that manufacturers need to be aware of to ensure timely compliance. Here are a few of the things you should be aware of in 2022 and into 2023.

 

 

Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

Understanding, Managing and Reducing Cost of Quality in Process Manufacturing

The FDA recently released industry guidance aimed at reducing foodborne illnesses traced to raw or lightly-cooked sprouts. The most commonly consumed sprouts are:

  • Alfalfa
  • Mung bean
  • Red clover
  • Radish
  • Broccoli 
  • Wheatgrass

Sprouts are considered to be “high risk” in the food chain because they are often consumed raw or lightly cooked, and their risk of contamination exists from multiple sources, from their initial growth to shipment.

The FDA recommends manufacturers learn as much as possible about the processes used by sprout suppliers, and maintain high standards for their employees in areas of education, training, and hygienic practices.

 

FDA Oversight of Food Covered by Systems Recognition Arrangements

Currently, the FDA recognizes their regulatory counterparts in Australia, New Zealand, and Canada as equivalent to ensure food safety and compliance on imported foods, which minimizes supply chain controls required for food imported from these counties. 

The FDA reports that last year there were 30 Class I and 34 Class II recall events attributed to imported foods. The FDA has introduced new guidelines regarding food importation that provide additional clarity for manufacturers who import food products from countries with Systems Recognition Agreements regarding FDA’s enforcement priorities.

 

White House Office of Management and Budget

Any changes or regulations developed by the FDA must be reviewed by the White House Office of Management and Budget. This makes sure the new changes or regulations align with the policies and goals of the White House and are generally decided anywhere between one and six months.

During this FSMA Friday webinar, we went over seven of these guidelines and changes that food and beverage manufacturers should know about.

 

Labeling of Plant-Based Milk Alternatives

Milk alternatives are rapidly gaining in popularity across the globe and, in the U.S., “generated the greatest retail sales in the plant-based food market” in 2020. The most popular types of milk alternatives fall into one of five categories:

  • Cereal-based 
    • Oat milk, Rice milk, Corn milk, Spelt milk.
  • Legume-based
    • Soy milk, Peanut milk, Lupin milk, Cowpea milk.
  • Nut-based 
    • Almond milk, Coconut milk, Hazelnut milk, Pistachio milk, Walnut milk
  • Seed-based
    • Sesame milk, Flax milk, Hemp milk, Sunflower milk.
  • Pseudo-cereal based
    • Quinoa milk, Teff milk, Amaranth milk.

Due to these plant-based milk alternatives becoming so popular among consumers, the FDA is now paying close attention to proper labeling of this segment. In a Request for Information (RFI), the FDA wanted to understand consumers’ thoughts regarding the use of the term “milk” to describe these plant-based alternatives (as well as cheese and yogurt), because the Food, Drug, and Cosmetic Act (FDCA) prohibits foods that are not properly branded, from being introduced to consumers.

 

“Closer to Zero” Action Plan

As the FDA begins instituting their Closer to Zero plan, aimed at reducing the amount of exposure to arsenic and heavy metals by infants and children, new actions are being suggested for manufacturers to be aware of.

The FDA's approach to reducing the amounts of arsenic and heavy metals in children’s and infants’ foods involves four steps:

  1. Evaluate the science for action levels
  2. Propose action levels
  3. Consult with stakeholders on feasibility and achievability of action levels
  4. Finalize action levels

Most recently, the FDA has reached action levels for arsenic in apple juice and lead in foods intended for babies or infants. According to the FDA:

“Action levels are a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. The FDA considers action levels, in addition to other factors and scientific evidence, when considering whether to bring enforcement action in a particular case.”

To assist in mitigating toxins in these foods, there has been some movement in Congress to change some of the ways these foods are developed and given to consumers, which could eventually develop into a new Office of Critical Foods.

 

Dietary Guidance Statements in Food Labeling

In May of 2020, as the Coronavirus pandemic spread across the globe, the FDA released temporary labeling requirements enforcement discretion to help manufacturers manage supply chain disruptions and continue distribution. 

Under these regulations - which were stated to remain in effect only during COVID-19 -  manufacturers could use existing labels when making minor adjustments caused by “unforeseen shortages or supply chain disruptions brought about by the COVID-19 pandemic,” without fear of regulatory enforcement when meeting FDA guidelines.

The FDA suggested printing new labels or using stickers when you’ve had a minor formulation change, but also provided guidance on things to consider when that is not feasible:

  • Ingredient substitutes should not cause safety concerns (e.g., allergens, gluten).
  • Quantity: Ingredients substituted should be 2% or less of finished food by weight.
  • Ingredient substitutions should not be prominent or part of a label statement (e.g., “made with real butter”)
  • Ingredient substituted is not characterizing or in ingredient name (e.g., raisins in raisin bread)
  • Substitution does not affect claims made for the food
  • Change does not have a significant impact on nutrition or function of finished product

While it may not be feasible to print new labels or use stickers, you can use point-of-sale labeling. If you are selling products online, label changes must be reflected on those product pages, including allergens. Online information is considered under the same regulatory requirements as labels, and this is true of both human and animal foods.

As long as it is clear you are attempting to be transparent to consumers about any formulation changes, the FDA is more likely to understand. It is unclear how long the FDA will extend these temporary food labeling guidelines as we continue to experience supply chain disruption.

 

FASTER Act: Sesame is a New Allergen

Approximately 0.23% of Americans are allergic to sesame, creating a public health issue, so the FDA has added it as the ninth allergen. If you have a product(s) that include sesame, you must include it in your “contains” statement or your ingredient list to stay compliant. 

The labeling requirement for sesame won’t go into effect until January 1, 2023, but the FDA recommends you begin labeling now. For products that are already on retail shelves, labeling won’t be required, but it’s a good idea - for the sake of transparency - to offer POS labels to reduce risks and customer confusion.

According to the FDA, as long as your product is on retail shelves before the deadline, you’re okay, but they still recommend you start labeling early. For manufacturers, you will also need to consider how this new regulation could impact other products through potential allergen cross-contact, and modify food safety plans and procedures accordingly.

 

Foreign Supplier Verification Programs (FSVP)

If you import any food or beverage products (including pet foods), you should stay on top of your FSVP Plan. In 2020 and 2021, several of the top citations issued by the FDA were related to FSVP, including:

  1. Hazard analysis written (5.2%)
  2. Supplier verification (5.3%)
  3. Evaluation-performance (5.4%)
  4. Develop FSVP (45.9%)

FSVP violations accounted for more than 60% of violations and failure to develop an FSVP was at the top. If you’re using a broker, you should discuss these as requirements as the broker or you will be considered the FSVP importer. You need to ensure that the appropriate entity is identified as the importer, and verify that requirements are being met.

Importer, defined:

  • “The U.S. owner or consignee of an article of food that is being offered for import into the United States.”
  • Can designate an agent or representative if no “U.S. owner or consignee”
  • Someone physically located in the U.S.

FSVP applies to all foods and beverages, except:

  • USDA regulated foods
  • HACCP regulated foods
  • Personal consumption
  • R&D use
  • Transhipped goods
  • Exported then returned without further processing

Important to note, the FDA is also no longer allowing the symbol “UNK” to be used on imported products as a facility identifier, starting July 24, 2022. Any products imported with the “UNK” symbol will be rejected by U.S. Customs and Border Control. So, be sure to get your DUNS number in order to properly identify your imported products during shipment.

Stay on top of your FSVP Plan with these nine steps, which must be completed before any food enters the country:

  1. Conduct a hazard analysis of the food (hazard ID and risk evaluation)
  2. Evaluate the foreign supplier’s food safety performance and risk posed by the food
  3. Based on this, approve the foreign supplier
  4. Establish written procedures to ensure the food is imported only from approved foreign suppliers
  5. Determine and apply appropriate verification activities
  6. Implement corrective action(s), if needed
  7. Re-evaluate foreign suppliers (at least every three years)
  8. Identify the FSVP importer at entry
  9. Keep meticulous records and documentation

 

Delta-8, THC, and CBD

The regulations (or lack thereof) have caused ongoing confusion around Delta-8 THC and CBD, and the regulations around their consumption.

The 2018 Farm Bill did legalize hemp and its derivatives, but the FDA retained explicit authority over its use in foods, dietary supplements, and drugs. Furthermore, there are still issues in the fact that the DEA may still have issues with the process of hemp products and consider them a controlled substance. The FDA does not consider delta-8 THC or CBD to be legal food ingredients. While enforcement has been fairly sparse, it has issued warning letters for products containing delta-8 THC and CBD, largely focused on companies making health claims that could be considered drug claims.

 

Recall Readiness in 2022

Food and cosmetic recalls were the second-highest of all recalls between the fiscal years 2012 and 2022. Recalls are one of a manufacturer’s greatest risks but having a plan in place can help reduce the impact on your company and stakeholders while protecting the consumer.

The FDA issued the Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff in March this year, to help manufacturers and distributors be prepared for recalls or market withdrawals. This guidance falls into seven basic steps and the FDA suggests you review your current processes and procedures, to make sure your organization is recall-ready.

Identify the Recall Team (And Backups)

Get the names and job responsibilities of your recall teams. Include backups in case members of your regular recall team are away on vacation or otherwise unavailable. Be sure their contact information is up-to-date.

Make Sure the Recall Team is Trained Up on Their Responsibilities

Including your backup members. Revisit their responsibilities so everyone is clear on their role in the recall plan.

A Clear Recall Communication Plan (Internal and External)

Develop and use a clear communication plan that outlines verbiage and information to be put out or used internally, during a recall.

Outline of Reporting Requirements (i.e., Reportable Food Registry)

Ensure you and your team are aware of reporting requirements, such as the Reportable Food Registry. Food recalls must be reported within 24 hours.

Product Coding for Traceability (Ingredients, In Process, and Finished Product)

Review your current product coding to make sure it’s clear and easy to understand, for better traceability, both forward and back.

Current Contact Information for Customers/Direct Accounts, FDA Recall Coordinator

This will help ensure you’re able to contact key stakeholders in a timely manner. It’s often a good idea to reach out to the appropriate FDA Recall Coordinator in your area to establish a connection.

Communication Templates For Customers/Direct Accounts, Public Notices

Establish communication templates for how you will communicate your recall details to the public and customers, including what you want them to do with the recalled product. This way you don’t have to do it from scratch and expedite the process. 

 

FSMA Compliance for 2022

As manufacturers continue to navigate shifting guidelines and regulations and on-site audits begin to return, FSMA compliance will be increasingly important to stay profitable and competitive.

Topics: Compliance, Quality, Audit