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Today’s world is always changing, and keeping our food safe is more important than ever. The latest updates to the Food Safety Modernization Act (FSMA) are not just new rules to follow, but a path to making food practices stronger and safer for everyone.
As 2024 brings new changes from the FDA, it’s key for all businesses in the food industry, no matter the size, to know what’s coming and be ready for it. In this blog post, we’re going to explain these changes and look at how they’re going to make food quality control systems better.
What’s in the New Guidance?
Advanced Hazard Analysis and Preventive Controls
These changes include:
- Comprehensive Hazard Identification: Food facilities are now expected to dive deeper into hazard identification, ensuring no stone is left unturned when it comes to any potential biological, chemical, and physical hazards that lurk beneath the surface. Eagle products can be instrumental here, offering state-of-the-art detection technologies that ensure comprehensive hazard identification, whether it’s a tiny shard of metal, a trace of chemical contamination, or an unexpected physical impurity.
- Preventive Control Implementation: Once the hazards are identified, the serious work starts. Facilities need to come up with and put in place food quality control systems to lower or, better yet, get rid of these risks. This means they have to think ahead and act before anything bad happens, not just react after the fact.
- Verification and Validation: Now, how can facilities be sure these preventive controls are not just for show? That’s where the necessity for ongoing verification and validation activities comes to the forefront. They must demonstrate that the food quality control systems they have in place are not just a façade but are genuinely effective at all times.
Amid these rigorous standards, Eagle’s dual energy x-ray inspection system becomes incredibly pertinent. The use of such x-ray technology in quality control is integral to preventing food contamination, illustrating the multifaceted approach required under the new FSMA guidelines.
Supply-Chain Program Requirements
- Supplier Evaluation and Approval: There’s no room for error when it comes to selecting suppliers. The effectiveness of food quality control systems often begins with rigorous supplier evaluation. Facilities must not let this crucial step fall down on the priority list. To ensure suppliers are up to the task of providing safe food, facilities must: review each supplier’s food quality control systems, examine their regulatory compliance history, search for potential red flags in online databases concerning warning letters, import alerts, and recall history.
- Performance and Compliance Tracking: Trust is good; continuous verification is better. Keeping track of supplier compliance shouldn’t grind to a halt after approval. Facilities now are expected to: monitor their suppliers constantly, ensure they adhere to stringent food safety standards, potentially utilize third-party certifications and audits to solidify the trust in these evaluations.
- Record Keeping: The 2024 FSMA updates demand that record maintenance not just be a checkbox task. Compliance records under subpart F of part 117 (21 CFR 117.475) should be: detailed and comprehensive, permanently recorded and legible, available in paper or electronic formats.
Food safety management software from Eagle integrates seamlessly into your FSMA compliance strategy. With Eagle’s robust food quality control systems, food manufacturers can efficiently assess supplier documentation and analyze performance, track compliance in real-time, and digitize records to make sure they are both indelible and accessible.
Food Allergen Labeling Requirements
The 2024 updates also encompass stringent allergen labeling rules as part of the Food Allergen Labeling and Consumer Protection Act (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act):
- Clear Labeling of Major Allergens: All eight major food allergens—milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans—must be explicitly listed on the labels of food products. Vague descriptions or technical jargon that consumers might not understand will simply not suffice.
- Preventive Controls for Allergen Cross-Contact: Facilities should implement controls that prevent allergen cross-contact during food production. This includes dedicated equipment, thorough cleaning protocols, and employee training.
Updated Recall and Crisis Management Protocols
Given the paramount importance of rapid response to food safety incidents, the updated FSMA guidelines put a premium on readiness and clarity in the event of a food safety emergency.
- Recall Readiness and Implementation: The need for facilities to have a comprehensive recall strategy in place has never been more critical. Facilities should now establish a recall plan that outlines steps for prompt removal of contaminated products from the marketplace. This includes identifying the scope of the recall, notifying customers and regulatory authorities, and managing the recall execution.
- Crisis Communication Plans: With stakes that can quickly grow so dire, effective communication frameworks should be in place to address potential food safety crises. This involves notifying stakeholders, managing public relations, and keeping regulatory agencies informed.
- Post-Recall Analysis: Conducting meticulous reviews post-recall to unearth the contamination’s origin is essential. Such analysis aids in refining safety protocols and implementing corrective measures to prevent future incidents.
Compliance Attestation for Qualified Facilities
Under the new guidelines, a facility categorized as a “qualified facility” must furnish an attestation via Form FDA 3942a, affirming its food quality control systems or adherence to applicable local food safety laws.
- Mandatory submission of Form FDA 3942a: Qualified facilities must submit this form as a precondition to operation or within set regulatory time frames, bolstering transparency and compliance at the get-go.
- Provision of Customer Assurance Documentation: These facilities are also expected to distribute copies of this form along with comprehensive documentation of their preventive food quality control systems, leaving their customers’ concerns about food safety hazards slim to none.
FDA’s 2025 Fee Updates for Food Quality Control Systems
The U.S. Food and Drug Administration (FDA) recently announced new fees for the 2025 fiscal year that affect certain import programs. These programs are critical for maintaining food safety for imports.
Understanding the Fee Updates
Here’s a breakdown of how the new fees impact two crucial food quality control systems:
Voluntary Qualified Importer Program (VQIP)
A cornerstone among food quality control systems, VQIP allows importers who maintain high standards in managing their supply chains to expedite their food imports into the U.S. The 2025 fees support the FDA in operating this program effectively from October 1, 2024, to September 30, 2025. Importers aiming to benefit from VQIP next year need to settle their fees by October 1, 2024. Notably, there’s no fee concession for small enterprises within this robust food quality control system.
For further details or assistance: Additional information is available in the Federal Register Notice, or you can reach out to the VQIP Help Desk at 1-301-796-8745 or FSMAVQIP@fda.hhs.gov.
Accredited Third-Party Certification Program (TPP)
This program plays a pivotal role in food quality control systems by allowing recognized bodies to audit and certify foreign food facilities’ safety standards. This mechanism ensures that the quality and safety of the food reaching consumers meet stringent standards. The fees for the TPP, like those for the VQIP, are set to facilitate the administration of this program from October 1, 2024, through September 30, 2025.
For inquiries: Contact the program via email at FDAthirdpartyprogram@fda.hhs.gov. Details about the 2025 Third-Party Certification Fees are also detailed in the Federal Register Notice.
Through these fee adjustments, the FDA reinforces its dedication to enforcing stringent food quality control systems, ensuring the safety and quality of food imports into the U.S.
FDA Regulations and Evolution
Our mission at Eagle is to ensure our technologies are woven seamlessly into your operations. We’re here to equip you with tools that don’t merely stride alongside the FDA evolution of proactive food safety strategies but propel your business to the forefront of quality and safety leadership.
Making headway in this dynamic environment requires a resolute commitment to invest in the future. It means sometimes we have to bite the bullet on upfront expenditures—recognizing these costs as investments in your brand’s reputation and the well-being of your customers.
Yes, achieving this level of readiness and resilience might cost a wing and a thigh, but we see this as an invaluable commitment to excellence. Cutting corners is not an option when it comes to the safety and quality that your consumers trust you to provide.
If you have questions on food quality control systems or our process, don’t hesitate to get in touch with us!
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