The Food Processing Industry’s Newest Challenge: Safe Quality Food’s Edition 8.0

The Safe Quality Food Institute (SQFI) is coming close to releasing its long-anticipated Edition 8.0. While many things could change during the final review and “sign-off” by the SQFI Technical Advisory Committee and SQFI staff, it is likely that the new SQF Edition 8.0 will have the following formatting and content changes. Some of these changes make the new Edition 8.0 more closely aligned with the FDA’s Preventive Controls for Human Foods (PCHF) regulation.

SQFI has indicated that Edition 8.0 will be enforced by SQF certification bodies six months after the implementation date (expected April 1, 2017). If SQFI meets its final publication schedule, all SQF-certifications after October 1, 2017 will have to have incorporated all Edition 8.0 changes.

Formatting Changes:

  1. Edition 8 has divided the food safety requirements in Edition 8 into specific food sectors as follows:
    • SQF Food Safety Fundamentals (applies to all food processors)
    • SQF Food Safety Code for Primary Production
    • SQF Food Safety Code for Manufacturing
    • SQF Food Safety Code for Storage & Distribution
    • SQF Food Safety Code for Food Packaging
    • The SQF Retail/Wholesale Grocery Code
    • The SQF Quality Code (Formerly Level 3)
  2. All food quality requirements have been incorporated into a separate “SQF Quality Code” and all previous food safety items have been relocated into the specific “SQF Food Safety Codes”.

Specific Operational or Substantive Changes:

  1. Levels #1, #2 and #3 have been eliminated.
  2. A food processor may forgo the unannounced certification audit once during each three (3) year cycle and voluntarily choose to move to annual unannounced recertification audits. Locations with annual unannounced recertification audits shall be recognized on the SQFI Certificate as an “SQFI Select Facility.”
  3. All products produced, stored or processed on site shall be included on the site’s certificate, unless exempted. The site must demonstrate that exemptions that are either site or product specific as part of the scope of certification do not put certificated product at food safety risk.
  4. The requirements for a food processor’s “Environmental Monitoring” have been expanded, similar to the FDA FSMA “Preventive Controls for Human Foods (PCHF)” requirements:
  5. SQFI and the certification body must be notified by the food processor in writing within 24 hours of becoming aware of a food safety problem that requires public notification. SQFI can be notified at foodsafetycrisis@sqfi.com.
  6. The site and the certification body shall agree on the audit scope before the certification audit begins. The agreed upon audit scope cannot be changed once the audit has commenced.
  7. The certification body must advise the supplier (food processor) of the name of the SQF food safety auditor at the time that the SQF audit is scheduled.
  8. In instances where a food processing plant has some operational written procedures or records kept or managed by the corporate office, the SQF audit may need to be conducted at the corporate office location as well as at the food processing plant location.
  9. The definition of “critical nonconformity” has been slightly expanded to include the failure to meet food safety regulations such as state, USDA or FDA regulatory actions.
  10. The section on “Food Defense” is now titled “Food Defense and Food Fraud”.
  11. Significant new requirements on allergen management have been added, consistent with the FDA FSMA “PCHF”.
  12. If a food processor chooses to not implement any Module 11 GMP-like requirements, the reason for not implementing must be submitted in writing to the certification body prior to the audit.
  13. Water requirements have been strengthened. Water stored on-site must be routinely monitored and water used as an ingredient in processing or for equipment cleaning and sanitizing must be treated, with water microbiological samples be taken annually.
  14. Lighting in food processing and handling areas and at inspection stations shall be at an average illuminance of 200 lux, or as required by applicable regulations.
  15. A current list of all chemicals used in the food processing plant is now a requirement.
  16. All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned to prevent unsanitary conditions.
  17. There are significant new written and operational requirements related to maintenance of the processing facility and processing equipment.

For more insight on the new SQFI Edition 8.0, contact Allen Sayler, EAS Senior Director of Food & Cosmetic Consulting Services at 571-48-5509 or asayler@easconsultinggroup.com.

EAS Consulting Group is a licensed SQFI Training Center and has scheduled SQF Edition 8.0 training sessions. EAS can also provide on-site SQF-based assessments by SQF-registered consultants.

A Good Time for Stakeholder Comment on FSMA Guidance

FDA has published and continues to prepare more draft guidances. As they become available, it’s important for companies to know how and what FDA expects to see during inspections. Now is the time to study the relevant draft documents and submit comments on agency expectations that will impose a high financial burden. In a very real sense, FDA relies on the regulated industry to help the agency understand the real-world implications of its policies as it begins enforcing the new FSMA rules.

The agency has said it will strive to achieve a balance between its public health mission and easing regulatory burdens, and the new administration is committed to continuing that approach.

A case in point is the water quality standards in the produce safety rule. In response to comments from stakeholders, the agency issued a March 20, 2017 notice acknowledging that parts of the FSMA produce rule setting numerical criteria for pre-harvest microbial water quality may be too complex to translate, understand, and implement. The agency is considering ways to simplify the water standards in a fashion that protects public health across the great diversity of circumstance for growing food.

Another issue with many moving parts and implications for industry is the use of third-party audits. The FDA has invited comments on its guidance on the Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards. There is no deadline for comment on this guidance.

The VQIP guidance document, FDA’s Voluntary Qualified Importer Program, is closely tied to Third-Party certification and it too needs advice and input from affected industry.

Another key FSMA document, FDA’s Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, is open for public comment through July 17, 2017.

Remember that even finalized guidance just represents the FDA’s “current thinking” on a topic and is not binding. Companies can “use an alternative approach if it satisfies the requirements of the applicable statutes and regulations,” the agency says. FDA suggests you contact its Technical Assistance Network (TAN) to discuss any alternative approaches. Although (necessarily) slow to answer policy questions, the TAN’s goal is to be an authoritative source for scientific and technical answers.