April 19, 2017
EAS Client - Exclusive Webinar
The US Food and Drug Administration’s will require all importers, starting at the end of May 2017 to have on hand for FDA review, significant new food safety documentation at their US office(s) for all foreign suppliers of food, food ingredients, and food additives. The FDA’s “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FDA Food Safety Modernization Act (FSMA) and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. The first step is to make sure all foreign suppliers are registered with FDA.
Since the FDA FSMA implementation will place significant regulatory food safety responsibility on a segment of the US food supply chain that had only limited past involvement in food safety regulatory compliance (importers), it is expected there will be both industry implementation and FDA enforcement problems. Any regulatory missteps by importers could trigger FDA import alerts to block importation of foods, food ingredients or food additives from foreign suppliers because of importer non-compliance. US food processors who rely on foreign sourced foods, food ingredients, and food additives could find themselves running short due to FDA blocking imports due to importer/broker regulatory issues related to the FDA FSMA requirements.
In an exclusive webinar for EAS, Independent Consultant Dr. Susan Moyers will discuss the FSVP rules and how to apply them, determining regulatory exposure by both importers and US-based food processors using foreign sources foods, food ingredients, and food additives, identifying exemptions, modified requirements, and documentation requirements.
This 90-minute webinar will offer practical and informative steps to ensure meeting compliance requirements, protecting against adulteration and misbranding as well as corrective actions should something go wrong.
Presenter: Dr. Susan Moyers, EAS Independent Consultant
About the presenter: Dr. Susan Moyers, has over 20 years of experience in developing, training and auditing food and dietary supplement management systems. She consults with facilities to develop and implement the BRC and SQF programs, as well as FDA’s Dietary Supplement cGMP, Preventive Controls, and Foreign Supplier standards. She also investigates and assists in resolving microbiological spoilage and food safety issues. Dr. Moyers is an SQF Registered Consultant and Trainer; a Lead Trainer for FDA’s Preventive Controls and Foreign Supplier Programs, and a consultant, auditor, and trainer for Dietary Supplement cGMPs and HACCP systems.
Dr. Moyers is a native of Philadelphia and received her undergraduate degree at Penn State. She holds a Ph.D. in Food Science and Nutrition from the University of Florida, and a Masters of Public Health degree from the University of South Florida. She currently resides in Tampa, Florida.
By Allen Sayler, EAS Senior Director for Food and Cosmetic Consulting Services
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.
- 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)
- 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:
- Levels #1, #2 and #3 have been eliminated.
- 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.”
- 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.
- The requirements for a food processor’s “Environmental Monitoring” have been expanded, similar to the FDA FSMA “Preventive Controls for Human Foods (PCHF)” requirements:
- 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 firstname.lastname@example.org.
- 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.
- 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.
- 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.
- 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.
- The section on “Food Defense” is now titled “Food Defense and Food Fraud”.
- Significant new requirements on allergen management have been added, consistent with the FDA FSMA “PCHF”.
- 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.
- 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.
- 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.
- A current list of all chemicals used in the food processing plant is now a requirement.
- All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned to prevent unsanitary conditions.
- 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 email@example.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.
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.