Supplier Food Safety Program in the Food Chain
A Critical Issue for the Philippine Food Industry
Text by DR. MANNY GARCIA
US FDA Food Safety Modernization Act Preventive Program – Impact on suppliers
The Food Safety Modernization Act (FSMA), passed in the United States in 2011, covers the most extensive reforms of the U.S. food safety laws to ensure that the food supply chain is safe and secure. It involves a shift in focus from responding to food contamination events to prevention-based controls for all food manufacturing processes. FSMA emphasizes that the food industry has the primary responsibility to produce safe food, but calls for government to develop a new framework for regulatory oversight, Integrated government food safety efforts, and public-private collaboration. FSMA’s main themes focus on (a) Prevention, (b) Inspections, Compliance, and Response, (c) Import Safety, and (d) Enhanced Partnership. FSMA requires that food facilities implement Hazard Analysis and Risk-based Preventive Controls (HARPC) to ensure that hazards are identified and addressed from farm-to-table.
Supplier Food Safety Assurance Program (SFSAP)1
An effective SFSA program should include:
- A supplier approval program for ingredients, packaging, and other services or supplies that may affect food safety;
- A reliable and approved supplier list that includes supplier performance evaluations;
- Requesting and maintaining (where possible) on file a Letter of Continuing Guarantee from each supplier;
- Incoming material specifications (if necessary, ask suppliers for input on the facility’s incoming product specifications) to ensure that incoming materials meet required or agreed upon specifications;
- Incoming product and release protocol (e.g. based on Certificate of Analysis or internal testing) for the facility’s receiving department (part of Prerequisite
Program on receiving and shipping);
- A written specification change procedure to organize and record all changes; and alternative plans for buying from “non-approved” sources in emergencies
US FDA Food Safety Modernization Act Preventive Program – Impact on suppliers
The Food Safety Modernization Act (FSMA), passed in the United States in 2011, covers the most extensive reforms of the U.S. food safety laws to ensure that the food supply chain is safe and secure. It involves a shift in focus from responding to food contamination events to prevention-based controls for all food manufacturing processes. FSMA emphasizes that the food industry has the primary responsibility to produce safe food, but calls for government to develop a new framework for regulatory oversight,
Integrated government food safety efforts, and public-private collaboration. FSMA’s main themes focus on (a) Prevention, (b) Inspections, Compliance, and Response, (c) Import Safety, and (d) Enhanced Partnership. FSMA requires that food facilities implement Hazard Analysis and Risk-based Preventive Controls (HARPC) to ensure that hazards are identified and addressed from farm-to-table.
“Supplier verification activities” form a key part of HARPC that cover foreign suppliers and importers of raw materials and ingredients for processing in the U.S. The principal direction adopted by FSMA is based on approaches that include sections emphasizing:
- Improved Capacity to Prevent Food Safety Problems (Sections 101-116),
- Improved Capacity to Detect Hazards and Respond to Food Safety Problems (Sections 201-211), and
- Improved Safety of Imported Food (Sections 301-307).
Details of these sections and miscellaneous items are found in the US FDA website (http://www.fda.gov/FSMA).
Not covered in FSMA are facilities under the responsibilities of the U.S. Department of Agriculture and other existing food safety regulations involving seafood, fishery products, low acid canning, and juices subjected to HACCP.
Tips to enhance the Supplier Food Safety Program
The Philippine food industry should take a proactive approach to prepare for the current and looming challenges of global food safety regulations for food suppliers. The following principal themes and activities are recommended:
- Manage a reliable Food Safety Supplier Approval Program
With the FSAP serving as the foundation, a robust and well-maintained supplier approval program should include other requirements by importing countries. In case of FSVP, some of these elements include:
- Corrective Action – a built-in procedure in cases of complaint and to review these actions and investigate the causes of complaints such as misbranding and adulteration
- Periodic Reassessment – to be conducted by the importer within a specified period; new information on potential hazards may need reassessment
- Importer Identification – Importer is required to use a Dun and Bradstreet Data Universal Numbering System (DUNS) for their organization
- Know your supplier
Some of the questions to clarify: Do you trust your suppliers and supplier’s supplier? Are they complying with importing countries’ regulations or certification requirements? Developing trust should include validation and audit of the supplier and ingredients. How are you keeping track of your suppliers? Will their records satisfy importer’s FDA inspection? How do you prevent EMA (Economically Motivated Adulteration) of Food and Food Ingredients from impacting your company?
- Aim for a preventive farm-to-table Food Safety Management System
Today’s global food safety depends primarily on the food industry initiative, with top-level management commitment, working in a continuous improvement mode to: (1) implement science and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and (2) manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented routinely. Government and industry, in partnership, should implement effective integrated food safety systems. Government leadership is needed in guiding industry to develop strategies to comply with international regulations in juxtaposition with the Philippine Food Safety Act of 2013.
- Select a reliable food testing laboratory
It is important to obtain reasonably accurate data on hazard identification and process verification that control these hazards. Philippine-based laboratories with ISO 17025 accreditation are certified for competency by the BPS (Bureau of Philippine Standards). Some large companies adopt their own Laboratory Quality Assurance Programs that exceed the minimum requirements of ISO 17025 and encourage electronic reporting.
- Support continuing food safety education and training
In any food company’s pursuit to achieve world-class status, education and training tops the list of its food safety and quality key performance indicators (KPIs). Training by experts should be taken advantage of to improve the staff’s knowledge and competence. Foremost among these is competency in developing hazard analysis and conduct risk-based preventative food safety systems.
- Mandating certification for supplier accreditation
FSMA Foreign Supplier Verification Program (FSVP)
Improved Safety of Imported Food sections include provisions for expanded oversight of imports, authority to require certification to US Standards, and a voluntary program for expedited import procedures. FSMA specifies that food importers for human and animals would be required to develop, maintain, and follow an FSVP. An importer is the U.S. owner or consignee of a food offered for import into the United States. This applies to most entities that import food into the United States from abroad including domestic facilities and food brokers. Among other items, importers are required to conduct reviews and risk verification of the imported goods, and third-party auditing of foreign food processors. An importer would be required to develop, maintain, and follow an FSVP that provides “adequate assurances” that its foreign supplier is producing the food in compliance with processes and procedures that provide “at least the same level of public health protection” as the US FDA’s standards.
The foreign supplier must also demonstrate that it is producing the food in compliance with the adulteration and allergen-labelling requirements of the Food Drug and Cosmetic Act. Record keeping should be maintained to diligently track and keep records of the mentioned activities including background checks for each product needed for import status compliance.
Key Features for Importers and Foreign Suppliers
US FDA has proposed two options for foreign suppliers to verify the safety of their products. (1) The importer is responsible for conducting or obtaining information on onsite auditing of the foreign supplier, if the latter controls the hazard at its establishment; (2) The importer needs to decide a verification procedure for all the hazards that the supplier controls themselves.
US FDA’s new key import authorities and mandates include:
- Importer accountability: Importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure safe food.
- Third Party Certification: An established program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports.
- Certification for high-risk foods: US FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification, or other assurance of compliance as a condition of entry into the U.S.
- Voluntary Qualified Importer Program (VQIP): US FDA must establish a voluntary program for importers that provides for expedited review and entry of food from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities.
- Under the revised FSMA proposed rule, if a manufacturing facility receives raw materials or ingredients from a supplier (either a facility or a farm), then the receiving facility must establish and implement a supplier program if the following conditions are met: (a) the receiving facility identifies a significant hazard with the raw material or ingredient; and (b) the supplier is the one controlling the hazard.
- Importers will be required to comply with FSVP no earlier than 18 months after issuance of final rule (i.e., May 2017)
If the foreign supplier is subject to preventive controls or product safety regulations, the importer must comply with FSVP within six months after the foreign supplier has complied with the relevant regulations (http://www.fda.gov/FSMA).
A supplier program is not required by FSMA if: (a) there are no significant hazards associated with the raw material or ingredient; (b) the receiving facility is implementing preventive controls that are adequate to significantly minimize or prevent the hazard (e.g. processing with a “kill step”); or (c) the receiving facility relies on its customers to control the hazard and annually obtains written assurance from the customer that explains the preventive controls the customer is following to significantly minimize the risk.
1 Supplier Food Safety Assurance. Food Safety Guidebook. Alberta Ministry of Agricultural and Forestry.