Whitepaper April 2014 UNDERSTANDING THE US FOOD SAFETY MODERNIZATION ACT 2011

Transcription

1 Whitepaper April 2014 UNDERSTANDING THE US FOOD SAFETY MODERNIZATION ACT 2011 Its Implications and Impacts on Suppliers, Producers and Exporters in Europe If your company exports food to the US or you are an importer of food to the US this document contains important information for your business. It takes you through the requirements of the new Food Safety Modernization Act (FSMA), provides details of the regulations being produced, what is required for exporters to the US and how you can ensure your systems and facility are compliant in readiness for the implementation of the regulations. The paper has been developed from a European perspective, but additional comprehensive information is available if you are based in the US and need to know how this affects you directly. Contact fsma@nsf.org

2 CONTENTS Page No. 1. EXECUTIVE SUMMARY BACKGROUND: WHY HAS FSMA BEEN DEVELOPED WHAT IS FSMA OVERVIEW OF KEY REQUIREMENTS THE IMPLICATIONS FOR EUROPEAN BUSINESSES STEPS TO ENSURE YOU ARE FSMA COMPLIANT NEXT STEPS Executive Summary The US Food Safety Modernization Act (FSMA) was signed into law in January 2011 and amends the Federal Food, Drug and Cosmetic Act (FFDCA) of FSMA is the most sweeping reform in over 70 years of food safety legislation in the US and has far reaching implications both domestically and globally. The Act makes extensive changes to US food safety laws, most notably shifting focus from reacting to food safety problems to preventing them in the first place. By requiring a risk-based approach to identifying hazards and implementing preventive controls, FSMA places new and more extensive requirements on domestic and foreign firms that manufacture, process, pack or hold human food. If you are an exporter to the US, you will be required to register with the FDA and significant new requirements will be placed on you, as a food processor, by FSMA. The FDA has issued a Proposed Preventive Controls Rule that defines those requirements for all facilities that manufacture, process, pack or hold human food. Importers, too, have new requirements placed upon them as a result of the proposed Foreign Supplier Verification Program (FSVP) Rule and they will be required to work with you to review your food safety plans and controls. A considerable number of regulation and guidance documents are to be produced in order to deliver this new legislation and these are being released in a phased approach with final rules by mid-2015 So, it is important to understand how FSMA will affect your company and prepare early, to ensure that your products can be exported efficiently once the new rules are actively enforced

3 2. Background: Why has FSMA been developed? There have been a number of high profile incidents and food poisoning cases over the last decade that have had negative impact on consumer trust and have caused food safety to become a major concern in the US. Data provided by the US Centers for Disease Control and Prevention (CDC) estimates 48 million, ie 1 in 6 Americans are affected each year by foodborne illness including 128,000 hospitalizations and 3000 deaths [source]. This is against a dynamic consumer background, including changing demographics and the desire for year-round supply of fresh foods, which is driving the need to source fresh food and ingredients from around the world. There are now more foods in the marketplace, presenting new and previously unknown hazards. Imported food currently accounts for 15% of the whole US food supply and has grown rapidly over the last 10 years, with certain products such as seafood and fresh produce accounting for up to 75% of the food supply [Source USDA]. These drivers and a general requirement to review and update food safety legislation have led the US legislature to pass the Food Safety Modernization Act, enabling the US Food and Drug Administration (FDA) to better protect public health by helping to ensure the safety of the US food supply. According to the FDA Commissioner, Margaret Hamburg, FSMA can help to avoid a breakdown at any point on the farm-to-table spectrum [because that] can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry. She elaborates by saying it examines the food system as a whole [in order to] be clear about the food safety responsibility of all of its participants, and strengthen accountability for prevention throughout the entire food system domestically and internationally. The Act signals the greatest expansion in food safety requirements and FDA authority since The aim of the legislation is to shift focus within the US food industry towards a proactive, preventive strategy founded on science-based standards. Historically, the approach to food safety incidents in the US has been reactive, investigating the reasons for contamination without tackling and preventing their occurrence throughout the food supply chain

4 3. What is FSMA? FSMA was signed into law in January 2011 and amends the Federal Food, Drug and Cosmetic Act (FFDCA) of Currently, the FDA is holding meetings and receiving comments on how to best implement the new law and produce effective regulations. To date, the FDA has published seven major Proposed Rules that will be the basis for compliance and enforcement once they are made final. A number of regulation and guidance documents are to be produced in order to deliver this new legislation and these are being released in a phased approach with final rules by mid Whilst the process is not yet complete there are key indications already available with regard to exporter requirements, and there is one clear piece of advice: don t wait. To ensure the FDA reaches as many foreign suppliers as possible and in order to help them understand the new requirements, documentation relating to FSMA is being produced in English and 11 other languages including Arabic, Chinese, French, Russian, Spanish, Italian, Japanese, Korean, Portuguese, Thai and Hindi. Additional updates can be found at The legislation is far reaching in scope, and seeks to ensure that the food industry is held to account for securing its supply chain. It covers the whole supply chain, from import of foreign products and transportation, through to domestic US food establishments, including processors and growers. FSMA places new and more extensive requirements on food manufacturers, processors, growers and importers by requiring a risk-based approach to identifying hazards and implementing preventive controls. Another important component of the legislation is FDA recognition of accredited third-party inspection and certification programs for imported foods. The aim is to ensure prevention or risk minimization of food safety issues through existing and new inspection and compliance processes, delivered through enhanced partnerships between domestic and foreign regulatory authorities

5 Fig 1: Main themes of the legislation [source: FDA] The Act focuses primarily on the following to minimize or prevent food safety hazards for: Human foods Produce safety Imported food safety Animal food. This is supported by: Mandated inspections on a risk based schedule Third party laboratory testing Ability to require mandatory third party certification for high risk foods FDA recognition of third party inspection & certification programs for imported food. The aim is for businesses to have transparent and documented procedures that reflect and strengthen best practice within the food industry. It is also important to note that there is a focus on improving areas that are currently weak, rather than replacing existing standards and certifications. GFSIrecognized food safety schemes will continue to provide businesses with elements of due diligence for FSMA

6 4. Overview of key requirements These fall into 4 key areas: 4.1 Preventive Controls Alters approach to focus on prevention rather than response. Shifts accountability onto food processing companies. Evaluates hazards and requires written plans of action to prevent food contamination. 4.2 Detection and response to food safety issues Requires biennial FDA registration of food production facilities no unregistered foreign site will be able to import to the US. Increased mandatory FDA inspections of US facilities high risk facilities within five years and thereafter every three years, and lower risk facilities within seven years and thereafter every five years. Evaluates hazards and requires written plan of action to ensure no adulteration, misbranding or incorrect labelling. The written plan must include hazard analysis, preventive controls, monitoring, verification, corrective actions, and record keeping. Product testing for specific regulatory compliance must be carried out in accredited laboratories. Foreign supplier audits must be conducted by accredited third party auditing organizations. 4.3 Imported food safety The Act: Expands FDA oversight of imports. Provides authority to refuse imports without prior FDA inspection. Requires Foreign Supplier Verification Programs. Provides authority to require certification of high risk products to US standards. Allows for the development of Voluntary Qualified Importer Program for expedited import procedures. 4.4 Expanded FDA Powers FDA is now authorized to order product recalls. FDA may suspend registration, effectively blocking production or sale of product for non-compliance. Funds will be made available for the food safety functions of the FDA. FDA staffing levels will be increased. Whistle-blowers will be protected

7 5. The implications for European businesses 5.1 Prevention of Hazards All registered facilities (including sites outside the US), must develop and implement a written food safety plan that will include preventive controls to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. These food safety plans must be science and risk-based in order to prevent hazards to public health. The new Preventive Controls Program combines Hazard Analysis and Risk-based Preventive Controls (HARPC) with a revised version of Current Good Manufacturing Practice (cgmp). HARPC requirements are similar to some of the fundamental elements of Hazard Analysis and Critical Control Points (HACCP), but differ in that there may be additional preventive controls, some without CCPs, primarily to prevent contaminated foods entering the food chain. The written food safety plan must be prepared and implemented by a qualified individual and include a recall program for quick and effective removal of contaminated product. There are some exemptions, such as seafood, juice processors and low acid canned products that are currently mandated to meet the requirements established by other FDA HACCP programs. In addition, small and very small processors may only have to meet modified requirements. It is likely that most EU facilities will already have documented food safety management plans in place, including HACCP, and these will therefore need to be reviewed in light of FSMA requirements to ensure they are comprehensive in scope and validated either by your import partner or approved third parties. The Preventive Control requirements will need to be taken into consideration as part of a typical Hazard Analysis and Critical Control Point plan, and must include requirements related to recall plans, sanitation, employee hygiene training, environmental monitoring, allergen control program, current good manufacturing practices, supplier approval and verification activities, corrective actions and verification activities, and records. 5.2 Completing a food safety plan The key steps to complete a food safety plan are detailed below: 1) Perform a Hazard Analysis. Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including: - 6 -

8 biological, chemical, physical and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and colour additives hazards that occur naturally, or may be unintentionally introduced hazards that may be intentionally introduced, including by acts of terrorism. You must develop a written analysis of the hazards. 2) Identify and implement Preventive Controls, including any critical control points, to provide assurance that: the hazards identified in the hazard analysis will be prevented, eliminated or significantly reduced food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act. 3) Monitor the effectiveness of the preventive controls you have implemented. 4) Establish corrective action procedures to ensure that, if the preventive controls are not properly implemented or are found to be ineffective: appropriate action is taken to reduce the likelihood of recurrence of the failure all affected food is evaluated for safety all affected food is prevented from entering into commerce if the owner, operator or agent in charge of your facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act. 5) Verify that: the preventive controls implemented are adequate to control the hazards identified hazards are being monitored you are making appropriate decisions about corrective actions The preventive controls implemented are effective in significantly minimizing or preventing the occurrence of identified hazards. This can be done through the use of environmental and product testing programs and other appropriate means There is documented, periodic reanalysis of the plan, not less frequently than once every three years, to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats. 6) Maintain records for not less than 2 years, documenting: the monitoring of the preventive controls implemented instances of material nonconforming to food safety - 7 -

9 the results of testing and other appropriate means of verification instances when corrective actions were implemented the effectiveness of preventive controls and corrective actions. 7) Prepare a written plan that documents and describes the procedures used by your facility to comply with the requirements of the Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards. Your written plan, together with the documentation must be made promptly available to a duly authorized representative of the FDA upon oral or written request. 8) Conduct a re-analysis of your preventive controls whenever a significant change is made in the activities conducted at your facility, if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. This re-analysis must be completed and any additional preventive controls needed to address the hazard identified must be implemented before the change in activities at the facility is operative. You must revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. 5.3 Foreign Supply Verification Program (FSVP) for Food Importers A key part of the new compliance requirements is that FSMA is moving the burden of imported food safety onto importers. Under the proposed new rules US food importers must ensure the safety of all food products and ingredients brought into the US. Importers will be held accountable for ensuring that their foreign suppliers are in compliance with the requirements of FSMA. Importers will be required to perform risk based foreign supplier verifications activities to ensure that food entering the US has been produced by companies employing preventive controls (as described above). All products to be imported (except seafood, juice and low-acid canned foods, which already have HACCP based controls in place as part of FDA programs) will need to comply with FSMA requirements. An importer is defined as the person in the US who purchased the food. If the food has not been sold to a person in the US, it would be the US consignee. If there is no owner or consignee, this is the US agent or representative of the foreign supplier. This means that US importers will need to work closely with you - their European food suppliers - to ensure that you meet the requirements of FSMA through their developed foreign supplier verification plans. In practice this requires close collaboration with your importer/agent to agree how this will work and that all steps are comprehensively covered. You will need to ensure that all key stages are in place and relevant documentation is correctly evidenced and available for each imported food as follows: - 8 -

10 For each imported food, unless otherwise exempt or subject to modified requirements, the importer will be required to develop and implement an FSVP with certain standard requirements, including: 1) A review of the compliance status of the food and supplier. 2) A hazard analysis to determine the hazards reasonably likely to occur in the imported food. This evaluation would include: Ingredients of the food Condition, function, and design of the foreign supplier s establishment and equipment Transportation practices Harvesting, raising, manufacturing, processing, and packing procedures Packaging and labelling activities Storage and distribution Intended or foreseeable use of the food Sanitation, including employee hygiene Any other relevant factors, such as a natural disaster, affecting the foreign supplier facility. 3) A list of its foreign suppliers. 4) The importer must establish FSV procedures to provide adequate assurances that the hazards identified as reasonably likely to occur are effectively controlled. This will include a periodic supplier review, ensuring Importer Identification numbers are present at entry, and that complaint monitoring, product sampling and testing and records at all stages are maintained. 5) The importer must conduct verification activities such as on-site audits of foreign suppliers, periodic sampling or lot testing, review of foreign supplier food safety records. 6) The importer must conduct investigative and corrective actions as needed. A Qualified Individual* is required to develop the FSVP and perform most verification activities. This person would perform verification activities related to preventive controls and must have training or experience in preventive controls. There is also provision for regulations to be developed to establish a new authority for import certifications that demonstrate compliance of food products with US standards. The certification process is likely to be managed by authorized independent third parties or governments and we await final details. * Qualified Individual would be defined as a person who has the necessary education, training, and experience to perform the activities needed to meet the requirements of the FSVP regulations. A qualified individual may be an employee of the importer or an outside consultant. A qualified individual may be, but would not be required to be, an accredited third party auditor or a foreign government employee. To prevent conflicts of interest, the proposed rule would require that a qualified individual who conducts any of the required verification activities may not have a financial interest in the foreign supplier, and payment of a qualified individual may not be related to the results of its verification activities

11 Fig. 2 Foreign Supplier Verification Requirements 5.4 Voluntary Qualified Importer Program FSMA outlines plans for the development of a voluntary program to provide expedited review of products from participating importers. It is proposed that importers will finance the program through a fee-based registration system. Eligibility to participate in the program will depend, in part, on the known safety risk of the food product or ingredient to be imported; the compliance history of foreign suppliers used by an importer; the capability of the regulatory system of the country of export to ensure compliance with US food safety standards; recordkeeping, testing, inspection, and audits of facilities; traceability throughout the supply chain; proof of consistent temperature controls; and the potential risk for intentional adulteration of the food. A facility certification will accompany products brought into the US under this program. This program is of considerable interest to an exporter. However, it is important to note that the

12 details of this program have not been wholly defined and we believe that it will be a number of years before the program is fully implemented. 5.5 What if my facility is already certified to a GFSI standard? Many suppliers will already have comprehensive food safety management systems in place, with certification by accredited certification bodies to approved Global Food Safety Initiative (GFSI) recognized manufacturing and primary production schemes, which already cover food safety management systems, GMPs and HACCP. These schemes include: BRC (British Retail Consortium) Global Food Standard FSSC Food Safety System Certification ISO Food Safety Management Standard and PRP Programme requirements (Pre- Requisite Programme) IFS The International Food Standard SQF Safe Quality Food Code BAP Best Aquaculture Practices Standards GlobalGAP. It is likely that companies in this position will only need to conduct a gap analysis of their food safety management system to ensure it is FSMA compliant, address any gaps and ensure that there is documented verification in place and available. 5.6 Produce suppliers The FDA is requiring those who produce fruits and vegetables to enact measures to ensure the safe production and harvesting of the produce. These requirements will apply to both domestic and imported produce and include controls over soil amendments, hygiene, packaging, temperature controls, animals, and water, so as to reduce or eliminate the likelihood of both natural hazards as well as those that may be intentionally introduced from impacting the safety of the product

13 6. The steps to ensure you are FSMA compliant There are a number of steps that can be taken to prepare your company for FSMA compliance. You need a full and comprehensive understanding of the requirements of FSMA and to do this we advise that you appoint a food safety team to develop or review your food safety management system. The team should be led by a qualified individual, conduct a gap analysis, implement changes and consider supply chain partners too. The key steps for European producers and manufacturers are: 1) Ensure that your prerequisite programs, including allergen controls, are well documented and implemented, and that they specifically address the preventive control examples set out in the Act. 2) Ensure there is a validated written food safety plan in place that includes preventive controls. 3) Establish a documented supplier approval and verification program. 4) Put in place documented and implemented corrective action procedures. 5) Maintain full food safety records. 6) Work with your importer to identify the testing plans and Certificates of Analysis required. 7) Maintain complaint records. 8) Undertake or maintain your accredited third party certification with full scopes covering the products to be exported and provide your importer with access to the report/certificate. Once all the above is in place, then it is important to monitor these systems and take corrective action when needed. Finally there must be a regular review to ensure any changes to your product or production processes are considered in order to maintain compliance with FSMA

14 7. Next Steps: NSF is here to help You need to act now and NSF International can help you to prepare and put in place a smooth transition to FSMA compliance. NSF has collaborated with the FDA, USDA, CDC and other government organizations on HACCP and other public health programs over the last 25 years. This means that we are intimate with the requirements and can support your business with the development and validation of your written food safety plans and preventive controls. As the leading provider of audit and certification services, NSF offers a range of GFSI accredited food schemes. We have a comprehensive infrastructure of auditors throughout the world, with the full range of technical competency for food and agricultural scopes. Globally we audit over 28,000 food facilities and farms to GFSI programs (BRC, IFS, SQF, FSSC and Global GAP). On our website you will find our free online FSMA readiness tool which you can use to assess how prepared you are and provide you a gap analysis service to review your current food safety management system against the proposed FSMA requirements. Our expert consultants can support you in filling the gaps, developing your written food safety plan and Preventive Controls and testing the efficacy of your traceability, recall and documented procedures. Our training courses are designed to assist both with understanding the requirements of FSMA at all relevant stages and in implementing the requirements. NSF International laboratories and testing services are based throughout the world and can provide testing to comply with FSMA requirements including certificates of analysis. Register now for our free live webinar on 14 th May and learn direct about FSMA requirements from our team of experts in North America and here in Europe - understand how it will affect companies in the EU exporting to the US and ask the panel all your burning questions. For more information about any of the issues raised in this document or for any other FSMA related queries please contact fsma@nsf.org

15 About NSF International About NSF International: NSF International is an independent organization that writes standards, tests and certifies products for the food, water and consumer goods industries to minimize adverse health effects and protect the environment ( ). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment. NSF International is one of the most widely known and respected food assurance brands operating in over 70 countries worldwide. We work with many global retailers and manufacturers, delivering food safety expertise to both established and developing food supply operations and regions. Our food safety services include assurance and certification, consulting, technical services, risk management and training, in addition to testing and standards creation. The NSF Global Food Division provides experienced and accredited services across all supply chain sectors, from agriculture, produce, processing, distribution and dairy, to seafood, retail and restaurants. Services include Global Food Safety Initiative (GFSI) certification (SQF, BRC, GLOBALG.A.P., FSSC, IFS, Aquaculture Certification Council (ACC)), Marine Stewardship Council (MSC) certification, plus expert auditing, consulting and technical services, HACCP validation and inspection, and organic and gluten-free certification through QAI (Quality Assurance International). NSF is also the leading certifier of foodservice equipment, nonfood compounds and bottled water/beverages. Additional NSF International services include dietary supplement and nutritional ingredient certification, drinking water certification and safety audits, and management systems registrations (e.g. ISO 9001, 22000, 14001). The NSF Strategic Consulting Group provides solutions to emerging issues in the food supply chain. As challenges such as food fraud and other serious supply chain risks manifest themselves on a global scale, the requirement is for a strategic global approach that also has the ability to pinpoint and remove risk in the supply chain at the most local level. The Group is addressing the most significant themes of today, including Risk Quantification & horizon scanning, Organisational Culture and Maturity Models for food safety systems, Behavioural Food Safety, Food Fraud in the Supply Chain and Crisis Management & Planning