President Obama signed into law a new food safety bill (HR2751: The FDA Food Safety Modernization Act’’) that gives FDA mandatory recall authority and requires food companies and their suppliers (including importers) to expand their food safety programs and in particular their documentation of what they do and why. The following is a summary of the act from the perspective of a food safety scientist who is NOT a legal expert. This is therefore not a legal interpretation of the act and its requirements, and you should not rely on this for the basis of any actions. Responsibilities for food companies that are identified in the new law: 1. Have a food safety plan that incorporates at least the following: a. A hazard analysis that are reasonably likely to occur (varies by facility)b. Put into place effective controls (have to work) and back up why they are adequatec. Monitor that they are working correctly and if not take corrective actions and document why and what was done (DOCUMENTATION is CRITICAL at inspection time)d. Verification activities – including both environmental and finished product testing - FDA can go back as far as records are kept (required to keep for 2 years)e. Redo at least every 3 yearsf. All records incl. food safety plan are available to FDA2. Have adequate and documented controls for the following: sanitation, training of personnel, environmental monitoring program including listeria, salmonella, etc, food allergen control program (a lot of specifics in the law on undeclared allergens),recall plans (basic parameters are already established in 21CFR), GMPs (prerequisite controls) and supplier verification programs 3. Supply chain management must include monitoring and control. Companies must know who they are and have a plan to ensure adherence. Companies must– ensure that the food (and ingredients used in the food) aren’t adulterated or misbranded (including undeclared food allergens). 4. The law also specifies new record keeping requirements and provides FDA with expanded access to the records. Maintain Documentation throughout it manufacturing processes and all documentation must now be available to FDA inspectors. This documentation includes the food safety plan, all monitoring, all testing, all corrective actions and the rationale for why the company has done what it is doing and why it isn’t doing other things. 5. Exemptions are allowed only for very small companies, with a small radius of product distribution (still have some requirements) 6. Warehouses are exempted from most of the requirements. 7. Biennial registration is required. The registration changes from essentially a directory to a “license” to sell foods that FDA can suspend for food safety reasons. 8. Includes safety standards for fresh fruits and vegetables. 9. Traceability of ingredients is addressed but this provision will not be implemented in the first phases. Imported ingredients and foods Companies must have a foreign supplier verification program that is risk -ased for ingredients, intermediate or final product. The program must include packaging. It will be prohibited for US owner or consignee to import a product that is not compliant with this section of the new law. It now becomes a basis to deny importation if there isn’t a compliant foreign supplier program in place. Ultimately it is the US owner, or consignee who is responsible. Depending upon contractual arrangements custom brokers/distributors could be responsible. The US company is responsible for ensuring that its suppliers and products from those suppliers are in compliance. and must show that it is as safe as domestically produced food (referencing the food safety plan and address critical control points, misbranding, etc. Each company will have to have a unique plan based on the foods, regulatory system in the location from which the food comes, tailored to the situation. Types of verification that may be needed include: monitoring of records, lot certification, annual onsite inspections, checking HACCP program, periodic testing and sampling, etc. There are exemptions for small quantities of product specifically designated for research or validation, for samples or for personal consumption. Records from the foreign suppliermust be maintained for 2 years and available to FDA on request (e.g. from US company). Time frame: guidance from FDA within 1 year of enactment (this time next year), (promulgate regulations by then), provision kicks in within 2 years of enactment (2 years from January 4, 2011 even if FDA doesn’t put forth regulations. If FDA decides there is a problem it can require certification from an accredited auditor (agencies of foreign government, persons accredited under 3rd party certification. The law specifies several types of audits and specifies penalties for auditors who make errors (or reach faulty conclusions). There are requirements for using accredited laboratories and a requirement that under certain circumstances the laboratory test results are to go directly from the laboratory to the FDA. Enhanced enforcement powers FDA inspections will increase for both domestic and international facilities and fees will be levied on firms whose food safety programs are such that FDA needs to increase its inspections further. FDA now has mandatory recall authority. However firms can avoid the fees and associated issues by agreeing to a voluntary recall. The law implements a registration system that will allow FDA to simply suspend registration and make it illegal for the company to operate (e.g. withdraw license temporarily). Until now FDA has needed credible evidence to detain product. The law will now allow detentions if there is reasonable evidence that it is adulterated or misbranded . (Most states already had this provision). The law has some new fees including the re-inspection fee noted above, an export ceritifcation fee and in the future a “fast lane” fee. The law doesn’t include civil money penalties unless you defy the recall, quarantine authority or subpoena or remote access to records. The FDA will have to come to the facility. Timetable: Small and very small companies have longer time frames but basically: • 18 months for food safety plans • 24 months for foreign supplier verification • Will become effective with or without FDA guidance/regulations • Registration begins in 2012 RIGHT NOW most companies need to get started on food safety plans, supply chain management – especially foreign supplier verification programs, records maintenance and access plans and testing of ingredients and finished products.