An analysis of the Food Safety Modernization Act and its potential effects on US importers.
by Arnim von Friedeburg
(a version in German language is available on www.germanfoods.org/exporters)
After many years of debate and negotiations, US Congress passed the Food Safety Modernization Act(FSMA) H.R. 2751 or S. 501 at the end of last year. The new bill – supported by a large group of food industry associations, consumer advocacy groups and retailers and signed into law by President Obama on January 4th, 2011 – is intended to improve the safety of the US food supply and strengthen the powers of the Food & Drug Administration (FDA).
Although the US food supply overall is very safe, there is still reason for concern. According to recently updated Centers for Disease Control and Prevention estimates, 48 million Americans suffer a foodborne illness every year. 128,000 of these are hospitalized and 3,000 die.
The following analysis of FSMA’s 220 pages highlights a) who will be responsible for food safety in the United States, b) which new authorities the Food & Drug Administration wields to enforce food safety, c) which potential impact the exact letters of the law would have on importing foods from abroad. It will take up to two years, until the FDA will have issued a final ruling, but importers and their export partners should think now about the potential consequences and costs associated with FSMA.
Here are the main changes mandated by the law:
- HACCP Plan: all domestic and foreign facilities who produce, process, pack, distribute, receive, hold or import are required to assess all hazards that could affect food, implement risk-based preventative controls, and maintain records that must be stored and shown to FDA inspectors upon request. This must be done according to a standard HACCP (Hazard Analysis Critical Control Points), which must include documents related to food allergens and recall procedures.
- Registration: Each facility inside and outside the USA that produces and stores food to be sold in the US must be registered independently from the Bioterrorism Registration). This registration must be renewed every two years and is subject to a fee (not set yet, but rumored to be $500). Without registration, the distribution and selling of food is strictly prohibited. The FDA has the authority to suspend or revoke a facility registration if there is s reasonable probability that the food of this facility maybe harmful.
- Importer Liability: At some point in the next two years, importer will be required to verify the product safety of all their foreign supplier (Foreign Supplier Verification Program) based on the supplier’s risk profile. Each shipment must be accompanied by a safety audit certification that needs to be checked and verifies by the importer. Importers who sell food without verifying their safety may be subject to injunction or criminal prosecution.
- FDA inspections: The FDA is now required to inspect virtually all facilities producing food inside and outside the USA within a specific time frame. These inspections are based on risk profiles of a given product, export nation, the exporter and his importer. Over the next four years, FDA is supposed to hire and train 17,000 inspectors for their local and overseas offices. Congress is supposed to allocate an incremental $1.6 billion to the FDA budget. A facility that fails the first inspection will have to be re-inspected at full cost to the owner. FDA is also required to inspect all facilities of importers.
- FDA Recall Authority: The FDA has now the authority to order a recall of products simply base on a reasonable suspicion that the food is contaminated, poisonous, causes negative health effects (for example when a product misses allergen statements). Until this year, FDA was only allowed to recommend a voluntary recall.
Possible consequences for German exporters and their US importers
In the following question and answer list, we highlight individual passages of the law and analyze potential consequences for US importers and their export partners:
Q: Which HACCP Plan is acceptable to the FDA standards?
A: FDA is required to determine over the next 6 months minimum standards for assessing food contamination hazards, methods of risk prevention and documentation. It is possible, that some current standards used by German or European producers may no longer be acceptable and would have to be changed.
Q: Will FDA accept current controls and certifications by foreign health, veterinary or other regulatory offices?
A: FDA will determine accreditation procedures for foreign governmental and non-governmental organizations to inspect and certify that food safety standards at food facilities conform to US
standards. It is likely that FDA will sign equivalency agreements with the EU and also accredit individual German organizations. Unfortunately, Germany does not have a national food safety agency. This is left to the individual states and local offices. Importers should consult with their suppliers – especially small companies – whether their current audit
system and certifications are acceptable to US authorities. (No doubt, German food safety standards are among the world’s best, but sometimes the paperwork gets in the way of free trade)
Q: Will FDA accept food safety certificates from “third party” auditors?
Although there is no requirement to use nongovernmental auditors or certification agencies, It is almost certain that on of the four leading HACCP certification standards accepted under the http://www.mygfsi.com/ Global Food Safety Initiative Global Food Safety Initiative (GFSI) will significantly improve the risk profile of any given food facility. These four standards (or schemes) are:
- International Food Safety – IFS (worldwide the leading standard, originated in Germany/France)
- Food Safety Standard Certification – FSSC 22000 (originated in the Netherlands, replaces the Dutch HACCP)
- British Retail Consortium Standard – BRC originated in Great Britain)
- Safe Quality Food – SQF (originated in Australia and the US)
Q. What must be included (among others)in a HACCP Plan according to the Food Safety Modernization Act?
- Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.
- Supervisor, manager, and employee hygiene training.
- An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.
- A food allergen control program.
- A recall plan.
- Current Good Manufacturing Practices (cGMPs).
- Supplier verification activities that relate to the safety of food.
Q. Which hazards need to be identified and evaluatedby manufacturers?
- Radiological Hazards
- Natural toxins
- Drug Residues
- Unapproved food and color additives
- Hazards that occur naturally
- Hazards that may be introduced unintentionally or intentionally
Q: What are the criteria that FDA will us to establish risk profiles for food facilities?
- The known safety risks of the food to be imported.
- The compliance history of foreign suppliers used by the importer, as appropriate.
- The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.
- The compliance of the importer with therequirements of section 805.
- The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.
- The potential risk for intentional adulteration of the food
Q Which type of food or food facilities are exempted from the law?
- Meat, poultry and eggs (which are regulated by the USDA)
- Fruit juices (already subject to FDA Juice HACCP Regulation)
- Low Acid Canned Food (already subject to FDA registration)
- Alcoholic beverages (subject to label approval by Tax and Trade Bureau of the Department of Homeland Security)
- Seafood (subject to separate Department of Commerce and FDA controls)
- Nutritional Supplements
- Small businesses under $500,000 revenue, small farms selling directly consumers within 250 miles of the farm
- Animal feed producer
- Facilities that store food in transit and where no one comes into contact with the food (at airports, for example)
Q: What can importers do to facilitate the importation of food?
A: Importers can participate in the “qualified importer program,” a fast track customs clearance
system by the FDA which will significantly lower the risk profile of the importer and, therefore, the risk of containers being detained. The participation is not free – the FDA will charge importers for that privilege, similar to the existing Customs-Trade Partnership Against Terrorism” (CTPAT) program by US Customs.
Q: Will the new law effect grey market products?
A: Yes.The new law (Sec. 309) requires the FDA to “develop and implement a strategy to better identify smuggled food and prevent entry of smuggled food into the United States. “Smuggled food’’ means “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead” FDA is particularly concerned about adulterated or misbranded food (for example missing allergen declarations) and can order an immediate recall solely based on suspicion that a food may be harmful to consumers. Grey market importers certainly will face a higher financial risk if their products are not labeled correctly.
Q: Will importers (and, by extension, exporters) face new costs due to the law?
A: Yes. Although not specifically mentioned in the law, industry rumors that FDA requires a fee for each registration and bi-annual re-registration of about $500. The law specifically demands fees for participation in the “Qualified Importer Program”, any re-inspection by the FDA, any recall related costs and any re-inspections of the importer’s facilities.
Q: When will FDA publish final rules?
A: Within 6 to 18 months, FDA is required to come up with a plan and final rules to implement the law. FDA is supposed to hire 20,000 new inspectors and invest in training and other programs at at cost of $1.6 billion. At this time it is unclear, whether the Republican controlled House of Representatives will authorize this incremental spending, given the enormous budget deficit.
Q: What should importers and their exporter do at this time?
A:There is no action required before FDA will publish the final rule.The team at German Foods North America, in close coordination with our partners and expert network, will submit guidance statements to the FDA and lawmakers to assist the FDA in implementing the law without disruption of trade and commerce. However, importers and exporters are advises to
- Work together to produce draft HACCP Plan und document potential hazards and their prevention.
- Agree on terms to share costs of registration and verification programs.
- Draft a joint plan for the event of a recall.
- Use experts to revise labels according to US regulations