FDA: US Agenten haften für ihre Auftraggeber

Nicht mehr nur ein Vermittler zwischen FDA und Exporteur

Seit dem Inkrafttreten der Bioterrorismusgesetze im Jahr 2003 müssen Hersteller von Lebensmitteln und Getränken bei der Registrierung ihres Betriebes einen FDA US Agenten bestimmen, der in den USA wohnhaft ist und jederzeit der FDA als Ansprechpartner zur Verfügung steht, um Mitteilungen oder Warnungen an den Auftraggeber weiterzuleiten.

Ab dem 1. Januar 2013 soll der FDA US Agent nun auch für alle außenstehenden Rechnungen seines Auftraggebers gegenüber der FDA haftbar gemacht werden.

FDA Gebühren können für folgende Vorfälle anfallen:

  1. die erneute Inspektion eines Betriebes, der die erste Überprüfung der FDA Inspektoren nicht bestand
  2. von der FDA angeordnete Rückrufaktionen
  3. Beschlagnahmungen und Aufbewahrung von Containern
  4. alle anderen gebührenpflichtigen Leistungen

Bei einem Honoraransatz von $325 pro Stunde für einen Inspekteur plus Reisekosten kann eine erneute Inspektion eines Betriebes, in Deutschland, je nach Größe und Anfahrtsweg, tausende von Dollar kosten. Die müssen nach Erhalt der FDA Rechnung innerhalb von 30 Tagen bezahlt werden. Auch der FDA US Agent erhält diese Rechnung und ist bei Nichtzahlung für die Begleichung der Rechnung haftbar. Darüber hinaus soll der US Agent sicherstellen, dass Auftraggeber die Lebensmittelsicherheits-vorkehrungen den amerikanischen HAACP Regeln entsprechen.

Trend Watch 2013: Nutrition Labels, Food Safety, and the Farm Bill

Proposed Rules Meeting

Exporters and importers should plan for major changes in FDA regulations for nutritional labeling, health claims, food safety and the import of olive oil in the coming year. The agency is under intense pressure by consumer advocacy groups and the media to implement the Food Safety Modernization Act (FSMA) and revise its standards of the Nutritional Labeling and Education Act (NLEA). It is likely, that exporters and importers will face greater scrutiny of their products at the border, the warehouse and the stores by FDA inspectors and consumers alike and the trade partners are well advised to plan for rigorous record keeping and potential recalls.

Here is an overview of five recent developments. Upon request, we will provide updates, in-depth analysis, and regulatory insights.

FDA may consider changes to NLEA standards of calories and serving sizes
In a recent letter to Food and Drug Administration chief Margaret Hamburg, the Center for Science (CSPI) in the Public Interest urged the agency to revise its serving-size regulations. The nonprofit consumer group advocates increasing the Reference Amounts Currently Consumed (“RACC”), which were established in the 1970s and may not reflect current consumer eating behavior. Moreover, CSPI wants FDA to take enforcement action against manufacturers who “understate the serving size for single serve products so that the actual consumption of sodium, fat or calories per serving is not revealed.” Recent USDA mandated changes to the nutrition labels on meat now show portion sizes and how many servings are in a package to help people make better caloric choices. On the flip side, recent studies claim that some nuts, seeds and vegetables contain less up to 20% fewer calories than stated in the RACC and that labels should be changed accordingly. The Almond Board of California is petitioning the FDA already to reduce the reference amount for almonds. FDA may look at a complete overhaul of the NLEA over the next two years.

Fortified Foods get a closer scrutiny
The Food & Drug Administration currently examines how consumer perceive the nutritional value of fortified foods. In 2004, the agency issued a set of principles for the fortification of food based on the belief that “random fortification of foods could result in over- and under-fortificaton of consumer diets and create nutritional imbalances in the food supply.” The fortification of fresh produce, meat, poultry, fish, sugar, candies, snacks and carbonated beverages is considered “not appropriate.” Exporters should expect greater scrutiny of claims and ingredients used in fortified food products

EU organic labels now permitted in the US and Canada
One positive breakthrough in the attempts to harmonize transatlantic standards and regulations is the agreement on organic food labels between the US and the EU. As of August 2012, EU organic symbols now suffice to declare a product organic. Previously, an organic food product had to comply with USDA standards to be labeled “organic” or carry he USDA organic seal. This agreement will reduce costs for exporters and their US trade partners . However, country-specific organic labels, such as the German Bio-Siegel, are not included in the agreement . That means, food products certified only according to German Bio-Siegel norms can still not be declared “organic” in the US.

FSMA Inspection fees and importer verification
It is not a secret that the implementation of the Food Safety Modernization Act by the FDA has slowed significantly over the last months. This is primarily due to the lack of sufficient funding and the unavoidable lengthy legal review of each new regulation. So far, the FDA has done a great job to keep all constituents informed about the progress of the FSMA implementation and to minimize the effects on international trade. However, mandated recalls of domestic and imported food products have increased dramatically, as have detentions of container at the border. Exporters and their importers are well advised to jointly plan and implement record keeping of HAACP procedures, potential recalls, and supplier verification mandates. At some point over the next year, FDA inspectors will control the offices or facilities of importers and exporters. The first visit is free, but any re-visit due to careless mistakes can be very costly. A third-party audit and certification based on Global Food Safety Initiative standards (such as IFS) may reduce the frequency of inspections or the risk of failing an inspection of production facilities, importer offices, warehouses and logistics providers.

The Rise of “Nanny State” Nutrition Laws
While it may take a while, before federal FD inspectors knock on the door, local and state agencies may act sooner. Over the past years, county and state legislatures have passed laws regulating what can be served in restaurants and supermarkets. A recent article in the Washington Post reported on a forced recall of completely safe white tuna salad. The problem: the salad contained partially hydrogenated vegetable oil. This oil contains trans-fats. And these are outlawed in Montgomery County, the largest county in Maryland. A consumer complaint lead to the inspection and the retailer was forced to pull the products off the shelves. In New York, a recent decree bans the sale of super-sized soft drinks in Manhattan. In the state of Washington, local taxes on sweets and soft drinks may come into effect over the next years. Exporters and importers need to be aware that “nanny laws” (regulations for the sake of consumer protection) may differ from state to state or between counties in one state and that consumers and local health inspectors increasingly look at the legality of labels.

New Farm Bill may mandate new standards for imported olive oil and honey
Both houses of the US Congress still have not passed the US Farm Bill 2012 into law. Although the US Senate passed their version, as did House of Representative’s agriculture committee, the full House of Representatives has yet to vote on the bill. One of the more contentious issues: a marketing order for olive oil. According to Section 10010 in the Farm Bill, olive oil may soon be included in import controls under the Agricultural Adjustment Act. That means that olive oil imports not conforming to certain US standards may be rejected at the border. What these standards will be is yet to be determined. Along the same lines, section 10008 requires research into the establishment of a standard

EFSA rules in favor of chocolate health claims


ZURICH, July 17 (Reuters) – The European Food Safety Authority (EFSA) has ruled that cocoa powder and dark chocolate can help people improve blood circulation – a claim made by Barry Callebaut, the world’s largest maker of chocolate products.

The Swiss group said on Tuesday it had provided evidence to EFSA that eating 10 grammes of dark chocolate or its equivalent in cocoa that were high in flavanols helped blood flow.

If the European Commission signs off on the EFSA ruling, the company and its customers would have the right to use the health claim on packaging for products such as chocolate drinks, cereal bars and biscuits, the company said.

For the clinical studies it conducted to back up the claim, Barry Callebaut said it used a special process to make cocoa products that maintains the flavanols, which are usually mostly destroyed during conventional chocolate-making.

In an opinion posted on the EFSA website, a scientific panel concluded that a cause and effect relationship had been established between the consumption of cocoa flavanols and the maintenance of normal vasodilation, which aids blood flow.

A string of scientific studies in recent years have shown the potential for health benefits from eating chocolate. Research last year suggested it might be associated with a one-third reduction in the risk of developing heart disease.

The European Union has been clamping down on health claims for food products, approving only some 200 out of over 2,500 applications earlier this year and giving food companies until the end of 2012 to remove any rejected claims.,Cocoa in chocolate improves blood circulation. EFSA ruling may allow health claim for marketing chcocolate

IFS Safety & Quality Certification Growing in US


Food safety and quality (in addition to taste and price) is a major concern for anyone involved in the industry – from farmer to retailer. New legislation (Food Safety Modernization Act – FMSA) and stepped up inspections have increased risks and costs for anyone involved in importing, distributing and selling food in the United States.

This is a reason why safety and quality certifications used by most global producers and retailers for years gain importance even for small and mid-size producer around the world. These certifications are based on stringent audits of production and logistics facilities and use HAACP (Hazard Analysis and Control Point) principles. They often exceed the standards set by local or national government agencies.

The leading German and European audit system is International Featured Standard (IFS), which is now also widely used around the world and in North America. The IFS certification is a symbol of excellence and for many products a pre-requisite to be considered for listings. IFS audit standards are not just used in food production (IFS Food), but also at packaging producers (IFS Packaging), distribution centers (IFS Logistics) and at importers, brokers, or sales offices (IFS Broker).

A major food service distributor, US Foods, has just made it mandatory that all logistics supplier are certified by IFS Logistics. Third party auditors conduct the audits and costs per audit vary by size of facilities and number of audit days. (Smaller companies usually require one audit day at a cost of less than $2,000).

The benefits for a certified company: consideration for listings at small and major retailers, reduction in customer complaints, costs savings in production and logistics, and reduced risk of recalls. Moreover, IFS certified companies are usually considered lower risk by FDA governmental inspectors under FSMA.

More information can be found at IFS North America

FDA rulings impacting all food importers in the US.

Proposed Rules Meeting


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.

Importer Liability: As of October 2011, importer are 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.

Grey Market Imports: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.

Price pressures still a major influence on US retail market

US Americans are back shopping, but most look for bargains over brands.

Here are the results of a survey conducted in December 2011 by WSL Group:

Discount, Discount

  1. Nearly three-quarters (75%) of female shoppers say “it’s important get the lowest price on everything they buy, up 12 percentage points. from 2008 and up 22 percentage points from 2004.
  2. 68% regularly use coupons to reduce costs — up 7 percentage points. vs. 2010.
  3. 45% claim they only buy items that are on sale — also up 7 percentage points.
  4. 43% make a point to search online for store discounts before they shop — up 10 percentage points.
  5. 66% ask themselves “Is this a smart use of my money?” before making a purchase (47% with household income of over $150,000).
  6. 58% claim to stick to brands and stores they can afford (36% with household income of over $150,000)
  7. 48% claim to stay out of stores where they might be tempted to overspend
  8. 43% claim to buy less when they go shopping

Well known brands need to work harder to be relevant

  1. 67% of surveyed women agreed that trusted brand names are not worth paying more for.
  2. 26% claim to have given up buying brand name products they know they could not afford.(up 7 percentage points from 2010.

Rich or middle class?30% of Americans in the $100-150K income bracket claim they can only afford the basics. Once considered affluent, six-figure income shoppers are now identifying themselves as middle-income.

This internet survey was conducted by WSL/Strategic Retail conducted from December 1-12, 2012. The survey called “How America Shops® MegaTrends report,Moving On 2012” included 1,950 respondents drawn from a nationally representative online same.

Exporting to the USA

What to Know and Where to Find Information

commercial container ship

Click here for an update of the Food Safety Modernization Act (FSMA)

The US is the world’s largest food market, with a retail turnover of over $1.2 trillion, with more than 900,000 stores and restaurants that sell food, with a high degree of transparency and data availability, and with retail shelves stuffed to the brim.

Every brand has a chance to make it here … and an equal chance to fail. The difference between success and failure is marketing: product and packaging choices, positioning, pricing, and promotion are all important. Creativity is key. Following are check lists of what to know, category-specific facts, and sources of further information.

What to Know:

  1. Exporting to the United States is a strategic decision, which requires substantial investments in time, energy and money.
  2. Knowledge of your specific category and the retail environment is key. Before selecting products for this market, visit the United States, conduct store checks in various channels, analyze competitive products, and make your product plans accordingly.
  3. Check if your product requires any permit or are subject to any export restrictions (quotas, tariffs, licenses).
  4. Create and produce a US-ready label, including ingredient statement, nutrition statement (may require laboratory analysis), country of origin statement etc. all with the right font size and space.
  5. Register your production and warehouse facilities at the Food and Drug Administration (FDA) according to the Bioterrorism laws.
  6. Find the right importer — one of the hardest tasks in the process. This will require visiting and exhibiting at various trade fairs and making a lot of calls. The choice of importer should be determined by your choice of target consumers, retail channels, product positioning and revenue expectations. Ask your potential import partners about their retailer networks, strength and weaknesses.
  7. Make sure that your first shipments are all correctly labeled and documented. Officials of the FDA and US Customs and Border Protection (CBP) can detain containers not properly labeled which may take your products beyond their shelf life.
  8. Gain retail distribution and keep it. This could be one of your biggest financial investments. In the highly competitive US market you can gain shelf space quickly, but you can loose it equally fast. Product positioning, communication and promotion are key to stay on the shelves.

Category-specific facts:

  • Pork: currently, only processed pork products from Germany are allowed into the United States, such as ham and sausages. Both slaughterhouses and processing facilities need to conform to USDA standards and will have to be inspected and certified by the USA. As this is a very cumbersome, lengthy and expensive process, only a handful of German processors have a USDA license to export to the USA. One of these is Meica, a premier German sausage brand.
  • Beef and poultry products may not be imported, due to different phytosanitary standards between the USA and the EU. However, the import of life animals, such as horses, is possible.
  • Egg products may not be imported due to the Avian flue virus (with a few exceptions.)
  • Milk and dairy products, such as quark, require a ‘Grade A’ permit, which is almost impossible to obtain. Hence authentic German products are not available in the USA.
  • Cheese imports in general are subject to high import duties (to protect the domestic industry), unless an importer has a license that allows to import a certain quota of cheeses from around the world an no or very little duty. The licenses are available at the FDA and will be renewed every year. There are some fine cheeses from Germany available in the United States, such blue cheese and Cambozola from Bavaria.
  • The US Department of Agriculture (USDA) regulates fresh products (meat, vegetables, dairy etc) while the Food & Drug Administration regulates most package goods and cheeses.
  • Low acid canned goods require a permit.
  • Organic products may carry the well known ‘National Organic Program’ (NOP) issued by the USDA, which clearly defines which products are organic according to specific standards and which are not. US organic standards differ from those in the EU. Imported organic products may not carry any seal of another country or region.
  • Alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of Homeland Security (DHS). Labels must be approved by the Bureau prior to import.

Sources of Further Information:

German Foods North America provides many service and expert advice for each step of the market entry and beyond. Please contact our office anytime.

Importers will be held responsible for food safety


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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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:

  1. International Food Safety – IFS (worldwide the leading standard, originated in Germany/France)
  2. Food Safety Standard Certification – FSSC 22000 (originated in the Netherlands, replaces the Dutch HACCP)
  3. British Retail Consortium Standard – BRC originated in Great Britain)
  4. 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?

  1. Biological
  2. Chemical
  3. Physical
  4. Radiological Hazards
  5. Natural toxins
  6. Pesticides
  7. Drug Residues
  8. Decomposition
  9. Parasites
  10. Allergens
  11. Unapproved food and color additives
  12. Hazards that occur naturally
  13. Hazards that may be introduced unintentionally or intentionally

Q: What are the criteria that FDA will us to establish risk profiles for food facilities?

  1. The known safety risks of the food to be imported.
  2. The compliance history of foreign suppliers used by the importer, as appropriate.
  3. The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.
  4. The compliance of the importer with therequirements of section 805.
  5. The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.
  6. 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

Neues US Gesetz nimmt Importeure in die Verantwortung für Lebensmittelsicherheit



Eine Analyse des Food Safety Modernization Act 

von Arnim von Friedeburg
eine Version in englischer Sprache ist auf www.germanfoods.org/trade zu finden

Der Food Safety Modernization Act (FSMA) umfasst die folgenden vier Haupthemen:

  1. HAACP Plan des Herstellers: Jeder Hersteller von Lebensmitteln im In- und Ausland wird verpflichtet, alle Gefahren der Verunreinigung bei der Produktion und Lagerung von Lebensmitteln gemäss eines gesetzlich vorgeschriebenen HACCP Plans (Hazard Analysis and Critical Control Point) zu analysieren, Vorbeugungsmassnahmen durchzuführen und sowohl Gefahren und Vorbeugung sorgfältig zu dokumentieren. Diese Dokumente müssen aufbewahrt und auf Verlangen der FDA vorgezeigt werden.
  2. Registrierung: Jede Produktions – und Lagerungsstätte im In-und Ausland muss sich bei der FDA registrieren (unabhaenging von der Bioterroismusregistrierung) und es dürfen nur Lebensmittel von registrierten Betrieben in die USA importiert und verkauft werden. Die Registrierung muss alle zwei Jahre erneuert werden. (Sec. 103, 415)
  3. Haftung des Importeurs: Jeder Importeur muss sicherstellen – und wird dafür haftbar gemacht – dass eingeführte Lebensmittel den Sicherheitsbestimmungen der USA entsprechen und dass die entsprechenden Herstellungs- und Lagerungsstätten der ausländischen Partner gemäss den US Standards kontrolliert und zertifiziert wurden. HAACP Pläne und Zertifizierungen müssen bei der Einfuhr auf Verlangen vorgezeigt werden. Wer vorsätzlich kontaminierte oder auch nur falsch etikettierte Lebensmittel in den Markt bringt, macht sich strafbar. (Sec. 201, 301, 302 und 107)
  4. FDA Kontrollen: Die FDA ist verpflichtet, jeden Herstellungsbetrieb von Lebensmitteln im In-und Ausland innerhalb einer bestimmten Zeitraumes zu kontollieren. Diese Kontrollen richten sich je nach Risikoprofil des Produkts und Herstellerlandes, sowie dem Status des Herstellers und Importeurs. Die FDA soll in den in den nächsten 4 Jahren über 17,000 Inspektoren in den örtlichen Büros anstellen und trainieren. Dafür (und andere Programme) soll ein Budget von $1.6 Milliarden zur Verfügung gestellt werden. Erneute Inspektionen von Betrieben, die bei der ersten Inspektion beanstandet wurden, sind kostenpflichtig, Die FDA is verpflichtet, auch die Betriebsstaetten von Importeuren zu kontrollieren (Sec. 201)
  5. FDA Befugnis zum Rückruf: Die FDA hat nun das Recht, schon bei begründetem Verdacht, das bestimmte Lebensmittel verseucht oder vergiftet sind, ein Rückrufaktion dieser Produkte anzuordnen. Bisher konnte die FDA nur nach klarer Beweisführung dem Hersteller empfehlen, freiwillig einen Rückruf durchzuführen.

Mögliche Konsequenzen und Kosten der Verordnungen für deutsche Exporteure und deren US Importeure:

In dem folgenden Fragen-und-Antworten Katalog werden einzelne Passagen des Gesetzestext beleuchtet und die wichtigsten potentiellen Auswirkungen für US Importeure und deren Exportpartner analysiert:

Q: Welcher HACCP Plan eines Hersteller wird von der FDA akzeptiert?

A: Die FDA wird in den nächsten sechs Monaten festlegen, welche Methoden der Rsikobewertung, Massnahmen zur Risikoverringerung und Dokumentation akzeptiert werden. Es kann gut sein, das einzelne bestehende Methoden der Sicherheitsüberprüfung im In-oder Ausland nicht mehr ausreichen werden, um eine Einfuhr zu garantieren.

Q: Welche Kontrollen und Zertifizierungen ausländischer Behörden oder Institutionen werden von der FDA akzeptiert?

A: Das wird in den nächsten sechs Monaten von der FDA festgelegt. Es ist anzunehmen, dass eine Reihe staatlicher und nicht-staatlicher Organsiationen in Europa im Rahmen des “Foreign Supplier Verification Programs”anerkannt und von der FDA akkreditiert werden. Da es in Deutschland allerdings keine nationale produktübergreifende Lebensmittelkontrolle gibt, kann es vorkommen, das Zertifikate einzelner Bundesländern oder örtlichen Behörden (Veterinär- und Gesundheitsämtern) den US Standards nicht entsprechen und somit nicht akzeptiert werden. Das muss im einzelnen Fall geklärt werden.

Q:Werden Sicherheitsüberprüfungen und Zertifikate von privaten „third party auditors“ wie dem TÜV, akzeptiert?

A: Vermutlich ja, aber diese sind nicht vorgeschrieben. Dennoch ist anzunehmen, daß die vier internationalen HAACP Standards der “Global Food Safety Initiative” (GFSI) das Risikoprofil eines Lebensmittelhestellers denkbar verbessern werden. Diese vier Standards sind

  1. International Featured Standard (IFS)
  2. Safe Quality Foods
  3. British Retail Consortium Standard
  4. FSC 22000

Der IFS Standard ist global am weitesten verbreitet und in Deutschland für alle Private Label Produkte schon fast eine Pflicht.

Q:Was muss der HAACP Plan eines Herstellers alles berücksichtigen?

  1. Sanitäre Massnahmen fuer alle Kontaktflächen, Werkzeuge und Geräte, die mit Nahrungsmitteln in Berührung kommen.
  2. Sicherheitstraining für Arbeiter und Vorgesetzte
  3. Umweltanalyse und Kontrollmassnahmen zur Vermeidung von Kontamination durch schädlichen Keimen, Bakterien
  4. Kontrollmassnahmen für Allergene
  5. Rückrufprogramm
  6. Pläne fuer die Durchführung von Good Manufacturer Practices (GMP)
  7. Rückverfolgbarkeit der Inhaltsstoffe verarbeiteter Lebensmittel

Q: Welche Gefahren muessen von Herstellern erfasst werden?

  1. Biologische
  2. Chemische
  3. Physikalische
  4. Atomare
  5. natürliche Gifte
  6. Pestizide
  7. Arzeneimittelrückstände
  8. Fäulnis
  9. Parasite
  10. Allergene
  11. die Anfälligkeit des Herstellungsbetriebes gegenüber natürlichen Katastrophen oder terroristischer Akte

Q:Nach welchen Kriterien sollen Risikoprofile für die Bewertung von Betrieben im In-und Ausland erstellt werden?

  1. Bekannte Risiken des Produkts
  2. Risiko des exportierenden Landes
  3. die vergangene Einhaltung der Vorschriften (“compliance history”) des Importeurs in Bezug auf Betriebssicherheit, Kontrollen, Dokumente, Rückrufe etc.
  4. Teilnahme des Importeurs im freiwilligen qualifizierten Importeurprogramm (“voluntary qualified importer program”) eine Art „fast track“, das eine schnelle und unkomplizierte Einfuhrkontrolle garantiert.
  5. die Genauigkeit, mit der ein Lieferanten aus dem Ausland überprüft werden (“Foreign Supplier Verification Program”), sowohl im jeweiligen Exportland und vom importeur.

Q: Welche Lebensmittel und Betriebe sind von dem Gesetz und der Registrierung nicht betroffen?

  1. Fleisch, Gefluegel und Eier, die werden vom US Landwirtschaftsministerium (USDA) überprüft
  2. Fruchtsäfte … die FDA hat für diese Ketegorie bereits einen HAACP Plan für Hersteller und Importeure vorgeschrieben
  3. Schwachsaure Lebensmittel … Hersteller müpssen sich bereits bei der FDA registrieren und dabei einen HAACP Plan vorlegen
  4. Alkoholische Getränke … unterliegen der Überwachung des Tax and Trade Bureau (TTB) im Heimatschutzministerium (Department of Homeland Security). Etiketten müssen vom TTB genehmigt werden. Einige Passagen des FSMA Gesetzes betreffen allerdings auch alkoholische Getränke!
  5. Meeresfrüchte .. unterliegen der Überwachung des Handelsministeriums (Department of Commerce) und der FDA
  6. Nahrungsergänzungsmittel (nutritional supplements)
  7. Kleinbetriebe unter $500,000 Umsatz, und Bauernhöfe, die innerhalb von einem Umkreis von 250 Meilen ihre Produkte direkt an Verbraucher verkaufen
  8. Tierfutterhersteller
  9. Betriebe, die Lebensmittel zwischenlagern ohne dass Lebensmittel irgendwie kontaminiert werden können (bei Flughäfen zum Beispiel)

Q:Was können US Importeure tun, um die Einfuhr von Produkte ihrer Exportpartner zu erleichtern?

A: Importeure können sich einer gesonderten Überprüfung seitens der FDA unterziehen, und dadurch die Einfuhr von Produkten auf einem „fast track“ deutlich beschleunigen. Die Teilnahme an einem solchen „qualified importer program“ ist für den Importeur kostenpflichtig. Derzeit gibt es bereits ein fast track Programm des US Zolls, das sogenannte „Customs-Trade Partnership Against Terrorism“ der US Zollbehörde, unter dem Container bereits vor der Verschiffung kontrolliert und dadurch bei der Einfuhr beschleunigt abgefertigt werden. Ob diese Programme zukünftig zusammen oder doppelt durchgeführt werden, ist noch unklar. Auf alle Fälle verringert die Teilnahme an einm oder beiden Programmen merklich das Risikoprofil des Importeurs und dadurch das Riskio, das ein Container am Zoll „hängenbleibt.“

Q:Welche Auswirkungen wird das neue Gesetz auf den “Graumarkt“ haben?

A:Interessanterweise wird im Gesetztext ausdrücklich erwähnt (Sec. 309), das die FDA bessere Strategien entwickeln soll, um den Schmuggel von Lebensmitteln (Graumarktware) zu verhindern. Ausserdem kann die FDA nun den sofortigen Rückruf von Lebensmittel ohne US-gerechter Ettikettierung oder solche mit fehlhafter Etikettierung anordnen. Diese Umsetzung dieser beiden Passagen des Gesetzes werden das finanzielle Risiko für Exporteure und Importeure von Graumarktwaren merkbar erhöhen.

Q:Welche zusätzlichen Kosten kommen auf Importeure und ihre Exporteure für die Einfuhr von Lebensmitteln zu?

  1. Obwohl im Gesetz nicht ausdrücklich bestimmt, sollen die FDA Registrierungen der Herstellungs – und Lagerungsstätten kostenpflichtig sein und müssen alle zwei Jahre erneuert werden. Es heißt, das eine Registrierung um die 500 Dollar kosten soll, aber das steht noch nicht fest und wird sich in den nächsten Monaten herausstellen.
  2. Wenn ein Herstellungsbetriebe aufgrund von Mängeln bei der Erstinspektion erneut kontrolliert werden muss, dann ist diese „re-inspection“ kostenpflichtig. Für ausländische Betriebe wird der „ United States agent for each foreign facility “ – also in den meisten Fällen der Importeur- haftbar gemacht.
  3. Sollte der Betrieb eines Importeurs Mängel aufweisen, dann muss er auch für eine erneute Kontrolle bezahlen.
  4. Ein Importeur, der einen von der FDA angeordneten Rückruf nicht unverzüglich und ordnungsgemäss durchführt, muss die Kosten der Durchführung seitens der FDA bezahlen
  5. Der Importeur muss Gebühren für die Teilnahme an dem „voluntary qualified importer program“ tragen. Diese Teilnahme verringert die Kosten bei der Einfuhr, vor allem das Risko einer Beschlagnahmung des Containers
  6. Darüberhinaus ist die Teilnahme am C-TPAT Programm kostenpflichtig. Diese Kosten richten sich nach der Größe des Betriebes und könnenzwischen $10,000 und $100,000 betragen.

Q:Wann wird die FDA verbindliche Regeln zur Durchführung des FSMA veröffentlichen?

A: Das kann noch bis zu 18 Monate dauern, vermutlich werden die ersten Regeln innerhalb eines Jahres herausgegeben. Es sollen vor allem 2.000 Inspektoren angeheuert und trainiert, sowie ein zusätzliche Budget von 1.6 Milliarden Dollar bereitgestellt werden. Derzeit ist noch nicht klar, ob dieses zusätzliche Budget zur Umsetzung des Gesetzes vom Kongress bewilligt wird. Das von der Republikanischen Partei dominierte Repräsentantenhaus, steht derFinanzierung aufgrund des hohen Haushaltdefizits skeptisch gegenüber.

Q:Welche Massnahmen sollten deutsche Exporteure von Lebensmitteln nun als erstes beruecksichtigen?

A: Zunaechst gibt es keinen akuten Handlungsbedarf, bevor die FDA endgültige Verordnungen veröffentlicht hat. Allerdings sollten sich deutsche Exporteure auf einschneidende Veränderungen bei der Einfuhr von Lebensmitteln gefasst machen und entsprechend vorbereiten:

  • Arbeiten Sie schon jetzt mit Ihrem Importeur zusammen, um einen HACCP Plan zu erstellen und entsprechend zu dokumentieren
  • Da nun der Importeur im Obligo steht, nachzupruefen und zu dokumentieren, das ein Exporteur akzeptable Sicherheitskontrollen durchfuehrt, kann es vorkommen, dass bestimmte Importeure die bisherige Zusammenarbeit mit Exporteuren aufgrund der Risiken einer Einfuhrverweigerung oder eines Rueckrufes aufgeben. So wird es in Zukunft wichtiger, einen verlaesslichen “Importer of record” zu finden, anstatt mehrere Importeure zu benutzen.
  • Prüfen Sie die Kapitalisierung Ihres Importeurs. Möglicherweise kann der Handelspartner die neu anfallenden Kosten nicht mehr decken und Sie haben das Risiko, das ein beschlagnahmter Container nicht mehr bezahlt wird.
  • Lassen Sie sich von erfahrenen Experten im Lebensmittelrecht und der US-gerechten Ettikettierung beraten. Es geht ja letzlich darum, daß Verbraucher wissen wollen und müssen, was in den Produkten enthalten ist, besonders solche Verbraucher mit Allergien, Diabetes oder anderen Krankheiten