All About the FSMA Food Safety Plan – in German

fda_buildingIm Jahr 2011 verabschiedete der US Kongress und Präsident Obama den Food Safety Modernization Act (FSMA). Dieses bahnbrechende Gesetz gibt der US Food & Drug Administration (FDA) grundlegend neue Befugnisse zur Überwachung und Regulierung von Lebensmitteln, die in den USA hergestellt oder vertrieben werden. Die Behörde brauchte immerhin fünf Jahre, um das Gesetz in umzusetzen. Hier sind die drei wichtigsten Eckpunkte:

  • Die Verantwortung und Haftung bei Ausbrüchen von Lebensmittelvergiftungen liegt nun ausschliesslich bei Herstellern, Importeuren, Großhändlern und Transportunternehmen, nicht bei der FDA
  • Die FDA hat nun die uneingeschränkte Befugnis, Lebensmittelbetriebe oder Importfirmen in den USA zu schliessen, wenn diese den Vorsorge und Kontrollpflichten nicht nachkommen und eine Gefahr für die Allgmeinheit darstellen.
  • Eigentümer und Angestellte von Betrieben und Importeure, die nachweislich und vorsätzlich vergiftete Lebensmittel vertreiben, werden nun immer häufiger und rigoroser vor Gericht gestellt und, wenn schuldig befunden, zu langen Haftstrafen verurteilt.

Wir können nur mit Nachdruck allen deutschen und europäischen Herstellern von Lebensmitteln, die von der FDA überwacht werden,  empfehlen, die neuen Regeln des Food Safety Modernization Acts zu lesen, zu verstehen und umzusetzen. So kann vermieden werden, dass Lieferungen an der Grenze hängenbleiben, FDA Kontrollen nicht bestanden werden oder US Handelskunden Aufträge stornieren oder andere Lieferanten bevorzugen.

Die folgenden Fragen und Antworten fassen die wichtigsten Bestandteile und Auflagen der FSMA Vorschriften zusammen.

Was schreibt FSMA vor?

FSMA reguliert drei Hauptbestandteile bei der  Lebensmittelherstellung:

  1. Current Good Manufacturing Practices – CGMP (Gute Herstellungspraxis/ Qualitätsmanagementsysteme)
  2. Hazard Analyis (Gefahrenanalyse)
  3. Risk Based Preventive Controls for Human Foods (Auf Risiken basierende Vorbeugungsmaßnahmen für die Herstellung von Lebensmitteln)

Ab wann müssen die FSMA Verordnungen befolgt werden?

Seit September 2015 sind diese Verordnungen für alle gesetzlich verpfichtend.

  • Ab September 2016 müssen alle Hersteller mit mehr als 500 Mitarbeitern die Vorschriften erfüllen
  • Ab September 2017 müssen kleine Betriebe mit weniger als 500 Mitarbeitern und über $1 Millionen Umsatz die Vorschriften erfüllen
  • Ab September 2018 müssen alle Kleinstunternehmen mit Umsätzen unter $2 Millionen oder sogenannte “qualified facitities” (z.Bsp. Bauernhöfe mit Lebensmittelherstellung) die Vorschriften erfüllen

Proposed Rules MeetingWer muss die neuen FSMA Vorschriften befolgen?

  1. Alle Betriebe in den US, die Lebensmittel (siehe Punkt 4) herstellen, weiterverarbeiten, verpacken, lagern, und transportieren, also bei der FDA registriert sind
  2. Alle US Importeure von ausländischen Lebensmitteln, die nun verpflichtet sind, die Sicherheit der von ihnen eingeführten Produkte zu überprüfen und für deren Sicherheit haftbar gemacht werden.
  3. Alle ausländischen Hersteller, die bei der FDA registriert sind und Lebensmittel (siehe Punkt 4) in den USA vertreiben. Nach letzter Schätzung sind das rund 114,000 Betriebe in 200 Ländern. Über kurz oder lang müssen alle ausländischen Betriebe von der FDA inspiziert werden (oder im Auftrag der FDA von einheimischen Organisationen). Wenn Betriebe die Inspektion nicht bestehen, kann die FDA die Registrierung löschen – und damit dürfen diese Betriebe dann keine Lebensmittel mehr in die USA vertreiben oder verkaufen.

Welche Lebensmittelkategorien unterliegen den FSMA CGMP Vorschriften?

  1. Zutaten für Nahrungsergänzungsmittel
  2. Säuglingsnahrung
  3. Getränke
  4. Früchte und Gemüse
  5. Fisch und Meeresfrüchte
  6. Milchprodukte
  7. Backwaren
  8. Snacks
  9. Süsswaren
  10. Gesäuerte und schwachsaure Lebensmittel
  11. Wildfleisch

Wer muss die neuen FSMA Vorschriften nicht, oder nur zum Teil, befolgen?

  1. Sehr kleine Betriebe (mit Umsatz unter $1 Millionen) und sogenannte “qualified facilities” mit Umsatz unter $500,000 müssen den FSMA Food Safety Plan nur bedingt erfüllen
  2. Hersteller von Fleisch- und Eiprodukten, die vom US Department of Agriculture überwacht werden
  3. Hersteller/Exporteure von Fischen und Meeresfrüchten, die die sogenannten Seafood HAACP Verordnungen befolgen müssen
  4. Hersteller/Exporteure von Fruchtsäften, die die sogenannten Fruit HAACP Verordnungen befolgen müssen.
  5. Hersteller/Exporteure von schwachsauren Lebensmitteln, die für mikrobiologische Gefahren die Low Acid Canned Food Verordnungen erfüllen müssen (sie benötigen ein spezielles Zertifikat der FDA), für alle anderen Gefahren aber den FSMA Verordnungen unterliegen
  6. Hersteller/Exporteure von Nahrungsergänzungsmitteln (die unterliegen den Nutritional Supplement Good Manufacturing Practices)
  7. Hersteller/Exporteure von alkoholischen Getränken (die unterliegen den Vorschriften des Alcohol and Tobacco Tax and Trade Bureau – TTB)

Wie müssen die FSMA Vorschriften befolgt werden?

Alle o.g. Betriebsstätten müssen eine sogenannten Food Safety Plan erstellen, der die folgenden Themen behandelt

  1. Hazard Analysis: Eine Analyse der Gefahren bei der Herstellung, Verabeitung, Lagerung, dem Einkauf von Zutaten und Transport, die zu Lebensmittelvergiftungen führen können
  2. Preventive Controls: Eine Liste und Zusammenfassung aller Präventivmassnahmen, um die analysierten Gefahren zu verhinden.
  3. Risk-based Supply Chain Program: Ein Plan zur Überwachung und Gefahrenvermeidung Ihrer Lieferkette – ein Schritt zurück, ein Schritt vorwärts
  4. Recall Plan: Ein Plan für den Fall einer Rückrufaktion. Die Anzahl von freiwilligen oder angeordneten Rückrufaktionen von Lebensmitteln hat sich seit FSMA mehr als verdreifacht.
  5. Monitoring the Implementation of Preventive Controls: Eine Beschreibung der Massnahmen zur Präventivkontrolle
  6. Verification of the effectiveness of preventive controls: Eine Beschreibung der Verfahrensweise zur Überwachung der Wriksamkeit von Präventivkontrollen und deren eventuellen Anpassungen

Je größer der Betrieb und je mehr Umsatz in den USA gemacht wird, desto eher wird empfohlen, diesen Food Safety Plan in englischer Sprache zu erstellen.

Wie unterscheidet sich der FSMA Food Safety Plan von Überprüfungen großer Handelsketten, also den Audit Standards der  Global Food Safety Initiative (GFSI), zum Beispiel IFS, BRC, FSSC 22000, oder SQF ?

Der FSMA Food Safety Plan muss von einem/r designierten Experten/in für Qualität und Lebensmittelsicherheit (qualified individual) erstellt werden. Mit großer Wahrscheinlichkeit sind fast alle Informationen von den Berichten der Prüfungsfirmen für die genannten  GFSI Standards enthalten. Es ist aber ratsam, dass sich die Betriebsexperten mit den Prüfungsfirmen oder den MItarbeitern der GFSI Standards auseinandersetzen und herausfinden, welche der auditierten Punkte den FSMA Vorgaben entsprechen.

Food_Processing_iStock_000018272872smHazard Analysis: Welche Gefahrenquellen müssen identifiziert werden ?

  1. Biologische – speziell mikrobiologische Gefahren, wie Parasiten, Bakterien, Viren und andere Pathogene aus der Umwelt
  2. Chemische – Nukleare Verseuchung, Pestizide, Arzeneimittelrückstände, natürliche Giftstoffe (wie Mycotoxine), Verwesung, nicht genehmigte Farbstoffe oder Zusatzmittel, nicht deklarierte Allergene
  3. Physische – Steine, Glas, Metallfragmente

Hazard Analysis – Bei welchen Aktivitäten müssen Gefahrenquellen analysiert und bewertet  werden?

Hier sind ein paar Beispiele:

  1. Lebensmittelzutaten – Säure oder Zusatzstoffe, die den Wachstum von Mikroorganismen verhindert oder diese abtöten. Manche dieser Zutaten können Allergien erzeugen
  2. Zustand, Funktion und Design des Betriebs oder der Maschinen – Lose Teile, die schlecht gereinigt werden, können Pathogene beherbergen. Machinen mit Metallteilen können Metallsplitter erzeugen
  3. Reinigung, Hygiene – Chemikalien während der Reinigung können in Lebensmittel greaten. Ungewaschene Hände von ungeschulten Mitarbeitern können zu Vergiftungen führen
  4. Zutaten – kontaminierte Zutaten, die nicht gescheckt wurden, können das fertige Lebensmittel vergiften
  5. Transportwege – Ungenügende Temperaturkontrollen während des Transports von Lebensmitteln können diese vor derm Verkauf verderben oder schädliche Krankheitserreger hervorbringen.
  6. Herstellungsprozess – Ungenügende Kühlung, Erhitzung oder Lagerung kann Krankheitserreger oder Giftstoffe hervorbringen.
  7. Verpackung und Etikettierung – Glasverpackung kann splittern. Fehler bei der Gestaltung, dem Druck und dem Anbringen von Etiketten können dazu führen, das Allergeninformationen für Verbraucher nicht verfügbar oder lesbar sind
  8. Lagerung und Distribution – Ungenügende Kühlung bei heissen Temperaturen oder während des Transports
  9. Vorhersehbare Benutzung des Produkts – Manche Lebensmittel, die gekocht werden sollten, werden auch manchmal roh gegessen. Hinweise müssen auf den Verpackungen erscheinen, die vor einem vorhersehbaren, unsachgemässen Verzehr des Produkts warnen
  10. Umweltverschmutzung – in bestimmten klimatischen Zonen können Krankheitserreger aus der Luft bestimmte Lebensmittel, die gleich verzehrt werden, kontamiieren.

Tomato_Inspected_iStock_000006170909MediumPreventive Controls: Was muss im FSMA Food Safety Plan enthalten sein?

  • Kontrollen an kritischen Kontrollpunkten (CCP – Critical Control Points)
  • Kontrollen ausserhalb der CCPs, an Punkten, die eenfalls kritisch für die Lebensmittelsicherheit sein können

Darunter fallen:

  1. Parameter und Kontrollen bei Kochprozessen, wie zum Beispiel Erhitzung, Säurung, Radiologische Behandlung, Kühlung
  2. Allergenkontrolle, Vermeidung von Cross-Kontamination, Kontrolle der Etiketten
  3. Kontrolle der sanitären Massnahmen
  4. Kontrolle der Lieferkette (supply chain program)
    • Auswahl von Lieferanten, die den FSMA Verordungen entsprechen
    • Regelmässige/jährliche Kontrolle der Sicherheit von Lieferantenprodukten
    • Möglicherweise direkte Audits der Betriebe von Lieferanten
    • Labortests und Bemusterung
    • Überprüfung der Sicherjeitsprotokolle von Lieferanten
  5. Kontrolle bei Rückrufaktionen:
    • Benachrichtigung der direkten Kunden,
    • Benachrichtigung der Öffentlichkeit,
    • Kontrolle der Wirksamkeit des Rückrufs,
    • Kontrolle der Vernichtung der rückgerufenen Lebensmittel
  6. Kontrolle der Schulung und Training von qualifizierten Mitarbeitern
    • Laut FSMA dürfen nur Mitarbeiter, die in “risk-based preventive controls,” Lebensmittelsicherheit und –hygiene geschult wurden, einen FSMA Food Safety Plan erstellen und dokumentieren.
    • Das Management eines Betriebes muss sicherstellen, dass die qualifizierten MItarbeiter für die Erstellung eines FSMA Fod Safety Plans entsprechend geschult werden oder von ausgebildeten Vorgesetzten betreut werden

Preventive Controls – Protokollierung

Die Dokumentation der Kontrollen und Massnahmen im Präventivsystem ist eine der wichtigsten Komponenten der FSMA Verordnung. Bei FDA Audits müssen die entsprechenden Protokolle der folgenden Aktivitäten vorgezeigt werden:

  1. Überwachung (Monitoring) der Kontrollpunkte und der Kontrollen
  2. Massnahmen zur Vermeidung und Beseitigung von potentielle Gefahren
  3. Sicherstellung und Bestätigung dieser Massnahmen
  4. Labortests und Umweltüberwachung
  5. Protokollführung

Wenn ein Betrieb bestimmte Lebensmittel an Weiterverarbeiter zuliefert und diese Weiterverarbeiter die oben genannten Präventivkontrollen zur Lebensmittelsicherheit durchführt, dann braucht der Zulieferbetrieb diese Protokollierung nicht durchführen.

commercial container shipDie Kontrollpflicht der Importeure

Eine der Säulen des Food Safety Modernization Acts ist das sogenannte “Foreign Supplier Verification Program”. Damit werden alle Importeure verpflichtet, die Sicherheit von Lebensmitteln zu überprüfen.

Die deutschen/europäischen Lieferanten von Importeuren, Großhändlern und EInzelhändlern sollten eine Kurzversion des Food Safety Plans Ihren Kunden senden, damit diese ihren Pflichten des Foreign Supplier Verification Programs nachkommen.

Mehr Informationen (auf Englisch)

Food Industry Faces Paradigm Shift

Brief Introduction to German Fruit Preserve Regulations

Here is a brief introduction to the German fruit preserve law, the classifications and legally prescribed fruit content.

Pumpkin orange ad 2Classification

The official term for fruit preserves in German is Konfitüre (fruit spread).  Yet, in  German vernacular, you can find many other words:

Marmelade (engl: marmelade): Derived from the Portugese word “marmelo” (engl: quince).  Most Germans use the word as umbrella term for all fruit preserves and jams. Yet, European and German law mandates that only citrus-based preserves may officially be called Marmelade  

Konfitüre (engl: fruit preserve or jam): This words leans on the French la confiture and stands for jams with visible bits of fruits or berries. Today, it’s the common term for all jams

Gelee (engl: jelly): Fruit jellies can only be made from fruit juices.

Fruchtbutter or -mus (engl: fruit butter): Fruit butter, like Pflaumenmus, or Apfelbutter, is a thick spread made from lots more fruits in weight than what comes out as fruit spread.

Conventional and Organic German PreservesQuality differences

German and EU law mandates the amount of fresh fruits that processors have to be use in the commercial production of jams, jellies and fruit butters.

  • For most fruit jams, the minimum is 35% (350g in 1000g jam).
  • For some berries, that may be too sour or inedible in their natural state, the minimum share of fresh fruit is 25% (this includes black and red currant, rosehip, sea buckthorn, and quince).
  • For plum butter, the amount of fruit used is 140% of the final product, because plums are slowly cooked and thicken over time.

Most German, Austrian or Swiss quality brands use between 45% and 55% for all fruit jams. In contrast to many of the widely distributed US brands, German fruit preserves do not contain corn-derived sweeteners,  just GMO-free sugar beets, fruit pectin as gellant and lemon juice as preservative. That makes all the difference in taste and texture.

Food Safety Modernization Act – Update

fda_buildingIt took five years from the president’s signature to the publication of the final rule.

Now it’s here: as of September 2015, the first final rule of the Food Safety Modernization Act (FSMA) comes into force.

In the following, we’ve summarized the most significant aspects of the FSMA rules and how they may impact producers, exporters and the import community (click on links to read more):

Significance:

  • The Food Safety Modernization Act of 2011 ist the largest overhaul of the US food safety system and Food & Drug Administration’s mandate since the presidency of Franklin Delaneor Roosevelt (the 1930s)
  • Prior to FSMA, the FDA’s food safety policies were primarily geared towards preventing the spread of food poisoning outbreaks. FSMA gives FDA the authority to prevent food outbreaks before they happen and puts the responsibility to prevent food-borne illnesses and outbreaks squarely onto the shoulders of food manufacturers and suppliers.
  • This increases the liabilities to own, operate and manage a food business. Shipping mis-branded or adulterated foods can be very costly, even if no consumer is harmed. The risk for manufacturers and importers residing in the US is financial, reputational and personal: owners and managers may go to jail, if their products caused severe harm to the health of consumers due to negligence or bad intent.

Scope:

  • FSMA and related laws literally affect anyone in the food industry: Retailers, Manufacturers, Distributors, Warehouse Operators, Transport Agencies, Importers, Exporters, Consultants, Audit Firms (Certification Bodies), and even Foreign Governments.
  • FSMA rules affect all segments of the food and beverage industries, with the exception of seafood, produce, and fruit juices. These three categories are subject to very similar, but separate rules, established in previous decades.   A separate law also regulates low acid canned foods; however, only in regards to microbiological hazards. FSMA also aligns with US Department of Agriculture (USDA) safety protocols guiding the meat industry.

The Eight Segments of FSMA

FSMA rulemaking is structured and implemented in four phases (final rule dates)

  1. Preventive Controls for Human Food (September 2015)
  2. Preventive Controls for Animal Food (September 2015)
  3. Standards for Produce Safety (November 2015)
  4. Foreign Supplier Verification Programs (FSVP) for Importers (November 2015)
  5. Voluntary Qualified Importer Program (November 2015)
  6. Accreditation of Third Party Auditors/Certification Bodies (November 2015)
  7. Transportation of Human and Animal Foods (April 2016)
  8. Strategies to Protect Food Against Intentional Adulteration/Food Defense (June 2016)

Implementation Schedule

The rules for Preventive Controls for Human and Animal Foods are final and must be implemented as follows:

  • Manufacturer
    • Medium to Large Size Businesses by September 2016
    • Small Businesses with fewer than 500 employees by September 2017
    • Very Small Businesses with less that $1 million in sales and assets, with FDA approved records that support their status by September 2018
    • Dairy Businesses subject to the Pasteurized Milk Ordinance by September 2018
  • Distributor/Warehouses/Receiving Facilities:
    • Medium and Large Businesses by March 2017
    • Small Business with less than 500 employees by September 2017

The 5 steps for Preventive Controls:

FSMA Preventive Control rules are essentially about risk based Current Good Manufacturing Practices (CGMP) Most established and experienced food manufacturers around the world will already employ CGMP in some form or another, especially if they are certified by standards under the Global Food Safety Initiative. Risk-based preventive controls include:

  1. hazard analysis and risk assessment
  2. preventive controls
    1. the process
    2. food allergens
    3. sanitation
    4. supply-chain program
  3. verification of these controls and corrective actions as necessary
    1. monitoring
    2. corrective actions
    3. verification
  4. recall plan
  5. record keeping requirements (all of the above)

Hazards? What Hazards?

  • Allergens: The failure or accidental mistake to declare all allergens present in a food is by far the Number One reason for recalls in the US
  • Microbiological contaminants: Interestingly, spices imported from around the world are most frequently identified as sources of contaminated food. Herbs, sprouts and produce follow suits as frequent carriers of dangerous bacteria, such as salmonella, listeria and E coli. FSMA mandates the verification of the entire supply chain!
  • Chemical contaminants, such as pesticide and herbicide residues or residues of chemical solvents or detergents, may be detected in food.
  • Physical hazards in food, such as glass, metal, plastic
  • Sanitation: The FDA has now the power to revoke the registration and order the shutdown of food facilities with unsanitary conditions or lack of proper cleaning procedures. This happens more frequently now.
  • Environmental contamination: This is especially important for processors of produce, but also applies to areas with a lot of wildlife, water pollution or animal diseases
  • Intentional contamination. Do you have procedures in place that prevent disgruntled employees or outsiders to enter your food production areas and contaminate your food intentionally?

Investment in People and Procedures (Preventive Controls)

  1. Employee Qualification: FSMA mandates that you have to employ a “qualified individual(s)” to conduct preventive controls and write a food safety plan. A random employee assigned to the task, including a senior manager, do not qualify, if he or she has not undergone extensive training. Similarly, all employees directly involved in “manufacturing, processing, packing or holding food” need to be qualified to perform their assigned duties.
  2. Education and Training: Qualified Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
  3. Product testing & Environmental Monitoring FSMA specifically mandates product testing and environmental monitoring for all manufacturers, on a risk based frequency. The results of the tests have to properly recorded and kept on file.

Written Food Safety Plans and Record Keeping

  • All steps of the hazard analysis and preventive controls, monitoring and verification, corrective action, and recall plans have to be documented and updated every three years.This is part of the FSMA’s record keeping mandate.
  • The Written Food Safety Plan must or should be shared with you importer of record. FSMA obliges importers to verify the safety of the products they bring into commerce in the US under the Foreign Supplier Verification Program
  • Also share the results of all food safety and quality audits with your importer. The audit schemes benchmarked under the Global Food Safety Initiative, such as IFS, BRC, SQF or FSSC 22000, are likely to be FSMA compliant (see below).

Foreign Supplier Verification and, if applicable, Voluntary Qualified Importer Program

Importers will be obliged to verify the food safety of their export partners on an annual basis and keep records of their verification. Specifically, importers have to

– Determine known or reasonably foreseeable hazards with each food

– Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

– Use that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

– Conduct supplier verification activities

– Conduct corrective actions

More specifically:

  1. Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
  2. Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
  3. Importers will be obliged to inspect foreign manufacturers facilities at least once a year if the food they import is deemed to be high risk, i.e. could cause “serious adverse health consequences or death to humans or animals.”
  4. Like domestic and foreign manufacturers, importers will also be subject to controls by FDA inspectors.
  5. Importers or the designated manufacturer agent will be liable for all costs related to FDA mandated recalls and re-inspection of facilities, if these failed the first inspection.
  6. Importer investment into verification, record keeping and qualified food safety personnel will likely increase the costs of doing business for many small importers (and may limit the number of available importers for exporters in the long run)
  7. Manufacturers samples and food imported for research purposes is not subject to Foreign Supplier Verification, but need to be produced according to FSMA standards.
  8. FDA will more vigorously target and pursue smugglers of food who illegally introduce imported food into commerce that could have a potential public health risk.

Third Party Accreditation and the Global Food Safety Initiative

This (not yet final) rule is all about enlisting non-governmental organizations, foreign governments, accreditation agencies and audit/certification bodies to control food safety in lieu of the FDA. The agency already has to few inspectors and limited budgets. The question is: who will be an accredited third party and what will that cost the accredited organization.

For example, most consumer packaged food and beverage companies are subject to retailer audits according to four major standards or schemes:

The accreditation of the private standards holders and their audit/certification bodies may fulfill the FSMA requirements for the audited firm and importer, which will greatly lower the risk for the imported or distributed foods.

However, the current draft rules suggest that a third party may have to pay in $16,000 per year for the accreditation and have to submit the audits to the FDA based on request. Many foreign governments and private organizations view these requirements as potential trade barriers and sticking points for compliance – issues that will likely be resolved before the final rules come out.

 

As NON-GMO Label Thrives, Calls for Mandatory Labeling Get Louder

Tomato_Inspected_iStock_000006170909MediumAs sales of non-GMO labeled products eclipsed $10 billion in 2014 and continues to pace at double digit growth, consumer and food industry advocates pressure the FDA and USDA to provide a clear guidance to what and what not constitutes foods free of genetically modified organisms. Current definitions and mandatory labeling laws vary from state to state, potentially leading to regulatory challenges for suppliers whose products are sold in multiple states, and confusion among consumers, who are paying more attention to such labels.

A Nielsen consumer survey found that 80 percent of respondents would pay a premium for non-GMO foods, though most say they don’t trust food labels. The independent Non-GMO Project, so far the most successful non-profit agency that has iussued guidelines for GMO-free foods, lists more than 24,500 products to date bearing the NON-GMO seal. Some of the Global Food Safety Initiative standards, such as IFS Food, the leading European standard, also audits Non-GMO records of food companies in Europe and the US.

Meanwhile, the Food and Drug Administration (FDA) has published a guidance of voluntary labeling of GMOs nationwide, but food industry critics demand mandatory labeling laws.

As the Food Safety News reported in February 2015:

Sens. Barbara Boxer (D-CA) and Richard Blumenthal (D-CT) and Rep. Peter DeFazio (D-OR) reintroduced legislation February 12 to label genetically engineered (GE) food.

The Genetically Engineered Food Right-to-Know Act would require the U.S. Food and Drug Administration to label GE food and foods containing GE ingredients.

“Consumers have a right to know what is in the foods they eat and parents have a right to know what they are feeding their families,” Boxer said.

“We cannot continue to keep Americans in the dark about the food they eat,” DeFazio said. “More than sixty other countries make it easy for consumers to choose. Why should the U.S. be any different?”

In 1992, FDA stated that it had no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.

FDA currently supports voluntary labeling in which food manufacturers indicate whether their products have or have not been developed through genetic engineering, “provided such labeling is truthful and not misleading.”

“The public wants more information about the food they are buying and how it’s grown,” said chef Tom Colicchio, who joined the lawmakers and advocates from Just Label It, Food Policy Action, Environmental Working Group and Center for Food Safety at a press conference announcing the bill. “I applaud Sens. Boxer and Blumenthal and Rep. DeFazio for their leadership and urge their colleagues to join them in standing up for the 93 percent of Americans who want to know whether their food has been genetically modified.”

To date, the Just Label It campaign has collected 1.4 million signatures on its petition to FDA seeking mandatory labeling of GE foods.

2015 Trend: New Era for International Trade

Cargo Ship3A nation’s economic prosperity depends on open and free trade with other nations and the international community is trying hard for the past 60 years to lower trade barriers, alas, with mixed success. The latest attempt to establish global free trade, administered by the Word Trade Organization, dubbed the Doha Round, went nowhere. So, the main economic centers are now working on bilateral deals, called the Trans Pacific Partnership (TPP = US and various Asian countries), and Transatlantic Trade and Investment Partnership (TTIP = US and the European Union). Despite ferocious opposition by vocal consumer and special interest groups, it is widely believed, that these trade deals are inevitable and will be signed in the next two years.

Here we’d like to focus on the the US-Europe free trade negotiations (TTIP) and highlight the opportunities and challenges for a final deal especially for the food and agricultural sectors.

The goal of TTIP:

– enable stronger economic activity and GDP growth,
– expand markets especially for small and mid-size producers,
– increase consumption and consumer choices
– provide long-term financial stability on both sides of the Atlantic.

How can that be done? First: reduce or remove all tariffs and customs duties. Second: harmonize as many import and regulatory rules in as many industries and as fast as possible.

The main sticking points:

a) although industry standards and regulatory frameworks are similar in many respects, especially in the US and European Union, it is very hard to harmonize or change them overnight. Governmental procedures, oversight authority and rule making differ substantially, often for historic and cultural reasons.

b) some regions and industry segments still need protection from open competition, especially in rural areas, or those vulnerable to unemployment.

c) Different world views about privacy, consumer vs.investor protection,  financial market regulation and de-regulation, business owners vs. employee rights and food production and safety practices  persist. These differences are based, again, on historical and cultural traditions, and are therefore highly emotionally charged. Even scientists cannot agree.

TTIP for the food and agricultural industries:

A transatlantic trade agreement would have to overcome a range of technical and perceptual hurdles, both of which are highly emotionally charged:

From the European side:

– widespread use of genetic modification, hormones and antibiotics in animal and crop farming
– food safety measures such as the chlorination of chicken
– disregard for the Protection of Geographic Indication for some foods, like Parmesan Cheese
– the domination of multinational corporations in the consumer foods industries and a penchant for mass produced, fast food in the USA

From the American side:

– High tariffs and protective measures
– Preference for imports from former colonial regions
– A disregard for science in regards to biotech and use of steroids and pharmacological products in agriculture
– A certain European arrogance in regards to the quality, taste and traditions of foods produced and consumed in the US

More to follow…