Comparison of European and US Food Law Regulations in the Context of the Transatlantic Trade and Investment Partnership

Master's Thesis, 2014

80 Pages, Grade: 1,3


Table of Contents


List of abbreviations

List of Figures

1. Introduction and Objective

2. Structure of the food safety system
2.1. Food Safety System in the U.S.
2.2. Food Safety System in the EU

3. Risk Analysis
3.1 Risk Assessment
3.2 Prevention of food safety problems
3.3 Response and risk communication

4. Special cases
4.1. Meat production
4.1.1. Hormones in meat
4.1.2. Antibiotics in meat
4.1.3. Beta-Agonists in meat
4.2. Organic food
4.3. Food labeling
4.4. Genetically modified crops, food and feed
4.5. Food additives
4.6. Eggs

5. Chances and challenges of the Transatlantic Free Trade Agreement (TAFTA)
5.1. The Transatlantic Trade and Investment Partnership (TTIP)
5.2. General Benefits
5.3. Consequences for the EU and the U.S.

6. Conclusion

7. Summary



I hereby affirm that I have prepared the present paper self-dependently, and without the use of any other tools, than the ones indicated. All parts of the text, having been taken over verbatim or analogously from published or not published scripts, are indicated as such. The thesis hasn’t yet been submitted in the same or similar form, or in extracts within the context of another examination.

Place, date of submission

Student’s signature

List of abbreviations

illustration not visible in this excerpt

List of Figures

Figure 1: FDA Organization chart

Figure 2: USDA Organization chart

Figure 3: Organisation structure of risk assessment and risk management in Europe

Figure 4: Organisational structure of the European Food Safety Authority

Figure 5: Organisational structure of the Health and Consumer Directorate DG-SANCO

Figure 6: RASFF process in general and in the case of the E.coli outbreak 2011

Figure 7: Principle of antibiotic resistancy development based on antibiotic use

Figure 8: EU organic logo for products complying with EU Organic standards

Figure 9: USDA organic logo for products complying with USDA organic standards

Figure 10: Current and proposed food labeling requirements in the US

Figure 11: Procedure of risk assessment and considered factors for GMOs

Figure 12: Approval process for GMOs under the responsibility of the USDA

Figure 13: Approval process for GMOs under the responsibility of the EPA

Figure 14: Decision tree for the approval of food ingredients

Figure 15: Combined U.S. – EU share of global economy

Figure 16: Tariffs for selected products in the EU U.S. trade area

1. Introduction and Objective

In July 2013, negotiations concerning the Transatlantic Trade and Investment Partnership (TTIP) were initiated. Objective of the negotiations is the generation of a Free Trade Agreement (FTA) between the United States (U.S.) and the European Union (EU) to promote trade by reducing trade barriers, including tariff and non-tariff ones.

In order to achieve this goal, several issue barriers have to be addressed, inter alia concerning non-tariff barriers including regulatory differences in the sectors of agriculture and food production. While the U.S. and the EU both have high standards concerning the consumer protection and food safety assessment, differences in the basic principle and implementation persist. Both countries pursue an agreement that follows the respective principles and still provides effective trade stimulation. However, based on the rooted differences in the particular food safety systems, challenges are inevitable.

The objective of this study is the presentation of the U.S. and EU food safety system as well as special cases highlighting the differences between both systems in terms of risk assessment, prevention, responses and risk communication. The different factors are analyzed both theoretically and on the basis of practical examples. Additionally, the different matters are described in the context of the TTIP to identify issues that may complicate the negotiations. Possibilities to resolve those issues are discussed and recommendations for positive outcomes given.

2. Structure of the food safety system

In order to understand the differences between the U.S. and the EU food law system, the structure of each system needs to be taken into consideration.

In both the U.S. and the EU food safety control and regulation take place on both federal and regional level. While the EU provides a more complex system given by the combination of different countries with different food standards and traditions, the U.S. system has to balance the authorities of each state with its own agencies and regulations. (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013)

2.1. Food Safety System in the U.S.

In total, 15 agencies govern food safety issues in the U.S., with about 30 food safety related laws as a basis. (2011a) The principal federal level of the U.S. food safety system is regulated by the Food and Drug Administration (FDA) of the United States Department of Health and Human Services (HHS) and the Food Safety Inspection Service (FSIS) of the United States Department of Agriculture (USDA). While the FSIS is responsible for the inspection of meat, poultry and egg production under the Meat and Poultry and Egg Inspection Acts and for certifying organic products, the FDA is responsible for almost all the remaining food supply (80%) (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013; Kirchsteiger-Meier and Baumgartner, 2014), regulated by the Food, Drug and Cosmetic Act and the Food Safety Modernization Act (FSMA), which is still in the process of being implemented. Exceptions to this are for example the grading of fish and seafood, drinking water, alcohol and pesticide residues. The conduction of the Egg Products Inspection Act is shared by the FDA and the FSIS. (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013; Johnson, 2014) The reason the food safety responsibility is divided between those two agencies can be found in history of food safety laws. In 1906 the framework acts were established, which are still valid until today: The Pure Food and Drugs Act and the Meat Inspection Act. While the Pure Food and Drugs Act covered “intentionally adulterated foods” (Johnson, 2014) and implementation was under the responsibility of the USDA Bureau of Chemistry, which later became the FDA, the Meat Inspection Act solely covered the safety of conditions in meat packing plants and was therefore under the responsibility of the USDA Bureau of Animal Industry. Segregation was further established in 1940 when the responsibility for safe food other than meat and poultry was assigned to the Federal Security Agency, which became later the HHS. (Johnson, 2014)

The implementation of food laws follows a two-step-procedure with the congress enacting broad laws and the federal agencies implementing those in specific regulations. This process is still ongoing for the FSMA, which was passed in 2009. In cases the law passed by the Congress may cause ambiguity concerning the interpretation, the U.S. court system becomes responsible. (Kirchsteiger-Meier and Baumgartner, 2014, pp. 279) In addition, “states remain free to pass their own laws that do not conflict with […] the federal requirements”. However, state laws may be preempted by federal laws to prevent conflicts. (Kirchsteiger-Meier and Baumgartner, 2014, p. 280) Examples are laws concerning food labeling, health claims and ingredient declaration.

The FDA responsibilities include measures to protect “the public health by assuring that foods […] are safe, wholesome, sanitary and properly labeled”. (Office of the Commissioner, 2014)

Therefore, the FDA is authorized to enforce the regulations given by the Food, Drug and Cosmetic Act as well as the FSMA. This includes for example inspections of manufacturers and processors, providing training and guidance to “state and local regulatory agencies, the industries they regulate and to public health partners”. (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013) The organisational structure of the FDA can be taken from figure 1.

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Figure 1: FDA Organization chart

with highlighted Offices responsible for the Food Safety (Office of the Commissioner, 2014c)

The responsibilities of the FDA cover an extensive area from medicine over tobacco, cosmetics and drugs. It consists of four directorates with the Office of food and veterinary medicine (FVM) being responsible for food safety issues. The main responsibilities of the FVM include the implementation of the FSMA and the recommendations of the President’s Food Safety Working Group (FSWG) as well as the achievement of the Agency’s public health goal by leadership, guidance and support. (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013)

The office is subdivided in four directorates: the office of resource planning and strategic management, the office of coordinated outbreak response and evaluation network, the center for veterinary medicine (CVM) and the center for food safety and applied nutrition (CFSAN).

The responsibilities of the CVM include the manufacturing and distribution of food additives and drugs given to animals, both consumption and pet animals. The CFAN covers principal food safety in order to “reduce the risk of foodborne illness, including standard setting and compliance strategies for domestically produced and imported products and the provision of technical guidance to states and localities”. (European Parliamentary Directorate-General for Internal Policies Policy Department A Economic and Scientific Policy, 2013)

The Department of Health and Human Services also includes the Center for Disease Control (CDC). It acts under the authority of the Public Health Service Act and is responsible for the monitoring, identification and investigation of foodborne diseases, as well as the development and evaluation of improved epidemiological and laboratory methods. (Johnson, 2014)

While most of the U.S. food regulations are the responsibility of the FDA, meat, poultry and eggs are mostly regulated by the FSIS. The Food Safety and Inspection Service is one of seven areas of responsibility of the U.S. Department of Agriculture.The organisational structure of the USDA is displayed in figure 2.

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Figure 2: USDA Organization chart

with Offices highlighted responsible for the Food Safety (USDA, 2013)

The main responsibility of the FSIS is the monitoring of all meat, poultry and egg products that are traded across states or are imported in the U.S.. If products are only sold within the state they are produced in, state inspection is sufficient and can be conducted by local agencies.

However, the competences of the FSIS do not include farms and food safety at retail. These sectors are covered by the FDA.

While both the FDA and the FSIS have similar tasks and intentions, the implementation of those differs in some aspects. For the enforcement of regulations, FSIS relies on the presence of food inspectors at the producing facility at all times. Guidelines include the supervision of slaughter plants at all operation times and processing plants have to be supervised at least once daily. (Johnson, 2014) Also, many products have to be cleared before they come into the market. (Kirchsteiger-Meier and Baumgartner, 2014, p.280) Enforcement by the FDA in contrast relies more on regulations, monitoring with spot inspections and post-marketing surveillance. (Kirchsteiger-Meier and Baumgartner, 2014, p.280, p.297)

A third federal agency responsible for food safety matters is the Centre for Disease Control and Prevention (CDC) with responsibilities covering the detection and investigation of foodborne illnesses as well as to “monitor the effectiveness of prevention and control efforts in reducing foodborne illnesses”. It is responsible for food crisis management and food risk communication as well as food risk evaluation.

Additionally to the principle federal agencies, several other agencies operate on federal and on state level. Examples for agencies responsible for federal sectors are the Environmental Protection Agency (EPA), responsible for safety of chemicals, for example pesticides, in food. While the EPA controls the use of pesticides based on regulations released by both the FDA and USDA, most of the decisions concerning the use and safety of chemicals in food are established by the EPA. Enforcement of pesticide use restrictions are administrated by state agencies under EPA contract, while pesticide tolerances are controlled by the FDA.

However, food safety tasks are not only responsibility of federal agencies. Over 3000 state and local agencies, mostly based on the state’s health and agricultural departments, play a role in food safety. Responsibilities include but are not limited to laboratory testing, surveillance, outbreak response and recalls and farm inspections.

Food-safety related laboratory testing is mainly conducted on state level, with some testing being performed on a local level. State agencies hold the key responsibility on foodborne illness surveillance by working both independently and in cooperation with the CDC and local agencies and by participating in national foodborne surveillance activities. On a local level, the responsibilities in the surveillance foodborne illnesses are to collect and report information and to respond to consumer complaints.

State agencies are solely responsible for farm inspections including inspection for animal health, enforcing federal pesticide use restrictions as well as assessment of the administration of Good Agriculture Practice.

In addition to the general small scale responsibilities, state and local agencies have the authority to regulate retail, food service establishments and farms if retail food, milk or shellfish are affected. These so called cooperative programs are supported by guidance, training and assistance by the FDA and are developed in order to increase consumer protection from foodborne illnesses. Cooperative Programs are also established with the FSIS. State Meat and Poultry Inspection has to meet the requirements given by the FSIS. However, a state may chose to assign the meat and/or poultry inspection to the FSIS, even if the product is not traded to other states. As of 2013, 27 U.S. states still operate their own inspection system. Meat and poultry produced under those systems may only be traded intrastate. (Johnson, 2014)

2.2. Food Safety System in the EU

The Food Safety System in the EU was a patchwork of the food safety systems of the different member states for a long time. As of 2014, the EU involved 28 member countries, and each historically developed an individual food safety system.

Especially after the Bovine Spongiform Encephalitis (BSE) in the 1990ies, the need for consistent rules and general responsible authorities was evident. In the following years, the Green Paper on Food Safety and the subsequent White Paper on Food Safety issued by the Commission of the European Communities addressed these problem and recommended potential solutions. As a result, in January 2002 the EU Regulation (EC) No 178/2002 on laying down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety was drafted. (European Parliament and Council of the European Union, 2002) Subsequently, subsidiary regulations were published. As of September 2014 there are 901 regulations, including implementing regulations, concerning the Environment, Consumer and Health Protection. On top of that, more than 500 directives, decisions and resolutions were published. (EUR-, 2014) The complexity of the regulations, as well as the socio economic importance combined with one of the most extensive legislative frameworks was an essential factor in the decision to perform a so called fitness check on the regulations. The sector of food safety is one of the most harmonized sectors, meaning that most issues are regulated on EU level. (FDA, 2011b)

However, the framework of the European Food Safety System is defined by the EU Regulation (EC) NO. 178/2002, supplemented by the so-called Food Hygiene Package consisting of the legislative Acts Regulation (EC) No. 852/2004 on the hygiene of foodstuffs, Regulation (EC) No. 853/2004 on laying down specific hygiene rules on the hygiene of foodstuffs and Regulation (EC) No. 854/2004 on laying down specific rules for the organization of official controls on products of animal origin intended for human consumption and the Feed and Food Control Regulation (EC) No. 882/2004. (European Parliament and Council of the European Union, 2004a, 2004b, 2004c, 2004d; Shames, 2009; Food Safety Authority of Ireland, 2012)

One important factor of the EU food safety system is the separation of risk assessment, conducted by the EFSA, and risk management, conducted by the European Commission. The purpose of this separation is to prevent influence of political opinions and motivations on the scientific risk assessment and therefore maintain an independent risk assessment. (FAO/WHO Consultation, 1997) This was for example the case during the BSE crisis, as the British Ministry for Agriculture, Fisheries and Food (MAFF) was not only responsible for consumer protection but also for the agricultural and industrial interests. This conflict of interest was one factor that caused the BSE crisis to become so extensive. (Kobusch and Prof.Dr. Abels, 2010) The organisational structure of risk assessment and risk management in Europe can be seen in figure 3.

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Figure 3: Organisation structure of risk assessment and risk management in Europe

(Henning et al., 2014)

The European Food Safety Authority (EFSA) is an independent scientific agency responsible for Risk Assessment, independent risk communication and crisis management. It was founded based on the EU Regulation (EC) No 178/2002 and organization and duties were additionally defined by the Regulation (EC) No. 1304/2003 on the procedure applied by the European Food Safety Authority to requests for scientific opinions referred to it and Regulation (EC) No. 2230/2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002. (Commission of the European Communities, 2003; EU Commission, 2004; European Commission, 2013c) The organisational structure of the EFSA is displayed in figure 4.

Requests for risk assessments conducted by the EFSA may come from the European Commission, the European Parliament, EU member states or the EFSA itself. Examples for recent risks assessments are for example a safety assessment of mycotoxins (2014c) or on the re-evaluation of Indigo Carmine (E132) as a food additive (2014a), both conducted on request by the European Commission. Findings are published on the EFSA website and referred to the inquirer. In the first 5 years of operation, EFSA published over 450 scientific options on a wide variety of topics. (Kirchsteiger-Meier and Baumgartner, 2014, p.119)

Development of risk assessments is administrated by scientific committees with focuses on particular topics, for example contaminants, genetically modified organisms, pesticides, feed and so on. Each committee is in charge of advising policy makers, for example the European Commission, the European Parliament or member states, as well as evaluating applications for approval, for example for additives. The responsibilities and organization of the scientific committees is based on the Commission Decision 97/579/EC. (Commission of the European Communities, 2012) However, recommendations made by EFSA are not mandatory. As the EU regulation (EC) 178/2002 states, EFSA may only act as” point of reference [and] shall act in close cooperation with the competent bodies in the Member States carrying out similar tasks to these of the Authority.” (European Parliament and Council of the European Union, 2002, Article 22) Although it is stated that member states have to take into account EFSA’s, if conflicts arise they may be resolved or the disagreement may be identified and documented. (European Parliament and Council of the European Union, 2002, Article 6 and 30; Leibovitch, 2008) Thus, the member states are not obligated to implement EFSA’s recommendations.

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Figure 4: Organisational structure of the European Food Safety Authority

(EFSA, 2014d)

The organisational structure of the EFSA reflects its mandate of risk assessment and risk communication. The agency is divided in five directories responsible for scientific matters, like evaluation, risk assessment and coordination, as well as communication offices and support offices. The EFSA is independent of political influences and operates without directive from the EU Commission.

Obligatory regulations in contrast are made by the so-called risk managers, namely the European Commission, the member state authorities and the European Parliament. The European Commission acts as an executive body responsible for legislature, food safety policies and, as mentioned above, risk management. It consists of 28 members, one for each member state, with each member representing one specific area, for example environment, health or trade. (European Commission, 2013f)

Legally binding regulations are drafted by the corresponded departments of the European Commission. Concerning food issues the EC Directorate-General for Health and Consumers (DG-SANCO) is responsible for legislative acts. This directorate was only founded after the BSE crisis and findings of dioxin in chicken in the 1990s and is independent from agricultural policy. (Shames, 2009) Its organisational structure is displayed in figure 5.

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Figure 5: Organisational structure of the Health and Consumer Directorate DG-SANCO

(DG- Sanco, 2014)

The organization of the DG-SANCO is subdivided in two main directorates: The office of Consumers and Health and the office of food chain responsibility. Responsibilities of the latter include food chain safety, veterinary and international affairs and the food and Veterinary office (FVO). (Henning et al., 2014)

As a part of the DG-SANCO, the Food and Veterinary Office (FVO) assists and advises the authorities in terms of risk management concerning the inspection and the control. The FVO acts as a control authority on the individual effective implementation of EU law in the member states. Responsibilities of the FVO include but are not limited to monitoring import from third party countries, inspections on behalf of the European Commission, and inspections on the compliance of regulations in EU member states. The FVO acts on the EU Regulation (EC) No. 882/2004 Articles 45 and 46 as an amendment to the EU Regulation (EC) No. 178/2002. Also, the European Union Reference Laboratories (EU-RL) act as an advisor to the European Commission, additionally to develop and validate test methods for example. Each EU-RL focuses on a specific set of substances, for example pesticides and responsibilities are defined in EU Regulation (EC) No. 882/2004, Article 32. (Federal office of consumer protection and food safety, 2014; Henning et al., 2014; Kirchsteiger-Meier and Baumgartner, 2014)

In addition to the European Commission, the Council of the European Union (CEU) and the European Parliament, which is directly elected by the citizens of the EU, are responsible for law making and food safety, as well as risk management. While the European Commission is responsible for proposing regulations, the CEU and the European Parliament decide on the release of them.

One of the main differences between the U.S. and the EU food safety systems is the federal and centralized character of the U.S. versus the non-federal organization of the EU. While the implementation of food related laws as well as the enforcement in the U.S. is concentrated on a federal level and law making is the responsibility of two authorities, each member state in the EU may interpret, translate and implement the regulations, directives or decisions provided by the European Commission in a different way. Each member state may formulate slightly different laws from EU decision and directives, which may result in different administrations. (Leibovitch, 2008) Also, member states are autonomously responsible for the implementation of the law, in terms of assigning a central competent agency and enforcing the compliment with the law. In general, the member states are responsible for the implementation, surveillance and control of the laws, while the EU legislation monitors the performance of the member states in terms of audits and inspections. (Shames, 2009, p.31) In Germany, the Federal Ministry of Food and Agriculture (BMEL) is the competent agency, assigning the Federal Institute for Risk Assessment (BfR) and the Federal Office of Consumer Protection and Food Safety (BVL). In France in contrast, the Ministry of Agriculture, Food, Fisheries, Rural Affairs and Land Planning (MAAPRAT) shares responsibility for risk communication and risk management with the Ministry of Economy, Finance and Industry (MEFI) and the Ministry of Health and Social Affairs (MASS). Risk assessment is conducted by the French Agency for Food, Environmental and Occupational Health and Safety, which was formed in 2010. Each of the 28 member states of the EU has its own organization of authorities and associated agencies and each country remains autonomous in the application of the law with the administrative procedures being dependent on the national law. (Kirchsteiger-Meier and Baumgartner, 2014, p. 113) The Authorities of the EU administer responsibility only in exceptional cases, for example if the national competent agencies report objections against applications for approval, for example for novel food. The basis of this approach is called subsidiary principle and is specified in Article 5 of the Treaty of the European Union. It states that the EU legislation may not intervene in cases the member state may act at least with the same efficiency as the Authority. This is for example the case for law implementation according to the regulations. (EUR-lex, 2010d) The complex subject of the subsidiary principle can be found in several areas of food safety, for example food labeling.

Food product labeling requirements are specified by six regulations and six directives, with one additional regulation and two additional directives compulsory in 2016. Actual implementation of these rules in national law differs highly among the member states of the EU. (Ministry of foreign affairs Netherlands CBI, 2012c) However, as of December 2014, the Regulation (EC) 1169/2011 comes into effect, overriding all directives except for the directive 89/396/EC and the Regulation 608/2004. (European Parliament and Council of the European Union, 2011) This may cause a more consistent implementation among the member states.

While all member states implemented the regulations and directives according to the specifications of the EU legislation, labeling requirements in the member states vary from one single regulation concerning all labeling in Austria to six individual regulations in Germany and France concerning allergens, nutrition, caffeine, lot marking, general labeling requirements and packaging gas, sweeteners and liquorices. However, the EU legislation does not interfere with the differences in the law making as long as the implementation is in accordance with the particular regulation. (EFSA, 2014e)

3. Risk Analysis

Comparing the legal framework for food safety will be done based on the federal law of both the U.S. and EU rather than focusing on the rules of the individual states. While both the EU and the U.S. have generalities concerning food safety, the individual states have to implement them respectively. The implementation will be addressed only shortly to maintain the comparability of both systems rather than concentrating on the individual realization of those.

The European and the American food regulations and food laws have some basic differences concerning the fundamentals. One possibility to address those differences is to analyze the differences in risk behavior of those two constitutions.

The American food laws have been revised as of 2011, when the FDA Food Safety Modernization Act (FSMA) was signed and in the years following with the rules according to the Act. However, one has to keep in mind that, although the implementation of the FSMA was scheduled to be realized within 3 years of announcement, the FDA received additional time to publish the final rules until May 2016 at the latest. Thus, many rules are not yet finalized and the existing rules may not be put into action by the companies until now if the implementation period for the corresponding company is not over yet. For example, rules concerning the Hazard Analysis and Risk-Based Preventive Controls for Human Food (Section 103 of the FSMA) were issued by January 2013 with a 120-day comment period, which was then further extended until January 2014. Companies are granted additional time for implementation after the final rule is published and has become effective. Large companies (> 500 employees) are granted 1 year, small companies (less than 500 employees) 2 years and very small companies (less than $250,000 sales volume or less than 1,000,000 sales) 3 years. Thus, the rule probably will not be implemented in all companies until mid 2017. (Biros, 2014)

Additionally, the FSMA does not include facilities under the control of the USDA, which includes meats, poultry and eggs, as well as juice manufactures, seafood processors and some other businesses. (Biros, 2014) A modification of the USDA Food Safety and Inspection guidelines has yet to be approached.

The modification of the U.S. food law include a shift of focus from reacting to problems to prevention of food safety problems, rapid detection and response to those and improving the quality of imported food. It is the most extensive reform of U.S. Food Law in over 70 years.

The Act gives more power to the FDA in terms of being authorized to issue a mandatory recall for unsafe foods in cases the company does not recall voluntarily as well as suspending the registration of a company. Companies are obligated to present a preventive controls plan and the FDA is required to announce mandatory produce safety standards.

The European Food Law framework is regulated according to the Regulation (EC) No 178/2002, published 2002 and its respective regulations. Food Safety Standards as well as the responsibilities of producers and the analysis of food risks are regulated according to this regulation.

Comparing the U.S. and the European Food Law, one can highlight the following chapters: risk assessment, prevention of food safety problems and response and risk communication.

3.1 Risk Assessment

Risk assessment describes the process of hazard identification, hazard characterization, exposure assessment and risk characterization. (Saxowksy, 2014b) The result of the risk assessment is the basis for the respective food law system.

Both the European and the U.S. Food Law have the intention to prevent food safety problems, rather than react to problems after they occur. However, differences in the implementation of the risk assessment subsist. In general, the differences in the prevention of food safety problems can be summarized in three chapters: The precautionary principle, the farm-to-fork approach and the acknowledgement of other factors in the evaluation of food safety.

Precautionary principle

Probably the most prominent difference in approaching prevention of food safety problems as well as in the context of the TTIP is the concept of the precautionary principle. (Barker, 2014) The EU General Food Law states that if there is the possibility of harmful effects but “scientific uncertainty persists” (European Parliament and Council of the European Union, 2002, Article 7), risk management measures may be conducted in order to maintain the high level of health protection while additional scientific data is obtained. That means, safety measures may be conducted although no certain scientific proof exists about the harmful effects of the product in question and thus, a proactive approach is chosen.

In contrast, the U.S. Food law states that a safe product is a product with a “reasonable certainty […] that the substance is not harmful under the intended conditions of use” and further that “it is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance” (Foods for human consumption, 21 C.F.R., Ch. I, § 170, 2012) Thus, while acknowledging that scientific proof lacks a degree of certainty, deciding on a retroactive approach. (Haniotis, 2000) This way, additives or procedures with possible and/or suspected harmful effects may only be prohibited if distinct proof of risks is given. And in most cases, for example concerning arsenic containing food additives, risk management measures may only be administrated for the specific product risks have been verified for, not the whole range of products.

Examples in the conduction of the precautionary principle may be the approach concerning growth hormones, which will be discussed later in this text, as well as arsenic feed additives.

Arsenic feed additives, for example 3-Nitro® (Roxarsone) by Pfizer, were used in the U.S. to increase the growth of animals, to prevent parasitic diseases and for a fresher appearance of the meat, since arsenic makes the meat appear pinker. As of 2011, the FDA reacted to the findings of levels of organic arsenic found in supermarket chicken. (Food and Drug Administration, 2011) Inorganic arsenic is a known carcinogen (IARC Working Group, 2004) and while the FDA states that organic arsenic, which is used in the feed additives, is not known carcinogenic, it is still a toxic substance. (World Health Organization, 2012; Center for Veterinary Medicine, 2014b)

After the presence of inorganic arsenic was detected in broiler chicken, the FDA published a statement defending their decision to approve arsenic containing feed additives. It stated: “The scientific understanding at the time of approval was that the organic arsenic in 3-Nitro® (Roxarsone) would be excreted as organic arsenic, which is not known to be a carcinogen. Until recently, scientific evidence indicated that animals exposed to organic arsenic rapidly excrete the compound in its original form - as organic arsenic. FDA approved the product at doses and withdrawal times that, based on this available information, allowed for the safe and effective use of the product when used according to the label directions.” (Center for Veterinary Medicine, 2014)

However, the agency admits that the scientific studies at the time of approval only determined the total arsenic in the meat from animals treated with arsenic feed additives, and assumed that the arsenic detected was organic arsenic. After different scientific reports over the period of several years showed that organic arsenic can in fact transform to inorganic arsenic, they performed actual testing of the meat for inorganic arsenic. As a result of these findings, the FDA advised Pfizer to voluntary suspend the sale of Roxarsone in the U.S., which they did. Yet, since only poultry treated with Roxarsone was tested, the FDA limited the response to Roxarsone. Other arsenic containing feed additives are still on the U.S. market, for example Nitarsone by Pfizer. As of today, it is not withdrawn from the market. (Center for Veterinary Medicine, 2014; FDA, 2014a)

In the EU, arsenic feed additives were never approved, based on the precautionary principle as too little data was available, for example concerning the metabolism in animals. (2004) In contrary, arsenic is found to be listed by the Directive 2002/32/EC on undesirable substances in animal feed. That is 11 years prior to the reaction of the FDA.

Farm-to-fork principle

Another critical difference between the food safety approaches of EU and U.S. is the farm-to-fork approach (EU) with focus on the whole process rather than on the end product (U.S.). In the EU, an integrated approach is employed, taking into consideration the whole food production chain including hygiene prerequisites and material traceability. (Kirchsteiger-Meier and Baumgartner, 2014, p.284) The differences between the U.S. and the EU can be recognized in many processes, for example the different approaches in the treatment of meat produce in the EU and U.S..

In the U.S., the treatment of meat includes standard chemical carcass treatment with for example lactic acid or chlorine-based substances. While lactic acid is now approved in the EU based on EU Regulation (EC) No. 101/2013, other chemical carcass treatments are not. (EU Commission, 2013a) Concerning the decontamination of carcasses, EFSA states that “besides using water to clean carcasses, decontamination treatments are not allowed to substitute good hygiene practices”. (EFSA, 2014a) Reasons are for example the missing proof of efficiency (2014d) and missing knowledge about the metabolism of the chemical substances with the meat. (2014d) Thus, meat processors in the EU have to maintain good hygiene during the whole process as major contaminations cannot be eradicated by the use of only hot water. U.S. meat processors in contrast can rely on the high antimicrobial effect of the disinfectants used at the end of the processing.

While the FSA does stress the importance of Hazard Analyses and Critical Control Points (HACCP) and current Good Manufacturing Practice (cGMP) measures, food safety is mainly concentrated on the final product rather than the individual steps of production. While meat processing is regulated by the U.S. Department of Agriculture, even under FSMA new rules concentrate rather on the end product. One example for this is the rule concerning produce safety. (Haniotis, 2000)

The FDA proposed the rule concerning most fruits and vegetables in raw condition stating for example measures in health and hygiene, agricultural water and domestic animals. One excerpt focuses on the health and hygiene, stating guidance for farm personnel to “use hygienic practices, including hand washing and maintaining adequate personal cleanliness”. However, the rule does not cover any raw fruits and vegetables that are “rarely consumed raw […] and (with certain documentation) those destined for commercial processing, such as canning, that will adequately reduce microorganisms of public health concern”. (Center for Food Safety and Applied Nutrition, 2014a)

This means that a subsequent treatment of the produce with for example heat or other microorganism reduction methods renders previous contamination prevention measures, like good personnel hygiene, unnecessary.

In contrast, the EU regulation regarding the hygiene of foodstuff (EU Regulation (EC) No. 852/2004) is valid for all foodstuff, with additional rules for high-risk foodstuff like meat to reduce the initial threat of contamination. Scientific basis for this approach was given for example by analyzing the contamination of broiler meat with Campylobacter. It was found that “the public health benefits of controlling Campylobacter in primary broiler production are expected to be greater than control later in the chain as the bacteria may also spread from farms to humans by other pathways than broiler meat.” (2011b)

Other differences concerning the farm-to-fork approach versus the focus on the end product can be found in issues of traceability of food components and preventive treatment with antibiotics, which will be addressed later.

Other factors

While the U.S. food law concentrates on scientific factors to render food products safe for the market the EU food law explicitly includes “other factors legitimate to matter under consideration”. (European Parliament and Council of the European Union, 2002) These factors could be ethical, economical or environmental and include for example consumer choices and concerns, for example concerning cloned animals or genetically modified organisms. (Castres, 2014) While the acknowledgement of those additional factors plays a role in authorization of foodstuff, for example regarding genetically modified food, it mainly affects in the labeling. The consumers’ right to know is defined in the white paper on food safety (2000): “Consumers have the right to expect information in food quality and constituents that is helpful and clearly presented, so that informed choices can be made.” The difference between U.S. and EU view on other factors becomes apparent in the issue of genetically modified organisms (GMO). GMO containing foodstuff must be labeled in the EU and the Commission’s decision on the strict regulation of GMO is, besides scientific findings, also based on the other legitimate factors specified in Regulation 178/2002. In fact, the Regulation 1829/2003 on genetically modified food and feed distinctly states that for risk assessment of genetically modified material “scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.” (European Parliament and Council of the European Union, 2003e) In contrast, the GMO approval process in the U.S. is much less limited and decisions are solely based on scientific facts. Also, GMO containing products do not have to be labeled.

The Codex Alimentarius, a collection of internationally accepted standards published by the WHO and FAO, acknowledges these other legitimate factors concerning risk assessment and risk management. However, it limits those factors to these relevant for the health protection of the consumer and fair trade. Additionally, unjustified barriers to trade should be avoided when considering those factors. (Codex Alimenatarius, 2007), Paragraph 32;Codex Alimentarius Commission, 2001) Though, the consideration of other legitimate factors does not only affect the restricting regulations. Other legitimate factors may also lower the levels of regulation, for example in cases of traditionally specific production methods. This is for example the case for maximum levels of nitrates and nitrites, regulated by Directive 2006/52/EC with exceptions for meat produced in a traditional way, for example Wiltshire bacon and ham and some other traditional dry cured meat products. However, those levels are still lower than those permitted in the U.S.. (ATSDR Agency for Toxic Substances and Disease Registry, 2013; Szajkowska, 2012, p. 123)

In contrast, traditional production methods are problematic in the U.S., as demonstrated in 2014 concerning the cheese production. A commonly used practice in the cheese production is the aging of the cheese on wooden boards. (New England Cheesemaking Supply, Inc, 2013) However, FDA inspectors found the wood boards to be unhygienic, stating that they do not comply with 21 CFR 110.40(a) which specifies that “all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained". However, after extensive protests the FDA declared that they would debate with the cheese industry on further actions. (Federal Government of the United States, 1986; Carpenter, 2014; McNeal, 2014)

3.2 Prevention of food safety problems

The prevention of food safety problems is based on several factors including an effective plan concerning manufacturing practices, principles of food risk evaluation as well as effective monitoring and tracing competences.

Food Risk Assessment

Risk assessment in the U.S. is mainly based on the company’s own risk assessment and only to some extend controlled by the FDA. Examples for this are the dealing with GMO, which will be discussed in detail later, and to some extend food additives. The FDA is not required to pre-approve any food except for most food additives, including color additives. (Kirchsteiger-Meier and Baumgartner, 2014, pp.285)

However, this procedure is controversial. In 2014, a lawsuit was filed against the FDA by the Center for Food Safety, an U.S. based non-profit organization, concerning the practices of food additives admissions. The subject of the lawsuit is the FDA practice to let companies decide whether food additives should be controlled by the FDA. This so called fast-track procedure allows producers to claim their food additive as generally recognized as safe (GRAS) by simply notifying the FDA and providing material supporting this decision. No further premarket approval from the FDA is necessary. (AIBMR Life Science, 2014) More than 190 food additives were proclaimed as GRAS from the producers and subsequently marketed. (AIBMR Life Science, 2014) However, the reason this approach can be appealed is the fact that the fast-track procedure was never officially finalized and therefore, not officially approved. Still, it does not apply to other food additives. (Stevens and O'Brien Nabors; Castres, 2014; Center for Food Safety, 2014a; Senomyx, 2014)

In the EU, all risk assessments are conducted by the EFSA as an independent agency not influenced by profit or political interest. However, EFSA’s risk assessments are only advisory, decisions on food risks are made by the European Commission. The risk assessment is defined that a “scientific assessment of risk must be undertaken in an independent, objective and transparent manner based on the best available science”. (European Commission, 2014a) Risk assessment is for the most part based on the precautionary principle and does acknowledge other relevant factors if applicable. (EFSA, 2014f)


One important factor in the prevention of food safety problems is the self-control of the establishments. While both the U.S. and the EU regulations acknowledge the need for federal control, inspections are only snap samples and the comprehensive prevention of food safety problems depends on the performance of the companies.

In the U.S. and the EU, Hazard Analysis and Critical Control Points (HACCP) self control is mandatory. (European Commission Health and Consumer Protection Directorate-General, 2005)

A HACCP plan covers seven essential principles in order to promote a preventive management system. (Ministry of foreign affairs Netherlands CBI, 2012b) These principles provide a plan for each company to follow in order to provide safe production environment and include the conduction of a hazard analysis, the determination of critical control points (CCPs), the establishment of critical limits, monitoring procedures, corrective actions, verification procedures and record-keeping as well as documentation procedures. (Center for Food Safety and Applied Nutrition, 1997) For each product, each facility and each procedure, an individual HACCP plan has to be provided.

In the U.S., the control of HAACP implementation differs between the FDA and the FSIS. While the FSIS does pre-approve every HACCP plan in order for a company to start production, the FDA does only control the presence and quality of HACCP plans upon inspection of the facility. (Animals and Animal Products, 9 C.F.R., § 417.4, 2012) Thus, responsibility of HACCP procedures is with the company until the FDA inspects the plan. (Food Safety and Inspection Service, 1998; Saxowksy, 2014b)

Previously to FSMA, not all FDA controlled facilities were required to provide a HACCP plan. Mainly dairy, juice, food service and seafood establishments were required to provide HACCP plans upon inspection. Under FSMA, all companies not previously employing HACCP are now required to provide a Food Safety Plan on the basis of HACCP. The food safety plan includes the HACCP principles, adding for example precautions concerning bioterrorism. (Center for Food Safety and Applied Nutrition, 2011; Kirchsteiger-Meier and Baumgartner, 2014; Saxowksy, 2014a)

The legal foundation for HACCP implementation is based on 9 CFR 417.2 (HACCP plan for animals and animal products) for FSIS regulated products, the FSMA for FDA regulated products and EU Regulation (EC) No. 852/2004, Article 5 for products in the EU. (Federal Government of the United States, 1997; European Parliament and Council of the European Union, 2004d)


Traceability of products and ingredients is significant in preventing food safety problems and in reacting to them as part of the risk management system.

In the EU, traceability is required in all stages of production, processing and distribution, including all ingredients, the processing history and the locations of distribution, according to EU Regulation (EC) No. 178/2002. (European Parliament and Council of the European Union, 2002; Ministry of foreign affairs Netherlands CBI, 2012d) This approach is intensified by the European farm-to-fork principle. Every food business is required to be able to identify both its direct supplier as well as supplied businesses. (European Parliament and Council of the European Union, 2002; Ministry of foreign affairs Netherlands CBI, 2012d) However, there are no requirements concerning the implementation of the law for food of non-animal origin as well as the consequences in cases of non-compliance. A guidance paper concerning the implementation is published, providing information on traceability guidelines like documentation. Still, this paper has no legal binding qualities. (Taillard and Informal Expert Group on Product Traceability, 2011) Traceability requirements on food of animal origin are determined according to EU Regulation (EC) No. 931/2011. (EU Commission, 2011) Additionally, the EU supported several projects to enhance the traceability of food, for example TRACES for animal movements and the prevention of animal diseases and FoodTrace for better traceability among businesses. (Health and Consumer Protection Directorate-General, 2007; EUR-lex, 2011) However, despite regulations recent food scandals have shown weaknesses in the EU traceability program. One example is the horsemeat scandal in 2013 where low-grade horse meat was incorporated in meat products without declaration. The contamination was found incidentally and most of the sources could be identified by means of the Rapid Alert Notification System (RASFF). Also, food processors not complying with the traceability regulations were prosecuted. (Mullin, 2014)

Under FSMA, the U.S. utilize an improved approach concerning traceability after several incidents of food safety issues concerning for example Listeria monocytogenes in cantaloupes and Salmonella of unknown origin, probably peppers and tomatoes, in 2008. (CDC Center for Disease Control, 2008; McGarry, 2012) The goal of the FDA is the implementation of a national food tracing system. Several pilot programs were conducted, including tracing systems of tomatoes and peanut butter between 2011 and 2013. (McGarry, 2012; Center for Food Safety and Applied Nutrition, 2014c) The recommendations were open for comments until mid-2013 and included many elements already implemented in the EU, for example mandatory record keeping, especially for high risk facilities, tracing plans and one-step-up, one-step-down information of the product. (Center for Food Safety and Applied Nutrition, 2011; Produce Traceability Initiative, 2014)

Concerning food of animal origin, the USDA revised their traceability programs in 2014. New requirements include detailed record keeping. (Maloy, 2014)


Another factor concerning food risk assessment is the monitoring of compliance with the regulations, especially concerning the food production.

Monitoring of compliance with regulations in the U.S. differs between the FDA and the USDA. While the USDA does monitor production and handling of foodstuff on a daily basis and food inspectors have to present at the point of production daily, the FDA does monitor food production facilities on an irregular level. (USDA Food Safety and Inspection Service, 2014b)

As mentioned previously, inspection and monitoring of food of animal origin normally under the responsibility of the FSIS may either be conducted by the FSIS or by the state inspection programs. However, products inspected under state inspection programs may only be sold within the respective state and the program is reviewed annually by the FSIS. Mostly small or very small establishments are affected by this. (USDA Food Safety and Inspection Service, 2013a) However, on-site inspections only cover a part of the respective states each year, the main review is conducted concerning self-assessment reviews of the states. Examples for States conducting their own state inspections program include Iowa, Kansas and Georgia. (FSIS, 2013)

Also, facilities processing food under the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act have to apply for federal inspection in order to be allowed for production. (USDA Food Safety and Inspection Service, 2013b) Therefore, they have to provide efficient measures to ensure the safe production of food.

With the implementation of the FSMA, the inspection of food production facilities by the FDA becomes more risk based than before. The basic principle of monitoring is based on quantitative and qualitative facts determining the so called inherited and firm specific risk factors. Inherited risk factors include recent outbreaks, recalls or other adverse events, while firm specific risks include the interval since the last inspection and inspection results. Previously to FSMA, product contaminations and support of evidence for assumed violations were the main reasons for inspections. (FDA, 2011b, 2011a) Based on this approach the FDA tries to improve the inspection frequency and usefulness of inspection. For comparison, the FDA inspected only 6% of domestic food producers in 2011. (Armour et al., 2012) In addition, food producers may be inspected by state inspectors under the authority of the state or on behalf of the FDA. (Kirchsteiger-Meier and Baumgartner, 2014, p.299)

Additionally, facilities operating under the Food, Drug and Cosmetic Act have to register with the FDA. This registration has to be updated every year and may be revoked in cases of noncompliance. (Center for Food Safety and Applied Nutrition, 2014g)

However, since inspections by the FDA have been infrequent, safety audits performed by private third-party operators, for example the American Institute for Baking, may be demanded by producers from the supplier. (Castres, 2014) Factors supporting this measure are the liability of the producer and costs, as private inspections tend to be much cheaper than federal ones, which may cost 8-times as much. (Moss and Martin, 2009) When choosing a third-party operator, companies may access FDA certified companies. (Office of the Commissioner, 2014b)

In 2009, a case of Salmonella contamination of peanut butter caused the death of nine people and officially 714 infected.(CDC Center for Disease Control, 2009) The plant was previously inspected by the private safety audit operator American Institute for Baking and graded as superior. However, when federal inspectors investigated the plant later, they found several security issues, for example a leaking roof and rodents. Also, previous testing from the company revealed Salmonella contaminations were identified by internal monitoring. However, they did not react to those findings and continued to ship the contaminated products. Also, the FDA was not able to force the release of those results at that time. (Moss, 2009; Moss and Martin, 2009; (FDA, 2009) Under FSMA, the FDA now has the authority to enforce the release of internal controls. (Center for Food Safety and Applied Nutrition, 2014d, 2014b)


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Comparison of European and US Food Law Regulations in the Context of the Transatlantic Trade and Investment Partnership
University of Bonn
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TTIP, tafta, Lebensmittelrecht, USA, EU, Food Law Regulations
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Julia Wilhelms (Author), 2014, Comparison of European and US Food Law Regulations in the Context of the Transatlantic Trade and Investment Partnership, Munich, GRIN Verlag,


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