New food safety law poses challenge to Chilean exporters

Industry stakeholders are in the process of implementing a series of actions to facilitate compliance with the seven regulations that comprise a new law emphasizing prevention.

By Catalina Jofré

On 4 January 2011, the President of the United States, Barack Obama, signed into law the Food Safety Modernization Act (FSMA). This piece of legislation signals a regulatory shift to guarantee that all food imported into the United States complies with the same standards as locally produced products. Currently, the responsibility for the fulfilment of the FSMA is that of the federal Food and Drug Administration (FDA).

By renewing a law that dated back to 1938, the FSMA represented an important legislative step. This is particularly the case since, as of a few years ago, approximately 20% of food products in the United States have come from abroad, of which about 50% constitute fresh fruit. The key point about the FSMA is that is places a strong emphasis on prevention and seeks to reduce the risk of disease from the ingestion of foreign products.

The World Health Organization (WHO) estimates that up to 600 million people around the world fall ill each year as a result of consuming contaminated food. In the United States, the annual figure is 48 million. Approximately 128,000 of these are hospitalized and 3,000 die as a result of diseases transmitted by food products.

Donald Prater, Acting Assistant Commissioner for Food Safety Integration at the FDA, explains that, in addition to prevention, the FSMA seeks to ensure that the food industry is responsible for anticipating food safety problems, as well as educating and training the general public on related matters.

With the FSMA still in its implementation phase, the standards of the Act are in the process of being adopted by all the countries that export food to the United States. This process is taking place in periods of between one and four years, which begin after the entry into force of each specific regulation.

The standard that regulates preventive controls to avoid food risks relating to human consumption entered into force in September 2016. Two more will enter into force in 2017: the transportation of food products for human and animal consumption and the verification of foreign suppliers; and in October, the regulation related to fresh foods.

The new regulations also include provisions in relation to food safety for businesses and the designation on one person as the qualified individual responsible for executing the food safety plan of the respective company. Furthermore, the legislation will include actions relevant to inventions that strengthen the control of food products at their point of cultivation, harvest, packaging, labelling and storage.

The FSMA applies to all establishments that produce food products for human and animal consumption and which are subject to FDA registration. Produce that remains beyond the scope of the regulations are meats, poultry and eggs, which fall under the remit of the United States Department of Agriculture (USDA). Juices and shellfish are also excluded and they will continue to be subject to the existing Hazard Analysis and Critical Control Points (HACCP) preventive control system.

In regard to sanctions, there is a broad range of mechanisms through which the FDA will enforce the new legislation, including the power to deny entry into the country to offending products.

The challenges facing Chile

Chile is a major exporter of fruit and vegetables to the United States. The Association of Chilean Fruit Exporters (ASOEX), the trade association which oversees the export of these products, states that 32% of all fruit and vegetable exports from 2015-2016 were to the United States, totaling 792,640 tonnes. Figures such as these exemplify the importance of Chile successfully adapting to the new legislation.

At the regional level, the Latin America Office of the FDA is responsible for bilateral relations with Mexico, as well as countries from Central America, the Caribbean and South America, including Chile. Its work focuses on issues of food safety protection and quality in the manufacturing of products and the promotion of training initiatives aimed at the community of food suppliers. Work of this nature has, therefore, been conducted in conjunction with the Chilean Food Quality and Safety Agency (ACHIPIA).

Michel Leporati, Executive Secretary of ACHIPIA, explains that in 2016 the Agency began a process of dissemination workshops aimed at raising awareness in regard to synthesis with the FSMA and its seven norms. To date, five of the norms have been finalized and 400 people from the public, private and academic sector have been informed accordingly. In addition, further similar initiatives have been implemented to strengthen the exchange of expertise. For example, a mission was sent to Mexico which included the presence of the Agricultural and Livestock Service (SAG) and ASOEX, and visits are held to grape and blueberry producers around the country to devise strategies to facilitate compliance with the FSMA.

Similarly, in May 2016 the FDA published the regulations pertaining to the FSMA so that interested Chilean companies could gain access to experts.


Moisés Leiva, Food Manager at Chilealimentos, says that historically the United States has been the main destination for Chilean agricultural exports. Despite ongoing programs aimed at reducing the risks facing the industry, he believes such efforts may be insufficient in generating compliance with the new legislation. As a consequence, “today companies are strongly focused on closing these gaps”, he notes.

One of the groups who will acquire far greater responsibility as a result of the FSMA is importers. They will be tasked with ensuring food safety across the entire production chain.

At present, Chilean exporters are in the stage of understanding the new requirements, which is why they are working with the FSMA Committee of Chilealimentos, in order to ensure compliance with the new rules, according the most feasible schedule possible. Initially, the timeframe in which importers were required to request compliance from suppliers was 2017, but this has subsequently been postponed to 2019.

Accordingly, Prater from the FDA says that the Foreign Supplier Verification Program (FSVP), which forms part of the legislation, requires importers to guarantee that their suppliers produce food that fully complies with US safety standards.

The regulation also establishes an accreditation system for organizations to conduct food safety audits, in order to certify that foreign food facilities and the products they produce comply with the legislation.

Company adaptation

From the perspective of producers, Ronald Bown, President of ASOEX, states that the sector is healthy. He explains that the risk from Chilean fruit is very low and that it is fully accepted across foreign markets.

“Chile has the most fruit plantations for export certified in Good Agricultural Practices in the world, covering approximately 62% of the total planted area”, says Bown.

Flavio Araya, Director of Production Standards at Fundación Chile has a slightly different view. He claims that there are certain differences in terms of adapting to the FSMA depending on the size of the exporting business. For example, he says that while large companies are prepared, difficulties exist for small and medium-sized enterprises (SMEs) that are interested in the US market, and that the latter two, “are facing a more complicated path”.

“Many SMEs in the food sector are weak, for example, in areas related to food safety registration, and the situation becomes quite complicated if they want to shift their focus to exports”, warns Araya.

Hortifrut is an example of a large company that sells products that are subject to the legislation and which has already incorporated the stipulated requirements into its operations. The company has provided its importer with its food safety plans, the deadline for which expired in September 2016, and it will do the same for its fresh fruit in time for next season.

“We are applying the regulations across the entire company, not only in relation to exports, but also to the internal market”, says Johanna Trombert, Head of Quality Assurance and Food Safety at Hortifrut.

Trombert explains that the majority of the protocols used in the field already cover most of the relevant requirements. However, the FSMA demands that certain additional conditions are met. These include: the appointment of an individual responsible for food safety and who is accredited by the FDA; requirements for bodies of water in agricultural settings in relation to the hygiene- and irrigation-related use thereof; and increasing environmental monitoring of fresh fruit that is ready for human consumption. Despite these new requirements, Trombert believes that Chilean production will not be adversely affected and she describes the legislation as, “manageable”.

Nuri Gras, Adviser at the Technical Center of Food Innovation and Technical Director at Food Intelligence Net Consulting, believes that Chile is viewed as a low-risk country in terms of food safety and that becoming certified in this field helps to increase consumer trust and to protect brand reputation.

In the absence of zero risk, the preventive approach proposed by the law will result in greater safety. As a consequence, “this will help to strengthen the position of Chilean firms and their products in different markets”, states Gras.

Looking ahead, Donald Prater acknowledges that the United States will not be able to implement the new FSMA alone. He explains that the country will have to rely on its work with the food industry in the US and those around the world, given that collaboration and cooperation are essential components of guaranteeing food safety.

What is food safety?

According to the General Principles of the Food Code of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), known as the Codex Alimentarius, food safety is the guarantee that foods will cause no harm to the consumer when it is prepared and/or consumed in line with the use for which it was intended. Accordingly, food safety relates to assurances that food products are not contaminated, which is achieved by means of control across every link in the chain, from production to consumption.

Source: Glossary,