United States passed very strict new regulations on food safety and imported products. Rules for alerts and withdrawals


United States passed very strict new regulations on food safety and imported products. Rules for alerts and withdrawals

It took 73 years, and a much younger President, to reform US food safety rules. On January 4, Barack Obama signed the Food Safety Modernization Act (FSMA), the first complete revision of the   Federal Food, Drug, and Cosmetic Act  (1938). A really useful and indeed providential review, given that food poisoning in the United States is still a current problem .

The ” Food Safety Modernization Act ” introduces new requirements for all operators in the food chain (producers, processors, packers, distributors) and significantly extends the powers of the ” Food & Drug Administration ” (FDA). The government body responsible for the implementation and control of the application of the rules relating to second food processing products and medicines. In summary:

Registration of food establishments . As already happens in the EU (thanks to the so-called Hygiene Package, EC reg. N. 852, 853, 854, 882/04 and subsequent), also in the United States, starting from 2012, all operators in the agri-food chain will have to register, and update the registration of all their establishments every two years.

However, the FDA can suspend the registration – and thus, the authorization – of an establishment if serious safety risks are found in the processed foods.

Self-control and risk analysis .  The owner or manager of each facility must:

– assess the dangers that could affect the safety of food produced, processed and packaged in the establishment. With explicit reference to physical, chemical, biological and radioactivity risks, natural toxins, pesticide and drug residues, allergen parasites and unauthorized additives,

– identify and implement preventive controls to prevent or mitigate the aforementioned risks, in order to ensure that food is safe and provided with the information on the label for safety purposes (e.g. allergens),

– monitor the controls on an ongoing basis, through a HACCP plan to be subjected to periodic review,

– record the procedures described above and keep the documentation relating to the self-control, including the results of the analyzes performed, for a period of at least two years.

All documentation relating to these controls must be made available to the FDA at all times.

In a nutshell, self-control and HACCP for all businesses: with the exception of “small” ones, as such defined as those with an annual volume of food sales of less than US $ 500,000, which are exempt from the aforementioned obligations.

Withdrawal of products at risk . Also in this case, as has already happened in the EU since 1.1.2005 thanks to the application of the so-called ” General Food Law” (EC regulation No. 178/02, art. 19), the FDA has the power to order the withdrawal mandatory from the food market when they can pose a serious risk to human or animal health. The authority must grant the operator the possibility of activating the voluntary withdrawal; in case of refusal by these, and of a compulsory withdrawal order by the authority, the FDA grants the interested party an informal hearing within two days to decide together what to do.

Protection of the informant / employee .  An element of novelty with respect to European legislation is the protection of the employee (with respect to possible retaliation by the employer) when:

– provides the employer, the US government or the investigating judiciary with news relating to any violation of the FSMA (so-called ” whistle-blowing ),

– testifies or intends to testify in a dispute relating to violations,

– assists, participates or intends to attend or participate in this procedure;

– refuses to perform duties assigned to him by his employer which he deems to be a violation.

Inspections and access to documents . The Food & Drug Administration will have to increase the frequency of inspections and may at any time request import certificates for certain products. 

In the event that the FDA deems there is a serious food safety risk, the FDA can access all documentation relating to import and procurement, processing, packaging, distribution, delivery, storage.

Imports . Regarding food imports to the USA:

– the responsibility of the importer is clearly reiterated, with checks on foreign suppliers

– an incentive is offered to importers who take additional safety measures. The FDA will be able to define a program whereby importers who adopt particular measures to guarantee the safety of food can take advantage of procedures for the rapid control of goods (voluntary program of qualified importer),


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