If you manufacture, process, pack, transport, distribute, receive, hold, export or import food, or food components for human or animal consumption in the USA, you will be affected by these new regulations.
The Centers for Disease Control and Prevention states that about 48 million people (1 in 6 Americans) get sick; 128,000 are hospitalized; and 3,000 die each year from food-borne diseases, most of which are preventable. The Food Safety Modernization Act (FSMA) of 2010 is the most sweeping food safety legislation in 70 years, and will require almost all food related companies doing business with or in the USA to meet stringent new safety standards. This legislation affects all food related companies, both domestic and international. While it is expected that there may be some adjustments in the requirements for certain businesses, at this time there are no exemptions provided for businesses based on the size of a firm or facility.
The scope of the FSMA is expansive. In essence, it creates a continuous chain of accountability from the farm to the table. While resources for this Act have not yet materialized – or even been requested of Congress by the Food & Drug Administration (FDA) – it is clear that the monetary impact of implementing these new requirements is going to be felt by the food industry. While the FSMA is scheduled to take effect over the course of the next couple of years, with final mandates in place before 2014, it is crucial that companies doing business that fall under FDA jurisdiction begin reviewing and modifying policies and procedures now in order to assure timely compliance.
The FSMA was signed into law on Jan 4, 2011, and many parts of the legislation became effective immediately. This included increased authority of the FDA to demand records access; greater frequency of inspections increasing based on risk-based priorities; strengthened “whistle-blower” protection; and mandatory recall authority for products that have a reasonable probability of serious adverse health consequences.
Measures that are part of the FSMA, but are not immediately in effect, include certification by certain entities of all food articles – this is expected to be in place by the end of 2013. The FDA has not yet clarified who will be considered “certifying entities”, however the Act states that they will be an agency or representative of the government of the country from which the article originates, or as the FDA designates, other third party auditors.
The FDA has yet to publish a list of all food categories that will require certification; they have, however advised that they expect to release this list within 12 months of enactment of the law. The criteria to be used in this placing a product on this list include: known safety risks for a particular food, country or region of origin of the food, or based on scientific, risk-based evidence of inadequacy of the food safety system of the country or region of origin.
In addition to the above certification, the FSMA also requires food facilities to implement a written preventive control (safety) plan, including provisions for monitoring of the effectiveness of those controls and develop written corrective action plans for potential mishaps. While there is currently an FDA Food Facility Registration in place, adherence and inclusion are expected to be more broadly required. Record-keeping systems and traceability will be highlighted, and food facilities which have not previously been required to do so will now be required to complete a risk-based Hazard Analysis and Critical Control Points (HACCP) plan.
To assist you in becoming more informed regarding this Act, Pacific Customs Brokers is hosting an FDA Seminar on Thursday, February 24, 2011. For more information on registering for the FDA Seminar, please email seminars@pcb.ca or contact Yvette Fox at 888.538.1566.
Tags: food safety, food safety monderization act
