The Food Safety Modernization Act (FSMA) was signed on January 4, 2011. Some requirements are already in place but it globally seems to take more time than expected to implement the whole regulation due to FDA budget constraints. Once fully applied, it will radically change how most food and beverage companies do business.
Quick facts about FSMA
Modernization needed since 1938
Food safety rules hadn’t been updated for over 70 years (since Franklin
D. Roosevelt passed America’s first food safety legislation in 1938)
before FSMA. An desire of a new food regulation was highly needed to
better fit and inform consumers about their food consumption and to
better prevent them from foodborne illnesses. Every year due to food
malpractices and diseases, 50 million U.S. people are sick, resulting in
128,000 hospitalizations and 3,000 deaths. Recently, egg products,
cantaloupe, ground beef, and cookie dough were pointed out and many
More global than ever
Supply chain is more global than ever. 15% of food sold in the US is imported and is in compliance with regulations in practice in the country of origin. It is crucial to be able to track the entire supply chain to avoid food sanitation issues.
Major rules and evolutions
Mandatory Recall Power
If the Administration finds a “reasonable probability” food has been misbranded, adulterated, or capable of generating serious adverse health consequences, it can issue a mandatory recall – not voluntary only anymore.
The FDA can demand records of other affected food products if it finds a reasonable probability of serious adverse health consequences in any food product. This underlies the need for recordkeeping and improved traceability.
Increased, Risk-Based Inspections
Businesses can expect more frequent inspections, including a classification of “high-risk” companies.
Suspension of Registration
The FDA has the power to suspend a facility’s registration if it finds the facility’s food poses a “reasonable probability of serious adverse health consequences or death.”
Order on Detention of Food
The FDA can hold products that may be contaminated or mislabeled. Previously, the FDA had the right to confine food when it had sufficient evidence it was mislabeled or contaminated.
Companies importing food have obligation to disclose whether any other country has rejected or refused a product.
Preventive Controls for Food Facilities
This rule goes for facilities manufacturing food products for human and animal consumption. Food processors are responsible for establishing the controls, though the FDA provides guidance on implementation as well as a self-assessment tool to help facilities determine whether they are in compliance.
Foreign Supplier Verification Program
International facilities that export foods into U.S. markets should meet or exceed the same standards applied to U.S. facilities, thereby ensuring complete accountability and consistency across food supply chains.
Accredited Third-Party Certification
The Act calls upon the FDA to develop a program to recognize accreditation bodies that grant accreditation to third-party auditors responsible for issuing key FSMA certifications. Accredited third-party auditors are required to alert FSMA if they identify a condition that could lead to a public health risk during an audit.
Overall the White House has requested $4.9 billion for FDA for 2016, which is $424 million, or 9% more than 2015. The majority will go for the implementation of the Food Safety Modernization Act. Line items included an increase of $25 million for inspection and training upgrades, a $32 million hike earmarked toward a national food safety system, and $25.5 million more for import safety and implementation of the Foreign Supplier Verification Program.
“Now we’re at a critical juncture as Congress considers the funding that will help transform all the plans and preparations we’ve shared with you into protections that will greatly reduce the number of illnesses caused by contaminated foods and greatly increase consumer confidence in the safety of our food supply,” Taylor wrote.
The question about the FSMA is not “if” anymore but “when”, and considering the current delays, it becomes FDA priority to deal with the Act application as soon as possible. It is crucial for manufacturers to be in compliance with this new regulation and be able to track products from raw material to the consumer. Lascom Solutions provides PLM to assist food companies in product compliance and product lifecycle.
- A central repository to benefit from a “single version of the truth” and store finished products, semi-finished products, raw material, ranges, versions, certifications, procedures and best practices, data and documents on a unique platform. Access rights are customizable regarding business roles in each project.
- An effective quality module to manage certifications, specifications, origins and risks – batches, allergens etc. Audits are easier to prepare and manage, as well as recalls.
- A supplier portal to improve collaboration all along the supply chain.
- An approval process with versioning feature, to be able to track products from raw material to the shelf.
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