The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of U.S. food safety laws in more than 70 years. It aims to assure the safety of food throughout the supply chain through the introduction of new requirements to food manufacturers, processors, transporters and distributors.
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What are the major elements of FSMA?
The elements can be divided into five key areas:
- Preventive controls – For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
- Inspection and Compliance – The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
- Imported Food Safety – FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
- Response – For the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
- Enhanced Partnerships – The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.
The FDA will charge $224-325 per hour of work spent fixing compliance issues.
This pertains to inspections, traveling, reviewing reports, monitoring, and directing any recalls.
Who does FSMA Effect?
FSMA affects all countries involved in the United States food supply chain.
Any food transportation company with revenues over $500,000 that serves as, shipper, carrier or receiver must comply with the Sanitary Transport of Human and Animal Food (STHAF) rule:
- A shipper is a person who initiates a shipment of food by motor or rail vehicle. Shippers are frequently the manufacturers or processors of food. They are responsible for supply chain functions initiated by a shipper even if they are performed by another person, such as a person who only holds food and physically transfers it onto a vehicle arranged for by the shipper.
- A carrier is a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. The carrier is responsible for all functions assigned to a carrier even if they are performed by other people such as a driver.
- A receiver is any person who receives food after transportation, whether or not that person represents the final point of receipt for the food. A receiver does not include an individual consumer or others s who are not in the business of distributing food.
Why is FSMA important?
According to the Centers for Disease Control and Prevention, about 48 million people get sick, 128,000 are hospitalized, and 3,000 die each year from food-borne diseases. With proper food handling and transportation practices, these incidents are largely preventable.
With the proposed Sanitary Transport of Human and Animal Food act (STHAF), the U.S. government is introducing new rules and regulations to assure the safety of food throughout the supply chain. These directives will create new requirements for food manufacturers, processors, transporters and distributors that must be followed.
Besides the obvious benefits of compliance to customers and consumers, shippers and carriers that do not comply can be subject to a wide range of penalties.
How can TydenBrooks help you be FSMA Compliant?
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If you need anything at all, we are here to help: firstname.lastname@example.org
Link to FSMA Compliance Law: Official FSMA Law
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