The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.
In the six month since it was signed into US law the relevant authorities have been putting in place various actions required to enforce the act. The total cost of the bill is estimated to be $1.4 billion and represents the biggest change to oversight of food safety in the US since 1938.
Its impact for regulatory bodies such as the FDA is significant. The impact on food processing businesses will also be felt. It is a fact of modern food production and supply that when regulators introduce new laws the burden on food plants increases. Often this extra burden is carried with the existing resources. In this discussion topic I would like to summarise and highlight the main changes and objectives of the Act. It may prove useful to food plant managers, students and food safety professionals. Feel free to discuss any aspect of the Act.
The requirements of the Act can be divided into two main areas:
• Food Safety
• Food Defense
FOOD SAFETY
The first area under food safety is Prevention. This is the main fundamental shift of the US's management of food safety and risk. The Act will introduce the following:
1. Expansion and clarification of the FDA's records inspection authority.
2. Introduction of registration renewal for food plants every two years and potential FDA inspection as a condition for renewal.
3. Hazard Analysis and prevention control implementation at critical control points every three years.
4. Performance standards review every two years.
5. Production and harvesting standards for raw agricultural commodities.
6. FDA to notify the Department of Homeland Security (DHS) in the event of FDA refusal to admit foods into the U.S.
DETECTION and RESPONSE
The Act was driven by a number of serious food outbreaks and the States response to these incidents. The Act will introduce improvements including:
1. Risk based prioritization of plant inspections.
2. Development and maintenance of accreditation standards for laboratory food testing.
3. Traceback and record keeping requirements to prevent/mitigate foodborne illness outbreaks.
4. Foodborne illness surveillance system enhancements
5. Mandatory recall authority for adulterated or misbranded products.
6. FDA to provide support to state and local governments in response to outbreaks.
FOOD IMPORTS
The Act will bring significant changes beyond the borders of the U.S. Companies exporting food into the U.S. and those agents importing foods will be required to meet specific demands including:
1. Importers to undertake risk-based foreign supplier verification program
2. Voluntary qualified importer programme for expedited review and importation for importers.
3. Import certification of foreign countries' controls and standards to verify implementation.
4. Inspection of foreign food facilities to verify federal compliance and accreditation of third party auditors to carry out those inspections.
5. Work with DHS to develop a strategy to identify smuggled foods to prevent entry.
I will add a summary of the requirements of the Act in the area of Food Defense in a couple of days.
George.
In the six month since it was signed into US law the relevant authorities have been putting in place various actions required to enforce the act. The total cost of the bill is estimated to be $1.4 billion and represents the biggest change to oversight of food safety in the US since 1938.
Its impact for regulatory bodies such as the FDA is significant. The impact on food processing businesses will also be felt. It is a fact of modern food production and supply that when regulators introduce new laws the burden on food plants increases. Often this extra burden is carried with the existing resources. In this discussion topic I would like to summarise and highlight the main changes and objectives of the Act. It may prove useful to food plant managers, students and food safety professionals. Feel free to discuss any aspect of the Act.
The requirements of the Act can be divided into two main areas:
• Food Safety
• Food Defense
FOOD SAFETY
The first area under food safety is Prevention. This is the main fundamental shift of the US's management of food safety and risk. The Act will introduce the following:
1. Expansion and clarification of the FDA's records inspection authority.
2. Introduction of registration renewal for food plants every two years and potential FDA inspection as a condition for renewal.
3. Hazard Analysis and prevention control implementation at critical control points every three years.
4. Performance standards review every two years.
5. Production and harvesting standards for raw agricultural commodities.
6. FDA to notify the Department of Homeland Security (DHS) in the event of FDA refusal to admit foods into the U.S.
DETECTION and RESPONSE
The Act was driven by a number of serious food outbreaks and the States response to these incidents. The Act will introduce improvements including:
1. Risk based prioritization of plant inspections.
2. Development and maintenance of accreditation standards for laboratory food testing.
3. Traceback and record keeping requirements to prevent/mitigate foodborne illness outbreaks.
4. Foodborne illness surveillance system enhancements
5. Mandatory recall authority for adulterated or misbranded products.
6. FDA to provide support to state and local governments in response to outbreaks.
FOOD IMPORTS
The Act will bring significant changes beyond the borders of the U.S. Companies exporting food into the U.S. and those agents importing foods will be required to meet specific demands including:
1. Importers to undertake risk-based foreign supplier verification program
2. Voluntary qualified importer programme for expedited review and importation for importers.
3. Import certification of foreign countries' controls and standards to verify implementation.
4. Inspection of foreign food facilities to verify federal compliance and accreditation of third party auditors to carry out those inspections.
5. Work with DHS to develop a strategy to identify smuggled foods to prevent entry.
I will add a summary of the requirements of the Act in the area of Food Defense in a couple of days.
George.
