FDA Food Safety Modernization Act (FSMA)
Food Safety Modernization Act 2011
The Food Safety Modernization Act, also known as FSMA (fizz-ma), was signed into law on January 4, 2011. The law (and its component rules) is administered by the U.S. Food and Drug Administration (FDA). It resulted from several years of foodborne disease outbreaks that were traced to food products produced by processors largely regulated by FDA, but not required to develop written food safety plans. Food safety plans, Hazard Analysis Critical Control Point (HACCP) plans, or preventive control plans, compel companies to systematically consider, and develop programs to prevent, the food safety hazards inherent in their facility, product or process.
Like the seafood, meat and poultry, and fresh juice HACCP regulations that came before FSMA, the focus of regulators shifts from reacting to an outbreak or contamination issue after the food enters the marketplace and people get sick to preventing the food safety problem from happening in the first place.
This legislation applies only to food products regulated by FDA, not meat, poultry, or processed egg products that are regulated by the US Department of Agriculture/Food Safety Inspection Service. Food commodities already regulated by a HACCP food safety program (seafood, fresh juice) are exempt from most provisions Preventive Controls Rule, but will need to address the revised Good Manufacturing Practices outlined in the Rule.
It is easy to keep track of the progress of the implementation of this regulation. You can go to this site and sign up for FSMA updates as well as other FDA communications.
Key provisions of FSMA
- Require food facilities to implement a written preventive controls plan which involves identifying food safety hazards, specifying preventive controls, and developing a plan for monitoring the controls.
- Establish mandatory science-based standards for the safe production and harvesting of fruits and vegetables.
- Issue regulations to protect against the intentional adulteration of food.
Inspection and Compliance
FSMA provides FDA with important new tools for inspection and compliance. The FSMA:
- Establishes a mandated inspection frequency, based on risk, for food facilities.
- Gives FDA access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
- Requires certain food testing to be carried out by accredited laboratories.
- Directs FDA to establish a program for laboratory accreditation.
FDA will have new enforcement tools and authorities, including:
- The authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.
- A more flexible standard for administrative detention (preventing the movement of product) of products that are potentially in violation of the law.
- The authority to suspend registration of a facility if it determines that the food poses a risk for serious adverse health consequences or death.
- A system that will enhance its ability to track and trace both domestic and imported foods.
- Recordkeeping requirements for facilities that manufacture, process, pack, or hold high risk foods.
The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards.
- Importers will be responsible for verifying that their suppliers have adequate preventive controls in place to ensure that the food they produce is safe.
- It establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards.
- FDA will have the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
- FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers.
- FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.
The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign, including, but not limited to the following:
- FDA must develop and implement strategies, including grant programs to build food safety and defense capacities of State and local agencies.
- FDA will develop a comprehensive plan (including training) to expand the capacity of foreign governments and their industries.
- FDA is authorized to rely on inspections of other Federal, State and local agencies to meet its increased inspection mandate for domestic facilities.
Do you want to read more about this?
On this site:
- Produce Safety Rule
- Preventive Controls Rule for Human Food
- Preventive Controls Rule for Animal Food