Food Safety Modernization Act
Sources: www.pma.com (Product Marketing Association)
TheU.S.congress passed the Food Safety Modernization Act in December of 2010 and the president signed the bill in January 2011.
The following are the key components of this bill and what those in the industry can expect from the FDA in the future.
- Produce Standards- Within one year of the law’s enactment, the FDA must issues proposed regulations on product standards. The standards are science-based and issued for those types of fruits and vegetables the agency determines need standards to minimize risk to human health. The rules must take into account environmental, organic and regional differences and prioritize based on known risks and the history of outbreaks,
- Food Safety Plans- Each food facility must have a written food safety plan that includes hazard analysis and preventative controls, a description of verification and recordkeeping, and procedures for monitoring, recall, and tracing. These plans must also address risks from intentional contamination such as terrorism. The plan must be updated every three years or when significant changes are made to the facility.
- Traceability and Recordkeeping- The FDA shall establish a system that improves the capacity to effectively track and trace foods. Enhanced record keeping will be required for “high-risk foods”. Grocery stores buying directly from farms are exempted from this recordkeeping.
- Access to Records- During an inspection the FDA (or its agent) may view and copy records bearing on whether the facility’s food is adulterated or misbranded.
- Registration- Facilities that process, pack or hold food (excluding farms, restaurants and retail) must register with the FDA and renew that registration every two years.
- Laboratory Accreditation and Testing- Within two years, FDA shall issue regulations on food testing as well as on accrediting laboratories to standardize and increase the number of laboratories eligible to perform testing.
- Small and Local Farms and Facilities- The bill exempts from the food safety plans and the produce standards facilities or farms that meet certain qualifications.
- Importer Verification of Foreign Suppliers- Importers will be required to verify that food imported is produced in compliance withU.S. food safety laws. Importers (the owner/consignee at the time of importation or theU.S. agent of a foreign owner/ consignee) must verify that food he or she handled was produced in compliance with applicableU.S. laws and is not adulterated.
- Fast Track Entry- Beginning within 18 months, FDA shall establish expedited entry for importers that participate in a voluntary certification program.
- Accreditation of Third Party Auditors- FDA must establish a program to accredit third-party auditors for inspections of foreign facilities.
- FDA Inspections- The frequency of inspections are to increase and categories of facilities will be created. The categories will be based on known risk factors, the history, of the facility and the rigor or its preventive controls.
- Evaluation of Foreign Regulatory Programs- The law broadens FDA’s ability to refuse entry into the United States food from a country with food safety system FDA has found to be inadequate.
- Recall and Outbreak Response- The bill beefs up FDA’s authority to require recalls.
- Posting of Recall- The bill requires FDA to draft rules requiring the posting of recall notices at grocery chains with at least 15 stores, which must display a recall notice in a “prominent and conspicuous location” in the store.
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