Improving Capacity to Prevent Food Safety Problems FDA Food Safety Modernization Act Moves Forward!
Released by the Senate Health, Education, Labor and Pensions (HELP), a copy of the FDA Food Safety Modernization Act (S. 510) was released this week. The bill is expected come to the Senate floor in September.
Many of the changes and responsibilities fall on the FDA, but there are also requirements for Food Facilities.
These are some highlights of sections that will impact Food Facilities directly:
Inspection of Records
The FDA will have expanded access to records when there is a threat of serious adverse health consequences from an adulterated food or a reasonable probability that a food will cause serious adverse health consequences.
Food Facility registration requirements will be expanded. All food facilities will need to register, and renew biennially. Registration may be suspended if there is a reasonable probability that food will cause serious adverse health consequences.
Hazard Analysis and Risk Based Preventative Controls
All registered domestic facilities will need to have a Hazard Analysis and Risk-Based Preventative Control program in place. Facilities must identify possible hazards and implement controls to minimize or prevent the risk of the hazard occurring. This requirement will include the need for a written plan, available to the FDA.
The FDA will be able to assess fees for compliance failures.
The FDA will promulgate regulations on the sanitary transportation of food.
The FDA would be able to allocate resources based on risk profiles. There would also be an increase int the frequency of inspections overall with facilities being inspected at least every 4 years, but as frequent as every year, based on risk profiles.
Mandatory Recall Authority
The FDA would have the authority to order food recalls if the food is not voluntarily recalled and could cause serious adverse health affects.
HOW WOULD THE BILL AFFECT IMPORTED FOODS?
Some of the requirements that will affect those that import foods, and the international companies that want to sell in the United States include:
The current version of bill requires importers to manage suppliers with supplier verification activities; importers will not be able to import without complying with this section.
Participation in a “Voluntary Qualified Importer Program” allows importers to qualify for expedited review. (Includes use of recognized Third Party Certification)
The FDA may require certification for high-risk foods and refuse admission of foods without required certification. (Includes recognized Third Party Certification)
The FDA would be able to arrange with foreign governments to facilitate inspection of foreign facilities and refuse entry of food from a country that does not allow inspection by the United States.
Accreditation of Third-Party Auditors
The FDA will recognize accreditation bodies to certify that foreign food facilities comply with U.S. food safety standards. Third party certification may be used for the “Voluntary Qualified Importer Program” to fulfill import certification requirements.