The FDA has proposed two new rules issued under the Food Safety Modernization Act (FSMA) that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods. If you want your voice heard, you have until May 16, 2013 to submit your comments to the FDA on the proposed rule. The FDA does take comments seriously, we’re here to help if you want assistance in drafting your comments. This rule is expected to be published shortly following the conclusion of the comment period on May 16, 2013.
The proposed rules would apply to facilities that manufacture, process, pack or hold human food. The rules focus on commonly identified routes of microbial contamination of produce, including:
(1) agricultural water
(2) farm worker hygiene
(3) manure and other additions to the soil
(4) animals in growing areas, and
(5) equipment, tools and buildings.
In general the facilities that are required to register include manufacturers, processors, warehouses, storage tanks, and grain elevators. However, there are a number of exemptions and modified requirements. We would be pleased to assist you in determining whether or not your facility may be exempt from these requirements.
Below is a recap of the proposed rules.
Rule #1 – Preventative Controls for Human Food. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:
- hazard analysis;
- risk based preventive controls;
- monitoring procedures;
- corrective actions;
- verification; and
Do you have your written plan in place yet?
Rule #2 – Produce Safety. The second rule proposes enforceable science- and risk-based safety standards for growing, harvesting, packing and holding fruits and vegetables on foreign and domestic farms. These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:
- Irrigation and other agricultural water
- Farm worker hygiene
- Manure and other additions to the soil
- Intrusion of animals in the growing fields.
- Sanitation conditions affecting buildings, equipment and tools
The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.
The rules still to come are:
- Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
- Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
- Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.
As FDA implements more of FSMA, we will keep you informed.
Do you need assistance in submitting a comment to FDA? Does your company need training on FSMA? If so, contact me anytime.