Facilities that are up for inspection should be prepared with a plan for employees during the inspection. The plan should include which employees will be working with FDA during the inspection, where the necessary documents are filed and how the facility will address any issues that arise from the inspection.
Also related to detection and response, feed companies that are required to register with FDA will be expected to participate in updating the Reportable Food Registry, when necessary. Such reports should be made less than 24 hours after a company learns of a reasonable probability that the use of or exposure to a certain food will cause harm to humans or animals.
There are also traceability responsibilities tied to reporting. Reporting companies may have to notify others in the chain of commerce, so staying on top of record keeping is essential.
FSMA gives new authority to FDA to issue a mandatory recall, although the agency must first request a voluntary recall from the firm responsible for the product. The FDA commissioner is the only person who can issue the recall, and the authority may be used only for serious adverse consequences or death in humans or animals.
Importers must verify foreign suppliers meet U.S. standards
In the area of imported products, under the proposed Foreign Supplier Verification Program (FSVP) rules, importers, defined as the owner of a food item or ingredient when it enters the U.S., are required to conduct in-person risk-based verifications of foreign suppliers to make sure they meet the same hazard identification and written risk management program requirements U.S. firms do. FDA expects importers to keep records associated with this verification for two years.
“This rule tells you what you have to do to go overseas and look at a facility, and what kind of records you have to have,” Sellers said. However, because the rules related to “what those controls are and what those records have to look like for feed have not been released, we’re sitting on part of the story, but not the whole story.”
Proposed in late July along with the FSVP rules, rules related to the accreditation of third-party auditors would establish a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. The third-party auditors, also known as certification bodies, will conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.
“This provision says if you don’t go over [to the foreign facility] and you don’t visit at periodic intervals, you can use an FDA-recognized third party, such as one of 30 foreign governments that will be recognized as having a sophisticated regulatory system, a private third-party certification program or another association FDA recognizes,” Sellers said.
FDA will have to determine what it requires for these third party entities to gain recognition. Importers will not generally be required to obtain certifications, but in certain circumstances FDA may use certifications from accredited auditors to help determine whether to admit certain imported food into the United States that FDA has determined poses a food safety risk. FDA may also use third-party auditors to determine whether an importer is eligible to participate in a voluntary program that will speed up the review and entry of food.
In addition, under FSMA, FDA has the ability to refuse entry into the U.S. food from a foreign facility if it is denied access by the facility or the foreign country.
Court establishes timeline
By a court order issued on June 21, FDA must publish all outstanding proposed rules, of which there were five, including those related to preventive control for feed, by Nov. 30, 2013. Additional outstanding rules are connected to international contamination and sanitary transport of food and feed. All comment periods for these proposals must close by March 31, 2014, and the final regulations have to be published by June 30, 2015. The court order stems from a suit filed in August 2012 against the FDA by the Center for Food Safety and the Center for Environmental Health. The groups were trying to compel the agency to implement what they considered were long-overdue provisions of the FSMA. This April, the U.S. District Court for the Northern District of California agreed FDA had failed to meet the deadlines established by Congress. Because FDA and the Center for Food Safety and the Center for Environmental Health could not agree on a timetable for deadlines, the court issued its own.