Source: https://fdasolutionsgroup.com/pages/fsma-faqs
Timestamp: 2018-08-17 20:44:58
Document Index: 339467443

Matched Legal Cases: ['§301', '§206', '§306', '§103', '§102', '§103']

FSMA FAQs – FDA Solutions Group
The Food Safety Modernization Act (FSMA), which became effective January 4, 2011, is the most significant change to U.S. food supply regulations since 1938. FSMA creates a comprehensive risk-based approach to food safety, giving the FDA new enforcement authority and tools.
There are five (5) key elements to FSMA:
Prevention Controls: For the first time, FDA’s focus will change from that of a reactive approach to a proactive regulatory approach, requiring comprehensive, prevention-based controls across the food supply.
Inspections and Compliance: Recognizing inspections as an important and essential tool for increasing the accountability of food producers, FSMA calls for increasing the number and frequency of food facility inspections.
Imported Food Safety: FSMA gives the FDA new tools for insuring the safety of imported foods, such as the foreign supplier verification requirement of §301, through which importers will need to verify that their foreign suppliers have adequate preventive controls in place to ensure food safety.
Response: For the first time FDA will now have the authority to force a food producer to institute a recall. This new power has been extended to all food products, including dietary supplements.
Enhanced Partnerships: FSMA recognizes the importance of strengthening all food safety channels across the country. FDA will be working with state, local, territorial, tribal and foreign officials to implement and enforce the FSMA provisions and controls.
WHAT ADDITIONAL AUTHORITY AND TOOLS WERE GRANTED TO THE FDA BY THE FSMA?
Among the additional authority and tools granted to the agency, are:
Mandate Food Recalls: Effective January 2011, FSMA §206 grants FDA mandatory food recall authority, where an article is “adulterated or misbranded and exposure to such article will cause serious adverse consequences to consumer.”
Mandated Food Facility Inspections: For the first time the FDA has been given an inspection mandate, requiring that:
All “high-risk” domestic food facilities be inspected within five (5) years of the bills signing, and at least once every three (3) years thereafter.
All other domestic food facilities shall be inspected within seven (7) years of the bill signing and at least once every five (5) years thereafter.
FDA increase inspections of foreign food facilities every year for the next five (5) years.
Under FSMA §306, requests for inspection shall be considered refused if factory, warehouse, etc. does not permit inspection during the 24 hours after request is made.
Suspend Food Facility Registrations: Under FSMA §103, the FDA may suspend the registration of a facility if the agency determines that food manufactured, processed, packed or held at a facility has a reasonable probability of causing serious adverse health consequences or death.
Harsher Criminal Charges
HOW DOES FSMA AFFECT FOOD FACILITY REGISTRATIONS?
Under FSMA §102, all domestic and foreign food facilities must re-register between October 1, 2012 and December 31, 2012. All food facilities will now be required to submit a bi-annual renewal registration. FSMA grants new authority to FDA to suspend or cancel a food facility registration if a facility is in non-compliance with FSMA or any other rules or regulations enforced by the FDA. Therefore, registration goes from passive database to active enforcement tool.
FSMA WILL AFFECT MY FOOD FACILITY REGISTRATION, BUT DOES IT CHANGE THE PRIOR NOTICE REQUIREMENT?
Under the Bioterrorism Act (BTA), any article of food that is being imported or offered for import into the United States requires the submission of a notice to the FDA, prior to its arrival in the U.S. Under FSMA, Prior Notice submissions must now also identify any country to which the article has been refused entry.
HOW WILL FSMA IMPOSE NEW CONTROLS ON THE MANUFACTURING OR PROCESSING OF FOOD?
Section 103, which becomes effective in July 2012, requires each owner, operator, or agent in charge of a food facility to:
identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, as well as those that may be intentionally introduced;
develop a written analysis of the hazards;
monitor the effectiveness of those controls; and maintain records of such monitoring.
Covered facilities will need to develop a written plan tailored to the facility and the risks associated with the facility’s food. The written plan together with documentation of the monitoring of preventive controls and corrective actions taken must be provided to the FDA upon oral or written request. This section also prohibits the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with this section.
THERE ARE VARIOUS TYPES OF HACCP, WHICH ONE WILL FSMA REQUIRE?
FSMA §103 will borrow heavily from HACCP and other international standards, but will not necessarily be exactly like HACCP. In July 2012 FDA will publish science-based standards for conducting hazard analysis & implementing preventive controls. It is believed that many of these standards could be similar to those contained in ISO22000 and FSSC22000.