New Inspection and Compliance Mandates under FSMA
Mandated inspection frequency
Testing by Accredited Laboratories
Mandatory Recall Authority with Informal Hearing Before Recall is Made
- Facility bi-annual re-registration, FDCA Section 415
- Enforcement Authority
- FDA can suspend facility registration pursuant to Section 415(b) in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
- FDA may by order suspend the registration of a facility that:
(1) Created, caused or was otherwise responsible for such reasonable probability.
(2) Knew of or had reason to know of such reasonable probability AND packed, received or held such food.
Effect of such facility suspension:
- No person shall import or export food into the US, offer to import or export food into the US, or otherwise introduce food into interstate or intrastate commerce in the US from such facility.
- Opportunity for hearing on suspension
- Mode of vacating suspension of registration order
FDA also has more flexibility in using its administrative detention authority to keep potentially adulterated/misbranded products from entering the marketplace.
Food Facility to Submit Additional Information to FDA to Receive a Food Facility Registration number
- Registrations are required to contain the email address for the contact person of the facility, or for a foreign facility, the email address of the US agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FDCA.
- If determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed or held at registering facilities.
Draft Guidance for Industry: FDA Records Access Authority Under Sections 424 and 704 of the FDCA) Issued February 2012
- FDA may access and copy records from domestic and foreign persons who manufacture, process, pack, transport, distribute, receive, hold, or import food if:
- FDA has a reasonable belief that the food and any other food that FDA reasonably believes is likely to be affected in a similar manner: Is adulterated, and Presents a threat of serious adverse health consequences or death to humans or animals.
- FDA believes that there is a reasonable probability that use of or exposure to the food, and any other food that the FDA reasonably believes is likely to be affected in a similar manner will cause serious adverse health consequences or death to humans or animals.
- Human Food and Animal Feed
- Domestic and Foreign Processors
- Records required by regulation under 414(b)
- Records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the food believed to be affected and any other article of food believed to be affected in a similar manner.
- Manufacturing records
- Raw materials (ingredients and packaging) receipt records
- Product distribution records
- Product inventory records
- Test records
- Recall records
- Reportable food records
- Customer distribution lists
- Complaint and adverse event reports
Records FDA may NOT Access
- Farm records
- Records from restaurants
- Records relating to food that is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act
- Financial Data
- Pricing Data
- Personnel Data
- Research Data
- Sales Data
When is FDA likely to exercise its authority under Section 414(a) and 704(a) of the FDCA to access and copy records?
- Reportable food reports
- Foodborne outbreaks
- Epidemiological evidence which implicates food causing illness or death
- Product recalls
- Adverse event reports
- Consumer complaints
- Situations in which specific foods (or other foods that are reasonably likely to be affected in a similar manner) present a threat of serious adverse health consequences or death to humans or animals.
Enforcement Action FDA May Take When a Firm Refuses to Permit Access to Records
- Suspension of food facility registration thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce
- Administrative detention of the food to control its movement
- Seizure of the food
- Issuance of a mandatory recall order for the food
- Injunction against the firm
FDA’s commitment to maintain confidentiality of any protected information in records it obtains
Guidance for Industry: Q&A Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Issued February 2012)
- Records Requirements
- Record Requirement Exclusions
- Additional applicable statutory provisions and regulations
- Whether Existing records satisfy the records requirements
- Information required in the records that must be established and maintained to identify the non-transporter and transporter immediate previous source and immediate subsequent recipients
- Records required to establish and maintain for tracing the transportation of all food
- Record retention requirements
- Record exclusion requirements
- Record availability requirements
- Consequences for failing to establish and maintain required records or make them available to FDA
- Compliance Dates for Records Requirements
Guidance for Industry: What You Need to Know About Administrative Detention of Foods (Issued October 2011)
- Food that is subject to administrative detention
- Length of Administrative Detention
- FDA may detain an article of food for a reasonable period, not to exceed 20 calendar days, after the detention order is issued. However, an article of food may be detained for 10 additional calendar days if a greater period of time is required to institute a seizure or injunction action. The entire detention period may not exceed 30 calendar days.
Criteria used by FDA to order an administrative detention
- Officer/or qualified FDA employee may order the administrative detention of any article of food that is found during an inspection, examination, or investigation under the FDCA if the officer or qualified employee has reason to believe that the article of food is adulterated or misbranded.
Information to be included on the FDA administrative detention order
- Detention order number
- Hour and date of the order
- Identification of the detained article of food
- Detention period
- Statement that the article of food identified in the order is detained for the period shown
- Brief, general statement of the reasons for detention
- Address and location where the article of food is to be detained and the appropriate storage and transportation conditions
- A statement that the article of food is not to be consumed, moved, altered or tampered with in any manner during the detention period, unless the detention order is first modified under 21 CFR 1.381(c)
- Name and title of the authorized FDA representative who approved the detention order
- Modification of an administrative detention order
- Applicable labeling requirements to an administratively detained food
- Expedited procedures when FDA initiates a seizure action against an administratively detained perishable food
- Conditions of holding the administratively detained food
- Differences between an import detention and administrative detention
- Persons entitled to appeal a detention order
- Requirements for Submitting an Appeal
- FDA statutory issuance of a decision on an appeal
- Termination of an administrative detention order
Product Tracing Summary (Issued July 2012)
FDA announced September 7, 2011 that the Institute of Food Technologists (IFT) will carry out two new pilot projects at the direction of FDA to explore and demonstrate methods for rapid and effective tracking and tracing of food as part of FSMA Section 204, Enhanced Tracking and Tracing of Food and Recordkeeping
Foods that will be part of the pilot program
Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools, and nursing homes, and through grocery stores.
Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken (because they contain multiple ingredients involved in significant outbreaks)
Jarred peanut butter and dry, packaged peanut/spice
FDA to use information from the pilot projects that FSMA requires to develop recordkeeping requirements for high risk foods and to provide potential guidance