Tag Archives: FSMA

FSMA (Section 107): What triggers the facility reinspection fee?

The FDA may assess fees under Section 107 of the FSMA whenever the FDA, or its agent, inspects a domestic or foreign facility and the final classification of the facility is:

            1.         Official Action Indicated, and

            2.         The non-compliance was “materially related to food safety.”

The fee will be assessed for a reinspection of domestic and foreign facilities to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction. 

What does the FDA mean by: “reinspection”?

Domestic Facilities: Reinspection means one or more inspections conducted under the FD&C Act subsequent to an inspection that resulted in a final classification of a facility as OAI and where the non-compliance was materially related to food safety.

Foreign Facilities: Reinspection means one or more inspections conducted by officers or employees duly designated by the Secretary subsequent to an inspection which identified non-compliance materially related to a food safety requirement under the FD&C Act. 

What does the FDA mean by: “materially related to food safety”?

Some examples of non-compliant conditions or practices that “materially relate to food safety” include, but are not limited to:

  • Food borne pathogens in ready to eat products
  • Pesticide residues on food or feed products above established tolerances
  • Failure to declare the presence of a major food allergen in product labels
  • Lack of adequate hazard controls (HACCP)

Who Pays the Facility Reinspection Fees?

The party responsible for paying the Facility Reinspection Fees include:

  • The responsible party for a domestic facility
  • TheU.S.agent for a foreign facility
  • Each importer subject to reinspection

How much will a reinspection fee cost my company?

Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour if no foreign travel is required and $325.00 per hour if foreign travel is required.

Number of FDA employees or agents assigned to a reinspection: The FDA will make this determination on a case-by-case basis.  Relevant factors for this decision include the size of the firm, number of products, number and nature of the violations observed in the initial inspection and the amount of expected resources needed to evaluate the firm’s corrective actions and current state of compliance with respect to the items identified in the initial inspection.   

Billable Activities: conducting the reinspection at the facility, making preparations and arrangements for the reinspection, traveling to and from the facility, analyzing records, analyzing samples, preparing reports or examining labels and performing any other activity deemed necessary to determine compliance with the regulation or statute found to be violated in the initial inspection.

FSMA – The FDA’s new records access authority

FDA’s INCREASED RECORDS ACCESS AUTHORITY  

Section 101 of FSMA amends the FD&C Act to increase the FDA’s authority to access and copy records.  Prior to the passage of FSMA, the Food Drug & Cosmetic Act (FD&C) provided the FDA access to records relating to food reasonably believed to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals.  FSMA expands this access to records beyond those relating to a specific suspect article of food to records relating to any other article of food the FDA reasonably believes is likely to be affected in a similar manner. 

This new grant of authority permits FDA inspectors to significantly expand the scope of their investigation as they are no longer confined to specific articles of food identified in a complaint as being potentially adulterated.

When the FDA may access and copy records:

Under FSMA, the FDA may access and copy records from domestic and foreign food companies who manufacture, process, pack, transport, distribute, receive, hold, or import food in either of the following two situations: (1) the FDA has a reasonable belief the food, and any other food articles likely to be affected in a similar manner, are (i) adulterated, and (ii) presents a threat of serious adverse health consequences or death to humans or animals; or (2) the FDA believes there is a reasonable probability that the use or exposure to an article of food, and any other article of food likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. 

Importantly, FSMA grants the FDA access to the records of both the domestic importer and its foreign supplier.  This is consistent with FSMA’s goal of making importers responsible for ensuring food from abroad is as safe as any of our domestic products. 

To be more clear, FSMA’s enlargement of FDA authority to access and copy records extends to those records required to be kept by law (e.g., FD&C Act, Bioterrorism Act, etc.), as well as any other records related to the manufacture, processing, packing, transportation, distribution, receipt, holding, or importation of the suspect food.  This applies to records maintained by or on behalf of the company in any format and at any location.  Examples of records the FDA can access include raw materials receipts; customer distribution lists; manufacturing, test, and recall records; and complaint and adverse event records.

Records the FDA may NOT access and copy:

Notwithstanding FSMA, the FDA may NOT access and copy the following types of records:

  • Records from farms, which include facilities that pack, hold, or manufacture/process food, provided all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership
  • Records from restaurants
  • Records relating to food that is within the exclusive jurisdiction of the Secretary of Agriculture
  • Recipes, which are defined as formulas that include: (i) ingredients; (ii) quantities, and; (iii) instructions necessary to manufacture a food
  • Financial, pricing, personnel, or research data
  • Sales data (other than shipment) regarding sales

Privacy protection

The FDA may lawfully obtain information under FSMA that includes non-public confidential or trade secret information. This reality must be reconciled with those laws that govern the FDA’s disclosure of information to the public. For example, can third parties gain access to non-public confidential information provided to the FDA with a Freedom of Information Act request?  The answer: YES… It could happen.  As it stands now, the FDA will only confirm that its personnel will comply with all applicable protections, procedures, and legal requirements that are intended to protect against the unauthorized or accidental disclosure of nonpublic information. 

Refusing to turn over records to the FDA

A refusal to permit the FDA access to or copying of records is prohibited by FSMA; in response, the FDA may initiate a regulatory, civil, or criminal action in connection with the records access request, refuse admission of food offered for import into theU.S., etc.  Separate and apart from a records access request, the FDA may also pursue actions such as suspension of a food facility’s registration (preventing imports/exports or selling food domestically), administrative detention or seizure of food, issuance of a mandatory recall order, or an injunction against the company.

The Opportunity and Challenge of Food Importation

Freeborn & Peters’ Food Industry Team is proud to sponsor the Global Midwest Alliance’s Chicago Winter Food Industry and Technology Event on March 1, 2012.

Featuring Keynote Speaker Dr. Robert E. Brackett, Vice President and Director, The Institute for Food Safety and Health at the Illinois Institute of Technology.  Dr. Brackett will discuss: How Importers Can Prepare for the Impact of the Food Safety Modernization Act.

Also featuring Industry Update Speaker Tejas Bhatt, Staff Scientist, The Institute of Food Technologists.   Mr. Bhatt will discuss: The FDA’s Food Safety Pilot Program: Meeting the Challenge of Traceability.

***This event is the part of the Global Midwest Alliance Food Trade and Technology Series.

http://foodindustry.eventbrite.com