Category Archives: Food Safety Modernization Act

FSMA: Comment Period Opened on Food Facility Information Collection Program

The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the proposed collection of certain information by the Agency.  This notice solicits comments on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and the new Form FDA 3797, which may be submitted electronically via the FDA Industry Systems Website. 

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) (the “Bioterrorism Act”) FDA was further authorized to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. The Bioterrorism Act added section 415 of the FD&C Act (21 U.S.C. 350d), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.  (emphasis added).  FDA regulations at 21 CFR 1.230 through 1.235 set forth the procedures for registration of food (including animal food/feed) facilities.

The types of information the FDA proposes to collect in its voluntary food facility profile includes, among other things:

  • The facility type (i.e. manufacturer/processor, re-packer/packer, warehouse/holding facility)
  • The products and related hazards (i.e. biological, physical, chemical), along with preventive control measures associated with said products
  • Facility information (i.e. food safety training, facility size, number of employees, operational schedule, etc.)

With respect to the collection of information, FDA invites comments on the following topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The deadline to submit either electronic or written comments on the collection of information summarized above is July 10, 2012.  Please take full advantage of this opportunity.  These rules will affect how the industry operates and establishs another key standards against which a food facility will be measured.  As such, it is important to voice your concerns to the FDA during these comment periods.

FSMA: Is There Penalty for Non-Compliance with a Recall Order?

YES!  The FDA may assess fees under Section 107 of the FSMA for non-compliance with a recall order under Section 423(d) or 412(f) of the FD&C Act. 

Non-compliance may include:

             1.         Not initiating a recall as ordered by the FDA

            2.        Not conducting the recall in the manner the FDA specifies in the recall order

            3.         Not providing the FDA with requested information regarding the ordered recall

Who Pays the fee for non-compliance with a recall order?

The party responsible for paying the non-compliance with a recall order fees include:

  • The responsible party for a domestic facility
  • An importer who does not comply with a recall order

The party paying the fee would be the party that received the recall order.  Importantly, this means that a distribution or storage company who owns or operates a food facility to provide services to others may be subject to this penalty even though they may not own the food. 

How much will a non-compliance with a recall order fee cost my company?

Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour is 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 anticipated number of direct hours spent on taking action in response to the company’s failure to comply with a recall order.  

Billable Activities: conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition.

How can my company guard against or minimize its exposure to these  fees?

BE PREPARED!

  • Successful inspections are the result of comprehensive preparation.
  • Assess your company’s compliance with all relevant statutory and regulatory requirements.
  • Understand the FDA’s inspection process and know your rights at every stage
  • Be prepared to manage and control the inspection process… don’t let it control you.

FSMA: Am I Operating a High-Risk Food Facility?

According to a recent FDA guidance document, the FDA’s risk-based model for prioritizing inspections of food establishments utilizes technology to analyze traditionally available information and to set the agency’s priorities for allocating domestic inspection resources. 

What does this mean in layman’s terms?

It means the FDA is going to analyze the data it already collects, tracks and monitors to determine the agency’s priorities when it comes to identifying food facilities to inspect. 

How does the FDA identify a high-risk facility?

The answer to this question is two fold.  First, the FDA looks at inherent risk factors at the industry wide level.  The industry wide risk factors include, but are not limited to:

  • foodborne illness outbreaks
  • recalls
  • reports of adverse events associated with a specific industry of category of food (i.e. cantalope, sprouts, etc.) 

Secondly, (and most importantly) the FDA looks at inherent risk factors at the firm or company level.  The firm or company level risk factors include, but are not limited to:

  • the known safety risks of the food manufactured, processed, packed or held at the facility.  (i.e. if your facility handles high-risk food(s) your facility will be deemed a high-risk facility based on that fact alone)
  • compliance history of the firm or company (i.e. food recalls, outbreaks of foodborne illnesses and prior violations of food safety standards)
  • the rigor and effectiveness of your hazard analysis and risk-based preventative controls.
  • whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.  (applies only to foreign food facilities)
  • whether the food or the facility the manufactured, processed, packed or held such food has received a certification from the FDA under the foreign supplier verification program or the voluntary qualified importer program.
  • anything else the FDA deems necessary and appropriate.  Two known examples include the establishment type / type of activity conducted at the facility (i.e. manufacturer/processor, repacker/packer, etc.) and the number of years since last inspection.

How is the information used to determine inspection priority?

The FDA’s decision-making process is based primarily on the first two bullets and the last.  The balance of the risk factors will be incorporated into the FDA’s decision-making process as they continue to develop their data collection and testing tools and will be laid out in the forthcoming Preventative Controls regulation.

In addition, the FDA may inspect facilities more often than the frequency mandate as a result of emerging public health information, follow-up to violative inspections and/or samples, etc.

From a technical position, the FDA is utilizing “a software program that assesses the characteristics of each facility in the agency’s inventory.”  This “software provides data access, analysis and reporting from the agency’s internal data systems.”   See Domestic Facility Risk Categorization

What does all of this mean to my business?

The FDA estimates that there are approximately 22,325 domestic high-risk (HR) food facilities and about 60,000 non high-risk (NHR) domestic food facilities.  FSMA calls for all HR domestic food facilities to be inspected within five years of the date the bill was signed into law.  Thereafter, all HR food facilities will be inspected once every three years and all NHR food facilities will be inspected once every five years.  Importantly, FSMA limits its inspection of food facilities to only those required to register under the Section 415 of the FD&C Act, which is the Bioterrorisim Act.

Food companies would be well advised to start preparing for inspections NOW before the USDA comes knocking.   A company may proactively mitigate many of the FDA’s risk factors through preparation.  For example, there should be no excuse for a food company not to:

  • be properly registered under the Bioterrorism Act.
  • have the proper food safety plans and related standard operating procedures prepared and ready for inspection. 
  • be in compliance with many of the already known food safety rules.  
  • possess a solid understanding of how to manage a FDA inspection
  • and more…

FSMA: Consumers are not protected when the FDA’s rules are “stuck in review.”

On March 19, 2012, the Consumer Federation of America announced that its members voted to support a resolution urging the Obama Administration to issue four proposed food safety rules, which have been delayed for over two months. 
 
“On behalf of CFA’s nearly 300 members, we urge the Administration to immediately issue these important food safety proposals,” said Chris Waldrop of CFA’s Food Policy Institute.  “The longer these proposals are delayed, the longer it will take to fulfill the promise of the Food Safety Modernization Act, which is intended to better protect consumers from foodborne illness.”  Simply put, “consumers won’t be adequately protected if the FDA’s proposals are stuck in review.”  See CFA Press Release.
 
Being in the trenches with my food industry clients on a daily basis, I can confirm that the CFA’s position is well aligned with the industry’s current thinking.   However, I would like highlight the importance of the food industry’s comment period and the FDA’s attention to our collective voice.   As we all know, it is critical for the food industry to speak up and use comment opportunities to help shape the very rules that govern our business operations. 
 
To rush this process and force a potentially premature closure to the FDA’s listening period (e.g. when FDA uses the industry’s comments to further modify the proposed rules prior to issuance) invites future litigation to resolve issues of fairness, application, constitutionality, language interpretation, etc.   Although accountability is critical, I always urge people to look at all sides of any given position.
 
With that said, we are all waiting for the FDA to issue its long overdue food safety rules.   

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.