Tag Archives: FDA inspection

Canadian Food Inspection Agency Not Liable for Negligent Performance of its Duties

Canadian Food Inspection AgencyIn April of 2013, Nicholas Kluge wrote an article titled: Government Liability for an Unnecessary Product Recall  This article analyzed the recent decision of Los Angeles Salad Co. v. Canadian Food Inspection Agency, 2013 BCCA 34, which is a British Columbia Court of Appeals case.  In this case, “the Court of Appeal addressed the issue of liability – or lack thereof – on the part of a Canadian government regulatory for damages arising out of negligent performance of its duties where the performance of those duties led to a recall of the plaintiff’s product.”  Id.

The plaintiff, Los Angeles Salad Co., supplied carrots to Costco outlets in the United States and Canada. According to the statement of claim, in 2007, the Canadian Food Inspection Agency (CFIA), the Canadian government regulator empowered to enforce food safety legislation in Canada, received reports from four consumers of the carrots who had contracted shigellosis, a potentially fatal illness caused by consumption of food contaminated with shigella bacteria. The CFIA, assisted by the Public Health Agency of Canada and Health Canada, inspected the carrots. The inspection was allegedly conducted negligently, and the CFIA informed Los Angeles Salad, Costco, the U.S. Food and Drug Administration and the public that the carrots might be contaminated with shigella bacteria, and advised the public not to consume them. As a result of this information, Costco recalled the carrots from its retail stores in Canada, and Los Angeles Salad voluntarily recalled its carrots from retail stores in the United States. The recalled carrots were destroyed, along with carrots in inventory and “in the ground.” It was ultimately determined that the carrots were in fact not contaminated with shigella bacteria and had not been the source of the shigellosis outbreak.

Los Angeles Salad sued the CFIA, alleging that the CFIA’s negligence in identifying its products as the source of the shigellosis outbreak was the proximate cause of economic losses suffered as a result of the recall and destruction of its carrots. The CFIA brought an application to strike out the action on the basis that the CFIA owed no private law duty of care to the plaintiffs.

The trial-level British Columbia court agreed with the CFIA and dismissed the action. Los Angeles Salad appealed the decision to the British Columbia Court of Appeal. In a decision released January 29, 2013, the Court of Appeal upheld the trial-level ruling, finding that under Canadian law there exists no private law duty of care owed by the CFIA to food sellers and similarly placed entities, as if such a duty were to be recognized, it would put the CFIA and other government regulatory bodies in the untenable position of having to balance public interests — ensuring food and product safety in the Canadian marketplace — with the private interests of commercial actors, which could produce a chilling effect on the proper performance of governmental duties.  Id.

Interestingly, the Canadian Court of Appeals decision in Angeles Salad Co. v. Canadian Food Inspection Agency, 2013 BCCA 34 is consistent with similar cases in the United States.  A review of relevant U.S. case-law shows, almost without exception, that no private cause of action exists for a violation of governmental duties owed to the public. The exception to this general rule is often found where the statute or ordinance imposes such a duty.  Accordingly, it is safe to say that the general rule is that a private party – even when actually harmed – cannot maintain a civil action against a governmental agency for negligence in either the U.S. or Canada.

What does this mean for the food industry?  As former president Ronald Regan said, “trust, but verify.”  A food company would be well advised to maintain command and control over its food safety program and any government inspection of its products and facilities.  Do not be afraid to get a second opinion from an independent laboratory and to challenge the government’s findings if a discrepancy is found.  After all, this is why both the FDA and the USDA provide the industry with due process rights.  Knowing what they are and how and when to use them may protect your company serious damage to its reputation, customer relations and back account.

FDA Reopens Comment Period for Draft Risk Assessment for Food Facilities

FSMA LogoAs reported by The Packer (and announced by the FDA), “the FDA is reopening the comment period for a draft risk assessment for certain food facilities that include farm packing operations for fresh fruits and vegetables.”  See FDA Reopens Comment Period on Food Facilities.

To be clear, comments on the FDA’s “Draft Qualitative Risk Assessment of Risk Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” are DUE ON MAY 16, 2013.

Here is a link to the Risk Assessment: DRAFT Qualitative Risk Assessment Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm

For those of you who have not yet read the risk assessment document mentioned above, this document addresses the various activities that occur on farms and other food facilities and categorizes the activities based on risk to human/animal health.  Make no mistake, a food facilities’ activities will directly affect its registration classification (high risk or low risk).  Specifically, the FDA will subject high risk food facilities (based on activity conducted therein) to more frequent inspections and other increased scrutiny.  Low risk food facilities are subject to a more lenient inspection schedule because the activities conducted in low risk facilities present a lower risk to human/animal health.

This rule recognizes that food facilities are often co-located on farms, but the activities conducted at the facility could be very different from the types of activities conducted on the farm itself.  As such, this rule provides a way for to classify food facilities based on the realities associated with they types of the activities actually conducted at the facility and without regard to its location or association with a high risk food facility or farming operation.  The differences will save the industry money in terms of the cost of legal compliance and that makes this document worthy of comment.

More importantly, the Risk Assessment document provides detailed responses to the following important questions:

Question 1: What are the foods that would be manufactured, processed, packed or held by a farm mixed-type facility?

Question 2: What are the activities that might be conducted by farm mixed-type facilities on those foods?

Question 3: What are the hazards reasonably likely to occur in those foods?

Question 4: For the purpose of determining whether an activity/food combination is low risk, which hazards should be considered to have a reasonable probability of causing serious adverse health consequences or death?

Question 5: For the purpose of determining whether an activity/food combination is low risk, what foods have inherent controls that significantly minimize or prevent a biological hazard that is reasonably likely to occur in these foods and that is reasonably likely to cause serious adverse health consequences or death?

Question 6: What interventions significantly minimize or prevent a hazard that is reasonably likely to occur in these foods and that is reasonably likely to cause serious adverse health consequences or death?

Question 7: Which of these activities are reasonably likely to introduce, or increase the potential for occurrence of, hazards that are reasonably likely to cause serious adverse health consequences or death and what are these hazards?

Question 8: Which of these activities are interventions to significantly minimize or prevent hazards that are reasonably likely to cause serious adverse health consequences or death from consumption of these foods?

Question 9: Which activity/food combinations are low risk?

Please take the time to read this document and exercise your right to comment upon how it affects your business.  Now is the time to voice any concerns.

Jason Klinowski Published in Food Safety Magazine

The September 2012 edition of Food Safety Magazine’s eDigest includes a Food Safety Modernization Act (“FSMA”) Update Article that I co-authored along with John Shapiro.

Please see a link to the article below:

FSMA Legislative Update

This article discusses the Food and Drug Administration (FDA)’s second annual report on the roll out of the Food Safety Modernization Act (FSMA) and illustrated how the report did not mention the FDA’s failure to promulgate five important regulations during 2012.

Along this same line, we discussed the Center for Food Safety and the Center for Environmental Health’s August 29, 2012 civil action against certain governmental agencies and officers to enforce the FSMA and to compel the promulgation of certain key regulations.

Jason Klinowski Published in Food Safety Magazine

The August 2012 edition of Food Safety Magazine’s eDigest includes a Food Safety Modernization Act (“FSMA”) Update Article that I co-authored along with John Shapiro.

Please see a link to the article below:

FSMA Legislative Update

This article discusses the July 31, 2012, Food and Drug Administration (FDA) announcement of the per hour FDA inspector charges it will levy against food companies in the upcoming fiscal year under the Food Safety Modernization Act (FSMA).  Those rates are $221 per hour if no foreign travel is required and $289 per hour if foreign travel is required. The new rates will take effect October 1, 2012, and will be effective through September 30, 2013. FDA intends to reassess the rates for the fiscal year starting October 1, 2013.

FSMA Update: Food Facility Registration and Updates to Food Categories

The FDA recently issued a DRAFT guidance for the food industry discussing the agency’s current thinking regarding the necessity of food categories in food facility registrations.

See Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories

DISCLAIMER: The forthcoming discussion relates to draft guidance that is still open for comment, modification and retraction.  As such, it is not intended for immediate implementation in its current form and it does not create a legally enforceable responsibility.

 

Step One: Relevant Rule (FD&C Act & Bioterrorism Act)

Section 305 of the Bioterrorism Act, generally required domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003 (See 68 FR 58894). This section also required facilities to submit registrations to FDA containing information regarding applicable food product categories as identified in 21 CFR 170.3.

Step Two: Necessity to be Determined by the FDA Through Guidance

Section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3) of food manufactured, processed, packed, or held at such facility.

Step Three: FDA Issued the Requisite Guidance and Finding of Necessity

On July 17, 2003, FDA issued a guidance stating that the agency had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415).

Step Four: Net Result…

Section 305 of the Bioterrorism Act, in relevant part, requires a food facility registrant to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3) of food manufactured, processed, packed, or held at such facility.

What’s New Under FSMA?

Step One: The New Relevant Rule

FSMA, enacted on January 4, 2011, amended section 415 of the FD&C Act. Section 415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, now provides in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance)  of any food manufactured, processed, packed, or held at such facility.

Step Two: Necessity to be Determined by FDA Through Guidance

FDA believes that it is necessary for a food facility to submit to FDA a registration containing the general food category as identified in 21 CFR 170.3 and any other food categories as identified below, if applicable, for a quick, accurate, and focused response to a food-safety related issue or an actual or potential bioterrorist incident, other food-related emergency, or food safety incident.

FDA believes that information about a facility’s food categories is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected.

Section 102 of FSMA, also provides in relevant part that FDA may, through guidance, determine that additional food categories, other than those listed in 21 CFR 170.3, are appropriate for the purposes of food facility registration under section 415 of the FD&C Act.

Step Three: FDA Issued a DRAFT Version of the Requisite Guidance and Finding of Necessity

This draft guidance document also addressed the FDA’s finding of necessity needed to include additional food categories into the food facility registration process.  To this end, the “FDA believes that the following additional food categories are appropriate for food facility registration and will include such categories as mandatory fields in the food facility registration form when FDA finalizes this guidance”:

Additional Food Categories for Foods for Human Consumption:

  • Acidified Food (see 21 CFR 114.3(b));
  • Cheese and Cheese Product Categories: Soft, Ripened Cheese; Semi-Soft Cheese; Hard Cheese; Other Cheeses and Cheese Products;
  • Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals;
  • Fisher/Seafood Product Categories: Fin Fish, Whole or Filet; Shellfish; Ready to Eat (RTE) Fishery Products; Processed and Other Fishery Products;
  • Fruit and Fruit Products: Fresh Cut Produce; Raw Agricultural Commodities; Other Fruit and Fruit Products;
  • Fruit or Vegetable Juice, Pulp or Concentrate Products;
  • Low Acid Canned Food (LACF) Products (see 21 CFR 113.3(n));
  • Nuts and Edible Seed Product Categories: Nut and Nut Products; Edible Seed and Edible Seed Products;
  • Shell Egg and Egg Product Categories: Chicken Egg and Egg Products; Other Egg and Egg Products;
  • Vegetable and Vegetable Product Categories: Fresh Cut Products; Raw Agricultural Commodities; Other Vegetable and Vegetable Products; and
  • Baby (Infant and Junior) Food Products Including Infant Formula.

Additional Food Categories for Foods for Animal Consumption:

  • Grain or Grain Products (i.e., barley, grain sorghums, maize, oat, rice, rye, wheat, other grains or grain products);
  • Oilseed or Oilseed Products (i.e., cottonseed, soybeans, other oilseeds or oilseed products);
  • Alfalfa Products or Lespedeza Products;
  • Amino Acids or Related Products;
  • Animal-Derived Products;
  • Brewer Products;
  • Chemical Preservatives;
  • Citrus Products;
  • Distillery Products;
  • Enzymes;
  • Fats or Oils;
  • Fermentation Products;
  • Marine Products;
  • Milk Products;
  • Minerals or Mineral Products;
  • Miscellaneous or Special Purpose Products;
  • Molasses or Molasses Products;
  • Non-protein Nitrogen Products;
  • Peanut Products;
  • Recycled Animal Waste Products;
  • Screenings;
  • Vitamins or Vitamin Products;
  • Yeast Products;
  • Mixed Feed (e.g., poultry, livestock, equine);
  • Pet Food;
  • Pet Treats or Pet Chews;
  • Pet Supplements (e.g., vitamins, minerals); and
  • If none of the above food categories apply, print the applicable food category or categories (that does not or do not appear above).

Step Four: Net Result…  (coming some in final form)

Once FDA issues the final version of the aforementioned guidance document, the foregoing rules about registrations and additional food category disclosures will become a mandatory requirement for food facilities and a legally enforceable obligation under FSMA.

My Company is Involved in a Foodborne Illness Outbreak… What do I do?

My phone rings the other day and I look at the number… I did not recognize it.  Of course, I answer the phone with a friendly, “Good morning, this is Jason.”  Just that quickly I am connected to a conference room filled with concerned produce company executives with little  time for pleasantries.  I quickly discover that the company is involved in a foodborne illness outbreak and has several concurrent fires to put out.  Against this back drop, the questions start flying:

  • Do I have to give the government copies of my customer list?
  • Do I have to allow the government to take pictures of my product, operation, etc.?
  • Do I have any rights when it comes to a government inspection?
  • What do I need to say or not say to my customers?
  • Is there something we should be doing that we are not?
  • Does my insurance policy cover this?
  • Do I have enough insurance?
  • Does it matter that the contaminated product was not ours?
  • Do we have any exposure here?
  • What should we be doing right now to mitigate our exposure to any type of litigation?
  • What should we be doing to protect our brand identify and the company name?

Grappling with any one of these questions while you are watching a foodborne illness outbreak unfold in real-time is both difficult and time sensitive.  In an ideal world, you would have a crisis management plan ready to be pulled off the shelf and executed upon.  Moreover, the company’s employees would be similarly prepared as they would have received re-occurring training on the company’s crisis management policies and procedures.

The reality for most produce companies is much different…  Under a sales driven business model, it is far to common for produce companies to rely on the food safety promises of third parties (many of which are not readily capable of verification) and for product testing to be too heavily focused on good arrival standards, which are governed by the relevant sales contracts.  Against this back drop, even successful produce companies find themselves in uncharted waters when they are thrust into the middle of a foodborne illness outbreak and forced to handle all the related media exposure, demands from government investigators and other unanticipated events.

So What Should You Do? (Top 10)

  1. Seek the advice of an experienced food law attorney of your chosing! 
  2. Through either your attorney or your company, have strategic partners identified and available for you to call upon for assistance.  This will help ensure that the crisis management activities of your company does not preclude the company from continuing its “normal” business operations.
  3. Don’t write anything or say anything that you do not want to see in the media.
  4. Know your rights and proactively manage any and all government inspections or requests for information.
  5. Prepare and implement a public relations plan designed to address at least two main target audiences: (i) your customers and (ii) the public.
  6. Initiate the audits necessary to both identify the source of the problem (contaminated product) and to trace all of the contaminated product that flowed through your company or which may still be in your company.
  7. Be aware of cross contamination issues…
  8. Know how to properly document all of the processes mentioned above.
  9. Know how to properly destroy contaminated food.
  10. Conduct a review of all relevant insurance policies, supply contracts and other documents that may contain contractual obligations the company must comply with during the crisis.  (i.e. are you obligated to notify your insurance carrier of the problem within a certain period of time?)

As you can see from the foregoing list, there are many things a produce company needs to know and do in order to protect itself (as best it can) from the fall out associated with a foodborne illness outbreak.  Many of these things can and should be prepared in anticipation of a foodborne illness incident that we all hope never occurs, but there are also many things that can be done and should be done as the event unfolds.

Again, if you find yourself in the middle of a foodborne illness outbreak or related recall you would be well advised to seek the advice of an experienced food law attorney of your choosing.  As we know from witnessing the Jensen Farms outbreak, few companies are adequately prepared to deal with these types of situations and that could lead to the demise of your company.  Of course, time is always of the essence in these types of cases.

Wrongful death cases related to foodborne illnesses cost the food industry billions of dollars each year and very few, if any, companies responsible for the problem live to tell the story.  Why?  Frankly this is the way juries like it when it comes to food safety and public health.  Accordingly, these types of cases are often won or lost before a civil action is ever filed.

Burch Farms – Melons Recalled After FDA Discovers Listeria

In a recent online article The Packer reported that:

“Listeria contamination is confirmed at the Burch Farms melon packing facility in Faison, N.C., according to the Food and Drug Administration.”

FDA officials also said the Listeria finding spurred Burch to expand its recall to include all cantaloupe and honeydew melons shipped this season. No illnesses have been reported in relation to the recalled melons.

“This recall expansion is based on the FDA’s finding of Listeria monocytogenes (L. mono) on a honeydew melon grown and packed by Burch Farms. The recall expansion is also a result of the agency’s finding of L. mono in the environment of the firm’s packing facility,” according to the notice.

FDA finds Listeria at Burch Farms

Food Safety News also picked up on this breaking news and reported as follows:

According to FDA, the recalled whole cantaloupes are identified by a red label reading Burch Farms referencing PLU # 4319. All cantaloupes involved in the recall were grown by Burch Farms, however some of the cantaloupes may have been identified with a “Cottle Strawberry, Inc.” sticker referencing the same PLU, but Cottle Strawberry, Inc. did not grow or process the recalled cantaloupe.

FDA said that honeydew melons involved in the recall expansion “do not bear any identifying stickers and were packed in cartons labeled melons.”

The melons were shipped to distributors in 18 states — Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Virginia, Vermont and West Virginia — but distributors in those states may have further distributed them to other states.

FDA Issues Update on Burch Farms Melons Recall

FSMA Update: 2013 Fee Schedule Features Reduced Rates!

On July 31, 2012, the FDA announced its fee structure for rates to be assessed under the Food Safety Modernization Act in 2013.  The rates for 2013 are $221.00 per hour if no foreign travel is required and $289.00 per hour if foreign travel is required.  These new rates will be effective from October 1, 2012 through September 30, 2013, which is when the next fiscal year’s fee schedule will be published.

The good news is that the 2013 rates are lower than the 2012 rates, which were $224.00 per hour is no foreign travel is required and $325.00 per hour if foreign travel is required.  Perhaps the rate reduction in 2013 is a sign that the FDA is attempting to implement FSMA in light of the known operational realities and pain tolerances for administrative fees that exist in the food industry.

With that said, it is important to remember that FSMA’s fee structure represents hourly rates charged by each FDA inspector participating any type of billable activity related to a given case.  As a reminder, billable activities include 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.  Other billable activities include 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.  Simply put, even with a reduced fee structure, FSMA related fees can add up quickly and significantly impact businesses.

Will the FDA charge and collect fees under FSMA in 2013?

Because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms.  FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.

Who will be affected by these fees?

Only those parties in the food and feed industry whose non-compliance results in the following activities:

  • Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
  • Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
  • Importer reinspections — follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.

Can small businesses have their fees waived?

The FY 2013 fee schedule does not contain any reduced fee rate for small business. However, FDA does not intend to issue invoices for reinspection or recall order fees until a guidance document to outline the process through which firms may request a reduction of fees has been published. Once published, invoices will be issued and firms can apply for reductions as outlined in the guidance.

How does FDA plan to charge these fees?

For facility reinspection fees, FDA will invoice the responsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.

Which fiscal year rate will be used and when?

The fiscal year in which the reinspection occurs dictates the fee rate to be applied. For example, if a reinspection was conducted in September, 2012 and the invoice was issued in October, 2012, the fee rate to be applied would be the FY 2012 rate. The invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount.

How long does the responsible party have to pay the fees?

Payment must be made within 90 days of the invoice date.

What happens if the responsible party or U.S. Agent does not pay?

Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.

Jason Klinowski Presents at the 3rd Advanced Summit on Food Safety Regulatory Compliance

Recently, I had the privilege of speaking at the American Conference Institute’s 3rd Advanced Summit on Food Safety Regulatory Compliance, which was held in Chicago, Illinois on June 26-27 2012.  My presentation discussed: “How to Prepare and Implement Effective Remediation and Corrective Action Plans Post-Inspection.”  Notable conference attendees included counsel and/or representatives from ConAgra Foods, H.J. Heinz Company, J.M. Smucker Company,  Whole Foods Market and others.  Freeborn & Peters LLP was a proud sponsor of this event.

My presentation provided a practitioner’s point of view (as outside general counsel to numerous food companies) on how to prepare a proper response to a FDA 483 Report of Investigation, which including drafting tips, best practices and response strategies.  Following this same format, I also discussed how to prepare effective corrective action plans  and reconditioning plans.

For those of you who may be interested, here is a link to my presentation:

Jason Klinowski’s – ACI Presentation

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…