Tag Archives: Food Safety

Jason Klinowski to Speak at Upcoming Food Executive Roundtable

On October 23, 2102, Freeborn & Peters and Mesirow Financial will host  a food industry roundtable event for food company executives.  At this event, Jason Klinowski will discuss legal issues related to food recall events, specifically addressing issues related to preparing for and managing government inspections.  Other speakers will discuss security and insurance issues related to food recall events.  Please contact me directly if you are interested in attending this “invite only” event.

Here are the details:

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 Speaks at the 13th Annual Illinois Food Safety Symposium

On September 19, 2012, Jason Klinowski addressed the 240+ attendees of the 13th Annual Illinois Food Safety Symposium, which was held in Bloomington, IL.

During his presentation, Jason Klinowski addressed the issue of whether a health department could recoup the costs it incurs responding to a foodborne illness outbreak in light of the department’s statutory duty to respond and to protect the public health.  The presentation looked at both the legal theories for recovery and the practical considerations (pros & cons) of such litigation.

This event was co-sponsored by the Illinois Department of Public Health and the Illinois Public Health Association.  A special thanks goes out to Kevin Dreesman of the Illinois Department of Health for organizing this event and for inviting me to address its attendees.

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.

Indiana Cantaloupes Linked to Multistate Salmonella Outbreak

As reported by Food Safety News and other sources:

“A multistate outbreak of Salmonella Typhimurium linked to cantaloupes grown in southwestern Indiana has killed two people in Kentucky and sickened 141 people nationwide, the Kentucky Department for Public Health and the Indiana State Department of Health have confirmed….”

See Salmonella Outbreak Linked to Indiana Cantaloupes

31 people have been hospitalized, according to the U.S. Food and Drug Administration.

A total of 20 states have been affected by the outbreak, FDA reports. Illnesses by state are as follows: Alabama (7), Arkansas (3), California, (2), Georgia (1), Illinois (17), Indiana (13), Iowa (7), Kentucky (50), Michigan (6), Minnesota (3), Missouri (9), Mississippi (2), New Jersey (1), North Carolina (3), Ohio (3), Pennsylvania (2), South Carolina (3), Tennessee (6), Texas (1) and Wisconsin (2).

Other reports indicate that there are currently 141 illnesses linked to the Indiana Cantaloupe Outbreak.  See Cantaloupe, a Deadly Fruit – Again.

As of the date/time of this posting, the identify of the farm or source of the outbreak has not been disclosed, but we do know the farm is located in Southwest Indiana.  Similarly, we do not know the name(s) of the grocery store(s) that sold the Cantaloupe to the public.  The investigation continues…

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