Monthly Archives: August 2012

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The FDA recently issued a DRAFT guidance for the food industry discussing the agency’s current thinking regarding the necessity of food categories in food facility registrations.

See Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories

DISCLAIMER: The forthcoming discussion relates to draft guidance that is still open for comment, modification and retraction.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…

Important New Bankruptcy Filings!

Please take note of the following two new food industry bankruptcies:

Cascade Ag. Services, Inc. d/b/a Pleasant Valley Farms, which filed a voluntary petition for chapter 11 bankruptcy protection in the Western District of Washington on August 13, 2012.  A review of the bankruptcy petition shows estimated assets between $10 MM and $50M with estimated liabilities within the same range.  By way of example, the claims of the top 20 largest creditors range from $2 MM to $119k.

California Organics LLC, which filed a voluntary petition for chapter 11 bankruptcy protection in the Northern District of California on  August 13, 2012.  A review of the bankruptcy petition shows estimated assets between $1 MM and $10M with estimated liabilities within the same range.  By way of example, the claims of the top 20 largest creditors range from $325K to $13k.

Please check your A/R to see if theses cases affect you.  If they do, please do not wait to assert your rights!

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

Midwest Produce Conference + Expo

I wanted to personally thank everyone who came out to Michael Jordan’s Steak House and joined Freeborn & Peters LLP’s Food Industry Team for a cocktail reception following the Midwest Produce Conference + Expo.  For those of you who could not join us, please look for us at the upcoming PMA Fresh Summit Convention this October!