Tag Archives: Food Safety

Government Not Required to Prove Intent or Consciousness of Wrongdoing to Convict the Jensen Brothers

Jensen Farms PicAs the produce industry follows the fate of Eric and Ryan Jensen many articles and commentary have surfaced in support of the brothers Jensen.  However, these articles and commentary all focus around a significant misconception about the government’s burden  of proof.  Specifically, the general misconception is that the U.S. Attorney’s Office must prove or otherwise show intent on the part of the Jensen brothers to obtain a criminal conviction.  This is wrong!

The Federal Food Drug and Cosmetic Act (“FD&C Act”) protects the consuming public by allowing the government to regulate the conditions under which food and drugs are manufactured and distributed and it requires those responsible to comply with its provisions.  Under the FD&C Act, misdemeanor criminal responsibility does not require intent or consciousness of wrongdoing.  On the other hand, felony criminal responsibility requires a knowing violation with the specific intent to defraud or mislead.  The FD&C Act also states that a  corporation may commit an offense and all persons who aid and abet its commission are equally guilty.

The Jensen brothers are facing misdemeanor criminal charges, which still carry the threat of imprisonment and significant financial penalties.  Given the misdemeanor nature of the charges, the U.S. Attorney’s Office does not need to allege or prove any type of intent on the part of the Jensen brothers to obtain a criminal conviction.

The foregoing is but one example of why the Jensen brothers’ criminal case is alarming to the produce industry.  With that said, are there any real and meaningful defenses available to the Jensen brothers?  The answer is yes!

Jason Klinowski to Speak at the Upcoming Food Regulatory Compliance Summit in Chicago

Food Regulatory Compliance Summit Logo

On October 4, 2013, Jason Klinowski will join Daniel Shaw – Vice President, Deputy General Counsel at H.J. Heinz Company – to address food recalls and to discuss practical tips and best practices for preventing common pitfalls and minimizing downstream litigation exposure.  Please join us at theWit for this two-day conference and connect with food industry leaders from The Hillshire Brands Company, Kellogg, US Foods, Nestle, MOM Brands, Cargill, H.J. Heinz Company, and others.

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.

Obama’s Proposed Budget for FY2014 Calls For $252 Million in Fees For the Food Industry

FDA Budget PicAs reported by Food Safety News on April 11, 2013, the Obama administration is “seeking a significant increase in funding at the U.S. Food and Drug Administration to help the agency implement the monumental Food Safety Modernization Act.”  Obama Administration Seeks FDA Funding Increase for FSMA Implementation

Noting that the “administration’s budget is very unlikely to be enacted,” Food Safety News reported that:

The White House proposed $3.8 trillion in spending for fiscal year 2014, including $4.7 billion for FDA, which represents a more than 20 percent increase over its 2012 budget. More than 90 percent of the $821 million boost would come from industry user fees.

For food safety, the administration is proposing a $295 million increase, compared to FY 2012, to “build a strong, reliable food safety system,” but only $43 million of that increase would be regular funding. More than $252 million of it would come from food facility registration and inspection fees and food importer fees, but it’s not clear that Congress will actually mandate those fees for the food industry.

According to the budget breakdown from the White House, legislation will be proposed to allow FDA to collect fees for food facility registration and inspection as well as for food import to implement the requirements of FSMA. The document says $59 million would come out of registration and inspection fees. On the import side, the administration estimates it would collect $166 million to support food safety efforts. The food industry has long argued against user fees.

As the FDA continues to roll out FSMA, the produce industry should make every effort to stay up-to-date on how FSMA will impact the industry from a practical standpoint.  To be clear, FSMA will (rightly or wrongly) bring global changes to the produce industry and those changes require funding.  No matter what the final budget looks like, the food industry will ultimately bear the bulk of the costs associated with implementing and enforcing FSMA.  For that reason alone, the produce industry should take great interest in every word used in every regulation and understand every dollar associated with every regulatory fee charged.  I urge you to contact your industry association, your peers, your lawyer, etc…. Voice your concerns about how FSMA affects your business.

United Fresh Produce Association Calls for More Time to Comment on FSMA’s Proposed Rules

United Fresh LogoOn April 11, 2013, United Fresh Produce Association, on behalf of almost 90 separate produce industry groups, formally petitioned the FDA to enlarge the May 16, 2013 deadline for submitting industry comments to the proposed Produce Safety and Preventative Controls Rules under FSMA.  United Fresh’s request for more time is “necessitated by the complex and substantial changes proposed for the fresh and fresh-cut produce industry by these proposed rules.”  United Fresh’s April 11, 2013 Letter to FDA

United Fresh’s letter further states that the proposed Preventative Controls Rule “represents a substantial overhaul of the Current Good Manufacturing Practices (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food.  The CGMP regulations were last revised nearly thirty years ago.”  Based on this and other facts, United Fresh stated that “it would be impossible for any interested party to meaningfully comment on these two proposed rules by the current deadline of May 16, 2013.”  And, that the Produce Safety Rule and the Preventative Controls Rule “are actually two of a suite of interlocking regulations that will fundamentally alter the global fresh and fresh-cut produce industry.”

To be clear, United Fresh is calling for no less than a 180 day extension of the comment period AFTER the FDA issues the last of the proposed rules for “the Foreign Supplier Verification Program, Preventative Controls for Animal Feed, and the Accredited Third Party Certification.”  The FDA has yet to announce the publication date for these already past due rules.

What does that mean?  This is an open-ended request for an enlargement of time that may fail because it is open-ended.  In my opinion, United Fresh’s position is well founded and their request is appropriate.  However, I would hate to see the FDA deny United Fresh’s request based on a technical foul, which is the absence of a specific comment period closing date.  I think the better procedural approach would be to ask the FDA for an enlargement of time from May 16, 2013 to a date certain and separately (but perhaps in the same letter) request that each new proposed rule be given no less than a 180 day comment period right out of the gate.

Please remember that many of FSMA’s proposed rules are already significantly past their legislatively imposed publication date.  As a matter of fact, the Center for Food Safety and the Center for Environmental Health filed a civil action in August of 2012 against the FDA and the White House Office of Management and Budget in an effort to compel the federal government to comply with FSMA’s deadlines.  Against this backdrop, it may be risky for United Fresh to seek an open-ended enlargement of time on any comment period… no matter how well supported.

FDA Extends Comment Period on the IFT’s Report to the FDA on the Improvement of Tracking and Tracing Food

IFT LogoOn April 2, 2013, the FDA issued a Notice extending the comment period on the Institute of Food Technologists’ findings and recommendations to the FDA for the improvement of tracking and tracing food under FSMA.  The new deadline to submit comments on the IFT’s report is July 3, 2013.

To be clear, the Federal Register of March 5, 2013 included a FDA Notice with a 30-day comment period for the industry to submit comments on the findings and recommendations contained in the IFT report and to submit additional information relevant to improving food traceability.  The IFT’s report, together with industry comments, will help the FDA as it forms its own recommendations as it works to prepare the agency’s report to Congress, which FSMA requires.

Those of you who follow these issues know that the IFT’s report is well over 300 pages long and is a technical document.  I think the FDA’s enlargement of time is appropriate because the industry needs time to review the IFT’s report and to prepare meaningful commentary and other related submissions.  Please use this time wisely.  As you can tell from recent FDA guidance documents, FSMA applies to everyone and the costs associated with food traceability will also affect everyone.  Now is the time to voice any concerns you or your association may have on this topic.

 

FSMA Update: FDA Issues Produce Safety Rule FAQs

FSMA LogoThis week the FDA launched an updated its Frequently Asked Question & Answer (“FAQs”) section to include detailed areas on the two recently introduced food safety rules, which addressed preventative controls and produce safety.

The updated FAQ section related to the Produce Safety Rule is a fifteen (15) page document that attempts to answer everything from “What does the proposed produce safety rule establish?” to questions about the FDA’s access to company records.  Here is a link to The Produce Safety Rule: Frequently Asked Questions and Answers – Produce Safety Rule

Produce industry stakeholders and related associations should take the time to read and understand the Produce Safety Rule FAQs because it addresses such critical issues as:

  • How does the proposed rule define “agricultural water?”
  • FDA access to company records
  • How does the proposed rule define “farm?”
  • When packing produce is subject to the Produce Safety Rule

As previously noted, the FDA extended the comment period on the Produce Safety Rule until May 16, 2013.  Please exercise your right to let the FDA know if you have any specific or industry related concerns about this rule.  Once the comment period closes, the FDA will respond to comments and finalize the rule.  At that point, the Produce Safety Rule will be binding and enforceable.

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 to Speak at Upcoming Arthur J. Gallagher & Co. Food Industry Event

Arthur Gallagher LogoOn Thursday, May 9, 2013, Jason Klinowski will be one of three panel speakers addressing the “Hottest Topics in Food Today” at a food industry event hosted by Arthur J. Gallagher & Co.  The topics the panel speakers will cover at this event include new food safety technology related to combating Listeria, alternative risk solutions for the middle market and a survey of legal issues affecting the food industry.  At this event, Jason Klinowski will specifically address issues relating to food recalls, FDA/USDA inspection management and the critical components of a good hold harmless agreement.

More information about this event will shortly follow.

What you Need to Know About Administrative Detention of Foods – New FSMA Guidence

FDA LogoThe FDA recently issued a revised industry guidance document titled: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide  Utilizing a question and answer format, this industry guidance document contains some valuable information.  Here are some of the highlights you need to know:

Why is administrative detention needed?

Administrative detention provides a means through which FDA can hold adulterated or misbranded food and prevent it from reaching the marketplace, thus further enhancing FDA’s ability to ensure the safety of food for U.S. consumers.

What food is subject to administrative detention?

The term food refers to (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article (section 201(f) of the FD&C Act [21 U.S.C. § 321(f)]).  The term food also refers to dietary supplements, which are to be treated as food under the FD&C Act (section 201(ff) [21 U.S.C. § 321(ff)]).

How long may FDA administratively detain an article of food?

FDA may detain an article of food for a reasonable period, not to exceed 20 calendar days, after the detention order is issued. However, an article of food may be detained for 10 additional calendar days if a greater period of time is required to institute a seizure or injunction action. The entire detention period may not exceed 30 calendar days (21 CFR 1.379).

What criteria does FDA use to order an administrative detention?

An officer or qualified employee of FDA may order the administrative detention of any article of food that is found during an inspection, examination, or investigation under the FD&C Act if the officer or qualified employee has reason to believe that the article of food is adulterated or misbranded (21 CFR 1.378).

May an administratively detained article of food be delivered to another entity or transferred to another location?

It is a prohibited act under section 301(bb) of the FD&C Act [21 U.S.C. 331(bb)] to transfer an article of food subject to an administrative detention order and/or to alter or remove any mark or label that identifies an article of food as administratively detained.

Can an administrative detention order be modified?

FDA may approve a request for modification of an administrative detention order to allow for the destruction of the article of food or movement of the detained article of food to a secure facility, to maintain or preserve the integrity or quality of the article of food, or for any other purpose that the authorized FDA representative believes is appropriate in the case (21 CFR 1.381(c)).

What’s the difference between an import detention and administrative detention?

FDA’s authority to administratively detain food under section 304(h) of the FD&C Act [21 U.S.C. 334(h)] is separate and distinct from detention that may occur during FDA’s import admissibility review. Under section 801(a) of the FD&C Act [21 U.S.C. 334(h)], when food is imported or offered for import into the United States, FDA conducts an admissibility review to determined whether to admit the product into United States or detain the product.

On the other hand for administrative detentions under section 304(h) of the FD&C Act, FDA will issue an order to the owner of the suspect food notifying him that FDA is administratively detaining the food and that he has an opportunity to appeal the detention with or without a hearing (see 21 CFR Part 1 Subpart K).

When does an administrative detention order terminate?

If FDA terminates an administrative detention order or the detention period expires, an authorized FDA representative will issue an administrative detention termination notice to any person who received the detention order (or that person’s representative), releasing the article of food, as quickly as possible. If FDA fails to issue an administrative detention termination notice and the detention period expires, the administrative detention is deemed to be terminated (21 CFR 1.384).

Who pays the costs associated with the detention order, such as storage, moving, disposal or reconditioning?

As stated in the preamble to the 2004 final rule (69 Federal Register 31659 at 31690), the party or parties responsible for paying the storage costs of food that FDA orders administratively detained is a matter between the private parties involved with the food. FDA is not liable for those costs. An owner, operator, or agent in charge of the place where the food is located can always request modification of a detention order to destroy the food if they do not want to store it.

Please take the time to read the entire guidance document.  It contains information about your rights and other deadlines that become very important if your product is administratively detained.