FMSA Moving Forward

In the future, we might look back at 2013 as the year the Food Safety Modernization Act (FSMA) finally got some teeth.  In January, the Food & Drug Administration (FDA) released two long awaited proposed rules, one aimed at food manufacturers and the other at farmers. A third rule is still in the drafting process and will require food importers to comply with United States standards through a stringent verification process.

It has been two years since President Obama signed FSMA into law, but these new rules proposed in January would be the first which actually give the FDA enhanced authority in its efforts to prevent food-borne illness. A major motive behind FSMA and the new rules is to allow the FDA to be proactive, rather than reactive, which, in turn, should lead to a tangible decrease in the number of food-related illnesses.  Presently, one in every six Americans suffers from a food-borne illness annually, with 130,000 requiring hospitalization and 3,000 dying each year.  As a result of these eye popping numbers, and increased media coverage, outbreak awareness and food litigation have exploded in recent years.   From the perspective of attorneys involved in food litigation, there are likely several ways which these new rules will impact current and future client.  Let’s take a closer look:

Rule #1, Manufacturers:

This rule will require food manufacturers to formulate a plan to prevent its food products from causing food-borne illness, as well as a plan to deal with any contamination or outbreak.  The rule also requires that the plan include a detailed strategy related to recall procedures.  Manufacturers will be required to document the plan and keep records to verify that their preventive steps are working. Furthermore, each plan will be evaluated by the FDA, and it will use the plan as a key factor in determining “high risk” facilities, which will be subject to increased inspections.  The new rule also grants audit power to FDA inspectors to confirm compliance with safety standards established in a plan.  Additional scrutiny by the FDA means more opportunity for a problem to be found, which could lead to increased future litigation. As such, compliance with the new rule is of paramount importance to any of your clients who manufacture a food product (which includes products originally manufactured in a foreign country). Your clients must be advised that a well-crafted, detailed plan is essential to both minimize risk of a contamination event, and to reduce the possibility of FDA scrutiny through audits and inspections. 

Also, it may sound obvious, but your clients must be instructed that going forward, they must comply with the plan at all times.  Having a plan is the first step, but that plan must be followed.  It is almost worse for your client to have a plan, if they do not comply with it.  After the rule is formally enacted, it is easy to envision how a plaintiff could exploit any inconsistencies or failure to comply with the plan that your


Continue Reading FSMA: Finally Moving Forward

Raw HamburgerOn May 2, 2012, the United States Department of Agriculture (“USDA”) announced a series of prevention-based policy measures that it believes will better protect consumers from foodborne illness in meat and poultry products.

The USDA states that the purpose of these new regulations is to better allow both manufacturers and the USDA to:

(1)  trace contaminated food materials in the supply chain;

(2)  react more quickly to contamination; and

(3)  establish effective food safety systems.

The first measure will allow the USDA’s Food Safety and Inspection Service (“FSIS”)  to speed up the process for tracking E. coli O157:H7 in the nation’s food supply.  Currently, after an initial report of E. coli, USDA officials are required to wait for additional confirmation before they can begin an investigation.  These new measures will now allow FSIS to  initiate its investigation after the first indication of a positive test and move quickly to identify the source of the contaminated product and any processors who may have received contaminated product.  Once the source is properly identified, FSIS can issue instructions for minimizing consumer cases of foodborne illness accordingly.

The second key measure announced by the USDA is the implementation of three provisions included in the Food, Conservation and Energy Act of 2008.  These provisions will now require food establishments to:

(1)  prepare and maintain recall procedures on site;

(2)  notify FSIS within 24 hours that a meat or poultry product which could harm consumers has been shipped into commerce; and

(3)  document each reassessment of their hazard control and critical control point (HACCP) system food safety plans.

In addition,  USDA will make publicly available guidance to plants on the steps that are necessary to establish that their HACCP food safety systems will work as designed to control the food safety hazards that they confront. This process, called “validation,” enables companies to ensure that their food safety systems are effective for preventing food borne illness.  The guidelines will be available on the USDA website.

Proactive compliance with food safety standards, such as these recent measures enacted by USDA is of paramount importance to any company in the food industry. We advise our clients that such a proactive approach is essential to minimize risk, protect  the company’s brand name, and most importantly, to protect the customer. As such, all food manufacturers, suppliers and processors should, as soon as possible, ensure that their plants are in compliance with the new USDA measures, particularly with respect to reporting potential contamination and documenting any changes to a HACCP plan.  Furthermore, companies should preemptively review the HAACP plan guidelines released by USDA to confirm that their food safety systems are adequate and in compliance with federal laws.  The USDA expects the new regulations to go into effect in July, which just happens to coincide with the peak grilling season in the United States.
Continue Reading USDA Tightens Oversight and Announces New Foodborne Illness Measures

Co-authored by Brian Gross 

Foodborne IllnessThe USDA has recently announced that it will delay implementation of a controversial new program to extend its Zero Tolerance Policy for E. coli 0157:H7 to include six additional E. coli serogroups:  O26; O45; O103; O111; O121; and O145, which the USDA declared adulterants in non-intact raw beef.  The new policy, which was to take effect on March 5, would require routine testing of raw beef for these six additional serogroups, and would prohibit any beef found to carry one of these pathogens from entering the food chain.

Although more than 700 serotypes of E. coli have been identified, very of few of those are foodborne pathogens.  In fact, only Shiga Toxin producing E. coli (STEC) serotypes are considered foodborne pathogens.  While there are but a few E. coli serotypes which are considered to be foodborne pathogens, theSTECserotypes are extremely virulent and require very little human exposure to cause infection.  The CDC estimates that there are approximately 265,000STECrelated illnesses each year, 64% of which are attributable to non-0157:H7 E. coli.

Compare that figure to the numbers 700 and 4, which is the reported amount of E. coli 0157:H7 related illnesses and deaths stemming from an outbreak traced to undercooked and contaminated meat served at a Jack in the Box on the west coast in 1993 and an expanded scope under the USDA’s policy make perfect sense.

The question remains however; despite heightened scrutiny, better processes and scientific advances why are we continuing to see a persistent increase in reported outbreaks and recalls related to E. coli? It seems counterintuitive. Dr. Marc Siegel, a senior contributor to the Fox News Channel’s Medical A Team offers up some valuable insights.

http://www.youtube.com/watch?v=T2Eqw_hZCi0

I couldn’t agree more with Dr. Siegel. Fear is one of the largest pathogens and unfortunately many attorneys are capitalizing on this symptom. Not only are we seeing a staggering increase in the number of reported E. coli illnesses, so too are the number of foodborne illness claims filed each year.

The result is that many good companies are now expending more resources then ever to defend foodborne illness claims, while at the same time working tirelessly to comply with a well intentioned, yet constantly evolving governmental mandate. As National Council for the one of the largest food service providers in the world, we’ve seen first hand how proactive compliance and best practices can have a significant impact in minimizing risk and exposure. Companies who truly care about their products embrace food safety because they understand that there is more at stake than the bottom line. Closely monitoring suppliers, using scalable HACCP Plans and implementing aggressive standards for quality control not only protect a company’s brand, but its customers. This makes it easier to withstand attacks from plaintiffs counsel so you can continue to put food on everyone’s table, including your shareholders.
Continue Reading Can The Food Service Industry Navigate The USDA’s Zero Tolerance Policy on E.coli and Still Put Food On The Table?