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

Congress

In our October 25, 2011 post, Food Safety Modernization Act: Did Congress Bite Off More Than It Can Chew? we expressed concern regarding the FDA’s ability to fully implement the Food Safety Modernization Act (“FSMA”) given its budgetary restrictions.   As outlined in our prior post, FSMA provides for increased regulation and oversight of the production of food by the FDA, both domestically and abroad, which will require significantly more resources.  Accordingly, President Obama proposed a budget of $2.75B for fiscal year 2012, an increase of $300M from 2011.  In June, however, Congress approved a 2012 budget for the FDA of less than $2.2B, a significant reduction from its 2011 budget, for a year in which the scope of its responsibilities will increase dramatically.

On Monday, November 14, 2011, Congress reversed course and it appears that Congress is prepared to approve a compromise bill which provides the FDA with a $2.5B budget for 2012, approximately $334M more than the FDA was allocated in June, and $50M more than it received for fiscal year 2011.

Although the FDA’s budgetary increase in 2012 is minimal in comparison to the expansion of its responsibilities provided under FSMA, the fact that it is receiving additional money is significant in light of the Federal deficit.  Congress’s decision to allocate additional money to the FDA during a time when Federal spending is being scaled back indicates that the government recognizes the increased importance of food safety.  Unfortunately, without continued increases in its funding, it appears unlikely that the FDA will be able to fully implement the mandates of FSMA, particularly with respect to the inspection and regulation of foods imported into the United States.  Case in point, Washington Post reporter, Brad Racino’s recent article explained that FSMA requires the FDA to inspect 600 foreign food facilities in 2011, and while the FDA expects to meet that requirement, based on current and expected future funding, it appears unlikely that the FDA can meet its requirement to double the number of foreign inspections in each of the next six years. This is likely to place a heavy burden on those companies which import food products into the United States, which, pursuant to FSMA, must now ensure that such food products meet the same safety standards as domestic food products.  The lack of inspections could certainly result in more food borne illness outbreaks, and as a result, an increase in the number of personal injury lawsuits these companies may face.

The implementation of FSMA will occur over a period of several years, and its success will hinge largely upon a number of different factors, but perhaps most importantly on the financial resources afforded the FDA.  Accordingly, this week’s development is significant and may suggest that the importance of safe food practices and prevention of food borne illness has finally entered the national consciousness.  Unfortunately, the flagging economy and increasing budget deficits may hamper the FDA’s ability to obtain the necessary funding to meet all of FSMA’s
Continue Reading Congress Boosts FDA’s Ability to Effectuate Food Safety Modernization Act

Co-authored by Brian Gross

Foodborne IllnessThe recently enacted Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, provides the U.S. Food and Drug Administration (FDA) with increased power.  The FSMA, which represents the culmination of more than a decade long effort to reform this country’s food safety oversight system, aims at limiting future occasions of foodborne illness by changing the FDA’s focus from reacting and responding when outbreaks occur to outright prevention.  While the FSMA certainly gives the FDA additional authority to regulate the production of food throughout the farm to table chain, the question remains whether it will have the necessary resources to do so.

The FDA is an agency of the United States Department of Health and Human Services which is responsible for overseeing an incredibly broad range of goods, including food, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, veterinary products, and cosmetics, amongst other things.   The FDA’s food-related responsibilities include regulation and oversight of roughly 80% of our country’s food supply, namely, all food products with the exception of meat and poultry.   The FSMA has given the FDA numerous new tools to perform its duties, a few of which will be discussed herein, including, mandatory recall, increased oversight and regulation of American facilities and those of foreign suppliers, and the implementation of a few small measures aimed at creating a more informed consumer.


Continue Reading Food Safety Modernization Act: Did Congress Bite Off More Than It Can Chew?

Co-authored by Brian Gross

Cargill Meat Solutions Corporation (“Cargill”) recently announced the voluntary recall of approximately 36 million pounds of ground turkey believed to be contaminated with salmonella.  The recall represents approximately 6% of the national production of ground turkey in a given year.  Federal Health authorities have attempted for several months to determine the source of a multi-drug resistant Salmonella Heidelberg outbreak that has killed one person and sickened 111 others in 31 states.  Authorities had previously traced the outbreak to ground turkey, but only recently determined that the contamination occurred in ground turkey products produced at Cargill’s Springdale, Arkansas plant between February 20 and August 2, 2011.   Cargill has suspended all production at its Springdale plant and is working with Federal authorities to determine the source of the contamination.

The Centers for Disease Control and Prevention (“CDC”) recently revealed that cultures of ground turkey taken between March 7 and June 27 from four different locations showed salmonella contamination, three of which were derived from the same source.  Additionally, a chart on the CDC’s website shows that multiple cases of illness have occurred each month since March, with the highest number of illnesses occurring in May and early June.   Despite determining that the illnesses of 77 individuals were related to the same strain of salmonella, Federal authorities were unable to prove a link to a specific source until now.

Salmonella is the most common bacterial form of food borne illness.  Symptoms typically include severe diarrhea, abdominal cramps and fever within 72 hours of consumption.  Salmonella is generally not life-threatening, though it can be to those with weakened immune systems.  It is safe to eat contaminated ground turkey provided it is cooked to an internal temperature of at least 165 degrees.  Consumers should be cognizant, however, of the potential risks of cross-contamination and be sure to wash their hands thoroughly as well as any surfaces which come into contact with meat.

As one can imagine, numerous lawsuits were recently filed by individuals allegedly sickened as a result of consuming the contaminated ground turkey processed by Cargill.  One such suit, brought by the law firm of Marler Clark on behalf of 2 Missouri residents, seeks punitive damages related to Cargill’s alleged failure to act despite knowledge that its product was contaminated.  An award of punitive damages, which is rare in food borne illness cases, would undoubtedly prompt increased litigation not only against Cargill, but also against any company whose contaminated products remain on the market for an extended period of time while government officials attempt to determine the source of the outbreak.  Such an award could also force manufacturers in future cases of potential contamination to take preemptive action and issue product recalls even before their product is definitively determined to be the source of the contamination.

 
Continue Reading Cargill Turkey Contaminated With Salmonella Bacteria Results In National Recall