Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Journal

Today the FDA released its Form 483 Inspection Observation Report from the on-site inspections it recently conducted at Wright County Egg's egg laying farms/plants, and the findings are nothing short of disgusting.  Here are just a sampling of the conditions witnessed by FDA's inspectors: 

• Chicken manure located in the manure pits below the egg laying operations was observed to be approximately 4 feet high to 8 feet high at the following locations: Layer 1 – House 1; Layer 3 – Houses 2, 7, 17, and 18. The outside access doors to the manure pits at these locations had been pushed out by the weight of the manure, leaving open access to wildlife or domesticated animals.
• Un-baited, unsealed holes appearing to be rodent burrows located along the second floor baseboards were observed inside Layer 1 – Houses 1-9 and 11-13; Layer 2 – Houses 7 and 11; Layer 3 – Houses 1, 3, 4, 5, and 6; Layer 4 – House 3.
• Dark liquid which appeared to be manure was observed seeping through the concrete foundation to the outside of the laying houses at the following locations: Layer 1 – Houses 1, 2, 3, 4, 5, 8, 11, 12, and 14; and Layer 3 – Houses 1, 8, 13, and 17.
• Standing water approximately 3 inches deep was observed at the southeast corner of the manure pit located inside Layer 1 – House 13.
• Un-caged birds (chickens having escaped) were observed in the egg laying operations in contact with the egg laying birds at Layer 3 – Houses 9 and 16. The un-caged birds were using the manure, which was approximately 8 feet high, to access the egg laying area.
• Layer 3 – House 11, the house entrance door to access both House 11 and 12 was blocked with excessive amounts of manure in the manure pits.
• There were between 2 to 5 live mice observed inside the egg laying Houses 1, 2, 3, 5, 7, 9, 10, 11, and 14.
• Live and dead flies too numerous to count were observed at the following locations inside the egg laying houses: Layer 1 – Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2 – Houses 7 and 11; Layer 3 – Houses 3, 4, 4, 5, 7, 8, 15, 16, 17, and 18. The live flies were on and around egg belts, feed, shell eggs and walkways in the different sections of each egg laying area. In addition, live and dead maggots too numerous to count were observed on the manure pit floor located in Layer 2 – House 7.
• You did not document washing and disinfecting of your dead hen truck and manure equipment prior to moving from farm to farm.
• You did not maintain records documenting the washing and disinfection of the trailers used for the movement of pullets to laying houses.
• Birds were observed roosting and flying, chicks heard chirping in the storage and milking facilities. In addition, nesting material was observed in the feed mill closed mixing system, ingredient storage and truck filling areas.
• Outdoor whole kernel corn grain bins 4 and 6 observed to have the topside doors/lids open to the environment and pigeons were observed entering and leaving these openings. Birds were also observed sitting/flying around and over the openings.

In addition, numerous samples were collected during the course of te inspection and tested by an FDA laboratory.  The results revealed the following positive analytical results for Salmonella Enteritidis:

• On 8/13/2010, an environmental sample was collected from Layer 2, house 7 manure swab from row 1 – left side.
• On 8/16/2010, an environmental sample was collected from Layer 2, house 11 at manure scraper blade from row 3 – right side.
• On 8/13/2010, an environmental sample was collected from Layer 4, house 3 at walkway 1 – right side and walkway 3 – right side.
• On 8/14/2010, a sample of meat and bone meal was collected from ingredient bin 7 located at your feed mill.
• On 8/17/2010, a sample of finished feed “Developer” pullet feed was collected from the feed mill.
• On 8/16/2010, an environmental sample was collected from the roof level covered ingredient bin chute 8; Second Floor ingredient bin cover 19 (ingredient bin 19 holds ground corn) located at your feed mill.

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The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a “dual jurisdiction establishment” that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?

By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.

Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm’s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)

For more, please click on the Continue Reading link.

The ineffectiveness of the FDA and USDA in these dual jurisdiction establishments was noted years ago. According to a March 2005 report by the General Accounting Office, there are 1,451 dual jurisdiction establishments in the United States—that is, plants that product food regulated by both the USDA and the FDA. (Other agencies that can have overlapping authority include the Environmental Protection Agency and the National Marine Fisheries Services.)

In analyzing how such dual jurisdiction work in practice, the GAO found that it imposes significant and unjustified burdens on the plants, failed to adequately coordinate inspection activities, and wasted large amounts of money through duplicative training programs for inspectors, and overlapping efforts that could and should be reduced. See GAO Report, www.gao.gov/new.items/d05213.pdf  Indeed, the GAO specifically noted that the 2002 Bioterrorism Act granted the FDA authority to allow USDA inspectors to alone inspect the dual jurisdiction establishments, but that the FDA has never taken any action in this regard. Finally, the GAO reminded that it had for quite some time promoted the creation of a single food safety agency with jurisdiction over all food production in the United States, stating “that improvements short of reorganizing the food safety system can be made to reduce overlaps and duplication, and to leverage existing resources.” GAO Report at 7.

Plainly effective coordination did not occur at the Nestle plant. The FDA personnel inspected the Nestle plant only every year or so (on 9/06, 9/05, and 7/04). The VDACS had inspected the plant on March 12, 2009, finding “no unsanitary conditions,” but noting “observed GMP deficiencies” on a state inspection report. (This is another report we are attempting to obtain.) The VDACS also inspected the plant twice in 2007, again under contract to the FDA. Whether the state of Virginia also had jurisdiction over the plant is right now unclear, but it appears to have also been inspecting the plant pursuant to its own jurisdiction.

Finally, as already noted, the USDA had an inspector onsite in the plant, but presumably the inspector stayed away from the part of the plant where the cookie dough was manufactured. This presumption is based on an USDA-FSIS Directive that states:

A. FSIS inspection program personnel are not to routinely enter or inspect an area of the establishment in which nothing that is subject to FSIS jurisdiction occurs. Inspection program personnel are to focus inspection toward the USDA regulated products. There may be situations where an FDA product is processed in close proximity to or on the same line as a FSIS regulated product, and, therefore, inspection personnel may be in the same area. In meat and poultry establishments the inspected facility is defined in the grant of inspection, and in egg products establishments the entire premises includes all buildings on the property.
B. If conditions in the area of the establishment that is only under FDA’s jurisdiction may lead to, or are creating, insanitary conditions in the FSIS inspected areas of the establishment as described in 9 CFR 416.2, Establishment grounds and facilities, or in 9 CFR 590,
1. Inspection program personnel in meat and poultry establishments are to:

a. take the appropriate action with respect to FSIS regulated products as set forth in FSIS Directive 5000.1, Revision 1, Chapter I, Sanitation and Chapter IV, Enforcement , and
b. notify the District Office of the situation through supervisory channels.

See FSIS Directive 5730.1, www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5730.1.pdf The Directive also makes clear that the agencies are supposed to communicate with each other when “foods produced in a DJE are implicated in outbreaks of foodborne illness,” but so far there has been no word yet whether such communication has taken place with regard to the Nestle Toll House cookie dough outbreak. It is also unclear what FDA policy is with regard to inter-agency communications related to an outbreak like this one.

In light of the foregoing, it is hard not to think of the story of the blind men and the elephant, with each inspecting only a part of the elephant, but none of them able to determine what it was they were inspecting, or reach any other conclusions. See “Blind Men and an Elephant, Wikipedia, en.wikipedia.org/wiki/Blind_Men_and_an_Elephant Because each blind man knew only part of the truth, none of them were able to come to agreement as to the whole truth, even after they compared notes.

In thinking about our current story, the one where cookie dough made by Nestle poisoned dozens, I can’t help but think of the FDA, USDA, and VDACS as three blind men inspecting an elephant. And perhaps the moral of our story is that it is long past time to have our food plants inspected by a single person, and one who is not blind.
 

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Two reports of past inspections were made public today.  The most notable inspection occurred in September 2006 at the Nestle plant in Danville, Virginia where it manufactures cookie dough products, as well as stuffed pastas and pasta sauces.  A number of deficiencies were noted as part of the inspection. These were:

Three live ant-like insects were observed on a ledge along the W wall of the powdered sugar dump station in the cookie dough manufacturing area.
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Dirty stainless steel equipment and utensils were observed in a bin which was identified as "clean" in the cookie dough cleaning area.
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Water or other clear liquid was observed dripping from an overhead line in the liquid egg receiving bay.
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The knock off ann for the check weigher was improperly timed or otherwise not functioning properly to remove trays of cookie dough on line ten.

More disturbing, however, is  the refusal by the plant to give FDA inspectors access to important food safety related documents and information, including:

Percent ofproducts which move in interstate commerce
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Review of complaint log
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Use of camera
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Review ofpest control records
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Review ofHACCP program
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Information on environmental testing program

This is troublingly reminiscent of the Peanut Corporation of America, which also refused to give access to important records, forcing the FDA to invoke the Bioterrorism Act of 2002. 

A copy of the FDA Inspection Report can be found here: www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM169114.pdf

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The FDA is conducting just half the food safety inspections it did three years ago, the Seattle Post-Intelligencer reports.

"We have a food safety crisis on the horizon," said Michael Doyle, director of the Center for Food Safety at the University of Georgia.

The cuts by the Food and Drug Administration come despite a barrage of high-profile food recalls.

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