Sally Jackson's Letter to the FDA

Sally Jackson's recalled cheese

You know how I feel about Sally Jackson’s cheese. Despite the FDA recall that has shut down this pioneering cheesemaker of 30 years, I have been enjoying her cheese. I have some in the fridge right now, and I believe it is safe to eat.

Google “Sally Jackson Cheese,” and you’ll think I’m crazy. Every food lawyer and consumer advocacy blog has spotlighted the recall. The FDA report is all over the web. I get it. But what about Sally Jackson? What about her response? Did anyone think to ask her about the inspection?

I did. Below, you’ll find the letter that Sally and her son John sent to the FDA. I am honored that Sally asked me to run it. Once you read it, I think you’ll scratch your head. Like me, you may begin to wonder whose interests a recall really serves.

29 December 2010

Charles Breen

U.S. Food and Drug Administration

22201 23rd Drive SE

Bothell, WA. 98021

RE: FDA Inspectional Observations of 12/15/2010 – 12/17/2020 (FEI # 3023450)

Mr. Breen:

We at Sally Jackson Cheese have read through the observations listed on FDA form 483, FEI # 3023450 and made by Scott W. Fox, Lon A. Cummings, and Belinda E. Clifton during an inspection of our plant over the time period of December 15, 2010 and December 17, 2010. We would like to take this opportunity to inform you of several inaccuracies that we have noted among the observations.

Observation 1:

“Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated. Specifically, the owner was observed throughout the day, to altemately perform cheese making functions, such as, stirring cheese curd with bare hands and wrapping cheese in grape leaves, with outside activities, such as milking.”

SJC Response to Observation 1:

Entire inspection staff was in an adjacent room swabbing surfaces during the time in question. Inspection staff directed Sally Jackson to continue making cheese. As inspection staff was not present during initial cheese making preparation, they failed to observe Sally Jackson washing her hands. Hand washing is performed prior to all cheese making activities at all times at Sally Jackson Cheese. If inspection staff was specifically observing this activity, it would have been their responsibility to be present while this operation (hand washing) was performed.

Observation 2:

“Failure to provide hand washing facilities at each location in the plant where needed. Specifically, the approximately 10 inch diameter, shallow bowl hand sink in the vestibule is too small for proper use, The sink drain pipe and water supply lines were disconnected. The two-compannent processing room sink was not set up for hand washing and there were no towels or soap available at either fixture.”

SJC Response to Observation 2:

Hand soap and towels ARE provided at two compartment processing room sink. This observation appears to imply a standard that is not referenced directly. This standard should be mentioned if an observation like this is to be made. The 10inch diameter shallow bowl hand sink is located in the vestibule and is therefore not intended for use when processing cheese.

Observation 3:

“Failure to use water which is of adequate sanitary quality in food and on food-contact surfaces. Specifically, the well water supply for the facility is not currently in microbiological compliance. The most recent water analysis was unsatisfactory for total colifom as evidenced by a test report from 10/4/10 observed at the facility. The well has not been retested.”

SJC Response to Observation 3:

Subsequent to the most recent water analysis of 10/4/10, the well has been treated for microbiological compliance with Clorox as routinely suggested by Okanogan County Test Board.

Observation 4:

“Plumbing is not of adequate size and design to carry sufficient quantities of water to required locations throughout the plant. Specifically, the immediate water supply for the plant's plumbing is gravity fed from an overhead (approx. 8 feet) storage tank (approx. 50 gallons) with insufficient pressure and capacity to meet the continuous sanitary needs of the facility.”

SJC Response to Observation 4:

This observation is vague and appears to be referencing a standard for water pressure and volume that Sally Jackson Cheese is unaware of. The inspectors should define this standard if this observation is to be considered valid. This water supply system has been approved for use in this facility by numerous state inspectors over the history of the plant.

Observation 5:

“Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination. Specifically, the wood fixtures, walls and floors were generally soiled and stained with grime/dirt. The floors also showed an accumulation of manure, mud. straw. Wood chips and other debris. Several areas of the ceiling showed black mold-like deposits, particularly near areas showing apparent water damage. Wood shelving, work tables and cheese storage boxes were observed throughout the facility. With accumulated product, grime and some black mold-like deposits. The galvanized pipes

And shelves used to store cleaned utensils appeared to have a build-up of grime. Cleaned utensils were also being stored on top of' the overflow water storage barrel that showed dirt and black deposits on the top and sides.”

SJC Response to Observation 5:

Sally Jackson Cheese recognizes that there is a small amount of accumulated grime, most specifically on the floor of the facility, and to a certain extent on window surfaces, walls, etc. This is a problem that SJC agrees must be addressed. Inspectors should more clearly define “accumulation” as this observation implies a very large amount of material. This is misleading.

Observation 6:

“Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated. Specifically, there are holes, open cracks, water damage and peeling paint/plaster in several ceiling and upper wall locations directly above exposed cheese on storage shelves and above or adjacent to food-contact surfaces. A section of the cheese room ceiling along the south wall is unfinished with exposed joists and insulation above the sink and clean utensil storage.”

SJC Response to Observation 6:

Inspectors should clarify part of this statement. There are no exposed joists above any of the cheese processing or storage areas. There are exposed joists in the facility, but only above a lower ceiling so effectively there are no exposed joists. Also, Sally Jackson Cheese had already started the process of upgrading facilities in the summer of 2010, prior to any interaction with FDA. The most recent upgrade was installation of a new roof on the cheese processing facility to prevent water leaks.

Observation 7:

“The plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair. Specifically, there was extensive use of undressed wood throughout the facility to include the window sills/frames, door jambs, storage shelving, cheese screen boxes, ceiling supports, floor areas, steps, work counters and other fixtures. The concrete floors of the cheese processing and the lower aging rooms show exposed aggregate, cracks and broken sections that are pooling water and collecting debris. Ceiling areas in each of the rooms and some walls show evidence of water damage with sagging holes/cracks, stains and peeling paint and plaster.”

SJC Response to Observation 7:

Exposed wood is not untreated. All exposed wood has been treated with anti-moisture compounds and is washable. Additionally, please see SJC Response to Observation 6.

Observation 8:

“Suitable outer garments are not worn that protect against contamination of food, food contact surfaces, and food packaging materials. Specifically, the owner wore manure soiled outer clothing during the production of cheese, handling utensils and direct handling of finished product. Owner was observed kneeling in fresh cow manure, while milking a cow outside, then brushed pants with a bare hand and was later observed standing over a bucket of drained curd in the cheese room with the soiled pants coming into contact with the edge of the bucket.”

SJC Response to Observation 8:

Inspectors were present during milking times. During these times, there is significant outdoor activity ongoing. Unfortunately, it appears that inspectors failed to distinguish

between outdoor activity which ALWAYS occurs on farms of this type and indoor activities. SJC agrees that additional precautionary measures may be necessary (i.e. protective outer garments or similar). However, it is an unavoidable circumstance in an operation like this that the workers may become soiled while working with animals.

Observation 9:

“The design and materials of equipment and utensils does not allow proper cleaning. Specifically, glazed ceramic flower pots (approx. 6-8 inch), some broken/cracked with missing pieces, were used as cheese molds. A flat wood stick (approx 1/4x2xl4 inches) was observed on a worktable in the cheese room during processing with fresh milk residue. The cheese screen boxes are constructed with undressed one-by pine boards. The welds along the interior bottom seams of the milk chill tank are rough and pitted.”

SJC Response to Observation 9:

The “glazed ceramic flower pots...” referred to by the inspectors are NOT flower pots, but rather are intended for use in making cheese and were manufactured as such. These pots have always passed inspection in the past. The observation regarding the “flat wood stick...” is puzzling as it does not imply what the inspector was getting at. The cheese screen boxes are used for aging cheese and SJC is unsure whether the inspector has an issue with just pine wood, or all wood in general; again, this is an aging box, not a processing box and all wood in the facility is dressed with anti-moisture compounds. It probably would have been helpful if the inspection team had simply asked about this.

Observation 10:

“Failure to lake necessary precautions to protect against contamination of food, food contact surfaces, and food packaging systems with microorganisms and foreign substances. Specifically, two garden hoses observed being used to transfer water from the overflow water barrel in the cheese room, to livestock water tanks and then stored in the cheese room between uses, near the stove where cheese was cooking. The hose surfaces had accumulated dirt/filth from being dragged across the livestock paddock area. There were several pans and buckets containing dirty water noted on the floor in the NE corner and to the right of the sink in the cheese room.”

SJC Response to Observation 10:

Food packaging “systems” consist of a single roll of saran wrap style plastic. It is unclear how this “system” could be improved. Food contact surfaces are frequently wiped clean with a sterilized cloth. This observation is generally poorly defined and unclear. For example, it is unclear how using a garden hose to transfer water from an overflow to outside stock tanks can affect processes going on in different areas of the plant. Also, the noted “several pans and buckets containing dirty water...” may have contained water but are not involved in cheese processing.

Observation 11:

“Personal clothing and belongings were stored in an area where food is exposed and equipment or utensils are washed. Specifically, hats, coats, dirty work gloves and cheese cloths were hung on walls, draped across pipes and the stored milk cooler in the main cheese room. Extensive clutter was observed on the floor, on shelves and counters of the main processing room and the aging rooms in close proximity or intermingled with finished and in-process cheese. These items included: empty jars, pails, papers, tools, personal food items, soiled cheese cloth, animal feeding tube, charcoal lighter fluid, bath towels and a bottle of aspirin.”

SJC Response to Observation 11:

No response. This observation sounds like a personal preference by the inspector.

Observation 12:

“Systems that discharge wastewater or sewage are cross-connected to systems that carry water for food or food manufacturing. Specifically, the overhead water storage tank is plumbed into plastic 50 gallon barrel used to collect overflow that occurs when the tank is filled. This water from the barrel is later pumped out to supply livestock via a garden hose. A hose connected to a hose bib was submerged in container of water on the floor next to the utensil sink.”

SJC Response to Observation 12:

This observation is simply incorrect. From a physical plant standpoint, Observation 12 represents an impossible situation. Sewer (or waste water) lines cannot cross incoming water lines as water would not flow. There are no instances of waste water and fresh water crossing in the plant. If the overflow tank is the subject of this observation, it should be noted that water from the overflow tank is never used in cheese making processes.

Sincerely,

Sally Jackson

Owner, Sally Jackson Cheese

16 Nealey Road

Oroville, WA. 98844