Comments and a Response on Proposed Changes to Alaska Cheese Regulations

As I referenced below, Alaska DEC is revising its rules on cheesemaking, found here and here.  

The following are my comments -- followed by a response from Mr. Fuller:

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Mr. Fuller:

The following are my comments on the proposed changes to the Alaska cheesemaking regulations. My primary concern is that these regulations will kill a new and promising industry for our state -- essentially making regulations so burdensome that they prevent anyone but large corporations from entering the business.

Some specific comments:

-These costly regulations are not responding to any actual food illness in Alaska. Nationally, there are few cases of foodborne illness during cheese manufacturing as compared with other industries. State and national data supports this:
     o DEC’s own reports show that there were NO cases of foodborne illness from cheese in Alaska from 2004 to 2008.
     o Nationally, from 1998 to 2007, cheese was involved in only 57 outbreaks with 1,436 illnesses – even though millions of pounds was produced and consumed.  That’s a 0.000005 per capita rate. Most of these cases were due to contamination by the end user – not manufacturing, further lowering this rate.
[Source: http://cspinet.org/new/pdf/outbreakalertreport09.pdf, Center for Science in the Public Interest. Dec 2009, “Closing the Gaps in Our Food Safety Net.”].
     o Nationally, there have only been 6 outbreaks related to domestic cheese contaminated during the manufacturing process over a forty year period ending in 1991.  [“Pathogens in Cheese” E.A. Zottola and L.B. Smith, University of Minnesota, Department of Food Science and Nutrition, St. Paul, MN 55108.
September 1991. FOOD MICROBIOLOGY, September 1991.]

-The USDA retains primacy for food inspection regardless of what DEC’s rules are.  Why is the state spending money on this? Let USDA continue to enforce their rules.

-If these rules are to be issued, DEC needs to issue additional standards for small producers with just a few animals. For example, the rules could specify a quantity threshold. I would recommend that individuals producing less than 1500 pounds of cheese per year be exempted, at a minimum, from the testing requirements. This equates to someone producing cheese from about 5 cows. DEC could require that such producers affix a warning label for consumer and could require pasteurization in these cases. HAACP rules similar to commercial kitchens could be required.

-Without changes to these rules, small farm owners and cheese-makers cannot start small. Most producers will have to finance these large capital expenditures upon startup. Unfortunately, most banks won’t loan money in cases where an individual has no experience in the business. This effectively excludes most small farmers, allowing only corporation or the very rich to start a cheese venture in this state. Would someone with a few animals in a remote village ever be able to sell cheese to their community? The state's goal should be to promote local production in the villages, thereby reducing exborbitant food costs, not deter it.

-Why issue permits for one year only? Permits should be good for five years instead of one. Such short permitting timelines deter investment in that it is uncertain from year-to-year what the whims of DEC will be – and what the requirements will be. This equates to higher financial risk.

-Why specify light levels? This is an OSHA issue beyond the purview of DEC.  Unless UV lights are used, this won’t affect bacterial concentrations.

-Does the requirement for vats encompass 5 to 10 gallon commercial pans cooked on stovetop? If so, this could be expensive for small producers. Mom and Pop commercial restaurant kitchens, especially in small communities, rarely have steam kettles - so this requirement seems excessive.

-Plastic is used frequently in commercial cheese presses, especially for smaller hand-formed cheeses. Lexan and other plastics are commonly allowed in commercial restaurants where there is significantly more food-borne illness. Why not allow them for cheese?

-Test requirements are excessive, even for mid-sized producers:
     o Eliminate bacterial test requirements completely (bacterial) for pasteurized cheeses. Cheese made from pasteurized milk rarely results in bacterial contamination. Sound science does not justify this!
[Reference: http://drinc.ucdavis.edu/dfoods5_new.htm . Food Safety and Cheese; Institute of Food Science and Technology Position Statement : “In thirteen out of sixteen outbreaks in the cheeses were known to have been prepared using unpasteurized milk.” They go on to say that the remaining three 3
may have involved contamination with raw milk (bypassed systems, etc).  “Microbiological tests on finished cheeses have an important place in quality control, but these tests cannot ensure the microbiological safety of the cheese (Desenclos et al. 1996; Rambling, 1996).” “In view of all these considerations
the Institute of Food Science and Technology considers that it is important to draw attention to the real hazards to human health due to pathogenic bacteria in raw milk cheeses, particularly of the soft and semi-soft type, and to encourage the use of pasteurized milk in the production of cheeses.”]
     o Allow records showing pasteurization occured, detailing temperature and time. These are sufficient to ensure proper pasterurization rather than using the phosphatase test:
                 a) Phosphatase testing cannot be done cost-effectively and accurately on a small scale. A small producer cannot do the 31-step Scharer method (requiring a full lab), resulting in errors if they even try. Who certifies the lab method is even accurate? Secondly, an automatic system (e.g. Fluorophos® ALP Test System) is expensive and beyond the means of small producers. Finally, test strips are difficult to procure, often inaccurate -- thereby not protecting food safety -- and still aren’t cost effective. 
               b) Phosphatase testing of milk has little use for raw milk cheeses. Testing of cheeses can be inconclusive due to molds (e.g. blue cheese), spices, or other ingredients added into the cheese itself as part of manufacturing.
     o Milkfat and moisture content tests should not be required. These do not indicate bacterial contamination, adulteration, or the safety of the product. This pertains to grading only - something under the purview of the USDA.

-Greatly simplify the recordkeeping requirements. Excessive record-keeping requirements usually result in inaccurate “pencil-whipped” records that are often inaccurate. The proof of sanitation should be a successful inspection of the kitchen by DEC – not a a successful inspection of the records. Records reviews are the tools of a lazy inspector.

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Mr. Fuller's response:


Thank you for your comments. The DEC will formally respond to all comments after the comment period ends July 6th.

I would like to address some of your questions now though.


We would prefer to prevent illness rather that respond after the fact. It is too late when people are sick and dead. Today in fact, reporters are asking pointed questions about the DEC's lack of testing of shellfish from non-commercial areas because several people were sickened and one died from eating shellfish that were not regulated or tested. People call us all the time wanting us to do more to ensure safe food. They want to see inspection records. They want to know how they can know if something is safe. They want us to shut down people who are selling food illegally or who seem to be doing a poor job of sanitation. They frequently complain about people selling raw milk. The public gets outraged when people die from cheese like in Canada or Austria (see links) and they don't accept preventable tragedies. A recent poll of Americans showed that 90% want the government to do more to ensure food safety, including increased oversight and inspections.


http://www.foodproductiondaily.com/Quality-Safety/Seventh-Listeria-death
-linked-to-Prolactal-cheese

http://www.cbc.ca/health/story/2008/08/29/samomella-que.html

http://bites.ksu.edu/blog/141212/10/03/08/quebec-cheesemakers-complain-about-inspection-want-taxpayers-pay-it


For perspective, there have been seven outbreaks associated with dairy products in the U.S. so far this year. Most outbreaks are associated with raw dairy products, not pasteurized. Dairy products are the highest
risk food that there is. The reason the numbers are "low" is because of the dairy regulation that has evolved over the past 80 years. Our testing program to date has already repeatedly kept contaminated cheeses
off the market in a state with only three cheese producers during the past 2 years. We are pretty sure that we saved lives. We just can't tell you how many.

There was only one commercial cheese producer in AK during 2004-2008, who operated under the Pasteurized Milk Ordinance because we had no other formal regulations. The regs heavily refer to the PMO, as required by Alaska Statute, but are designed to be more user friendly than the 380 page PMO that is difficult to read through.

The USDA does not oversee cheese or dairy production. States do so. 
Business people I talk to say that they would not commit to establishing a business until rules are set. As it is now, there are no formal regulations, so if we wanted to, we could operate "on our whim" under only the broader statutory mandate of the PMO. That would not be fair to businesses. It would seem that once requirements are set, then a person can commit to establishing a business.

There is only one accepted set of standards for commercial pasteurization in America and that is the Pasteurized Milk Ordinance. The DEC is mandated by statute to regulate dairy products in accordance
with the PMO.

Every micro dairy in America operates under standards similar to what we have drafted. Artisan cheese makers around the country have come to the realization that their livelihood depends on making a safe product. One bad event and they all will suffer. A goat dairy with seven goats was permitted here. Every person who has approached the DEC to get permitted to make cheese has been able to meet the requirements and been granted a permit.

Operators are not required to do phosphatase tests. The state does them. They would not be done on raw milk cheeses. The tests do not cost the producer anything.

Light levels are consistent with the PMO. Good lighting promotes cleanliness.

The Alaska Food, Drug and Cosmetic Act requires that foods be labeled honestly as described in Federal standards. Cheese must meet certain standards to call themselves cheddar, or whatever. Milkfat and moisture testing determine whether a cheese meets CFR standards for the type it claims to be. We cannot break statutory law by not requiring any milkfat or moisture content testing, which again, cost the producer no money. This again, is not under USDA purview. The standards are  written into the Code of Federal Regulations, which Alaskan agencies are required by law to adopt.

Pasteurization vats must have the proper construction to prevent productcontamination, ensure complete pasteurization, and be operated according to the PMO. Of course, they must have accurate thermometers that record the pasteurization process as you mentioned. Vats used for making cheese can be any size.

Record keeping requirements are not intended to be a substitute for inspection. They allow trace back of foods in the event of a recall. Also, if no pasteurization records are kept, the inspector cannot tell if the milk was heated to the right temp and for the right length of time. For an automated clean in place system, if no record of equipment cleaning is kept, the inspector cannot know it ever happened. If hand washing is used, and sanitizing with bleach solution is done, they should test it with a dip stick. If they use hot water as a sanitizer, they should take the temp and record it. These are exactly the types of things that would normally be recorded as part of a HACCP plan.


The reg does not prohibit plastic utensils, although we do require stainless steel for wires and molds to prevent the possibility of rust contamination. It refers to the 3-A standards, which has a section describing allowable plastics. I am still considering possible edits to the section on equipment. That section was written to try and simplify and clarify rules that would otherwise be buried in hundreds of pages of other regulations, but we realize that this sometimes causes more fear than relief. Nobody else has commented specifically on the equipment requirements. If you have more information on materials that are commonly used for specific functions in cheese making, please pass it along.

We understand that businesses need start up capital to meet these requirements, however, we cannot compromise the safety of the product to something below what the rest of the world does. You can see this link for how one guy did it in Massachusetts with a small facility and home designed pasteurizer vat to save some money. He milks six goats.

http://carlislefarmsteadcheese.com/

Thanks,

Jay Fuller, DVM
Assistant State Veterinarian