Final Report for LNE06-250

LNE06-250 (project overview)

Project Type: Research and Education

Funds awarded in 2006: $151,682.00

Projected End Date: 12/31/2010

Region: Northeast

State: Massachusetts

Project Leader:

Dr. Lynda Brushett

Cooperative Development I

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Project Information

Summary:

From milk through finished cheese, this project researched, developed a pilot, tested, evaluated and proposed a prototype product safety risk reduction program for farmstead cheesemakers and provided a framework to convert the added-value of program participation into a marketing advantage. Producers assessed the impact of the pilot program on their business and evaluated the feasibility of creating a Cheesemakers Quality Assurance Program to make the program self-sustaining.

The project resulted in the targeted outcome: a prototype technical assistance, testing program for and supported by cheesemakers. Producers indicated that a risk management program provided a financial benefit in the form of quality assurance, or as a few stated, “insurance”, by reducing the likelihood that cheesemakers will incur considerable financial losses due to failed batches of cheese or unsafe final products. Cheesemakers also reported that their confidence in producing safe, quality cheeses increased after participating in risk management programming.

The project took work done by the region’s universities to help farmstead cheesemakers develop Hazard Analysis and Critical Control Point (HACCP) food safety plans to the next level: a formal program for monitoring plans though producer oversight and independent verification through testing, with results going to the farm and a technical advisor, and assistance for corrective action if needed. The project adapted the well-established European Union (EU) Directives for risk reduction. The project’s technical advisor worked with cheesemakers in a two year on-farm pilot to not only develop, but monitor and verify HACCP plans by testing for microbiological contaminants and help the farm work through any problems surfaced by testing. Twenty farmers volunteered to participate in the two-year pilot consisting of technical assistance, sampling and testing to monitor risk management plans. Producers evaluated the program at the end of the first year, and again a year after the pilot concluded. The pilot was later supplemented by a HACCP Certification training program. Both programs were evaluated with findings incorporated into protocols for risk management.

The project sought the perspective of buyers to assess the need and value of risk assurance in the marketplace and consulted with FDA in program design. A set of risk management protocols was developed combining elements of the pilot with a HACCP training for review by cheesemakers. The HACCP element was tested by producers and evaluated with results integrated into the final recommendation for a Cheesemakers Quality Assurance Program (CQAP).

The CQAP will provide technical services and undertake marketing and promotional efforts targeted at wholesale and retail buyers to return the added value of the program to producers who adopt a verifiable risk reduction regime as part of their operations.

Introduction:

Cheesemakers in New England and New York are becoming increasing recognized for high quality small batch cheeses made on the farm. While there is a considerable body of literature and expertise in our region to support milk production and cheesemaking, training and institutionalized systems to assure product safety are lacking. Farmstead cheeses are not commonly tested for fecal indicator organisms (coliform bacteria) or pathogens; only one milk sample, taken every month from each farm, is screened for total bacteria and somatic cell counts. This testing protocol is inadequate if contamination is to be detected and cheese safety assured. The current dairy industry regulatory system in the US relies on pasteurization and a 60-day minimum aging period for raw milk cheese to assure product safety. With the effectiveness of the “60-day aging” rule being questioned by the FDA, there is a need to pro-actively create an alternative to mandatory pasteurization—which would destroy the emerging farmstead industry—that will assure the safety of farmstead cheese. Over the four-year SARE project, concern about the safety of local cheese increased on the part of producers, industry and government. More FDA inspections of creameries were conducted, more buyers asked about or required assurance of food safety measures, and more producers worried that a ‘bad’ batch would reach the market and taint everyone’s business. Debate over provisions of the Food Modernization Act served to heighten motivation by cheesemakers to be proactive in putting together a risk management program that would allow them to manage and monitor their operations without ‘one-size-fits-all’ mandated federal legislation and to preserve their ability to continue using raw milk in their cheesemaking.

Performance Target:

The New England/NY Farmstead Cheese Program’s met its Performance Target: the 100 farmers who participate in one of three Farmstead Cheese Safety Risk Reduction Seminars, [Accomplished, Objective 1] 20 will join the New England/NY Farmstead Cheese Pilot Program. [Accomplished, Objective 2] Of these, fifteen will adopt the risk reduction assessment, monitoring and testing systems developed by the pilot program as a permanent feature of their operation [Accomplished, Objective 3] and will form the core of a regional cheesemakers association to provide on going technical assistance, testing and marketing services to members. [Accomplished, Objective 4] These farms will take this action because the program 1) produced a quantifiable increase in the profitability of their operations, over and above its cost, by the prevention of at least one batch of cheese and/ or by retaining or adding or expanding a market outlet [Accomplished, Performance Target Part 1] and 2) made the cheesemakers feel more secure, more positive and less anxious about the future of their industry. [Accomplished, Performance Target Part 2] Objective 1 - 100 cheese producers participate in one of three seminars on farmstead cheese safety risk reduction to learn how to use HACCP risk analysis and planning to reduce potential for pathogen contamination of their products. Verified by attendance records and workshop evaluations. 2007: With the help of state cheese maker organizations and Cooperative Extension, four day-long HACCP Seminars were held around region (NY, CT, VT, ME) to provide training on HACCP planning and recruit farms for the risk management program. NH farms were invited to attend the VT and CT workshops; MA invited to VT and CT workshops, RI to CT workshop, and VT to NY and VT workshops. 5 of the farms had a HACCP plan in place; all but one farm felt their knowledge of HACCP had increased; and all but 4 farms indicated they would look for and be more aware of contamination points and or write or update a HACCP plan. From the 70 participants, 24 farms signed-up for the program, 22 joined and 21 stayed with it. They are a mix of large and small producers from VT, NY, ME, MA and CT who make sheep, goat and cow cheeses, some from milk produced on-farm, some from off the farm and some from both. Objective 2 - 20 farmers see the value of joining a pilot program to verify through testing the effectiveness of their HACCP plans and work together to plan a self-sustaining association to carry on the program. Achievement of this objective was verified by producer participation in the program and evaluations. 2007: 24 farms signed-up for the program, 22 joined and 21 continued as members of the pilot. Seminars were evaluated; pre-pilot survey was collected. Site visits were held on pilot farms; HACCP plans were reviewed; sampling protocols put in place and farmers trained to collect and ship samples; samples collected, analyzed and test results reported. Approximately 400 raw milk, 120 cheese, and 120 environmental samples were tested. Identified problems were discussed and solved. The project paid for the cost of testing. A halfway point survey captured producer provided insight to project benefits and drawbacks which were integrated into the design of year two of the pilot program. 2008: Of the 21 participants in the first year of the pilot project, 17 farmstead cheesemakers remained committed to inclusion in the pilot group and agreed to pay for the testing themselves. Four of the original participants decided not to continue in 2008 because the cost of testing did not justify the value of the project to them even though they reported that the project was valuable to them in 2007 when the cost was covered by SARE. Two of these remaining 17 cheesemakers were not able to operate sampling/testing programs in 2008, citing personal reasons, but remain committed to the project. Two new farmstead cheesemakers joined the group in 2008, for a total of 19 in year two of the pilot. Objective 3 - 20 farmers will evaluate the pilot program and 15 will determine that it should become a permanent part of their operations. Verified by producer participation and evaluation including a halfway point evaluation and a post-pilot survey on experience with new sanitation practices, testing, etc., numbers of batches, pounds per batch, etc. of cheese produced under the pilot regime, and number of batches (pounds) lost, and why, industry and marketing concerns, etc. and an assessment of benefits (e.g. increased numbers of successful batches, grater confidence in cheesemaking, etc.) and costs (e.g. time, changes in facilities, equipment, testing, etc.) 2008: 17 farmstead cheesemakers continued to monitor their risk reduction programs with periodic sampling and testing of milk, cheese and the environment. By the end of 2008, 11 had stayed with the sampling/testing aspect of program for their entire time of cheese production, which ranged from six to twelve months depending on ruminant species and management style, e.g. seasonal or year-round. Cheesemakers who did not continue their sampling/testing for the entire production period cited testing cost, time constraints, adequate regulation in their own states, and confidence in the quality and risk reduction because of improvements made during the pilot. 2010: Nineteen of 20 pilot producers participated in a program evaluation. Fourteen out of these pilot producers continue to monitor plans though testing. In addition 19 producers (a mix of pilot producers and others) went through a project sponsored HACCP training program to become HACCP certified. Of the 16 people who completed post-training evaluations, all stated they were very or probably likely to complete and implement HACCP plans. Another six producers (a mix of pilot producers and others) participated in a privately sponsored HACCP certification program; all developed and are implementing HACCP plans. Objective 4 - 15 farmers will institutionalize milk and cheese risk management planning and testing into certification, technical assistance and marketing program and seek the participation of other cheesemakers in the program by sharing their experiences and the business feasibility study at a series of regional cheese safety seminars. Verified by business feasibility planning, producer participation and decision-making. 2009: Findings from the two year pilot were shared with over 200 farmers. 2009: The Vermont Cheese Council decided to pursue development of a quality assurance/risk reduction program and sponsored a feasibility study. Eight of the pilot project participants were Vermont producers. Project staff worked with the VCC to develop a model program that can be adopted by Vermont and other states. 2010: The Vermont Cheese Council Executive Committee agreed in principle that HACCP or HACCP type training and related plan development, and implementation support should be part of every cheesemakers education and operation. The Cheesemakers Quality Assurance Program developed by the project provides the framework. Performance Target Part 1 All of the 19 pilot producers who completed the final program evaluation recommended that risk management planning be part of every cheesemaker’s operation and that cheesemakers adopt testing procedures to monitor quality. Two of the producers qualified this response by recommending that the program be administered on a voluntary basis rather than be made mandatory. This is the direction that producers decided to pursue. Data from the halfway point and final pilot surveys clearly and conclusively indicate that the program provided participants a financial benefit in the form of quality assurance, or as a few stated, “insurance”, by reducing the likelihood that cheesemakers will incur considerable financial losses due to failed batches of cheese or unsafe final products. At the same time producers were not able to quantify additional profits but insisted that the testing would have saved them money if a problem did arise. Producers put the financial value in these ways: “Certainly if a problem existed and were found, the negative financial impact of the results would be significant”. ”We believe that the quality of the cheese was much improved after your visit and consultation. As a result, we know that the sales of the cheese were improved.” ”I can't calculate the savings from the program, but obviously only having to discard a few batches of cheese is greatly preferable to having to continue to discard cheese while we slowly located the problem.” “We were able to correct the problem [E. Coli showing up from the farm’s milk provider's equipment, which was found quickly after testing] I only had to discard a few batches” “We probably profited a few hundred dollars from having the coli form testing done when we were losing cheese to early blowing.” In addition, changes made to production and storage methods spurred as a result of participating in the program generated in the final survey can be read as a list of potential costs averted. Regarding marketing, one producer stated that program was indirectly responsible for entering new markets due to the fact that less cheese was wasted as a result of testing, one stated specifically that it allowed them to sell cheese through a major grocery chain, and another said it gave her a marketing edge “as I can reassure my costumers that we follow good practices and test regularly. This elevates cheesemaking in the eyes of many customers!” Performance Target Part 2 Beginning with the halfway point survey, producers reported an increase in confidence in their skills and food safety systems. Producers consistently said that in some cases the program provided assurance that their production methods were sanitary and in others helped them develop or refine their quality assurance protocols. The program helped producers “identify areas of weakness where we can improve upon our cleaning and sanitation. This is turn will help us to produce a more consistent, high quality product, and that hopefully leads to a more successful business and more money!” Twelve of respondents in the final pilot program evaluation said that their confidence in producing safe, quality cheeses had increased since participating in the program, another six said theirs had remained the same in part due to prior training. Every respondent recommended that risk management planning be part of every cheese maker’s operation and that cheese makers adopt testing procedures to monitor quality. Everyone who went though the HACCP training reported they were somewhat to extremely confident in their ability to assess and manage food safety. Respondents who indicated that they were somewhat confident pointed to the need for some additional practice in the field to make the HACCP training/certification was fully effective. The following comments captures the experience: “(HACCP planning) is eye opening and helped me become aware of potential hazards.” “Very good conceptual and practical training program, but takes field experience to master.” Those who took the HACCP course agreed that all cheesemakers should have HACCP training.

Cooperators

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Peter Dixon
dairy food consultant/cheesemaker

Research

Materials and methods:

Approach: 1. Conduct regional cheese product safety risk reduction seminars to teach producers how to develop HACCP plans and discuss the need for and value of verification procedures. Include information to help farmers weigh food safety ramifications and estimate costs and returns in their cheese operations. 2. Develop a risk management/reduction program based on a 1) EU style risk assessment leading to HACCP plan development and implementation, 2) milk and cheese sampling, testing, interpretation, and 3) technical assistance to verify plans are working and are adjusted as needed, as well as to help with problem solving 3. Involve twenty farms (at least one from each state, a mix of cow, sheep and goat producers) in a pilot study to test the risk management/ reduction program 4. Farm visits to assess risk issues and develop risk management/reduction plans 5. Interviews with farmstead cheese distributors and retailers to ascertain interest in and value of a food safety certification program, an assessment of EU competition, recommendation for a business model, estimated costs and revenues and organizational development. 6. Develop a prototype Quality Assurance Program based on producer and buyer findings. 7. Present risk management findings from the pilot and a prototype Quality Assurance Program to producers 8. Test and evaluate of a HACCP certification program for cheesemakers 9. Work with cheesemakers to institutionalize a risk management/ reduction quality assurance program within the cheesemaker's association.

Research results and discussion:

See Performance Target Objectives section of the report as these are the project’s milestones. See also Outcomes The number and kind of participants in the project unfolded as planned. The only course correction was to work exclusively with the Vermont Cheese Council (VCC) in developing a Quality Assurance Program, rather than work toward creation of a new, region-wide organization. The VCC is very well organized, is recognized as a leader in the regional and national industry, has identified cheesemaker risk management as a priority, has the resource of the Vermont Institute for Artisan Cheese whose staff were doing work in this area, and most important had a strong interest in developing a Quality Assurance Program. making it possible to develop a prototype with in the timeframe of the project. Once developed the program could be extended to other cheesemaker organizations in the region to adopt or adapt. The project worked with the Vermont Cheese Council to develop a Strategic Plan. Cheesemaker education and training including food safety was included as an important part of the plan. Findings from the two year risk management program work with the project’s farmers was shared with more than two hundred farmers at the New England Direct Marketing Conference and organized in to a draft Cheesemakers Risk Management Protocol. Findings: • To maintain buyer belief in and assurance of the quality of farm made cheeses, cheese-makers need to do more than current regulations require. • While the federal/state systems in place for testing milk for total bacteria counts are adequate for assuring food safety, sampling that differentiates total bacteria counts into groups of bacteria for closer evaluation enables cheese-makers to be proactive in finding and fixing problems before they occur. For example differentiating the sample to determine presence of Staphylococcus aureus, as is done in the EU, and bacteria in the Coli form group alerts the cheese-maker to identify the sources of potential pathogens and take actions to prevent an accumulation that will eventually raise the total bacteria count above the regulated limit. • The environmental testing aspect of the pilot was very effective. These points of contamination are not currently regulated and are the current focus of FDA inspections. For example producers were able to identify and take actions to eliminate potential pathogens in drains, floors, storage areas and added ingredients. • All the cheese-makers in the pilot program saw the benefits of self-directed actions to identify potential points of contamination in their operations (milk, environment, cheese) and the ability to verify the presence or not of contaminants through periodic testing. Many mentioned the value of consistent testing and the timely reporting of results as a means to improve their sanitary and hygienic practices, particularly in the production of milk and in the daily operations of the creamery where cheese is made, aged, packaged, and stored before delivery. • The primary barrier for the cheese-maker to doing testing was “finding the time” and cost and logistics (prepping and shipping) lab tests. Improvements to cheese quality (flavor, texture, etc.) and increases in the number of successful batches were related more to assistance and education of the cheese-maker in the technical aspects of making and aging cheeses rather than from information gained from testing. Testing regimes should relate to the producers cheeses and operations. One size does not fit all. • Current regulations that provide for cheese testing are not necessarily directed towards testing cheeses with the highest risk to public health. Testing by the cheese-maker was effective in preventing unsafe product from reaching the market. • A risk reduction program should be an integrated partnership of state regulators combined with self-regulation by the cheese-maker; participation in the program should be required to obtain a license to process milk for cheese. A program that integrates state regulation and self-monitoring to reduce the risk of an unsafe farm made cheese reaching the market may include the following: 1. HACCP plan. Can be developed by the producer using a cheesemakers or other HACCP manual, with or with out formal certification, depending on market requirements. 2. Milk testing: Twice monthly sampling and testing of milk used for cheese production. At minimum, one sample should be differentiated; at best, both samples would be differentiated to include testing of Staphylococcus aureus and Coliform bacteria. As is now the typical practice, one sample would be collected by the state for testing at the state lab. This would be followed in two weeks by another collected by the cheese-maker, which would be tested at an independent, certified lab such as the Agi-Mark Central Lab in West Springfield, MA. The cost to producer @ $25/ sample for shipping and testing. Technical assistance to identify and solve any potential problem provided though VIAC, VCC or private consultants. The records of the two milk tests should be viewed by the state inspector and the producer on a monthly basis. 3. Environmental testing: A plan for environmental testing of the creamery should be developed by state regulators with the assistance of the producer. Once every two months the producer collects samples from at least four potential points of contamination for testing at the state lab. One additional sample of cheese brine should be tested. State inspector to work with producer to identify where to sample, how to sample, and what to test for. Sampling of sites in the cheesemaking and brining areas should be done when in production; sites in the aging rooms and packaging area should be sampled all year round. Technical assistance to identify and solve any potential problem provided though VIAC, VCC or private consultants. 3. Cheese testing. Monthly sampling of highest risk cheeses by the state. Inspectors will work with producers to identify the highest risk raw milk cheeses from a food safety perspective, e.g. high moisture, surface-ripened, low acid at time of consumption. To ensure that pasteurization is effective, in addition to reviewing posted pasteurization charts, inspectors will sample pasteurized cheeses aged less than 60 days to ensure that the risk of post pasteurization contamination is low. This amounts to at least two samples of cheese each month. Technical assistance to identify and solve any potential problem provided though VIAC, VCC or private consultants. Proposal: * These criteria could be included in cheese-maker licensing standards or in a Cheese Quality Assurance Program that cheese producers would apply to. * A Cheese Quality Assurance certifier (if state inspectors are used, they would need education and technical support) would work with producers to develop HACCP plans, monitoring, sampling etc., identify cheeses that pose a high risk to public health, certify producer documentation * Producers need education and technical support to develop HACCP (certified or not) monitoring plans, training in how to take and package samples, and interpretation of results to solve problems to avoid risks to public health. As far as the design of a technical assistance risk management program for cheesemakers is concerned, pilot project producers evaluated which of the five aspects of the pilot program—(i) farm advisory visits, (ii) risk management assessment and planning, (iii) sampling and getting test results, (iv) discussion of results and action steps, (v) and technical cheese-making and aging assistance and advice—to keep, make optional or to not include in future iterations of the program, none of the respondents indicated that any part of the program should not be included. A large majority of respondents, ranging from 100% in the case of sampling and getting test results, to 70% in the case of technical cheese-making and aging assistance and advice, indicated that the components were “very helpful, keep in program” (see the chart immediately below for a breakdown of responses by program component). Remaining respondents marked “helpful, make optional”. Cheesemaker Evaluation of Program Components: see table With the producer side of the equation drafted, emphasis shifted to evaluating market perceptions, need and support for a producer risk management program. To this end, the project partnered with the Vermont Agency of Agriculture, the Vermont Cheese Council and consultant Rosalee Wilson to assess whether and how a risk management program could offer artisan cheese makers opportunity to not only maintain existing market share and wholesale buyer confidence but also capitalize on the added value consumer level marketing. Wilson conducted interviews with sixteen distributors and twenty retailers, varying in size from independent artisan cheese stores to national supermarket chains to determine: 1) Do wholesale and retail buyers feel there is a need for or interest in a risk management program for farmstead cheeses? If so a. Do they have quality assurance standards in place as a requirement with their vendors, and if so, and what are they? b. And, what are the areas of concern? 2) Do they feel that an RMP, based on what they see as areas of concern, could provide added value or a marketing advantage to artisan cheese makers? For example, would having symbol of approval type of certification or branding element strengthen perceived value to retailers and consumers? a. Could this enable the cheeses to command a higher price? b. Would it help purchasers at the point of sale in selecting these products over others, thus increasing sales volume? c. Would retailers and distributors be more likely to select and promote these cheeses, thus expanding market sector and new markets? d. What suggestions might there be in promoting and marketing this program? Findings from the feasibility study: 1. Buyers hold an inherent assumption that Vermont artisan cheese makers, by their very nature of being small, being in direct connection with retailers and distributors, and being in Vermont, have high quality standards and are following good practices. Therefore the need for a “formalized” program or bureaucratic approach is considered unnecessary. To the degree that this is a genuine compliment to the Vermont artisan cheese industry, it also represents a real threat to the Vermont brand and to individual cheese makers should a situation ever arise to challenge this assumption. 2. Good milk though cheese making and handling practices are valued, and that documentation of good practices could become the basis for a risk management program. Recommendations: 1. By documenting adherence to principles and good practices (as contained in a implemented and monitored through testing HACCP plan) for the entire product lifecycle—from animal health, husbandry, and milk production through cheese production, all the way to shipping, handling, and distribution—in a manner which third parties can understand, and if necessary verify, Vermont cheese makers can fulfill an industry assurance to suppliers and retailers that they are receiving product at the cusp of its ark of brilliance and in perfect condition, while also creating traceability that would satisfy food safety and risk management needs. 2. Adopting a “documentation program” could expedite new vendor application processes with larger retail establishments, potentially even becoming acceptable as an alternative to a chain’s own pro forma documentation. 3. A “documentation program” that included a marketing campaign that fostered networking opportunities between cheese makers and industry decision makers in key cities, and used point of sales materials to introduce consumers to the farms and families who produce the cheese, and depicted the values adhered to in making the cheese, would resonate with consumers and decision makers, increasing sales and market share for artisan cheeses. 4. Shippers, distributors, wholesalers and retailers who need to be trained in proper handling, storing, packaging, and shipping of artisan cheese. If cheese makers wish to protect product and brand integrity they will need to take it upon themselves to train shippers, handlers, wholesalers, and retailers—all individuals and entities coming into contact with their products, about good practices and principles. 5. Within the industry and the general public there is confusion regarding what constitutes artisan scale versus commercial scale cheese production. At what size, scale, and volume would a producer be considered too large to fit the definition of artisan cheese? This is considered a significant finding because value was placed on creating formalized oversight for larger scale operations but not for smaller scale operations. Summary: A documentation approach to risk assumes that producers have information and training, plans, systems and monitoring in place and allows each individual producer the autonomy to document their food safety risk plan and procedures. By creating and naming a template for producers to document their risk management procedures that is easily recognizable within the industry, the documentation approach could be incorporated into a quality assurance marketing campaign focused on buyers that in turn could be used to promote products to consumers.

Risk Management Program Elements

Participation Summary

Education

Educational approach:

The project began with an educational seminar of interest to all cheesemakers. Using farm and sustainable agriculture networks we spread the word to cheesemakers and agricultural resource providers across the region. Producers who had taken cheese-making courses offered by consultants, Cooperative Extension, the Vermont Institute for Artisan Cheese, etc. and who are members of associations like the Vermont Cheese Council and the Maine and NY Cheesemakers Guilds were targeted.

No milestones

Additional Project Outcomes

Project outcomes:

Impacts of Results/Outcomes

The impact of the project was tracked for the core group of 20 farmers who participated in the two year pilot project. As reported in the Halfway Point survey, producers said the program provided assurance that their production methods were sanitary and where problems were found, solutions also were found: “it has been reassuring to find no pathogens in obvious places”, “it was very reassuring that my sanitation and production methods seem to be working!”, “the environmental swabs reinforced that we were doing a good job cleaning all surfaces”, Producers also said the program helped them develop or refine their quality assurance protocols. As one producer put it: ‘The project has helped us structure our testing into a more meaningful and systematic routine. The use of environmental swabs has expanded our tracking of food risks in our plant. The testing of milk butterfat and protein helped track seasonal changes throughout the year. “ Producers described specific problems that were identified and remedied as a result of testing. Producers gave instances where the testing helped them find problems with their milk collecting equipment, a problem in receiving bagged milk and a need to keep drying boards cleaner. Another said it “helped me identify some problematic individual milkers in my herd, indicating that I probably should be drying the older ones off on an earlier schedule….I had also never thought about the brine tank being a possible source of contamination.” One producer noted that the program helped “narrow down our search for a coli form problem we were having,” while another noted that it “helped us solve our quality control issue.”. Farmers reported making these kinds of improvements: • Addressing the fact that a foreign body was found in milking lines, • Setting up brine monitoring, • Different ways to sanitize surfaces for ripening cheeses • More frequent washing down of aging racks • Improving milk delivery protocols • Finding better ways of managing bagged milk • Putting covers over coolers where none existed before, • Increased cooking times to dry some cheeses • Better sanitizing • Different storage method for products that are added to cheese • Improvements in bulk tank room • More thorough cleaning of floors and other rough surfaces • Use a footbath in the can receiving area to put the bottom of the cans in before bringing them into the cheesemaking room. • Use a footbath in the walkway between the milk room and the creamery to prevent barn environmental contaminants from entering the cheese production area. • Monitor the sanitation practices of the farmers who produce and deliver milk to us. This includes inspecting the condition of the cans and delivery vehicles. Other impacts included • Improved skills or confidence: 70% of the pilot project producers reported an increase in cheesemaking skills. “The program is a wonderful resource to help me understand what was going on with my milk and cheese in a timely manner.” “We know how we are doing based on the information received during the project. It has given us more confidence that we are making safe products.” • Better sales: “We believe that the quality of the cheese was much improved after your visit and consultation. As a result, we know that the sales of the cheese were improved.” • New markets: for some producers the program was indirectly responsible for entering new markets due to the fact that less cheese was wasted as a result of testing, one stated that it allowed them to sell cheese through a major grocery chain, and another said it gave her a marketing edge “as I can reassure my costumers that we follow good practices and test regularly. This elevates cheesemaking in the eyes of many customers!” • Fewer bad batches saying that ”I can't calculate the savings from the program, but obviously only having to discard a few batches of cheese is greatly preferable to having to continue to discard cheese while we slowly located the problem “, “we were able to correct the problem [E. Coli showing up from the farm’s milk provider's equipment, which was found quickly after testing] I only had to discard a few batches” and ‘we probably profited a few hundred dollars from having the coli form testing done when we were losing cheese to early blowing.” 7. Economic analysis--describe the economic repercussions of your project on farm viability. If applicable, include information about inputs, changes in profits, changes in yield, or any other data that indicates a change in farm income. Responses to the halfway point and final pilot surveys indicate that the program provided participants an economic benefit in the form of quality assurance, or as a few stated, “insurance”, by reducing the likelihood that cheesemakers will incur considerable financial losses due to failed batches of cheese or unsafe final products. Producers expressed this benefit in these ways: “Certainly if a problem existed and were found, the negative financial impact of the results would be significant”. “We believe that the quality of the cheese was much improved after your visit and consultation. As a result, we know that the sales of the cheese were improved.” “ can't calculate the savings from the program, but obviously only having to discard a few batches of cheese is greatly preferable to having to continue to discard cheese while we slowly located the problem.”

Economic Analysis

Responses to the halfway point and final pilot surveys indicate that the program provided participants an economic benefit in the form of quality assurance, or as a few stated, “insurance”, by reducing the likelihood that cheesemakers will incur considerable financial losses due to failed batches of cheese or unsafe final products. Producers expressed this benefit in these ways: “Certainly if a problem existed and were found, the negative financial impact of the results would be significant”. “We believe that the quality of the cheese was much improved after your visit and consultation. As a result, we know that the sales of the cheese were improved.” “ can't calculate the savings from the program, but obviously only having to discard a few batches of cheese is greatly preferable to having to continue to discard cheese while we slowly located the problem.” See table: Changes in Cheese Sales and Shrink

Changes in Cheese Sales and Shrink

Farmer Adoption

Given the recent spotlight put on food safety in the artisan cheese industry due to nationally publicized FDA inspections, it is clear that there should be better risk management training for licensed cheesemakers. While people can become accomplished cheesemakers in a few years, many can do so and lack the skills to develop and operate HACCP plans or similar risk reduction controls. Knowing how to access the risk of pathogenic contamination in cheesemaking, especially from the environment surrounding the process of making and aging cheese, is critical to operating a successful cheese business. This is because success is measured by staying in business. FDA inspectors may not understand how cheese is made but they do understand sanitation. When they pay a visit to a creamery they will most likely be doing a visual inspection and also take many swab samples of the environment and several cheeses to test for pathogens in the lab. The inspection results can lead in different directions. The cheesemaker may be given a clean bill of health and operations will not be interrupted in any way. If the cheesemaker is in control of their environment, this should be the outcome. If pathogens are found in cheese a recall will be required. The cheesemaker will have to produce a clean bill of health before they are allowed to sell cheese again. Environmental swab sample results should lead cheesemakers towards problem areas and give them information to prevent pathogens from getting into the cheese. A NY Times article by William Neuman from November 19, 2010 mentions that at least nine artisan cheesemakers have had recalls this year. Two of these cheesemakers Estrella Family Creamery in Montesano, WA and Bravo Farms in Traver, CA were in the news in the past several months. They are both award winning cheesemakers. On December 20, 2010 cheeses made by Sally Jackson, another veteran farmstead cheesemaker, were recalled by Whole Foods stores throughout the US. It may be that the FDA is increasing its surveillance of smaller-scale cheesemakers. Regardless of the FDA’s motive, commercially licensed cheesemakers are all regulated by this agency. FDA agents can show up at any time, take environmental swab samples from top to bottom in our creameries and aging facilities, take samples of cheeses, and have these tested at their lab for pathogens. They should not find pathogens in the cheese and very few in the environment. The pathogen of concern is always Listeria monocytogenes. This is the most important one that is tested in the creamery and aging room environment. Its presence indicates adequate controls are not in place to keep pathogens out of the cheese. FDA inspectors will provide results but may not make recommendations for improvement. Cheesemakers who are faced with a recall need to immediately seek expert advice to access their situation and make recommendations and make changes in their operations. The FDA will return, usually within a month, to inspect again and, if Listeria is still present, the creamery will be shut down. To be proactive, cheesemakers need to get training in hygiene and sanitation, food microbiology, food safety, and HACCP planning and implement risk reduction measures and testing. A quote from USDA’s FSIS (Food Safety and Inspection Service) inspector L.E. Peterson (L. E. Peterson - October 26, 2010 4:55 PM) about the Estrella Family Creamery’s case reveals important details about how these government agencies operate. Peterson states, “I don't how the FDA works but as a FSIS inspector, I do know how Listeria monocytogenes sampling works in FSIS facilities. All FSIS facilities that produce ready to eat products like lunch meat and hot dogs are required to have a Listeria monocytogenes control program in place. If it's not a requirement in raw milk dairies under FDA jurisdiction, it should be. FSIS ready to eat establishments go through repeated sampling and cleaning until ALL samples come back negative. While this is going on, product is usually held until the results come back. If it's negative, the product ships. If there's a positive, they clean/ test again and again and again until all results are negative. The system is not perfect because recalls still happen. Mandatory testing and hold of all products that could carry Listeria monocytogenes or E. coli O157:H7 should be a matter of practice. The fact that positive samples were returned at all indicates the sanitation measures taken by Estrella Creamery were ineffective. If the corrective actions had been sufficient to eliminate Listeria monocytogenes all the samples would have come back negative. Listeria doesn't "die off" if you let cheese sit around awhile and age. It continues to grow, especially when it has a nice lovely cheese as a food source. The cheeses that were affected by the positive result SHOULD HAVE BEEN DESTROYED. NO if's, ands, or buts.” FDA inspections of farmstead creameries include many environmental swab samples. They are hunting to find contaminants, i.e. Listeria species, in the environment surrounding the cheesemaking, aging, packaging, and distribution processes. They are also concerned about record keeping, product tracking in the market, and recall protocols. Cheesemakers should be able to comply with these regulations. This involves developing an overall risk reduction program for a creamery. These programs are structured based in the HACCP approach. The SARE Farmstead Cheese Risk Reduction Project trained twenty farmstead cheesemakers in the Northeast to do this by participating in a two-year pilot project. Results from the pilot project indicated the importance of this training in improving farmstead cheese businesses. There were positive outcomes for these cheesemakers. The majority gained confidence in their ability to control their environment and produce safe food. The project training and test results provided them with the assurance that their production methods were sanitary. All of the participants recommended that risk reduction planning be part of every artisan cheesemakers operation and that they adopt testing procedures to monitor quality. Strong elements of the project were: farm advisory visits, risk management assessment and planning, sampling and getting test results, discussion of test results and action steps, and technical cheesemaking and aging advice. Establishing risk management plans for cheesemakers and the other benefits of the project taught cheesemakers to be proactive and stay one step ahead of the regulators. This is the concept of self-regulation, which makes cheese businesses financially stronger. These cheesemakers will continue to produce cheese safely by reducing the risk of hazards and controlling pathogens and protect the creamery against financial losses due to creamery shutdowns and product recalls. Recent FDA visits to creameries in VT bear this out—all the farms had HACCP plans and procedures in place, all passed the inspections. The project’s two-day HACCP training seminar provided producers with a fresh view of HACCP planning. Seminar leader Dr. Scott Donnelly was adamant that in developing a HACCP plan for cheesemaking (that involves a lactic fermentation) the raw or pasteurized milk has nothing to do with prevention of pathogens. Listeria will not grow if the starter culture is active. They will come from the environment after the fermentation is finished. In other words, preventing post process contamination is the focus for controlling these hazards. Sanitation is a critical control point (CCP) for environmental contamination. A Standard Sanitary Operating Procedure (SSOP) Program is a prerequisite program for the HACCP plan. This plan involves documenting the task to be performed, chemicals and equipment used, methods used, position responsible, and monitoring for efficiency. In the new approach to HACCP the prerequisite programs are the preliminary steps for HACCP plan development and provide the means to control the hazards. Other important prerequisite programs to cheesemakers are Personnel Practices, Environmental Monitoring (swabbing critical areas), Cheese Make Procedures (pH development), Traffic Flow, and Trace and Recall. By the end of the seminar producers had worked together to create HACCP plans for some artisan cheeses. It was made very clear that the focus of monitoring has now shifted to the environment. This experience showed producers that the food safety picture is evolving and that it is important to stay informed. Cheesemakers need invest time and energy to learn more and improve their practices. Food safety planning is an integral part of cheesemaking businesses. As the spotlight continues to shine on food safety in cheesemaking businesses it is imperative to build practical knowledge about food safety equal to the level of the craft of cheesemaking into these businesses. A combination of a formal HACCP seminar taught by an expert in the field and a testing program supported by a field technician should be part of commercial cheesemaker licensing. This should be affordable to all cheesemakers regardless of scale. The project challenges academics, industry, and regulators to see the value of cheesemaker self-education and work together to create such an opportunity. Resource Documents on Recent Artisan Cheese Recalls http://www.nytimes.com/2010/11/20/business/20artisan.html By WILLIAM NEUMAN Published: November 19, 2010 At least nine artisan cheesemakers have had recalls this year. Most involved listeria in soft cheeses, but this month, a California cheesemaker, Bravo Farms, recalled a gouda, a semi-hard cheese, from Costco stores after it was linked to an E. coli outbreak that sickened 37 people. http://www.fda.gov/Safety/Recalls/ucm237750.htm FOR IMMEDIATE RELEASE - December 20, 2010 - Whole Foods Market announces that it is recalling cheese sold in California, Nevada, Washington State and Washington, D.C. that came from its supplier Sally Jackson Cheese of Oroville, Washington. The recalled cheese was cut and packaged in clear plastic wrap and sold with a Whole Foods Market scale label; some scale labels also list “Sally Jackson” as part of the description. Sally Jackson Cheese recalled its cheese products, including cow, goat, and sheep, because they may be contaminated with Escherichia coli O157:H7 bacteria. E. Coli 0157:H7 causes diarrhea illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure. Young children and the elderly are most susceptible to serious complications and even death. Consumers should seek immediate medical care if they develop these symptoms. http://www.marlerblog.com/case-news/should-estrella-family-creamery-be-treated-differently-than-sangar-when-it-comes-to-listeria/ Should Estrella Family Creamery be treated differently than Sangar when it comes to Listeria? POSTED BY US ATTOURNEY BILL MARLER ON OCTOBER 26, 2010 • On September 1, 2010, the FDA and the WADA initiated the most recent inspection of Estrella. During this inspection, Estrella provided laboratory reports that revealed product it sampled on May 28, June 15, June 26, June 29, July 8, and August 30, 2010, had tested positive for L. mono. Investigators also found three paper-wrapped cheeses labeled “FDA sample, do not sell” stacked together on an aging shelf that appeared to be the three remaining cheeses from the lot that was sampled by FDA on August 16, 2010 and tested positive for L. mono. Estrella had previously informed FDA that cheese had been destroyed. The presence of the contaminated cheese presents an additional potential source of contamination. • Also during the September 1, 2010, inspection, FDA investigators observed that employees did not take necessary precautions to protect against contamination of food contact surfaces. Most significantly, the owner was observed tasting the cheese and placing the uneaten portion back into the cheese wheel. Conditions similar to those observed during the previous August 2010 inspections were also observed during this inspection. • On September 3, 2010, the agency requested that Estrella recall all cheese products. The firm declined. • On September 4, 2010, FDA issued an FDA News Release advising consumers that consumption of all Estrella Creamery cheeses put them at risk for L. mono related illnesses. • During FDA’s inspections of Estrella, FDA investigators also observed unsanitary conditions in the production areas including tape and peeling paint on cheese press handles; flying insects and spiders on the walls and ceiling of the milk room vestibule and in the cheese processing room; and uncovered whey collection tank located against the exterior wall of the processing facility; milk residue build-up on the whey discharge sink, and rough bare wood shelving covered with cheese product residue in the cheese aging areas. In short, the persistent presence of L. mono in both product and environmental samples from Estrella and the unsanitary conditions repeatedly observed by FDA investigators causes all food articles held at Estrella to be adulterated. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm232748.htm FDA NEWS RELEASE For Immediate Release: Nov. 4, 2010 Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA UPDATE: Nov. 23, 2010: Bravo Farms is voluntarily recalling all cheese. The action follows laboratory testing by the California Department of Food and Agriculture that revealed the presence of Listeria monocytogenes and E. coli O157:H7 in cheeses. The Bravo Farms press release and label images are posted here. UPDATE: Nov. 16, 2010: Laboratory testing conducted by the New Mexico Department of Health on an unopened (intact) package of Bravo Farms Dutch Style Gouda Cheese purchased from a Costco retail location has identified E. coli O157:H7 matching the outbreak strain. This is the first confirmation from an unopened cheese sample, and is consistent with previous laboratory testing conducted on two opened packages of the Bravo Farms Dutch Style Gouda Cheese purchased at Costco, which also identified E. coli O157:H7 matching the outbreak strain. These opened packages were from two different case patients’ homes. Testing on two additional opened packages from other case patients’ homes is in process. UPDATE: Nov. 10, 2010: Laboratory testing conducted on two opened packages of Bravo Farms Dutch Style Gouda Cheese purchased at Costco from two different case patient’s homes has identified E. coli O157:H7 matching the outbreak strain. Preliminary laboratory testing conducted on an unopened package of Bravo Farms Dutch Style Gouda Cheese obtained from a Costco retail location has identified E. coli O157:H7. Additional laboratory testing is currently ongoing. Preliminary laboratory testing conducted on two additional opened packages of Bravo Farms Dutch Style Gouda Cheese purchased at Costco from two other case patient’s homes has indicated the presence of E. coli O157:H7. Additional laboratory testing is currently ongoing to confirm these results. FDA is working with its state partners to investigate Bravo Farms and to identify potential sources of contamination. FDA has collected product samples for testing. On Nov. 5, 2010, Bravo Farms voluntarily recalled all Dutch Style Gouda cheese because it may be contaminated with E. coli 0157:H7. The product was distributed primarily through Costco in Southern California, Nevada, Arizona, Utah, Colorado, and New Mexico in 1.5 lb. pieces. It was also distributed through various retail stores within California in 8 oz. pieces. The lot codes are numbers less than 0233. As of Nov. 10, 2010, the CDC reports that 33 persons infected with the outbreak strain of E. coli O157:H7 have been reported from five states since mid-October. The number of ill persons identified in each state with this strain is as follows: AZ (15), CA (3), CO (10), NM (3) and NV (2). There have been 15 reported hospitalizations, 1 case of hemolytic uremic syndrome (HUS), and no deaths.

Assessment of Project Approach and Areas of Further Study:

Areas needing additional study

Food safety planning is an integral part of cheesemaking businesses. As the spotlight continues to shine on food safety in cheesemaking businesses, especial farmstead and artisan ones, it is imperative to build practical knowledge about food safety equal to the level of the craft of cheesemaking into these businesses. A combination of a formal HACCP seminar taught by an expert in the field, development of a HACCP plan and a testing program supported by a field technician should be part of cheesemaker licensing. This should be affordable to all cheesemakers regardless of scale. The project challenges academics, industry, and regulators to see the value of cheesemaker training, especial in the area of food safety, and work together to create such an opportunity.

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Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and should not be construed to represent any official USDA or U.S. Government determination or policy.