2024 Annual IAFP Meeting in Long Beach, California

The International Association for Food Protection (IAFP) held its annual meeting from July 14-17. The IAFP meeting is the largest food safety conference in the world; this year, over 3,000 people from industry, government and academia attended. The meeting is the conference for the industrial food system; this year, as in the past, Merck Animal Health and Cargill were major sponsors. Labor shortages and broken down supply chains over the past few years have made the food safety regulators’ jobs more thankless than ever. The regulators might have to deal with a foodborne illness outbreak that contains ingredients sourced from multiple countries where the traceability is difficult. The FDA Food Safety Modernization Act (FSMA), which went into effect in 2011, was supposed to reduce the number of foodborne illnesses in the U.S. A high ranking FDA official provides a regulatory update at the meeting each year; until the 2023 conference, that official acknowledged that the number of foodborne illnesses has remained flat. The past two years, the official giving the regulatory update hasn’t covered the matter; with the noticeable deterioration in quality in the conventional food supply, the likelihood is that foodborne illness has not declined.

A solution to the food safety problem would be to decentralized food production and deregulate both food production and distribution at the state and local level—a move attendees at the conference do not consider; their job is to figure out and implement improvements to food safety under the existing industrial paradigm. Nevertheless, the IAFP meeting is an important event to follow; it can serve as an incubator for laws and policies that have an effect on the local food system.

The following is a review of some topics covered at this year’s meeting.

Bird Flu—Highly Pathogenic Avian Influenza (HPAI)

With reports on the bird flu “pandemic” being blared in the media daily, a panel consisting of federal government regulators (FDA, USDA, CDC) and individuals from academia and industry convened to discuss what to do about the outbreak of HPAI that had first spread to dairy cattle towards the end of March.¹ The panelists lamented how the public was not listening to their warnings not to consume raw milk; in May, one polling firm estimated that demand for raw milk had risen as high as 65% since the onset of the “pandemic”. The panel members spoke about how social media such as TikTok and Instagram are influencing the public to purchase raw milk. One panel member thought the public was buying raw milk out of fear. Another panelist was closer to the truth when he acknowledged that mistrust of government, academia and industry has led to an increase in the consumption of raw milk. Accurate science was what the panel thought could stop or slow down the increase in raw milk consumption.

Another reason brought up in the discussion about why the consumption of raw milk was going up was a fear of industrial food and not knowing where your food was coming from. One panelist thought the consumer would support locally produced pasteurized milk. A panel member resolved to gather more information on why consumers think raw milk is the right thing. The panel agreed that HPAI was going to be around for a while and that it would be important to harmonize messaging with partners whether they be in the federal government, state government, or in industry.

Reports are that labs are using the notoriously inaccurate PCR test to test for HPAI; numerous labs during COVID were running the test at 40 cycles or more where the chances of a false positive test result were high. Two employees for a lab exhibiting at the IAFP conference tradeshow guessed that their lab was running the PCR test at 45 cycles to test for HPAI. Interestingly, an official with the Massachusetts Department of Agriculture and Natural Resources stated, “PCR tests are only viable up to 30 cycles, so these labs would likely run no more than 30 cycles.”² Massachusetts has been the only state so far to require raw milk dairies to test for bird flu; so far, all milk samples tested have been negative for HPAI.

Cronobacter

Another talk impacting raw milk at IAFP was a panel discussion on cronobacter³, a pathogen found mainly in powdered infant formula. A speaker at a past IAFP conference disclosed that there is a 20% mortality rate for infants infected with the pathogen. A panelist at the 2024 conference stated that cronobacter can survive in the powdered formula up to five years. Another panelist said that cronobacter has characteristics of both salmonella and listeria. Takeaways from the panel discussion were that cronobacter is ubiquitous in the environment and that there’s still lots to be learned about the pathogen.

In 2022 an Abbott Laboratory plant in Michigan shut down after infant formula produced in it was linked to deaths and illnesses caused by cronobacter. Shortly after the shutdown, traffic to a page on raw milk infant formula on the Weston A. Price Foundation’s website went up 1,000% as demand for raw milk surged. Much of the panel discussion centered on how difficult and complex the cleaning process is in a plant producing powdered infant formula; profit margins are high so firms in the business have the incentive to stay in even though the risks are considerable compared to most foods. It would not be surprising if future problems with cronobacter occur in infant formula plants, directly leading to further jumps in the demand for raw milk.

Food Fraud

One of the more eye-opening sessions at IAFP was a panel discussion on food fraud⁴—something that affects 10% of the commercial food supply according to a speaker at the session. Food fraud is especially present with honey, oils, spices, fish, and juices. Food fraud is the intentional adulteration and mislabeling (misbranding) of products; one trick of the trade is altering expiration dates on the label, and another is putting a low quality product in the packaging and labeling used by a competitor and passing that product off as the competitor’s. Undeclared allergens on food labels are also a problem.

Protecting against food fraud is a complex and arduous process for a business. Different sectors within a firm work on it from product development to quality assurance to procurement. Tracking supply chains, vulnerability (to fraud) assessments, verifying authenticity (e.g., GMO-free, organic, country of origin), lab testing ingredients or finished food products, and being in compliance with legal requirements are all part of the process. The world of food fraud is great incentive for buying directly from a farmer you know and trust.

Cell Cultured Meat (CCM)

Investors have spent billions on cell cultured meat but so far there is very little product on the market. Pre-market approval from FDA is necessary to sell cell cultured meat; that agency has joint jurisdiction with USDA in regulating that product. In IAFP session on cell cultured meat (CCM)⁵, a speaker said that FDA had only granted approval for two cell cultured poultry products, and no approval for any beef or pork products yet. Another speaker remarked that price and perfection for cell cultured meat are not there. The legal framework to navigate to get approval is difficult. A typical CCM product will have anywhere from 60 to 100 inputs (ingredients); FDA evaluates each to determine whether it is a food additive recognized in the law or, in most cases, whether it is GRAS (generally recognized as safe). One speaker remarked that the infrastructure for the CCM industry is lacking; there is no large-scale commercialization of the product. Another said that pathogens such as Campylobacter, Salmonella, and E. coli in CCM are a problem. There was a comment that, with the expense of manufacturing CCM, there was little product available. One of the speakers disclosed that the U.S. is a test market for CCM and that much of the investment in the product was European. The upshot of the session was that CCM is not having success getting established in the market; the speakers at the session spent little or no time addressing the complete lack of demand for CCM.

Attending the IAFP conference is an affirmation of how important it is to build out a parallel food system; the pace which favorable laws and infrastructure for a prosperous local food system is rounding into place needs to increase.

Footnotes:
1. Anderson N, Detlefsen C, Nichols M, Martin N, Suarez D, & Sinatra J. (2024, July 16). LB – Late Breaking Session – Responding to an Outbreak of Highly Pathogenic Avian Influenza (HPAI). [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/10155

2. Cahill M. (2024, August 28). Government email. MA Dept. of Agricultural Resources Div. of Animal Health.

3. Clifford D, Farber J, Gollinger M, Hanlin J, van der Sanden J, & Warren B. (2024, July 15). RT11 – Cronobacter spp. Control: Bridging Knowledge Gaps and Taking Action. [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9571

4. Burke J, de Leonardis D, Jorgens A, & Winkel, C. (2024, July 15). RT10 – Think Like a Criminal – The Dark World of Food Fraud. [Panel discussion]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9766

5. Anandappa A, Overbuy K, Pantano A, Rainer N, & Yang L. (2024, July 17). S64 – Cultivating Meaty Cells – A Perspective Focus on Food Safety, Regulatory, and Experiences. [Conference symposium]. IAFP 2024 Annual Meeting, Long Beach, CA. https://iafp.confex.com/iafp/2024/onlineprogram.cgi/Session/9808

The post Industrial Food Safety: 2024 IAFP Meeting Recap appeared first on Real Milk.

The largest food safety conference in the world took place from July 31 to August 3 when the International Association for Food Protection (IAFP) held its annual meeting in Pittsburgh. IAFP’s mission is “to provide food safety professionals worldwide with a forum to exchange information on protecting the food supply.”1 More than three thousand professionals from government, industry, academia and nonprofits attended this year’s meeting. The IAFP meeting is a window into what’s coming down the pike with food, food safety and food regulation. Food safety professionals have a thankless job, investigating foodborne illness outbreaks involving foods that often have ingredients obtained from multiple countries, due to the globalization of the food supply.

Globalization and a continued decline in food quality and transparency have made it difficult for government and industry to bring down the number of foodborne illnesses. Frank Yiannis, Deputy Commissioner for Food Policy and Response of the U.S. Food and Drug Administration (FDA), noted in a regulatory update he gave at IAFP that the number of foodborne illnesses in the U.S. has been flat for two decades.

SALMONELLA IN POULTRY

A major topic at this year’s meeting was the persistent problem of illness caused by salmonella in poultry. In a regulatory update she gave for the United States Department of Agriculture (USDA), Sandra Eskin, USDA Deputy Under Secretary for Food Safety, conceded that the department has consistently failed to meet public health goals with regard to salmonella in poultry. To deal with the salmonella issue, USDA implemented performance standards for poultry in 2015—testing requirements that disproportionately impacted small-scale USDA slaughter and processing establishments and were a factor in Texas terminating its state poultry inspection program. The performance standards led to fewer positive tests for salmonella in the facilities USDA regulates, but the number of illnesses attributed to salmonella in poultry—the bottom line in evaluating the effectiveness of that or any other food safety initiative—remained the same. USDA responded to its failure to make any progress by announcing on July 31 that it was establishing a zero tolerance standard for breaded poultry products, a first step in extending zero-tolerance to other poultry.

USDA-inspected poultry establishments commonly slaughter between two hundred thousand and three hundred thousand birds per day, a production level that makes quality control difficult to attain. Instead of imposing performance standards and zero tolerance, decentralization of poultry production would likely be more effective in reducing illness. Over fifty years ago, USDA’s Food Safety Inspection Service (FSIS) issued a regulation allowing on-farm poultry processing of up to twenty thousand birds per year without an inspector present for slaughter and processing; the number of foodborne illness outbreaks attributed to producers operating under the exemption are few, if any.

FSMA RULES

The most alarming news at the IAFP meeting was the announcement by Yiannis that FDA will be issuing a final rule on food traceability in November for what the agency designates as “high risk foods.” The proposed rule on food traceability, authorized by the Food Safety Modernization Act (FSMA), imposes extensive recordkeeping requirements; it even covers those who produce cottage foods in home kitchens and farmers who sell any of their private production to anyone other than the final consumer—the regulation could easily drive small-scale producers out of business. Unless the final rule is a substantial improvement on the proposed rule, the traceability regulation which should start going into effect next year represents the biggest threat FSMA has posed to the viability of small farmers and local artisans.

Another FSMA rule that was a focus of the meeting was the regulation on agricultural water (‘ag water’) used by produce growers; to say the ag water rules and the implementation of them are confusing would be an understatement. Rules on harvest and post-harvest agricultural water quality are going into effect in January 2023 for “very small business” January 2024 for “small business,” and January 2023 for all other business. In July 2022, FDA issued a proposed rule for preharvest agwater; that rule will go into effect for very small business in two years and nine months, for small business in one year and nine months and for other business in nine months after the final rule for preharvest ag water goes into effect. The proposed rule will require producer farms to do a preharvest agricultural water assessment covering matters such as water source and location, animal impacts, biological soil amendments of animal origin, adjacent land activity, untreated human waste and environmental conditions.

One speaker at the meeting commented that the implementation of the ag water rules will be complex and that there will need to be training and retraining of the trainers teaching farmers how to get into compliance with the new regulations. A state regulator remarked that there is no way farmers and regulators will be ready to implement and enforce the harvest and post-harvest ag water requirements when they start going into effect. Another speaker noted that there are still numerous knowledge and data gaps in understanding exactly what FDA wants on the ag water requirements. The extensive monitoring and recordkeeping requirements of the ag water rules make it a potential threat to the viability of small and midsize growers. Both the food traceability and the ag water rules look to be ways to consolidate market share into fewer and fewer hands.

TECHNOLOGY

The traceability rule in particular is an opportunity for FDA to further roll out what it calls “The New Era of Smarter Food Safety,” a campaign that “represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.”2 In his talk at the meeting, Yiannis told the audience to envision a future where all information on food (how it was produced, where it’s available, etc.) is such that food can be traced in seconds. He encouraged the attendees to imagine buying foods “you can trust” at a store because you know everything about it. Yiannis stated that we are moving toward an age where everything will have a digital footprint and voice so that inspectors can monitor a food processing plant whenever they want, not just inspect once every five years. He warned, “Things
are going to change dramatically in the years ahead.”3

One technology that Yiannis favors is blockchain, a digital ledger that can be used to trace food from farm to fork. One presenter at the IAFP meeting spoke about a Chinese blockchain product called GoGo Chicken. According to its manufacturer Zhong An Technology, “All info related to the chicken can be verified in the blockchain.”4 This includes “the chicken’s age and location, how far it walks each day, air pollution, the quality of water it drinks, when it’s quarantined, when it’s slaughtered…” and more.4 According to Yiannis, hundreds of Chinese poultry farmers raising free-range organic birds are using the technology to combat fraud from factory farms that are also claiming their birds are free-range. The organic birds are tagged with an anklet “that tracks and reports every aspect of their lives.”4

Another blockchain product, the IBM Food Trust, is a network used by over eighty brands. Consumers can use a QR code to determine the processor and the farmer of the food they are eating—a globalized virtual version of “know your farmer, know your food.” Blockchain is being used for beef to determine whether the cattle are, in fact, grass-fed; it can detect other kinds of food fraud as well. A speaker at the conference indicated that blockchain could be a fit for the FDA traceability rule. There are a number of potential downsides to blockchain. It is expensive and incredibly energy-consuming; one speaker conceded that there must be mass participation for blockchain to make sense. It is unclear how well blockchain protects the confidentiality of proprietary information.

Cybersecurity could be another issue; one speaker said that there had been two hundred cyber attacks on food and agriculture and that the government was monitoring over forty groups for ransomware activities. Scalability could also be a problem with blockchain as the required data storage capacity of the technology is huge. Further, blockchain is immutable once data are entered into it and timestamped; incorrect data can’t be rectified.

ARTIFICIAL INTELLIGENCE

Another technology in favor with government and industry is artificial intelligence (AI) defined at the meeting as “the ability of a digital computer or computer-controlled robots to perform tasks commonly associated with intelligent beings.”5 One presenter at IAFP spoke of Industry 5.0. Another commented that AI has a big role in FDA’s “New Era of Food Safety.”

AI can be used to make decisions on the farm regarding seed selection, water content, soil selection and crop monitoring. In a food processing plant, AI can be used to remove defective products through optical sorting and through sensory smell and taste through an electronic nose (known as an enose) that would replace human noses in a production setting. The industry can also use AI for selection and analysis of components in food, to identify flavor and provide quality assurance for packaging. AI can be used for warehousing and storage, analysis of delivery routes, for maintenance and timely repairs of equipment. For sanitation, the future is robots doing the cleaning instead of humans; robots can be made sterile so the thought is that pathogens would be less likely to crop up in the plant. Moreover, AI has been used to evaluate workers’ personal hygiene.

Aside from blockchain and AI, speakers at IAFP mentioned a number of other technological tools for food safety. There is facial recognition technology, which can be used for purposes ranging from determining when an individual came to and left a food processing plant on a particular day to how many people with a red shirt and black pants were in an area of the plant on a specific date. There is wearable vision technology with a remote or off-site assessor to direct an on-site inspector to potentially problematic areas of the plant. For the on-site inspector, there are body cameras used for a similar purpose. There are drones used to inspect silos or areas of a roof; there are temperature sensors to stay with the food product throughout its whole journey from the processing plant to the customer’s home. It all adds up to expensive, broad-spectrum, 24/7 surveillance.

FOOD SAFETY PROBLEMS MULTIPLY

Despite whatever technologies government and industry use to improve food safety, the fact is that regulators have a myriad of problems to contend with. The breakdown in supply chains has led to conditions more conducive to food fraud, something that is common with foods like honey and olive oil. One speaker commented that with the breakdown in supply lines, it’s all manufacturers can do to find the ingredients they need, much less verify them for authenticity. Another challenge is foreign materials, such as metals, found in food products. According to one conference presenter, foreign materials are the number one reason for food recalls in the industry, surpassing allergens. Some plants have installed x-rays or metal detectors to deal with the issue. Another problem is the continually increasing antibiotic resistance in livestock and poultry. One speaker commented that surveillance for antimicrobial resistance is becoming increasingly common, with resources and costs being a challenge.

Nanoparticles in food are another threat to the safety of the food supply; recent articles in the media have covered the considerable number of food products that contain nanoparticles. A study displayed at the meeting found that currently used methods for washing produce did not get rid of silver nanoparticles in romaine lettuce. According to one of the authors of the study, the silver nanoparticles accumulate in both the liver and kidneys.

As if regulators didn’t have enough to contend with, the introduction of insects into the food supply is another food safety risk they will be taking on; categorization of insects as a food allergen is under consideration. In the meantime, the number of products on the market containing insects appears to be rapidly increasing; the authors of one study on edible insects, publicized at the meeting, used—among other products for their work—a trail mix containing black scorpions as an ingredient.

CONCLUSION

The best response to all the problems the industrial food system is suffering is to support the production and consumption of locally produced food. The digitization and massive overregulation in the industrial system is unlikely to reverse the deterioration in quality of conventional food nor to reverse the increasing lack of transparency of what is actually in the food. The answer isn’t increasing regulation to the point it further consolidates the food industry; instead, it̕’s deregulating locally produced food to increase its market share. There is no need to spend billions on transparency and traceability—those are already built into local food. More of being able to look the producer of your food in the eye—fewer QR codes to see who grew your favorite food five thousand miles away—is the path to improve nutrition, health and community.

Part of this article first appeared at Solari.com in “Surveillance and Centralization on the Menu.”

REFERENCES

1. About IAFP. International Association for Food Protection. https://www.foodprotection.org/about/

2. FDA (2020, July). New Era of Smarter Food Safety: FDA̕’s Blueprint of the Future. [PDF], p.1. https://www.fda.gov/media/139868/download

3. Yiannis, F. (2022, Aug 1). U.S. Regulatory Update on Food Safety. [Conference session]. IAFP 2022 Annual Meeting, Pittsburgh, PA.

4. Peters, A. (2018, January 12). In China, You Can Track Your Chicken On–You Guessed It–The Blockchain. Fast Company. https://www.fastcompany.com/40515999/in-china-you-cantrack-your-chicken-on-you-guessed-it-the-blockchain

5. Virtual Food Safety Monitoring, Auditing, and Artificial Intelligence Applications. (2022, Aug. 2). [Conference session]. IAFP 2022 Annual Meeting, Pittsburgh, PA.

The post 2022 IAFP Meeting: What’s Happening with Big Food appeared first on Real Milk.

By Pete Kennedy, Esq.

The International Association of Food Protection (IAFP) held its annual meeting in Louisville July 21-24 at the Kentucky International Convention Center. Over 3,800 food safety professionals from industry, federal and state regulatory agencies and academia (students and faculty) attended this year’s meeting.¹

Food safety continues to be a growth industry. In spite of the Food Safety Modernization Act (FSMA) and various food safety measures undertaken by the United States Department of Agriculture (USDA), foodborne illness outbreaks in the U.S. have not declined much, if at all. One of the sessions at the meeting was titled “Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems?”² Globalization and a deterioration of quality in the industrial food system remain as drivers of the food safety industry. Recently, USDA issued a proposed rule to allow the import of poultry slaughtered in China.

The IAFP meeting is a huge networking event with a friendly and collegial atmosphere for attendees. Food safety troubles represent a substantial business opportunity and enable IAFP to serve as an incubator for the development of food legislation, like FSMA, which advances the financial position of each of the groups attending IAFP. The way this works is that the industrial food companies cause the food safety problems, Congress increases the budget of the U.S. Food and Drug Administration (FDA) and USDA to deal with these problems, then part of that budget increase goes to academia for grants to come up with solutions for the problems and another part goes to state agencies in grants to do the Fed’s bidding (e.g., state inspections to enforce the new federal laws); further, the newly legislated requirements give labs and other firms involved in food safety more revenues, and the industrial food companies get one-size-fits-all food safety regulations that increase their market share when their smaller competitors cannot afford the cost of compliance.

One sector that is not a part of the food safety trail of revenue is the local food system. Regulators, industry and academia have done some great work dealing with problems in the industrial food system but they have never acknowledged how a stronger local food system can improve overall food safety. So the question is: if the small farmers and artisans making up the local food system don’t have a place at the table, are they on the ‘menu’ for the players in the food safety industry? For now, it looks like local food producers still have ways of staying off the ‘menu’ but the food safety industry is monitoring them, possibly considering ways to get them more under the industrial food regulatory umbrella.

During a roundtable session at IAFP titled “Cottage Foods — Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry”³, regulators on the panel expressed some frustration at the lack of uniform regulation for cottage foods in the U.S. but none of them indicated that legislation to make state cottage food laws the same would have any traction.

There was also a panel for the topic, “Has the Time Come for the Complete Adoption of the Food Code?”⁴ The Food Code is a set of onerous model regulations that FDA develops to govern retail sales of food to the consumer. All states have adopted at least some portion of the Food Code but full adoption would mean the repeal of laws in states such as Wyoming, Maine, Utah, and North Dakota that currently allow unregulated sales from producer direct to consumer of foods needing time and temperature control (e.g., dairy and foods with dairy as an ingredient). Again, no one on the panel for this presentation stated there was a legitimate chance that this kind of legislation would pass.

The most alarming news at the conference was the disclosure by an FDA official regarding the agency’s inspections of food facilities for compliance with Current Good Manufacturing Practices (GMPs) which are one-size-fits-all regulations governing plant construction and design, sanitation, and warehousing and distribution. Producers with less than $1 million in sales per year come under the Tester-Hagen qualified exemption and are to be exempt from FSMA requirements for a food safety plan and, arguably, from the GMPs. Nonetheless, assumed as part of its duties under FSMA, FDA has been conducting GMP inspections of these exempt facilities anyway. A reading of the relevant FSMA statute indicates that FDA doesn’t have the authority to require compliance with GMPs by firms under Tester-Hagen. The typical FDA inspection for GMP compliance can last 2-½ to 3 days. [see “Is FDA Exceeding FSMA Inspection Authority”]

FSMA provides an absolute exemption from the food safety plan requirement for those producers who derive over half of their sales revenues from direct-to-consumer transactions. Most small farmers and local artisans fit this description, but expanding their sales to restaurants and retail stores is a step many of them need to take to increase business. The unauthorized FDA inspections for GMPs make that a more difficult road to travel if their direct-to-consumer sales fall below half of their total revenue.

A growing local food system can make the food safety regulators’ jobs easier. At the IAFP meeting, a high-ranking FDA official acknowledged that the “Achilles heel” of the food safety system is the lack of traceability for industrial food, an admission that isn’t surprising given the international food trade and the long complex supply chains that result. Nothing is more traceable than locally-produced and -consumed food. Deregulating local food producers and increasing their numbers is the path to fewer foodborne illness outbreaks and safer, more nutritious food.

Instead of FDA inspectors and state regulators spending a few days on the premises of small producers, they could invest their time more productively by inspecting imports. One speaker at the meeting displayed a graph showing that from 2009-2016 the greatest number of foodborne illness outbreaks were caused by seafood (25%) followed by produce (15%).⁵ It is estimated that 90% of the seafood consumed in the U.S. is imported⁶; a 2018 article citing USDA data on produce for 2016 estimated that 53% of fresh fruits and 31% of fresh vegetables are imported⁷.

Over 8 years after passage, FSMA is now close to being fully operational. A food law attorney speaking at the meeting observed that FDA was getting more strict on its interpretation of the FSMA requirements. The attorney also noted that FDA inspectors are called “investigators”, meaning that their purpose is primarily to find problems in a food facility they inspect rather than working with the facility to assure compliance with the law. The unstated goal of FSMA has always been to consolidate the food supply.

With the way the law now stands, the key for local producers to survive FSMA over the long-term is to educate the public on how the most safe, nutritious food is found in the local food system. It is the best way to stay clear of a regulatory scheme that can put producers providing nutrient-dense food out of business. More retail outlets will be adopting requirements similar to those in FSMA for producers wanting to sell to them.

The Weston A. Price Foundation (WAPF) has started a campaign to encourage its members to spend at least 50% of their food dollar purchasing raw dairy, meat, poultry, eggs, and produce direct from local farmers and artisans. For improved public health and the viability of producers in the local food system, buying more food directly from local producers is a critical step for consumers to take.

——–

1. International Association of Food Protection, “Annual Meeting”. Statement: “The IAFP Annual Meeting is attended by more than 3,800 of the top industry, academic and governmental food safety professionals from six continents.” Accessed 6 Sep 2019 at https://www.foodprotection.org/annualmeeting/

2. Prince, G., S. Crowley, and N. Anderson. S11: Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems? Annual Meeting of the International Association for Food Protection. Louisville, KY. Symposia. July 22, 2019

3. Andress, E., E. Ceylon, E. Edmunds, J. Eifert, S. Giovinazzi, and A. Snyder. Cottage Foods: Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT15. July 23, 2019

4. Bryant, V. D. Detwiler, J. Horn, G. Lewis, and A.M. McNamara. Has the Time Come for Complete Adoption of the Food Code?, Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT16. July 23, 2019.

5. Sayler. A. “FDA’s FSMA Enforcement Impact on Non-U.S. Food Manufacturers – Examples: Food Retailer: Examples, Case Studies and Recommendations”, Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Symposia S1, 4th Presentation, Slide #4, “CDC Foods Causing Foodborne Illness 2009-2016”. July 22, 2019.

6. NOAA Fisheries, “Fisheries of the United States, 2012: A Statistical Snapshot of 2012 Fish Landings. National Oceanic and Atmospheric Administration”, 2013, p. 4. Accessed at https://www.st.nmfs.noaa.gov/Assets/commercial/fus/fus12/FUS_2012_factsheet.pdf

7. Karp, D. “Most of America’s Fruit Is Now Imported. Is That a Bad Thing?” New York Times online, 13 March 2018. Accessed at https://www.nytimes.com/2018/03/13/dining/fruit-vegetables-imports.html

Last updated 11/21/2019

The post No Place at the Food Safety Table for Local Producers appeared first on Real Milk.

By Pete Kennedy, Esq.

FDA has compiled statistics for the first half of 2019 on the number of inspections it and state regulatory agencies under contract to FDA have conducted pursuant to the Food Safety Modernization Act (FSMA).¹ What stands out in the numbers is that by far, the most inspections FDA has conducted has been for compliance with Current Good Manufacturing Practices (GMPs).²

The GMPs are a one-size-fits-all regulatory scheme that includes requirements for plant construction and design, equipment, sanitation, and warehousing and distribution; GMPs are broadly worded and subject to varying interpretations by inspectors. According to an FDA official who spoke at the recent annual meeting of the International Association for Foods Protection (IAFP), some of those inspections for GMP compliance were for firms under the Tester-Hagan exemption that removes the requirement of having a food safety plan (known as HARPC or Hazard Analysis and Risk-based Preventive Controls). The average inspection for the GMP requirements is 3 to 4 days; if the firm has a compliance history with FDA, that inspection could be as long as 7 to 9 days.³ Arguably, FDA has no legal authority under FSMA to conduct GMP inspections of most or all of the Tester-Hagen exempt firms.

Among other requirements, FSMA requires facilities engaged in processing, manufacturing, packing, or holding food to have a written food safety plan showing that the facility

• has identified the potential hazards associated with the food being produced, packed, or held;
• has implemented preventive controls to address the hazards; and
• is monitoring the performance of the preventive controls to ensure that such controls are effective.

This requirement for HARPC is found in 21 CFR 117 Part C.

HARPC for human food has several exemptions from its mandates, one of which is a “qualified exemption for those firms grossing less than one million dollars per year ⁴, an exemption known as Tester-Hagen. In addition, to be eligible for the exemption, the facility must make more than half its sales either directly to consumers or to a restaurant or retail food establishment located either in the same state or within 275 miles of the facility.⁵

To obtain the exemption, facilities must submit a form to FDA that includes one of the following attestations:

• that the facility has a modified food safety plan addressing most of the HARPC requirements [FDA could mandate that the food safety plan include GMPs]; or
• that the facility is “in compliance with state local, county, tribal or other applicable non-Federal food safety law…including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency such as a state department of agriculture, or other evidence of oversight.”⁶

A reading of the federal statute on HARPC, 21 USC 350g, shows how FDA could be exceeding its authority by inspecting those under the Tester-Hagen exemption for the GMP requirements; 21 USC 350g(L)(2)(A) provides that a qualified facility “(A) shall not be subject to the requirements under Subsection (a) through (i) and Subsection (n) in an applicable calendar year….” Subsection (c) covers preventive controls, which is defined in Subsection (o) as:

• “…those risk-based, reasonably appropriate procedures and practices, and processes that a person knowledgable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include: …(F) Current Good Manufacturing Practices under part 110 of title 21, Code of Federal Regulations (or any successor regulations).”⁷

  NOTE: The Current Good Manufacturing Practices (CGMP) have since been moved to the HARPC section (part 117).

Most, if not nearly all, facilities exempt by Tester-Hagen would obtain the exemption by attesting that their business is subject to some kind of state regulation. Why spend that time and resources drawing up a modified HARPC plan when you can get the exemption by sending FDA a copy of a state license or other proof of state oversight?

The only food business that would not be subject to state regulation would be those selling only direct to consumers; those firms would not have to register as food facilities and, therefore, would not have to be subject to any of the FSMA requirements for HARPC if over half of their gross revenues are from direct-to-consumer sales in which case they would be exempt as a “retail food establishment” under federal regulation.⁸

FDA hasn’t divulged how many facilities with a qualified exemption it has inspected but it looks like it has exceeded its authority if it has inspected any facility that obtained its exemption through an attestation that it was subject to non-federal regulation. To go from being allowed to include GMPs as a part of preventive controls regulations to issuing GMP rules under FSMA that are separate from preventive controls is a big reach. There was never any deliberation by Congress contemplating separate regulation of requirements for CGMPs as part of FSMA.

A food law attorney speaking at the IAFP conference observed that FDA is paying close attention to GMP compliance and has no tolerance for GMP violations. Given the length of GMP inspections, how FDA is interpreting the GMPs more strictly, and the number of enforcement tools the agency has which use to cripple a small business without the economies of scale to comply, it’s recommended that small farmers and local artisans have, if at all possible, over half of their sales as direct-to-consumer to be exempt from the food facility registration requirement. This includes firms currently registered; there is a procedure to cancel registration.⁹

The time to move is now; it looks like FDA’s interpretation of the FSMA requirements will only be getting more strict. The likelihood is that neither Congress or the court will exercise oversight to limit FDA’s inspection authority to what FSMA provides.

————–

1. Bass, Glenn. US Food and Drug Administration. “FDA’s Perspective and Experience on FDA Enforcement and Inspection.” Symposia S1: Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection, 22 July 2019. Speech, Kentucky International Convention Center, Louisville, KY.

2. Ibid. Out of nearly 9,000 FSMA inspections conducted, over 7,500 included assessing GMP compliance as well as HARPC (of which 7,000 were inspections for limited provisions of HARPC). Of the remaining, the FSMA inspections fell into the following categories: Sanitary Transport, Foreign Supplier Verification Program, Produce Safety Standards, HARPC for Animal Food, and GMPs for Animal Food.

3. Ibid.

4. 21 CFR 117.5

5. 21 CFR 117.3, see definition of “qualified end-user”

6. 21 CFR 117.201

7. 21 USC 350g(L)(2)(A)

8. 21 USC 350d, 21 CFR 1.226, 21 CFR 1.227

9. 21 CFR 1.241(c)

The post Is FDA Exceeding FSMA Inspection Authority? appeared first on Real Milk.

By Pete Kennedy, Esq.

The International Association of Food Protection (IAFP) held its annual meeting July 8-11 at the Salt Palace Convention Center in Salt Lake City, Utah. The event is the world’s largest food safety conference. The IAFP meeting is where food safety professionals meet to discuss pathogens in food and ways to prevent and respond to the problems those pathogens cause. The meeting is an incubator for the one-size-fits-all food safety laws that make it more difficult for small farmers and artisan food producers to make a living. Most of the crowd at the meeting does not distinguish between the industrial food system and the local food system; the regulations the conference sets in motion are geared for industrial food production and distribution and should apply to all food production and distribution in the eyes of the majority of attendees.

Food safety is a growth industry. Globalization and deteriorating quality in the industrial food system are drivers. Over 3,500 attended this year’s meeting; FDA and USDA both sent dozens of personnel to Salt Lake City. State regulatory agencies, academia (students and faculty) and big business were all well represented at this year’s meeting. Cargill, Merck Animal Health, Smithfield, Kroger, the Grocery Manufacturers Association and Walmart were all sponsors of the event.

Food safety is about the prevention of or response to cases of acute illness; there was little mention at the meeting about nutritious or nutrient-dense food and its role in the prevention of chronic disease.

A point those at the meeting frequently discussed was the complexity of long supply chains starting with the manufacturers of ingredients used by the food producer and continuing through various phases of distribution leading to the purchase of the food by the final consumer. The talk was about difficulties in traceability and ensuring safe food along the supply chain. An antidote to this problem would be to facilitate the local production and distribution of food with its short, direct supply chain, and high level of traceability but that was a solution that was seldom, if at all, brought up at the meeting.

Presentations at the meeting included talks on recent outbreaks, developments in testing for pathogens, and various food safety processes such as HACCP. At the same time the presentations are taking place, there is a trade show where vendors showcase, among other things, the latest products for testing and sanitation measures. Also present in the same location as the trade show are posters (written summaries) of studies related to food safety that are displayed for viewing by meeting attendees. Individuals who worked on the studies are present to answer questions.

Some takeaways from the meeting:

• The FDA’s longtime plan to extend the aging requirement for raw cheese from 60 days to 90 days is alive and well. Part of the evidence for the latest push on this 90-day requirement is an FDA study on how raw gouda cheese inoculated with listeria still contained listeria after 90 days. The FDA scientists who spoke on the study at the meeting acknowledged that the raw milk used in the experiment was intended for pasteurization not direct consumption–a continuation of the agency’s refusal to recognize that raw milk for the pasteurizer and raw milk for the consumer are two different products. Two food safety professionals contacted at the meetings said privately that listeria was a bigger health threat in pasteurized cheese than it was in raw cheese. Regardless, those at the meeting overwhelmingly favor the “kill step” of pasteurization for all dairy products and for other foods.

• A high-ranking USDA official disclosed that the Office of Investigation, Enforcement and Audit (OIEA), a division of USDA’s Food Safety Inspection Service (FSIS), has undertaken an initiative to increase inspections of small and very small plants (e.g., slaughterhouses and processing facilities); there is evidence that this initiative includes inspecting small food buyers clubs selling meat to their members. The question is why? As of 2016 there were only 150 OIEA inspectors in the whole country. Few, if any, food safety problems have been attributed to small plants and very small plants much less to small private food buyers clubs. Wouldn’t it be a more productive use of resources to have the OIEA personnel increase oversight for imported meat and large USDA facilities slaughtering 300-400 cattle an hour–where there are many more food safety problems?

• A high-ranking FDA official spoke about the proposed merger of food regulation between USDA and FDA with the former taking over all food regulation The official said it could be a long process but did not dismiss the merger. The merger would likely be an improvement over the current situation; FDA policies on positive bacteria test results are more strict than either the USDA or European Union countries and lead to more cases of quality, safe food winding up in a landfill.

• One of the featured speakers at the meeting supported the universal adoption of the FDA Food Code, a burdensome regulatory scheme whose cost of compliance is difficult to afford for many small farmers and local artisans producing nutrient-dense food. The late Sue Wallis, the legislator who initially introduced the Wyoming Food Freedom Act, indicated that the main reason she introduced the legislation was to get local food producers selling direct-to-consumers as far away from the requirements of the Food Code as possible. Since 2015 four states–Wyoming, North Dakota, Utah and Maine–have passed food freedom legislation allowing for the unregulated sale of food direct to consumers. As far as is known not a single foodborne illness outbreak has been attributed to a producer operating under these laws in any of the four states.

• Bill Marler, regarded by many as the leading foodborne illness personal injury lawyer in the country, acknowledged that in his 25 years of experience he could not recall having a single client sickened by food purchased at a farmers market.

• There was lots of discussion at the meeting about the recent outbreak attributed to the consumption of romaine lettuce where 5 people died and over 200 others became ill. It turns out that the plant which processed the lettuce was subject to the requirements of the Food Safety Modernization Act (FSMA). Excessive regulation from FSMA doesn’t necessarily mean greater food safety but can mean a decline in food safety with small and midsize producers going out of business due to being unable to afford the cost of compliance.

• Out of 50 states, 46 have signed cooperative agreements with FDA, receiving federal grant money in return for carrying out inspections to enforce FSMA’s federal produce safety. An attendee at the conference from a state public health department related how her department ran out of the federal money in carrying out a cooperative agreement with FDA and had to tap into a state general fund to get more money to finish carrying out the agreement. This is not uncommon. State agencies signing cooperative agreements with FDA should have a clause in the agreement that they do not have to carry out any further duties under it if the federal money runs out.

• Most of the presentations and posters at the meeting had to do with industrial food but there were at least a couple exceptions that were favorable to local food. A USDA scientist did a presentation on pastured poultry reporting among other things that poultry fed a soy-free diet had substantially less campylobacter in their systems. There was a poster on the quality of raw milk for retail sale in Maine reporting on the low incidence of illness attributed to raw milk consumption in that state.

• The atmosphere at the meeting was friendly, a good one for engaging attendees on why locally-produced food should not be regulated the same as industrial food. Most of those attending are trained that there is only one food system. One individual who worked on a poster supporting more regulation of cottage food producers was asked if she was aware of any cases of foodborne illness attributed to the consumption of cottage foods. She said no but then added that it was because cottage foods weren’t traceable. In general there are hardly any foods that are more traceable than cottage foods.

Most cases of foodborne illness are caused by industrial food; this is true even when factoring in the market share industrial food has compared to local food. Unregulated local food producers have plenty of incentive to produce safe food: their families consume the same food they are selling, one recall can put them out of business, and one case of foodborne illness can put them out of business. Food safety regulators like dealing with short supply chains and a high degree of traceability; local food producers–regulated or not–satisfy both of these parameters

When you also factor in the amount of chronic illness the local food and industrial food systems are responsible for, there is no question the local food system is responsible for fewer cases of chronic illness even when the market share of the two systems is accounted for. Take a survey on the demand those who obtain a majority of their food from the local system make for services on the medical system versus those who obtain a majority of their food from the industrial system. Policymakers should take both acute and chronic illness into consideration when crafting food regulations and legislation. The more local food producers there are the less demand there will be on the medical system for services; food freedom laws lead to more local producers.

The IAFP meeting is a place where ideas for food safety legislation are first introduced. It can also be the place where the effort begins to convince regulators that there are two food systems and that one-size-fits-all food safety regulation doesn’t work.

Food safety professionals have done a great job improving safety in areas of the industrial food system; often when dealing with multiple producers/distributors and multiple countries in an investigation–thankless work. Laws and policies contributing to an increase in local food production would make their jobs easier.

The post A Tale of Two Food Systems appeared first on Real Milk.

The International Association of Food Protection (IAFP) is a member-based association of more than four thousand food safety professionals “committed to Advancing Food Safety Worldwide by providing food safety professionals worldwide with a forum to exchange information on protecting the food supply.” The organization puts on three large conferences every year—one in the U.S., one in Europe and one in Asia—bringing food safety professionals together to learn the latest ways of pasteurizing, poisoning, zapping and pressure-treating our food to make it completely lifeless and sterile.

A REQUEST FOR DEBATE

Former WAPF board member Geoffrey Morell has attended the IAFP meetings for the last five years, and has personally urged Allan Saylor, past president of IAFP, to host a presentation on raw milk at the U.S. conference. Saylor’s reply was that the IAFP was founded to promote pasteurization—even though in the early days, the IAPF clearly supported certified raw milk. According to the IAFP history, “…the annual meetings continued to emphasize the healthfulness of dairy products, their importance as foods for adults as well as for children and infants, and the need for laws providing for the pasteurization of all milk and cream unless it was known to be from a certifiably safe source [emphasis ours].”

Geoffrey’s requests must have had their effect (perhaps because other IAFP members were also asking for a session on this increasingly popular food), because this year, the IAFP hosted a raw milk debate as an “Amicable Exchange of Experts.” The panel at the August 3rd debate included Ted Beals, MD, and Joseph Heckman, PhD, arguing in favor—and both noting proudly their status as WAPF honorary board members—and Jeffrey Farber, PhD, and Jeff Kornacki, PhD, decidedly against. The organizers made a point of including only PhDs or MDs on the panel, noting that the debate that featured myself and David Gumpert at Harvard University in 2012 “included no PhD- or MD-credentialed participants.”

PRO AND CON

Heckman and Beals brought up points that are familiar to WAPF members: health officials need to distinguish between raw milk destined for pasteurization (which we all know can contain a lot of pathogens) and raw milk destined to be consumed unprocessed; that many studies show that raw milk can provide powerful protection against asthma, allergies, skin problems and infectious disease; that the data show that raw milk is as safe as, or safer than pasteurized milk; that raw milk tastes much better than pasteurized; and that because demand for raw milk is growing rapidly, we need reasonable standards for its production. Heckman surprised the audience by noting that immigrants to the U.S. want raw milk because this is what they are accustomed to drinking in their native countries, where it is often available from vending machines.

Beals argued that there is no rational justification to focus national attention on fresh unprocessed whole milk, which may be associated with fifty to two hundred illnesses per year among more than eleven million consumers, a rate no greater than .002 percent; whereas the rate of confirmed bacterial infections from all food in the U.S. is about .03 percent. Beals noted that there are three thousand deaths per year in the U.S. from bacterial foodborne infections, and he could have added that there have been no deaths from raw milk since at least the 1970s.

THE JOHNS HOPKINS STUDY

Both raw milk opponents dismissed the European studies showing that raw milk provides a protective effect against asthma, allergies, skin problems and infectious disease as “unconvincing.” And both justified their claim that raw milk is dangerous by citing a 2014 Johns Hopkins report, which concluded that “the relative risk of individual illness is almost 150 times greater per unit of nonpasteurized dairy product, compared to pasteurized.”

WAPF published a critique of this conclusion in 2015.¹ The claim is derived from an analysis published by Langer and colleagues in 2012, which actually found no statistical difference in the rate of illness (as opposed to the number of “outbreaks”) attributed to raw milk or products produced from raw milk compared to those produced from pasteurized milk. In addition, the Langer analysis limited its time frame to the years between 1993 and 2006. By selecting such a narrow time period, the data excluded the nation’s largest outbreak of salmonella: in 1985, a multi-state outbreak of salmonella was traced to pasteurized milk from a Chicago milk plant. This resulted in over sixteen thousand confirmed cases, and the investigators estimated that between 150,000 and 200,000 people were sickened.

Our own analysis of illnesses attributable to raw and pasteurized milk over the years 1980 to 2005 indicate almost eleven times more illnesses attributed to pasteurized milk than to raw milk. Using the estimate that one percent of milk is consumed raw, we can calculate that, on a per serving basis, raw milk is less than twice as dangerous as pasteurized milk. As recent data suggest that as many as 3 to 4 percent of Americans consume raw milk, and using these data instead of the one percent figure would make pasteurized milk twice as dangerous as raw milk on a per-serving basis.

Although the Johns Hopkins authors acknowledge that a clinical trial would provide needed clarity, they do not cite the only randomized, controlled trial to examine the effect of milk pasteurization on infectious disease. This trial compared the rate of infections in infants fed raw human milk or a mixture of pasteurized human milk and formula. The infants suffered three times as many infections when fed pasteurized human milk and formula, even though 15 percent of the raw human milk samples contained pathogenic organisms, which were eliminated by pasteurization.

NATURE IS WILD

The most interesting aspect of the debate was the clear difference in world view between the for and against camps. “My assumption is not that nature is perfect,” Kornacki said. “My assumption is that nature is wild and can be dangerous.” He then referenced the death angel mushroom, which can kill you with one bite—as if to say that raw milk is not just risky, but downright toxic.

True to his public health training, Kornacki noted that 25 percent of foodborne illnesses were associated with milk in 1938; now it’s less than one percent. He left out the fact that these illnesses were in steep decline long before pasteurization became mandatory. Better housing, the advent of refrigeration, the replacement of the horse with the car, better water management, and the closing of filthy inner-city dairies are more likely candidates for the decline.

But to compare the food that nourishes all mammalian infants to a death angel mushroom shows the blinkers that hamper rational thought among public health officials, even those who have a PhD!

When you assume that nature is imperfect and dangerous, you end up with all kinds of inappropriate procedures—from pasteurization to routine antibiotics to vaccinations. For sure, nature needs a certain amount of thoughtful management to make it compatible with human life, but during the last few decades, science has revealed the fact that raw milk is perfect—full of many marvels, with more likely to be revealed. Raw milk contains numerous bioactive components that kill pathogens, strengthen the immune system, create a strong gut wall, nourish our gut bacteria, ensure the assimilation of 100 percent of all the nutrients in the milk, and protect it against rot. These are largely destroyed by the rust belt technology of pasteurization.

The closer we look at nature—whether we study raw milk, the human biome, the construction of bone, the radar system of bats or the length of eyelashes, the more we are guided to the obvious conclusion: nature is infused with wisdom, and it is incumbent on man to recognize and honor that wisdom. The raw milk drinker looks at nature with awe and respect; the raw milk opponent looks at nature with fear and anger, as something that needs to be sanitized and “improved.”

REFERENCES
1. realmilk.com/safety/the-johns-hopkins-raw-milk-study/

This article first appeared in the Fall 2016 issue of Wise Traditions, the quarterly journal of the Weston A. Price Foundation.

ABOUT THE AUTHOR
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Intrepid WAPF secretary Geoffrey Morell attended the 100th year meeting of the International Association for Food Protection (IAFP), held in Milwaukee, Wisconsin, July 31 through August 4. Twenty-five hundred people from across the world—from the U.S., China, Europe and Australia—attended the five-day event. IAFP was founded one hundred years ago with a focus on “making milk safe,” and later morphed into an organization dedicated to making all foods safe. The conference theme of “Good Safe Food” possibly reflected criticism voiced by Geoffrey at last year’s conference that complete “safety” results in food that is actually dangerous for our health.

Geoffrey attended a workshop on milk safety held on the first day. Only one speaker made any mention of the farmer’s role in producing clean, high quality milk from well tended cows. Virtually the entire focus was on treatment at the processing plant, but several admitted that these pasteurization plants are often filthy. One report showed that there were more bugs in the milk after pasteurization than before, due to contamination from the pasteurization machinery. Yet attendees appeared to speak in one voice in support of some kind of treatment of milk—if not pasteurization, then treatment with new technologies like ultra violet light—rather than providing good clean milk raw.

Likewise, for other foods, the emphasis was on some kind of treatment to make foods safe, with no one discussing how to build healthy immune systems. Instead the focus is on pasteurization, irradiation, sterilization, chemicalization and other treatments that so deaden the food as to render it an assault on the immune system.

There was a huge collection of exhibitors, some with very elaborate displays, and poster presentations, including one by food safety attorney Bill Marler to advertise his website realrawmilkfacts.com. It was clear from the displays that there is an enormous investment in food safety treatments, which translates into strong lobbying in government circles. An exhibit booth advertising sanitary wipes for the handles of supermarket carts epitomized the prevailing attitude—not children drinking raw milk and playing in the sand box to build up their immunity, but belief in a hostile world full of dangerous germs that must be sterilized and sanitized.

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WAPF “gate crashers” Michael Schmidt, David Gumpert, Tim Boyd, Geoffrey Morell and Sally Fallon Morell.

On February 17 the International Association for Food Protection (IAFP) sponsored a symposium on raw milk entitled, “Raw Milk Consumption: An Emerging Public Health Threat?” John Sheehan, Director of the U.S. Food and Drug Administration (FDA) Division of Plant and Dairy Food Safety, was scheduled to speak at the symposium, but cancelled his appearance at the last minute as did a number of other FDA officials who were scheduled to attend. The likely reason for the cancellation was that Sheehan found out members of the Weston A. Price Foundation would be in attendance at the conference. FDA views the issue of raw milk safety as not debatable and will not discuss raw milk with anyone holding an opposing viewpoint.

The agency would rather work behind the scenes to impose its beliefs on the public, pressuring state officials to restrict the sale of raw milk or ban it altogether, and working with Congress to obtain more regulatory power over the intrastate sale of raw milk. FDA has never wavered from its goal of eliminating all sales of raw milk.

For an amusing description of the talks given at the conference, see David Gumpert’s blog at  www.thecompletepatient.com.

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I had the privilege to attend the 93rd annual conference of the International Association for Food Protection (IAFP), August 12th through 16th in Calgary, Alberta, Canada, thanks to sponsorship from the Weston A. Price Foundation and courtesy of an invitation from one of the organizers, Ron Schmidt from the University of Florida. My participation marked an historic first–the first time that a proponent of raw milk was represented at this conclave of conventional food processors and health officials. In fact, I was joined by another advocate of raw milk, Claudia Coles, Food Safety Program Director from Washington State.

Most of the 3000 members of the International Association of Food Protection (IAFP) members were there to discuss and compare new technologies in the detection and surveillance of food-borne pathogens in the world’s food supply. Industry manufacturers of testing supplies and protocols were well represented in the exhibitors hall. University faculty and state and federal government officials were also present.

I was invited to present the consumer-producer side of the raw milk issue in a round table discussion. My invitation to participate grew out of the growing pressure in certain states to pass laws in favor of raw milk sales.

The Conventional View

The IAFP is the premier association that government officials look to in order to set up food safety nets that protect the public from food-borne illness and create safeguards within the processing industry. Representing the conventional view, this group has long advocated pasteurization of milk, as the officials in this organization know that a certain percentage of herds are infected with numerous pathogens that will lead to illness when consumed by humans.

While walking around the exhibit hall I was treated as a regular Joe Attendee and was able to talk with a great many of the premier food safety specialists from around the world. But I was only able to talk to the English-speaking contingent extensively, which I found out was the only group of attendees that had a problem with the general consumption of raw milk.

Members from nations whose language is other than English and with whom I spoke a little, told me that raw milk was not an issue with them. They had other things to gain control over and did little or no testing of raw milk or raw milk products within their countries. Granted some of those countries did not have the volume of consumption as we do in the U.S., nor did they have the size and range of milk processing. Most of their raw milk was still produced on small farms, or by a herder with few animals with local distribution and processing, mostly for cheese making.

But when talking to representatives in the industry, and by industry I mean government, universities and the industry doing tests and developing tests in Canada, the U.S. and Australia, I heard a lot about the dangers of raw milk. But when digging further into the results of those tests, I found a common thread within the information and the results put forth as fact. Most if not all the tests, safety recommendations and contamination percentages of raw milk, as it is currently known to food safety professionals, came from large confinement dairies and large scale processors.

Raw Milk in the Wings

I got little or no information about testing of raw milk from small scale farms until I talked with a graduate student from the University of Vermont (UV). His department is currently studying the infection rates of raw milk cheeses produced within the state over a period of two years. The study has gone on now for six months with a total of eleven small farms, ranging in size from four to fifty cows, including goat and sheep dairies. All these farmers have raw milk cheese permits with the state of Vermont. UV is testing milk from these farms weekly for four pathogens– Listeria monocytogenes, Salmonella spp, E-coli O157H7 and Staph aureus–as well as the general Grade A tests of SCC, plate count, PI and coliform tests.

For the first 24 weeks, no pathogens have been found in any of the tests. That’s eleven samples of raw milk a week times the four pathogen tests for a total of 1056 tests, with no pathogens found.

The farmers whose cheese is being tested are given the results of the Grade A standards tests within the week they are taken and have complimented UV on its promptness of test returns. Any sanitation problems that arise are found much quicker this way, and as a result, maintenance is performed immediately instead of waiting the usual month between tests to monitor the milking equipment, which is standard Grade A practice.

A second common thread emerged as I chatted with attendees: most of them, as many as 80 percent, currently drank raw milk or grew up on it as a child. Most would quickly qualify the statement by saying that it was safe for them to drink raw milk from their own cows because they had done so all their lives, but that they would have a problem drinking raw milk from “somebody down the road.” Most talked reverently about the wonderful taste, delicious cream and what you could do with it, and how they as kids never seemed to be sick. Yet after the glow faded there was always the qualification, “Well I’m sure you do a good job on your milk but I have seen many who do not.”

The Discussion

As time neared for the roundtable discussion, I was greeted by the moderators and organizers: Ron Schmidt from the University of Florida, Gainesville, and Allen Sayler, Senior Director, Regulatory Affairs and International Standards for IDFA as well as Director of the International Dairy Food Association, member of the National Cheese Institute and the International Ice Cream Association.

They introduced me to the other panel members, which included Claudia Coles representing Washington state and the U.S. regulatory perspective; Re’jean Brossard of Ag Canada for the Canada regulatory perspective; Carolyn Smith Dewaal of the Center for Science in the Public Interest who gave their perspective on the consumer; and Bill Marler, lawyer of Marler Clark, which specializes in food-borne illness outbreak law suits.

I had time to talk with Ms. Coles at length about many issues regarding raw milk and milk safety and I was pleased to find out we were not very far apart on the issue. Ms. Coles has been dealing with raw milk for fifteen years and has proved that a farmer can, under her state-authorized program, hand milk cows and maintain safe milk. Through the Washington state testing regime, she has proven that raw milk can be produced more safely by hand than raw milk coming from Grade A facilities she oversees.

The main theme that was present in the pre-roundtable discussions was safety for the farmer and the consumer, and protecting the good name milk has “as a cornerstone in a healthy diet.”

In my discussions, they were glad to hear of the testing I endorsed and encouraged to assure a safe product, and the responsibility taken by those I worked with to assure that the milk and environment was clean via a HACCP plan based on common sense and traditional husbandry, backed up with the industry’s own testing protocols. I think that threw them off balance for they were expecting to hear the extremist view point of “leave me alone, this is my right and not any of your business!” They told me several times of instances of that very nature. I was actually surprised to hear from many just how close we were to being on the same page.

Gasps and Shock

The main roundtable discussion began with Allen Sayler presenting what the industry knew of the Weston A. Price Foundation and what consumers are led to believe raw milk can do for them, and “why in the world would the Association take ninety minutes out of its schedule on an issue such as this.” The answer: “We all know the problems, yet a growing number of people want raw milk because they believe. . .”

And then it got a little ugly. Gasps and shock met Sayler’s presentation of WAPF claims that raw milk could reduce asthma, help with weight loss, increase bone density, reduce cholesterol and could safely be fed to infants and old people. The response from the participants was that these claims were being made without their verification standards, leading people to consume a product rife with pathogens and putting them in mortal danger.

Then it was Claudia Coles’ turn. She gave a quick overview of raw milk programs in various states before getting to the heart of the matter. The great state of Washington allows the sale of raw milk and has seen an increase of raw milk permits from 15 to 60 over the last eight months. Gasps and awe again from about 100 or so people in the audience. Claudia went on to say that she could not, from verified experience and industry testing methods, say that all raw milk was bad–she had the documentation and years of experience to prove the safety of raw milk and has overseen the safe production of raw milk for nearly ten years.

Next up, Re’Jean Brossard from Ag Canada in less than three minutes said Health Canada and Ag Canada has not and will not ever allow the sale of raw milk.

Next to speak was Carolyn Smith Dewaal from CSPI. Ms. Dewall outlined consumer trends regarding raw milk but provided no statistics on the numbers of raw milk consumers. Carolyn remarked that the only information she was able to find was the increase in reports of illness due to raw milk consumption over the past six years, although she did point out that people often confuse organic milk with raw milk. She also emphasized that the Center for Science in the Public Interest does not endorse raw milk consumption and presented some charts showing dairy product-related outbreaks over the last 15 years: according to the Centers for Disease Control statistics, 165 people were involved in unpasteurized milk product outbreaks in the U.S. and 5530 people were involved in pasteurized milk product outbreaks.¹ Unfortunately, the graph Dewaal presented did not indicate incidents per serving, which would have given a better clue to the risks involved in both kinds of milk.

Ms. Dewall did expand on the consumer movement towards knowing where our food comes from and the explosion of interest in organics. CSPI believes that the raw milk movement is a part of this greater movement, of consumers needing to know and trust the source of their food. CSPI endorses better production and processing practices to ensure the safe delivery of wholesome food to the consumer.

Next it was my turn. I started out telling the crowd that raw milk was a consumer-led movement, and that people were coming to the farmer for the product. As a farmer, I responded to that demand, and did not start providing raw milk as a way to generate income. I briefly explained the battle with the state of Wisconsin and its resulting farm share agreement where I formed a company with the farm assets to allow purchase of shares in that company. These shares, bought in complete disclosure, allowed share holders to receive milk from the farm and in turn pay a service fee for the work performed to produce the product.

I also mentioned the thousands of farmers I have talked to who are experiencing the same demand and are responding to the needs of the consumer.

I shared the view as a person directly responsible for the very life of those for whom he produces and thanked them for the testing programs I ran on my farm, with no pathogens found over three years of testing. I mentioned how these increasingly sensitive tests have proven what raw milk drinkers have thought and experienced about the safety of raw milk produced on small, grass-based farms.

Although I did not have the knowledge or the time to address the science behind the claims that raw milk helps cure many diseases, I did say that my experience as a farmer, hearing the benefits of raw milk, is not the same as the experience of a food safety professional. All I know is that people’s health improves, vitality is regained, children thrive and are seldom sick, medications are reduced or eliminated altogether–these plus multitudes of other conditions reported by every farmer and raw milk consumer I talk to from around the world.

I explained it was not up to me to determine when people came to me whether they are motivated by religious belief, personal experience, pleading by a friend to give it a try to turn around a condition unrelieved by any other treatment, or because they are sent home to die after a long and extensive cancer treatment.

I also mentioned that I personally have seen my animals’ condition and vitality improve by providing a diet closer to that which they were meant to eat.

As a layman, I would think the same result would happen in humans, yet my only duty as a person who feeds other people is to make sure I do the best job possible to create a safe product.

“There are those who say raw milk can cure all that ails you,” I told them. “Some insist that the state has no right in the business of the home. I can only relate what I know from my experience: from your testing protocols I have proven that raw milk can be produced safely and routinely from a 36-cow herd. I also know it can be produced safely from a 100-cow organic grass-based herd.

“Trust in the product but verify,” I cautioned. “Everything else is up to the individual consumer.”

A Lawyer’s View

Next to speak was Bill Marler. As the prominent lawyer who sued Jack-in-the-Box over contaminated meat, Mr. Marler explained the reasoning behind the chain of responsibility in law suits and who would be responsible for a raw milk outbreak. According to Marler, it would be the parents, the farmer, the creamery the farmer is under contract with, the foundation or association that encouraged the farmer and/or the parent who purchased the product that caused the infection in a family member. The blame would be put on everybody who came in contact with the product, he insisted, rather than on any specific area of breakdown in the handling of the milk or the herd health.

Mr. Marler went on to explain it was only a matter of time before cowshares and or farmers would be brought to court, as well as the foundations or associations that promote the product. Yet, during the past few years, as raw milk has become more popular, no sickened individual and or individuals have come forth to sue anybody in relation to any alleged raw milk-caused outbreaks.

Marler never discussed the chain of safety–why are these pathogens present in milk from some sources and where are they prevalent, at what point do they begin to take prevalence, what is their source?

Many Questions

The question-and-answer portion went very well with most questions directed to me or the lawyer. There were many questions about cow-share agreements and there seems to be a movement by state agriculture agencies to abolish them, based on questions coming from state officials in the audience.

I pointed out that I was one of the first to test the cow-share model in Wisconsin, that cow shares can work, but other forms of ownership allow more involvement of the consumer with the farm–involvement which I felt was needed to assure that small farms stay around when besieged by increasing pressure from many sides. There were also many questions about my testing regime.

After the question-and-answer session, attendees mulled around the commons and most greeted me with thanks and handshakes, acknowledging my bravery for being at a conference of food safety professionals. Some offered advice of additional insurance, and others just wished me well.

As I spent more time in the exhibition hall, I posed more questions to a few academics and industry personnel. Just where do these bugs come from? Who is looking for the source of these pathogens? At what point do pathogens get out of hand? At what size does the facility or the group of animals lose the ability to suppress the bugs that cause 76 million cases of food-borne illness each year in the U.S. alone?

The answers I got were: “We only look where we are paid to look;” “Small farms are an insignificant number to do valid tests on and usually not close to testing facilities;” “There are too many variables to understand the cause;” “We only perfect the ability to keep it out of our food source, that’s why I like irradiation so much;” and “We knew years ago that raw milk is unsafe so why look at it again?”

Discussion Important

The graduate student from Vermont, being the young turk and as yet unjaded, said it best: “Research follows money and companies need protection from lawsuits. We try to provide that by studying that which puts them at risk. We now are trying to find out where milk gets contaminated to reduce the risk of contamination in raw cheese. Eleven farms, six months of weekly testing and I haven’t found anything yet.”

It is extremely important that we continue the discussion among both sides of the raw milk issue, to alleviate extremist viewpoints that both sides have of each other. They need to hear our arguments and testimonials so that slowly the conventional view of raw milk can change. My participation in the conference was an important first step in making this happen.

1. Almost certainly, the figure of 165 includes the 75 or so said to have come down with campylobacter infection, blamed on raw milk produced by my farm Clearview Acres in 2002. Although these statistics dwell on the CDC website, lab tests found no pathogens in my milk. Actually, as many as 800 people became sick during the outbreak, only a few of whom consumed raw milk. The source of infection was likely underdone hamburger for sale in restaurants and grocery stores in the northwest Wisconsin area. See 14 JUL 2002 press release, Wisconsin Campylobacter Outbreak Falsely Blamed On Raw Milk.

Sidebars

What They Test for in Raw Milk

• Specific Pathogens: Testing requirements vary by state. Listeria monocytogenes, Salmonella spp, E. coli O157H7 and Staph aureus are considered the most dangerous.
• Somatic cell count or SCC: White blood cell count present in the milk. This indicates the general health condition of the udder and levels of mastitis infection, as well as indications of overall cow health and environmental pressures affecting the animal.
• Plate count: Indicates the overall cleanliness of milking equipment and the bacteria levels within milking equipment.
• Preliminary Incubation (PI): This is a test of a family of equipment bacteria that grow in cold temperatures. They are non harmful to humans but they shorten the shelf life of the milk.
• Coliforms: A test for general air and ground-borne Coliform bacteria (E. coli), which gives a good indication of the cow prep prior to milking and the quality of the environment the animals in question are exposed to.

My Safety Regime for a Small Farm

• Somatic cell count less than 300,000 on yearly average. My levels are under 200,000.
• Plate count less than 10,000 p/mL. Mine routinely ran 1000 or less.
• Coliform count less than 10 p/mL. Mine was always less than ten.
• PI count less than 50,000 p/mL.
• Johnes-free herdwith 100 percent of herd tested.
• TB-free herd.
• Brucellosis vaccination for heifers between four to eight months. All purchased cows meet same requirements before brought on farm.
• Pathogen tests monthly of E-coli O157H7, Salmonella, Listeria monocytogynes, and Campylobacter for a period of six months then drop to quarterly tests.
• Monthy bulk tank cultures that identify mastitis types, equipment bacteria, as well as environmental contamination the cows are exposed to.
• Mastitis type testing on questionable quarters; cull all Staph. aureus-positive cows.
• Milking system checked by professionals every six months.

In my opinion, all tests for pathogens should be done at state-certified labs. On-farm testing is a few years away as the culture of the tests can be spread and infect animals if not handled properly and destroyed with an autoclave.

This article appeared in the Fall 2006 edition of Wise Traditions, the quarterly journal of the Weston A. Price Foundation.

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