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.

Blog post first published July 19, 2023. Updated for journal publication and republished September 30, 2023.

Graphic: Real Milk Legal Map [1]

View the updated Raw Milk Legal Map, color index, and state-by-state status

Over the past decade or so, a growing number of states have passed laws to either legalize the sale of raw milk and raw milk products or increase access to raw dairy; no year has been as productive as 2023. Resistance from the dairy industry and public health agencies is not as great as it once was, and demand for raw dairy products is increasing rapidly. Through either statute, regulation or policy, 46 states now allow the sale of raw milk for human consumption, the sale of raw milk for pet consumption, or the distribution of raw milk through herdshare agreements.¹ The four outliers prohibiting any sale or distribution of raw milk are Hawaii, Louisiana, Nevada, and Rhode Island.

LEGISLATION

The states passing raw dairy legislation this year include:

• IDAHO – Senate Bill 1036 (SB 1036) removes the limit on dairy animals that herdshare operations can have; under prior law, herds were limited to seven cows, fifteen goats, or fifteen sheep.
• IOWA – Iowa became the 46th state to legalize raw milk sales or distribution when Senate File 315 (SF 315) passed into law. The bill allows the sale from producer direct to consumer on the farm or through delivery of any dairy product. There are testing, labeling and recordkeeping requirements.
• NORTH DAKOTA – House Bill 1515 (HB 1515) legalized the unregulated sale of raw milk and any other raw dairy products from producer direct to consumer. Under prior law only distribution of raw milk and raw milk products through herdshare agreements was legal. HB 1515 originally allowed only Grade A dairies (who produce milk for pasteurization) to sell raw milk to the consumer, but those supporting raw milk sales by all dairies hijacked the bill, turning it into the version that passed. The North Dakota Department of Agriculture (NDDA) has issued a press release² claiming that sales are limited to raw milk only (and not other raw dairy products) under HB 1515 even though the bill states that farms selling raw milk direct to consumers aren’t subject to any provision of the chapter in the North Dakota statutory code, titled “Dairy Product Regulation.”³
• UTAH – House Bill 320 (HB 320) legalizes retail sales of raw milk and any product produced from raw milk if a licensed producer has a majority ownership in the retail store. Licensees may also sell these products on-farm as well deliver and/or sell via refrigerated mobile unit. Prior law limited the raw dairy products licensees could sell to milk, butter, and cream. sell via refrigerated mobile unit. HB 320 marks the fourth raw milk bill since 2015 that the mother-daughter team of Symbria and Sara Patterson, founders of the nonprofit Red Acre Center, have been responsible for passing.
• WYOMING – Senate Bill 102 (SB 102) allows the sale of any raw dairy products produced by unregulated producers in retail stores. Prior law limited transactions to direct-to-consumer. When it comes to food freedom of choice, Wyoming remains way ahead of the curve; allowing any raw dairy products produced by an unregulated farmer to be sold in a retail store would be unfathomable in any other state. How much raw dairy is sold in Wyoming retail stores will likely be determined by what stores’ requirements for a producer to obtain product liability insurance are; it is difficult enough for regulated raw milk producers to get a product liability policy.

The biggest development in 2023 was in Iowa, a state that had once jailed someone for selling raw milk. Senator Jason Schultz (R) and farmer Tom German had been trying for 17 years to legalize raw milk sales in the state. A difference maker this time around was dairy farmer Esther Arkfeld, a mother with young children, who was the face of the effort to legalize raw milk sales in Iowa. Lobbyist Tyler Raygor of Americans for Prosperity (AFP) also helped; Raygor and another member of AFP were the only ones who registered with the state to lobby for the bill; 24 people—representing government agencies, the dairy industry, and Farm Bureau among other organizations—registered to lobby against SF 315.

The national opposition to further legalization of raw milk sales in any state made Iowa a litmus test. Mary McGonigle-Martin, a board member of the national food safety group Stop Foodborne Illness said, “Public health has lost the war on raw milk”⁴. McGonigle-Martin had testified four different times in opposition to Iowa raw milk bills. Passage of SF 315 into law struck a nerve with the mainstream media, which published more stories about raw milk after the Iowa law went into effect than it had in years. USA Today, the New York Times and Forbes, among other major media, ran stories warning about the “health risks” of drinking raw milk in an attempt to dissuade their readers from joining the millions of people who are already consuming the product.

A trend in recent years that accelerated in 2023 was the legalization of the sale of raw dairy products other than milk. In addition to Iowa, North Dakota, Utah, and Wyoming, laws have also gone into effect since 2021 in Alaska, Montana, New Hampshire, and Texas, allowing the sale of numerous products made from raw milk. Value-added is where the money is at; the trend bodes well for the ability of small-scale dairy farmers to make a living. It appears that the dairy processing lobby is no longer fighting the legalization of value-added raw dairy sales like they once did.

The food safety argument–the only argument the opposition has staked its stance on–is increasingly in favor of raw milk proponents. The latest foodborne illness outbreak figures from the Centers for Disease Control (CDC) are that in 2020 there were five foodborne illness outbreaks resulting in 28 illnesses that were attributed to raw milk consumption.⁵ The number of raw milk consumers continues to increase considerably; hundreds of thousands of consumers go to realmilk.com each year for the first time to find a source of raw milk in their state. The number of illnesses attributed to raw milk consumption is significantly less than it was a decade ago.

Increased demand, fewer illnesses, and deteriorating quality in the conventional food supply are a formula for raw milk legalization. The next state to lift the prohibition on any raw milk sales or distribution could be Hawaii. That state has had bills for legalizing raw milk sales by micro dairies passed out of the House the last two years only to die in Senate committee.  There is only one dairy producing raw milk for pasteurization in Hawaii. For reasons of food security alone, a raw milk bill there should pass into law.

Whichever of the four remaining states is next to get rid of the ban, the goal of Weston A. Price Foundation President Sally Fallon Morell to have legal raw milk distribution in every state is getting closer to realization.

REGULATION CHANGE

MISSISSIPPI: Until recently, Mississippi allowed the sale of only raw goat milk, and then only if the farm had nine goats or fewer. Thanks to state Agriculture Commissioner Andy Gipson, that has now changed per the policy of the Mississippi Department of Agriculture. Under the policy, distribution of raw milk (including cow’s milk) through herdshare agreements is legal; there has been some pushback from the state department of health, but the policy remains in place. Farm-to-Consumer Legal Defense Fund (FTCLDF) has written herdshare contracts for its Mississippi members. Gipson has been one of the more progressive agriculture commissioners in the country. In 2020 he adopted a policy on distribution of meat from custom slaughtered and processed animals—better enabling small farmers and ranchers to make a living—by removing the limit on the number of owners there could be for a custom animal. Prior to becoming commissioner, Gibson served in the Mississippi legislature where he supported several food freedom bills, including legislation to legalize the sale of raw cow’s milk.

COURT CASE: TEST CASE FOR MAINE FOOD SOVEREIGNTY ACT

An important case from Maine Food Sovereignty Act (FSA) and possibly the state’s Right to Food Constitutional Amendment (RTFA) is ongoing in Kennebec Superior Court. Nathan and Rhiannon Deschaine, owners of Kenduskeag Kitchen, their customer Frank Roma, and the Farm-to-Consumer Legal Defense Fund (FTCLDF) have sued Jeanne Landrew, Commissioner of the state Department of Health and Human Services (DHHS), for violations of the FSA and the RTFA. The Deschaines prepare and sell home-cooked meals in Kenduskeag, a town which per the FSA, has passed an ordinance allowing the unregulated sale of most foods direct from the producer to consumer. The FSA gives towns and cities in Maine, the power to adopt ordinances legalizing unregulated local producer-to-consumer commerce within their boundaries.

DHHS sent an enforcement letter to the Deschaines in October 2022, claiming that the couple needed a license to operate their business because, among other reasons, “Kenduskeag Kitchen does not meet [the] definition of direct producer to consumer transactions because it is preparing and selling meals that contain food products and/or ingredients that are purchased from other sites.” The FSA contains no restriction that producers engaging in unregulated commerce under a town ordinance are limited to preparing food with only ingredients that they grow.

Roma is suing DHHS for a violation of the RTFA, which gives individuals the right “… to consume the food of their own choosing …as long as an individual does not commit trespassing, theft, poaching, or other abuses of private property rights, public lands, or natural resources in the harvesting, production or acquisition of food.” Plaintiffs are seeking to have DHHS enjoined from regulating the operation of Kenduskeag Kitchen and requiring it to be licensed; the department has filed a motion to dismiss the lawsuit. A favorable resolution to the case for
the Deschaines, Roma and FTCLDF should lead to a more expansive interpretation of the FSA and RTFA statewide, improving food security and food quality in Maine.

This article was originally a blog post on realmilk.com, and then updated and published in the Fall  2023 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.

References

1. WAPF, Raw Milk Legal Map and State-by-State Notes, latest update July 11, 2023. https://www.realmilk.com/realmilk-legal-map/
2. NDDA, “Raw milk sales now legal, limited to fluid milk,” [Press release], August 4, 2023. https://www.ndda.nd.gov/news/raw-milk-sales-now-legal-limited-fluid-milk
3. North Dakota Century Code, Chapter 4.1-25, “Dairy Product Regulation,” p. 10 (point 3 of clause 4.1-25-40.1). https://ndlegis.gov/cencode/t04-1c25.pdf#nameddest=4p1-25-40p1
4. Tony Leys “Public Health Has Lost the War – States legalize raw milk, despite public health warnings,” USA Today, July 3, 2023. https://www.usatoday.com/story/news/nation/2023/07/03/raw-milk-legalized-states-unpasteruizeddisease-risks-public-health/70369454007/
5. Centers for Disease Control and Prevention (CDC). Access® database for outbreaks reported from 2005 to 2020 from all transmission sources (food, water, animal contact, environmental, and person-to-person) provided by Hannah Lawinger, CDC NORS Data Request Manager on May 26, 2021.

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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.

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“Tennessee Welcomes You” sign at the state border

On July 1st Senate Bill 693 (SB 693), also known as the Tennessee Food Freedom Act, went into effect as law. SB 693 is a major step in expanding consumer access to homemade food in Tennessee and keeping more of the food dollar in the state. State Senator Frank Niceley sponsored the bill; Representative Justin Lafferty was the sponsor of companion legislation House Bill 813 (HB 813).

SB 693 allows the unregulated sale of all food that does not require time or temperature control for safety (including fermented foods) by homemade food producers direct to the consumer or “a third-party vendor, such as a retail shop or grocery store.” Sales can be made to the consumer remotely through telephone or internet order. Deliveries of homemade food can be made through third-party carriers; all transactions under SB 693 must be in intrastate commerce only.

The production and sale of homemade foods is exempt from all “licensing, permitting, inspection, packaging…laws of this state, except when the department of health is investigating a reported foodborne illness.” The only requirement under the bill is the disclosure through labeling or other communication (depending on the food sold and the type of transaction) of the following information: the producer’s contact information, the name of the food item, its ingredients, and the statement: “This product was produced at a private residence that is exempt from state licensing and inspection.”

Prior law allowed the sale of “not potentially hazardous” foods (mostly the same foods that can be sold under SB 693) by the producer without a permit directly to the consumer only; further, the producer was subject to inspection and other requirements under the old law. The deregulation of the production and sales of homemade foods along with the now legal third-party sales of these items should increase the number of homemade food producers as well as consumer access substantially. Food buyers clubs, food hubs, and mom-and-pop stores are all possible venues for the sales of homemade food

Niceley has made a huge impact on the fortunes of small farmers in Tennessee. In 2009 he was the sponsor of a bill legalizing the distribution of raw milk through cowshare agreements; he followed up on that success in 2012 by getting an Attorney General’s opinion that it was legal to distribute other raw dairy products through a cowshare arrangement as well. In 2019 he sponsored a successful bill legalizing the retail sale of raw butter by licensed dairies.

In 2014 Niceley sponsored a bill adopting the federal poultry exemption enabling farmers to process up to 20,000 birds a year; the state has since expanded that exemption by policy to include rabbit processing on the farm. In 2017 he sponsored a bill adopting the federal exemptions on custom slaughter and on non-amenable species—the latter exemption allows the sale of meat from animals such as bison and domestically raised deer that are slaughtered and processed at a custom facility. That same year he also sponsored a bill that exempted from licensing and inspection food buyers club and other entities that distribute the products of farmers.

A fifth-generation cattle farmer himself, Niceley is largely responsible for Tennessee having one of the strongest local food systems in the country. He is the legislator small farmers across the state most turn to when they have a regulatory issue.

With the looming engineered shortages in the conventional food supply, it is critical to deregulate the production and sale of locally produced foods. Shortening the supply chains and enabling communities to be more self-sufficient in food production is a way to fight back against corporate tyranny and the threat of food scarcity. All 50 states have Cottage Food laws, with some states such as Wyoming and Montana allowing the unregulated sale of nearly all foods other than meat; illnesses attributed to producers operating under cottage food and food freedom laws are almost nonexistent. States like Tennessee and laws like its Food Freedom Act can be a model going forward for deregulation in other states.

Congratulations to Senator Niceley, Representative Justin Lafferty, Weston A. Price Foundation chapter leader and lobbyist Shawn Day, and others who worked in support of the bill for their success!

Photo Credit: Andrey Krav via iStock.com

The post Tennessee Food Freedom Act Now Law appeared first on Real Milk.

On May 24, U.S. District Judge Rudolph Contreras (2021)¹ rubber-stamped the U.S. Food and Drug Administration‘s (FDA’s) denial of a citizen petition² filed by the Farm-to-Consumer Legal Defense Fund and dairy farmer Mark McAfee (petitioners) to lift the interstate ban on raw butter, disposing of petitioners’ appeal³ by granting FDA‘s motion for summary judgment. The upshot of the judge’s decision is that FDA can ban any food in interstate commerce it wants under its power to regulate communicable disease;⁴ FDA did not provide any evidence in the case specifically establishing that commercially produced raw butter has ever been blamed for causing a foodborne illness outbreak in the U.S.⁵

FDA had rejected the petition in February 2020⁶, and FTCLDF and McAfee appealed to the U.S. District Court for the District of Columbia. Two issues were before Judge Contreras: whether FDA had the statutory authority to require pasteurization for butter, and second, whether FDA acted arbitrarily when it banned a food in interstate commerce that had little or no record of making people sick.

Through a statute in the Federal Food, Drug and Cosmetic Act (FFDCA, 21 USC 341⁷), Congress has given FDA the power to issue standard of identity regulations for most foods; standard of identity regulations are requirements prescribing what a food product must contain to be marketed under a certain name in interstate commerce. For instance, the standard of identity for milk in final package form requires that it be pasteurized or ultra-pasteurized and that it contain not less than 8.25% non-fat milk solids and not less than 3.25% milkfat.⁸ FDA’s long-held position is that the pasteurization requirement can be part of the standard of identity. As Judge Contreras noted in his opinion (p. 6),⁹ standards of identity “promote honesty and fair dealing in the interest of consumers.”

There are several foods that Congress prohibits issuing standard of identity regulations for and one of those is butter. Congress has defined butter in the FFDCA which serves as a standard of identity for the food; that definition does not require that butter be pasteurized. When FDA violated the FFDCA by requiring that butter in interstate commerce be pasteurized, they claimed it had the power to do so under the authority given it to regulate communicable disease⁴. The Public Health Service Act (PHSA) authorizes FDA “to make and enforce such regulations as in its judgment are necessary to prevent the introduction, transmission or spread of a communicable disease from foreign countries into the states or possessions or from one state or possession into any other state or possession” (42 USC 264).¹⁰ There is little or no evidence that Congress intended to give FDA the power to ban a food completely in interstate commerce under the PHSA, but that is what the judge found in his opinion.

In discussing the conflict between the FDA’s pasteurization requirement under the PHSA and the FFDCA’s statutory definition of butter, the judge stated:

• [T]he two statues hardly touch on the same topic, much less conflict in such a way that one would have to supersede the other. While the PHSA is concerned with containing the spread of infectious diseases regardless of the means of transmission, standards of identity are meant to ensure that consumers know what foods they are buying. Rarely do two statutes with such different purposes conflict.⁹ (p. 7)

What the judge ignored in making this statement is that both standard of identity regulations and Congress’ definition of butter are concerned with public health; the 60-day aging requirement for raw cheese and the pasteurization requirement for milk and other dairy were implemented by FDA because of the agency’s health concerns. When Congress passed the law creating the definition for butter, it didn’t think a pasteurization requirement was necessary to protect the public health; it could have amended the definition at any time since to require pasteurization but has never done so.

The second issue before the court was petitioners’ claim that the pasteurization requirement for butter was scientifically “unsupported” and therefore “arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law” (pp. 4, 17).³ On this issue, the judge’s holding against McAfee and FTCLDF was even more troubling. The most important consideration in determining whether there is scientific support for banning a food in interstate commerce is looking at the food’s history of making people ill. In the court record before Judge Contreras, there are only two foodborne illness outbreaks since 1908 where raw butter is definitively listed as the suspected cause of illness; in both outbreaks the butter was homemade.¹¹ In its letter to McAfee and FTCLDF rejecting the petition, FDA included a table listing 13 foodborne illness outbreaks attributed to butter from 1908 through 2003. There is a column in the chart indicating pasteurization status; only one of the outbreaks has “unpasteurized” in the column while the other 12 have either “not specified” or “not specified but commonly unpasteurized” in the table (pp. 18-22).¹¹

The judge upheld the ban on raw butter in interstate commerce even though FDA failed to specifically link a single outbreak to commercially produced raw butter. There are a dozen states that allow the sale or distribution of raw butter, including California where Organic Pastures Dairy Company, a business McAfee founded, has sold well over 2 million pounds of raw butter the past 20 years without incident (p.14).³

The judge justified his decision by indicating FDA’s findings that raw butter could contain pathogens that may cause illness were sufficient for him to uphold the ban, but shouldn’t the number of illnesses a food has caused be a more important consideration? Moreover, any food that is improperly produced or handled is capable of making people sick. FDA shouldn’t have the power to ban any food under its authority to regulate communicable disease; under the judge’s ruling, there isn’t a food the agency conceivably couldn’t ban.

In his ruling, Judge Contreras stated that the court had to be “highly deferential” on FDA‘s decision to ban raw butter, citing a legal doctrine called Chevron Deference, a doctrine which basically leaves the courts powerless to overturn agency decisions (p. 4).¹ As long as Chevron Deference is in effect, lawyers for the agencies before the court might as well write the opinions themselves. If the courts ever want to reestablish their independence in reviewing agency decisions, this doctrine needs to go.

The best path to overturning the sham that is the raw butter ban is to legalize its sale or distribution one state at a time. Tennessee legalized the retail sale of raw butter in 2019.¹² Utah did the same in 2020,¹³ and Montana has legalized the sale from producer direct to consumer in 2021.¹⁴ The petition has further established the excellent track record for food safety of raw butter; the move to legalize sales of the product in the state legislatures should continue.

Alexia Kulwiec, executive director of the Farm-to-Consumer Legal Defense Fund, offered this statement, “FTCLDF is very disappointed¹⁵ in the decision, and has until late July to decide whether it will appeal. FTCLDF is considering all available options at this time.”¹⁶

Photo Credit: “Bread and Butter” by Marina Shemesh on PublicDomainPictures.net

References

1. Contreras, R. (2021, May 24). Order: Denying plaintiffs’ motion for summary judgment and granting defendant’s motion for summary judgment. [19-3161 (RC)] U.S. District Court for District of Columbia. https://www.realmilk.com/wp-content/uploads/2021/07/2021-05-24-Order-Denying-Plaintiff_Granting-Def-SJ.pdf

2. McAfee, M., & Farm-to-Consumer Legal Defense Fund. (2016, June 22). Citizen petition seeking legalization of interstate transport of unpasteurized butter. p. 5.
https://www.realmilk.com/wp-content/uploads/2020/03/1-CitPetFDA-Butter-062216-1-1.pdf

3. McAfee, M., & Farm-to-Consumer. (2020, May 25). Second amended complaint [Civil Action No. 19-3161]. https://www.realmilk.com/wp-content/uploads/2021/07/Filed-Second-Amended-Complaint-5.26.20.pdf

4. Kennedy, P. (2017, April 14). Raw butter, a communicable disease? A Campaign for Real Milk. https://www.realmilk.com/raw-butter-communicable-disease/ (Originally published 2016, June 23 at
Farm-to-Consumer

5. Kennedy, P. (2016, March 17). OPDC citizens petition for raw butter. A Campaign for Real Milk. Citing “the CDC has no outbreaks, no cases of illness or death recorded in its databases related to commercially produced raw butter illness or pathogen defects.” https://www.realmilk.com/opdc-citizens-petition-for-raw-butter/

6. Kennedy, P. (2020, March 18). FDA Denies Petition to Lift Interstate Ban on Raw Butter. A Campaign for Real Milk. https://www.realmilk.com/fda-denies-petition-to-lift-interstate-ban-on-raw-butter/

7. United States Code. (1938/1993). 21 USC 341 – Definitions and standards for food: “No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons.” Legal Information Institute, Cornell Law School. Retrieved July 4, 2021 from https://www.law.cornell.edu/uscode/text/21/341

8. Department of Health and Human Services. (1993/2020, November 10). 21 CFR 131.110(a) – Milk. Code of Federal Regulations. Retrieved July 4, 2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=131.110

9. Contreras, R. (2021, May 24). Memorandum opinion: Denying plaintiffs’ motion for summary judgment and granting defendant’s motion for summary judgment. U.S. District Court for District of Columbia. [McAfee et al v. U.S. Food and Drug Administration, No. 1:2019cv03161 – Document 23 (D.D.C. 2021). https://law.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2019cv03161/212153/23/] Accessible at https://www.realmilk.com/wp-content/uploads/2021/07/2021-05-24-Memorandum-Opinion-on-SJ-Orders.pdf

10. United States Code. (1944/2002). 42 USC 264 – Regulations to control communicable diseases. Legal Information Institute, Cornell Law School. Retrieved July 4, 2021 from https://www.law.cornell.edu/uscode/text/42/264

11. FDA. (2020, February 27). Letter from FDA to Mark McAfee and Pete Kennedy, Re: Docket No. FDA-2016-P-1852 [Letter]. https://www.realmilk.com/wp-content/uploads/2021/07/FDA-RawButterPetition-Response-2-27-2020.pdf

12. Kennedy, P. (2019, May 7). Raw butter sales now legal in Tennessee. A Campaign for Real Milk. https://www.realmilk.com/tennessee-raw-butter-sales-now-legal/

13. Kennedy, P. (2020, April 19). Raw Butter and Raw Cream Sales Now Legal in Utah. A Campaign for Real Milk. https://www.realmilk.com/raw-butter-and-raw-cream-sales-now-legal-in-utah/

14. Kennedy, P. (2021, May 10). Montana Local Food Choice Act Now Law. A Campaign for Real Milk. https://www.realmilk.com/montana-local-food-choice-act-now-law/

15. Kennedy, P. (2020, March 21). FTCLDF Takes the FDA to Court Over Raw Butter Petition. A Campaign for Real Milk. https://www.realmilk.com/ftcldf-takes-the-fda-to-court-over-raw-butter-petition/

16. Kulwiec, A. (personal communication via email, 2021, June 16).

The post Judge Upholds FDA Raw Butter Ban 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.

The distribution of raw milk through herd share agreements is legal by policy in Ohio¹; Kremer thinks that distribution capability is key to success and that this hinges on restoring the tradition of the milkman–the raw milkman.

In 1995, there were 6,800 dairies in Ohio; today there are about 2,000. In recent months, the average price of milk conventional farmers receive is around 30 percent (30%) below the cost of production. Dairy cooperatives are sending suicide hotline numbers along with milk checks. Organic dairies can’t compete with the certified organic mega-dairies in Texas and Colorado that are flooding the market with “organic” milk while violating federal regulation on the amount of time their herds should be out on pasture.

Kremer says, ”Many in the industry consider the disappearance of the family dairy farm as inevitable. We do not. In fact, we are convinced that this crisis event is an opportunity to strengthen the economic base of this demographic and re-establish it under its own branding.”

“To continue in dairy, the farmers will need an alternate market. We are encouraging them to consider the real or raw milk market. It would mean having direct and independent access to the public, a sufficient margin for their family’s economic viability, and the opportunity to work collaboratively with those of us they would serve to ensure the integrity and safety of their product. Most importantly, it will mean restoring the direct relationship between us and them.”

The first milkman in the U.S. was a raw milk man; home deliveries of raw milk began in Vermont in 1785^2,3. In the 1950s over half of the milk sales were made through home delivery; even though these sales were mostly pasteurized milk there were still home deliveries of raw milk. By 1963 29.7% of milk sales were made through home delivery⁴; the growth of supermarkets and other factors contributed to the decline. By 2005 only 0.4% of milk sales were made through home deliveries.⁵

Since 2005 home deliveries from the milkman have started to make a comeback. Distributors are delivering not only pasteurized milk but other foods such as meat, eggs and produce.

Deliveries of raw milk and raw milk products have been on the rise for a while as well but these deliveries mainly take place at a central drop-site and not door-to-door. It is the hope of Kremer that he and others will have enough demand to start home deliveries of raw milk to individual shareholders who request it.

American consumers like their convenience; door-to-door raw milk delivery fills this need and tries to give raw milk drinkers no reason not to order the product. Home delivery is becoming an increasingly important part of the overall competition for the food dollar; chains like Whole Foods are using the delivery service Instacart to drop off food orders at customers’ homes. Instacart claims it can make deliveries in as little as an hour after the customer places the order. Raw milk sales can help dairies currently producing only pasteurized milk remain in business; the easier the dairies make it for the consumer to obtain their products the better their chances of success.

Many baby boomers who grew up in the 50s and 60s nostalgically recall the milkman as someone who was part of their community or as someone who was like an extended family member. There’s no reason that can’t happen for the raw milkman; a familiar face in the neighborhood can bring on additional demand.

Kremer is starting a campaign to grow consumer demand for raw milk through increased participation in herd share programs. He hopes increased demand will encourage more dairy farmers to make the transition to producing raw milk for distribution through herd shares; bringing back a piece from our cultural past and restoring the tradition of the milkman–is part of the path to success.

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[1] In Darke County herd shares are legal by judicial decision thanks to a 2006 court ruling in the case of Daley v. Schmitmeyer
[2] Drink Milk in Glass Bottles. “The Day the Milkman Went Away: A History of Home Milk Delivery” [Blog post]. Last retrieved 12/5/2018 from http://www.drinkmilkinglassbottles.com/a-quick-history-home-milk-delivery/
[3] Stanpacnet. “Brief History of Home Milk Delivery Service” [Blog post]. Last retrieved 12/5/2018 from
http://www.stanpacnet.com/a-brief-history-of-home-milk-delivery-service/
[4] Eve Tahmincioglu, “Remember the Milkman? In Some Places, He’s Back”, New York Times, December 16, 2007. Last retrieved 12/5/2018 from https://www.nytimes.com/2007/12/16/business/yourmoney/16milk.html
[5] Ibid.

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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 interstate ban on raw milk for human consumption went into effect in 1987. The position of the Food and Drug Administration (FDA) has long been that the prohibition applies to all raw milk in interstate commerce. The truth is otherwise; a reading of the law clearly shows that the ban applies only to cow’s milk. The shipment of raw goat milk, raw sheep milk, raw camel milk, raw water buffalo milk, etc., in interstate commerce is all legal; the ban on raw dairy from animals besides cows applies only to products other than raw milk and aged raw cheese. In other words, for cows only aged raw cheese is legal; for all other dairy animals, raw milk and aged raw cheese are legal.

Like so many laws, it all comes down to the definitions in the regulations. The federal regulation establishing the ban, 21 CFR 1240.61, states: “(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized….”

A separate regulation, 21 CFR 1240.3, has the applicable definitions of “milk” and “milk products.” The definition in 21 CFR 1240.3(i) states, “Milk is the product defined in ß131.110 of this chapter.” Regulation 21 CFR 131.110 provides, in part, “Milk is that lacteal secretion practically free from colostrum, obtained by the complete milking of one or more healthy cows….” By contrast, the definition of “milk products” in 21 CFR 1240.3(j) is “Food products made exclusively or principally from the lacteal secretion obtained from one or more healthy milk-producing animals….” (emphasis added).

In 1992 when FDA proposed adding the definitions for “milk” and “milk products” to 21 CFR 1240.3, the agency made the following statement in the Federal Register (57 FR 1407.1408): The purpose of these technical amendments is, first, to set out these dairy products that are covered under Section 1240.61. Therefore, in Section 1240.3, FDA is defining “milk” and “milk products.” FDA is proposing to adopt as its definition for “milk” the standard of identity for this food in 21 CFR 131.110. FDA is proposing to use the standard as its definition because the agency believes that it should use consistent definitions in regulations. The definition for “milk products” includes all foods other than “milk” normally regulated by state and regulatory agencies as dairy products under federal or state law or under state model ordinances such as the Grade A Pasteurized Milk Ordinance (emphasis added).

The judicial and administrative actions over thirty years ago that led to the raw milk ban concerned, either entirely or almost entirely, only cow’s milk. If FDA is contemplating amending the regulation establishing the ban to extend it to all raw milk, the agency needs to consider the fact that the ban on raw cow’s milk has been about as effective as the prohibition on alcohol was during the 1920s. The sign of a bad law is one that otherwise law-abiding citizens violate regularly; 21 CFR 1240.61 fits that description to a T. The ban came about because a court ordered FDA to issue a regulation, not because of any law passed by the people’s branch, Congress. Instead of expanding the ban, FDA should repeal it, legalizing the sale of all raw dairy products in interstate commerce; thirty years of the agency denying freedom of food choice on these products is more than enough.

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

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