The most important legislation for the local food movement that has been before Congress the past eight years has been the Processing Revival and Intrastate Meat Exemption Act, known as the PRIME Act; in this current session, the bill has been introduced as House Resolution 2814 (HR 2814) [1] and Senate Bill 907 (S. 907) [2]. The PRIME Act would allow states to pass laws legalizing the sale of custom slaughtered and processed meat in intrastate commerce; the lack of slaughterhouse infrastructure throughout most of the U.S. is the biggest weakness of the local food system. Under current law, only the owners of an animal can receive the meat slaughtered and processed at a custom facility; only meat from an animal slaughtered and processed at a federal- or state-inspected facility can be sold.

The PRIME Act would amend the Wholesome Meat Act of 1967 (WMA), the legislation that established these requirements. Unless you are an oligopolist, the WMA has been a disaster. At the time the act passed into law, there were around 9,600 slaughterhouses in the U.S. [3];  the country’s population at the time was around 200 million. Today there are between 2,800 and 2,900 slaughterhouses [4] in the country and the current U.S. population is around 335 million. Four companies now control over 80% of beef processing in the U.S., and four companies control over 60% of pork processing [5].

There has never been a better chance to pass this bill than now. Congress is currently in the process of writing up the 2023 Farm Bill. The PRIME Act has a legitimate chance to be included in the Farm Bill; it has much less chance to pass as a standalone. Giving the bill momentum was a congressional hearing in June that the House Judiciary Subcommittee on the Administrative State, Regulatory Reform and Antitrust held titled, “Where’s the Beef? Regulatory Barriers to Entry and Competition in Meat Processing” [6]; the PRIME Act was a focus of the hearing. Farmer/slaughterhouse owner Joel Salatin testified on how it could be a solution to the difficulties small farmers and ranchers have in meeting demand for local meat with the current laws in place that favor the big meatpackers.

Congressman Thomas Massie, a cattle farmer representing Kentucky’s 4th district, is the lead sponsor for HR 2814 as he has been since he first introduced the PRIME Act in 2015. Adding more urgency to the need to have the legislation included in the 2023 Farm Bill is a statement Massie made in a Washington Post interview earlier this year, indicating that he might serve only one more term [7], meaning he wouldn’t be around when the next Farm Bill would be deliberated in 2028. There is no one in Congress who would put in anywhere near the time and resources to pass the PRIME Act that Massie has; neither is there anyone who has the expertise on the matter that he does.

To say passage of the PRIME Act is badly needed is a huge understatement. Demand for locally produced meat is booming, but it is difficult for farmers and ranchers to meet that demand with the lack of access to slaughterhouses under inspection. Right now in parts of the country, farmers have to book a slaughterhouse slot as much as 1-1/2 to 2 years in advance. Moreover, farmers often have to transport their animals several hours to an inspected slaughterhouse, increasing their expenses and stressing out the animals which could affect the quality of the meat. The majority of livestock farmers live closer to a custom slaughterhouse than an inspected slaughterhouse.

Aside from better enabling farmers to meet the demand for local meat, passage of the PRIME Act could begin the long-overdue process of decentralizing meat production in the U.S.  According to USDA data from 2022 [8], 52 federally inspected slaughterhouses account for around 93% of the cattle slaughtered in the U.S.; 60 federally inspected facilities account for nearly 98% of the hogs slaughtered in the country. This centralization along with the supply chain breakdowns and labor shortages of the past few years has made the meat supply more vulnerable as well as leading to a decline in quality. It’s likely that passage of the PRIME Act would initially impact a fraction of 1% of meat production, but its revival of the community abattoir would improve food security through increased self-sufficiency at the local level.

Massie said several years ago that he knew of 1,000 shuttered slaughterhouses in the country whose owners would re-open if the PRIME Act became law; the owners did not want to run a business if an inspector was present each time they were slaughtering animals (government regulators typically inspect a custom house only once or twice a year). The owners did not believe they could generate enough revenue operating under laws prohibiting the sale of meat slaughtered and/or processed at a custom facility.

The only argument the opposition to HR 2814 has is food safety, but the data shows they don’t even have that. In response to a Freedom of Information Act (FOIA) request filed by the Texas nonprofit Farm and Ranch Freedom Alliance (FARFA), the USDA acknowledged that between 2012 and 2020 there were no cases of foodborne illness due to the consumption of custom slaughtered and processed meat [9]. By contrast, according to the Centers for Disease Control (CDC) between 2005 and 2020, over 6,000 cases of foodborne illness were attributed to beef and pork consumption [10]; the likelihood is that all or nearly all that meat was slaughtered in big USDA facilities that process 300-400 cattle per hour. The big plants process more animals in a day than a custom house would in a year. There is better quality control in a custom facility, inspector or no inspector.

A key part of food safety is traceability–another advantage meat from a custom house has over meat from one of the big USDA facilities. A hamburger in the industrial food system could come from hundreds of cattle raised in multiple states and countries; a hamburger from a custom facility is going to be from one cow.

Increasing the amount of locally produced meat available for consumption would not only benefit food security and food safety but also human health and the economy. With passage of the PRIME Act, there would be less money spent on, and less demand for, resources of the healthcare system—freeing up money to be spent in more productive areas of the economy. The records on foodborne illness outbreaks indicate that a higher percentage of people per serving who consume meat produced by the big plants of the conventional industry cost the healthcare system more money than the people who obtain locally produced meat from small farmers and ranchers. The likelihood is also that people who purchase locally produced meat place less demand for resources on the medical system in the treatment of chronic disease then do those who buy their meat from the industrial system.

Beyond the deterioration of quality the centralization of meat production has caused, there is another development in the conventional industry making passage of the PRIME Act imperative: the production and marketing of alternative proteins, such as cell-cultured meat and insects. Industry has spent billions in the development of alternative proteins even though there is little or no demand for them—with two of the major meatpackers, Tyson and Cargill, being investors. The question is: what will the ruling establishment do to help industry get a return on its investment? Will it involve enforcing policies that will make animal proteins less available? The best response to the ruling elites’ plans is to build out a parallel food system as independent of federal control as possible; a robust slaughterhouse infrastructure will be a centerpiece of that system. The PRIME Act will be a catalyst in making that happen–moving the system towards a day when the local abattoir will once again dot the countryside.‍

References‍

[1]  U.S. Congress. (2023). House Resolution 2814. [PDF]. Introduced April 25, 2023. PDF accessed at https://www.congress.gov/bill/118th-congress/house-bill/2814/text‍

[2]  U.S. Congress. (2023). Senate Bill 907. [PDF]. Introduced March 22, 2023. PDF accessed at https://www.congress.gov/bill/118th-congress/senate-bill/907/text

[3] USDA, Statistical Reporting Service Crop Reporting Board. (1969). Annual Livestock Slaughter, April 1969. [PDF] “Table 20 – Number of Livestock Slaughtering Establishments, March 1, 1967, 1968, 1969”, p. 35. PDF accessed at https://usda.library.cornell.edu/concern/publications/r207tp32d

[4] USDA, National Agriculture Statistics Service. (2023). Livestock Slaughter 2022 Summary (April 2023). [PDF]. [Table – “Livestock Slaughter Plants by Type of Inspection – States and United States: January 1, 2022 and 2023″ Inspected Percent of Total Commercial Slaughter by Species, Month, and Total – United States: 2022 and 2021 Total”, p. 62]. PDF accessed at https://usda.library.cornell.edu/concern/publications/r207tp32d

[5] James, H.S., Hendrickson, M.K., and Howard, P.H. (2012, February). Networks, Power and Dependency in the Agrifood Industry. Department of Agricultural & Applied Economics Working Paper. College of Agriculture, Food and Natural Resources: University of Missouri. Available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2004496 (Accessed: 7 September 2023). [See  “Table 1 – Concentration ratios and dominant firms for selected agrifood sector”, p. 32]

[6] Forbes Breaking News. (2023, June 13). ‘Where’s The Beef?’: Thomas Massie Leads House Judiciary Committee Hearing On Meat Industry. [Video]. YouTube.com. https://youtu.be/jky4-J-Tsc0?si=qfEkqL2BsH9rATQF‍

[7] Will, G.F. (2023, June 22). “Meet the implacable, off-the-grid libertarian working to energize Congress”. The Washington Post. https://www.washingtonpost.com/opinions/2023/06/21/kentucky-republican-thomas-massie-congressional-plan/‍

[8] USDA, National Agriculture Statistics Service. (2023). Livestock Slaughter 2022 Summary (April 2023). [PDF]. [calculated from tables on pp. 8 and 61]. PDF accessed at https://usda.library.cornell.edu/concern/publications/r207tp32d‍

[9] USDA. (2020, June 25). [Foodborne illness from custom meat]. FOIA response, 2020-FSIS-00397-F.

[10] Centers for Disease Control and Prevention (CDC). (2021, May 26). Access® database for outbreaks reported from 2005 to 2020 from all transmission sources (food, water, animal contact, environmental, and person-to-person) [Data set]. Provided by Hannah Lawinger, CDC NORS Data Request Manager.

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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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Raw dairy products are the only foods for human consumption banned in interstate commerce. A question for the court of appeals to consider is: does FDA have the power to prohibit raw butter from crossing state lines when the record before the court does not list a single foodborne illness outbreak definitively attributed to the consumption of commercially produced raw butter?

FDA is claiming it can ban raw butter in interstate commerce under its authority to regulate communicable disease [1], a power granted the agency by the Public Health Services Act (PHSA). Thirty years ago FDA issued a regulation banning all raw dairy products in interstate commerce other than cheese aged 60 days [2].

Does FDA have the power to issue a blanket ban on a food? Or is its authority limited to instances when a specific batch or a lot is suspected of being adulterated and/or making people sick?

The Department of Health and Human Services (HHS) has been getting lots of mileage out of its authority to regulate communicable disease. In 2020 the Centers for Disease Control (CDC) used that power to justify an order staying any eviction of residential tenants by landlords during the COVID crisis. In striking down the order, the Supreme Court found that “regulations under this authority have generally been limited to quarantining infected individuals and prohibiting the import or sale of animals known to transmit disease” [3].

Another question for the court is: can FDA require that butter be pasteurized under its power to regulate communicable disease, when the Federal Food, Drug and Cosmetic Act (FDCA) seemingly prohibits the agency from doing just that?

There is a conflicting statute in the FDCA defining butter that does not require it to be pasteurized [4]. A separate statute in the FDCA specifically mandates that “[n]o definition and standard of identity and no standard of quality shall be established for … butter” [5]. Standards of identity are requirements for prescribing what a food product must contain to be marketed under a certain name in interstate commerce; they are intended to promote honesty and fair dealing for the benefit of consumers.

The U.S. Supreme Court has held that a standard of identity exists, for purposes of the FDCA, whenever the government, “by regulation, fix[es] the ingredients of any food,” such that “a commodity cannot be introduced into interstate commerce which purports to be … [that] food … unless [the commodity] is composed of the required ingredients” [6]. The regulation governing the interstate raw dairy ban provides, in part, “No person shall cause to be delivered into interstate commerce or shall sell, or otherwise distribute…any milk or milk product [e.g., butter]…unless…made from dairy ingredients… that have all been pasteurized…” [7].

The demand for raw dairy in the U.S. is booming. There are around a dozen states that currently allow the distribution or sale of raw butter. A court decision in favor of McAfee and FTCLDF will increase that number rapidly in a short period of time as well as reduce the power of an agency that is a major threat to bodily autonomy and freedom of choice and that has long placed the profits of the pharmaceutical and biotech industries ahead of the public health.

The oral argument before the court of appeals will be livestreamed.

• For the archive of Oral Argument Recordings, find links at

https://www.cadc.uscourts.gov/recordings/recordings.nsf

A recording of all Oral Arguments for April 8, 2022, will also be posted on YouTube at https://www.youtube.com/watch?v=jyWi9futNwg

Livestream link – https://www.cadc.uscourts.gov/internet/home.nsf/Content/VL%20-%20Calendars%20-%20Live%20Audio%20Streams%20of%20Oral%20Arguments

For more background on the Raw Butter case and related documents, go to the Farm-to-Consumer Legal Defense Fund website at https://www.farmtoconsumer.org/campaign-for-raw-food/

FOOTNOTES
1. See 42 USC 264(a)
2. 21 CFR 1240.61
3. Ala. Ass’n of Realtors v. HHS 141 S. Ct. 2485, 2487-2488.
4. 21 USC 321a
5. Subbaraman, M. Principal Brief of Appellants Mark McAfee & Farm-to-Consumer Legal Defense Fund. USCA Case 21-5170 (Document #1929731, filed 01/07/2022), p. 24 citing 21 USC 341. https://www.farmtoconsumer.org/wp-content/uploads/2022/01/Raw.Butter.1.07.22.ECF-Stamped-Opening-Merits-Brief.pdf
6. Subbaraman, p. 24 citing 62 Cases of Jam v. United States 340 U.S. 589, 593 (1951) (internal quotation marks omitted)
7. 21 CFR 1240.61(a)

Photo Credit: congerdesign on pixabay.com

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The onset of the COVID crisis in March 2020 increased the wait times for small farmers and ranchers to send their livestock for slaughter and processing; that trend has continued since. It isn’t uncommon for slaughterhouses in numerous areas around the country to be booking into 2023. The recent ‘ransomware’ attack against the world’s largest meat company, JBS, is a warning that future cyber attacks against one of the major meat packers could push the wait for small producers even further out. As it is, the inadequate slaughterhouse infrastructure in the U.S. will be forcing more livestock farmers to choose between either violating the law or going out of business. A sure sign of a bad law is one that otherwise law-abiding citizens violate with regularity. Unless Congress acts soon, that could be the future for the Federal Meat Inspection Act (FMIA).

State legislatures have passed several bills during the 2021 session to strengthen slaughterhouse infrastructure. Arkansas passed legislation establishing a state meat inspection program (Oregon passed similar legislation in 2020). Montana passed an Interstate Meat Compact Act which would allow the shipment and receipt by Montana businesses of state-inspected meat from other states that were also members of the compact; federal law prohibits this practice, so the Montana legislation taking effect is contingent on either Congress amending the FMIA or a successful court challenge to that Act within the next four years.

Both Colorado and Nebraska passed meat share bills, allowing someone with an undivided ownership interest in a herd of animals to obtain custom slaughtered and processed meat from those animals; Wyoming passed a meat share law in 2020.

At the federal level, legislators have introduced bills this session that would allow the sale of state-inspected meat in interstate commerce; current law only allows the shipment of state-inspected meat across state lines if the plant slaughtering and/or processing the livestock has no more than 25 employees and that plant has been approved to participate in the Cooperative Interstate Shipments (CIS) program. Plants cannot join the program unless the state elects to participate in the CIS program; to this point, only seven of the 29 states with their own meat inspection programs have done so.

All of these state and federal efforts can improve slaughterhouse infrastructure, but none of them would be as effective as passage of the PRIME Act. As Massie has pointed out, allowing the sale of custom meats would lead to the greatest increase in slaughterhouses. Many of those interested in starting up custom facilities—if the PRIME Act became law—would not want to invest in a state- or a federally-inspected slaughterhouse (where both an inspector would be present every time the plant was in production and a HACCP plan would be a requirement).

The biggest criticism of the PRIME Act is that it would jeopardize food safety, but the evidence is otherwise. In 2020 the nonprofit Farm And Ranch Freedom Alliance (FARFA) submitted a Freedom of Information Act request to USDA’s Food Safety Inspection Service (FSIS) seeking to find out the number of foodborne illness outbreaks attributed to the consumption of custom slaughtered and processed meat from 2012 until June 2020; the FSIS response was zero. By contrast over the past three years, there have been several multi-state outbreaks attributed to consumption of USDA-inspected beef that sickened 106,209 and 403 people, respectively. With many federal and state plants—particularly the large federal facilities—stretched beyond capacity more than ever, passage of the PRIME Act would improve the quality control of our nation’s meat supply. In effect, the bill is a food safety measure.

H.R. 3835 has been assigned to the House Committee on Agriculture; S.2001 has been assigned to the Senate Committee on Agriculture, Nutrition and Forestry. Look for action alerts from the Weston A. Price (WAPF) on this critical legislation.

Action Alert
PRIME Act needs your support in the new Congress!

Photo Credit: “Meat” by Kyle Mackie on Unsplash.com

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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.

The Farm-to-Consumer Legal Defense Fund and Mark McAfee responded to FDA’s denial of their citizen petition to lift the interstate ban on raw butter by filing a complaint on May 25 with the U.S. District Court for the District of Columbia, seeking a court ruling overturning the FDA rejection of the petition (see FDA Denies Raw Butter Petition for background.) Among other things, the complaint asks for a court declaration that the denial of the petition violates the Food, Drug and Cosmetic Act (FDCA). On July 24, FDA filed an answer to the complaint, unconvincingly denying petitioners’ allegations as to why the raw butter ban is illegal. If anything, the agency’s response to the lawsuit further exposed the weaknesses in its justification of the ban.

In its February 27 letter denying the petition, FDA included a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized (1908 to 2003),” listing thirteen outbreaks during the ninety-five-year period attributed to raw butter consumption. The cause of five of those outbreaks was listed as typhoid fever with a sixth outbreak blamed on both diphtheria and tuberculosis. The only deaths listed in the table were six fatalities caused by a typhoid fever outbreak in 1913. The latest U.S. outbreak according to the table was 2002; one of the thirteen listed outbreaks occurred in England.

FTCLDF and McAfee’s complaint notes, “. . . the pathogens causing diseases, including typhoid fever, diphtheria, and tuberculosis, which the FDA attributes to butter in its data in Table 1 are not listed as pathogens of concern in butter in an independent report prepared for the FDA by the Institute of Food Technologists (“IFT”), (FDA/IFT 2001). Instead of using this study and others available to the FDA, or peer-reviewed publications regarding well characterized outbreak investigations, the FDA relied on summaries in chapters in an outdated encyclopedia of food microbiology, a trade newsletter, and a lawyer’s website for references to ‘illnesses and deaths associated with butter not known to be pasteurized’ in its Table 1.”

FDA’s response to this observation was, “Defendant admits that typhoid fever, diphtheria, and tuberculosis are not included as ‘pathogens of concern’ in Table 1 on page 11 of the report prepared by the Institute of Food Technologists (“IFT”) (FDA/IFT, 2001), available at fda.gov/files/food/published/Evaluation-and-Definition-of-Potentially-Hazardous-Foods, pdf.” In other words, FDA believes that six outbreaks with no recorded fatalities attributed to “pathogens of concern” over a period of one hundred twelve years (1908-2020) is justification for the ban. In addition, FDA is clearly violating the FDCA standard-of-identity law—standards-of-identity requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. FDA has claimed that pasteurization can itself be part of a standard-of-identity requirement. The FDCA prohibits the agency from issuing a standard-of-identity requirement for butter; FDA is claiming that its power to regulate communicable disease has precedence over the standard-of-identity law. The evidence in the case is increasingly showing that FDA is banning a food under its power to regulate communicable disease that has made few people sick. The appeal of the FDA’s denial of the raw butter petition will be a costly process. Those wanting to support this important effort to expand freedom of food choice can donate to FTCLDF online at farmtoconsumer.org/rawbutter or call 703-208-3276.

This article was first published in the Fall 2020 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.

About the Author

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The post Lawsuit Over FDA Raw Butter Petition appeared first on Real Milk.

Access to slaughterhouses has been poor for small livestock producers in most of the country for many years now but has become considerably worse since the onset of the COVID-19 crisis. USDA-inspected slaughterhouses have since last spring been booking customers as far out as 2022. Many custom slaughterhouses are now booking well into 2021.

Demand for locally raised meat is only going to increase. At a recent food safety conference, a high ranking official from the United States Department of Agriculture (USDA) announced that the department was working to have low-dose ionizing radiation, known as irradiation, to be considered as a “processing aid”^a which means there would be no labeling requirement to inform consumers that meat or poultry they were purchasing had been irradiated.

One possible answer for the slaughterhouse logjam is the personal use exemption codified in federal regulation at 9 CFR 303(a)(1). The regulation states:

The requirements of the [Federal Meat Inspection] Act and the regulations in this subchapter for the inspection of the preparation of products do not apply to: (1) The slaughtering by any individual of livestock of his own raising and the preparation by him and transportation and commerce of the carcasses, parts thereof, meat and meat food products of such livestock exclusively for use by him and members of his household and his non-paying guests and employees.[1]

On May 24, 2018, USDA’s Food Safety and Inspection Service (FSIS) published a guidance document titled, “FSIS Guidelines for Determining Whether a Livestock Slaughter or Processing Firm Is Exempt from the Inspection Requirements of the Federal Meat Inspection Act.” In the guidance, FSIS explains what those under various exemptions from inspection, including the personal use exemption, can legally do. FSIS’s interpretation of the guidance provides a way for farmers to sell live meat animals while being under the personal use rather than the custom slaughter exemption.

The guidance states that under the personal use exemption,

A person may purchase livestock from a farm or ranch and then slaughter it onsite using the farm or ranch facilities or equipment.    a. If a person purchases livestock, and uses the on-site facilities without assistance from the seller, then the activity remains personal use.     b. If the seller participates in the slaughter or processing activity, then the facility owner is subject to the custom [slaughter] exempt criteria….[2]

The document goes on to state, ”the owners of the livestock may or may not reside at the same physical location as the animal”[3], establishing that there can be more than one owner under the personal use exemption. FSIS does not say how many owners there can be under the exemption, but it has stated that there can be unlimited owners under the custom slaughter exemption.[4] FSIS has stated that all owners must obtain some portion of the custom animal but has not required that there be a specific minimum amount.[5]

The only other requirements listed in the guidance for the personal use exemption have to do with adulteration. FSIS requires:

• “No livestock are slaughtered which are unfit for human consumption.”[6]
• “Specified risk materials (SRMs) are inedible and prohibited for use as human food.”[7]
• “The carcasses and parts are not prepared, packed or held, under insanitary conditions.”[8]

There are many more requirements for the custom slaughter and custom processing exemption than there are for the personal use exemption including requirements for the physical facility, water, labeling, recordkeeping, and ingredients used in the preparation of meat products.[9] There are also state licensing requirements for custom facilities; usually there is no licensing requirement for a farmer operating under the personal use exemption.

Most, if not all, states have adopted the personal use exemption as part of their law, few of those states have imposed additional requirements beyond what the Feds’ mandate.

There is no limit on the number of livestock that an owner may slaughter and process for their personal use.[10] Livestock slaughtered and processed under this exemption can be shipped across state lines.[11] For the farmer shut out at inspected and custom slaughterhouses, it’s possible to sell live animals under the personal use exemption if one of the owners is experienced at meat processing, whether that individual is another farmer or someone specializing in the trade.

^aProcessing aids: Ingredients that are present in a meat or poultry product in an insignificant amount and that have no functional or technical effects in the finished meat or poultry product are considered to be processing aids. Processing aids are not required to be listed in the ingredients statement for a meat or poultry product. [FSIS, “Compliance Guide on the Determination of Processing Aids”, PDF, April 8, 2008; weblink]

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1. 9 CFR 303.1(a)(1), see also 21 USC 623(a)

2. USDA-FSIS, “FSIS Guidelines for Determining Whether a Livestock Slaughter or Processing Firm Is Exempt from the Inspection Requirements of the Federal Meat Inspection Act”, PDF, May 24, 2018, p. 3. Accessed 11/5/2020 at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines/2018-0007

3. Ibid.

4. FSIS, “For Dr. Gillespie – ownership, custom meat”, AskFSIS, PDF, April 13, 2017

5. Ibid.

6. Guidelines, p.3

7. Ibid.

8. Ibid. See also 9 CFR 310.22

9. See 9 CFR 303.1(a)(2)

10. Guidelines, p.3

11. Ibid.

The post Remedy for Slaughterhouse Logjam? appeared first on Real Milk.

If anyone needed evidence on the importance of passing the PRIME Act (H.R.2859 / S.1620), the bill enables states to pass laws allowing the sale of meat from an animal slaughtered and processed at a custom facility), the logjam at slaughterhouses around the U.S. should provide it. Federally inspected slaughterhouses, state-inspected slaughterhouses, and custom facilities around the country are stretched beyond capacity. With the COVID-19 crisis triggering a shift in demand from industrial to locally produced meat and the concerns about food security leading to increased stocking, the market demand for local meat has never been greater. Compounding the strain on slaughterhouses is the demand from livestock farmers that previously sold to the major meat packers until they lost that business in the shutdown or slowdown of the country‘s biggest processing plants.

There are USDA slaughterhouses around the country now booking into 2022; many custom houses are taking reservations for well into 2021. It is not uncommon for livestock producers who were able to get a slaughter date two or three months out are now having to book eight months or more in advance. More farmers are considering whether to construct a custom facility on their own land. Under federal law, which states are required to follow, farmers can slaughter animals they have raised without regulation as long as the meat from the slaughter only goes to the farmer’s family, non-paying guests and employees. If anyone else obtains meat from an on-farm slaughtered animal, the farmer must comply with federal regulations governing custom slaughter and processing.

A number of states have taken steps during COVID-19 to increase the meat supply. In May, the Mississippi Department of Agriculture and Commerce issued an emergency regulation lifting the restriction on the number of owners there could be for a custom processed animal.¹ Prior to the emergency rule (which will be converted into a permanent rule sometime this summer), there was a limit of four owners per custom animal; now a farmer can distribute beef direct to the consumer without limitation on the number of individual owners. Agriculture Commissioner Andy Gipson said Mississippi residents wanting to buy local beef or pork “can buy a share in that animal whatever the farmer wants to sell” or however he wants to divide it up.² The new rule is in line with USDA’s position that federal regulations do not set a limit on the number of owners there can be for a custom animal.

On April 28, the Utah Department of Agriculture and Food (UDAF) announced that it had “invited ten qualifying custom exempt slaughter establishments in Utah” to come under state inspection which would allow the sale of meat from animals processed at those facilities in intrastate commerce. A UDAF press release stated that “if all the [invited] custom exempt plants take part in this emergency program it could increase Utah’s processing capacity by at least 10 percent.”³

USDA has a cooperative interstate shipments program (CIS) which allows meat from approved state-inspected slaughter and/or processing facilities—with no more than 25 employees—to be shipped in interstate commerce if the plant is located in a state that FSIS has approved to participate in a state meat inspection program. At the present time, FSIS has only approved seven of the 27 states with their own meat inspection programs to be part of the CIS.

In May, Maine and Wisconsin, two states participating in the CIS program, each sent waiver requests to FSIS asking that the Feds allow meat from all state-inspected plants to be shipped in interstate commerce.

In a May 7 letter to FSIS, Commissioner Amanda Bill of the Maine Department of Agriculture, Conservation and Forestry (MDACF) said, “Given the current challenges of the COVID-19 pandemic, we ask that FSIS grant a temporary waiver to allow all state-inspected meat to be sold in interstate commerce or to be donated to food banks that require federally inspected products. This temporary waiver would lift usual restrictions on place of sale and allow for more processing and marketing opportunities for Maine producers and consumers during the unprecedented crisis. USDA processing facilities in Maine are under immense pressure to meet demand and are reportedly booked out over a year in advance in some locations. Allowing state-inspected meat to temporarily cross state lines will greatly support regional marketing opportunities, smooth out bottlenecks in the local food chain, reduce the need to cull healthy livestock and poultry, and support those who are food insecure during this extremely difficult time.”⁴

In his letter to FSIS, interim secretary Randy Romanski of the Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) also asked USDA to grant a temporary exception to allow state-inspected meat to be sold or donated across state lines. Romanski stated, “Our agricultural development staff have been working tirelessly to identify state-inspected Main Street meat processors who may be willing to slaughter and process even an extra dozen animals a week. Our state meat inspectors stand ready to provide additional slaughter inspection days as necessary. We feel that new partnerships between farmers, processors and consumers or food donation programs are vitally important in responding to this pandemic.”⁵

Oregon, earlier this month, passed a bill authorizing the start up of a state meat inspection program. North Carolina and Minnesota have both recently had bills introduced that would provide financial help to improve slaughterhouse infrastructure and capacity.

There is currently legislation before Congress, Senate Bill 1720 (S.1710) that would allow the sale of state inspected meat and poultry in interstate commerce. S.1720 is legislation that needs to pass with its potential to increase the supply of meat available to consumers that is outside the meat packers’ monopoly, but the bill won’t have the impact on improvising the slaughterhouse infrastructure in the U. S. that the PRIME Act would.

Custom slaughter and processing facilities are less expensive to construct then federal and state-inspected plants; they are also considerably less expensive to operate, with the custom facilities not having requirements such as HACCP plans. Representative Thomas Massie (R-KY), the lead sponsor of the PRIME Act, has said that he has been contacted by a number of people who owned buildings that were once slaughter facilities. They have told Massie that if the PRIME Act passes into law, they could have their slaughter plants up and running in five weeks. Many of those individuals would not be interested in operating a facility again if an on-site inspector had to be present–a requirement for state and federally inspected facilities but not for custom, Only a custom facility from which meat could be sold by the cut will get them back into business. The PRIME Act will increase the number of slaughterhouses more than S.1720. Currently, 27 states have their own meat inspection program; all states except South Carolina allow the operation of custom facilities. It has been many years since FSIS has approved the start up of a state meat inspection program.

The notion has been planted in the public mind that meat can’t be produced safely without an inspector being present for slaughtering and processing, but the truth is otherwise. Custom slaughtered and processed meat has an excellent track record for food safety. USDA recalls over 20 million pounds of meat in a typical year, little or none of that comes from custom facilities. It isn’t uncommon for hundreds of people to become ill from meat processed at the large USDA-inspected processing plants; few cases of foodborne illness have been blamed on meat processed at a custom house. Where is there a better quality control, an inspected plant slaughtering 300 to 400 cattle an hour or a custom facility slaughtering a few beeves a day? Fifty such plants account for nearly 98% of the meat production in this country according to a story posted by The New York Times referencing beef analyst Cassandra Fish.⁶

The PRIME Act has over 50 sponsors in the House; the support is there to pass the bill. The biggest weakness in the local food system is the lack of community slaughterhouses. The existing custom houses can’t keep up with the demand. Passage of the PRIME Act is the best way to get additional slaughterhouses online now.

How You Can Make a Difference

Please call your U.S. Representative and Senators asking them to cosponsor the PRIME Act. For more information on the PRIME Act see the previous post and view the latest WAPF action alert posted at www.westonaprice.org under “Get Involved”.

You can look up your two U.S. Senators by selecting your state at www,senate.gov in the “Find Your Senator” field near the top of the webpage and your U.S. Representative by entering your zip code at www.house.gov again at the top of the webpage; you may also call the Capitol Switchboard at 202-224-3121

Article – PRIME Act Reintroduced in Congress
https://www.realmilk.com/prime-act-reintroduced-in-congress/

Action Alert – Tell Congress the PRIME Act is the Best Shot for Small Livestock Farmers!
https://www.westonaprice.org/tell-congress-the-prime-act-is-the-best-shot-for-small-livestock-farmers/

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[1] Mississippi Administrative Bulletin, Rule: Mississippi Department of Agriculture and Commerce. Title 2, Part 1, Subpart 4, Chapter 07, Subchapter 01, Section 111. Amended May 7, 2020. Bulletin, System Number 24883 [entry search parameters: Title 2, dates 5/7/2020] https://www.sos.ms.gov/adminsearch/default.aspx?current_page=Bulletin

Yields amended rule (bulletin entry cited below), retrieved from https://www.sos.ms.gov/adminsearch/ACProposed/00024883b.pdf

“Due to issues related to the COVID-19 emergency and the impact the spread of the disease has had on the meat supply chain, the Department issues this temporary rule in an effort to increase meat availability to consumers. The temporary rule will increase the number of people that can own an animal (cattle, sheep, swine, and goats) from four to multiple owners for the purposes of the custom slaughter exemption of the meat inspection laws. The regulation will be effective for 120 days from May 7, 2020 through September 3, 2020.”

[2] Brandy McGill, “Miss. Dept. of Agriculture changes rules on how farmers can sell meat products”, WDAM7 News, May 17, 2020 (6:17 PM CDT – Updated May 18 at 3:35 PM CDT). PM. Retrieved from https://www.wdam.com/2020/05/18/miss-dept-agriculture-changes-rules-how-farmers-can-sell-meat-products/

[3] Utah Department of Agriculture and Food, “UDAF to Allow Private Custom Meat Plants to Slaughter and Process Livestock for Commercial Sale”, Press Release, April 28, 2020. Retrieved from https://ag.utah.gov/wp-content/uploads/2020/04/2020-4-28-UDAF-Allows-Custom-Meat-Plants-to-Process-Commercial-livestock.pdf

[4] Department of Agriculture, Conservation and Forestry, “Commissioner Beal Calls on USDA to Allow State-Inspected Meat to Cross State Lines during COVID-19 Pandemic”, Maine Government News, May 8, 2020. Retrieved from https://www.maine.gov/tools/whatsnew/index.php?topic=Portal+News&id=2509074&v=article-2017

[5] “DATCP asks USDA for meat shipment flexibility”, Morning Ag Clips, May 6, 2020. Retrieved from https://www.morningagclips.com/datcp-asks-usda-for-meat-shipment-flexibility/

[6] Michael Corkery and David Yaffe-Bellany, “The Food Chain’s Weakest Link: Slaughterhouses”, New York Times, April 18, 2020. Excerpt below retrieved from https://www.nytimes.com/2020/04/18/business/coronavirus-meat-slaughterhouses.html

“After decades of consolidation, there are about 800 federally inspected slaughterhouses in the United States, processing billions of pounds of meat for food stores each year. But a relatively small number of them account for the vast majority of production. In the cattle industry, a little more than 50 plants are responsible for as much as 98 percent of slaughtering and processing in the United States, according to Cassandra Fish, a beef analyst.”

The post PRIME Act Now — Demand Overwhelms Slaughterhouses appeared first on Real Milk.

As expected, the U.S. Food and Drug Administration (FDA) has denied a citizen petition from the Farm-to-Consumer Legal Defense Fund (FTCLDF) and Organic Pastures Dairy Company (OPDC) to lift a ban on the interstate distribution and sale of raw butter.

In a February 27 letter to FTCLDF and OPDC, Mark Moorman, director of the FDA’s Office of Food Safety and Applied Nutrition, stated: “Your petition does not contain facts demonstrating reasonable grounds. . . to allow the interstate delivery or sale or distribution of raw cream butter. Further, your petition does not substantially show that your proposal is in the public interest and will promote the public health objectives of FDA and the statutes we administer.”

Allowing access to a nutritious raw dairy product like butter is not a “public health objective” of FDA. While FDA’s decision wasn’t a surprise, the weakness of its response to the petition was. At the end of the FDA letter was a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized, (1908 to 2003).” There were thirteen outbreaks during that ninety-five-year timeframe attributed to raw butter consumption, with one of the outbreaks occurring in England.

Of those thirteen outbreaks, all but one described the butter as “not specified but commonly unpasteurized” or “not specified.” The one entry listed as “unpasteurized” is a 2001-2002 outbreak where two hundred two people in North Carolina allegedly became ill from butter. This entry conflicts with the CDC’s foodborne illness outbreak database, which attributes the illnesses to “other milk, unpasteurized.” According to published articles, homemade butter was served to elementary school students as part of a demonstration.

Seven of the thirteen outbreaks fail to specify the “total number of illnesses”; one shows “reports of consumer injuries” while six show “NA” (meaning “not available or not reported”).

One of the entries, a 1991 outbreak where two hundred sixty-five people became ill in California and Nevada, lists the implicated food as “blended butter and margarine products.” How often has raw butter been blended with margarine—ever?

Two of the thirteen outbreaks indicate that someone was hospitalized—one person in one case, four in the other. The remainder indicate that no data are available. Only one of the thirteen outbreaks specified whether there were any deaths (six in a 1913 Minnesota outbreak). Again, the remainder indicated that no data are available.

If a petitioner had submitted a graphic to FDA with data this incomplete, the agency would have rejected it out of hand. Even if FDA is correct on the number of outbreaks attributed to raw butter consumption, the total amounts to one outbreak every seven or eight years. If that is the standard for banning a food in interstate commerce, many foods would be illegal.

Much of FDA’s response consisted of disagreeing with the petitioners’ interpretation of various studies regarding butter and pathogenic bacteria, as well as citing challenge tests (such as studies in which butter is inoculated with pathogens, then observed to monitor what happens). Shouldn’t the ultimate determining factor, from a scientific standpoint, be how many people have gotten sick from consuming a food?

The CDC database on foodborne illness outbreaks from 1998-2016 that FTCLDF and OPDC used in their petition to FDA doesn’t blame a single outbreak on commercially produced raw butter, and only one outbreak is blamed on homemade raw butter.

FDA tried to downplay raw butter’s impressive safety track record by pointing to the 1987 interstate ban as the reason there have been almost no outbreaks. However, raw butter sales have been legal in California since the state’s inception.

Mark McAfee, OPDC’s president, stated that his company has sold well over two million pounds of raw butter over the past twenty years without illness. About ten other states allow the sale or distribution of raw butter.

Aside from the small number of foodborne illness outbreaks attributed legitimately or otherwise to raw butter consumption over the past one hundred twelve years, the FDA denial of the petition could be vulnerable to a court challenge in other areas.

The butter ban is illegal according to a statute (21 USC 341) in the Federal Food, Drug and Cosmetic Act that governs “standard of identity” for food, which are requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. For instance, the standard of identity for milk requires that it be pasteurized or ultra-pasteurized and that it contain not less than 3.25 percent milkfat [21 CFR 131.110]. The citizen petition notes that FDA addressed the question of requiring pasteurization as part of a standard of identity regarding milk and found that such health-based requirements were properly addressed as standards of identity stating, “The Commissioner rejects the contention that section 401 of the act does not permit provisions of a standard of identity to be promulgated for health reasons.” [39 Fed. Reg. 42,351 (Dec. 5, 1974)]

Congress has given FDA power to establish standard of identity requirements for most foods but specifically prohibits the agency from doing so for butter. In its response, FDA justified its violation of the standard of identity by claiming the Public Health Service Act gives it authority to require pasteurization for butter as part of its power to regulate communicable disease, a stretch given the food safety track record of raw butter. FDA, in its response, argued that standard of identity was about protecting consumers against economic adulteration and reflecting consumer expectations about food, contradicting its earlier statement that health reasons can also be a factor in these regulations.

A second area where FDA is on weak ground is that, in the lawsuit that resulted in the court order to FDA to impose the ban [Public Citizen v. Heckler, 653 F. Supp. 1229 (D.C. District, 1987)], butter is not mentioned at all in the court record of the case. Butter, like cheese, is considered a manufactured milk product. The lawsuit sought the ban of all raw milk and raw milk products in interstate commerce. The definition of “milk products” in the FDA Pasteurized Milk Ordinance (PMO)—the governing document for the production and distribution of milk and milk products in interstate commerce—does not include butter or cheese.

The court record discussed only dairy products that were listed in the PMO definition of “milk product.” When the court ordered FDA to ban “raw milk” and “raw milk products” it was only those products under that definition.

In its response, FDA claimed the court order banned all products made from raw milk but if the agency is correct in its interpretation, aged raw milk cheeses wouldn’t be legal in the U.S. as they have always been. The impetus for the litigation that resulted in the court order was the lack of FDA enforcement on standard of identity regulations requiring pasteurization for milk and various milk products—because of the statutory prohibition, there is no standard of identity regulation for butter.

FTCLDF is appealing the FDA denial to the federal district in court in the District of Columbia. The appeal to challenge FDA is likely to be costly as it will require paying scientific experts as well as attorneys. FTCLDF could really use your financial support. Overturning the butter ban is a big step toward a day when all raw dairy products will be legal in interstate commerce. To donate specifically to support the case to overturn the FDA decision, please go to farmtoconsumer.org/rawbutter or call (703) 208-3276. The Weston A. Price Foundation has provided $12,000 in support of this cause.

This article was first published in the Spring 2020 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.

Fall 2020 UPDATE: Lawsuit over FDA raw butter petition

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With all the laws on the books today favoring industrial food under the guise of protecting the public health, one that stands out is the federal prohibition on fresh cheese (raw cheese aged less than sixty days). The cheeses whose producers are hurt by the sixty-day aging requirement are the soft-ripened and semi-soft cheeses defined in regulation by FDA in the Code of Federal Regulations, 21 CFR 133.182 and 21 CFR 133.187.

The production and sale of fresh cheese has been legal in Europe for centuries, with an excellent overall track record for safety. Moreover, the legal shelf life of a raw cheese like camembert in Europe is only fifty-five days, mainly due to the increased chance of the growth of listeria after that time; so in the U.S., artisan cheesemakers producing camembert or a similar cheese must wait longer than they should have to in order to get paid while being forced into selling a product that has a higher risk of contamination. Each type of cheese has its own pH and moisture level, two among other factors that need to be taken into account before determining the proper aging time for the cheese.

The FDA has no intention of changing its one-size-fits-all aging requirement for cheese, but a recently published book, titled Ending the War on Artisan Cheese, should help any effort to go in that direction. The book, written by Catherine Donnelly who is a professor of food science and nutrition at the University of Vermont, covers in extensive detail how the FDA’s policies on raw cheese aren’t based on science but rather on creating a climate of fear and intimidation against artisan producers to protect and expand the market share of industrial cheese makers.

The FDA actions Donnelly lists against artisan producers include:

• Inspections, along with product detentions during each inspection, of every cheesemaker (as well as two Whole Foods stores) who attended a 2013 workshop in Georgia titled “Food Safety and Hygiene in Artisan/ Farmstead Cheesemaking” that was cosponsored by the Georgia Department of Agriculture, the Innovation Center for U.S. Dairy and Whole Foods.1 The workshop was designed for small-scale cheesemakers and also included invitations to federal and state inspectors, the thought being that many of the inspectors were “not always knowledgeable about artisan cheesemaking.”2 The inspections and detentions occurred the day after the workshop. As Donnelly states, “the notion that attendance at, or sponsorship of, an educational workshop could subject an artisan cheesemaker or cheesemonger to regulatory scrutiny defeated the very purpose for which these workshops were intended.”3

• The American Cheese Society (ACS) is the leading organization in the U.S. supporting the promotion of artisan, farmstead and specialty cheeses. As Donnelly explains it, “Attendees at the American Cheese Society began to notice some interesting connections between the dates when the annual ACS meetings were occurring and the timing of FDA recall announcements and unannounced visits to their establishments. Cheesemakers would lament that they were unable to bring the quality assurance members of their organization to the ACS annual meetings because it becomes a matter of routine that unannounced inspections from the FDA occur during the ACS meeting.”4

• FDA officers would take cheese from producers for “microbiological compliance sampling,” which then requires cheesemakers to “withhold the production lots being tested from distribution into commerce until results of the FDA’s analysis were returned. Affected companies noticed a pattern: Many times results were released only after the products had reached the end of their sell-by dates. And in most cases, the tested products met compliance criteria: They were salable products that fully complied with regulations, but they could not be sold, because of regulatory targeting and testing of these goods.”5

• In 2009-2010 FDA changed the tolerance level of generic E. coli in raw milk cheese from ten thousand colony-forming units per gram of cheese (cfu/g) and lowered it to ten Most Probable Number (MPN) per gram in “two or more subsamples or greater than one hundred MPN per gram in one or more subsamples.”6 The European Union hasn’t established a generic E. coli tolerance level for raw cheese, only pasteurized cheese. The new tolerance levels effectively prohibited artisans from being able to release significant amounts of their product into commerce. Extensive sampling by FDA from 2004-2006 before the new requirements went into effect showed that about 70 percent of the cheese tested then would not have met the new standard.7 This standard especially created trouble for producers of raw milk soft and semi-soft cheeses; the long acidification times often involved in the production of those cheeses can easily lead to levels above ten MPN. There is no scientific evidence that these new standards lead to safer cheese. Thanks to political pressure, FDA finally halted using the one hundred-to-ten MPN standards in 2016.8

During most of the time FDA actions against artisan cheesemakers were occurring under the aegis of the Center for Food Safety and Applied Nutrition (CFSAN), John Sheehan was the director of FDA-CFSAN’s Division of Dairy, Egg and Meat Products. Monica Metz was the chief for FDA-CFSAN’s Milk and Milk Products Branch; both Sheehan and Metz were former employees of industrial cheesemaker Leprino Foods.9

FDA established the 60-day aging rule in 1950. Donnelly shows that: the regulations were formulated around the behavior of bacterial pathogens such as Salmonella typhi and brucella in Cheddar cheese, the predominant cheese variety produced in the United States in 1950. Cheddar cheese has a low moisture content, high salt content and low pH/high acidity, and these parameters interact to create an environment that is inhospitable to bacterial pathogens, so they die off as cheese ages over the course of sixty days or longer. Not all cheeses share these characteristics, however, and the regulations currently upheld in the CFR have been broadly applied to a number of specified cheese varieties despite scientific evidence that suggests such regulations are inappropriate for certain cheeses, such as soft-ripened varieties like Brie and Camembert.10

For reasons of food safety and quality, soft and semi-soft cheeses should have shorter aging requirements. While it’s true that soft and semisoft cheese have been responsible for more foodborne illness outbreaks than hard cheeses, there is plenty of evidence that these cheeses can be produced safely.

Donnelly herself has been part of a successful effort to produce safe raw cheese through her work with the Vermont Institute for Artisan Cheese (VIAC), which has developed risk reduction protocols and process control measures for Vermont artisan cheesemakers that have resulted in more sanitary facilities. When FDA conducted nationwide environmental sampling for listeria at soft cheese firms, not a single Vermont cheese facility tested had a positive test for listeria out of one hundred to three hundred environmental swabs taken at each facility.11

FDA has more than shown it is interested only in destroying artisan cheesemakers, but the legislative process is a vehicle to lower and/or eliminate aging requirements to allow the sale of fresh cheese. There is no prohibition against the sale of unaged raw cheese in intrastate commerce; Wyoming, Kansas and some seventy to eighty towns in Maine currently allow the direct producer-to-consumer sale of fresh raw cheese. Fresh cheese is a great opportunity for small farmers and local artisans to produce a safe, nutritious product. The demand and the safety protocols are in place to make that happen.

REFERENCES

1. Catherine W. Donnelly, Ending the War on Artisan Cheese: The Inside Story of Government Overreach and the Struggle to Save Traditional Raw Milk Cheesemakers. White River Junction, Vermont: Chelsea Green Publishing, 2019. Paperback, p. 94.
2. Ibid.
3. Ibid.
4. Ibid., p. 127.
5. Ibid.
6. Ibid., pp. 57-58 citing from “Compliance Policy Guide Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity,” Federal Register notice of availability, December 23, 2010.
7. Ibid., p. 67.
8. Ibid., pp. 69-70 referring to an FDA press release, “Constituent Update,” February 8, 2016; accessible 3/11/2020 at https://www.fda.gov/food/cfsan-constituent-updates/fda-taking-new-look-criteria-raw-milk-cheese.
9. Ibid., p. 106 citing about Monica Metz from Barbara Boland, “Former employee of ‘big cheese’ wrote FDA letter that put NY artisan cheese makers out of work”, CNSNews, June 13, 2014. Accessed 3/11/2020 at https://www.cnsnews.com/mrctv-blog/barbara-boland/formeremployee-big-cheese-wrote-fda-letter-put-ny-artisancheese-makers. [Note: Confirmed from “Experience” listed on LinkedIn for John Sheehan as quality control manager for Leprino 1988-2000; accessed 3/11/2020 at https://www.linkedin.com/in/john-sheehan-94a0588]
10. Ibid., p. 21.
11. Ibid., p. 92-93.

This article was first published in the Spring 2020 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.

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