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

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The late Dr. Theodore (Ted) Fairbank Beals, MD, made significant contributions to bringing more science into dialogues about raw milk benefits and risks.

Dr. Beals was instrumental in obtaining data through the Freedom of Information Act (FOIA) from U.S. states that monitor microbes in raw milk from farms licensed at the state level. Dr. Beals introduced these FOIA data to readers of this journal before his death last year in 2021.¹

My collaborators and I share the belief articulated by Dr. Beals that policies without a sound basis in scientific evidence cannot promote health and well-being in the populations subject to those policies. Yet, policies around pasteurizing raw milk, both human donor breastmilk and milk from ruminants, are not based on 21st-century scientific evidence. This article will introduce readers to highlights from the FOIA data project report and provide information about its application in Microbial Risk Assessment (MRA) (See below).

HIGHLIGHTS OF THE FOIA DATA AND EXPOSURE ASSESSMENT

The objective of our project was to summarize the data from routine testing for microbial pathogens in fresh unprocessed milk from licensed farms obtained by FOIA through Dr. Beals as mentioned above. Results from the Microsoft Access database project are summarized in Table 1 below.²

A more extensive table on pathogen testing results for raw milk was developed from multiple documents, which summarized the data from FOIA as well as data from multiple countries (Canada, Finland, Germany, Poland, U.S., and U.K.). The overall results are shown in Table 2 below.³ Note that pathogens were detected in 0.01 percent or fewer of all samples.

Although just knowing data on the occurrence (frequency or rates of pathogen positives) in foods is insufficient to estimate risk, it is reasonable to ask how a food with such extensive recent data from around the world documenting that more than 99 percent of routine samples were undetectable for major foodborne pathogens is an “inherently dangerous food.” From my experience, experts with pro-pasteurization biases provide no recent evidence or analysis that supports this opinion.

TABLE 1. Results Reported under FOIA on Detection of the Presence of Major Microbial Pathogens in Raw Milk from Licensed Dairy Farms in Four State Sampling Plans.²

TABLE 2. Recent Results on Pathogen-Positive Rates in Raw Milk Reported in Peer-Reviewed Studies and Recent FOIA Data.³

MICROBIAL RISK ASSESSMENT

Microbial or Microbiological Risk Assessment (MRA) is a rigorous interdisciplinary process organized around a consensus framework ratified in 1999 by the one hundred sixty-three member countries of the Codex Alimentarius Commission.^11,20 MRAs may apply qualitative methods and report categories of risk levels (such as negligible, low, moderate, high risk) or quantitative methods (QMRAs) and report risk estimates per year or per serving.

Foodborne risk is estimated by conducting a series of discrete and interconnected technical analyses illustrated in Figure 1.²¹ These involve:

• Hazard Identification
• Exposure Assessment
• Dose-Response Assessment
• Risk Characterization

This article emphasizes Exposure Assessment because the data received through the Freedom of Information Act (FOIA)1 and the growth study are useful for estimating and assessing the likelihood and magnitude of pathogen exposures to consumers in servings of contaminated foods.

It’s important to understand one basic principle of Dose-Response Assessment: as the number of pathogens ingested increases, the frequency (likelihood) and severity of illness increases. “Low levels equal low risk.”²²

Some key general principles of the eleven listed in the 1999 consensus document on principles and guidelines for Microbiological (Microbial) Risk Assessment11 are as follows:

1=Microbiological Risk Assessment should be soundly based upon science.
5=The conduct of a Microbiological Risk Assessment should be transparent.
11=A Microbiological Risk Assessment may need reevaluation, as new relevant information becomes available.

GROWTH AND SURVIVAL OF PATHOGENS

Regarding growth and survival of pathogens for exposure assessment, analysts may select growth models that intentionally over-estimate risk, such as using data for optimal growth of pathogens in pure culture broth.

However, a recent pilot study conducted by a certified laboratory4 and funded by the Raw Milk Institute (RAWMI) documented the inability of the major bacterial pathogens to grow in raw milk for a week of storage at the temperature that U.S. regulatory agencies recommend for refrigerated foods: 4.4 °C (40°F).⁵

20TH vs 21ST-CENTURY SCIENCE

Many 21st-century studies of the microbiota of milk^3,6 are inconsistent with beliefs based on 20th century science. Certainly, 20th-century science, opinions and beliefs selected by Food Standards Australia New Zealand (FSANZ)7 in 2009 swayed the Toronto judge in the recent decision maintaining Canada’s prohibition on access to raw milk.⁸ The judge apparently believed the pro-pasteurization argument that milk should be sterile and the microbes present are the result of fecal contamination.

Apparently, the Toronto judge relied on an outdated quantitative method whose models simulated not data from sound scientific studies, but a series of worst-case assumptions, extrapolations and opinions that intentionally overestimated risk and underestimated uncertainty. Further, the judge and others mistakenly assumed that evidence from outbreaks was sufficient to estimate risk, while evidence from predictive microbiology was excluded, dismissed or ignored.

Contrary to FSANZ’s view, pathogens in feces are not predictive of pathogen presence or levels in raw milk. My recommendations to FSANZ from a technical review⁹ included abandoning its outdated views on fecal contamination for raw milk and conducting a reassessment of their 2009 simulations using recent evidence for benefits and risks.

I am not the only scientist to question the assumptions and outputs of the 2009 FSANZ simulations. The European Food Safety Authority (EFSA)¹⁰ also considered the FSANZ 2009 report and peer-reviewed publications on more recent risk assessments for raw milk. EFSA concluded that risks for raw milk consumers can be mitigated and reduced significantly by controlling temperature, limiting shelf life and engaging consumer compliance with controls (that is, maintaining proper refrigeration temperatures for raw milk).

Further, EFSA concluded that many potential pathogens are not main hazards to consumers in the European Union including Listeria monocytogenes and Staphylococcus aureus.

Those familiar with New York state regulations for raw milk monitoring may be puzzled about the EFSA determination that these two pathogens are not considered main hazards to raw milk consumers. In fact, farmers who pay the licensing fee in New York state are paying for routine testing for two pathogens never linked to an outbreak associated with raw milk in the state, based on data obtained from the Centers for Disease Control (CDC).

The FSANZ modeled or simulated potential risk based on a series of intentionally conservative (biased) assumptions and indirect or extrapolated data that have not been validated then or since. FSANZ seems to have selected assumptions, opinions and extrapolations that exaggerated risks and underestimated uncertainties, consistent with their pre-conceived pro-pasteurization bias articulated throughout the report.

The FSANZ simulations were not soundly based on science, nor were alternative assumptions tested to increase transparency. In short, FSANZ did not comply with principles and guidelines stipulated from international consensus.¹¹ My peer review of the FSANZ report,⁹ undertaken twelve years after its release, identified many relevant studies available before release of the report that were intentionally or inadvertently excluded by FSANZ. I strongly recommended that FSANZ update the assessment and incorporate scientific data from technological advances of the last decade to improve the credibility of the assessment.⁹

Fear and dread of many (or all) microbes as “germs” that will kill us (germophobia) appear to factor strongly into policies requiring pasteurization and regulations on the presence of potential pathogens, not their levels or their risk for causing illness. The fear of microbes as “germs” appears to be entrenched even among well-meaning scientists and regulators in misconceptions of 20th-century science, and wall them off from any consideration of the tremendous advances in knowledge about the microbiota of milk, particularly the rich body of evidence for both benefits and risks of raw milk from both humans6 and cows.³ At present, the pasteurization and zero-tolerance policies for potential pathogens in raw milk appear inconsistent with the available evidence and the state of the science in the 21st century.

FUTURE FOR EVIDENCE-BASED POLICIES ON RAW AND PASTEURIZED MILK

Readers of Wise Traditions may be aware that many factors influence what is published and what is rejected about science and its applications in risk assessment. According to a recent report by the National Science and Technology Council,¹² novel scientific discoveries that challenge established dogmas may be suppressed, manipulated and inappropriately influenced by political pressures and interference to distort outcomes to maintain the status quo or meet preferred policy objectives or decisions. To quote from this report, scientific integrity can be impeded by “mischaracterizing, fabricating, removing, or disregarding relevant scientific information.” Undoubtedly, there is great need for developing or improving evidence-based decisions guided by the best available science and data, recognizing that scientific and technological information and data are central to the development and iterative improvement of sound policies. The report further describes political interference as “inappropriate, scientifically unjustified intervention in the conduct, management, communication, or use of science.”

Just as scientists are not unbiased or immune to economic, political and social pressures, neither are editors and reviewers for scientific journals. A recent New York Times article by Gina Kolata and Benjamin Mueller13 mentioned an innovative scientific paper “summarily rejected” by two prestigious journals (Nature and Science) before its eventual acceptance in a “niche publication called Immunity.” Similarly, our work on bovine milk was rejected by two scientific journals before acceptance by the Open Access journal Applied Microbiology. Certainly, my co-authors and I improved the publication and its communication of the evidence map work in responding to reviewers in three separate peer-review processes. However, I have no doubt that pro-pasteurization biases delayed publication of a comprehensive and simultaneous analysis of benefits and risks for raw milk for more than two years.

If you followed the Toronto case involving raw milk farmer Michael Schmidt, you may have realized that the U.S. government is on record for attempting to interfere with an independent scientific journal that published the 2018 Whitehead and Lake analysis of CDC data on raw and pasteurized milk outbreaks (see Table 3).¹⁴ The U.S. government expert (Mr. John Sheehan, FDA) testified that U.S. government analysts were working to repeat both the Whitehead and Lake analysis (2018) and a subsequent analysis of the same data by statistician Dr. Nick Azzolina¹⁵ who submitted an affidavit with his analysis of the same CDC dataset. The important point is that for the years 2005-2017, the CDC recorded more illnesses from campylobacter and listeria in pasteurized milk compared to raw. I am collaborating with Nick Azzolina, Joanne Whitehead, Bryony Lake and Michele Stephenson to extend the analysis for more recent outbreak data from the CDC for 2005 to 2019.

In cross-examination, Toronto attorney Ian Blue asked the government official whether the results of their reanalyses would be published if consistent with prior analyses. To date, I am aware of no subsequent publication that either refutes or confirms the findings of Whitehead and Lake or Azzolina. Yet the Toronto judge appears to have succumbed to blatant political intrusion and aligned her decision with the unsupported opinions of the government official over independent statistical analysis of U.S. outbreaks by an accomplished statistician.

Clearly, processes for scientific peer review are subject to political and other pressures. Yet, peer-reviewed studies are crucial to providing credible evidence about raw milk benefits and risks to courts, legislatures and regulatory agencies around the world. Even when some opinions and claims are made that pasteurization is a silver bullet that decreases risk and increases benefits to consumers, peer-reviewed studies with robust statistical analysis are crucial to helping judges, legislators and regulators to properly acknowledge and weigh the evidence.

TABLE 3. CDC Outbreak Data for Two Pathogens.¹⁴

RECOMMENDED DAILY ALLOWANCES FOR MICROBES?

A question that may be of interest to WAPF members concerns the concept of expanding Recommended Daily Allowances (RDAs) for vitamins to RDAs for microbes.^16,17 These studies were the subject of my Society for Risk Analysis webinar last year entitled “Resilience and the Human Superorganism: Give Us this Day Our Daily Microbes.”¹⁸ Foods naturally enriched in microbes, including raw milk¹⁹ and fermented foods (such as cheese, kefir, kimchi and kombucha), certainly could contribute to RDAs for microbes.

I strongly believe that questions from raw milk stakeholders are essential for consideration of the evidence (or lack thereof) behind pasteurization policies and monitoring requirements for farms licensed to sell raw milk. Consumers deserve to have a voice in decisions about pasteurizing donor breastmilk and cow milk, particularly to maintain and extend freedom of choice to consumers around the world.

In summary, recent research on the benefits and risks of raw milk³ does not support the outdated assumptions that raw milk is inherently dangerous, and that existing hygiene management programs, including Hazard Analysis and Critical Control Points, and Test-and-Hold Programs, cannot ensure a safe, low-risk product for raw milk consumers.

This article was first published in the Spring 2023 issue of Wise Traditions in Food, Farming, and the Healing Arts, the quarterly journal of the Weston A. Price Foundation.

ABOUT THE AUTHOR

Peg Coleman, MS, is a medical microbiologist, a microbial risk assessor and a fellow of the Society for Risk Analysis (SRA). Her long career as a microbial risk assessor began with the U.S. federal government (USDA/FSIS) and continues as a consultant. Her primary interests are benefit-risk analysis and resilience of human superorganisms, Homo sapiens complete with microbial partners in health.

ACKNOWLEDGMENTS

I am deeply grateful for contributions from WAPF, the Raw Milk Institute (RAWMI) and others through a 2018 crowdfunding campaign (Whole Truth, Whole Milk) through the Society for Risk Analysis (SRA) that provided partial support for preparing the two evidence map publications.^3,6 I appreciate ongoing support from Mark McAfee of RAWMI and Sally Fallon Morell of WAPF. I strongly value the opportunity to serve on the advisory board of RAWMI. I acknowledge support from Mark McAfee of RAWMI and Abby Rockefeller of Churchtown Dairy on the pathogen growth study project.

REFERENCES

1. Beals T. Observations on the collection of fresh unprocessed milk samples from states regulating dairies: There are two kinds of milk. Wise Traditions. Summer 2021;22(2):97-100. https://www.westonaprice.org/wp-content/uploads/Summer2021.pdf
2. Stephenson M, Coleman ME. Final report: Database of primary microbial testing program data for raw milk stored in Microsoft Access®. Coleman Scientific Consulting, Aug. 27, 2021. Available at https://www.realmilk.com/database-of-primarymicrobial-testing-program-data-for-raw-milk-storedin-microsoft-access/.
3. Dietert RR, Coleman ME, North DW, Stephenson MM. Nourishing the human holobiont to reduce the risk of non-communicable diseases: A cow’s milk evidence map example. Appl Microbiol. 2022;2(1):25-52.
4. Brandt AL. Determination of Growth Rate of Salmonella enterica spp., E. coli O157:H7, Campylobacter spp., and Listeria monocytogenes in Raw Milk. Food Safety Net Services, Mar. 15, 2022. Available for download at https://www.rawmilkinstitute.org/updates/pathogen-growth-in-raw-milk?rq=determination%20of%20growth%20rate%20of%20salmonella.
5. Smith S. How well do pathogens grow in raw milk? Raw Milk Institute, Mar. 16, 2022.
6. Coleman ME, North DW, Dietert RR, Stephenson MM. (Examining evidence of benefits and risks for pasteurizing donor breastmilk. Appl Microbiol. 2021;1(3):408-425.
7. Food Standards Australia New Zealand. Microbiological Risk Assessment of Raw Cow Milk. Risk Assessment Microbiology Section, Dec. 2009. https://www.foodstandards.gov.au/code/proposals/documents/P1007%20PPPS%20for%20raw%20milk%201AR%20SD1%20Cow%20milk%20Risk%20Assessment.pdf
8. Affleck v. The Attorney General of Ontario, 2021 ONSC 1108 (CanLII). https://www.canlii.org/en/on/onsc/doc/2021/2021onsc1108/2021onsc1108.html
9. Coleman ME. Improving the Credibility of the Food Standards Australia New Zealand Report Entitled Microbiological Risk Assessment of Raw Cow Milk (2009) Considering New Evidence. Report submitted to Australian Raw Milk Movement, July 26, 2021. Available at https://www.ausrawmilk.org/.
10. European Food Safety Authority (EFSA) Panel on Biological Hazards. Scientific opinion on the public health risks related to the consumption of raw drinking milk. EFSA Journal. 2015;13(1):3940.
11. Codex Alimentarius Commission (CAC). Principles and Guidelines for the Conduct of Microbiological Risk Assessment. 1999. Accessed Mar. 8, 2021 at https://www.fao.org/3/y1579e/y1579e05.htm.
12. National Science and Technology Council. Protecting the Integrity of Government Science. Scientific Integrity Fast-Track Action Committee, Jan. 2022. https://www.whitehouse.gov/wp-content/uploads/2022/01/01-22-Protecting_the_Integrity_of_Government_Science.pdf
13. Kolata G, Mueller B. Halting progress and happy accidents: how mRNA vaccines were made. The New York Times, Jan. 15, 2022.
14. Whitehead J, Lake B. Recent trends in unpasteurized fluid milk outbreaks, legalization, and consumption in the United States. PLoS Curr. 2018;10:ecurrents.outbreaks.bae5a0fd685616839c9cf857792730d1.
15. Azzolina NA. Summary Report: Statistical Analysis of Raw Milk-Related Outbreaks, 2005-2016, 2019, as reported in Supplemental Table 1 from Whitehead and Lake, 2018. Analysis funded by RAWMI and submitted subsequently as an affidavit for the Toronto case.
16. Hill C. RDA for microbes—are you getting your daily dose? Biochem (Lond).2018;40(4):22-25.
17. Marco ML, Hill C, Hutkins R, et al. Should there be a recommended daily intake of microbes? J Nutr. 2020;150(12):3061-3067.
18. Society for Risk Analysis. Resilience and the human superorganism: Give us this day our daily microbes. June 2, 2021. https://www.sra.org/webinar/resilience-andthe-human-superorganism-give-us-this-day-our-daily-microbes/
19. Oikonomou G, Addis MF, Chassard C, et al. Milk microbiota: What are we exactly talking about? Front Microbiol. 2020;11:60.
20. LeJeune JT, Zhou K, Kopko C, Igarashi H. FAO/WHO joint expert meeting on microbiological risk assessment (JEMRA): Twenty years of international microbiological risk assessment. Foods. 2021;10(8):1873.
21. Coleman ME, Dietert RR, North DW, Stephenson MM. (2021). Enhancing human superorganism ecosystem resilience by holistically “managing our microbes.” Appl Microbiol. 2021;1(3)471-497.
22. Chen Y, Ross WH, Scott VN, Gombas DE. Listeria monocytogenes: low levels equal low risk. J Food Prot. 2003;66(4):570-577.

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For the fourth time in 2 years, the North Dakota Department of Health (NDDH) is trying to water down the state cottage food law, also known as the 2017 North Dakota Food Freedom Act (FFA). The FFA allows the unregulated sale by producers direct to consumers except those foods that have either meat or raw dairy as an ingredient. NDDH has issued proposed regulations that would make illegal the unregulated sale of a number of foods that are currently legal under the 2017 law. In doing so, NDDH is overstepping its authority and is arguably hurting food safety; the proposed regulations are not about food safety–they are about control.

The FFA clearly states, “Notwithstanding any other provision of law, a state agency or political subdivision may not require licensure, permitting, certification, inspection, packaging, or labeling that pertains to the preparation or sale of cottage food products under this section….” Under the FFA, “cottage food product” means “baked goods, jams, jellies, and other food and drink products produced by a cottage food operator”; it was the NDDH that actually convinced the legislature to adopt this definition for the FFA. The legislature initially included the unregulated sale of raw dairy products in the FFA but pulled those foods out of the bill. The FFA excludes the sale of any uninspected products made from meat. There is no exclusion on any other foods in the FFA.

Shortly after the legislation passed in 2017, NDDH issued a guidance document for the FFA that prohibited the sale of a number of foods other than meat and raw dairy. FFA supporters didn’t abide by NDDH’s interpretation of the law; in 2018 the department followed up with proposed rules that would have again banned the unregulated sale of foods that are legal under the FFA. When food freedom proponents and members of the legislature defeated that effort, NDDH through its allies in the legislature introduced a bill in the 2019 session to roll back the FFA. The legislation, Senate Bill 2269 (SB 2269), as introduced would not only have prohibited the unregulated sale of a number of legal foods but also would have banned the unregulated sale of all drink products. The House of Representatives eventually killed the bill. SB 2269 represents the only legal attempt NDDH has made to dilute the FFA.

The proposed regulations have a number of the same changes that were in the bill that the legislature rejected. Among other things, the bill would have changed the law by making the unregulated sale of low-acid canned foods such as carrots, beets or beans illegal. The rules would prohibit the sale of unrefrigerated foods unless they are frozen–foods such as banana cream pie, potato salad, and carrot and celery sticks would all be affected. The proposed rules define “frozen foods” as foods maintained at temperatures no higher than zero degrees Fahrenheit.

The FFA allows the sale of all foods subject to time and temperature control other than those with meat or raw dairy as an ingredient. The proposed rules would limit the sale of time-and-temperature-control foods to baked goods (e.g., cream pies that are “frozen”) and home processed fresh-cut fruits and vegetables that are either “dehydrated or freeze-dried” or “blanched and frozen” ( i.e., no longer fresh).

The FFA specifically states that no government agency can require licensure for anything pertaining to the preparation of cottage food products, but that is what NDDH is trying to do in prohibiting the unlicensed sale of many foods that are currently legal to sell without a license. There are also labeling and certification requirements elsewhere in the proposed rules, both in violation of the FFA.

Beyond the proposed rules exceeding NDDH’s authority, what makes the department’s action a waste of taxpayer dollars is that in the two-plus years the FFA has been in effect, there has not been a single case of foodborne illness attributed to a producer operating under the state cottage food law. Cottage foods are thriving in the state, bringing in an estimated $1.5 million per year for producers and their families.¹ The rules are a “solution” in search of a problem.

The experience of other states allowing the unregulated sale of time-and-temperature-control foods is similar to North Dakota. Towns in Maine have allowed the selling without regulation time-and-temperature-control foods direct from producer to consumer other than meat and poultry as far back as 2011 under local food sovereignty ordinances; no case of foodborne illness has been attributed to any producer operating under the ordinance. Under the Wyoming Food Freedom Act, producers in that state can sell any food product other than meat without regulation; in the 4-1/2 years since the law went into effect, no one operating under the Act has been found to make anyone sick. The same goes for the Utah Homemade Food Act which went into effect over a year-and-a-half ago, that Act allows the sale of all foods other than meat and raw dairy from the producer direct to the consumer without regulation.

The track record in these states indicates that NDDH’s proposed rules would hurt food safety in North Dakota if they become law. Some producers currently selling under the FFA will not be able to afford the cost of compliance if a license is required for the foods they sell require; others currently producing safe and nutritious food will stop if the law requires them to get a license because they don’t want a government inspector in their home kitchens. Fewer local producers will likely result in more purchases of industrial food which has a higher rate of foodborne illness outbreaks then foods produced under the FFA. The more producers operating under the cottage food law the better the public health is served. Instead of trying to dilute the FFA, there are ways NDDH could be spending taxpayer dollars productively to work with cottage food producers. Farmer LeAnn Harner, a leader in the North Dakota Food Freedom Movement, pointed out that the department could help provide education, equipment, and free testing of recipes to cottage food producers.² The more cottage food producers there are, the safer the food supply, the stronger the local economy, the more self-sufficient communities will be in food production, and the better the health of North Dakota residents.

NDDH has a chance to be an agency that promotes the production and sale of nutritious food rather than being a bureaucracy that restricts it or, in the words of North Dakota Representative Daniel Johnston (R-Kathryn), “the Department of Control”.³

North Dakota residents have until October 12th to comment on the proposed rules. It is important to call and or email NDDH asking that they withdraw the proposed rules. The phone number for the Division of Food and Lodging is 1-701-328-1291 or 1-800-472-2927; the email address is foodandlodging@nd.gov.

Please take action now.

If you are a producer affected by the proposed rules, let NDDH know what products you sell and how the Food Freedom Act has helped your business.

Consumers should let NDDH know what healthy nutrient-dense products the Food Freedom Act has enabled them to purchase direct from producers.

</ br>

———

[1] Harner, LeAnn. “Testimony of Cottage Food Rules”. North Dakota Department of Health hearing on proposed rules, Bismarck, North Dakota. October 2, 2019.

[2] Ibid.

[3] Dura, Jack. “North Dakota Department of Health accused of ‘arrogance’, confusion in proposed cottage food rules”, Bismarck Tribune, October 2, 2019. Accessed at https://bismarcktribune.com/news/local/govt-and-politics/north-dakota-department-of-health-accused-of-arrogance-confusion-in/article_d800a478-ac7d-5a88-8a6c-2f841cf81b96.html

</ br> photo by XXX from Pixabay

The post The Department of Control Strikes Again 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 media have been taking their cues from press releases issued by public health departments that have been giving the advice to pasteurize all milk. However, the solution to avoid getting brucellosis is far different from what public health and the media are telling you. In the words of one healthcare professional, “For public health officials to issue public notices that the solution to this avoidable problem is to pasteurize all milk, is astonishing.”

First off, the three cases of brucellosis are the only known cases attributed to raw milk consumption over the past 20 years. Brucellosis is a systemic disease in cattle and humans that is caused by the bacteria Brucella abortus. At one time the disease in cows caused severe reductions in offspring and was a problem for the cattle industry. A national eradication campaign was launched in the 1950s and, according to USDA statistics, the number of cattle/bison herds affected by brucellosis in the U.S. has been less than 10 every year from 2003 onward.¹

The eradication program’s success has led to a huge decline in the number of brucellosis cases in humans; estimates are that there are about 100 cases of human brucellosis per year in this country.² In the U.S. this is mainly an occupational disease with most of the rare cases of brucellosis being in people who attended the birth of an infected cow and then became infected during handling of the birth tissues and fluids.^3,4

In an infected dairy cow, the Brucella abortus pathogen can proliferate in the mammary glands and then enter the milk. The pathogen can pass to humans when drinking the infected milk but, as mentioned, the cases of brucellosis (also known as undulant fever) attributed to drinking raw milk in the U.S. are extremely rare.

The “milk ring test” is the traditional and commonly used method to screen dairy herds to detect any cows with brucellosis; the test is performed on the herd’s milk to check for the rare presence of Brucella antibodies.

Two vaccines against brucellosis have been developed for calves: the S19 vaccine and the RB51 vaccine. The S19 vaccine is effective but it has the disadvantage of causing testing for antibodies to become positive. The vaccine can make it difficult to distinguish between a vaccinated cow and an infected cow. The RB51 vaccine does not cause the antibody testing of cows to become positive but another problem arises with its use.

The RB51 vaccine must be administered to calves before they become fertile; a side effect is that, if a cow is given the RB51 vaccine when pregnant, it may actually cause an infection with the vaccine strain of Brucella in the vaccinated cow. It is, therefore, possible that if the RB51 vaccine isn’t given strictly according to the protocol, the vaccinated cow may become infected and may shed the pathogen (i.e., the RB51 strain of Brucella) into the milk.

Public health officials have found in all three cases of illness from brucellosis attributed to raw milk consumption, the strain of Brucella abortus discovered in the three individuals was the RB51 vaccine strain. In fact, in November 2017, the Pennsylvania Department of Agriculture sent a letter to licensed raw milk producers in the state advising them to stop immunizing cows from brucellosis with the RB51 vaccine.⁵

So the solution to preventing brucellosis in raw milk is not for producers to pasteurize the milk but rather to either stop giving their herd the RB51 vaccine or to make sure their vets give the calves the vaccine before the calves become fertile. Worth noting, too, is that hundreds of people drank raw milk produced by the herds responsible for the three cases of brucellosis and, as far as is known, no one else became sick.

In the meantime, the media fear-mongering continues on. The latest case of brucellosis attributed to raw milk consumption dates back to November 2018, but to read the stories in the media, you would have thought it was just discovered. CDC press releases on this latest case dated January 23, 2019, and February 11, 2019, are providing the impetus for the flood of media reports.

Has an agenda ever gotten so much mileage over three illnesses?

A fear-inciting statement from the February 11 CDC press release that the media have parroted is, “the CDC and state health officials are investigating potential exposures, to Brucella strain RB51 in 19 states, connected to consuming raw (unpasteurized) milk from Miller’s Biodiversity Farm in Quarryville, Pennsylvania.”⁶ (The farm allegedly distributed raw milk to people in the 19 states listed later in the release.) Being exposed to a pathogen is far different than being sickened by it; we are exposed to various pathogenic bacteria such as listeria and e. coli in the environment every day.

One headline screamed, “Deadly Disease Caused by Raw Milk Has Already Put 19 U.S. States on High Alert.”⁷ There have been no deaths from brucellosis attributed to raw milk consumption since the eradication program succeeded in substantially eliminating the incidence of the disease and possibly even long before then.

The public health agencies and their allies in the press have been misleading the public long enough on raw milk and brucellosis. It’s time for fear and hysteria to give way to science and common sense.

——
¹ “Brucellosis Affected Cattle/Bison Herds by State, FY 1997-2018” graph [PDF]. USDA-APHIS National Brucellosis Eradication Program (September 10, 2018), https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-brucellosis-eradication/brucellosis-eradication-program

² “Facts About Brucellosis” [PDF]. USDA-APHIS National Brucellosis Eradication Program, Section “Resources” link (see question #21), https://www.aphis.usda.gov/animal_health/animal_diseases/brucellosis/downloads/bruc-facts.pdf

³ “How Brucellosis is Spread” section. USDA-APHIS National Brucellosis Eradication Program (September 10, 2018) [PDF], https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-brucellosis-eradication/brucellosis-eradication-program

⁴ “Fast Facts: Brucellosis, Undulant Fever” [PDF]. Iowa State University, The Center for Food Security & Public Health. April 2008, http://www.cfsph.iastate.edu/FastFacts/pdfs/brucellosis_F.pdf

⁵ Letter dated November 30, 2017 [PDF]. Pennsylvania Department of Agriculture, Bureau of Animal Health and Diagnostic Services, Dr. David Wolfgang (Director) and Dr. Lydia Johnson (Director, Bureau of Food Safety & Laboratory Services); accessed at https://www.yourfamilyfarmer.com/uploads/documents/RB51-Brucellosis-Letter-PDA-2017.pdf

⁶ Media Statement [PDF]. CDC (February 11, 2019),
https://www.cdc.gov/media/releases/2019/s0211-brucellosis-raw-milk.html

⁷ “Deadly Disease Caused by Raw Milk Has Already Put 19 U.S. States on High Alert” [PDF]. ScienceAlert.com, Carly Cassella (February 15, 2019), https://www.sciencealert.com/it-s-dangerous-to-drink-raw-milk-the-cdc-warns-for-the-umpteenth-time

The post Cutting Through the Propaganda on Raw Milk and Brucellosis appeared first on Real Milk.

The way FDA is interpreting these regulations, many local food producers will be under FDA‘s jurisdiction and subject to inspection by the agency, possibly even including a home kitchen producing cottage foods. The biggest potential problem for local food producers is not going to be the HARPC requirements but rather the CGMP mandate.

HARPC–Who Is Exempt?
HARPC does not apply to any business manufacturing, processing, packing or holding food that is not required to register with FDA as a “food facility.” There are a number of exemptions from the registration requirements; the exemption most applicable to local food producers would be the one for “farms” and “retail food establishments.“⁵

“Farm” is defined, in part, as “an operation under one management in one general physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood) or any combination of these activities.⁶ The term “farm“ also includes “packaging and labeling raw agricultural commodities when these activities do not involve additional manufacturing/processing. Farmers growing/raising and selling raw milk, eggs, raw honey⁷, whole fruits and vegetables⁸, meat from amenable species (cattle, hogs, sheep, goats and poultry)⁹ or any combination of the above foods would qualify as a farm and be exempt from the registration requirement. The farmer/producer selling any processed fruits and vegetables (with one exception)¹⁰, any products processed from raw milk, maple syrup¹¹ or any meats from non-amenable species (e.g., rabbit, bison, deer, elk)¹² would result in the loss of the “farm“ exemption from registration.

If the farm business doesn’t qualify as a “farm“, it can still be exempt from the registration requirement if it qualifies as a retail food establishment. A business qualifies as a retail food establishment if over half of the “annual monetary value of its sales of food products are direct to consumers.¹³ This would include sales of all food products sold by the farmer/artisan not just food products that the business produced.

For those not aware of the “farm” or “retail food establishment” exemption who have registered with FDA, it is recommended—if your business qualifies as a farm or retail food establishment—that you contact FDA and request that it cancel your registration. If FDA independently verifies that your business is not required to register, it will cancel your registration.¹⁴

Those registering with FDA as a food facility with less than $1 million in annual sales are eligible for a “qualified facility” exemption from the HARPC requirement.¹⁵ To obtain the exemption, eligible facilities must submit form FDA 3942a to the agency by December 17, 2018 (those facilities starting up their business after September 17, 2018, must submit the same form before beginning operations).¹⁶ According to FDA’s Outreach Info Center, form 3942a will be available September 19; currently, only a draft version of the form is in circulation.

On the form, those seeking the exemption must attest that they are a qualified facility¹⁷ (e.g., a “very small business“) and either that they “have identified the potential hazards associated with the food being produced, are implementing preventative controls to address the hazards, and are monitoring the performance of the preventative controls to ensure that such controls are effective“¹⁸ or that they are in compliance with state or other applicable non-federal laws and include evidence of regulatory oversight¹⁹ (e.g., licenses, permits). Beginning in 2020, those seeking the exemption must submit form 3942a every two years.²⁰ Under certain circumstances, FDA can revoke the qualified facility exemption.²¹

CGMPs
The CGMP requirements are where FDA will directly regulate local food producers. FDA has been low-key about to whom it will apply the CGMP requirements²², but a read of the regulations indicates that FDA can apply them to local food. Unlike the HARPC requirement, small farms and local artisan producers will have no exemption from the CGMP mandate based on their revenues. Among those exempt from the CGMP are: producers exclusively under USDA jurisdiction (e.g., producing and selling only beef, pork, lamb, goat and poultry products); and farms meeting the “farm” definition discussed above. It appears all, or nearly all, other local food producers will be subject to the CGMPs. According to FDA, the CGMP requirements apply even to businesses operating only in intrastate commerce.²³

CGMPs are a one-size-fits-all regulatory scheme–easily subject to varying interpretation by inspectors–that contain requirements for personnel²⁴, plants and grounds²⁵, sanitary operations²⁶, sanitary facilities and controls²⁷, equipment and utensils²⁸, processes and controls²⁹, warehousing and distribution³⁰, holding and distributing distribution of human food by-products for use as animal food³¹, and the defect action levels³². These are requirements that state legislatures should be determining but FDA wants to regulate as much food and as many food producers as possible. Value-added products are where the money is; FDA wants to have jurisdiction over all of these products, no matter how small the food producer is.

The FDA Bootstrap
As far as is known, Congress never brought up CGMPs when the Food Safety Modernization Act was under consideration but FDA took advantage of the broad power the Act gave it to issue regulations and bootstrapped the CGMP requirements into FSMA. FDA had long contended that FDA could regulate intrastate food commerce under powers granted it by the Public Health Service Act (PHSA) to regulate communicable disease; it wasn’t until FSMA became law that the agency had the traction to do so (the CGMPs had their own Part in the Code of Federal Regulations, 21 CFR 110; FDA used FSMA to insert the CGMPs into Part 117 and 21 CFR 110 will be repealed on September 17, 2018).

The PHSA provides that:

• “The Surgeon General, with the approval of the Secretary [of Health and Human Services] is authorized to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the states or possessions, or from one state or position into any other state or possession. For the purposes of carrying out and enforcing such regulations the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, distraction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.”

³³

That this power authorizes FDA to inspect home kitchens making cottage foods is definitely a reach. There is nothing in the PHSA or in its legislative history indicating FDA has the authority to inspect an intrastate food business when there is no credible evidence that the business is producing food under unsanitary conditions or is responsible for a foodborne illness outbreak. FDA has claimed that “due to the nationwide interrelated structure of the food industry, communicable disease may, without proper intrastate food controls, easily spread interstate.“³⁴ That statement describes the industrial food system, not the local food system. FDA should recognize the difference between the two and leave the latter alone.

In addition to being beyond its power, enforcing the CGMPs against local food is a waste of resources if FSMA is about improving food safety. Instead of spending whatever money FDA intended to budget towards inspections of intrastate food producers, why doesn’t FDA put its resources towards areas of the food sector where there are actually food safety problems, like imported food?

There are built-in incentives for small farmers and local artisans to produce safe food; those producers are feeding the same food to their families, one product recall can put them out of business, one case of foodborne illness can put them out of business. Legislatures in nearly all states have recognized this with the passage of cottage food bills that allow the direct-from-producer-to-consumer sale of a variety of foods with little or no regulation. Four states have passed food freedom bills and other legislation that allow the unregulated sale from producer to consumer of nearly all foods other than meat. There have been few, if any, cases of foodborne illness attributed to producers operating under cottage food or food freedom laws.

Will FDA actually inspect private home kitchens to make sure that the kitchens are in compliance with applicable CGMP requirements? If there were inspections, they would likely be conducted by state agencies pursuant to a cooperative agreement with FDA. So, state legislators who voted on behalf of their constituents who want to deregulate local food transactions between consumers and producers are now being told by FDA that the same state agencies that the legislators didn’t want inspecting local food producers will now be inspecting them; this even though there is little or no evidence that Congress wanted FDA to inspect these same producers for compliance with CGMPs.

FDA might not have the resources to carry out widespread inspections of local food producers, but the threat is that FDA can create a chilling effect on local food production with a small number of inspections of small farms and cottage food operations; convincing some local food producers to get out of business while deterring others from starting up operations.

There are ways to fight against FDA’s attempt to regulate all local food production. For starters, having Congress deny FDA funding to conduct inspections of those in the food business who are not required to register with the agency as a food facility. State legislatures could also require that any FSMA cooperative agreements between state agencies and FDA exclude in the agreement inspections of businesses not required to register as food facilities. Congress could also amend FSMA to clarify that those not required to register as a food facility be exempt from the CGMP requirements. Those processing, manufacturing, packing or holding food for animal consumption not required to register with FDA don’t have to comply with the CGMP mandate³⁵; FDA can apply the same standards to human food.

An immediate move FDA can make is to include additional kinds of manufacturing/processing under the definition of “farm”, enabling farmers to produce more value-added products while still remaining under the “farm” exemption. The agency is currently in the process of amending that definition.³⁶

The more local food producers there are the safer food will be in this country; applying the CGMPs to small farmers and local artisan producers is a big step in the wrong direction.

—————–
FOOTNOTES

[1] The exact definition of “very small business” in 21 CFR 117.3 reads:

Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

[bolded emphasis added]

[2] The definition of manufacturing/processing is extremely broad; 21 CFR 1.227 and 21 CFR 117.3 state the same definition:

Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.

[bolded emphasis added]

[3] 21 CFR Part 117
[4] The deadline for compliance with the CGMP and HARPC requirements is September 17, 2018, for those very small businesses that manufacture, process, pack and/or hold animal food. “Very small business”, in the case of animal food, is roughly defined as those businesses with under $2.5 million in annual sales. See 21 CFR 507.3 and 21 CFR 507.5
[5] 21 USC 350d(c)(1), 21 CFR 1.226(b) and (c)
[6] 21 CFR 1.227
[7] FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry, August 2018, pp. 10-11. Last viewed 8/30/18 at https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf
[8] Farms growing and selling vegetables could be subject to FSMA’s produce safety standards depending on their income levels and whether the vegetables are usually cooked before being consumed. See 21 CFR 112.1-112.5
[9] Meat from amenable species is not considered a raw agricultural commodity but, since it is under USDA’s jurisdiction, a farmer selling meat from amenable species the farmer raised would not cause the loss of “farm” status.
[10] “Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing….” — from definition of “farm”, 21 CFR 1.227
[11] FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry, August 2018, p. 9. Last viewed 8/30/18 at https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf
[12] Ibid., p. 21
[13] 21 CFR 1.227
[14] 21 CFR 1.241(c)
[15] 21 CFR 117.3 contains definitions and 21 CFR 117.5 gives greater detail about exemptions.

Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:

(1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and

(2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation. Qualified facility exemption means an exemption applicable to a qualified facility under § 117.5(a).

[21 CFR 117.3, bolded emphasis added]

[16] 21 CFR 117.201(c)(2)(i)(A)(b)
[17] Applicants for the exemption must have financial records from 2016-2018 to show that they are a “very small business” as defined in 21 CFR 117.3
[18] 21 CFR 117.201(a)(2)(i)
[19] 21 CFR 117.201(a)(2)(ii)
[20] 21 CFR 117.201(c)(2)(i)(C)(ii)
[21] 21 CFR 117.251
[22] FDA states on its website, “It is important to note that applicability of the CGMPs is not dependent on whether a facility is required to register.” See “FSMA Final Rule for Preventive Controls for Human Food” webpage. Last viewed 8/30/18 at https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
[23] 78 FR 3646, 3651
[24] 21 CFR 117.10 – employee cleanliness and disease control
[25] 21 CFR 117.20 – plant construction, condition of the grounds
[26] 21 CFR 117.35 – general maintenance, cleaning food and non-food contact surfaces, storage of equipment and utensils
[27] 21 CFR 117.37 – water supply, plumbing, sewage disposal, toilet facilities, handwashing facilities, garbage disposal
[28] 21 CFR 117.40 – equipment design requirements
[29] 21 CFR 117.80 – operational requirements for food manufacturing, and food and ingredient storage
[30] 21 CFR 117.93 – sanitary requirements for storage and transportation of food
[31] 21 CFR 117.95 – includes requirements on containers, equipment, and labeling food by-products
[32] 21 CFR 117.110 – Defect action levels. Per 21 CFR 117.3, “Defect action level means a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product ‘adulterated’ and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.” [bolded emphasis added]
[33] 42 USC 264(a)
[34] 78 FR 3646, 3651 citing 44 FR 23238 at 33239
[35] 21 CFR 507.5(a)
[36] Letter from FDA Commissioner Gottlieb, July 31, 2018. Last viewed 8/30/18 at
https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM615393.pdf

Photo source at top of article: Sandrine Perez. Photo source at bottom: FSMA webpage on FDA website

The post FSMA Food Safety Regs Going Local appeared first on Real Milk.

By Pete Kennedy, Esq.

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

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

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

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

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

Some takeaways from the meeting:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The ordeal of the investigation has led the owners of French Broad Farm, Earl and Cheri Cruze, to shut down their herd share operation, a huge loss for the local food community in the Knoxville area. Earl Cruze, 75 years young, has milked cows for 68 years and has always been the only milker for the herd share. Raw milk drinkers in the metro Knoxville area are now out a source of their sustenance.

The department decided to lift the directive, in part, because according to County Health Director Martha Buchanan, “there is no ongoing transmission” of E. coli; the last illness KCHD connected to the dairy occurred on June 3. Buchanan indicated that the department believed that French Broad Farm was the source of the E. coli O157:H7 bacteria that sickened seven children that drank raw milk the farm produced. Interestingly, at the same time the department was investigating the dairy, it had also determined that at least four children had become ill through E. coli O157:H7 poisoning at a daycare center through direct or indirect contact with farm animals. KCHD’s investigation found no connection between the dairy and the daycare center.

What Buchanan or anyone else with KCHD never did explain was why there were no test results from milk and manure samples the department had collected from the farm over a week earlier. KCHD had gone to the farm to take milk samples on June 5 and manure samples on June 6. In addition, the department also collected an unopened container and opened container of raw milk that were produced on the suspect batch dates of May 24 and May 25.

KCHD originally sent the samples to a Tennessee lab but then on June 11 had them transferred to a more sophisticated laboratory in Iowa.

It only takes lab technicians 48 hours to make a preliminary determination on whether a sample is positive for E. coli O157:H7. Typically, if a sample is positive, a health department or other agency will issue a press release announcing the positive test and will continue with its order prohibiting the producer from distributing the suspect food. The likelihood was that all tests the Tennessee and Iowa labs took of the milk and manure samples were negative for E. coli O157:H7; it’s possible that the department didn’t announce any test results because the Iowa lab was still running tests to find e. coli.

Campylobacter, the pathogen most commonly responsible for outbreaks of foodborne illness attributed to raw milk is rarely found in samples tested in a lab; campylobacter grows and disappears quickly. E.coli, including E. coli O157:H7, is different; e. coli will often continue to grow after a sample is taken to a lab for testing. As a result it would be more likely to have a positive test result for e-coli than campylobacter. While all negative test results wouldn’t necessarily clear French Broad Farm of blame for the illnesses, they are evidence that the dairy is not responsible for the E. coli O157:H7 outbreak. The more negative tests the Tennessee and Iowa labs have the greater the evidence the dairy is not responsible for the illnesses. Buchanan did say the department looked for other commonalities among the sick children such as ground beef consumption and swimming pool usage but there are possibly other common activities among the seven children KCHD is unaware of.

Something to look at would be the multi-state foodborne illness outbreak this spring attributed to romaine lettuce contaminated with E. coli O157:H7. There have been five deaths and nearly 200 illnesses in the U.S. blamed on romaine lettuce consumption, including at least three illnesses in Tennessee. From May 16 to June 1, the Centers for Disease Control (CDC) identified an additional 25 cases of illness it blamed on romaine lettuce. Reports are that there is a high level of secondary transmissions from the outbreak.

Earl Cruze ran a Grade A operation, Cruze Farm Dairy, for over thirty years. Cruze Farm Dairy is a completely separate operation from French Broad Farm and is now run by Cruze’s daughter Colleen Cruze Bhatti and son-in-law Manjit Bhatti.

The Tennessee herd share law went into effect in 2009. Since that time, herd share programs have thrived in the state; hundreds of dairies have operated herd shares at one time or another in Tennessee. The French Broad Farm investigation marks the second time herd share operations have been blamed for a foodborne illness outbreak in the state.

The post Popular Tennessee Herd Share Dairy Shuts Down appeared first on Real Milk.

This was one of the largest food safety scandals in Chinese history, and serves as an example of how imperative it is to stay away from processed foods and instead build a diet with natural, wholesome foods.

Now Chinese scientists have discovered a new, faster, simpler and more reliable test that will detect melamine in milk – in hopes of making it more difficult for farmers and dairy producers to get away with this crime. After learning that gold nano-particles (AuNPs) bond easily with melamine, the researchers were able to devise a test using just AuNPs and a UV-Vis spectrophotometer to watch for a color change in the solution. This on-site test takes about 15 minutes from start to finish and can detect melamine levels as low as two parts per million.

Support the Campaign for Real Milk, join the Weston A. Price Foundation, today!

The post Chinese Researchers Discover New Test to Detect Melamine in Milk & Infant Formula appeared first on Real Milk.