Tennessee Passes Resolution Commending WAPF and 50% Pledge Campaign

On June 15th Tennessee Governor Bill Lee signed Senate Joint Resolution 841 (SJR 841), a resolution to commend and support the Weston A. Price Foundation’s “50% Pledge” campaign. State senator Frank Niceley sponsored SJR 841.

The resolution reads:

      WHEREAS, this General Assembly finds that the family farmer is the backbone of the Tennessee economy; and

      WHEREAS, Tennessee family farms produce some of the highest quality food in the country; and

      WHEREAS, it is the policy of the General Assembly to support Tennessee residents in their endeavors to purchase as much of their food as possible from Tennessee producers; and

      WHEREAS, prosperous family farms improve food security and the ability of our State to be self-sufficient in food production; and

      WHEREAS, keeping more of the food dollar in the local community will strengthen Tennessee’s rural economy; and

      WHEREAS, the Weston A. Price Foundation, a nutrition nonprofit organization, has launched a campaign called the “50% Pledge,” a campaign to encourage people to purchase at least half of their food directly from local farmers and artisans; now, therefore,

      BE IT RESOLVED BY THE SENATE OF THE ONE HUNDRED ELEVENTH GENERAL ASSEMBLY OF THE STATE OF TENNESSEE, THE HOUSE OF REPRESENTATIVES CONCURRING, that we hereby commend and support the Weston A. Price Foundation and its “50% Pledge” campaign.

    Demand for food direct from the farm, especially meat, has skyrocketed since the onset of the covid-19 crisis in March. This has resulted in the single greatest shift away from the cheap-food, high-healthcare-cost paradigm the country has been mired in for decades. The highest quality food is mostly found from small farmers and local artisans. The more food that is purchased direct from small farms, the stronger individual health, consumer freedom of choice, rural economies, food security, food safety and the sense of community will become. WAPF’s “50% Pledge” campaign is an effort to help make that happen.

    For more information on the campaign, click here for the story on realmilk.com about the 50% Pledge Campaign. Those interested in supporting the campaign can order free “50% Pledge” postcards through this link on the westonaprice.org website.

Charter Challenge to Canada’s Raw Milk Ban

In Ontario, a constitutional (charter) challenge to a national and provincial ban on the sale and distribution of raw milk is nearing the finish. In November, attorneys for the 19 consumers and 2 farmers (applicants) who filed the challenge, and attorneys for the Attorney General of Ontario, the Attorney General of Canada, the Dairy Farmers of Ontario and the Dairy Farmers of Canada will argue the case before the Ontario Superior Court of Justice in what should be the final phase of the litigation. Among those challenging the ban in court is dairy farmer Elisa Vander Hout whose husband is Michael Schmidt, the one who has done more to promote and increase access to raw milk than anyone in Canada.

The main claim of the applicants is that the ban violates the provision in the Canadian Charter of Rights and Freedoms guaranteeing freedom of conscience and religion. A brief filed in the case states that the two farmers, Vander Hout and Paul Noble, “each believes as a matter of conscience in the health benefits of raw milk and that they have a duty to provide it to consumers who share their beliefs.” The 19 consumers have purchased raw milk, consumed it, and provided it to their families because “they believe as a matter of conscience in the health benefits of raw milk. They further believe that as a matter of conscience that they and their families need to consume raw milk because doing so protects their health.”

The case boils down to a battle of dueling experts over the safety and risks of raw milk consumption. Thanks to affidavits from microbiologist Peg Coleman and Dr. Nadine Ijaz, the record in the litigation establishes more strongly than ever that the Canadian raw milk ban is not about public health but rather about protecting the market share of the country’s powerful dairy cartel. Their testimony shows how the science on raw milk safety and benefits has strengthened considerably in recent years. Applicants’ attorney, Queen’s counsel Ian Blue, points out in a court filing that calling raw milk a public health risk:

  • ignores the fact that raw milk has unique health benefits not possessed by pasteurized milk;
  • is based on dated and incomplete pathogen prevalence and outbreak reports;
  • ignores that in the western world illnesses from raw milk are a de minimis food safety and public health issue;
  • ignores the role of openness, scrutiny and food safety management programs in minimizing the health risk of raw milk; and
  • ignores that almost everywhere else and in the western world, the sale and distribution of raw milk is legal; and
  • misses that over the last 20 years, the legalization of the sale of raw milk [in the U.S. and elsewhere] has significantly increased while outbreaks of illnesses from raw milk have significantly decreased.

At issue in the case has been a 2018 study finding that “the rate of unpasteurized milk-associated outbreaks has been declining since 2010, despite increasing legal distribution. Controlling for growth in population and consumption, the outbreak rate has effectively decreased by 74% since 2005” (the study looked at outbreaks from 2005 to 2018). The government has not been able to discredit the study during the litigation.

The government’s position during the litigation has been that the prevalence of pathogens in raw milk is reason enough to maintain the ban; this is a double standard applied to raw milk–if it’s not perfect then sales should be illegal. The applicants’ response has been to show that pathogen prevalence alone is not a reliable indicator of risk because of risk-mitigating factors such as the dose of the pathogen (is there enough in the milk to make someone sick); the consumer’s immunological status; production, storage and transport conditions of the milk; and the mitigating presence of beneficial bacteria. In her affidavit, Ijaz noted, “The risk per serving of foodborne illness…associated with consumption of milk procured in its raw state –while not negligible–is significantly lower than that from other foods commonly implicated in foodborne outbreaks, i.e., leafy green vegetables, ground beef hamburger, home cooked chicken.”

The government has moved to exclude evidence provided by Coleman and Ijaz, among others, on the grounds that they are biased in favor of raw milk. In commenting on the motion in a court document, Blue observed that “the lawyer’s law is sometimes phrased as when the facts are against you, argue the law. When the law is against you, argue the facts. And when both the law and the facts are against you, call the other side names.” When asked by Blue during cross-examination, two of the government’s witnesses acknowledged that informed consumers should have the freedom to consume raw milk.

Blue, a litigator with 50 years’ experience in the courts, has estimated that there are over 30,000 pages of documents in the case. The dairy cartel has a strong influence in the country but, with a fair-minded judge, this is a winnable case. Kudos to Ian Blue and his law firm of Gardiner Roberts LLP for providing representation for applicants at a substantial discount.

1967 Wholesome Meat Act: Disaster for Small Slaughterhouses

Passage of the PRIME Act [H.R. 5859 / S. 1620] would give states the power to legalize the sale of custom processed meat in intrastate commerce (i.e., meat from an animal slaughtered and processed at a facility where an inspector is not required to be present to observe the slaughtering and conduct an ante mortem and post mortem inspection of the animal).

Currently, federal law prohibits the sale of custom processed meat; the prohibition went into effect with the passage of the Wholesome Meat Act of 1967. The Act mandated that meat could not be sold unless it was slaughtered and processed at a facility that was either federally inspected or one inspected in a state whose meat inspection laws were at least as strict as the federal requirements; meat slaughtered and processed at a state facility could only be sold within the state.

The Wholesome Meat Act has done tremendous damage to local slaughterhouse infrastructure around the country. In 1967 there were nearly 10,000 slaughterhouses in the country1; today there are less than 3,000.2*

The bottleneck caused by the lack of slaughterhouses has frustrated small livestock operations in getting their products to market and has led to an inability to meet the overall demand for locally produced meat. The 1967 Act has been one of the worst laws ever passed for local food; what’s more, it was known from the beginning that the Act would have the effect it did.

On September 16, 1971, the Small Business Administration (SBA) presented a paper to the United States Senate Select Committee on Small Business titled: “The Effects of the Wholesome Meat Act of 1967 upon Small Business – A Study of One Industry’s Economic Problems Resulting from Environmental-Consumer Legislation Prepared by the Small Business Administration.”3

The SBA paper3 discusses the cost of compliance (mainly, the costs of facility upgrades) with the requirements of the Act and the effects it could have on small-scale slaughterhouses and processing plants. The paper includes the following comments:

  • “[I]t could be argued that the Wholesome Meat Act was as much of a disaster for many small meat firms as a hurricane….” [p. 32]

  • During the Congressional deliberations in 1967 over the Wholesome Meat Act, there was little discussion of the effects that the Wholesome Meat Act would have upon those 15,000 or so firms who now would be subject to rigorous inspection of their product. [p.31]

  • Emphasis was upon “consumerism”, the American housewife and her family. And this was “consumerism” in a rather narrow sense. There was little or no consideration given to the costs, particularly in the first few years, that would have to be borne by the meat industries in order to comply with the Wholesome Meat Act. “…[I]t was likely that meat prices would increase for several years, because of the Act. Scant attention was paid to this highly important problem during the Congressional consideration of the Wholesome Meat Act.” [p. 31]

  • Nor was much attention paid to the potential effects of the new law upon competition within the meat industries. “[T]he meat industries are among the more competitive in the American economy. But the Wholesome Meat Act could lead to a significant diminution of competition. How many firms would have to shut down because they could no longer compete due to the new law? … Would the Wholesome Act lead, however unwittingly, to an undesirable increase in concentration in the meat industries? Questions such as these, highly fundamental questions, were barely raised during the legislative process.” [p. 31]

  • The SBA report notes that following passage of the Wholesome Meat Act, legislation was introduced in Congress that would have allowed SBA disaster loans for slaughterhouses attempting to become compliant with the Act if the slaughterhouse’s financial need could not be met “by private financial institutions or by regular Government credit programs.”  As recorded in the report, “the SBA disaster fund ‘is based upon the legal principle that the emergency is created by the act of the sovereign U.S. Government which is beyond the control of the individual business. This may cause major losses to the businessman, particularly if the company is forced out of business. The sovereign act is thus similar to a natural disaster…’” [p.33]

  • “We find that the small business concerns affected by the Act need a substantial amount of financial assistance in effecting compliance with the Wholesome Meat Act. The establishments not in conformance with the Wholesome Meat Act say they need $278.6 million to make the improvements needed to conform to the law. Of this amount, the establishments surveyed say $132.2 million is unavailable. In addition, fully one-third of the establishments not in conformance with the Act report that financing is unavailable…. We find that the amount that may be forthcoming from private financial institutions is seriously deficient.” [p.84]

  • “The Wholesome Meat Act only directly affects strictly intrastate producers whose production at the most is 20-25 percent of the total national products of meat. Of this intrastate group, slightly less than half are not in conformance with the Wholesome Meat Act and probably about one-third or so of the group not in conformance will go out of business if some form of Federal loan program is not developed for their benefit.” [p. 86]

  • “The authors think the empirical evidence contained in this report points inevitably to the conclusion that many firms will suffer substantial economic injury without Federal assistance. In fact, many face terminal economic injury without some form of Government relief.” [p.87]

Much of what the SBA report questioned about the Wholesome Meat Act has come to pass. The Act did contribute significantly to the consolidation of the meat industry; today four companies control over 80% of beef processing in the U.S. and four companies control over 60% of pork processing.4

The inability to comply with costly federal requirements has led to thousands of slaughter and processing facilities going out of business; many of these were small facilities processing only for commerce within the state. These facilities might have been accountable for only 20-25 percent of national meat products but they gave the small livestock farmer much better access to slaughterhouses at a better price than is the case today. The local abattoirs that dotted the country are mostly gone. Passage of the PRIME Act can begin the process of bringing them back.

The Wholesome Meat Act has not led to the production of safer meat today; there are more recalls than ever for positive pathogen tests in meat products. The 1967 Act has also contributed to higher meat prices as the writers of the SBA report predicted; the higher costs with expanded federal regulation have been passed on to the consumer. The Wholesome Meat Act has failed small-scale slaughterhouses, family farms, consumers and communities on numerous levels.

It’s time to start the process of rolling it back by passing the PRIME Act. Call you representative and ask that they sign on as a cosponsor of HR 2859 / S 1620.

ACTION ALERT 5/6/2020 – Help pass the PRIME Act – Call today!

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REFERENCES
1 Denny, R.C.H. (2012). Between the Farm and the Farmer’s Market: Slaughterhouses, Regulations, and Alternative Food Networks (Master’s thesis). Retrieved from Auburn University AUETD database, https://etd.auburn.edu/handle/10415/3247*

2 United States Department of Agriculture, National Agricultural Statistics Service. Livestock Slaughter 2019 Summary. April 2020. p. 62. Posted at http://www.usda.gov/nass/PUBS/TODAYRPT/lsan0415.pdf [View PDF – http://bit.ly/1i6sxS9]

3 United States. Small Business Administration, and United States. Congress. Senate. Committee on Small Business. The Effects of the Wholesome Meat Act of 1967 Upon Small Business: A Study of One Industry’s Economic Problems Resulting from Environmental-Consumer Legislation. Washington: U.S. Govt. Print. Off., 1971.

4 Heffernan, W. & Hendrickson, M. (2007). Concentration of agricultural markets. University of Missouri, Department of Rural Sociology. Posted online at http://www.foodcircles.missouri.edu/07contable.pdf [View PDF – http://bit.ly/1JZuqGf

Reprinted by permission of the Farm-to-Consumer Legal Defense Fund from article originally posted September 10, 2015, titled “The Wholesome Meat Act of 1967: Disaster for Small Slaughterhouses from the Start“. Republished here with minor edits.

Raw Butter and Raw Cream Sales Now Legal in Utah

On March 25, Governor Gary Hebert signed House Bill 134 (HB 134) into law. The bill legalizes the sale of raw butter and raw cream in Utah; HB 134 took effect immediately. Representative Kim Coleman (R) was the lead sponsor for the legislation.

With the Utah law taking effect, there are now around twenty states that allow the sale or distribution of raw cream for human consumption; around a dozen states allow the sale or distribution of raw butter. There are at least two other states considering the legalization of raw butter sales.

The United States Food and Drug Administration (FDA) remains the greatest roadblock to the legalization of raw dairy products in the U.S. On February 27, FDA rejected a petition to lift the interstate ban on raw butter filed by the Farm-to-Consumer Legal Defense Fund and Mark McAfee, the biggest producer of raw butter and cream in the country. In its rejection letter, one of the agency’s justifications for maintaining the prohibition was that raw butter was responsible for a foodborne illness outbreak occurring on average every 7 or 8 years; a standard that, if applied consistently across our food supply, would make many foods illegal in interstate commerce. As time goes on, an increasing number of states will no longer side with FDA, taking matters into their own hands by legalizing sales of raw dairy products in intrastate commerce.

HB 134 marks the third time in the last five years that a Utah raw milk bill has passed into law. In 2015, the mother-daughter team of Symbria and Sara Patterson were mainly responsible for the passage of a law legalizing the distribution of raw milk and raw milk products through micro-dairy herd share agreements. In 2018, Red Acre Center, a nonprofit formed by the Pattersons, was the driver in passing a law allowing the unlicensed on-farm sale of raw milk and the delivery of raw milk by licensed dairies. A bill similar to HB 134 nearly passed in the 2019 session; under the new law, licensed dairies can sell raw butter and raw cream on the farm, through delivery, and at a retail store if the dairy has a majority ownership interest in the store.

The passage of HB 134 comes at a time when, with the Covid-19 situation, demand for food direct from the farm is soaring. Legal raw butter and cream will move more of the food dollar to where it belongs–at the farms producing some of the safest, most nitrient-dense foods available.

Graphics credit: Jon Tyson, neon lit butter sign at unsplash.com

FDA Denies Petition to Lift Interstate Ban on Raw Butter

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

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

Allowing access to a nutritious raw dairy product like butter is not a “public health objective” of FDA.

While FDA’s decision wasn’t a surprise, the weakness of its response to the petition was. At the end of the FDA letter was a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized, (1908 to 2003).” There were 13 outbreaks during that 95-year timeframe attributed to raw butter consumption, with one of the outbreaks occurring in England.

    Of those 13 outbreaks, all but one described the butter as “Not Specified but commonly unpasteurized” or “Not Specified.” The one entry listed as “Unpasteurized” is a 2001-2002 outbreak where 202 people in North Carolina allegedly became ill from butter. This entry is different from the CDC’s foodborne illness outbreak database, which attributes the illnesses to “other milk, unpasteurized”. According to published articles, homemade butter was served to elementary school students as part of a demonstration.
    Seven of the 13 outbreaks fail to specify the “Total Number of Illnesses”; one shows “reports of consumer injuries” while six show “NA” (meaning, “Not Available / Not Reported”). One of the entries, a 1991 outbreak where 265 people became ill in California and Nevada, lists the implicated food as “blended butter and margarine products”. How often has raw butter been blended with margarine — ever?
    Two of the 13 outbreaks indicate that someone was hospitalized — one person in one case, four in the other. The remainder indicate that no data is available. Only one of the 13 outbreaks specified whether there were any deaths (i.e., six in a 1913 Minnesota outbreak). Again, the remainder indicated that no data is available.

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

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

The CDC database on foodborne illness outbreaks from 1998-2016 that FTCLDF and OPDC used in their petition to FDA doesn’t blame a single outbreak on commercially produced raw butter, and only one outbreak is blamed on homemade raw butter [Utah in 2007].

FDA tried to downplay raw butter’s impressive safety track record by pointing to the 1987 interstate ban as the reason there have been almost no outbreaks. However, raw butter sales have been legal in California since the state’s inception. Mark McAfee, OPDC’s president, stated that his company has sold well over 2 million lbs. of raw butter the past 20 years without illness. About 10 other states allow the sale or distribution of raw butter.

Aside from the small number of foodborne illness outbreaks attributed legitimately or otherwise to raw butter consumption over the past 112 years, the FDA denial of the petition could be vulnerable to a court challenge in other areas.

The butter ban is illegal according to a statute (21 USC 341) in the Federal Food, Drug and Cosmetic Act that governs “standard of identity” for food which are requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. For instance, the standard of identity for milk requires that it be pasteurized or ultra-pasteurized and that it contain not less than 3-¼ percent milkfat [21 CFR 131.110]. The citizen petition notes that FDA addressed the question of requiring pasteurization as part of a standard of identity regarding milk and found that such health-based requirements were properly addressed as standards of identity stating: “The Commissioner rejects the contention that section 401 of the act does not permit provisions of a standard of identity to be promulgated for health reasons. [39 Fed. Reg. 42,351 (Dec. 5, 1974)]”

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

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

The court record only discussed dairy products that were listed in the PMO definition of “milk product.” When the court ordered FDA to ban “raw milk’ and ‘raw milk products’, it was only those products under that definition. In its response, FDA claimed the court order banned all products made from raw milk but, if the agency is correct in its interpretation, aged raw milk cheeses wouldn’t be legal in the U.S. as they have always been. The impetus for the litigation that resulted in the court order was the lack of FDA enforcement on standard of identity regulations requiring pasteurization for milk and various milk products–because of the statutory prohibition, there is no standard of identity regulation for butter.

Farm-to-Consumer Legal Defense Fund (FTCLDF) is appealing the FDA denial to the federal district in court in the District of Columbia. The appeal to challenge FDA is likely to be costly as it will require paying scientific experts as well as attorneys. FTCLDF could really use your financial support. Overturning the butter ban is a big step toward a day when all raw dairy products will be legal in interstate commerce.

To donate specifically to support the case to overturn the FDA decision, you may donate online or call 703-208-3276.

Shortlinks:
citizen petition –
https://wp.me/a44gEP-2vE

FDA response –
https://wp.me/a44gEP-2vD

NOTE: clicking on the image below to donate online goes this url, https://app.moonclerk.com/pay/5skqzg80s35d

Take the 50% Pledge!

Spread the word! Order free postcards at www.westonaprice.org

Spend at least 50% of your food dollars on direct purchases from local farmers and artisans; with the remainder of your food dollars, you can celebrate how small the world has become!

This commitment to supporting local farms crowns the 20th year of the ongoing crusade by the Weston A. Price Foundation (WAPF) to disseminate accurate information on diet and health.

There is every reason to take the 50% Pledge, a campaign of WAPF to have its members spend at least half their food dollar purchasing food from local farmers and artisans.

By taking and making good on the pledge, you will be improving your own health and the health of your families. The highest quality food is mostly found from small farmers and artisans in the local food system. The likelihood is that you will be spending less money on doctors and medication. If you are currently spending little or nothing on medical services taking the 50% pledge is a great way to maintain that lifestyle.

Taking the pledge contributes towards small farm prosperity and increases the chances of your local food source remaining in business. There are still too many one-size-fits-all food safety regulations that squeeze regenerative family farms; they need all the business they can take on. The quality of the industrial food supply continues to deteriorate; by helping to keep quality local producers in business  through your patronage, you will be better able to avoid health-robbing foods in the industrial system. The medical system currently accounts for 17% of our gross national product (GNP); reducing demand for medical services leads to a more productive use of resources. Small farmers are the true frontline healers in our healthcare system.

Taking the pledge will benefit the local economy by keeping more of your food dollar in the community. In many states, less than 10% of the food residents consume is produced in that state. The industrialization of agriculture has drained rural America.

Stronger local food systems lead to better food safety. At an international food safety conference in July 2019, a high-ranking FDA official stated that traceability was the Achilles heel of the food system; nothing is more traceable than food locally produced and consumed.

A country’s ability to be self-sufficient in quality food production is its first line of national defense. A strong small-farm sector marketing most of its production direct to the final consumer is the path towards making that happen.

There are other steps you can take beyond the 50% Pledge; you can pass word of the campaign on to non-WAPF members and convince them to take the pledge. Educate them on how important it is for their own health and the health of their families to have a prosperous local food system. The enemy is convenience; explain to them why it’s worth it to go the extra mile and purchase direct from local farms and artisans.

WAPF has created postcards explaining the 50% Pledge that are free for the asking to make people think more about where they are spending their food dollar. Request a free set of postcards through the online store at westonaprice.org or email a request postcards to info@westonaprice.org or call 703-820-3333.

The conventional food system is changing rapidly. The expansion of home delivery systems for industrial food, the growth of industrial organic, and the targeting of the traditional livestock business through plant-based and cell-cultured “meat” and “dairy” products threaten to weaken local food systems. Mass participation in the 50% Pledge campaign is a way to stem the threat, creating more demand for the raw dairy products, meat, poultry, eggs, produce and other nutrient-dense foods that small farmers and local artisans produce.

Need help to find local foods? Click here to learn more.

Farmer, Wife and Law on Trial in Florida

On October 21st and 22nd, Dennis and Alicia Stoltzfoos, owners of Full Circle Farm, went on trial at the Suwannee County Courthouse in Live Oak, Florida. The dairy farmer and his wife were both charged with one criminal misdemeanor for selling food without the proper permit. The couple represented themselves; their three-and-a-half-month-old daughter, Luanna, was at the defense table for much of the trial. Judge William F. Williams found Dennis and Alicia both guilty but deferred sentencing until April 14, 2020. On November 12, the Florida Department of Agriculture and Consumer Services (FDACS) piled on, filing an administrative complaint against the couple, proposing to fine them $3,000 for permitting and labeling violations. The Stoltzfooses have until December 4 to respond to the complaint.

With the way the trial turned out, applying the law to the Stoltzfooses’ situation was on trial as well. There have been a number of “what’s wrong with this picture” moments in the case since the state filed the charges in May, raising the question of why did this case have to go to trial. Dennis attended several pretrial hearings at which most of the cases before the court were for shoplifting along with possession or distribution of crystal meth or opioids; so, in the midst of a group of people charged with causing injury to others or themselves was a farmer and his wife both charged with activity that has made others well.

A trial like the Stoltzfooses’ would usually be held in a misdemeanor court room, but the crowd was too big; so, the trial was moved to a larger courtroom. For most misdemeanor cases, it’s typical to have two or three people present; at the Stoltzfoos trial, it was estimated that close to 100 people, including a number of children, were in the gallery. The first day of the trial, Judge Williams commented, “These kids are so much better behaved than I was at that age. My compliments to the parents of the kids.” The second day of the trial, the judge said, “My parents would have given their right arm for me to behave like that.”

While the state called no witnesses saying the food produced by Full Circle Farm (FCF) had made them sick, Dennis and Alicia submitted into evidence over 100 testimonials from customers on how FCF’s food had benefited their health.

State investigations are usually complaint-driven, but the state investigated the Stoltzfoos operation on its own initiative. There has never been a consumer complaint filed against FCF in all the years it has been in business.

Dennis had a prior run-in with the FDACS in 2005 over selling food without a permit; that case was settled when he agreed to obtain a Master Feed Registration that enabled him to sell pet food. He’s sold raw dairy products and other nutrient-dense foods under the registration [other than aged raw cheese, sales of raw dairy products in Florida are only legal for pet consumption]. Customers place orders on the farm’s website and pick up the orders at various delivery sites around north and west central Florida.

From 2006 until 2018, Dennis renewed the registration then let it lapse a year ago. In January of this year, an undercover agent from FDACS made a “buy” of raw milk and other foods from the farm, leading to criminal and administrative charges against farmer and wife.

Dennis admitted at the trial that he did not have a permit when the undercover officer made the purchase and, going forward, would obtain the permits he needed to be in compliance. He was negotiating with the state’s attorney right up to before the day of the trial to reach a settlement in which the charges would be dropped in return for Dennis obtaining the Master Feed Registration and submitting correct labels for the products he wanted to sell. Just 15 minutes before the trial was to start, the state’s attorney told him he would need to get a food establishment permit to sell at least some of the foods he lists on his website for human consumption as well. What foods the farm would have to sell for human consumption the attorney did not say.

There are a number of small farmers in Florida producing safe, nutritious food that, because of the costly requirements of producing and selling food for human consumption (i.e., installing bathrooms, triple sink, etc.), can only afford to sell their food for pet consumption. Those farmers cannot advertise pet food as being for human consumption but, at the same time, the producers have no legal responsibility to stop their customers from eating pet food. There is high quality human food being sold as pet food and people are seeking it out for their own health and the health of their families.

Dennis was a trailblazer in the 1990s in Florida for promoting the principles of the Weston A. Price Foundation (WAPF) and was one of the first Weston Price chapter leaders in the country. He is an educator and has been operating his farm as a healing ministry for nearly two decades, always looking for ways to produce the healthiest food possible. Dennis used the trial as an opportunity to educate the court on the need for changes in the law such that there would be no government interference with producers benefiting health and decreasing medical expenses through the sale of nutrient-dense food. In addition to introducing the customer testimonials as evidence, Dennis also submitted a copy of Joel Salatin’s book, Everything I Want to Do Is Illegal, to be a part of the court record. Judge Williams admitted the testimonials and the book as evidence, carrying the trial over to a second day so that he would have a chance to read both before rendering his verdict.

After Judge Williams found both defendants guilty, the prosecution asked the judge to sentence the defendants to six months probation, payment of $273 in court costs, and the payment of over $900 to FDACS for the cost of its investigation. The prosecution also asked that the court issue an order prohibiting Full Circle Farm from advertising food on its website and selling food until it obtained the required permits, a possible ‘death sentence’ for the farm given how long the licensing process could take. The judge responded to the state’s request by deferring sentencing for six months so that the Stoltzfooses would have enough time to get the needed permits. The crowd at the trial and the testimonials made the difference in the judge’s decision to defer sentencing.

One of the frustrations Dennis had with the labeling requirements was that his operation was transparent without having to have labels on his products. Customers order only through the farm website so they know what they are purchasing. The couple also has an open-door policy; people can call anytime they have questions or go to the farm to look around. Instead of spending $5,000 per year on labeling, why couldn’t that money go towards further enriching the soil on the farm?

The couple had surveyed its customers on labeling earlier, and the consensus was that the customers didn’t want labeling nor any other regulation. As the globalization of the food supply continues, it’s becoming more apparent that unregulated locally-produced food is safer and more nutritious than regulated food from the industrial food system, especially when that food is coming from countries with food safety systems that are substandard to the one in the U.S. Florida has found out how free ”free trade” is with greening disease, an imported malady that has devastated the state’s citrus industry. FDACS’s time would be better spent on imported food than on investigating farms like Full Circle that have never had a customer complaint. There is significant transparency in the operation of the farm without regulation.

The more local food producers there are in Florida, the safer the state’s food supply will be. Passing a law allowing for more unregulated sales from local producers direct to consumers would be the path towards that goal. It’s time for the legislature to consider doing so.

The Department of Control Strikes Again

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.

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[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

photo by XXX from Pixabay

No Place at the Food Safety Table for Local Producers

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.

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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

Is FDA Exceeding FSMA Inspection Authority?


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.

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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)