Several major farm organizations, including the Iowa State Dairy Association and Iowa Dairy Foods Association, registered to lobby against the bill. Proponents included Americans for Prosperity, a conservative-leaning national libertarian group that helped organize the Tea Party movement.

“The passage of SF 315 is a victory for families and agriculture across our great state and reaffirms that the government has no right to dictate what Iowans choose to drink,” Tyler J. Raygor, deputy state director of Americans For Prosperity-Iowa, said in a statement following the Senate’s vote. “With this legislation, Iowans will have the freedom to choose what to feed their family while enabling innovation in the fresh milk industry.”

The new law has requirements for storing and selling raw milk and preventing sales if the cows, goats or sheep recently received antibiotics. It also outlines testing for bacteria and requires the records be made available to consumers and state officials.

A big thank you to dairy farmer Esther Arkfield who has lobbied patiently for allowing raw milk sales in Iowa.

With the bill’s passage, there remain only four states where farmers cannot provide raw milk in any manner: Louisiana, Hawaii, Nevada and Rhode Island.

We are also working to liberalize regulations in a number of states, particularly New York, where regulations allow only raw milk sales from the farm. New York raw milk farmers are prevented from delivering to the huge market of New York City, or from selling at farmers markets.

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

The post Raw Milk Updates, Summer 2023 appeared first on Real Milk.

GEORGIA – HOUSE BILL 1175 FOR RAW MILK SALES

If there ever was a sign of how much the political and regulatory landscape for raw milk has changed, it is House Bill 1175 (HB 1175), legislation that is currently before the Georgia Senate Agriculture and Consumer Affairs Committee after having passed out of the House by a 100-62 vote. HB 1175 would legalize the licensed sale of raw milk for human consumption direct to consumers—something many bills in state legislatures around the country have proposed in recent years. Georgia law has long allowed the sale of raw milk for pet consumption. What’s different about this bill is that the driving force behind it is Georgia Milk Producers (GMP), marking the first time in memory that a conventional dairy industry group is pushing for legal raw milk sales.

GMP is a producer organization located in Watkinsville, Georgia; its mission is to support, sustain and help the Georgia dairy industry grow. On March 10, 2021, GMP Executive Director Farrah Newberry testified before the Georgia House Committee on Agriculture and Consumer Affairs that GMP had changed its position on raw milk and now supported legalization of sales for human consumption. In her testimony, Newberry disclosed that Georgia had declined from five hundred twenty-five dairies producing raw milk for pasteurization in 2000 to one hundred fourteen in 2021. She noted that Kroger and Publix operate the only processing plants in the state; Georgia has no plants producing either ice cream or cheese. Newberry told the committee that Grade A pasteurized milk was selling for $2.99 to $3.99 per gallon in Georgia while raw pet milk was going for $8 to $12 per gallon. She concluded her testimony by stating that legal raw milk sales for human consumption would protect the dairy industry in Georgia by having adequate safeguards in law for the production of safe raw milk and would provide market opportunities for smaller Grade A producers.

HB 1175 contains provisions not usually found in raw milk bills, such as clauses governing adding water to the milk, the use of “processed animal waste derivatives used as feed ingredients for any portion of the total ration of the lactating dairy animal,” and the prohibition against “unprocessed poultry litter and unprocessed recycled animal body discharges being fed to lactating dairy animals.” The bill gives broad power to the Georgia commissioner of agriculture to adopt regulations implementing and enforcing the bill’s requirements; the regulations must be of uniform application. The bill is written for Grade A dairies also wanting to sell raw milk for direct consumption; it’s unlikely that micro dairies looking to sell raw milk direct to the final consumer will be able to afford the cost of compliance.

ALASKA – REGULATIONS TO LEGALIZE RAW MILK SALES

Another sign of how much the political and regulatory landscape has changed for raw milk is a proposed regulation the Alaska Department of Environmental Conservation (DEC) issued on January 17 that would legalize sales of raw milk, cheese, butter, cream, yogurt, kefir and ice cream direct to the consumer and at retail stores. Less than a year ago, Governor Mike Dunleavy signed House Bill 22 (HB 22) into law, legislation that legalized the distribution of all raw dairy products through herdshare agreements; DEC opposed the measure when Representative Geran Tarr introduced the bill in 2019. The impetus for the proposed regulation was a survey DEC conducted in August 2021 through the Office of the State Veterinarian to determine the level of interest in raw milk sales; one hundred seventy-nine people responded, with nineteen animal owners interested in selling their animals’ milk and one hundred four consumers interested in purchasing raw milk.

In support of its decision, DEC posted the following statement on its website: “The most critical concern Alaskans hold for the future of food is the security of its food supply,” read a 2014 study on food security commissioned by the Alaska Department of Health and Social Services, with collaboration from the Alaska Food Policy Council. The supply chain disruptions that Alaskans have observed during the Covid-19 pandemic have further highlighted Alaska’s need to enhance the security of its in-state food supply.

Under the proposed regulations, producers are not required to have a permit but must register with DEC and obtain a registration number. DEC would not conduct routine inspections; the department would inspect only in the event a consumer complaint is filed or if either a foodborne illness or an animal health outbreak is suspected. There are container labeling, recordkeeping and physical facility requirements as well as a requirement to keep milk samples taken from each batch for fourteen days after milking; there is no routine testing mandate. The proposed regulation also mandates a “veterinarian-client patient relationship to oversee the health of the herd.”

There are provisions in the proposed regulations that could be amended to help producers. The draft regulation prohibits the sale not only of raw milk but any other raw milk products, including butter, more than four days after the production date. The draft could have amended the state food code to allow retail stores to sell raw milk without having to obtain a variance to do so; under current law, retail stores can sell only Grade A pasteurized milk products (except for raw cheese aged sixty days). It is also unclear how many of the dairies interested in selling raw milk and raw milk products would be able to meet the physical facility requirements in the proposed regulation.

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.

The post Raw Milk Updates, Spring 2023 appeared first on Real Milk.

GEORGIA

On May 13, Governor Brian Kemp signed into law House Bill 1175 (HB 1175), also known as the Georgia Raw Dairy Act. HB 1175 legalizes the sale of raw milk for human consumption direct to the consumer by licensed dairies. The new law will go into effect July 1, 2023.

What was unusual about HB 1175 was that the driving force behind the bill was the Georgia Milk Producers (GMP), a conventional dairy industry group. Typically, state dairy associations along with public health organizations and the farm bureaus represent the biggest opposition to raw milk legislation.

In testimony before the Georgia legislature in 2021, GMP executive director Faith Newberry stated that Georgia had declined from five hundred twenty-five dairies producing raw milk for pasteurization in 2000 to one hundred fourteen in 2021. Newberry said that legal retail raw milk sales would provide market opportunities for the smaller
Grade A dairies.

Georgia law currently allows the sale of raw milk for pet consumption with minimal regulation; a number of small producers sell under this law. It remains to be seen whether these producers will benefit from the Georgia Raw Dairy Act. HB 1175 gives broad rulemaking power to the Georgia commissioner of agriculture to adopt regulations implementing the bill’s requirements; the regulations must be of uniform application. It is uncertain at this time whether small, non-Grade A producers wanting to sell raw milk direct to the consumer will be able to afford the cost of compliance.

HAWAII

Hawaii is one of the remaining six states where any raw milk sale or distribution is illegal. Over the past decade, numerous raw milk bills have been introduced, with none of them making it out of committee. This year was different; House Bill 2028 (HB 2028) passed out of the House before dying in the Senate when the chairs of a joint committee assigned the bill refused to give it a hearing.

HB 2028 would have legalized the licensed sale of raw milk and raw milk products direct to the consumer; licensed producers were limited to two lactating cows. The bill also legalized the sale of raw goat milk for pet consumption; in 2021, state officials confiscated raw pet goat milk from some twenty stores on the island of Oahu, issuing cease and desist orders to the store owners. A major flaw in the bill was that it gave broad rulemaking power to the state department of health, an agency very hostile to any raw milk sales or distribution. The state is badly in need of legal raw milk; at this time, there is not a single Grade A dairy producing milk in Hawaii—leaving the state dependent on milk shipped from California.

IOWA

Iowa is another state prohibiting any raw milk sales and distribution. In recent years, no raw milk bill introduced has made it out of committee. Like Hawaii, this year was different; Senate File 2309 (SF 2309) passed out of the Senate before dying when the House Agriculture Committee refused to give the bill a hearing.

HF 2309 would have allowed the unlicensed sale of raw milk and raw milk products direct to the consumer on the farm or through delivery. There were testing, recordkeeping and labeling requirements but there would be an inspection under the bill only if the dairy’s milk was believed to be the cause of illness. Opposition from the Iowa Farm Bureau was a key factor in SF 2309 not passing. All states bordering Iowa have legalized raw milk sales or distribution to some extent—costing Iowa dairy farmers substantial income.

MISSOURI

Missouri law already allows the unregulated sale of raw milk and cream on the farm and through delivery; licensed dairies can also sell direct to the consumer at other venues such as farmers markets. House Bill 1977 (HB 1977) would have also allowed the sale of raw milk and cream by licensed dairies direct to grocery stores, restaurants and similar establishments as long as the dairies met the standards established for Grade A pasteurized milk in the state. HB 1977 passed through the House but was still in Senate committee when the 2022 legislative session ended.

NEW HAMPSHIRE – RAW ICE CREAM SALES NOW LEGAL

On March 18, Governor Chris Sununu signed into law House Bill 95 (HB 95), legislation making the unregulated sale of raw ice cream and raw frozen yogurt legal from producers direct to consumers. HB 95 went into effect on May 17.

The new law allows “producer-distributors” to process up to 20 gallons of raw milk into ice cream and/or frozen yogurt daily and sell those products direct to consumers at the producer’s farm or farmstand or at a farmers market in intrastate commerce. Ice cream and frozen yogurt produced under HB 95 must be packaged in containers no larger than 6 fluid ounces and must be “marked with an expiration date 30 days from the date of manufacture.”

All producers are exempt from licensing and inspection. HB 95 expands prior law which allowed the unregulated sale of raw milk by producers of up to 20 gallons per day and the unregulated sale by producers of cheese aged 60 days, yogurt, cream and butter processed from up to 20 gallons of raw milk daily. The new law does require that producers selling any raw dairy product sold under the exemption have a label with the name, address and phone number of the producer-distributor’s farm, the name of the product and the following statement: “This product is made with raw milk and is exempt from licensing and inspection. RAW MILK: consuming raw milk may increase your risk of foodborne illness.”

New Hampshire is the latest of numerous state legislatures in recent years to expand the sale or distribution of raw dairy products other than milk. Less resistance from the dairy processing industry along with increased consumer demand for raw dairy indicate this is a trend that will continue.

The post 2022 State Legislature Recap (US) appeared first on Real Milk.

There is no statute or regulation that expressly prohibits the sale of raw pet dairy products in Hawaii; the law HDH referenced in its order governs only raw milk for human consumption.

In a press release about the enforcement action, a department official claimed, “The goat milk is being advertised as ‘pet food’ but the sale of any form of raw fluid milk is a risk to public health because it is easily diverted for human consumption.” Again, HDH provided no evidence that this was happening.

The department’s actions have caused law-abiding pet food store owners—and national pet food manufacturers selling to those stores—a substantial loss of revenue. The manufacturers produce products that are not only regulated by state agencies but by FDA as well. The manufacturers, some of the affected stores, and pet owners were all looking at ways to challenge HDH’s action, an action that arguably exceeded its legal authority.

The post Raw Pet Milk Embargo Hawaii appeared first on Real Milk.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

References

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The post Judge Upholds FDA Raw Butter Ban appeared first on Real Milk.

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 post Farmer, Wife and Law on Trial in Florida appeared first on Real Milk.

On August 9 Governor Charles Baker amended a provision in an appropriations bill that would have expanded raw milk access for consumers and better enabled raw milk producers to make a living. Currently only the licensed on-farm sale of raw milk is legal in Massachusetts; House Bill 4835 (H.4835) would have allowed licensed raw milk farmers to:

• deliver raw milk directly to a consumer, off-site from the farm if the raw milk farmer has a direct contractual relationship with the consumer;
• contract with a third party for the delivery of raw milk off the farm to a consumer;
• deliver raw milk through a CSA (community-supported agriculture) delivery system;
• make deliveries to the consumer’s residence or to a pre-established receiving site so long as the site was not in a “retail setting”. Raw milk producers, however, could make deliveries in a retail setting through a CSA delivery system provided that the raw milk met the stipulation that it “shall be kept separate from retail items for sale and shall not be accessible to the public.”
• sell raw milk from the farmer’s farm stand even if the stand is “not contiguous” to the farmer’s raw milk dairy. Current law requires the farm stand to be on the same property where the raw milk dairy is located.

H.4835 had a labeling requirement for raw milk being sold or delivered to consumers off-farm and the bill gave the state department of agricultural resources and the state department of public health joint responsibility to issue regulations governing the handling, packaging, storage and testing , and transportation of raw milk.¹

The amendment Governor Baker sent back to the legislature for consideration as House Bill 4884 (H.4884) mentioned none of the benefits of H.4835 except for the sale of raw milk at a farm stand off-site from the dairy farm.

The summary to H.4884 reads:

An act, a message from His Excellency the Governor returning with his disapproval of a certain section, and also with recommendations of amendments of certain sections contained in the engrossed Bill promoting climate change adaptation, environmental and natural resource protection, and investment in recreational assets and opportunity [see House, No. 4835]. August 9, 2018.

H.4884 states, in part, that “the commissioner of public health, shall, … adopt and promulgate rules and regulations to reduce the risk of milk-borne illness associated with the consumption of unpasteurized milk that is sold off-site of the farm at which such milk was produced. Such rules and regulations may include, but shall not be limited to, the sanitary and operational standards for the transportation, receiving, handling, storage, processing, packaging, labeling and sale of milk intended for human consumption prior to pasteurization. … Such regulations shall allow the sale of milk intended for human consumption prior to pasteurization at a farm stand owned or operated by the producer of said milk that is not on the site of the farm at which the milk was produced.”

Given the bias of the public health department against raw milk, it’s unlikely that any of the other benefits provided in H.4835 would be included in a regulation. H.4884 also requires raw milk producers selling at an off-site farm stand to obtain an additional license from the department of public health.²

Governor Baker based his authority to amend the raw milk section of H.4835 on a provision in the Massachusetts Constitution that states, in part, “the governor may disapprove or reduce items or parts of items in any bill appropriating money… As to each item disapproved or reduced, he shall transmit to the house in which the bill originated his reason for such disapproval or reduction, and the procedure shall then be the same as in the case of a bill disapproved as a whole.”³

There is nothing in the state constitution that says that the governor can amend the substantive language in a bill, but the way the executive branch of government has gotten out of control these days at both the federal and state levels in exceeding its powers with little resistance from either the legislative or judicial branch, there’s little reason to believe Governor Baker won’t get away with his violation of the Massachusetts Constitution.

Even if H.4884 is lawful, it’s a poor decision from a policy standpoint. The state’s licensed raw milk producers have an excellent track record of safety with few, if any, foodborne illness outbreaks attributed to the consumption of raw milk in Massachusetts. H.4835 was a way to help raw milk producers—at little or no risk to the public—which is especially important given the current crisis the dairy industry is in today. In 1997 there were 353 dairy farms in Massachusetts; at the end of 2017, there were 135.⁴

Instead of helping Massachusetts dairy farmers the way he had a chance to, Governor Baker bought into the fear-mongering on the “dangers” of raw milk fed him by his department of public health. The nanny administrative state marches on.

H.4884 has been referred to the House Ways and Means Committee.

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[1] Massachusetts House Bill H.4835, accessible at https://malegislature.gov/Bills/190/H4835
[2] Massachusetts House Bill H.4884, accessible at https://malegislature.gov/Bills/190/H4884
[3] Massachusetts Constitution, Article LXIII, Section 5
[4] Thomas Farragher, “The demise of a Massachusetts dairy farm”, The Boston Globe, 23 January 2018. Last viewed 9/10/18 at https://www.bostonglobe.com/metro/2018/01/23/the-demise-massachusetts-dairy-farm/G0tyAng0VJ9Ovy8nVvjrZK/story.html

Photo by Navraj Narula, Staff of Daily Free Press, published 9 January 2015

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By Pete Kennedy, Esq.

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

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

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

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

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

Some takeaways from the meeting:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Wisconsin organic dairy farmer Chaz Self is a face of the crisis confronting milk producers across the country. Self’s cooperative recently dropped him as a member, leaving him scrambling to find another buyer for the milk his farm, Grassway Organics, produces. Self could be making up for some of the lost sales by selling raw milk; Wisconsin law allows the sale of raw milk on an “incidental basis.” The Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) could be helping farmers like Self by using its enforcement discretion to let him sell raw milk. DATCP, however, recently served the farmer with a summary special order threatening the loss of his Grade A Milk Permit if he sold any raw milk for human consumption.

The farmer is currently dumping hundreds of gallons of high quality raw milk. Self’s case provides a great look at the unprecedented emergency dairy farmers are facing and how selling raw milk is a potential way to help keep thousands of them in business.

Self maintains a herd of around 100 cows on a 400-acre farm where he lives with his wife Megan and their three young children. His Jersey herd is 100% A2. The Selfs sell poultry, eggs, pork and beef to their customers on the farm and at farmers markets.

Last year Self appeared in the Netflix documentary, Rotten, a series of episodes uncovering fraud and corruption in the industrial food system. Self appeared in the episode “Milk Money” which discussed the production and sale of raw milk. Self never stated that he sold raw milk but the narrator of the episode implied that he did. Shortly after the episode aired, DATCP started investigating Self; the investigation wound up with the department issuing an order allowing him to keep his Grade A permit on the condition that he stop selling raw milk. This was an unjustified move, given that DATCP based its decision solely on what the narrator said he was doing; there was no other evidence mentioned in the order about Self selling raw milk.

To compound matters, on April 1 Self’s cooperative, Westby Creamery, terminated his membership; on April 18 DATCP sent Self a “notice of deadline to change assigned dairy plant”, stating the farmer has until April 30 to find a processor to pick up his milk. If he fails to do so, DATCP will revoke his Grade A permit; with the current state of the dairy industry, that is not an easy task.

The American dairy sector has been in a decades-long decline that is currently accelerating. In 1992 there were 131,535 licensed dairies in the U.S., at the end of 2017 there were 40,219.¹ The number of dairies closing shop has increased substantially since the beginning of the year. In 1992 the average herd size for farms was 74 cows; by 2017 it had risen to 234², showing the consolidation in the dairy industry and the exit of small farms from the commodity milk system.

Wisconsin went from about 29,000 dairy farms in 1995 to a little over 9,000 at the end of last year.¹ Two particular recent developments have accelerated the decline of conventional and organic dairies in Wisconsin. First, more conventional milk is being shipped into Wisconsin from other states. In 2017 more than 100 trailer loads of milk per day³ was coming into Wisconsin from states such as Michigan, Indiana and Ohio; frequently this milk was being sold more cheaply than the price sellers of conventional fluid milk would normally get.

Secondly, this year certified organic CAFO dairies in Texas have increased shipments of milk to Wisconsin. According to a USA Today March 24 story by a Milwaukee Journal Sentinel writer, six certified organic dairy farms in Texas produced about 23% more milk than all of Wisconsin’s 453 organic dairy farms combined in 2016.⁴ The greater supply of organic milk has led to more quotas for producers and co-ops cutting back on members; in addition to Self, Westby Creamery recently terminated the contracts of seven other members.

The commodity milk system is becoming more untenable than ever for small farms. Recent prices around the country for conventional milk have been as low as $1.11 per gallon; while there are some organic producers that are still doing well, prices overall have declined substantially for organic milk. Farmers wanting to sell cows are finding little or no market. Oversupply and lower pay prices mean a race to the bottom for commodity milk.

One way for producers to escape or survive the commodity milk system is to sell raw milk for direct consumption; prices farmers can get for raw milk sales to the consumer are much higher than what they can receive for either conventional or organic milk intended for pasteurization. In Wisconsin the law is there for dairies to sell raw milk and improve their bottom line; the problem has been DATCP and its interpretation of what an “incidental sale” is.

The legislature passed the incidental sale law in 1957. The original intent of the law was that any sale of raw milk for human consumption was an incidental sale. At the time the law went into effect, there were over 100,000 dairies selling raw milk intended for pasteurization in the state ⁵; for all of them, sales of raw milk for direct human consumption were likely a very small percentage of total sales.

At one time DATCP interpreted the incidental sales law as meaning only one sale of raw milk per customer ever. In 2008 the department changed that, issuing a regulation that stated, “a sale is not incidental if it is made in the regular course of business, or is preceded by any advertising, or solicitation made to the general public through any communications media.” There is nothing in the statute legalizing incidental sales that prohibits advertising or solicitation.

DATCP’s interpretation of “not in the regular course of business” has been unfavorable to raw milk producers and consumers. It’s time for that to change; America’s Dairy Land is in an emergency situation. Dairies are going out of business every day in the state. DATCP can help Wisconsin dairy farms by either adopting a more liberal interpretation of what constitutes “not in the regular course of business” or by waiving enforcement against dairies selling raw milk direct to consumers in the regular course of business. For precedent on the latter step, DATCP only needs to look at the bordering state of Michigan.

Michigan law prohibits the sale or distribution of raw milk for human consumption; nevertheless in 2013 the Michigan Department of Agriculture and Rural Development (MDARD) adopted a written policy in which it would not take action against dairy farms distributing raw milk through herdshare agreements. MDARD set parameters that had to be in place, such as a written contract between the farmer and consumer for it to waive enforcement; DATCP could take a similar tact in Wisconsin.

DATCP is charged with promoting Wisconsin agriculture; one way it can do that with the current dairy crisis is to change its enforcement or interpretation of the law to one that benefits raw milk producers and consumers. Producers like Chaz Self have the quality raw milk and the potential demand to succeed. DATCP shouldn’t be preventing Self from selling raw milk. DATCP has an opportunity to help dairy farms stay in business. Ultimately, it would be great to pass a bill taking the word “incidental” out of the Wisconsin raw milk statute; but with the accelerated decline dairy is going through, there is no time to waste. The department should either adopt a new interpretation of the raw milk law or exercise its enforcement discretion now.

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[1] Dennis Halladay, “Here it comes: less than 40,000 dairies”, Hoard’s Dairyman, March 19, 2018. Last viewed 4/25/2018 at https://hoards.com/article-22818-here-it-comes-less-than-40000-dairies.html

[2] Corey Geiger, “Dairy farm numbers hover near 40,000”, Hoard’s Dairyman, February 26, 2018. Last viewed 4/25/18 at
https://hoards.com/article-22687-dairy-farm-numbers-hover-near-40000.html

[3] Pete Hardin, “March Dairy Meetings Somber in Wisconsin…”, Milkweed, Issue No. 465, April 2018; p. 5. [Wisconsin Farmers Union, “How Does It Work, and Would it Work Here?”, Dairy Supply Mgmt. in Canada, meeting 15 March 2018 at Dodger Bowl Banquet Center, Dodgerville, WI, recorded by www.wiseye.org; last viewed 4/25/2018 at http://www.wiseye.org/Video-Archive/Event-Detail/evhdid/12277]

[4] Rick Barrett, “Wisconsin’s small organic dairies squeezed by Texas mega-farms”, USA Today, March 24, 2018. Last viewed 4/25/2018 at https://www.usatoday.com/story/money/business/2018/03/24/wisconsins-small-organic-dairies-squeezed-texas-mega-farms/455330002/

[5] U.S. Department of Commerce, “County Table 10 – Dairy products and poultry and poultry products sold from farms: Censuses of 1959 and 1954”, U.S. Census of Agriculture: 1959, Volume 1, Part 14: Wisconsin (Chapter B – Statistics for Counties), p. 163. Last viewed 4/25/2018 at http://usda.mannlib.cornell.edu/usda/AgCensusImages/1959/01/14/866/Table-10.pdf

Photo courtesy of Grassway Organics LLC facebook page

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The agency is claiming that authority given it by the Public Health Service Act (PHSA) to regulate communicable diseases gives it the power to impose cGMP requirements. The PHSA provides that “[t]he Surgeon General, with the approval of the Secretary [of Health and Human Services], is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession 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, destruction 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.”¹

A common sense reading of this power would be that FDA could get involved if there was a foodborne illness outbreak confined to one state or if a producer solely in intrastate commerce was found to be manufacturing food under unsanitary conditions but, according to the agency, its power to regulate communicable disease gives it the authority to impose cGMP requirements on all food manufacturers (other than those in the meat and poultry business) for the following: “plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; processes and controls; warehousing and distribution; and natural or avoidable defect levels.”²

The cGMPs are part of a one-size-fits-all regulatory scheme; unlike some of the more onerous FSMA provisions such as the national produce safety standards and the food safety standards (HAPRPC – Hazard Analysis Risk-Based Preventive Controls) in which many smaller producers are exempt from those mandates, there are no exemptions from the cGMP requirements.

FDA has long held that cGMPs apply to food manufacturers in intrastate commerce but the agency’s position fell on deaf ears until after the passage of FSMA. The cGMPs used to have their own section in the Code of Federal Regulations (21 CFR part 110) but, when FDA issued regulations governing the HARPC requirement (21 CFR part 117), it moved the cGMP regulations over to that section as well. FDA wants to make it seem like cGMPs are part of FSMA even though they were never brought up when Congress was considering the food safety legislation in 2009 and 2010.

At this time FDA doesn’t have nearly the resources to enforce the cGMP requirements across the board but that doesn’t have to happen for the agency to create a chilling effect among local food producers; an occasional inspection of or enforcement action against a raw milk producer or cottage food operation will do the trick. The cGMPs potentially threaten to roll back some of the progress made in recent years through legislative and policy changes in the areas of consumer access to raw dairy and cottage foods.

There are ways to protect against the cGMP threat to intrastate business. One way would be for state legislatures to more closely monitor FDA cooperative agreements between state departments of health and agriculture to make sure the state agencies don’t impose these requirements on food producers operating only in intrastate commerce; with FSMA, states will be counted on to carry out much of its enforcement. Another way would be to amend the Federal Food, Drug and Cosmetic Act to make it clear that the cGMP requirements only apply to firms operating in interstate commerce. As it is FSMA is possibly the most draconian piece of food legislation ever passed; FDA needs to be stopped from expanding its power beyond what Congress ever intended.

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¹ United States Code of Laws, 42 USC 264(a). Accessed 2/28/2018 at https://www.law.cornell.edu/uscode/text/42/264

² Federal Register, 78 FR 3651. Section II.B.1 accessed 2/28/2018 at
https://www.federalregister.gov/documents/2013/01/16/2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human

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