Cutting Through the Propaganda on Raw Milk and Brucellosis

Various media have been waging one of the bigger anti-raw milk propaganda campaigns in memory through their reporting on a recent individual case of brucellosis attributed to raw milk consumption. The media are using the case of the third individual incidence of brucellosis blamed on raw milk consumption in the past year and a half to warn the public that people are putting their health in jeopardy if they don’t consume milk that is pasteurized. The illnesses occurred in Texas in August 2017, New Jersey in October 2017 and New York in November 2018 with the latest illness blamed on Miller’s Biodiversity Farm of Quarryville, Pennsylvania; there is currently a quarantine in effect prohibiting the farm from distributing raw dairy products. A cow that tested positive for Brucella has been removed from the dairy herd.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

North Carolina Herdshares Under Attack


The North Carolina Department of Agriculture and Consumer Services (NCDA), the North Carolina Farm Bureau, and the state’s dairy industry are working to repeal a 4-month-old law legalizing herdshare agreements. It is not known whether they have been able to find a legislator willing to sponsor such a freedom-robbing bill.

A herdshare agreement is a private contractual arrangement in which someone purchases an ownership interest in a dairy animal (or herd of dairy animal) and pays a fee to a farmer for boarding, caring for and milking the animals. The 2018 North Carolina Farm Bill contained a provision stating, nothing . . . shall prohibit the dispensing of raw milk or raw milk products for personal use or consumption to, or the acquisition of raw milk or raw milk products for personal use or consumption by, an independent or partial owner of a cow, goat, or other lactating animal.”1

NCDA Commissioner Steve Troxler isn’t waiting for a change in the law to begin restricting herdshares. The department has issued a directive prohibiting dairies from selling shares in dairy animals at state-run farmers markets. There is nothing in the herdshare law, or any other law, that gives it this authority.

The dairy industry’s push to repeal the herdshare law is coming at a time when many of the state’s Grade A dairy farms are either going out of business or barely hanging on. The distribution of raw milk through herdshare agreements can help save some of these dairies; the state’s dairy farms need all the help they can get. Between April 2017 to April 2018 North Carolina lost a staggering 24% of its Grade A dairies, dropping from 192 to 146. For the past four years, conventional dairies have been receiving a price for their milk that is well below the cost of production–a trend that shows no signs of going away.

The strategy for those trying to repeal the herdshare law will be to play the fear card trying to convince legislators that raw milk is major health threat, especially to children. When the recent deadly foodborne illness outbreaks involving foods such as romaine lettuce, ice cream, and cantaloupe are taken into consideration, there is a double standard in banning raw milk sales for human consumption in North Carolina (raw milk sales are legal for pet consumption). In spite of the efforts of CDC and FDA to make it seem otherwise, there have been no deaths legitimately attributed to raw milk consumption since the current CDC foodborne illness database started up in 1998. According to a recent study, the number of illnesses attributed to raw milk consumption in the U.S. has actually gone down as demand and consumption have increased.2 Reports are that herdshare farmers asking the state-run labs to test raw milk to help assure safety have been turned down.

The dairy industry leaders might also play the fear card with the state’s Grade A dairies, warning them that one outbreak blamed on raw milk could damage the conventional industry. The evidence shows otherwise–that the price of pasteurized milk and the demand for it aren’t affected by a foodborne illness outbreak blamed on raw milk consumption. If Farm Bureau, the dairy industry, and NCDA are successful in repealing herdshares, at least some of the Grade A dairies will be without a potential lifeline that could keep their operations going in the face of the low prices they are receiving for their milk intended for pasteurization. Raw milk produced for pasteurization and raw milk produced for direct consumption are mostly not in competition; if North Carolina raw milk consumers can’t get raw milk in the state, most will not drink pasteurized milk but will look outside the state for raw milk sources.

The Grade A dairies and many other farms can benefit from the herdshare law; raw milk is often the draw that leads to sales of other farm products such as meat, poultry, eggs and produce. The herdshare law can help the small farm sector in the state, enabling the start-up of micro-dairies. Michele Presnell, the state representative for the 118 District, noted that 60 years ago there were around 50 Grade A dairies and 150 other dairies in her home county of Yancy and today she knows of none. Reviving the dairy sector through herdshares can keep more of the food dollar in the community.

The herdshare law can make raw milk the centerpiece of a small diversified farm. In neighboring Tennessee where herdshare agreements have been legal for about 10 years, shareholder dairies have thrived; it is estimated that there are around 300 herdshare programs operating in Tennessee.

If the effort to repeal the herdshare law is successful, the 2004 law expressly banning herdshares goes back on the books, and the state will continue to lose business to South Carolina where the sale of raw milk is legal. Over the years this ban has resulted in millions of dollars of lost revenue.

There never should have been a herdshare ban in the first place; to say that someone with an ownership interest in a dairy animal can’t get milk from the animal unless it is boarded on the owner’s premises is a basic denial of property rights. For those who believe in property rights, freedom of food choice, and the right of dairy farmers to make a living keeping the herdshare law intact is a fight worth taking on.

See the February 12th action alert posted at www.westonaprice.org

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[1] North Carolina General Assembly, Session Law 2018-113 (Senate Bill 711), Section 15.2, June 27, 2018. Retrieved October 9, 2018 from https://www.ncleg.net/Sessions/2017/Bills/Senate/HTML/S711v8.html

[2] Whitehead J, Lake B. Recent Trends in Unpasteurized Fluid Milk Outbreaks, Legalization, and Consumption in the United States. PLOS Currents Outbreaks. 2018 Sep 13. Edition 1. doi: 10.1371/currents.outbreaks.bae5a0fd685616839c9cf857792730d1

Joel Salatin: Illegal to Drink Milk from Your Own Cow in Tenn?

Posted here by permission from Joel Salatin. Originally published at TheLunaticFarmer.com on January 10, 2019, under the title “Tennessee: Illegal to Drink Milk from Your Own Cow”. Be sure to read other posts by Joel. Click to see “What You Can Do

Just when you think you’re making progress in the food freedom arena, along comes a kind, sincere-minded loving zealot to throw a monkey wrench in things.

Such is the case in Tennessee, where Senator Briggs, a medical doctor, has filed Senate Bill 15 [SB 15] to criminalize drinking the milk from your own cow. An ecoli outbreak in Knox County apparently triggered the Draconian response from this well-meaning doctor. Of course, as is common in these cases, the outbreak was never actually tied to raw milk, but government bureaucrats color any opportunity to question and science generally flies out the window.

The bill “prohibits a person who owns a partial interest in a hoofed mammal from using the milk of the animal for the person’s personal consumption or other personal use.” If you ever wanted to see a bill targeted specifically at food freedom, this one is the prime example. Aimed squarely at herdshare, which has been the work-around for raw-milk prohibitive states, it also denies a person who owns a cow or a goat (any hoofed animal) the freedom to consume the milk from their own animal.

“Partial interest” would include both partial and full interest; in other words, if I have a goat that I want to milk and it’s mine alone, I certainly have a partial interest; lots more than partial, but at least partial. You don’t have to be a lawyer or linguist to appreciate the broad reach of this terminology. Every homesteader and farmsteader who has a goat or cow for their own personal milk consumption would be a criminal under this statute.

The sad part is that this doctor is a kind, well-meaning fellow. He doesn’t want to see anyone else get hurt. Therein lies the crux of the problem. It isn’t the government’s responsibility to keep people from getting hurt. If we really want to keep people from getting hurt, we should fill in all the backyard swimming pools, where we know 50 children will drown this year, just like every year. We would outlaw skiing, race car driving, and certainly football. We would outlaw pets because they scratch, bite and sometimes kill.

Safety is highly subjective. I don’t think it’s safe to drink 3 cans of Coca-cola a day, but that’s legal. I don’t think it’s safe to eat veggie burgers, but people do. If we’re going to pick and choose everything that could be unsafe and outlaw it, we might as well all go live in a bubble room and put on respirators. We pick and choose risks. Some eat at McDonald’s; others don’t. Some take the flu vaccine; others don’t. The critical thing to understand is that if the government is responsible for my health, then it necessarily has a fiduciary responsibility to penetrate every health-impactful decision I make in order to protect itself from economic liability.

It comes down to who owns the person. As long as the state owns the person, which is where America is right now, nothing is beyond the regulatory purview of the police, the ultimate enforcer of the laws. As the state micromanages our lives, the need for more police to enforce those regulations increases. The more police, the less freedom. Any society needing more police per capita is a society heading toward tyranny.

So here’s to hoping the good folks of Tennessee raise their milk glasses to liberty and defeat the good senator’s bill, regardless of how well intended. It’s a diabolical attack on freedom and personal autonomy.

Can you think of any food that should be illegal? Yeah, I didn’t think so.

WHAT YOU CAN DO
SB15 has been referred to the Senate Commerce and Labor Committee. Email committee members asking them to refuse any hearing on SB15 and to vote NO on the bill.

1. Email these Honorable Senators (PLEASE DO NOT CALL); you may copy/paste the entire block to email the whole committee:

    sen.paul.bailey@capitol.tn.gov; sen.art.swann@capitol.tn.gov; sen.jon.lundberg@capitol.tn.gov; Sen.Raumesh.Akbari@capitol.tn.gov; sen.dolores.gresham@capitol.tn.gov; sen.jack.johnson@capitol.tn.gov; sen.frank.niceley@capitol.tn.gov; sen.steve.southerland@capitol.tn.gov; sen.bo.watson@capitol.tn.gov

2. Please call and email sponsors of the legislation, asking them to withdraw their respective bills.

    sen.richard.briggs@capitol.tn.gov
    Contact Senator Briggs (615-741-1766, his staffer is Sarah Adair) and ask him to withdraw SB15.

    rep.patsy.hazlewood@capitol.tn.gov
    Contact Representative Patsy Hazelwood (615-741-2746, staffer is Kyle Faulkner), the sponsor of the companion bill banning herdshares in the General Assembly (the bill doesn’t have a number as of yet) and tell her to withdraw the herdshare bill.

FTCLDF Hires Jim Turner to Litigate Raw Butter Petition


The Farm-to-Consumer Legal Defense Fund (FTCLDF) has hired veteran Washington, D.C. attorney, Jim Turner, to litigate an FDA Citizen Petition seeking to lift the interstate ban on raw butter for human consumption. FTCLDF and Mark McAfee, president of Organic Pastures Dairy Company (OPDC), filed the petition with the Food and Drug Administration (FDA) on July 1, 2016; to date, FDA has yet to provide a substantive response.

The Weston A. Price Foundation (WAPF) and the Communities Alliance for Responsible Eco-agriculture (CARE) are providing funding for Turner’s legal expenses. WAPF is the leading advocacy group in the U.S. for raw milk and raw milk products, including butter. CARE is a Pennsylvania-based food buyers club that has long been a strong supporter of freedom of food choice, especially raw dairy products.

Turner is no stranger to FDA, having dealt with the agency on various matters since the 1960s. His law practice consists of representing businesses, individuals, and consumer groups on regulatory issues concerning food, drug, health product safety and environmental matters.

In 1970 he was largely responsible for getting Cyclamate, an artificial sweetener, pulled off the market. For nearly ten years he fought against FDA and the G.D. Searle Corporation in an effort to take the artificial sweetener, aspartame, off the market. There have been more complaints filed with FDA about aspartame than any other food product.

Federal law requires FDA to file a response to a citizen petition within six months after receiving a copy. In December 2016 FDA sent FTCLDF and McAfee a letter stating it needed more time to review the petition; in the two years since, the agency has sent nothing to the two petitioners. If Turner can’t convince FDA to issue a substantive response to the petition, he will likely file a writ of mandamus motion in a federal district court to have the court compel FDA to respond. If FDA rejects the petition, petitioners can appeal the agency’s decision to a federal appellate court.

There has been a federal ban on raw milk and raw milk products for human consumption (other than raw cheese aged sixty days) in interstate commerce since 1987 when FDA issued a regulation (21 CFR 1240.61) establishing the ban in response to a court order. Three arguments Turner can make to lift the ban are: that FDA exceeded its authority in banning raw butter since the case resulting in the court order, Public Citizen v. Heckler, only concerned fluid milk products (milk, cream, yogurt) not manufactured milk products (butter, cheese); that federal statute (21 CFR 341) prohibits FDA from issuing a federal ‘standard of identity’ regulation for butter [standards of identity are requirements prescribing what a food product must contain to be marketed–pasteurization is one such requirement]; and that there isn’t a single foodborne illness outbreak attributed to the consumption of commercially produced raw butter [OPDC has sold over 2 million pounds of raw butter since 2001 without incident]. FDA is basically claiming that its power to regulate communicable disease allows it to ban a food that makes few, if any, sick.

The butter petition is a great opportunity to weaken the interstate raw dairy ban — a significant step towards the day when the transport of all raw dairy products across state lines will be legal. Jim Turner has the experience and ability to make that happen.

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Image from video: Jim Turner Recalls Rumsfeld Meeting over Nutrasweet Toxicity, published on YouTube October 7, 2011

Return of the Milkman in Ohio


Like the rest of the country, Ohio is the in the midst of a dairy crisis that shows little sign of getting better for most farms producing raw milk for pasteurization. Yorkshire farmer, Dan Kremer who also owns and operates the Eat Food For Life buyers club, believes that family dairy farms, particularly those producing organic milk, can stay in business by producing raw milk for direct consumption. Kremer who raises beef, poultry, and eggs also distributes raw milk through a herd share agreement; his brother-in-law manages a herd of Jersey cows on the same farm.

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

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

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

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

The first milkman in the U.S. was a raw milk man; home deliveries of raw milk began in Vermont in 17852,3. In the 1950s over half of the milk sales were made through home delivery; even though these sales were mostly pasteurized milk there were still home deliveries of raw milk. By 1963 29.7% of milk sales were made through home delivery4; the growth of supermarkets and other factors contributed to the decline. By 2005 only 0.4% of milk sales were made through home deliveries.5

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

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

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

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

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

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

Raw Milk – Rx for Dairy Crisis


The New Jersey Department of Agriculture (NJDA) held a statewide Dairy Summit on October 11 to show the state’s dairies ways to survive the current crisis the industry is going through. The event was great testimony to how unfair the commodity pricing system, the Federal Milk Marketing Order (FMMO), is and how legalization of raw milk sales and/or distribution in the state can help dairy farms remain in business. In the mid-1970s there were over 500 dairy farms operating in New Jersey, today there are 48.

Earlier this year the state’s Grade A dairies were receiving around $14 per hundredweight (one hundred pounds of milk), that figure shrunk to $12 after deducting transportation costs (moving the milk from the farm to the processing plant of the farmer’s dairy cooperative). According to one of the speakers at the summit, the average cost of production for the dairies is $18.50, a path to bankruptcy.

Dairy farmers know the FMMO pricing system robs them of revenues they should be earning but the pricing is complicated enough so that it is difficult to figure out exactly how the FMMO denies them income that should rightly be theirs. Most dairy farmers are captive to the FMMO and the commodity pricing system; they belong to a cooperative which bottles and markets their milk. In that situation, individual farmers do not set their own price.

Four ways a dairy farmer can escape or survive the commodity system are:

  • Own bottling and pasteurization equipment; this is a major expense most dairy farmers cannot afford.
  • Find a creamery willing to bottle and pasteurize an individual farmer’s milk, something that’s not easy to do. Jared Weeks, a dairy farmer from Ringoes, who spoke at the summit, has been able to find a creamery in Pennsylvania to take some of his milk for bottling and pasteurization, but few, if any, other dairy farmers in the state have been able to make the same arrangement.
  • Make value-added dairy products, such as butter, cream, and yogurt; again, this is typically a substantial expense most dairy farmers cannot afford.
  • Sell or distribute raw milk for direct consumption – this is a less expensive way to escape or survive the commodity system whether the farmer is selling direct to the consumer, distributing direct to the consumer through a herd share agreement or selling to retail stores.

New Jersey is one of seven remaining states that do not allow any raw milk sales or distribution. Legislators began introducing raw milk bills in the New Jersey General Assembly back in 2006; since that time New Jersey has lost more than half of its remaining dairies.

The New Jersey Department of Agriculture is not opposed to legislation legalizing raw milk sales and/or distribution; it is the New Jersey Department of Health (NJDOH) that opposes raw milk legalization. The health department sees raw milk as a health threat but a recent Canadian study found, “The rate of unpasteurized milk-associated outbreaks [in the U.S.] has been declining since 2010. Controlling for growth in population and consumption, the outbreak rate has effectively decreased by 74% since 2005.” According to the Centers for Disease Control from 1998-2016, there were only seven (7) foodborne illness outbreaks attributed to the consumption of raw goat milk, an average of about one outbreak every three years.

Raw milk sales or distribution was not on the agenda for the Dairy Summit. The focus was on individual dairy farmers having access to or building a processing plant that would bottle and pasteurize milk as well as manufacture value-added dairy products. Jon McConaughy, the owner of Double Brook Farm in Hopewell, estimated that it would cost $450,000 to build a processing plant. Daniel Wunderlich, Dairy Program Coordinator for NJDA spoke about having a group processing plant that would bottle both conventional and organic milk. McConaughy said, at this time the New Jersey General Assembly had not allocated any money towards such a project. There were speakers for various agencies of USDA and other organizations who spoke about loans to farmers for marketing and dairy processing plants and equipment but how can farmers qualify for a loan when they are already deeply in debt and are losing money with every shipment of milk they make to their cooperative. Dairy farmers need a decent price for their milk more than they need a loan.

Even though the FMMO wasn’t a topic at the Dairy Summit, the information speakers presented was still an indictment of the commodity milk pricing system.

Tom Beaver, Director of Marketing and Development for NJDA said that New Jersey dairies produce one percent (1%) of the milk New Jersey residents consume. NJDA has established a Jersey Fresh logo that in-state producers of milk and other foods can put on their labels to promote their products. If it looks like the state is down to 48 Grade A dairies because New Jersey consumers don’t want to purchase milk produced in-state, that is not so.

Beaver said that NJDA recently conducted a Jersey Fresh Milk Consumer Survey throughout New Jersey and all five boroughs of New York City; 85% of those responding to the survey “indicated an interest in buying Jersey Fresh milk; 23% of those surveyed would be willing to pay a premium, with the average premium being $1.74 above what respondents are currently paying for a half gallon.” What is wrong with this picture?

Dairy farmer Pete Southway, owner of Springhouse Creamery in Sussex County, said that the fifty cows he milks only provide 7% of the milk residents of his county need. McConaughy estimated that producers free from the commodity system and the milk cooperatives could take in as much as $104 per hundredweight (about $9 per gallon). The demand for local milk is there, it’s not the lack of consumer demand as much as the commodity pricing system that are driving dairies out of business.

Retired dairy farmer John Pugh attended the summit. Pugh, who is 97 years young, recalled how once the FMMO went into effect that he switched his herd from Guernseys to Holsteins, placing greater emphasis on the quantity of milk production and less on quality. Legalizing raw milk sales and distribution in New Jersey is a way to put more quality milk on the market and to revive the dairy business in the state that the FMMO helped destroy.

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About the top photo:
“Let the Good Times Flow for National Dairy Month!”
Posted 6/4/2015 by Dana Coale, Deputy Administrator of the Agricultural Marketing Service’s Dairy Program
Source: https://www.usda.gov/media/blog/2015/06/04/let-good-times-flow-national-dairy-month

North Carolina Lifts Herdshare Ban


Earlier this year the North Carolina legislature passed a bill containing a provision that ended a 14-year ban on herd share agreements in the state. Herd share agreements are private contractual arrangements in which someone purchases an ownership interest in a dairy animal (or herd of dairy animals) and pays a fee to a farmer for boarding, caring for, and milking the animal(s). The herd share law went into effect on October 1. With the new law, only two states remain that have expressly banned herd shares by either statute or regulation: Maryland and Nevada.

Session Law 2018-113, also known as the North Carolina Farm Act of 2018, contains a clause stating, “nothing…shall prohibit the dispensing of raw milk or raw milk products for personal use or consumption to, or the acquisition of raw milk or raw milk products for personal use or consumption by, an independent or partial owner of a cow, goat, or other lactating animal.”1

The new herd share law marks the continued move away from earlier attempts to ban raw milk distribution in the state. The sale of raw milk for human consumption has long been illegal in North Carolina. In 2004 an official from the state Department of Environment and Natural Resources was able to successfully engineer a stealth bill banning herd shares through to passage in the final hours of the legislative session. Sales of raw pet milk were still legal at the time but the state Department of Agriculture attempted, in 2008, through rulemaking to require all pet milk to be denatured before sale. Opponents led by then Weston A. Price Foundation (WAPF) chapter leader, Ruth Ann Foster, were not only successful in defeating the proposed rule but were able to pass a bill in 2009 that legalized the unlicensed sale of raw pet milk.

North Carolina is the second state to pass raw milk legislation this year; in March, Utah enacted a law allowing the delivery of raw milk by licensed producers and the on-farm sales by unlicensed producers on a limited basis. With the crisis the conventional dairy industry is going through, there will be more opportunity to increase raw milk access around the country; raw milk is a way to survive or escape the commodity system that is throwing so many dairy farmers out of business.

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[1] North Carolina General Assembly, Session Law 2018-113 (Senate Bill 711), Section 15.2, June 27, 2018. Retrieved October 9, 2018 from https://www.ncleg.net/Sessions/2017/Bills/Senate/HTML/S711v8.html

Massachusetts Governor Meddles With Raw Milk Bill


The founding fathers saw the separation of powers among the legislative (making laws), executive (enforcing laws) and judicial(interpreting laws) branches as a bedrock of our constitutional republic, but what passes for the separation of powers under our current system of government has little resemblance to what our founding fathers intended, especially when a governor is directly introducing legislation.

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

Virginia Ag Department Clarifies Policy on Herdshares


After two consecutive legislative sessions in which unsuccessful efforts were made that would have either banned or severely restricted herd share agreements, the Virginia Department of Agriculture and Consumer Services (VDACS) has clarified its policy on herd shares. In an email to the Farm-to-Consumer Legal Defense Fund (FTCLDF), a VDACS official stated, “The agency has currently taken a hands off approach to herd shares as long as there is a legitimate contractual relationship conveying ownership between the consuming individual and the animal/herd. Value added products such as yogurt, etc. (again in the context of a contractual relationship between owner and consumer) are still on the table and I’m not sure where we are going with that but the agency is not taking any action regarding those types of products at this time.”1

Herd share agreements are private contractual arrangements in which someone purchases an ownership interest in a dairy animal (or herd of dairy animals) and pays a fee to a farmer for boarding, caring for and milking the animal(s). The owner has the property right to obtain raw milk from the animal(s). It’s legal to purchase ownership in a dairy animal and it’s legal to obtain milk from a dairy animal you co-own; currently, there is nothing in the Virginia Code on herd shares. Herd share programs have been thriving in Virginia for many years.

In 2017 an amendment to a food freedom bill was introduced that would have banned herd shares; the inducement for the ban was the legalization of the regulated on-farm sale of raw milk. The Virginia Independent Consumers and Farmers Association (VICFA) and others–including the bill’s original sponsor, Nick Freitas–was successful in killing the legislation.

In 2018 opponents of herd shares–such as Virginia Farm Bureau, Virginia Agribusiness Council, and the Virginia State Dairymen’s Association–took a different tact; supporting the introduction of legislation in the Senate (SB 962) and the House of Delegates (HB 825) that would have officially legalized herd shares while attempting to intimidate both consumers and farmers from either entering into or continuing on with herd share agreements. Both bills required that shareholders assume joint liability if the herd or any milk produced by the herd was responsible for injury or illness; the way both bills read, giving raw milk to family or guests would be a crime. Both bills provided that violating any of the requirements in them would be first degree misdemeanors with criminal penalties of up to one year in jail and $2,500 in fines; everyday the violation continued would be a separate offense. Strong grassroots mobilization led by VICFA with help from the Weston A. Price Foundation (WAPF), FTCLDF and other organizations, carried the day; both bills died in committee.2

VDACS has long had a hands-off policy towards regulating herd share agreements but there have been reports of agency inspectors telling farmers that herd share agreements are illegal. Having a statement in writing from VDACS should help increase the sizable number of herd share programs in the state that already exist. The position of VICFA and its members has always been that the state has no jurisdiction over property rights in dairy livestock acquired through private contract, but there are others who were more hesitant to enter into herd share agreements without something in writing from VDACS on herd shares; they now have it.

In the past VDACS has been reluctant to acknowledge the legality of value-added products distributed through a herd share agreement, but recent precedent in other states shows the wisdom of VDACS current hands-off policy towards the distribution of raw dairy products other than milk.

In 2016 a Michigan court found a herd share operation not guilty of contempt for distributing butter and cream, among other product, to its shareholders; there was an injunction against the operation prohibiting it from violating Michigan’s dairy laws. The Michigan Department of Agriculture and Rural Development (MDARD) had adopted a written policy allowing only the distribution of fluid raw milk through herd share agreements; in spite of the policy and plenty of evidence showing that other raw dairy was distributed through the herd share, the judge ruled that MDARD had not made its case that there were any violations of the state dairy laws. The case turned in favor of the herd share operation when one of its shareholders, Mike Lobsinger, successfully intervened as a party to the contempt proceeding. One of the arguments made by Lobsinger’s attorney was that, with the raw milk being his property, it was none of MDARD’s business if he had that milk processed into cream.3,4

In 2012 the Office of the Tennessee Attorney General issued an opinion finding that an “independent or partial owner of any hoofed mammal” may use a dairy product made from the milk produced by such animal for the owner’s personal consumption or other personal use.”5 Tennessee has a herd share statute recognizing that anyone who has an ownership interest in a dairy animal can use “the milk from such animal for the owner’s personal consumption or other personal use.”6 When the Tennessee Department of Agriculture claimed that the statute only allowed the distribution of raw milk and no other dairy product, State Senator Frank Niceley, the sponsor of the herd share bill that passed into law in Tennessee, sought the attorney general opinion.

Herd share programs are at the heart of Virginia’s local food system; the written statement of policy from VDACS should only strengthen that. Hopefully, it will help convince herd share opponents not to introduce legislation again in the next legislative session; if they do, the grassroots will be there once more to contest them.

[1] Email dated August 7, 2018
[2] Pete Kennedy, “Victory in Virginia – Bills Threatening Herd Shares Now Dead”, RealMilk.com, 6 February 2018. Last viewed 9/12/18 at https://www.realmilk.com/victory-virginia-bills-threatening-herd-shares-now-dead/
[3] Pete Kennedy, “Wild Day in Michigan: A Court Victory and A Raid”, Farm-to-Consumer Legal Defense Fund website, 13 December 2016. Last viewed 9/12/18 at https://www.farmtoconsumer.org/blog/2016/12/13/wild-day-michigan-court-victory-raid/
[4] James S. Jamo, “Opinion and Order”, MDARD v Hill High Dairy, LLC et al, File No. 15-574-CZ, 8 December 2016. [view PDF]
[5] Robert E. Cooper, Jr., “Owner’s Use of Milk and Licensing of the Sale of Eggs”, State of Tennessee Attorney General Office, Opinion No. 12-04, 13 January 2012
[6] Tennessee Statute 53-3-119

FSMA Food Safety Regs Going Local

Starting September 17, 2018, all “very small business“ (roughly defined as business with less than $1 million in annual sales1) manufacturing, processing2 or holding food must be in compliance with applicable federal regulations issued pursuant to the FDA Food Safety Modernization Act (FSMA) that govern “Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food.”3 These regulations break down into two different requirements: first, that the food business be in compliance with current good manufacturing practices (CGMPs) and, second, that it develop and implement a food safety plan that effectively performs a hazard analysis and designs risk-based preventive controls for human food (HARPC, Hazard Analysis and Risk-based Preventive Controls).4

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

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

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

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

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

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

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

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

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

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

The PHSA provides that:

    “The Surgeon General, with the approval of the Secretary [of Health and Human Services] is authorized to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the states or possessions, or from one state or position into any other state or possession. For the purposes of carrying out and enforcing such regulations the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, distraction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.”33

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

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

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

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

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

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

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

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

Those with questions about food facility registration or exemptions from the HARPC and CGMP requirements can email Pete Kennedy at pete@realmilk.com.

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FOOTNOTES

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

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

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

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

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

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

      (1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
      (2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation. Qualified facility exemption means an exemption applicable to a qualified facility under § 117.5(a).

    [21 CFR 117.3, bolded emphasis added]

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


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