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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Photo Credit: congerdesign on pixabay.com

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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

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