Is FDA Exceeding FSMA Inspection Authority?

Posted on August 21, 2019 by Pete Kennedy

FDA has compiled statistics for the first half of 2019 on the number of inspections it and state regulatory agencies under contract to FDA have conducted pursuant to the Food Safety Modernization Act (FSMA).¹ What stands out in the numbers is that by far, the most inspections FDA has conducted has been for compliance with Current Good Manufacturing Practices (GMPs).²

The GMPs are a one-size-fits-all regulatory scheme that includes requirements for plant construction and design, equipment, sanitation, and warehousing and distribution; GMPs are broadly worded and subject to varying interpretations by inspectors. According to an FDA official who spoke at the recent annual meeting of the International Association for Foods Protection (IAFP), some of those inspections for GMP compliance were for firms under the Tester-Hagan exemption that removes the requirement of having a food safety plan (known as HARPC or Hazard Analysis and Risk-based Preventive Controls). The average inspection for the GMP requirements is 3 to 4 days; if the firm has a compliance history with FDA, that inspection could be as long as 7 to 9 days.³ Arguably, FDA has no legal authority under FSMA to conduct GMP inspections of most or all of the Tester-Hagen exempt firms.

Among other requirements, FSMA requires facilities engaged in processing, manufacturing, packing, or holding food to have a written food safety plan showing that the facility

has identified the potential hazards associated with the food being produced, packed, or held;
has implemented preventive controls to address the hazards; and
is monitoring the performance of the preventive controls to ensure that such controls are effective.

This requirement for HARPC is found in 21 CFR 117 Part C.

HARPC for human food has several exemptions from its mandates, one of which is a “qualified exemption for those firms grossing less than one million dollars per year ⁴, an exemption known as Tester-Hagen. In addition, to be eligible for the exemption, the facility must make more than half its sales either directly to consumers or to a restaurant or retail food establishment located either in the same state or within 275 miles of the facility.⁵

To obtain the exemption, facilities must submit a form to FDA that includes one of the following attestations:

that the facility has a modified food safety plan addressing most of the HARPC requirements [FDA could mandate that the food safety plan include GMPs]; or
that the facility is “in compliance with state local, county, tribal or other applicable non-Federal food safety law…including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency such as a state department of agriculture, or other evidence of oversight.”⁶

A reading of the federal statute on HARPC, 21 USC 350g, shows how FDA could be exceeding its authority by inspecting those under the Tester-Hagen exemption for the GMP requirements; 21 USC 350g(L)(2)(A) provides that a qualified facility “(A) shall not be subject to the requirements under Subsection (a) through (i) and Subsection (n) in an applicable calendar year….” Subsection (c) covers preventive controls, which is defined in Subsection (o) as:

⁷

NOTE: The Current Good Manufacturing Practices (CGMP) have since been moved to the HARPC section (part 117).

Most, if not nearly all, facilities exempt by Tester-Hagen would obtain the exemption by attesting that their business is subject to some kind of state regulation. Why spend that time and resources drawing up a modified HARPC plan when you can get the exemption by sending FDA a copy of a state license or other proof of state oversight?

The only food business that would not be subject to state regulation would be those selling only direct to consumers; those firms would not have to register as food facilities and, therefore, would not have to be subject to any of the FSMA requirements for HARPC if over half of their gross revenues are from direct-to-consumer sales in which case they would be exempt as a “retail food establishment” under federal regulation.⁸

FDA hasn’t divulged how many facilities with a qualified exemption it has inspected but it looks like it has exceeded its authority if it has inspected any facility that obtained its exemption through an attestation that it was subject to non-federal regulation. To go from being allowed to include GMPs as a part of preventive controls regulations to issuing GMP rules under FSMA that are separate from preventive controls is a big reach. There was never any deliberation by Congress contemplating separate regulation of requirements for CGMPs as part of FSMA.

A food law attorney speaking at the IAFP conference observed that FDA is paying close attention to GMP compliance and has no tolerance for GMP violations. Given the length of GMP inspections, how FDA is interpreting the GMPs more strictly, and the number of enforcement tools the agency has which use to cripple a small business without the economies of scale to comply, it’s recommended that small farmers and local artisans have, if at all possible, over half of their sales as direct-to-consumer to be exempt from the food facility registration requirement. This includes firms currently registered; there is a procedure to cancel registration.⁹

The time to move is now; it looks like FDA’s interpretation of the FSMA requirements will only be getting more strict. The likelihood is that neither Congress or the court will exercise oversight to limit FDA’s inspection authority to what FSMA provides.

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1. Bass, Glenn. US Food and Drug Administration. “FDA’s Perspective and Experience on FDA Enforcement and Inspection.” Symposia S1: Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection, 22 July 2019. Speech, Kentucky International Convention Center, Louisville, KY.
2. Ibid. Out of nearly 9,000 FSMA inspections conducted, over 7,500 included assessing GMP compliance as well as HARPC (of which 7,000 were inspections for limited provisions of HARPC). Of the remaining, the FSMA inspections fell into the following categories: Sanitary Transport, Foreign Supplier Verification Program, Produce Safety Standards, HARPC for Animal Food, and GMPs for Animal Food.
3. Ibid.
4. 21 CFR 117.5
5. 21 CFR 117.3, see definition of “qualified end-user”
6. 21 CFR 117.201
7. 21 USC 350g(L)(2)(A)
8. 21 USC 350d, 21 CFR 1.226, 21 CFR 1.227
9. 21 CFR 1.241(c)

2019 Raw Milk Legislation Summary

Posted on June 24, 2019 by Pete Kennedy

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Seventeen states had bills legalizing or expanding the sale/distribution of raw milk and raw milk products before the legislatures during the 2019 session. Three states have passed legislation so far this year but, with many states in the first year of a two-year session, there are a number of bills that still have a chance of passing in 2020.

An untapped source of revenue for producers is the sale/distribution of raw dairy products other than milk and aged cheese. The sale of butter, cream, yogurt, and kefir is illegal in a majority of states but, given the excellent track record for food safety of all these products, there is a good chance that more states will be passing bills in the near future to legalize the sale of these products.

States having raw dairy bills in 2019 include:

ALASKA
The distribution of raw milk through herdshare agreements is currently legal by regulation; House Bill 16 (HB 16) would make it legal by statute and would also allow herdshare dairies to distribute all other raw dairy products to their shareowners in Alaska. HB 16 has passed out of the House and was assigned to a Senate committee before the 2019 session adjourned; so, it will start the 2020 session in the Senate Resources Committee.

ARKANSAS
Current law allows raw milk producers to sell up to a total of 500 gallons of raw goat milk and/or raw cow milk on an average monthly basis. House Bill 1699 (HB 1699) amends the law to also legalize the sale of raw sheep milk as part of the 500-gallon limit. HB 1699 passed the legislature and became law on April 10.

MISSOURI
House Bill 1090 (HB 1090) will allow licensed dairies meeting sanitary standards to sell raw milk and raw cream to grocery stores, restaurants, and similar establishments. Under current law, licensed raw milk dairies can sell raw milk and cream on the farm and through delivery. HB 1090 has been referred to the House Agriculture Policy Committee. The Missouri legislature just finished the first year of a two-year session.

MONTANA
House Bill 490 (HB 490) would have legalized raw milk sales and created a two-tier system in which those producing ten gallons of raw milk per day would operate under a small-scale raw milk license while dairies producing more than ten gallons per day would need to obtain a commercial raw milk license. In effect, HB 490 would have acted as a de facto ban on raw milk.

Those producing more than 10 gallons per day would have had to have the dairy’s physical facility be up to Grade A standards, a cost of tens of thousands of dollars. Even small-scale raw milk dairies could have been subject to onerous physical facility requirements. The bill also could have subjected dairies to expensive testing requirements and have made them pay for costs of a foodborne illness outbreak investigation even if they weren’t held responsible for the outbreak. HB 490 died on the House floor vote.

Two other bills died without a hearing that, respectively, would have legalized herdshare agreements (House Bill 521 – HB 521) and would have legalized sales of raw milk and raw milk products by producers with herds of less than 10 cows, 20 goats, or 20 sheep (House Bill 516 – HB 516).

NEVADA
Under current law, producers can only sell raw milk and raw milk products where a county milk commission has specifically certified those foods; Nye County has the only county milk commission in the state. Senate Bill 418 (SB 418) would have allowed producers to sell statewide the raw milk and raw milk certified by a county milk commission. SB 418 also would have exempted micro-dairies [with up to 5 cows, 10 goats, 10 sheep] from certification standards and allowed them to sell raw dairy without regulation directly to the consumer at the farm where the milk is produced. SB 418 passed the Senate but died without a hearing in the Assembly Committee on Health and Human Services.

NORTH CAROLINA
Sponsors introduced three raw milk bills in the 2019 session. House Bill 103 (HB 103) would allow the licensed sale of raw milk in retail stores by dairies with no more than 10 lactating cows, 10 lactating goats, or 10 lactating sheep. Companion bills, Senate Bill 509 (SB 509) and House Bill 385 (HB 385), would ban herdshare agreements; the state legalized the distribution of raw milk and raw milk products through herdshare agreements as part of the 2018 North Carolina Farm Bill. None of the three bills have received a hearing but the legislature’s rule allows bills to be tacked on to unrelated legislation; this is what happened in 2004 when the legislature passed a herdshare ban at the end of the session. As long as the legislature is still in session, SB 509 and HB 385 remain dangerous.

NEW YORK
Assembly Bill 5867 (AB 5867) would legalize herdshare agreements, referred to in the bill as “shared animal ownership agreements”, without regulation. Currently, in New York, the licensed on-farm sale of raw milk is legal. AB 5867 has been referred to the Assembly Agriculture Committee.

TENNESSEE
There were several raw dairy bills before the legislature. Senate Bill 358 (SB 358) which allows the sale of raw butter by producers with a dairy plant license became law on April 30; the bill requires dairy plant operators to keep the butter-making separate from the production of other dairy products. Producers must also put a warning label on the packages containing the raw butter.

Senate Bill 15 (SB 15) would have banned herdshare agreements; the bill died because no companion House bill was introduced. The sponsor of SB 15 later tacked on an amendment to an unrelated bill, Senate Bill 1123 (SB 1123), but that bill died in committee. Current law allows the unregulated distribution of raw milk and raw milk products through herdshare agreements.

UTAH
The final version of House Bill 182 (HB 182) would have allowed licensed dairies to sell raw butter and raw cream; currently, the only raw dairy products licensed producers can sell are milk and aged cheese. HB 182 passed out of the House and the Senate committee, but time ran out on the 2019 session before a vote of the full Senate could take place.

VERMONT
House Bill 525 (H.525) became law on June 17. Among other things, the bill legalizes the sale of raw milk at consumers’ homes and at farmers markets if the producer is in compliance with statutory requirements for animal health, sanitation, labeling, recordkeeping (as well as signage and registration requirements for those selling at farmers markets). Prior to the passage of H. 525, those producers meeting the same requirements could sell milk only on the farm and then deliver it to their customers (either at their homes or at farmers markets).

PRIME Act Reintroduced in Congress

Posted on June 1, 2019 by Pete Kennedy

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On May 23, Representatives Thomas Massie (R-KY) and Chellie Pingree (D-ME), and Senator Angus King (I-ME) reintroduced the Processing Revival and Interstate Meat Exemption Act (H.R. 2859 / S. 1820), also known as the PRIME Act. The legislation would return power to the states to determine appropriate regulations for meat processing within their borders. The bills have been referred to the House Committee on Agriculture and the Senate Committee on Agriculture, Nutrition and Forestry, respectively.

The PRIME Act would give states the option of passing laws to allow the sale of custom-slaughtered and processed meat in intrastate commerce direct to the consumer and to venues such as restaurants, hotels, grocery stores, and boarding houses. Federal law currently prohibits the sale of custom-processed meat; meat from a custom facility can only go to the individual or individuals who own the animal at the time slaughter takes place–a requirement costing farmers a substantial amount of business. Many potential customers either don’t have the funds to buy a whole animal or the freezer space to store it.

Farmers who sell meat by the cut must use a slaughterhouse that has an inspector present during the actual slaughtering. Many communities in the U.S. have custom facilities nearby but not inspected slaughterhouses; this means hauling the animals several hours to an inspected facility, driving up the farmer’s costs and stressing the animals. There are places in this country where the farmer has to book a year in advance with the slaughterhouse under inspection for the slaughtering of livestock.

The decline in slaughterhouse infrastructure since the passage of the Wholesome Meat Act in 1967 has been one of the biggest problems small farmers face. The Wholesome Meat Act gave the federal government jurisdiction over meat processing and sales in intrastate commerce. At the time the Act passed, there were nearly 10,000 slaughterhouses in the U.S.¹; as of January 1, 2019, there were 2,766.²

Passage of the PRIME Act is more important than ever. There continues to be growing demand for grass-fed beef, but with the lack of local slaughterhouses, small farmers are missing out on much of that business. Instead of business that could go to small American farmers, imported “grass-fed” beef has the dominant market share in the U.S. According to reports, 75% to 80% of grass-fed beef sold in this country is imported. Due to lax country-of-origin-labeling laws, much of this meat is labeled as being produced in the U.S.³

It remains to be seen how much market share laboratory plant-based “meat” will capture at the expense of small-scale livestock farmers, but the fake meat industry is growing rapidly at this time with support from major Wall Street banks and investment firms [see underwriters listed in the prospectus for Beyond Meat, Inc.⁴].

Small farmers badly need greater access to slaughterhouses to be able to compete on more even footing with agribusiness. Currently, only four companies control over 80% of the beef processing in this country; four companies control over 60% of pork processing.⁵

The meat industry consolidation has led to significant food safety concerns. Inspected slaughterhouses are stretched beyond capacity. In recent years the industry has had over 100 recalls each year totaling over 20,000,000 pounds of meat and poultry products being recalled annually.⁶

Few, if any, recalls and cases of foodborne illnesses have involved meat slaughtered and processed at a custom facility. Custom slaughterhouses are generally small facilities where often only a few animals are slaughtered and processed each day; contrast this with the USDA plants where up to 300-400 cattle are slaughtered per hour.⁷ The custom houses, even without an inspector on site, have a much better track record for food safety. Passage of the PRIME Act will improve food safety in the industry.

Representative Massie said, “Consumers want to know where their food comes from, what it contains, and how it’s processed. Yet federal inspection requirements make it difficult to purchase food from trusted local farmers. It is time to open our markets to give producers the freedom to succeed and consumers the freedom to choose.”⁸

The PRIME Act was originally introduced in 2015. In the House, H.R. 2859 and currently has eleven co-sponsors; the Senate companion bill, S. 1620 has two co-sponsors.

Please support this crucial legislation. The Weston A. Price Foundation (WAPF) will be sending out an alert on the PRIME Act in the near future.

———–
[1] Riva Caroline Hodges Denny, “Between the Farm and the Farmer’s Market: Slaughterhouses, Regulations, and Alternative Food Networks ” (Master’s thesis), 2012, p. 2. Retrieved from Auburn University AUETD database, https://etd.auburn.edu/handle/10415/3247
[2] USDA, National Agricultural Statistics Service (NASS), Livestock Slaughter 2018 Summary, April 2019; Table “Livestock Slaughter Plants by Type of Inspection – States and United States: January 1, 2018 and 2019”, p. 62. Posted at https://downloads.usda.library.cornell.edu/usda-esmis/files/r207tp32d/8336h934w/hq37vx004/lsslan19.pdf
[3] Deena Shanker, “Most Grass-Fed Beef Labeled ‘Product of U.S.A.’ Is Imported”, Bloomberg News, May 23, 2019. Posted at https://www.bloomberg.com/news/articles/2019-05-23/most-grass-fed-beef-labeled-product-of-u-s-a-is-imported
[4] Prospectus for Beyond Meat Inc. Posted at https://www.sec.gov/Archives/edgar/data/1655210/000162828019004543/beyondmeats-1a5.htm

The Complete Patient

https://www.davidgumpert.com/the-fake-meat-explosion-could-be-great-news-for-grass-fed-meat-and-raw-dairy

[5] USDA, Grain Inspection, Packers and Stockyards Administration, 2016 Annual Report: Packers and Stockyards Program, Table 5 “Four-Firm Concentration in Livestock Slaughter by Type of Livestock and Poultry – Federally-Inspected Plants”, p. 11. Posted at https://www.gipsa.usda.gov/psp/publication/ar/2016_psp_annual_report.pdf

https://thefern.org/ag_insider/beef-packing-merger-threatens-last-competitive-cash-cattle-market-in-u-s/

[6] USDA, Food Safety Inspection Service (FSIS), Summary of Recall Cases for 2015-2018 are available at https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-summaries
[7] National Academy of Sciences, Institute of Medicine, & Food and Nutrition Board, Cattle Inspection: Committee on Evaluation of USDA Streamlined Inspection System for Cattle (SIS-C), Washington, D.C.: National Academy Press, 1990, pp. 8, 11, 37, 73, 74, 75 & 86. Downloadable from https://www.ncbi.nlm.nih.gov/books/NBK235649/
[8] “Representatives Massie and Pingree Introduce Bipartisan PRIME Act to Empower Local Cattle Farmers, Meet Consumer Demand”, U.S. Representative Thomas Massie website (massie.house.gov), May 23, 2019. Press release posted at https://massie.house.gov/newsroom/press-releases/representatives-massie-and-pingree-introduce-bipartisan-prime-act-to-empower

Raw Butter Sales Now Legal in Tennessee

Posted on May 7, 2019 by Pete Kennedy

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On April 30 Governor Bill Lee signed into law Senate Bill 358 (SB 358); the legislation legalizes the sale of raw butter by licensed producers in Tennessee. SB 358, sponsored by Senator Frank Niceley, a long-time champion of the small farmer and local food, goes into effect immediately.

SB 358, as amended in the House and passed, provides that

“the department [of agriculture] shall not regulate the production of unpasteurized butter provided that it is produced:

(A) In a facility separate from production of pasteurized products;

(B) Solely for intrastate commerce; and

(C) By a person licensed by the department as a dairy plant.

On any raw butter sold, the bill also requires a warning label stating, among other things, that the product has not been inspected and that butter “may contain disease-causing micro-organisms.”¹

According to the Centers for Disease Control (CDC), between 1998 and 2016, there was not a single foodborne illness outbreak attributed to the consumption of commercially-produced raw butter²; during that time, California-based Organic Pastures Dairy Company (OPDC) sold over two million pounds of the product without incident³. The labeling requirement was a concession that had to be made if the bill was going to pass.

It’s not clear why the Tennessee Department of Agriculture (TDA) would not regulate the production of butter from a licensed dairy plant but the answer could possibly be because of some agreement the department has with the federal government.

SB 358 allows the retail sale of raw butter; Tennessee joins Arizona, California, Idaho, and Maine as states allowing the sale of the product in retail stores. There are around a dozen states that allow the sale or distribution of raw butter for human consumption.

Niceley introduced a bill in 2018 that would have legalized raw butter sales, but that legislation didn’t make it out of House committee after passing the Senate. With the accelerating decline of the state dairy industry over the past year, SB 358 did not have any significant opposition. One point Niceley made during consideration of the bill was about the increasing competition from lab-grown dairy products to the conventional industry, saying that laboratories could produce pasteurized dairy products at a much lower price than the dairy industry could and that the industry needed to separate itself from that competition with the production and sale of raw dairy products.

It is uncertain at this time how many of the state’s licensed dairy plants are interested in selling raw butter but the potential is there. None of Tennessee’s neighbors allow raw butter sales; there could be out-of-state customers buying butter in Tennessee. Cheesemakers from other states could be moving in with an additional high-demand product to sell. If demand does take off, some of the state’s remaining dairies could obtain higher prices for their milk by selling some of their production to dairy plants instead of cooperatives where most are losing money with each load they ship.

The Farm-to-Consumer Legal Defense Fund (FTCLDF) has a citizen petition⁴ before the U.S. Food and Drug Administration (FDA) to lift the interstate ban on sales and distribution of raw milk and other raw dairy products (except aged cheese). If the petition is successful, it is likely raw butter sales would be legal in all states within a few years. Until that time, there should still be a steady increase in states allowing raw butter sales or distribution.

Brentwood Chapter Leader Shawn Dady lobbied for the bill on behalf of the Weston A. Price Foundation (WAPF). Congratulations to her, Senator Niceley, and the other Tennesseans supporting SB 358 for legal raw butter sales⁵, in time for the spring flush.

===============
[1] House Amendment Number 1 to HB0532 (HA0116), Tenn. House § 1 (2019). Last accessed 5/7/2019 at http://www.capitol.tn.gov/Bills/111/Amend/HA0116.pdf
[2] Mark McAfee and Farm-to-Consumer Legal Defense Fund, “Citizen Petition Seeking Legalization of Interstate Transport of Unpasteurized Butter”, petition, June 22, 2016; p. 10
[3] Ibid. p. 11
[4] For more details about the citizen petition, read “FTCLDF Hires Jim Turner to Litigate Raw Butter Petition” at https://www.realmilk.com/turner-litigate-raw-butter-petition/
[5] Thanks to an opinion from the Attorney General, the state has allowed the distribution of raw butter and other dairy products since 2012 through herdshare agreements.

Raw Milk Enforcement Moves to Alberta, Canada

Posted on March 17, 2019 by Pete Kennedy

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Raw milk enforcement actions continue in Canada; this time it’s Alberta. The Crown has brought three charges against Innisfail farmer David Rand for alleged violations of Alberta’s dairy law: the unlicensed production or processing of dairy products, selling raw milk, and “obstructing, hindering or impeding an inspector in carrying out their duties” under the Alberta Dairy Industry Act. A trial will likely take place this fall; each of the charges carries a maximum $25,000 fine. [For those who would like to support Rand, a GoFundMe campaign has been set up at ca.gofundme.com/dairy-freedom.]

In addition to the charges, the Alberta Health Services (AHS) has issued a “Notice of Closure” to Rand ordering him to “cease and desist the distribution, transport, processing or sale of unpasteurized milk or unpasteurized milk products.” One of the grounds for the order was that “distributing, transporting, processing or selling unpasteurized milk products” was in violation of an Alberta health regulation stating, “no person shall create, commit or maintain a nuisance.” Alberta Agriculture and Forestry (AAF) issued a second order to Rand, a “Notice of Seizure or Detention” requiring that all milking equipment and any dairy products, including all future production, remain on Rand’s farm.

The charges and the orders against Rand stem from a November 7, 2018, raid on Rand’s farm and a supposed raw milk distribution site in Red Deer, Alberta, by officials from both AAF and AHS as well as the Royal Canadian Mounted Police (RCMP). The officials conducted the raid at both locations without any warrant.

The law in Alberta, as in all provinces of Canada, prohibits any sale of raw milk; there is a federal ban in the country as well. The ban has served as a protection racket for dairy industry but some of the farmers making up the industry might want to consider obtaining another outlet for their milk. The Canadian quota system has been held as a model for the struggling U.S. dairy industry but there has been a tremendous decline in the number of Canadian dairies, falling from nearly 140,000 in 1960 to fewer than 12,000 today according to The Globe and Mail.¹

In Ontario, there is an ongoing court case where 21 Ontario farmers and consumers have filed in a Toronto Superior Court a constitutional challenge to the province’s ban on raw milk sales and distribution.² In 2010 an Ontario court ruled in a case the Crown had brought against Michael Schmidt for illegally selling raw dairy that there was a legal distinction between the public and private distribution of food and that informed consumers can waive the protection of public health laws. That ruling was reversed on appeal; raw milk proponents could use a similar decision in the country that is the most oppressive in the world when it comes to enforcement against raw milk sales and distribution.

Supporters of raw milk access in Canada may go to the educational Facebook page for Farm-Fresh-Milk (be sure to include the hyphens). The intention is to show that raw milk needs to be on the policy platform of every party. There is also a website with a petition for Canadians to have the right to obtain fresh milk produced by local farms recognized by the legislation; to endorse “We Choose Fresh” petition, go to www.farmfreshmilk.ca/wechoosefresh.

Links:
GoFundMe – https://ca.gofundme.com/dairy-freedom
Facebook – https://www.facebook.com/Farm-Fresh-Milk-217362812483137
Petition – http://www.farmfreshmilk.ca/wechoosefresh

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[1] Barrie McKenna, “Canada’s dairy industry is a rich, closed club”, The Globe and Mail, 25 June 2015 (updated 15 May 2018), https://www.theglobeandmail.com/news/politics/canadas-dairy-industry-is-a-rich-closed-club/article25124114/
[2] Pete Kennedy, “Farmers & Consumers Challenge Raw Milk Ban”, RealMilk.com, 19 February 2018, https://www.realmilk.com/farmers-consumers-file-constitutional-challenge-ontario-raw-milk-ban/

Cutting Through the Propaganda on Raw Milk and Brucellosis

Posted on February 28, 2019 by Pete Kennedy

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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.

——
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

Posted on February 15, 2019 by Pete Kennedy

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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 on February 1, 2019 by Pete Kennedy

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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

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

Posted on December 20, 2018 by Pete Kennedy

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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

Posted on December 8, 2018 by Pete Kennedy

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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 1785^2,3. 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.

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Return of the Milkman in Ohio