Tag Archives: regulations

FDA Permits Three Exceptions From Sanitary Transportation Rule

The Food and Drug Administration (FDA)  has published three waivers  to the now final Sanitary Transportation rule mandated by the  Food Safety Modernization Act (FSMA).

 The waivers are for businesses whose transportation operations are subject to separate State-Federal controls. They include:

  • Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.

  • Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. (Examples include restaurants, supermarkets and home grocery delivery services.)


To finish reading the article, read more at Food Safety Magazine.

Why are there regulations on milk?

How did regulations start?

As people moved to the cities, the milk supply became unhealthy.  Milk had to be transported longer distances and was held at higher temperatures for longer times. As a result, many people, especially children, became sick and died after consuming contaminated milk.

In the late 19th century, public health reformers started working toward a safer milk supply. One such reform was, in 1910, the city of Chicago required milk to be pasteurized.  Farmers and sellers sued the city stating that requirement was unnecessary and costly.  In 1914, the Illinois Supreme Court decision in Koy vs City of Chicago required pasteurization of milk sold in the city.  By 1920, regulations regarding milk had spread across the nation.

This proved to be a public health victory.  In 1938, disease outbreaks from milk counted for 25% of all outbreaks from food and water.  As of 2002, that number was down to 1%.

In 1924, the United States Public Health Service (USPHS), a branch of the FDA, developed what is now known as the Pasteurized Milk Ordinance (PMO).  The PMO contains provisions governing the production, processing, packaging and sale of Grade “A” milk and milk products.  This includes the barns, equipment, water, testing, cleaning, etc.  The 2013 PMO is over 430 pages.

The PMO is the basic standard used in the Voluntary Cooperative State – USPHS/FDA program for the Certification of Interstate Milk Shippers (IMS).  To be involved with Grade “A” milk, you must be “listed” in the IMS.  This includes dairy processors, laboratories, container and closures companies.  All 50 states, DC and US territories participate in the IMS program. Forty-six states have adopted the PMO for their own milk safety rules. The other 4 states have passed laws very similar.

Federal law prohibits the interstate sale of raw fluid milk.  In 1987, the FDA banned the state-to-state shipping of raw milk. They mandated the “pasteurization of all milk and milk products in final package form for direct human consumption.”


Why pasteurize?

The leading human illnesses attributed to milk before pasteurization were brucellosis, diphtheria and tuberculosis.  These are well-controlled or virtually eliminated in modern dairy herds in the United States. They do still occur in other countries.

Predominant illnesses today from raw milk and raw milk products are normally caused by Salmonella sp, Campylobacter sp, E. coli and Listeria sp.

RAW MILK OUTBREAKS in unpasteurized (raw) milk and raw milk products, United States 1998 – 2013       (15 years)

136 total outbreaks

102 were from fluid milk

28 were from raw milk cheese.

6 wer from multiple raw dairy products.

2,468 total illnesses, 2 deaths

1,803 fluid milk-related illnesses.

608 cheese-related illnesses, 2 deaths

57 illnesses from multiple raw dairy products.

From January 2015 to March 2016 (15 months), there were 15 recalls of unpasteurized milk.  The states include California (4), Pennsylvania (3), New York (3), Washington (2), Idaho, Tennessee and Indiana.

The contaminates were Campylobacter sp. (7), Salmonella sp. (2), E. coli 0157:H7 (4), Listeria sp. (4), and Cryptosporidium (1).   Two recalls were for more than one contaminant. Some recalls were in response to routine testing that yielded positive results. Others were due to illnesses related to the consumption of raw milk.  In states that allow the sale of raw milk, there are mandatory testing requirements of the raw milk that vary from state to state.  Some states require routine pathogen testing, while others do not until there is a complaint or outbreak.


How does raw milk get contaminated?

There are many avenues for contaminates to get into the raw milk.  It can come from the processing equipment such as the milking equipment, lines, tanks and containers. milking-1466846-640x480

Environmental factors can include dirt, mud, fecal matter in the straw, and standing water in the area.

Cows at feeding time on the dairy farm. Rear view

Rodents, including mice, rats, insects and chicken and poultry can contaminate the area and the milk.field-mouse-1526371-640x480 (1)

Other avenues can come from the humans on their boots, gloves, hands and soiled clothing. boots-1238700-639x852

The animals themselves can be the source of contamination due to the inadequate cleaning of the udders, broken skin or illness.

What testing is done?  Report to follow.

What Does That Food Label Mean?

In the US, food labels are required for most prepared foods.  They are mandated to list several things such as calories and dietary fiber. The label must also include any vitamins or minerals added to enriched foods.  Specific additives such as color additives must also be listed.  Finally, the FDA requires labeling of ingredients that can impact human allergies, such as milk or nuts. All of these requirements are based on scientific and medical guidance.

Recently, companies have been adding labels to increase the marketability of their products by appealing to the health consciousness of the consumer. There are FDA-approved descriptors and claims that may be added to food labels. The FDA seeks voluntary compliance from the food companies for science based labeling.  The labels are to use statements that are truthful and not misleading. They should not state or imply that organic food is superior to traditional food products.

Antibiotic Free

  • “No Antibiotics added” indicate livestock was raised without the use of antibiotics. It should also indicate that the claim is USDA verified.
  • “Antibiotic-free” is not authorized or approved by the USDA.
  • All meat is free from antibiotics due to governmental regulations and farmers compliance. After treatment with antibiotics, there is a mandatory withdrawal period to ensure there are no antibiotic residues in the animal.
  • All milk is free from antibiotics for the same reason.  Cows being treated are milked separately and that milk is destroyed. The animal has a withdrawal period and milk is tested for residue before it can be returned to the herd. The milk is also retested before it is unloaded from the tank.

All Natural

  • According to the FDA, “it is difficult to define a food product as ‘natural’ because the food has probably been processed and is no longer the ‘product of the earth'”.
  • The FDA has not developed a definition, but does not object to the use of the term if the “food does not contain artificial colors, flavors or synthetic substances.”
  • The USDA classifies “minimally processed foods without artificial ingredients” as natural.

No Hormones

  • “No added hormones” indicates no hormones were administered during the animal’s lifetime.
  • FACT: Hormones are approved for the use in beef cattle and lamb production.
  • FACT: The use of hormones is not permitted in pork or poultry.  Using “hormone-free” or “no hormones added” labels on pork or poultry is false advertising.

Free Range

  • The USDA does not define that term for labeling.
  • The required provisions for the “free range” label use include unlimited access to food, fresh water and continuous access to outdoors.
    • Continuous access to the outdoors can mean many things. They may have access, but may prefer to stay inside with the food and water. Windows count as access.
    • Access may mean more space, but with poultry, that can lead to increased aggression and injury and worse air quality. Yes, the “pecking order” is real.

Grass Fed

  • After weaning, livestock is fed nothing but grass and other forages. 
  • Other forages include grasses, cereal grains in the pre-grain state, hay, haylage, baleage, silage, legumes and crop residue.
  • Animals must have continuous access to grass during the growing season. There are no other regulations other than what is applied to conventionally raised livestock.


  • Organic foods are produced according to the standards in the Organic Food Production Act (OFPA). An Organic label means:
    • “The use of irradiation, sewage sludge, synthetic fertilizers, prohibited pesticides and genetically modified organisms is not permitted.”
    • Livestock is produced according to health and welfare standards.  No antibiotics or growth hormones can be used. Livestock is fed with 100% organic feed and provided access to the outdoors.
    • 95% of the ingredients of a multi-ingredient food must also be organic.
    • Before products can be labeled USDA Organic, a USDA-accredited certifying agent must verify the practices as compliant.
  • According to the Mayo Clinic, organic food is not safer or healthier than conventionally grown foods.

USFDA "Labeling & Nutrition. July 2015
MedlinePlus. Food Labeling.15 May 14.
USFDA. "What is the meaning of 'natural" 8 Jun 15
National Chicken Council. "Chickopedia. 20 Jul 15
Consumers Reports. June 2012
Wall Street Journal.  19 May 2016
USDA Agriculture Marketing Service Grading, Certification & Verification. 29 Sep 08
USDA "Meat & Poultry Labeling Terms"  24 Oct 14
USDA "Organic Standards" 11 Jun 15
Mayo Clinic. "Organic foods: Are they safer?"  Mayo Clinic 9 Jun 14
Illinois Farm Bureau

FDA Seeking Information on Raw Milk Cheese

On Monday, the U.S. Food and Drug Administration (FDA) started collecting public comments on cheese made from unpasteurized milk.

Agency officials want any information or scientific data that would help them identify and evaluate measures that might minimize the impact of pathogens in raw milk cheese.

The public comment period will remain open for 90 days from Aug. 3.

Read more here.