Testing times in US quality control

The United States’ Food & Drug Administration (FDA)’s decision, on 21 April 2025, to suspend a quality control programme for tests on ‘Grade A’ milk and finished pasteurised dairy products, has caused concern about future milk and dairy product safety. It runs counter to global trends towards intensifying dairy product safety testing.

The suspension follows US President Donald Trump’s controversial move to impose budget cuts to the FDA’s department of health and human services (HHS), contributing to 3,500 redundancies, and halting operations at the FDA’s Moffett Center Proficiency Testing Laboratory, which is where the tests are undertaken. The FDA’s HHS press secretary, Vianca N Rodriguez Feliciano, has promised the programme will resume once transferred to another FDA laboratory, but as of press time this has yet to happen.

The Wisconsin Cheese Makers Association (WCMA), an advocacy group representing 650 dairy cooperatives and companies, has released a letter saying suspension of proficiency testing threatens “our collective ability to prevent foodborne illness and to consumer confidence.” This was followed up by a newsletter statement saying that, “After our letter urging action to resume Grade ‘A’ milk proficiency testing, USFDA officials have reinstated employees who oversaw the testing programme.” FDA senior science advisor for milk safety Beth Briczinski also noted the agency is working to ensure proficiency testing will remain available.

But in the meantime, noted the Washington DC-based International Dairy Foods Association (IDFA), this internal proficiency test, ensuring FDA-affiliated laboratories accurately analyse milk samples, will be halted. In these tests, laboratories are asked to test milk samples spiked by FDA with contaminants and evaluated to see if their results match those of FDA reference labels.

A US FDA spokesperson stressed to DII that “the FDA’s long running Grade A milk proficiency programme follows the International Organization for Standardization ISO 17043 rules, and is considered one of the most well-recognised and respected for the dairy industry.”

Strict standards govern milk safety and export, she continued: “All US-produced milk intended for interstate commerce or export must meet the (1938) US Federal Food, Drug and Cosmetic Act requirements, stating food (milk) must be prepared “from sound, wholesome raw materials, prepared, packed and held at all times under sanitary conditions, the food itself must be safe, clean and wholesome and the labelling honest and informative.”

She noted that these tests cannot be undertaken by American dairy companies on their own products, only by FDA-designated independent laboratories. “These standards are implemented through the Pasteurised Milk Ordinance (PMO), which is now 100 years old, with the PMO 2023 Revision the current benchmark for milk quality.”

In a statement, the USA National Milk Producers Federation (NMPF) emphasised the PMO contains “exhaustive rules and regulations on how milk must be handled and tested, including checks for the presence of drug residues or antibiotics and to see if milk is the right temperature, and an alkaline phosphatase test to check the milk has been properly pasteurised.”

“The cost of testing is somewhat variable and depends on many factors,” the FDA spokesperson added.

Given that these actual direct tests will continue, industry organisation US Dairy’s vice president, corporate communications, Joe Micucci, cited a 12 May Simply Recipes news article stressing that American milk quality control remains in place, without making any direct comments.

According to Roberta Wagner, senior vice president of regulatory and scientific affairs at the IDFA, “The suspension does not reduce the types or frequency of milk quality tests for Grade A milk or finished dairy products during the supply chain from farms to stores across the country.” She added, “All Grade A milk continues to be subject to stringent testing and oversight throughout the supply chain.”

For the time being, Jukka Likitalo, secretary general of EU dairy trade association Eucolait, told DII, the EU has not imposed additional safety checks on imported US dairy products as a result: “I am not aware of any additional measures or restrictions taken against the US following the announced suspension,” he said.

But the EU milk and dairy safety test regime is certainly stringent. European Dairy Association (EDA) communication officer Alexander Roth noted: “The EU has a robust sanitary and phytosanitary system to ensure that all food placed on the EU market meets high levels of human health protection.”

A European Commission official confirmed animal health requirements for imports of raw milk and finished milk-based products into the EU are long-standing and set in Commission Delegated Regulation (EU) 2020/692, with “no change in substance compared to provisions of the now repealed Commission Regulation 605/2010 on animal, public health and veterinary certification conditions to introduce raw milk and dairy products into the EU.”

Public health requirements are set in Regulation (EC) No 853/2004 and model certificates for import are laid down in Commission Implementing Regulation (EU) 2020/2235, she added.

As in the US, the EU sets a minimum standard needed to sell milk across the EU. Milk must notably comply with hygiene regulations setting requirements for microbiological criteria. For example, raw cow’s milk must not contain more than 400,000 somatic cells/ml (excessive numbers may signal inferior quality quality), be of a certain temperature and not contain antibiotic residues.

“There is also a specific EU legislative framework to market milk and milk products and protect dairy terms in Annex VII, Part III of Regulation (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products,” the official told DII. Drinking milk (for human consumption) standards are laid down in Annex VII, Part IV of this regulation.”

In addition, she said imported US milk must comply with the relevant import requirements and certified in accordance with Regulation (EU) 2020/2235 by the competent authorities.

The EDA’s Roth noted that dairy-containing composite foods may require certification or attestations depending on their dairy content and assessed risk. The frequency of import checks is based on updated risk assessments, depending on the product type and on the country of origin.

Eucolait’s Likitalo stressed EU dairy companies and other food business operators are responsible for their products’ safety under EU law. They need to have appropriate HACCP [Hazard Analysis and Critical Control Points] in place, supervised by member state competent authorities.

The legal framework for this is largely European, he said, covered by general EU food law and food hygiene regulations.

The main official controls legislation, Commission Regulation (EU) 2017/625, governs how milk checks are financed. On costs, “member state governments can largely decide how to finance official controls,” said Eucolait’s Likitalo. “But they need to ensure that control authorities have sufficient resources. For some activities, there are mandatory fees to be paid by food business operators,” which can be flat-rate fees or those based on the cost of each individual control.