The lawsuit was filed in the US District Court for the District of Columbia.
The US Food and Drug Administration (FDA) is being sued under the Administrative Procedure Act (APA) which requires federal agencies to decide on all rulemaking petitions within a ‘reasonable’ period. The complaint alleges that the agency has violated this mandate by failing to provide plaintiffs with final decisions on the petition submitted in 2012 and a related one submitted in 2020.
The plaintiffs are seeking a declaration that the FDA has violated the APA and an order compelling the agency to provide plaintiffs with "substantive" responses to the applications.
The organizations filing the lawsuit also argue that the US continues to allow ractopamine residue levels in meat that exceed those adopted by the international UN food standards body, the Codex Alimentarius Commission.
Safety of the additive
Ractopamine is a feed additive for pigs and beef cattle produced by Elanco Animal Health that has received a lot of attention over the last several years. Livestock producers use the product to enhance or increase muscle mass and improve feed efficiency in animals.
A report by authors with Michigan State University (MSU) Extension noted that the FDA has reviewed many studies designed to establish the safety of ractopamine, and that the US agency has determined that meat from animals fed ractopamine is safe for human consumption when fed to pigs and cattle according to the manufacturer’s recommendations. Because ractopamine is metabolized and cleared rapidly from muscle (meat), the product can be fed right up to time of harvest.
China and EU ban
Though the FDA found that meat from animals with ractopamine is safe for human consumption, some global markets, including China and the EU, require that all beef and pork sold there be free of the beta-agonist drug, or from animals never fed the product. While ractopamine is cleared rapidly from muscle, it accumulates in greater amounts and persists longer in certain tissues, including liver, lungs, kidney, eyes, and hair, reads the MSU report. US consumers do not typically eat these tissues, but they can be eaten in some other markets, including China, noted the authors.
Some US meat packers stopped accepting ractopamine-supplemented pigs for processing, and economics have played a key role. As China and the EU have become increasingly important export markets for US pork, many large meat packers in the US – Hormel, JBS and Tyson Foods - stopped processing ractopamine fed pigs beginning in late 2019 and early 2020 to help preserve their access to those markets.
