adverse effects of ractopamine in pigs since the drug'sapproval, far outpacing those for any other livestock drug.Livestock producers reported pigs treated with ractopamineexperiencing “hyperactivity, trembling, broken limbs, in-ability to walk and death.”
While the FDA has stated thatthese reports do not prove that ractopamine caused thesymptoms, the FDA required Elanco to add a warning labelto the drug stating,“CAUTION: Ractopamine may increasethe number of injured and/or fatigued pigs during market-ing.”
Because ractopamine is fed to livestock in the last fewweeks before slaughter, residues of the drug are left behindin the animal's meat.
Of the small fraction of meat testedfor ractopamine residues, none have registered above theFDA's permitted tolerance levels.
The FDA has not approved beta agonists for medical usein people, but the drugs are used off-label for asthma andheart failure. Elanco's human safety tests for ractopaminemainly included tests on animals, with only one studyinvolving six human subjects.
What constitutes an accept-able level of ractopamine in meat is a matter of interna-tional dispute.
International Controversy Over Ractopamine
Although 27 countries, including the United States,Canada, Mexico and Japan, allow ractopamine use, 160countries, including the EU and China, do not.
Coun-tries that use ractopamine generally cannot sell meat tocountries that do not allow it. The EU and China combinedrepresent 70 percent of global pork consumption, a hugepotential market for U.S. pork producers.The United States began pressuring the international fo-rum on food safety standards, the United Nations' CodexAlimentarius Commission (Codex), to set a residue limitfor ractopamine in meat shortly after the FDA first ap-proved the drug.
A Codex-approved ractopamine residuelimit would effectively force countries to allow the importof meat treated with ractopamine because Codex is theaccepted standard under international trade rules. Codexremained deadlocked for four years over the issue and onlynarrowly set an amount of ractopamine residue that canremain in meat and be considered safe to eat in 2012.
Forcountries that ban ractopamine, the Codex decision repre-sents a weakening of international rules.The new Codex standard is more stringent than the FDAallows, meaning that the United States falls outside the Co-dex standard.
Nonetheless, the EU, Russia and China allinsisted that they would maintain their ractopamine bansdespite the Codex standard.
Russia has demanded thatthe United States certify that its meat is ractopamine-free.Since the United States tests so little meat for residues, andthe meat tested for ractopamine frequently contains smallresidues, Russia has banned U.S. beef and pork imports.
U.S. Agriculture Secretary Tom Vilsack and U.S. TradeRepresentative Ron Kirk contend that Russia's actions con-tradict its World Trade Organization commitment to followthe Codex standards.
To access the Russian market, Brazilhas banned ractopamine use in its livestock until it devel-ops a dual-track supply chain to ensure that it can provideractopamine-free meat to Russia, the largest customer forBrazil's beef.
Since the Codex decision, Taiwan has set its own maxi-mum allowable ractopamine residue levels for beef, butnot pork. In 2011, Taiwan found ractopamine residues inU.S. meat imports, resulting in recalls and a steep dropin U.S. meat imports.
In the spring of 2012, the UnitedStates threatened to discontinue any new trade agree-ments with Taiwan over its refusal to establish maximumallowable ractopamine residue levels. Taiwanese citizens,including livestock producers, have held repeated publicdemonstrations, opposing any imports of meat from ani-mals treated with ractopamine.
The U.S. government intends to force global acceptance of ractopamine, by challenging bans on the drug as WTO-illegal trade barriers.
The U.S. livestock and pharmaceuti-cal industries insist that foreign opposition to ractopaminestems from protectionism, not food safety concerns.
Meanwhile, two organizations, the Center for Food Safetyand the Animal Legal Defense Fund, have petitioned theFDA to perform its legal obligation to review the scientificbasis of the Codex decision and also to reduce the U.S.maximum residue levels in meat to the Codex standard orlower.
The citizen petition cites several of the European FoodSafety Authority's (EFSA's) objections to the alleged safetyof ractopamine residues for people.
The EFSA found that