ISSUES & ANSWERS

Raise the safety bar on aquaculture drugs

By Dick Gutting


Experts forecast that aquaculture will account for more than half the U.S. seafood supply in the near future.  To achieve this milestone, farmers around the world must overcome the ever-present threat of disease.

New therapeutic drugs can help, but the residue sometimes left behind in farmed products is emerging as an issue that could disrupt aquaculture’s future and undermine markets for all seafood.

Residue can induce allergic reactions, be toxic or increase antibiotic resistance. For these reasons, all drugs used to raise seafood in the United States are strictly regulated by the Food and Drug Administration and must be proven safe and effective.

The drug residue issue is complicated by the fact that many more aquaculture drugs are used in other countries that export seafood to the U.S. market. Ninety percent of the world’s farmed seafood is grown in developing countries, where aquaculture production is increasing six times faster than in developed countries. Government controls on the use of animal drugs in these developing nations vary from none to very restrictive.

In nations where therapeutics are regulated, obtaining the needed approvals can be as complicated and expensive as it is in the United States. There often are too few aquaculture producers for pharmaceutical companies to justify the major expenditures needed to prove that animal drugs are safe and effective.

As a result, few therapeutic drugs are approved for seafood. This may change domestically if U.S. legislation to facilitate approval for “minor use” drugs passes Congress. Coop-erative efforts also are under way in Canada and Europe to gain similar approvals.

Progress is needed to also address the failure of some nations to adequately regulate the use of aquaculture drugs. European officials, for example, are rejecting seafood imports from several nations because unapproved residue of drugs such as chloramphenicol was found. The FDA considers any detectable residue of unapproved drugs to be unlawful in imports, even a level considered safe by the exporting country, and it has joined European authorities in stepping up import testing. 

But the safety of imports cannot be achieved solely by surveillance at the border. Aquaculture is growing faster in some parts of the world than the local oversight needed to keep it sustainable.

The safety bar needs to be raised. Aquaculture drugs must be used in a manner to avoid risks to human and environmental health and to avoid loss of consumer trust. The situation demands increased coordination between the FDA and its regulatory partners around the world.

A more harmonized global system is needed to reduce gaps in foreign oversight and ensure that safe therapeutics are available. International agreement is needed on: drug approval requirements, maximum allowable residue levels, drug testing protocols and HACCP-based processing and farming protocols.

We also need open and frank discussions about how best to protect consumers. A 1997 law paves the way, and the Codex Alimentarius Commission offers an ideal forum to accomplish this.

The FDA must be proactive if aquaculture’s full potential is to be realized.