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As overfishing, poor fisheries management, and increasing seafood demand have led to a rapidly dwindling population of wild fish worldwide, aquaculture is being billed by some as the next –– and only practical –– frontier in fish and seafood production.

Despite some inland and near shore fish farming producing pollution that can threaten human health and the environment, the federal government now wants to allow aquaculture in our oceans. Indeed, the Bush administration is pushing Congress to approve a new federal law that would open our federal waters –– typically anywhere between three and 200 miles from shore –– to industrial fish farming. Officials from the National Oceanic and Atmospheric Administration, an agency of the U.S. Department of Commerce, argue that allowing open ocean aquaculture, also known as offshore aquaculture, or ocean fish farming, is the best solution to our country’s seafood trade deficit. Ocean fish farming proponents fail to mention that the drugs and chemicals, sometimes used to keep the thousands of fish crammed into cages free from disease and the cages clean, can harm consumers and wreak havoc on the environment. In addition to those chemicals and drugs, fish waste and processed fish food escape into the surrounding marine environment, combining for a real mess. The U.S. Food & Drug Administration and the Environmental Protection Agency supposedly regulate what –– and how –– chemicals and drugs are used in aquaculture, and the industry’s effects on the environment. Unfortunately, neither agency has sufficient regulations in place to keep our seafood safe and our waters clean. Until a stronger and more effective regulatory system is established for FDA and EPA to adequately oversee existing inland and coastal fish farms, we should not even consider allowing offshore aquaculture.

I. Food & Drug Administration

If open ocean aquaculture is allowed as proposed, it will likely be plagued by the problems inherent to other aquaculture facilities. For example, fish farmers generally need dangerous drugs and chemicals to keep diseased fish from dying in cramped, unnatural conditions. Although it’s against the rules,¹ they also inappropriately use drugs and chemicals to stimulate unnatural growth, affect reproduction and tranquilize fish for transport.²

Without regulation, these practices in offshore aquaculture, as in other aquaculture, will be dangerous for public health. Although drugs might help aquaculture operations sell more fish, they can harm consumers. Many drugs used in aquaculture are hazardous to humans because they leave residues in the treated fish that can cause allergic reactions and even cancer.³ In addition, many of the drugs used are antibiotics, which can create antibiotic resistance in microbes that can infect the humans who eat them.⁴

Existing Regulations

The Food and Drug Administration regulates the manufacture and use of aquaculture drugs. Under the Federal Food Drug and Cosmetic Act (FFDCA), an aquaculture drug is a new animal drug, which must be proven “safe and effective for its intended use” in order to be marketed legally.⁵ It is also a minor species drug because fish are considered minor species, along with all other species that are not cattle, horses, swine, chickens, turkeys, dogs or cats.⁶

FDA provides special incentives for aquaculture drug development under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS). Under MUMS, a sponsor of a minor species drug can gain conditional approval if they prove that the drug is safe, which means the sponsor can market it for up to five years before proving that it is also effective.⁷ A sponsor can also seek “designation” as a MUMS drug, which means the drug in development is eligible for special grants and seven years of exclusive marketing rights.⁸

Although the federal government provides regulatory incentives for the development of aquaculture drugs, it has approved only nine active ingredients for the 16 drugs currently on the market.⁹

In order to be used properly under the FFDCA, aquaculture drugs must be administered according to the directions on the label.¹⁰ FDA recognizes that because so few drugs are approved for use in aquaculture, many fish farm operators use drugs and chemicals that are not approved or use approved drugs in ways that differ from the labeled instructions.¹¹ Unfortunately, instead of conducting routine inspections of all aquaculture facilities, the agency uses “regulatory discretion” ¹² to determine when and where to intervene, and considers violations on a “case–by–case” ¹³ basis. This means that many unsafe drug practices on aquaculture farms are not prevented by federal oversight.

For example, although FDA has established regulatory priority guidelines for some drugs, chemicals that have not been assigned to these categories can easily escape regulation. Some drugs are more likely to be regulated because they are considered a “high regulatory priority.” ¹⁴ These drugs specify on the label that they are not to be used on food animals.¹⁵ Other drugs are “low regulatory priority” drugs, which FDA is unlikely to object to as long as the use follows specific guidelines. However, some drugs, such as copper sulfate and potassium permanganate, have specifically had their status deferred, pending further study. These chemicals are known to be potentially dangerous: exposure to copper sulfate can cause liver and kidney damage,¹⁶ and potassium permanganate can cause nausea, vomiting, abdominal pain, and kidney damage.¹⁷ Since they have not been designated in a regulatory category, there are no set standards for their use, which leaves aquaculture operators the freedom to use them however they see fit.

In addition to using unapproved drugs, fish farmers often use approved drugs for unapproved purposes. This is called “extra–label” use of the drug. Although extra–label use is considered adulteration and therefore a violation of FFDCA,¹⁸ the Animal Medicinal Drug Use Clarification Act of 1994 allows extra–label use if it is under the supervision of a licensed veterinarian.¹⁹

In general, FDA does not allow extra–label use of drugs when they are administered as feeds.²⁰ However, it makes an exception for medicated feeds used in aquaculture because there is often no practical way to medicate fish except through feed.²¹ This exception applies to only two medicated feeds, Romet and Terramycin.²² Aquaflor and Aquaflor–CA1, both of which contain the Veterinary Feed Directive drug florfenicol, cannot be prescribed for extra–label use.²³

Unfortunately, by allowing veterinarians to prescribe extra–label use of drugs and medicated feeds, FDA is condoning improper use of drugs. While FDA expects veterinarians to use their scientific knowledge to prescribe drugs safely, the veterinarians do not have established guidelines to follow and may therefore fail to ensure consumer safety. Moreover, since FDA does not inspect aquaculture facilities, there is little oversight to ensure that prescribed extra–label directions are being followed.

Even more disturbing is the fact that under existing regulations, fish farmers can legally use unapproved drugs by participating in what are called Investigational New Animal Drug (INAD) studies. INADs are drugs that are in process to be approved, but have not yet been adequately tested for safety and effectiveness.²⁴ The drug companies that wish to market these drugs get an exemption from FDA to allow their drugs to be used without approval, as long as it is part of a study.²⁵ Because this is considered confidential business information, FDA does not keep records of these studies, but relies on the drug company to do so.²⁶ This means that potentially dangerous substances are used legally on aquaculture farms without FDA supervision.

Since FDA does not routinely inspect aquaculture facilities, the agency attempts to prevent drug–laden fish from reaching consumers through its Hazards Analysis and Critical Control Point (HACCP) program. Under HACCP, seafood processors are expected to reject fish from farms that use drugs illegally.²⁷ Unfortunately, this does not prevent the drugs from being used, and puts the burden of enforcement on processors who may not have the means to verify the safety of the products they receive. INAD use is considered confidential business information, so seafood processors have no way of confirming that the experimental drugs are being used properly, and must rely on a written certification that INAD use conforms to the standards set by the study.²⁸ Thus, FDA’s main enforcement mechanism for ensuring consumer safety is actually the seafood processors, not the FDA itself. HACCP is an insufficient means of protecting consumer health because it depends on businesses to enforce each other, rather than a publicly accountable government agency.

Needs for Improvement

As aquaculture proponents suggest an expansion of the industry to the open ocean, FDA must rethink its approach to aquaculture regulation. If the agency wishes to ensure consumer safety it should consider the following steps, at minimum:

1. All drugs and chemicals knowingly used in aquaculture must have FDA established safe levels of usage and established regulatory priority.
   Without guidelines for safe drug usage, ensuring that fish farmers will use those drugs in a manner that promotes public health is difficult.
2. FDA should prohibit extra-label use of all approved drugs.
   Extra-label use of approved drugs allows fish farmers to use drugs in ways that have not been proven safe or effective. This can be dangerous for the public health.
3. FDA should not allow Investigational New Animal Drugs to be studied in the field without requiring public documentation of INAD use.
   Without public documentation, there is no way to keep track of untested, potentially dangerous substances that could end up on consumer plates.
4. FDA should monitor and enforce proper aquaculture drug use rather than relying on risk-based inspection to ensure consumer safety.
   Risk-based inspection does not sufficiently prevent overuse and misuse of drugs in aquaculture facilities.
   
   If the aquaculture industry expands to the open ocean without such safeguards in place, it will become even more difficult to enforce proper drug use with expanded practices, and the chances of seafood-borne illnesses from farmed fish will only increase.
   
   What’s more, the drugs and chemicals are not only a threat to public health, but also potentially a grave danger to the environment. Drugs and chemicals used in aquaculture can have devastating effects on the marine ecosystem, including wild fish. Although the environmental effects are connected to drug use, the burden of preventing these effects falls on the Environmental Protection Agency, which is also sorely unequipped to deal with the consequences of open ocean aquaculture.

II. Environmental Protection Agency

Putting net pens and cages in the open oceans exposes our U.S. waters to a range of potentially dangerous pollutants. Fish wastes and uneaten food –– often laced with antibiotics and metallic supplements like copper zinc, manganese, and iron –– fall freely from cages.²⁹ Depending on conditions, this can lead to oxygen depletion in surrounding sediment and water, and in extreme situations, to a decline in animal diversity around the cages.³⁰ The environmental and ecological effects of the chemicals used in aquaculture feed have not been sufficiently studied, and their use often goes under–reported,³¹ making damage difficult to prevent, regulate, or remediate. One review used data on the waste released per kilogram of farmed salmon and data from the aquaculture industry from British Colombia to estimate that a $5 billion U.S. marine aquaculture industry would discharge 108,000 to 158,000 metric tons per year, which is equivalent to the nitrogen in untreated sewage from roughly 17.1 million people, or to the waste spewing from the notorious factory hog farms in North Carolina.³²

Among its many duties, EPA is charged with ensuring that aquaculture operations follow the Clean Water Act, enacted in 1972 to “restore and maintain the chemical, physical, and biological integrity of the nation’s waters.” ³³ To reduce fish farm pollution, the agency must limit waste discharges and require reporting from aquaculture operations. In reality, EPA lacks the resources –– and some would argue the will –– to ensure that current or future open ocean operations will adhere to standards, limit pollution, or avoid dangerous drugs and chemicals. As the Marine Aquaculture Task Force has pointed out, EPA’s regulatory approach does not appear to take future growth in aquaculture into account. Its approach “allows neither meaningful assessment nor mitigation of cumulative impacts from aquaculture operations.” ³⁴

Existing Regulations

“Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category,” sets forth EPA’s guidelines for aquaculture. These regulations were developed to ensure that aquaculture facilities do not operate against the standards of the Clean Water Act. The historic law says that industries directly discharging pollutants into the ocean must comply with the standards of National Pollutant Discharge Elimination System permits. This includes offshore fish farms. These permits, which are issued by state and regional EPA offices, include “technology–based effluent limitations which are derived from effluent limitations guidelines and new source performance standards promulgated by EPA, as well as occasionally from best professional judgment analyses.” ³⁵ That vague bureaucratic description leaves room for great variance in permitting requirements from state to state, and they are not always stringent enough.

To regulate aquaculture pollution, EPA focuses mainly on decreasing the discharge of total suspended solids, which include waste and uneaten feed that fall out of the fish pens. However, the agency has not established numerical limits for the amount of solids that aquaculture facilities can send into the ocean because it asserts that the appropriateness of such limits may vary from state to state.³⁶ Although EPA is apt to recognize the variation in aquaculture environments between regions, using this as a reason to completely avoid implementing numerical limitations is something like a police department deciding that because it is complicated to decide how many patrol cops are required in each part of a city to ensure safety, they will withhold sending out any at all. If allowed, offshore aquaculture would take place outside state waters, so having no national standards for such operations is especially frightening. Without national standards, these potential operations could escape enforceable, measurable pollution limitations.

So, in place of numerical limitations, EPA tries to use qualitative measures to limit discharge. It requires the “implementation of effective operational measures in order to achieve reduced discharges of solids and other materials.” ³⁷ Facilities are required to develop and implement what are called Best Management Practices –– strategies, plans, and practices geared to increasing production efficiency while reducing pollution.³⁸ For example, EPA mandates that with these plans, net pen aquaculture facilities will actively monitor their operations to reduce the amount of uneaten fish feed discharged into the ocean,³⁹ eliminate spillages of drugs, pesticides, and feed, and establish safe storage methods.⁴⁰ While the concept of best management practices may sound good on paper, in reality it is difficult to enforce, because while EPA requires written certification that such plans exist, it does not subject them to review. In essence, this allows industry to set the standards for management practices at the level that is most easily achievable, rather than at the level that reduces the most amount of discharge. As the Marine Aquaculture Task Force has pointed out in the case of Florida, most best management practice plans “lack the adequate specificity to provide meaningful management should commercial marine finfish aquaculture occur.” ⁴¹

EPA also requires that net pen facilities routinely inspect and maintain their systems and train all employees in necessary precautions.⁴² Aquaculture operators are required to report drug, chemical, and feed spills; failure of or damage to their facilities; and the use of certain drugs.⁴³ These are important requirements, but their success in preventing pollution relies strictly on the responsibility and honesty of facility operators. In essence, industry is left to oversee its own compliance with regulations. EPA does not require operators to report use of approved drugs, or even INADS (investigational new animal drugs) or extra–label use of drugs if they have already been approved for use in similar conditions.⁴⁴ Not having complete records of all the drugs in use at aquaculture facilities means that EPA has no method for analyzing the overall environmental impact of aquaculture drugs in a given region.

Unfortunately for consumers and the environment, EPA is just as lax in regulating aquaculture’s use of pesticides as it is drugs. In fact, the agency exempts pesticides from reporting requirements because the Federal Insecticide, Fungicide and Rodenticide Act authorizes EPA to allow field–testing of pesticides through permitting. FIFRA also allows states to employ a pesticide for unregistered use for a limited amount of time if EPA determines that emergency conditions exist. However, EPA is required to determine that no unreasonable adverse environmental effects will result from pesticide exemptions.⁴⁵ Currently, this is done by requiring that applicants submit information on the potential environmental effects of the pesticide in order to receive a permit, and that they report any adverse effects if they occur. Unfortunately, there is no means in place to ensure that applicants are submitting all the relevant information. EPA has not established numeric limitations for any pesticides or drugs used in aquaculture.⁴⁶ Here again, industry holds the power to oversee itself.

Needs for Improvement

As the Marine Aquaculture Task Force 2007 stated, “Little is known about the assimilative capacity of the marine environment for the wastes produced by aquaculture operations… Pollution from a greatly expanded industry could have significant effects locally and regionally.” ⁴⁷ Accepting offshore aquaculture as a solution to America’s seafood deficit will introduce a host of unknown environmental effects.

The regulatory structure EPA has in place is insufficient to protect American waters from excessive discharge of feces, chemicals, and other wastes. In order to uphold the standards of the Clean Water Act, EPA must take new steps to create a sound permitting process before a bill allowing offshore aquaculture can be approved. These must include:

1. A detailed model of likely impacts.
   EPA should create a model of the likely effects of offshore aquaculture, if it were allowed, and a way to evaluate them. To date, there have been no evaluations with sufficient information to understand the environmental affects of offshore aquaculture or how to regulate them. When the “Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category” were developed, EPA gathered data from 125 aquaculture facilities. Only nine of these were net pen facilities, and none were offshore.⁴⁸ A model would provide a basis for regulations that are appropriate to offshore aquaculture facilities.
2. New ocean water quality criteria that function as Total Maximum Daily Loads.
   In order to keep the oceans clean, EPA must establish criteria that define acceptable water quality. These criteria can also limit the total amount of pollutants that can be discharged into a certain body of water each day. All aquaculture waste, approved drugs, extra-label drugs, and experimental drugs should count toward these maximum loads.
3. National effluent limitation guidelines with technology driven numerical standards.
   EPA needs to establish national numeric limitations on the pollutants that can be discharged from individual offshore aquaculture facilities. These should be based on the capabilities of existing technology to limit effluence and should include limitations for chemicals, pesticides, and escaped fish. Limiting the amount of drugs that can be discharged from offshore aquaculture facilities should minimize the amount of drugs that are used to begin with. Even drugs approved for use in aquaculture by FDA can have negative environmental ramifications when used in excessive amounts. A minimum limitation would guarantee a measure of protection for all of America’s water, and would still allow each state to develop more stringent limitations when deemed appropriate.
4. Stricter pesticide regulation.
   FIFRA authorizes EPA to allow field–testing of pesticides through experimental use permits and to allow states to use a pesticide for unregistered uses for a limited time in the case of emergency conditions. However, EPA still has the responsibility to determine if these uses will cause unreasonable adverse environmental effects. To do this, EPA should only allow field–testing and unregistered use if it does not cause facilities to exceed total maximum daily loads of discharge. Aquaculture facilities should be required to report all pesticide use, and EPA should enact surprise inspections to stop unauthorized pesticide use.
5. NPDES permits with national guidelines.
   Permits should, at a minimum, be based on the technology driven standards and higher water quality criteria as established by the national effluence limitations. Every aquaculture facility must receive a National Pollution Discharge Elimination System permit from their state or regional EPA office. In order to ensure that these permits have satisfactorily stringent criteria, they should be based, at minimum, on EPA guidelines. If permit–holders commit violations, permits should be revoked.
6. No pollution trading.
   EPA must ban pollution trading, so that there is no risk of aquaculture facilities, now or in the future, trading their effluent allowances. Without such a ban, there is the possibility of local areas receiving a greater daily load of pollutants than they can handle.

III. Analysis and Conclusion

Our analysis of FDA and EPA aquaculture regulations reveals many inadequacies that must be addressed to meet even minimum human health and environmental safety standards necessary for allowing offshore aquaculture. As the Marine Aquaculture Task Force has pointed out, “The current regime for marine aquaculture does not provide for clear federal leadership. Numerous agencies have responsibility for aspects of aquaculture regulation, but currently no agency is charged to coordinate the overall process… it results in a lack of accountability among federal agencies for marine aquaculture activities and its impacts on the marine environment.” ⁴⁹ The current system of regulating aquaculture lacks accountability. If drugs used in aquaculture accumulate in parts of the ocean, damaging aquatic life and prohibiting recreational activity, who is at fault? FDA for allowing extra–label prescription drugs, the veterinarian for prescribing them, the fish farmer for excessively applying them, or EPA for failing to limit effluence? Who will accept all accountability when consumers digest trace amounts of dangerous aquaculture chemicals in their dinners?

The recommendations in this paper should help to more firmly establish both agencies’ roles in aquaculture regulation, but there still remains a need to more closely examine the overall system. Some, such as the members of the Marine Aquaculture Task Force, have recommended that Congress assign the responsibility of coordinating aquaculture regulation to a single agency.⁵⁰ This would provide for a more coherent regulatory structure. Open ocean aquaculture could introduce many unknown and unforeseeable issues and effects, all of which requires massive changes in the regulatory structure. Unless this happens, consumers cannot be sure that their fish is safe for them, or safe for the environment.