Restraints to Shipping Live Product:
Lessons from the AquaSeed Corporation Experience
by Per O. Heggelund
Printed in: Marketing and shipping live aquatic products: Proceedings of the Second International Conference and Exhibition, November 1999, Seattle, WA
SUMMARY
The Lacey Act is the U.S. federal law governing a broad range of commercial activities including the live shipment of fish and shellfish. This act, since its revision in 1981, regulates the shipment of all fish and wildlife, dead or alive, from egg to the adult life stage. Application of the Lacey Act can conflict with individual state laws. Consequently, complying with the dictates of this body of regulations can be confusing and frustrating for live shippers. As an owner of a private aquaculture operation that ships live product worldwide, I will present the problems associated with regulatory compliance from the shipper's point of view.
INTRODUCTION
In his contribution, Don Kramer made some interesting points related to the topics I cover in this paper. Dr. Kramer stressed human health issues associated with live shipping - specifically food safety issues. He also noted that there are no HACCP regulations covering fish as long as they are alive. However, we do have other regulations that have an important bearing on this industry. This other body of regulations relates to fish health. In fact, some of the concepts behind these fish health regulations are more stringent, at least in philosophy, than those that deal with human health issues.
Many, if not most, of the fish health regulations being referred to here are based on the principle of zero tolerance to a long list of bacteria and viruses. We do not often have this degree of stringency in human food health regulations. Consequently, as I will describe, there are anomalies in some of these regulations.
I reviewed a very similar topic a couple of years ago at this same conference. I learned that some of my listeners were frightened by the content of that presentation and thought that I might have been trying, in essence, to scare other producers away from the live shipping industry by providing a review of the heavy-handed regulation present in the industry. Today I will again present practical information about the nature of regulation in this industry. I am not trying to eliminate competition in the section of the industry in which AquaSeed operates. I wish only to present an objective interpretation of an important business planning concern.
I will describe the body of regulations, the Lacey Act, which comprises the most stringent portion of fish health regulations present in the live industry worldwide. My message is that you, as a member of this industry, must watch this regulatory "bar" or hurdle. Great caution will be needed, because I think this bar will be further elevated in the future. You will need to abide by this Act, something that may prove to be very difficult. As members of this sector of the live industry, we are excluded from many markets simply because we, as producers operating within the United States, cannot meet these regulations and, consequently, cannot conduct our business. I encourage you to look at the current mass of regulations and be certain that you do not fall into any of a number of traps as you develop new markets.
In this report I cover the fish health regulations that pertain specifically to salmonids-salmon and trout species in the United States and internationally. I am using salmonids as an example because this is the section of the live seafood industry that I am involved with and have been working in for the last 20 years.
OVERVIEW OF THE AQUASEED CORPORATION
I will start with a brief overview of what the AquaSeed Corporation attempts to do. AquaSeed Corporation is a breeder of Pacific salmon. We breed coho salmon and Donaldson steelhead. We have accumulated a 30-year history for the selective breeding of coho salmon. Our effort is based on a classical breeding program that we purchased from Campbell's Soup in 1991. Campbell's Soup began developing this program in the early-1970s as a cooperative project with Sea Grant at University of Washington. The breeding protocol was patterned after a similar program developed in the poultry industry. Since our acquisition of the program, AquaSeed has seen a salmonid growth rate that is five times faster than that of our stock when the start-up program was initiated in the 1970s.
We sell the eyed eggs, or embryos, of coho salmon and steelhead. We also sell a few fry and smolts, which are in the category of live fish. I have been working with these live products through AquaSeed for about 15 years. I have been involved in the salmon farming industry since 1980 and was involved in the importation of Norwegian salmon to the West Coast of North America in 1981. I believe that it was the first time this farmed Atlantic species was imported into the western United States.
Our company headquarters is located in Seattle, Washington. Our production facility is located just south of Olympia in the small town of Rochester. It is in an inland location and has available fresh water that is totally pathogen free. We pump this water from wells at the rate of about 5,000 gallons a minute. Our main markets are Japan and Chile. We operate a marketing company in Chile and sell domestically in the United States, as well.
REVIEW OF THE LACEY ACT
With that background, I will now cover the U.S. federal laws that govern shipment of live seafood and shellfish. These laws govern AquaSeed's ability to ship and control associated certification procedures. I will also look at some of the pertinent state laws that are on the books. In the United States, we do not have a uniform federal law dealing with fish health specifically, so every state must have its own set of laws. The Lacey Act sits on top of these state laws and provides federal penalties for these laws.
The Lacey Act was the first fish and wildlife law that was developed in the United States and was enacted around 1900. Originally, it was essentially a means of removing wild game from commerce.
Like so many other pieces of legislation, the Lacey Act has been rewritten and various amendments have been made to it over the years. The last rewrite occurred in 1981, when Congress merged three other wildlife laws or acts into the Lacey Act. That is when fish became an official part of the Lacey Act.
Because the Lacey Act deals specifically with wild animals and birds, livestock is exempt from it. However, we do not have a definition for livestock that specifically includes fish. As a consequence, fish and mollusks are not exempt from the dictates of the Lacey Act. All fish and shellfish are included in the Lacey Act, whether we farm them or catch them in the wild. That is essentially our problem as farmers-we have been sucked into the Lacey Act in a way that makes some of us uncomfortable. We have witnessed at least three or four cases in which fish farmers, primarily trout farmers, have been sued and taken to court under the Lacey Act. In three of these cases, the resulting litigation has had a devastating effect on their business.
Even if you are in a business like ours where you are dealing with the eggs and fry from farmed animals that we have laboriously domesticated over the past 30 years, you will still be part of the Lacey Act. Somebody within the regulatory structure could pick up some aspect of your business and really make things difficult for you.
As can be seen, the Lacey Act is being used to federalize penalties if state or international laws are broken. Using an example from another session at this conference, the International Pacific Halibut Commission's international treaty could, technically, be enforced by the Lacey Act.
The Lacey Act is enforced by two agencies - the U.S. Fish and Wildlife Service under the Department of Interior, and the National Marine Fisheries Service under the Department of Commerce. They have dual responsibilities and both agencies are fully involved with the implementation of the Lacey Act. For example, the Lacey Act is often used to prosecute foreign fleets or fishing activities that break either international treaties or U.S. treaties and laws. The Lacey Act also gives teeth to the state regulations. If you do not comply with a state regulation, the federal government can prosecute you under the Lacey Act.
OUTLINE OF REGULATIONS GOVERNING EXPORTATION
I would like to review the export documentation needed in order to ship products such as those marketed by the AquaSeed Corporation. Again, these requirements specifically pertain to salmon and trout. As mentioned previously, in many cases these requirements are more stringent than those involved with the shipment of live mussel and other types of live seafood. The documentation process has become rather complicated. I am hoping that over time the government, working in a cooperative manner with industry, will be able to streamline the process. For example, we would like to use electronic documents. Currently we must complete the required documents entirely by hand and place blue signatures upon the completed forms. The entire process has become quite cumbersome.
Among other things, we are required to complete two forms for the State of Washington. The first form deals with all imports or transfers of live finfish within Washington and must be used whenever any products, not just salmonids, are moved through the State of Washington. The second form covers fish health regulations involving required tests for viruses and bacteria. The diseases that need to be tested for vary from species to species. It is a multiple-use form for the export, import, or transfer of product between facilities.
Several years ago, the state came up with a supplemental certificate to be completed by the shipper. If you are bringing product into the state, this certificate must be included with the shipment. We proposed to state workers and the Department of Fish and Wildlife that we just add a box to a form in current use and continue to use just one form. Little progress has been made.
In addition to the previously mentioned state transfer permit, an underlying certificate is required. It must be signed by a veterinarian who has tested the fish for the different diseases. Quite a few diseases must be screened. This is the third piece of paper from the State of Washington that we encounter when shipping salmon and trout.
There is very little uniformity in certificates used within states or between states. Forms originating from the State of Oregon are very different from those from Washington. If we intended to ship my product from Washington to Oregon, we would be obliged to use a transfer permit in the State of Washington, a health certificate, and Oregon's form, as well.
An additional form, this one federal, from the U.S. Fish and Wildlife Service is sometimes required. U.S. Fish and Wildlife Service is one of the agencies assigned the task of enforcing the Lacey Act. This document is a certificate that is directly linked to the Lacey Act. We have now been exempted from using this form when we export salmon products such as eyed salmon eggs. However, when we import from across the federal border, we need to complete this item.
Similar to the way the State of Washington deals with the non-native species, Maine requires a zebra mussel certificate. The supplier must sign this declaration. So, if you are working with farming operations in Maine, this export declaration must be completed in addition to the regular health certificates previously described.
INTERNATIONAL REGULATIONS
There are approximately 50 different fish health regulations in the United States that are currently active. Adherence to this body of regulations can be very confusing. In addition, every country in the world has its own set of regulations. Obviously, this does not simplify the process of conducting international business. The International Organization of Epizootics (OIE), located in Paris, attempts to streamline international and national fish health regulations. This agency is now part of the World Trade Organization and is playing a bigger role than previously. These international workers are now in the process of developing what I would describe as fairly stringent regulations. These fish health regulations are beginning to mirror the regulations we are currently dealing with in terms of salmon and trout species.
CONCLUSION
Using history as a guide, I would say that the bar is gradually being raised for us, not just for salmon and trout, but for almost all live seafood. This concerns me because, in the long run, it will hamper international trade. This is a problem that our industry will be forced to deal with.
On the international level, I think that the best forum to address this concern is through the OIE (Office International des Epizooties). Unfortunately, this organization is currently little more than an academic technical organization without much input from the industry. There is no industry panel, for example, something that is needed to keep the developing body of regulations from becoming impractical.
The paperwork load encountered when complying with these regulations is horrendous. Also, the animal testing required by these same regulations is impractical. For example, all of the live fish and shellfish being tested have to be killed. Industry members cannot just take blood samples in a manner similar to what is done with livestock and, for that matter, humans. These are lethal samples and this sacrifice has become extremely costly for the industry. This is something that we are currently trying to change.
We are also trying to have our farm products redefined as livestock in the United States. The thought here is that if the industry can gain the livestock designation, our products would then be looked upon as farmed animals and would be out from under the Lacey Act. We have a petition in front of the U.S. Secretary of Agriculture requesting this redefinition. It has taken a long time and we still do not have this more appropriate designation.
I hope that changes like this will simplify our industry. We have an infant industry that is being overburdened with fish health regulations. There are far too many agencies involved and it is constraining the development of the live industry. It may come to pass that sectors of our industry will have to deal with separate regulations. For example the livestock products such as farmed fish and shellfish would be regulated differently from fish that are used for enhancement. We may have to consider options such as this in order to develop a viable farmed fish and shellfish industry in the United States. We are simply not able to accomplish this important task under the present regulatory environment.
QUESTIONS FROM THE AUDIENCE QUESTION: What would you say are the most significant hazards posed by your product and how do you handle them to minimize those hazards in terms of fish health?
HEGGELUND: In terms of fish health? Well, right now, we have to do lethal sampling of all our fish and have them checked according to regulations that are established by recipient countries, in this case either Japan or Chile. We follow them to the teeth - you cannot afford not to.
QUESTION: What level of testing would you consider to be appropriate in order to handle what you consider to be the legitimate hazards that are associated with your product?
HEGGELUND: First of all, we have to go to the traditional livestock - type sampling, meaning non-lethal testing, where we take blood samples and then run statistical inferences on whatever diseases we are concerned with. We also have to recognize the fact that we can never have zero tolerance for any type of organism. It is impractical. We used to have zero tolerance provisions in the United States on human food with the Delaney Clause under the Food and Drug Act. However, this was removed about three years ago. We have to set tolerances that are realistic, rather than zero. Zero is not a realistic tolerance. Many of these items will have to be negotiated with the concerned parties, so I do not have a particular number to give you right now.
QUESTION: A comment concerning the previous answer. Even if you are sampling for vibrios or ISA (infectious salmon anemia), zero tolerance is not involved. Rather, what is involved is the statistical detection level technical limit using a sample of 150 fish. I am well aware of the situation on the East Coast where we found that a vaccine being used had statistically few, but nonetheless a few living organisms carried by the vaccine. The vaccine actually created the disease that it was meant to control. My point is that this problem was not detected using standard detection systems. Zero tolerance is only a statistical level of safety.
HEGGELUND: Yes. Disease testing is only as good as the methodology that is being used. People in the industry are extremely concerned about the new sensitive testing methods that are coming out, such as DNA probes. These new strategies can sample and detect fragments of a pathogen, rather than the whole viable pathogen. We feel that we do not need to detect the pathogen; rather we need to deal with the disease. These are fish health and disease regulations - not pathogen regulations. So we may have to look at changing the philosophy of these regulations, because they are impractical for us to live with. Also, we see the regulatory bar being raised. We are now looking for more bugs and, on top of that, we are getting methodology that is more sensitive. We see this as a problem.
QUESTION: How are the regulations here in the United States compared to Norway? Are the regulations more stringent there than here?
HEGGELUND: There is a total ban on salmon smolts and eyed eggs transported into Norway. The Norwegians do not accept them, period. We see the same situation in other countries, for example New Zealand and Australia. To some extent, part of Canada is also involved. To give you a specific example, we can transport a smolt from British Columbia to the State of Washington. We, however, cannot ship smolts into British Columbia. In terms of the regulations in Norway, a ban is about as strict as you can get. I have transported eyed eggs from Scandinavia into the State of Washington and other parts of the United States.
Per Heggelund, a native of Norway, came to the United States in 1965. He holds a B.S. from the University of Washington School of Fisheries. In addition, he holds an M.S. in food science and an M.B.A. in finance and international business. He held a faculty position at the University of Alaska as a seafood specialist and later worked with the National Food Processors Association in Seattle and Washington, D.C. In the early 1980s, he pioneered the importation of farmed salmon from Norway to the U.S. West Coast. Later he obtained federal permits to import eyed eggs to the Pacific Northwest.