FSMA Era Opens with Uncertainties for Seafood
By Jacqueline Kochak
The question seems simple enough: How will the Food Safety Modernization Act (FSMA) affect domestic fish producers and importers? Start asking people associated with the seafood industry, however, and they’re likely to respond, “Let me know when you find out.”
President Barack Obama signed FSMA into law on January 4, 2011. Most food safety professionals are aware that the law is the most sweeping reform of food safety laws in more than 70 years, shifting the focus of the U.S. Food and Drug Administration (FDA) away from responding to problems and toward preventing problems in the first place. The law deals with imported and domestically raised foods of all sorts, including seafood.
The increasing globalization of our food supply—food imports have more than tripled in the past decade—is one reason given for why FSMA is needed, and one of the law’s priorities is creating a new system of import oversight. According to The New York Times, FDA currently inspects less than one pound in a million of imported foods. This is especially pertinent to the seafood industry, because FDA estimates that some 80 percent of the seafood eagerly consumed by Americans is imported from faraway places such as Norway or Chile or Thailand. By contrast, some 15 percent of the total U.S. food supply is imported from other countries.
For that same reason, a good share of FDA attention is already focused on imported seafood. There is a real possibility that not much will change for either domestic fish producers or seafood importers, those interviewed say. In fact, many domestic food producers of all types supported FSMA’s passage in hopes that better oversight would diminish the frequency and high cost of food recalls.
Then again, there could be big changes. As noted, FSMA aims to shift the U.S. food safety system from primarily reactive to proactive and prevention focused. The devil is in the details, however, and some of the confusion about the impact of the law results from the fact that specific FSMA regulations or guidance documents have yet to be announced. The question of what the new regulations will require is far more than academic, because while new guidelines will improve food safety in the U.S., adhering to more stringent requirements could translate into dollars and cents for producers, suppliers and importers.
“There are a lot of theories about why there is a hold-up, but FSMA could be costly for the industry,” says Lisa Weddig, director of regulatory and technical affairs for the National Fisheries Institute (NFI), an industry organization dedicated to education about seafood safety, sustainability and nutrition.
What to Do?
Many producers and importers are already doing exactly what they should be doing to ensure food safety, but the good apples might have to pay for the sins of the rotten ones. There is even discussion in some quarters about whether some importers can survive. However, FDA doesn’t have any data about whether a deficiency in seafood safety is caused by intentional neglect by an importer or supplier or is due to other causes, says Sebastian Cianci, an FDA policy analyst/press officer and trade press liaison.
The consensus seems to be that domestic fish producers probably will not see big changes, because they already have systems in place to ensure safety, and neither the press nor the public has raised a hue and cry about domestic seafood safety. As part of its food safety program, FDA mandates that domestic fish producers have a Hazard Analysis and Critical Control Points (HACCP) plan in place. The HACCP system focuses on identifying and preventing hazards that could cause foodborne illnesses, and one of the things FSMA does is extend HACCP to other kinds of food production and processing. FDA already mandates that domestic and international seafood processors have HACCP plans, rather than rely on spot checks of finished seafood products to ensure safety.
“We have been under HACCP requirements and subject to HACCP regulations for a long time, since the mid-1990s. Domestic fish farms are among the most highly regulated in the world,” says Randy MacMillan, Ph.D., vice president for research, environmental affairs and quality assurance for Clear Springs Foods Inc., perhaps the world’s largest producer of rainbow trout. Located in Idaho’s Magic Valley, Clear Springs also imports rainbow trout grown and processed in Chile.
For Importers, the Outlook Is Murky
For seafood importers, however, the outlook is a little less clear. Like domestic fish processors, all processors of seafood intended for the U.S. market are required to identify potential hazards associated with the types of seafood they process and then to develop and implement an HACCP plan to control for any likely and reasonable hazards, Cianci says.
“This includes hazards that can occur before, during and after harvest, both inside and outside of the processing plant,” he says. “With appropriate preventive controls in place, the likelihood of there being a problem with the food should be very small.”
Unfortunately, there is a public perception—probably correct—that not all international seafood suppliers are following the rules, and not all importers are requiring the suppliers they work with to follow the rules.
“Where there has been some deficiency is that Hazard Analysis and the enforcement of the HACCP plan have not been going on with international and some domestic suppliers,” admits Clear Springs’ MacMillan. “This has always been a requirement, although it hasn’t been well publicized. With FSMA, that requirement is more explicit, and that is a good thing.”
MacMillan says that a large part of the industry is already policing itself. At Clear Springs Foods, for example, one of MacMillan’s tasks is to verify that any seafood the company imports from Chile or any other country comes from a supplier with an HACCP plan in place. The company’s research and development division provides quality assurance services to the company’s farms as well as to Chilean partners, with HACCP compliance verified by testing fish randomly.
FDA is and always will be dependent on industry to play this kind of active role in curtailing violations, because the agency will never have the personnel or the budget to inspect every shipment of seafood that comes into the country. However, the truth is that no one really knows how well the industry is policing itself, because FDA inspectors currently inspect just 1 percent of seafood imports as they come into the country.
When student journalists for News21, part of the Carnegie-Knight Initiative on the Future of Journalism Education, investigated seafood safety in 2011, they found that more than 51 percent of the seafood that was inspected and turned away from ports was spoiled or contained physical abnormalities, or was contaminated with a foodborne pathogen. About 20 percent of those cases involved Salmonella, according to their analysis of FDA import refusal data. Nevertheless, it isn’t clear how much of a food safety problem imported seafood really poses, and given its limited resources, FDA has been struggling valiantly to protect the nation’s food supply.
“The information FDA gleans from country assessments, foreign inspections and importer inspections helps to target the products the agency chooses to examine more closely,” Cianci says. “Products with a greater likelihood of posing a food safety risk are inspected at a greater frequency than those with lower risk.”
MacMillan says that in his view, the FDA is already doing a good job.
“If seafood was a real food safety problem, would there be illness associated with it the way there was with peanuts, spinach and cantaloupe?” he asks.
The Foreign Supplier Verification Program
One of the things FSMA will do is create a foreign supplier verification program. All food importers will be required to verify that their foreign suppliers have HACCP plans in place—but facilities already in compliance with FDA’s seafood products requirements are explicitly exempt. Nevertheless, since the specific regulations for this section of FSMA have not yet been released, there are questions about whether HACCP will be enough, or if there will be a push for additional expensive requirements for producers and importers who are currently in compliance and how compliance will be verified.
“If seafood is exempt, it will be business as usual,” says NFI’s Weddig. “But until we see the extent of the exemption, it is hard to know the impact.”
“There is greater potential for enforcement,” MacMillan agrees. “Whether that means much to seafood is a good question because we’re already under mandatory HACCP. The key will be verification of compliance.”
FSMA gives FDA greater authority to detain products in violation of U.S. safety requirements, and those in the industry agree that that’s a good thing. Another concern, however, is that a more flexible standard for detaining products potentially in violation could sweep up innocent companies in a net from which it might be very difficult and expensive to extricate themselves. There is also a concern that FSMA will require additional record keeping, with FDA having greater access to all records—including food safety plans and other information that could be considered sensitive or private.
“One way to look at this is whether the extra cost is worth it to ensure the U.S. food supply is safe,” MacMillan says. “If you look at foodborne illness from all causes, seafood (except for shellfish eaten raw) is a very low risk. Fresh produce, peanuts and peanut butter and some cantaloupe have caused far more foodborne disease.”
At the same time and on the positive side, FSMA specifies that the process of importing safe seafood will be expedited for those who are already cooperating. The act states that 18 months after FSMA enactment, a program will be established to “provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program” and “establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program.”
The act goes on to require a guidance document spelling out various aspects of the program, including eligibility. Eligible importers must have the required HACCP certifications, but eligibility also will depend on factors such as identified safety risks associated with the food, the compliance history of foreign suppliers, the regulatory system of the country the food is imported from, the importer’s practices having to do with record keeping, testing, inspections and audits of facilities, and finally, traceability.
That reference to traceability also has some importers concerned. They say a traceability system can be very expensive, and some importers already have sophisticated systems in place because of customer demand. They don’t want to see another system mandated if one already exists. But for now, all they know is that FSMA requires the secretary of Health and Human Services to establish pilot projects in coordination with the food industry to “explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak.”
FSMA also requires the FDA to significantly step up the number of inspections of all foreign food facilities exporting to the U.S. In the first year, FDA is expected to inspect at least 600 foreign facilities, and in each of the following 5 years, the number is supposed to double. Which facilities will be inspected will depend on factors such as the known safety risks of the food, safety risks in the country of origin, importers’ compliance history and whether an importer participates in the voluntary qualified importer program.
Although FSMA expands the effort, Cianci says the FDA already conducts inspections of foreign processors to observe their seafood HACCP programs, as well as inspecting domestic importers to confirm they have verified foreign suppliers’ food safety measures.
Nevertheless, the reality is that a minuscule number of inspections of foreign facilities are actually performed. To export to the U.S., foreign processing companies simply register online with the FDA, and most never see an inspector. According to the News21 project (citing Government Accounting Office figures), FDA inspected an average of less than one-half of 1 percent of an estimated 17,000 foreign processing facilities each year between fiscal 2005 and 2010.
Because more seafood than any other kind of food is imported into the U.S., the requirement for an increased number of inspections likely will disproportionately impact foreign seafood producers and processors. Again, the mandate is unfunded, and it is not clear who will be doing the inspections and who will pay.
“Again, what is the cost of a better food safety program?” asks MacMillan. “Should consumers bear the brunt of food safety problems or should suppliers?”
FSMA does provide that FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards, and products from facilities that refuse inspection can be banned from entering the country.
FDA already utilizes a risk-based approach in conducting both foreign inspections and wharf examinations, Cianci says. Currently, if FDA finds food safety hazards in imported seafood, the foreign processor is placed on Import Alert. In September 2012, for example, FDA’s website showed 148 fishery/seafood products refused entry, from countries as diverse as India, Latvia, Nicaragua and Thailand.
Future shipments of the problem product are prohibited from entering the United States until the product is shown to be safe by a third-party verification lab. Samples have to be pulled by a third-party sampler or an FDA agent has to be present to witness the pulling of samples, and the “chain of custody” has to be documented.
“In certain situations, such as those requiring the imposition of an Import Alert, sampling and testing can go up to 100 percent for those shipments subject to the alert,” Cianci says.
How Much of a Hazard Are Antibiotics?
One area of contamination in foreign food imports that has gotten a lot of attention in recent years is the use of banned antibiotics by foreign seafood producers. Cianci says that any hazards associated with the use of animal drugs in aquaculture already must be addressed in the processor’s HACCP program, and measures to control such hazards must be established, validated and monitored. An international supplier who has an appropriate HACCP plan in place and has analyzed the likely hazards will have already identified any hazards associated with drugs or chemicals, he says.
“FDA also visits countries that ship a lot of aquacultured product to the U.S. and countries where we have had problems with aquacultured product in the past, so we can assess how they regulate their aquaculture industry,” he says. “We look at the availability of aquaculture drugs, the permitted use of the drugs, and how they test for drug residue.”
Cianci says that when seafood comes into the country, FDA collects a subset of the product inspected on the wharf for lab testing. Because FDA inspects only 1 percent of all the seafood coming into the country, an even smaller fraction is tested for chemical additives such as antibiotics.
“The challenge is that some seafood industry sectors have made a big deal about incoming fish being contaminated with drugs, and that has created this impression that a large part of imported seafood is contaminated,” MacMillan says. “That is very, very misleading.”
In 2010, for example, the news media gobbled up the story that Alabama scientists who tested more than 250 samples of catfish and related species from the Far East found 44 percent testing positive for an antibiotic not approved for use or with no established tolerance in the U.S. Alabama is home to the country’s second-largest domestic catfish industry, and critics responded that the tests were done on behalf of U.S. aquaculture farmers who want to reduce competition from overseas.
Likewise, testing in the European Union in 2001 found a prohibited broad-spectrum antibiotic called chloramphenicol in a number of food products, including seafood from several Asian countries. Testing in the U.S. later identified chloramphenicol in some imported seafood, and malachite green, nitrofurans, fluoroquinolones and gentian violet have also been found in seafood ranging from crab and shrimp to catfish and tilapia.
“It is undeniable that some imported farmed seafood does have detectable drug residues. Are the antibiotics unsafe?” MacMillan asks. “With the exception of chloramphenicol, the antibiotics are not toxic. They are not supposed to be in the food because there is no established tolerance in the U.S., but there may be a tolerance for the drugs in other countries. Ideally, there should be international agreement as to what is safe and not safe, but that will take a long time.”
Farm-raised seafood is indeed a fast-growing sector of the world food economy. U.S. seafood is imported from more than 60 countries, and a significant percentage of that seafood is raised on farms. Some domestic farmed fish producers claim that the use of antibiotics that are not approved for use in the U.S. gives foreign competitors an unfair advantage. MacMillan is among those who counter by saying the “antibiotic problem” is vastly overstated because antibiotics are not that effective in giving producers a competitive boost. In fact, he says, the use of antibiotics may increase production costs, and their efficacy is a real question.
“To say antibiotics enable them to outcompete is a real leap,” MacMillan adds. “The domestic channel catfish industry is suffering a good bit, but the crux of the problem is more that labor costs in Southeast Asia are a lot less compared to the U.S., and that decreases the costs of producing and processing.”
In fact, he says, focusing the public attention on antibiotic residues in catfish could have a paradoxical effect, because consumers who can’t differentiate between catfish from China and catfish from Mississippi might just stop buying the product altogether.
The fact is, Cianci says, that FDA really has no idea how much seafood around the world would be considered safe enough for the U.S. market, because the agency’s emphasis is on protecting what actually gets into this country. The perception that all foreign seafood is automatically unsafe is incorrect, however. For example, MacMillan says, seafood is actually more closely regulated in some countries than in the United States.
“We have a long-term contract with a rainbow trout grower in Chile, and they are subject to their own government’s food safety requirements that are more stringent than ours,” he says. “Chile requires mandatory testing every three months or so, with the government actually coming in and pulling samples.”
Nevertheless, consumer demand has led to several expensive international third-party certifications requiring annual audits, and MacMillan says some large domestic customers are requiring these certifications for all the seafood they buy, even if it is domestic or comes from a country with stringent regulations. That leads to a perplexing catch-22 for some producers—should they pay a lot of money to become certified by an international organization?
“It’s becoming more difficult to compete in the U.S. because you have all these customers demanding a certain certification, which takes both human and financial resources,” MacMillan says. “The question is, do we really need these international certifications for producers in the U.S.?”
When Will FSMA Regulations Be Final?
There could be a real problem if FSMA requirements end up being expensive to implement—and possibly redundant for producers and processors who have HACCP plans in place and in some cases are paying big bucks for international certifications. The question of when final regulations will be formulated to ease industry anxieties is still open, however. A lawsuit filed in August by the Center for Food Safety and the Center for Environmental Health against FDA and the White House Office of Management and Budget seeks a court order requiring FDA to enact FSMA regulations by a court-imposed deadline.
Although FDA has been criticized because all necessary regulations haven’t yet taken shape, some work has been completed. One of FSMA’s provisions was to update the fish and fisheries products’ HACCP guidance, which happened on schedule, but FDA was also supposed to issue a report evaluating the impact of any changes to the seafood HACCP regarding postharvest processing on the competitiveness of the domestic oyster industry in the United States and in international markets. That report doesn’t yet exist.
“Publishing the FSMA rules is a priority for the agency,” Cianci notes. “While the rule-making process can be complex and demanding, it will eventually provide for a framework that will have an enormous impact in modernizing the food safety system. We have made every effort to engage with all interested stakeholders throughout the process and will continue to do so after the rules are published.”
Everyone recognizes that building a new food safety system based on prevention will take time, and FDA says it is creating a process for getting this work done. FDA funding, which affects staffing and vital operations, affects how quickly FDA can put FSMA into effect. So for now, questions remain.
FSMA’s Section 104 says the FDA can determine there are hazards for which standards need to be determined, and NFI’s Weddig says that could impact the industry in the future. The act also calls for protecting the food supply against intentional adulteration—which would include antibiotics—and that particular regulation doesn’t yet exist either. Finally, regulations regarding sanitary transportation of food will impact everyone in the food industry, Weddig says, and that regulation hasn’t been developed either.
“Until there are regulations, it is hard to tell how FDA will deal with seafood suppliers,” Weddig says. “From everything we’ve heard, regulations won’t apply to you for preventive controls regulation and foreign verification—but other aspects of FSMA will apply.”
Jacqueline Kochak is communications director for the Auburn University Food Systems Initiative, an interdisciplinary multi-institutional program integrating research, outreach and academic efforts to enhance the safety of the nation’s food supply, from producer to consumer.