Applied Food Technologies
Encyclopedia
Applied Food Technologies, Inc. (AFT) is a privately held, woman-owned corporation in Alachua
, Florida that develops diagnostics needed in the seafood industry and runs fee-for-service species identification and verification programs. The DNA-based species identification diagnostics developed by AFT are used in-house and are also packaged in a kit format and sold to federal, state and private laboratories in the US, Europe and Asia. AFT has established an extensive library of taxonomically verified fish species and has developed DNA standards for these fish.
Applied Food Technologies is primarily a research and development company focusing on fish species identification using DNA and environmental contaminant detection using gene expression in sentinel organisms. AFT also offers a fee-for-service business for seafood species identification.
Applied Food Technologies was showcased on a national broadcast of The Early Show
on CBS on June 8, 2011 to discuss seafood mislabeling after release of a national publication on the issue by consumer advocate group Oceana
and a subsequent New York Times Publication on the subject. Although in business for several years, Applied Food Technologies came to the national attention after becoming the first company with DNA based fish species identification methods recognized by the FDA to test all catfish imported from China in the late 2000s. Applied Food Technologies was subsequently interviewed in May, 2010, by ABC affiliate WCJB-TV. Applied Food Technologies will also be showcased in University of Florida’s Explore Magazine November, 2011 issue.
AFT has been criticized as being "in industry's pocket" because AFT has been a loud voice in support of industry against media reports of mislabeling. AFT claims their internal testing has shown a much lower mislabeling rate than media reports. Although Applied Food Technologies has been included in numerous media reports concerning seafood species mislabeling and has been contacted to conduct testing for the media many times, AFT does not perform species identification testing for the media, which may be the cause of some criticism. AFT's mission statement includes offering a testing service to the seafood industry utilizing the "best available science" for the purpose of improving the industry to better serve the consumer. Typically the media outlets are unable to meet the chain of custody requirements within the "best available science" component, which is one of the principle reasons AFT does not offer testing to the media.
Applied Food Technologies offers fee-for-service business in several areas including fish species identification (also known as Fish ID), seafood net weight, and antibiotic residue testing, which are described in detail below.
required the Jews to identify certain types of fish to maintain a kosher diet. Kashrut does not require rabbis to "bless" fish to make it kosher, but rather to identify the features the fish must have to meet kosher requirements (among others) and confirm their existence.
In the 13th century, the King of England passed first law concerning proper labeling requirements, the Assize of Bread and Ale
, regulating weight and quality of bread and ale. These laws were codified in the colonies, being a part of Britain, in some form. For instance, in 1758, the Georgia Legislature passed the Act for Regulating the Assize of Bread requiring bakers to make an identification mark on their bread to show a source of origin, among other rules. Fines were imposed by the statute for lacking this labeling requirement, even if the bread conformed in all other manners.
However, although the United States and each State had adopted the common law
of Britain, the regulations on bread did not last long in the colonies. Because bakers in the colonies were subject to the free-market forces of supply and demand, unlike the bakers’ monopolies of the Old World, the colonial bakers began to protest the burdens of these laws and they were eventually repealed once independence was declared. One prominent protest in Massachusetts laid out the economic differences of the colonies and the Old World as a plea to remove these requirements. While the gist of these protests focused on the pricing restrictions, some were directed toward the labeling requirement as well.
After just over a century as a nation, the United States began to recognize
, once again, the need to regulate food packaging. In 1898, the Association of Official Agricultural Chemists established a Committee on Food Standards headed by Harvey W. Wiley
and thereafter states began incorporating these standards into their food statutes. In 1900, the Lacey Act
was first passed in the US providing for criminal and civil penalties for transporting certain species of wildlife in commerce. While the Lacey Act was directed toward conservation efforts, the law also created a de facto labeling requirement for certain types of products, such as fish.
The first direct statutory regulation of food labeling did not take effect until January 1, 1907. The 59th Congress of the United States passed, and President Theodore Roosevelt
signed into law, the nation’s first act regulating food and safety, The Pure Food and Drug Act
of 1906 (34 U.S. Stats. 768). The Pure Food and Drug Act, which was initially created to ensure products were labeled correctly, also prohibited interstate commerce of misbranded and adulterated foods. Under this statutory authority, one of the most famous cases was a federal misbranding suit against
Coca-Cola, claiming that “Coca-Cola” was “misbranded” because the product no longer contained “coca” as an ingredient.
However, the 1906 Act had a number of problems. In 1938, the Federal Food, Drug, and Cosmetic Act
(52 US Stat. 1040) was signed into law by Franklin D. Roosevelt
replacing or updating most of the 1906 Act. The 1938 Act provides much of the statutory framework that exists today. In 20 chapters, this Act defines food, among other regulated areas, and proper food labeling. For instance, 21 USC § 403, Misbranded Food, states, “A food shall be deemed to be misbranded: (a) (1) If its labeling is false or misleading in any particular… (b) If it is offered for sale under the name of another food.” Seafood is, thus, misbranded if the package claims to contain one species of fish but actually contains another species of fish that would mislead.
Although the 1938 Act provides the structural framework for labeling laws in the United States, statutory updates and additions have been made. For instance, in 1966, Fair Packaging and Labeling Act
was passed requiring all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods. The Food Quality Protection Act
(FQPA), or H.R.1627, was passed unanimously in 1996 by Congress and signed into law by President Bill Clinton
, regulating the use of certain chemicals on commodity foods. All of these laws were enacted for the health, safety and welfare of the consumer.
Federal statutes are usually broad and require Federal agencies or Federal Courts to define the scope, boundaries and definitions of the statutory language. In the case of seafood labeling, the FDA created the Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce. The Guide provides guidance on which types of fish labels would be correct descriptions of certain fish species and which labels would be misleading. The market label for specific species of fish can be found on the FDA’s Seafood List website. The FDA explains the history of how this list evolved:
"Through the years, the Federal Government has worked to provide consistent and scientifically sound recommendations to
industry and consumers about acceptable market names for seafood sold in interstate commerce. This advice was consolidated in 1988
when The Fish List was first published by FDA in cooperation with the National Marine Fisheries Service to provide a source of
names that would facilitate consistency and order in the U.S. market place and reduce confusion among consumers. Although The Fish
List had significant success in achieving its goal, its usefulness was limited because it did not include invertebrate species. In
1993, The Fish List was revised to include the acceptable market names for domestic and imported invertebrate species sold in
interstate commerce, and renamed The Seafood List. The Seafood List provides information to assist manufacturers in properly labeling
seafood and to reflect the acceptable market names of new species introduced into the U.S. marketplace."
The list allows multiple different species of certain fish to be marketed under the same market name. For instance, the FDA lists 14 species of fish that can be labeled as "tuna
”. The list does not allow, however, common substitutes to be listed as the fish they are commonly substituted as. For instance, escolar
, the most common substitute for tuna in retail locations, is not one of the fish legally allowed to be labeled as "tuna." These market names were created both for the safety of the consumer and to prevent economic fraud.
toxins, and Scombroid
food poisoning. Mislabeled seafood may also harm pregnant women who are told to avoid certain species of fish during pregnancy. However, according to a recent Congressional Research Service report, seafood mislabeling is widespread. A recent report by the consumer advocacy group Oceana reported that mislabeling can be as high as 70% in certain species of fish, although certain species are more commonly misidentified than others. Health and safety risks occur because consumers are unable to purchase certain seafood products to protect themselves against these risks based on the product label.
Ciguatera fish poisoning (or ciguatera) is an illness caused by eating fish that contain toxins produced by a marine microalgae called Gambierdiscus toxicus. People who have ciguatera may experience nausea, vomiting, and neurologic symptoms such as tingling fingers or toes. They also may find that cold things feel hot and hot things feel cold. Ciguatera has no cure. Symptoms usually go away in days or weeks but can last for years.
Because the toxins are very heat-resistant, consumers cannot protect themselves by cooking these contaminated fish. When fish are collected from certain areas known to contain these toxins and are mislabeled, consumers may be seriously injured. Although there is a treatment for the disease, the disease is not often properly diagnosed and the treatment is most effective if administered within 72 hours of exposure. Avoiding the species of fish known to contain the disease or avoiding eating fish from locations known to have the disease are the only preventative measures.
family (tuna
, mackerel
, skipjack and bonito
). Fish outside Scombridae have been found to cause scombroid fish poisoning, including mahi mahi, bluefish, marlin, and escolar. When these fish are not refrigerated properly, bacteria can metabolize naturally occurring histamines in these fish to produce scombrotoxin. To prevent illness in these species of fish, ensuring the proper storage conditions of the fish from water to plate is of utmost importance. Freezing, cooking, smoking, curing and/or canning do not destroy Scombroid toxins. Thus, lack of proper species knowledge can make it difficult to ensure proper storage conditions both for suppliers and consumers of fish.
, tilefish
, swordfish
, and king mackerel
. When people eat the types of fish that are high in methylmercury
, it can accumulate in the blood stream over time and may take over a year for the levels to drop significantly. Thus, it may be present in a woman even before she becomes pregnant. Thus, women who are trying to become pregnant should also avoid eating certain types of fish well before they become pregnant. Because these fish can be substituted for other fish, however, consumers may have a difficult time avoiding these species of fish.
, which can cause life-threatening breathing, cardiac, and gastrointestinal symptoms. Pollock
, salmon
, cod
, tuna
, snapper
, eel
, and tilapia
are among the fish that commonly elicit fish allergies. People often determine which fish to which they have allergies and avoid those types of fish. However, with common substitution of certain fish, avoiding certain species of fish can be difficult.
. Economic fraud occurs when a lower-priced fish is labeled as a higher priced fish in order to sell the lower-priced fish for a higher price. Once someone within the supply chain sells mislabeled seafood, every company or consumer that purchases the mislabeled seafood is a victim of this economic fraud. In certain species, mislabeling can be quite substantial, such as in a 2007 study of red snapper in sushi restaurants in Chicago, where none of the 14 samples of “red snapper” tested were, in fact, red snapper. In 2008, two high school girls did a study and found that one-fourth of the fish samples with identifiable DNA were mislabeled. In a 2011 two-part study, the Boston Globe tested 183 samples from retailers across the Boston area and found 87 were sold with the wrong species name (48 percent), including 24 of the 26 red snapper samples, mentioning many retailers by name. Less than a week after the Boston Globe report, international consumer advocate group Consumer Reports Magazine released the results of a study they planned to release in their December, 2011, issue which further discussed the extensive amount of mislabeling seen at retail.
Mislabeling is not just occurring in the US. In Canada, a study found 34 of 153 fish samples from grocery stores were mislabeled. In Ireland, scientists found that 28% of cod products in Ireland are mislabeled and 7% are mislabeled in Britain. In a study conducted by the Australian government, 32 of 138 (23%) fish samples were incorrectly labeled. Australia found that food service companies (e.g. restaurants) had the highest level of mislabeling with 24 out of 67 (35.8%) samples mislabeled, 5 out of 44 (11.3%) samples from retailers (e.g. fishmongers, supermarkets) mislabeled and 1 out of 24 (4%) samples from wholesalers were mislabeled. The Australian study makes sense because certain amounts of mislabeling can occur at each step in the distribution process.
Mislabeling was also found in tuna cans in a large European study funded by Greenpeace. In this study, they found 30.3% of the tuna cans displayed a different species in the can than on the label or a mixed species of fish within the cans. However, the Greenpeace study was conducted based on EU labeling rules and would likely have produced a lower mislabeling rate under US law. For instance, Greenpeace considered mixing of two species within a single can to be mislabeling, which may be a violation of EU law. However, in the U.S. while ‘albacore’ must be a specific species of fish, ‘light tuna’ can refer to a few other tuna species that are not albacore. There are numerous differences between European and U.S. law that require knowledge of these laws to ensure proper labeling in both countries.
Mislabeling is most often an economic fraud issue, but sometimes is related to differences in labeling laws around the world. For instance, a recent US Government study estimated that US fishing activities had an estimated 17% bycatch, which is the discarded catch from fishing activities, such as protected species, non-marketable species, etc. A species that may be discarded in the US may be a marketable fish in another nation. Thus, commonly included substitutes may sometimes be species of fish that are caught in the same areas and are legally co-marketed in the country of origin.
The market name for species varies widely from nation to nation as well. The FDA details what types of product descriptions are acceptable in the U.S. and provides a list of what species of fish can be sold under certain market names in the US. However, the same fish can be sold under any number of names around the world. For instance, Patagonian toothfish (Dissostichus eleginoides), also known in the U.S. as Chilean Sea Bass, may be labeled as Merluza negra in Argentina and Uruguay, Bacalao in Chile, Mero in Japan, Légine australe in France, Marlonga-negra in Portugal, and Tandnoting in Sweden. The Chileans were the first to market toothfish commercially in the United States, earning it the name Chilean sea bass, although it is really not a bass and it is not always caught in Chilean waters. Chilean sea bass is a different species type than the sea bass caught in U.S. waters and is not allowed to be labeled as such. Thus, sometimes what might be a proper name in one country is not proper in the US. However, this would still likely be considered economic fraud under US law, even if unintentional, because the US consumer is confused as to the product being sold.
The largest Federal investigation related to economic fraud resulting from seafood mislabeling came after import alert 16-128 was issued. The U.S. Food and Drug Administration held up every Chinese catfish load when it arrived to verify that they were genuine channel catfish (Ictalurus punctatus), rather than other Asian species, such as basa
, tra
, panga
, swai
and sutchi. The FDA hired Applied Food Technologies to analyze the DNA of all detained catfish from China.
The species of seafood being sold is not the only form of economic fraud. The label of “wild-caught” fish to describe fish grown in aquaculture would be mislabeling of the fish, even if they were of the same species, because this misleads the consumer.
maintains a "one strike and you're out" policy that ends contracts with fish suppliers that sell wrongly labeled grouper, and US Food Service
’s Jorge Hernandez said in an interview, “food testing ensures that the product they're selling is the product they say they're selling”.
, differ from those of higher-level organisms (eukaryotes), such as fish. Antibiotics are chemicals designed to either kill or inhibit the growth of pathogenic bacteria while exploiting the differences between prokaryotes and eukaryotes in order to make them relatively harmless in higher-level organisms. Antibiotics are constructed to act in one of three ways: by disrupting cell membranes of bacteria (rendering them unable to regulate themselves), by impeding DNA or protein synthesis, or by hampering the activity of certain enzymes unique to bacteria.
Antibiotics are used in aquaculture
to treat diseases caused by bacteria. Sometimes the antibiotics are used to treat diseases, but more commonly antibiotics are used to prevent diseases by treating the water or fish before disease occurs. While this prophylactic method of preventing disease is profitable because it prevents loss and allows fish to grow more quickly, there are several downsides.
The overuse of antibiotics can create antibiotic-resistant bacteria. Antibiotic-resistant bacteria can spontaneously arise when selective pressure to survive results in changes to the DNA
sequence of a bacteria allowing that bacteria to survive antibiotic treatments. Because some of the same antibiotics are used to treat fish that are used to treat human disease, pathogenic bacteria causing human disease can also become resistant to antibiotics as a result of treatment of fish with antibiotics. For this reason, the overuse of antibiotics in treatment of fish aquaculture (among other agricultural uses) could create public health issues.
The issue has two sides. In some foreign countries, clean water supplies for aquaculture are extremely limited. Untreated animal manure and human waste are used as feed in shrimp farms and tilapia farms in China and Thailand, in addition to the collection of waste products accumulating from inadequate sewage treatment. In order to prevent the spread of bacteria and disease in contaminated water, some foreign fish farms put U.S.-banned antibiotics into their fishmeal. However, because the more stringent growing regulations in the US increase the price of food, imports from nations without these regulations are increasing based on price and profit.
Between 1995 and 2005, the first ten years of the NAFTA-WTO era in the US, seafood imports increased 65 percent and shrimp imports increased 95 percent. Today, 80 percent of American seafood is imported, about half coming from aquaculture. China, Thailand and Vietnam together account for 44 percent of seafood imports into the United States.
The FDA has been testing for chemicals in aquaculture products for over two decades. In November 2005, the testing program for aquaculture drugs was revised to include antibiotics such as chloramphenicol
, fluoroquinolones, nitrofurans, and quinolones, as well as antimicrobial compounds like malachite green
that are not approved for use in aquaculture fish. From October 1, 2006, through May 31, 2007, FDA tested samples of catfish, basa, shrimp
, dace, and eel from China, finding twenty-five percent of the samples to contain drug residues. Hearing on “Safety of Chinese Imports”, statement of Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Program before the Senate Committee on Commerce, Science & Transportation, July 18, 2007. See: http://www.fda.gov/NewsEvents/Testimony/ucm110728.htm FDA has approved five different drugs for use in aquaculture as long as the seafood contains less than a mandated maximum residue limit: florfenicol, sulfamerazine, chorionic gonadotropin, oxytetracycline dihydrate, oxytetracycline hydrochloride, as well as a drug combination of sulfadimethoxine and ormetoprim. FDA has approved two drugs—formalin and hydrogen peroxide—for which it has not set a tolerance.
The FDA now enforces regulations in the US requiring testing of certain imported products for antimicrobial agents under Import Alert 16-131. The Import Alert provides that the use of antimicrobials during the various stages of aquaculture, including malachite green, nitrofurans, fluoroquinolones, and gentian violet, may contribute to an increase of antimicrobial resistance in human pathogens and that prolonged exposure to nitrofurans, malachite green, and gentian violet has been shown to have a carcinogenic affect. In a consumer brochure, the FDA describes the reasoning for enforcement under the import alert:
"After FDA repeatedly found that farm-raised seafood from China was contaminated, the agency announced on June 28, 2007, a
broader import control of all farm-raised catfish, basa, shrimp, dace(related to carp), and eel from China. During targeted sampling,
from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood from China was contaminated with antimicrobial agents
that are not approved for use in the United States. More specifically, the antimicrobials nitrofuran, malachite green, gentian violet,
and flouroquinolones, were detected."
Due to limitations on funding and resources, U.S. Government Accountability Office
states that only 1% of seafood, compared with 2% of all imports, is inspected and only 0.1% of all seafood is tested for antibiotic residue.
of specific animal species by those who are not expert taxonomists, even if they are identifying whole animals, is inaccurate and difficult. Three molecular targets to test for species identification exist: protein, DNA, and RNA. However, for forensic testing using DNA
is considered to be more accurate (by increasing discriminating power).
DNA testing provides a reproducible means of differentiating one species from another. DNA testing was originally developed using microsatellite
regions that vary within a species, but do not readily change from generation to generation. DNA and RNA tests were further developed using DNA barcoding to differentiate different species of organisms from each other, while ensuring each organism within a species is properly grouped. Thus, using the barcode method, a lab can identify any species of fish, even without their visual characteristics, as long as the fish has previously been sequenced.
“Linking DNA sequences to specimens in museum collections is therefore critical for the success of barcoding. The deposition of voucher
specimens will ensure that all results entered into GenBank or a similar database can be checked and corrected. Voucher specimens are not a
requirement by GenBank today, which is a known problem as errors are frequently discovered in the submissions without any possibility of
checking the original material.”
The FDA, agreeing with the need to insure a vouchered and taxonomically validated reference is used, maintains the requirement that only validly authenticated standards be used to make regulatory decisions. In order to help the industry comply with labeling requirements, FDA has worked with the international research effort The Fish Barcode of Life campaign “FISH-BOL” to catalog the world's fish and make the sequences publicly available. The FDA states, "Once completed, the FISH-BOL database will enable a fast, accurate, and cost-effective system for molecular identification of the world's icthyofauna." But, as of today, because FISH-BOL "is not currently searchable against only vouchered species with authoritative taxonomic identifications" this database cannot currently be used for regulatory compliance testing because "FDA will only make regulatory decisions based on identifications using adequately authenticated standards."
Applied Food Technologies maintains an internal DNA database generated from a collection of economically important seafood specimens, which were taxonomically identified by third-party institutions, such as the Smithsonian and the Florida Museum. These taxonomically validated specimens were sequenced in multiple regions to create a database of unique sequences capable of correctly identifying and distinguishing different seafood species.” Because only species identification testing that compares the sequence to a validated reference meets the current FDA guidelines for species identification, any lab not using a validated reference does not meet the FDA requirement.
(SBIR) Awards totaling approximately $1,000,000.00. AFT was formed in 2003 in Blacksburg
, VA, by LeeAnn Applewhite and Maureen Dolan to be the fee-for-service testing laboratory and manufacturing and marketing arms for APL Science, Inc. AFT has also been awarded several SBIR grants and industry research contracts including most recently a grant to develop a method for species identification for the U.S. shrimp industry.
2002 – Developed and launched the PCR multiplex Authenti-kit(SM) for Crab diagnostic kit for crab species identification.
2004 – Developed and launched the PCR multiplex Authenti-kit(SM) for Catfish diagnostic kit for catfish species identification.
2005 – Began partnering with US Foods after US Foods approached AFT to start a grouper authentication program, following recommendation by NOAA NMFS.
2006 – Collaborated extensively with FDA to create regulatory standards and protocols currently recommended for molecular regulatory compliance testing for species identification.
2007 – AFT’s regulatory testing program expanded to collaborations with multiple state agencies to create state standards and testing programs for species identification testing using Authenti-kit(SM) for Catfish.
2008 – Teamed with FDA to develop the requirements for private laboratory data reports (ORA Laboratory Manual, Section 7) for DNA-barcoding for Import Alert 16-128.
2009 – Initiated substantial research and development program to create DNA mini-barcoding and real-time PCR methods to discriminate closely related species, allowing AFT to distinguish between
2010 - AFT moved operations from Virginia to Alachua, Florida and reincorporated in Florida.
2011 - AFT purchased the assets of EcoArray, Inc., bringing AFT into the environmental arena. AFT currently resides in the Sid Martin Biotechnology Incubator
.
Today, AFT focuses on research and development work, which constitutes a majority of AFT revenues. AFT offers contract research services in its product portfolio. After the acquisition of EcoArray assets, AFT entered into the environmental water testing market. EcoArray’s core proprietary technology offers a comparison of fish gene expression with and without a certain environmental toxin to determine if the toxin is present in the water. AFT is also branching out into species identification testing in a number of new areas.
Alachua, Florida
Alachua is a city in Alachua County, Florida, United States. According to 2006 U.S. Census Bureau estimates, the city's population was 7,554. The city is part of the Gainesville, Florida Metropolitan Statistical Area, which is home to 243,985 people....
, Florida that develops diagnostics needed in the seafood industry and runs fee-for-service species identification and verification programs. The DNA-based species identification diagnostics developed by AFT are used in-house and are also packaged in a kit format and sold to federal, state and private laboratories in the US, Europe and Asia. AFT has established an extensive library of taxonomically verified fish species and has developed DNA standards for these fish.
Applied Food Technologies is primarily a research and development company focusing on fish species identification using DNA and environmental contaminant detection using gene expression in sentinel organisms. AFT also offers a fee-for-service business for seafood species identification.
Applied Food Technologies was showcased on a national broadcast of The Early Show
The Early Show
The Early Show is an American television morning news talk show broadcast by CBS from New York City. The program airs live from 7 to 9 a.m. Eastern Time Monday through Friday; most affiliates in the Central, Mountain, and Pacific time zones air the show on tape-delay from 7 to 9 a.m. local time. ...
on CBS on June 8, 2011 to discuss seafood mislabeling after release of a national publication on the issue by consumer advocate group Oceana
Oceana (non-profit group)
Oceana is the largest international ocean conservation and advocacy organization. Oceana works to protect and restore the world’s oceans through targeted policy campaigns....
and a subsequent New York Times Publication on the subject. Although in business for several years, Applied Food Technologies came to the national attention after becoming the first company with DNA based fish species identification methods recognized by the FDA to test all catfish imported from China in the late 2000s. Applied Food Technologies was subsequently interviewed in May, 2010, by ABC affiliate WCJB-TV. Applied Food Technologies will also be showcased in University of Florida’s Explore Magazine November, 2011 issue.
AFT has been criticized as being "in industry's pocket" because AFT has been a loud voice in support of industry against media reports of mislabeling. AFT claims their internal testing has shown a much lower mislabeling rate than media reports. Although Applied Food Technologies has been included in numerous media reports concerning seafood species mislabeling and has been contacted to conduct testing for the media many times, AFT does not perform species identification testing for the media, which may be the cause of some criticism. AFT's mission statement includes offering a testing service to the seafood industry utilizing the "best available science" for the purpose of improving the industry to better serve the consumer. Typically the media outlets are unable to meet the chain of custody requirements within the "best available science" component, which is one of the principle reasons AFT does not offer testing to the media.
Applied Food Technologies offers fee-for-service business in several areas including fish species identification (also known as Fish ID), seafood net weight, and antibiotic residue testing, which are described in detail below.
History of fish species labeling laws (US)
Proper species identification of fish has been important to consumers since ancient times. The Jewish dietary laws known as kashrutKashrut
Kashrut is the set of Jewish dietary laws. Food in accord with halakha is termed kosher in English, from the Ashkenazi pronunciation of the Hebrew term kashér , meaning "fit" Kashrut (also kashruth or kashrus) is the set of Jewish dietary laws. Food in accord with halakha (Jewish law) is termed...
required the Jews to identify certain types of fish to maintain a kosher diet. Kashrut does not require rabbis to "bless" fish to make it kosher, but rather to identify the features the fish must have to meet kosher requirements (among others) and confirm their existence.
In the 13th century, the King of England passed first law concerning proper labeling requirements, the Assize of Bread and Ale
Assize of Bread and Ale
The Assize of Bread and Ale was a 13th-century statute in late medieval English law, which regulated the price, weight and quality of the bread and beer manufactured and sold in towns, villages and hamlets. This statute is usually attributed to act 51 Hen. III, occurring about 1266–1267. It was...
, regulating weight and quality of bread and ale. These laws were codified in the colonies, being a part of Britain, in some form. For instance, in 1758, the Georgia Legislature passed the Act for Regulating the Assize of Bread requiring bakers to make an identification mark on their bread to show a source of origin, among other rules. Fines were imposed by the statute for lacking this labeling requirement, even if the bread conformed in all other manners.
However, although the United States and each State had adopted the common law
Common law
Common law is law developed by judges through decisions of courts and similar tribunals rather than through legislative statutes or executive branch action...
of Britain, the regulations on bread did not last long in the colonies. Because bakers in the colonies were subject to the free-market forces of supply and demand, unlike the bakers’ monopolies of the Old World, the colonial bakers began to protest the burdens of these laws and they were eventually repealed once independence was declared. One prominent protest in Massachusetts laid out the economic differences of the colonies and the Old World as a plea to remove these requirements. While the gist of these protests focused on the pricing restrictions, some were directed toward the labeling requirement as well.
After just over a century as a nation, the United States began to recognize
Early history of food regulation in the United States
The history of early food regulation in the United States started with the 1906 Pure Food and Drug Act, when the United States federal government began to intervene in the food and drug businesses. When that bill proved ineffective, the administration of President Franklin D. Roosevelt revised it...
, once again, the need to regulate food packaging. In 1898, the Association of Official Agricultural Chemists established a Committee on Food Standards headed by Harvey W. Wiley
Harvey W. Wiley
Harvey Washington Wiley was a noted chemist best known for his leadership in the passage of the landmark Pure Food and Drug Act of 1906 and his subsequent work at the Good Housekeeping Institute laboratories. He was the first commissioner of the US Food and Drug Administration...
and thereafter states began incorporating these standards into their food statutes. In 1900, the Lacey Act
Lacey Act
The Lacey Act of 1900, or more commonly The Lacey Act is a conservation law introduced by Iowa Rep. John F. Lacey. Protecting both plants and wildlife by creating civil and criminal penalties for a wide array of violations, the Act most notably prohibits trade in wildlife, fish, and plants that...
was first passed in the US providing for criminal and civil penalties for transporting certain species of wildlife in commerce. While the Lacey Act was directed toward conservation efforts, the law also created a de facto labeling requirement for certain types of products, such as fish.
The first direct statutory regulation of food labeling did not take effect until January 1, 1907. The 59th Congress of the United States passed, and President Theodore Roosevelt
Theodore Roosevelt
Theodore "Teddy" Roosevelt was the 26th President of the United States . He is noted for his exuberant personality, range of interests and achievements, and his leadership of the Progressive Movement, as well as his "cowboy" persona and robust masculinity...
signed into law, the nation’s first act regulating food and safety, The Pure Food and Drug Act
Pure Food and Drug Act
The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
of 1906 (34 U.S. Stats. 768). The Pure Food and Drug Act, which was initially created to ensure products were labeled correctly, also prohibited interstate commerce of misbranded and adulterated foods. Under this statutory authority, one of the most famous cases was a federal misbranding suit against
United States v. Forty Barrels and Twenty Kegs of Coca-Cola
United States v. Forty Barrels and Twenty Kegs of Coca-Cola, , was a federal suit under which the government unsuccessfully attempted to force the Coca-Cola company to remove caffeine from its product.-Claim:...
Coca-Cola, claiming that “Coca-Cola” was “misbranded” because the product no longer contained “coca” as an ingredient.
However, the 1906 Act had a number of problems. In 1938, the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
(52 US Stat. 1040) was signed into law by Franklin D. Roosevelt
Franklin D. Roosevelt
Franklin Delano Roosevelt , also known by his initials, FDR, was the 32nd President of the United States and a central figure in world events during the mid-20th century, leading the United States during a time of worldwide economic crisis and world war...
replacing or updating most of the 1906 Act. The 1938 Act provides much of the statutory framework that exists today. In 20 chapters, this Act defines food, among other regulated areas, and proper food labeling. For instance, 21 USC § 403, Misbranded Food, states, “A food shall be deemed to be misbranded: (a) (1) If its labeling is false or misleading in any particular… (b) If it is offered for sale under the name of another food.” Seafood is, thus, misbranded if the package claims to contain one species of fish but actually contains another species of fish that would mislead.
Although the 1938 Act provides the structural framework for labeling laws in the United States, statutory updates and additions have been made. For instance, in 1966, Fair Packaging and Labeling Act
Fair Packaging and Labeling Act
The Fair Packaging and Labeling Act is a US law that applies to labels on many consumer products. It requires the label to state:*The identity of the product;*The name and place of business of the manufacturer, packer, or distributor; and...
was passed requiring all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods. The Food Quality Protection Act
Food Quality Protection Act
The Food Quality Protection Act , or H.R.1627, was passed unanimously by Congress in 1996 and was signed into law by former U.S. President Bill Clinton on August 3, 1996...
(FQPA), or H.R.1627, was passed unanimously in 1996 by Congress and signed into law by President Bill Clinton
Bill Clinton
William Jefferson "Bill" Clinton is an American politician who served as the 42nd President of the United States from 1993 to 2001. Inaugurated at age 46, he was the third-youngest president. He took office at the end of the Cold War, and was the first president of the baby boomer generation...
, regulating the use of certain chemicals on commodity foods. All of these laws were enacted for the health, safety and welfare of the consumer.
Federal statutes are usually broad and require Federal agencies or Federal Courts to define the scope, boundaries and definitions of the statutory language. In the case of seafood labeling, the FDA created the Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce. The Guide provides guidance on which types of fish labels would be correct descriptions of certain fish species and which labels would be misleading. The market label for specific species of fish can be found on the FDA’s Seafood List website. The FDA explains the history of how this list evolved:
industry and consumers about acceptable market names for seafood sold in interstate commerce. This advice was consolidated in 1988
when The Fish List was first published by FDA in cooperation with the National Marine Fisheries Service to provide a source of
names that would facilitate consistency and order in the U.S. market place and reduce confusion among consumers. Although The Fish
List had significant success in achieving its goal, its usefulness was limited because it did not include invertebrate species. In
1993, The Fish List was revised to include the acceptable market names for domestic and imported invertebrate species sold in
interstate commerce, and renamed The Seafood List. The Seafood List provides information to assist manufacturers in properly labeling
seafood and to reflect the acceptable market names of new species introduced into the U.S. marketplace."
The list allows multiple different species of certain fish to be marketed under the same market name. For instance, the FDA lists 14 species of fish that can be labeled as "tuna
Tuna
Tuna is a salt water fish from the family Scombridae, mostly in the genus Thunnus. Tuna are fast swimmers, and some species are capable of speeds of . Unlike most fish, which have white flesh, the muscle tissue of tuna ranges from pink to dark red. The red coloration derives from myoglobin, an...
”. The list does not allow, however, common substitutes to be listed as the fish they are commonly substituted as. For instance, escolar
Escolar
The escolar, Lepidocybium flavobrunneum, a species of fish in the family Gempylidae, is found in deep tropical and temperate waters around the world...
, the most common substitute for tuna in retail locations, is not one of the fish legally allowed to be labeled as "tuna." These market names were created both for the safety of the consumer and to prevent economic fraud.
Risks to health, safety, and welfare of the consumer resulting from seafood mislabeling
Mislabeled seafood can create serious health risks, including conditions which may even be fatal. Three common health risks include escolar substitution, CiguateraCiguatera
Ciguatera is a foodborne illness caused by eating certain reef fishes whose flesh is contaminated with toxins originally produced by dinoflagellates such as Gambierdiscus toxicus which lives in tropical and subtropical waters. These dinoflagellates adhere to coral, algae and seaweed, where they are...
toxins, and Scombroid
Scombroid
Scombroid food poisoning is a foodborne illness that results from eating spoiled fish. It is the second most common type of seafood poisoning, second only to ciguatera. However it is often missed because it resembles an allergic reaction...
food poisoning. Mislabeled seafood may also harm pregnant women who are told to avoid certain species of fish during pregnancy. However, according to a recent Congressional Research Service report, seafood mislabeling is widespread. A recent report by the consumer advocacy group Oceana reported that mislabeling can be as high as 70% in certain species of fish, although certain species are more commonly misidentified than others. Health and safety risks occur because consumers are unable to purchase certain seafood products to protect themselves against these risks based on the product label.
Escolar substitution for tuna
Escolar is commonly substituted for tuna in sushi restaurants. Escolar, which is much less expensive than tuna, is a fish with a diet high in wax esters. Since these wax esters are not digestible, these wax esters have a laxative effect in humans. The laxative effect is not merely an inconvenience, but can be very serious. Although not affecting all people, the wax esters are indigestible in humans and to those susceptible can cause constipation, followed by severe oily diarrhea (keriorrhoea), rapid loose bowel movements, with onset 30 minutes to 36 hours after consumption. In fact, the FDA recommends, “Escolar should not be marketed in interstate commerce” and the Hawaiian Legislature is considering legislation to ban escolar for the same reasons. However, multiple studies have shown that a sushi restaurant advertising a “white tuna” is more likely to be selling escolar than any fish allowed to be labeled as “tuna” according to the FDA., In the US, ‘white tuna’ is identified as albacore tuna (Thunnus alalunga) by the US Food and Drug Administration.Ciguatera
A very common foodborne illness in fish is Ciguatera, which is caused by eating certain reef fishes whose flesh is contaminated with toxins. The CDC states the following about Ciguatera:Ciguatera fish poisoning (or ciguatera) is an illness caused by eating fish that contain toxins produced by a marine microalgae called Gambierdiscus toxicus. People who have ciguatera may experience nausea, vomiting, and neurologic symptoms such as tingling fingers or toes. They also may find that cold things feel hot and hot things feel cold. Ciguatera has no cure. Symptoms usually go away in days or weeks but can last for years.
Because the toxins are very heat-resistant, consumers cannot protect themselves by cooking these contaminated fish. When fish are collected from certain areas known to contain these toxins and are mislabeled, consumers may be seriously injured. Although there is a treatment for the disease, the disease is not often properly diagnosed and the treatment is most effective if administered within 72 hours of exposure. Avoiding the species of fish known to contain the disease or avoiding eating fish from locations known to have the disease are the only preventative measures.
Scombroid
Scombroid food poisoning is syndrome resembling an allergic reaction that occurs within a few hours of eating fish contaminated with scombrotoxin. Scombroid poisoning derives its name from the family of fish most commonly associated with the disease, the ScombridaeScombridae
Scombridae is the family of the mackerels, tunas, and bonitos, and thus includes many of the most important and familiar food fishes. The family consists of about 55 species in 15 genera and two subfamilies...
family (tuna
Tuna
Tuna is a salt water fish from the family Scombridae, mostly in the genus Thunnus. Tuna are fast swimmers, and some species are capable of speeds of . Unlike most fish, which have white flesh, the muscle tissue of tuna ranges from pink to dark red. The red coloration derives from myoglobin, an...
, mackerel
Mackerel
Mackerel is a common name applied to a number of different species of fish, mostly, but not exclusively, from the family Scombridae. They may be found in all tropical and temperate seas. Most live offshore in the oceanic environment but a few, like the Spanish mackerel , enter bays and can be...
, skipjack and bonito
Bonito
Bonito is a name given to various species of medium-sized, predatory fish in the Scombridae family. First, bonito most commonly refers to species in the genus Sarda, including the Atlantic bonito and the Pacific bonito ; second, in Japanese cuisine, bonito refers to the skipjack tuna , which, in...
). Fish outside Scombridae have been found to cause scombroid fish poisoning, including mahi mahi, bluefish, marlin, and escolar. When these fish are not refrigerated properly, bacteria can metabolize naturally occurring histamines in these fish to produce scombrotoxin. To prevent illness in these species of fish, ensuring the proper storage conditions of the fish from water to plate is of utmost importance. Freezing, cooking, smoking, curing and/or canning do not destroy Scombroid toxins. Thus, lack of proper species knowledge can make it difficult to ensure proper storage conditions both for suppliers and consumers of fish.
Mercury
Pregnant women are warned against eating certain fish during pregnancy. Most notably, the fish not recommended for consumption during pregnancy are sharkShark
Sharks are a type of fish with a full cartilaginous skeleton and a highly streamlined body. The earliest known sharks date from more than 420 million years ago....
, tilefish
Tilefish
Tilefishes, also known as blanquillo, are mostly small perciform marine fish comprising the family Malacanthidae.They are usually found in sandy areas, especially near coral reefs....
, swordfish
Swordfish
Swordfish , also known as broadbill in some countries, are large, highly migratory, predatory fish characterized by a long, flat bill. They are a popular sport fish of the billfish category, though elusive. Swordfish are elongated, round-bodied, and lose all teeth and scales by adulthood...
, and king mackerel
King mackerel
The king mackerel is a migratory species of mackerel of the western Atlantic Ocean and Gulf of Mexico. It is an important species to both the commercial and recreational fishing industries.-Description:...
. When people eat the types of fish that are high in methylmercury
Methylmercury
Methylmercury is an organometallic cation with the formula . It is a bioaccumulative environmental toxicant.-Structure:...
, it can accumulate in the blood stream over time and may take over a year for the levels to drop significantly. Thus, it may be present in a woman even before she becomes pregnant. Thus, women who are trying to become pregnant should also avoid eating certain types of fish well before they become pregnant. Because these fish can be substituted for other fish, however, consumers may have a difficult time avoiding these species of fish.
Anaphylaxis
Food allergies to fish, unlike most allergies, often begin in adulthood. The greatest risk from fish allergies is anaphylaxisAnaphylaxis
Anaphylaxis is defined as "a serious allergic reaction that is rapid in onset and may cause death". It typically results in a number of symptoms including throat swelling, an itchy rash, and low blood pressure...
, which can cause life-threatening breathing, cardiac, and gastrointestinal symptoms. Pollock
Pollock
Pollock is the common name used for either of the two species of marine fish in the Pollachius genus. Both P. pollachius and P. virens are commonly referred to as pollock. Other names for P...
, salmon
Salmon
Salmon is the common name for several species of fish in the family Salmonidae. Several other fish in the same family are called trout; the difference is often said to be that salmon migrate and trout are resident, but this distinction does not strictly hold true...
, cod
Cod
Cod is the common name for genus Gadus, belonging to the family Gadidae, and is also used in the common name for various other fishes. Cod is a popular food with a mild flavor, low fat content and a dense, flaky white flesh. Cod livers are processed to make cod liver oil, an important source of...
, tuna
Tuna
Tuna is a salt water fish from the family Scombridae, mostly in the genus Thunnus. Tuna are fast swimmers, and some species are capable of speeds of . Unlike most fish, which have white flesh, the muscle tissue of tuna ranges from pink to dark red. The red coloration derives from myoglobin, an...
, snapper
Lutjanidae
Snappers are a family of perciform fish, mainly marine but with some members inhabiting estuaries, feeding in freshwater. Some are important food fish. One of the best known is the red snapper....
, eel
Eel
Eels are an order of fish, which consists of four suborders, 20 families, 111 genera and approximately 800 species. Most eels are predators...
, and tilapia
Tilapia
Tilapia , is the common name for nearly a hundred species of cichlid fish from the tilapiine cichlid tribe. Tilapia inhabit a variety of fresh water habitats, including shallow streams, ponds, rivers and lakes. Historically, they have been of major importance in artisan fishing in Africa and the...
are among the fish that commonly elicit fish allergies. People often determine which fish to which they have allergies and avoid those types of fish. However, with common substitution of certain fish, avoiding certain species of fish can be difficult.
Economic fraud resulting from fish mislabeling
Aside from the numerous health risks that are associated with mislabeled fish, seafood substitution is also a form of economic fraudFraud
In criminal law, a fraud is an intentional deception made for personal gain or to damage another individual; the related adjective is fraudulent. The specific legal definition varies by legal jurisdiction. Fraud is a crime, and also a civil law violation...
. Economic fraud occurs when a lower-priced fish is labeled as a higher priced fish in order to sell the lower-priced fish for a higher price. Once someone within the supply chain sells mislabeled seafood, every company or consumer that purchases the mislabeled seafood is a victim of this economic fraud. In certain species, mislabeling can be quite substantial, such as in a 2007 study of red snapper in sushi restaurants in Chicago, where none of the 14 samples of “red snapper” tested were, in fact, red snapper. In 2008, two high school girls did a study and found that one-fourth of the fish samples with identifiable DNA were mislabeled. In a 2011 two-part study, the Boston Globe tested 183 samples from retailers across the Boston area and found 87 were sold with the wrong species name (48 percent), including 24 of the 26 red snapper samples, mentioning many retailers by name. Less than a week after the Boston Globe report, international consumer advocate group Consumer Reports Magazine released the results of a study they planned to release in their December, 2011, issue which further discussed the extensive amount of mislabeling seen at retail.
Mislabeling is not just occurring in the US. In Canada, a study found 34 of 153 fish samples from grocery stores were mislabeled. In Ireland, scientists found that 28% of cod products in Ireland are mislabeled and 7% are mislabeled in Britain. In a study conducted by the Australian government, 32 of 138 (23%) fish samples were incorrectly labeled. Australia found that food service companies (e.g. restaurants) had the highest level of mislabeling with 24 out of 67 (35.8%) samples mislabeled, 5 out of 44 (11.3%) samples from retailers (e.g. fishmongers, supermarkets) mislabeled and 1 out of 24 (4%) samples from wholesalers were mislabeled. The Australian study makes sense because certain amounts of mislabeling can occur at each step in the distribution process.
Mislabeling was also found in tuna cans in a large European study funded by Greenpeace. In this study, they found 30.3% of the tuna cans displayed a different species in the can than on the label or a mixed species of fish within the cans. However, the Greenpeace study was conducted based on EU labeling rules and would likely have produced a lower mislabeling rate under US law. For instance, Greenpeace considered mixing of two species within a single can to be mislabeling, which may be a violation of EU law. However, in the U.S. while ‘albacore’ must be a specific species of fish, ‘light tuna’ can refer to a few other tuna species that are not albacore. There are numerous differences between European and U.S. law that require knowledge of these laws to ensure proper labeling in both countries.
Mislabeling is most often an economic fraud issue, but sometimes is related to differences in labeling laws around the world. For instance, a recent US Government study estimated that US fishing activities had an estimated 17% bycatch, which is the discarded catch from fishing activities, such as protected species, non-marketable species, etc. A species that may be discarded in the US may be a marketable fish in another nation. Thus, commonly included substitutes may sometimes be species of fish that are caught in the same areas and are legally co-marketed in the country of origin.
The market name for species varies widely from nation to nation as well. The FDA details what types of product descriptions are acceptable in the U.S. and provides a list of what species of fish can be sold under certain market names in the US. However, the same fish can be sold under any number of names around the world. For instance, Patagonian toothfish (Dissostichus eleginoides), also known in the U.S. as Chilean Sea Bass, may be labeled as Merluza negra in Argentina and Uruguay, Bacalao in Chile, Mero in Japan, Légine australe in France, Marlonga-negra in Portugal, and Tandnoting in Sweden. The Chileans were the first to market toothfish commercially in the United States, earning it the name Chilean sea bass, although it is really not a bass and it is not always caught in Chilean waters. Chilean sea bass is a different species type than the sea bass caught in U.S. waters and is not allowed to be labeled as such. Thus, sometimes what might be a proper name in one country is not proper in the US. However, this would still likely be considered economic fraud under US law, even if unintentional, because the US consumer is confused as to the product being sold.
The largest Federal investigation related to economic fraud resulting from seafood mislabeling came after import alert 16-128 was issued. The U.S. Food and Drug Administration held up every Chinese catfish load when it arrived to verify that they were genuine channel catfish (Ictalurus punctatus), rather than other Asian species, such as basa
Basa fish
The basa fish, Pangasius bocourti, is a type of catfish in the family Pangasiidae. Basa are native to the Mekong River Delta in Vietnam and Chao Phraya basin in Thailand. These fish are important food fish with an international market. They are often labeled in North America and Australia as "basa...
, tra
Iridescent shark
The iridescent shark is a species of shark catfish native to the rivers of Southeast Asia. It is found in the Mekong basin as well as the Chao Phraya River, and is heavily cultivated for food there...
, panga
Panga
Panga is the common South African name for Pterogymnus laniarius, a small, ocean-dwelling fish, native to the southeast Atlantic Ocean and southwest Indian Ocean. Alternatively called "torpedo scads", they are cold-blooded with white flesh...
, swai
Iridescent shark
The iridescent shark is a species of shark catfish native to the rivers of Southeast Asia. It is found in the Mekong basin as well as the Chao Phraya River, and is heavily cultivated for food there...
and sutchi. The FDA hired Applied Food Technologies to analyze the DNA of all detained catfish from China.
The species of seafood being sold is not the only form of economic fraud. The label of “wild-caught” fish to describe fish grown in aquaculture would be mislabeling of the fish, even if they were of the same species, because this misleads the consumer.
Illegality of mislabeling
Mislabeling, also known as misbranding under US law, is enforced under several different Federal statutes as well as some state statutes. The Federal statues include: Federal Food, Drug, and Cosmetic Act (FD&C Act), Sec. 403. [21 USC §343] Misbranded Food, Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II), Lacey Act, Fair Packaging and Labeling Act, Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and the Tariff Act of 1930 (19 U.S.C. § 1592), Section 592. A number of U.S. states enforce their own mislabeling laws. Mislabeling is also illegal in the European Union, Australia, and Canada, among others.Voluntary testing by US companies to prevent economic fraud
Testing to identify the species of fish sold in commerce in the US does not appear to be mandatory under US law, but rather facilitates compliance with the law by ensuring the proper species are being sold through a company’s supply chain. For these reasons, some companies have decided to implement voluntary testing programs. For instance, SyscoSYSCO
Sysco Corporation is the global leader in marketing and distributing food products to restaurants, healthcare and educational facilities, hotels and inns, and other foodservice and hospitality businesses...
maintains a "one strike and you're out" policy that ends contracts with fish suppliers that sell wrongly labeled grouper, and US Food Service
US Foods
US Foods is one of the country’s leading foodservice distributors. With nearly $19 billion in annual revenue, US Foods is the 10th largest private company in America. Many of the entities that make up US Foods were founded in the 19th century, including one that sold provisions to travelers...
’s Jorge Hernandez said in an interview, “food testing ensures that the product they're selling is the product they say they're selling”.
Testing of Seafood by FDA to Prevent Mislabeling
The FDA announced on November 3, 2011, that they had begun using DNA methods for testing seafood for species mislabeling.The fraudulent practice of adding glaze as part of the frozen weight of fish
Section 402(b) of the Federal Food Drug and Cosmetic Act (FD&C Act) prohibits the adulteration of food by adding any substance (such as ice glaze) to increase its bulk or weight. Section 403(e)(2) of the FD&C Act and section 4(a)(2) of the Fair Packaging and Labeling Act require food to bear an accurate statement of the net quantity of contents. Overstating the net quantity of contents (such as including the weight of ice glaze) misbrands the products under these sections. Violations of this kind could be criminally prosecuted under the FD&C Act as felonies since they are committed with the intent to defraud or mislead.Antimicrobials in aquaculture
The cells of bacteria (prokaryotes), such as salmonellaSalmonella
Salmonella is a genus of rod-shaped, Gram-negative, non-spore-forming, predominantly motile enterobacteria with diameters around 0.7 to 1.5 µm, lengths from 2 to 5 µm, and flagella which grade in all directions . They are chemoorganotrophs, obtaining their energy from oxidation and reduction...
, differ from those of higher-level organisms (eukaryotes), such as fish. Antibiotics are chemicals designed to either kill or inhibit the growth of pathogenic bacteria while exploiting the differences between prokaryotes and eukaryotes in order to make them relatively harmless in higher-level organisms. Antibiotics are constructed to act in one of three ways: by disrupting cell membranes of bacteria (rendering them unable to regulate themselves), by impeding DNA or protein synthesis, or by hampering the activity of certain enzymes unique to bacteria.
Antibiotics are used in aquaculture
Aquaculture
Aquaculture, also known as aquafarming, is the farming of aquatic organisms such as fish, crustaceans, molluscs and aquatic plants. Aquaculture involves cultivating freshwater and saltwater populations under controlled conditions, and can be contrasted with commercial fishing, which is the...
to treat diseases caused by bacteria. Sometimes the antibiotics are used to treat diseases, but more commonly antibiotics are used to prevent diseases by treating the water or fish before disease occurs. While this prophylactic method of preventing disease is profitable because it prevents loss and allows fish to grow more quickly, there are several downsides.
The overuse of antibiotics can create antibiotic-resistant bacteria. Antibiotic-resistant bacteria can spontaneously arise when selective pressure to survive results in changes to the DNA
DNA
Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...
sequence of a bacteria allowing that bacteria to survive antibiotic treatments. Because some of the same antibiotics are used to treat fish that are used to treat human disease, pathogenic bacteria causing human disease can also become resistant to antibiotics as a result of treatment of fish with antibiotics. For this reason, the overuse of antibiotics in treatment of fish aquaculture (among other agricultural uses) could create public health issues.
The issue has two sides. In some foreign countries, clean water supplies for aquaculture are extremely limited. Untreated animal manure and human waste are used as feed in shrimp farms and tilapia farms in China and Thailand, in addition to the collection of waste products accumulating from inadequate sewage treatment. In order to prevent the spread of bacteria and disease in contaminated water, some foreign fish farms put U.S.-banned antibiotics into their fishmeal. However, because the more stringent growing regulations in the US increase the price of food, imports from nations without these regulations are increasing based on price and profit.
Between 1995 and 2005, the first ten years of the NAFTA-WTO era in the US, seafood imports increased 65 percent and shrimp imports increased 95 percent. Today, 80 percent of American seafood is imported, about half coming from aquaculture. China, Thailand and Vietnam together account for 44 percent of seafood imports into the United States.
The FDA has been testing for chemicals in aquaculture products for over two decades. In November 2005, the testing program for aquaculture drugs was revised to include antibiotics such as chloramphenicol
Chloramphenicol
Chloramphenicol is a bacteriostatic antimicrobial that became available in 1949. It is considered a prototypical broad-spectrum antibiotic, alongside the tetracyclines, and as it is both cheap and easy to manufacture it is frequently found as a drug of choice in the third world.Chloramphenicol is...
, fluoroquinolones, nitrofurans, and quinolones, as well as antimicrobial compounds like malachite green
Malachite green
Malachite green is an organic compound that is used as a dyestuff and has emerged as a controversial agent in aquaculture. Malachite green is traditionally used as a dye for materials such as silk, leather, and paper...
that are not approved for use in aquaculture fish. From October 1, 2006, through May 31, 2007, FDA tested samples of catfish, basa, shrimp
Shrimp
Shrimp are swimming, decapod crustaceans classified in the infraorder Caridea, found widely around the world in both fresh and salt water. Adult shrimp are filter feeding benthic animals living close to the bottom. They can live in schools and can swim rapidly backwards. Shrimp are an important...
, dace, and eel from China, finding twenty-five percent of the samples to contain drug residues. Hearing on “Safety of Chinese Imports”, statement of Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Program before the Senate Committee on Commerce, Science & Transportation, July 18, 2007. See: http://www.fda.gov/NewsEvents/Testimony/ucm110728.htm FDA has approved five different drugs for use in aquaculture as long as the seafood contains less than a mandated maximum residue limit: florfenicol, sulfamerazine, chorionic gonadotropin, oxytetracycline dihydrate, oxytetracycline hydrochloride, as well as a drug combination of sulfadimethoxine and ormetoprim. FDA has approved two drugs—formalin and hydrogen peroxide—for which it has not set a tolerance.
The FDA now enforces regulations in the US requiring testing of certain imported products for antimicrobial agents under Import Alert 16-131. The Import Alert provides that the use of antimicrobials during the various stages of aquaculture, including malachite green, nitrofurans, fluoroquinolones, and gentian violet, may contribute to an increase of antimicrobial resistance in human pathogens and that prolonged exposure to nitrofurans, malachite green, and gentian violet has been shown to have a carcinogenic affect. In a consumer brochure, the FDA describes the reasoning for enforcement under the import alert:
broader import control of all farm-raised catfish, basa, shrimp, dace(related to carp), and eel from China. During targeted sampling,
from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood from China was contaminated with antimicrobial agents
that are not approved for use in the United States. More specifically, the antimicrobials nitrofuran, malachite green, gentian violet,
and flouroquinolones, were detected."
Due to limitations on funding and resources, U.S. Government Accountability Office
Government Accountability Office
The Government Accountability Office is the audit, evaluation, and investigative arm of the United States Congress. It is located in the legislative branch of the United States government.-History:...
states that only 1% of seafood, compared with 2% of all imports, is inspected and only 0.1% of all seafood is tested for antibiotic residue.
Malachite Green
In 1983, the FDA banned the use of malachite green in aquaculture. Toxicity studies have shown that this chemical can have serious toxic side effects. Malachite green is not actually an antibiotic, but has antibiotic properties. Malachite green is somewhat stable within the environment and, therefore, is detectable in fish that were treated with the chemical at some point even after treatment has discontinued. After more stringent testing and inspection by the governments of Western Countries, the use of malachite green began to wane and other drugs began to become more prevalent.Chloramphenicol
While the U.S. has tested farm-raised shrimp for chloramphenicol since 1994, over the last decade the FDA developed a more sensitive testing methodology and changed the levels of detection for chloramphenicol in response to increasing discovery of traces of chloramphenicol in imports. In response to the US discovery of chloramphenicol in imported shrimp and subsequent increased testing sensitivity, the use of this compound in aquaculture began to decrease.Gentian Violet
Gentian violet, also known as crystal violet has antibacterial, antifungal, and antiparasitic properties. This compound was used during the World War I era as a topical antiseptic, but has been replaced in modern times with more modern treatments. The FDA prohibits the use of gentian violet in aquaculture because of numerous studies showing increased risk of certain cancers related to the compound and a showing that the chemical is bioavailable in fish when used in aquaculture.Nitrofurans
Nitrofurans are broad spectrum antibiotics, being effective against Gram-positive and Gram-negative bacteria. In 1991, the FDA withdrew several approved food animal nitrofuran products as a result of research showing nitrofurazone, one of the nitrofurans, can produce mammary tumors in rats and ovarian tumors in mice. The FDA also concluded that some people may be hypersensitive to this product. The FDA states, “Absolutely, no extra-label use of the nitrofurans is permitted in any food animals, including seafood.” The FDA currently detains certain seafood imports without physical examination due to nitrofuran use by the producer.Floroquinolones
Fluoroquinolones have been prohibited from extra-label use in the U.S. and many other parts of the world in aquaculture because of public health concern about the development of such antimicrobial resistance. Chinese authorities have acknowledged permitting the use of fluoroquinolones in aquaculture, even though the use of fluoroquinolones in food animals may increase antibiotic resistance in human pathogens compromising the effectiveness of the use of this critically important class of antibiotics in human medicine. The Chinese government has established a higher maximum residue limit than the US and research in China has shown that the Chinese are effectively meeting the Chinese limits. Because of concerns about the presence of fluoroquinolones in the food supply, not only in aquaculture, but also in foods like honey, the U.S. is continuing to develop methods and strategies to detect illegal residues and prevent their introduction into the U.S. food supply.Species identification testing
Because filleted fish are often visually indistinguishable, having lost their skin, fins, and other identifying marks, molecular methods provide the only means of exact identification of fish. Furthermore, visual taxonomic identificationTaxonomy
Taxonomy is the science of identifying and naming species, and arranging them into a classification. The field of taxonomy, sometimes referred to as "biological taxonomy", revolves around the description and use of taxonomic units, known as taxa...
of specific animal species by those who are not expert taxonomists, even if they are identifying whole animals, is inaccurate and difficult. Three molecular targets to test for species identification exist: protein, DNA, and RNA. However, for forensic testing using DNA
DNA
Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...
is considered to be more accurate (by increasing discriminating power).
DNA testing provides a reproducible means of differentiating one species from another. DNA testing was originally developed using microsatellite
Microsatellite
Microsatellites, also known as Simple Sequence Repeats or short tandem repeats , are repeating sequences of 2-6 base pairs of DNA....
regions that vary within a species, but do not readily change from generation to generation. DNA and RNA tests were further developed using DNA barcoding to differentiate different species of organisms from each other, while ensuring each organism within a species is properly grouped. Thus, using the barcode method, a lab can identify any species of fish, even without their visual characteristics, as long as the fish has previously been sequenced.
Taxonomic validation
In the late 2000s, as DNA sequencing became more accessible, so did the error rate in public DNA databases. As late as 2010, the US General Accounting Office reported, “Public databases seldom use validated fish standards and thus are likely to contain incomplete and/or inaccurate DNA sequences.” The authors of “What can biological barcoding do for marine biology?” explain the reason U.S. Government believes “validated fish standards” are important:specimens will ensure that all results entered into GenBank or a similar database can be checked and corrected. Voucher specimens are not a
requirement by GenBank today, which is a known problem as errors are frequently discovered in the submissions without any possibility of
checking the original material.”
The FDA, agreeing with the need to insure a vouchered and taxonomically validated reference is used, maintains the requirement that only validly authenticated standards be used to make regulatory decisions. In order to help the industry comply with labeling requirements, FDA has worked with the international research effort The Fish Barcode of Life campaign “FISH-BOL” to catalog the world's fish and make the sequences publicly available. The FDA states, "Once completed, the FISH-BOL database will enable a fast, accurate, and cost-effective system for molecular identification of the world's icthyofauna." But, as of today, because FISH-BOL "is not currently searchable against only vouchered species with authoritative taxonomic identifications" this database cannot currently be used for regulatory compliance testing because "FDA will only make regulatory decisions based on identifications using adequately authenticated standards."
Applied Food Technologies maintains an internal DNA database generated from a collection of economically important seafood specimens, which were taxonomically identified by third-party institutions, such as the Smithsonian and the Florida Museum. These taxonomically validated specimens were sequenced in multiple regions to create a database of unique sequences capable of correctly identifying and distinguishing different seafood species.” Because only species identification testing that compares the sequence to a validated reference meets the current FDA guidelines for species identification, any lab not using a validated reference does not meet the FDA requirement.
Purpose for its creation
Even with the plethora of laws and regulations protecting consumers from mislabeling of seafood, enforcing compliance has been challenging because of the unique nature of seafood itself. Unlike cattle, poultry, pork, crops, or other land-based food sources, the “farms” on which wild seafood is grown cannot easily be inspected. LeeAnn Applewhite realized in 2000 that modern technology could be used to solve this problem, was awarded several USDA SBIR research awards to develop the tools, and founded AFT to create a solution.History
Applied Food Technologies CEO, LeeAnn Applewhite, incorporated APL Sciences in 1997 after inventing a seafood test kit and licensing the technology to Neogen Corporation. APL Sciences received five USDA Small Business Innovation ResearchSmall Business Innovation Research
The Small Business Innovation Research program is a United States Government program, coordinated by the Small Business Administration, in which 2.5% of the total extramural research budgets of all federal agencies with extramural research budgets in excess of $100 million are reserved for...
(SBIR) Awards totaling approximately $1,000,000.00. AFT was formed in 2003 in Blacksburg
Blacksburg, Virginia
Blacksburg is an incorporated town located in Montgomery County, Virginia, United States, with a population of 42,620 at the 2010 census. Blacksburg, Christiansburg, and Radford are the three principal jurisdictions of the Blacksburg-Christiansburg-Radford Metropolitan Statistical Area which...
, VA, by LeeAnn Applewhite and Maureen Dolan to be the fee-for-service testing laboratory and manufacturing and marketing arms for APL Science, Inc. AFT has also been awarded several SBIR grants and industry research contracts including most recently a grant to develop a method for species identification for the U.S. shrimp industry.
Milestones
2000 – Started development of DNA-based diagnostics for seafood species identification through USDA SBIR research grant targeted toward the growing national issue of seafood mislabeling.-
- Collaborated with the Seafood Industry to collect fish and shellfish species for taxonomical verification at museums across the country to establish a validated database of reference specimens.
2002 – Developed and launched the PCR multiplex Authenti-kit(SM) for Crab diagnostic kit for crab species identification.
2004 – Developed and launched the PCR multiplex Authenti-kit(SM) for Catfish diagnostic kit for catfish species identification.
2005 – Began partnering with US Foods after US Foods approached AFT to start a grouper authentication program, following recommendation by NOAA NMFS.
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- – Worked with US Foods, FDA, and other Seafood Industry stakeholders to develop an acceptable sampling plan for species identification testing.
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- - AFT began using protein fingerprinting techniques to perform species identification on a larger number of species.
2006 – Collaborated extensively with FDA to create regulatory standards and protocols currently recommended for molecular regulatory compliance testing for species identification.
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- – Authenti-kit(SM) for Catfish becomes the first DNA method accepted for regulatory compliance testing by FDA after FDA approves Authenti-kit(SM) for Catfish for use in regulatory compliance testing under Import Alert 16-128.
2007 – AFT’s regulatory testing program expanded to collaborations with multiple state agencies to create state standards and testing programs for species identification testing using Authenti-kit(SM) for Catfish.
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- – Collaborated with FDA to develop the extraction protocol for DNA-barcoding for fish species identification which later became FDA LIB-4420.
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- – Greatly expanded industry and regulatory testing programs using DNA-barcoding for most fish species outside the Authenti-kit(SM) product line.
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- - AFT began to use DNA techniques exclusively to identify seafood species.
2008 – Teamed with FDA to develop the requirements for private laboratory data reports (ORA Laboratory Manual, Section 7) for DNA-barcoding for Import Alert 16-128.
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- – Began analyzing DNA sequence discrepancies in commonly used databases, such as Genbank and Fish Barcode of Life, to develop definitive secondary tests to differentiate between
- closely related species of commercially important seafood that cannot be distinguished using data from the public databases alone.
2009 – Initiated substantial research and development program to create DNA mini-barcoding and real-time PCR methods to discriminate closely related species, allowing AFT to distinguish between
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- closely related species that are indistinguishable using current DNA-barcoding or public database-related protocols.
2010 - AFT moved operations from Virginia to Alachua, Florida and reincorporated in Florida.
2011 - AFT purchased the assets of EcoArray, Inc., bringing AFT into the environmental arena. AFT currently resides in the Sid Martin Biotechnology Incubator
Sid Martin Biotechnology Incubator
The Sid Martin Biotechnology Incubator is a facility at the University of Florida which has as its mission to meld the latest in research innovation with the marketplace...
.
Today, AFT focuses on research and development work, which constitutes a majority of AFT revenues. AFT offers contract research services in its product portfolio. After the acquisition of EcoArray assets, AFT entered into the environmental water testing market. EcoArray’s core proprietary technology offers a comparison of fish gene expression with and without a certain environmental toxin to determine if the toxin is present in the water. AFT is also branching out into species identification testing in a number of new areas.